US (United States) Code. Title 21. Chapter 9: Federal Food, Drug and Cosmetic Act

Codificación normativa de EEUU (Estados Unidos) Legislación Federal estadounidense # Food and drugs

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  • Idioma: inglés
  • País: Estados Unidos Estados Unidos
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-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part B - Drugs for Rare Diseases or Conditions

-HEAD-

Sec. 360bb. Designation of drugs for rare diseases or conditions

-STATUTE-

(a) Request by sponsor; preconditions; ''rare disease or

condition'' defined

(1) The manufacturer or the sponsor of a drug may request the

Secretary to designate the drug as a drug for a rare disease or

condition. A request for designation of a drug shall be made

before the submission of an application under section 355(b) of

this title for the drug, or the submission of an application for

licensing of the drug under section 262 of title 42. If the

Secretary finds that a drug for which a request is submitted under

this subsection is being or will be investigated for a rare disease

or condition and -

(A) if an application for such drug is approved under section

355 of this title, or

(B) if a license for such drug is issued under section 262 of

title 42,

the approval, certification, or license would be for use for such

disease or condition, the Secretary shall designate the drug as a

drug for such disease or condition. A request for a designation of

a drug under this subsection shall contain the consent of the

applicant to notice being given by the Secretary under subsection

(b) of this section respecting the designation of the drug.

(2) For purposes of paragraph (1), the term ''rare disease or

condition'' means any disease or condition which (A) affects less

than 200,000 persons in the United States, or (B) affects more than

200,000 in the United States and for which there is no reasonable

expectation that the cost of developing and making available in the

United States a drug for such disease or condition will be

recovered from sales in the United States of such drug.

Determinations under the preceding sentence with respect to any

drug shall be made on the basis of the facts and circumstances as

of the date the request for designation of the drug under this

subsection is made.

(b) Notification of discontinuance of drug or application as

condition

A designation of a drug under subsection (a) of this section

shall be subject to the condition that -

(1) if an application was approved for the drug under section

355(b) of this title or a license was issued for the drug under

section 262 of title 42, the manufacturer of the drug will notify

the Secretary of any discontinuance of the production of the drug

at least one year before discontinuance, and

(2) if an application has not been approved for the drug under

section 355(b) of this title or a license has not been issued for

the drug under section 262 of title 42 and if preclinical

investigations or investigations under section 355(i) of this

title are being conducted with the drug, the manufacturer or

sponsor of the drug will notify the Secretary of any decision to

discontinue active pursuit of approval of an application under

section 355(b) of this title or approval of a license under

section 262 of title 42.

(c) Notice to public

Notice respecting the designation of a drug under subsection (a)

of this section shall be made available to the public.

(d) Regulations

The Secretary shall by regulation promulgate procedures for the

implementation of subsection (a) of this section.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 526, as added Pub. L. 97-414, Sec.

2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-551, Sec.

4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec. 3(a)(2),

Aug. 15, 1985, 99 Stat. 387; Pub. L. 100-290, Sec. 2, Apr. 18,

1988, 102 Stat. 90; Pub. L. 105-115, title I, Sec. 125(b)(2)(H),

(I), Nov. 21, 1997, 111 Stat. 2326.)

-MISC1-

AMENDMENTS

1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 125(b)(2)(H), struck

out ''the submission of an application for certification of the

drug under section 357 of this title,'' before ''or the submission

of an application for licensing of the drug'' in introductory

provisions, inserted ''or'' at end of subpar. (A), redesignated

subpar. (C) as (B), and struck out former subpar. (B) which read as

follows: ''if a certification for such drug is issued under section

357 of this title, or''.

Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(I)(i), struck out

'', a certificate was issued for the drug under section 357 of this

title,'' before ''or a license was issued''.

Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(I)(ii), struck

out '', a certificate has not been issued for the drug under

section 357 of this title,'' before ''or a license has not been

issued'' and '', approval of an application for certification under

section 357 of this title,'' before ''or approval of a license''.

1988 - Subsec. (a)(1). Pub. L. 100-290, Sec. 2(a), inserted after

first sentence ''A request for designation of a drug shall be made

before the submission of an application under section 355(b) of

this title for the drug, the submission of an application for

certification of the drug under section 357 of this title, or the

submission of an application for licensing of the drug under

section 262 of title 42.''

Subsecs. (b) to (d). Pub. L. 100-290, Sec. 2(b), added subsec.

(b) and redesignated former subsecs. (b) and (c) as (c) and (d),

respectively.

1985 - Subsec. (a)(1). Pub. L. 99-91 struck out ''or'' at end of

subpar. (A), struck out subpar. (B) and substituted subpars. (B)

and (C), and inserted '', certification,'' after ''approval''.

1984 - Subsec. (a)(2). Pub. L. 98-551 substituted ''which (A)

affects less than 200,000 persons in the United States, or (B)

affects more than 200,000 in the United States and for which'' for

''which occurs so infrequently in the United States that''.

EFFECTIVE DATE OF 1985 AMENDMENT

Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section

8(b) of Pub. L. 99-91, set out as a note under section 360aa of

this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 355a, 360cc, 360dd,

360ee, 379h of this title; title 26 section 45C; title 42 sections

236, 1395l.

-CITE-

21 USC Sec. 360cc 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part B - Drugs for Rare Diseases or Conditions

-HEAD-

Sec. 360cc. Protection for drugs for rare diseases or conditions

-STATUTE-

(a) Exclusive approval, certification, or license

Except as provided in subsection (b) of this section, if the

Secretary -

(1) approves an application filed pursuant to section 355 of

this title, or

(2) issues a license under section 262 of title 42

for a drug designated under section 360bb of this title for a rare

disease or condition, the Secretary may not approve another

application under section 355 of this title or issue another

license under section 262 of title 42 for such drug for such

disease or condition for a person who is not the holder of such

approved application or of such license until the expiration of

seven years from the date of the approval of the approved

application or the issuance of the license. Section 355(c)(2) of

this title does not apply to the refusal to approve an application

under the preceding sentence.

(b) Exceptions

If an application filed pursuant to section 355 of this title is

approved for a drug designated under section 360bb of this title

for a rare disease or condition or if a license is issued under

section 262 of title 42 for such a drug, the Secretary may, during

the seven-year period beginning on the date of the application

approval or of the issuance of the license, approve another

application under section 355 of this title or issue a license

under section 262 of title 42, for such drug for such disease or

condition for a person who is not the holder of such approved

application or of such license if -

(1) the Secretary finds, after providing the holder notice and

opportunity for the submission of views, that in such period the

holder of the approved application or of the license cannot

assure the availability of sufficient quantities of the drug to

meet the needs of persons with the disease or condition for which

the drug was designated; or

(2) such holder provides the Secretary in writing the consent

of such holder for the approval of other applications or the

issuance of other licenses before the expiration of such

seven-year period.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 527, as added Pub. L. 97-414, Sec.

2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-417, title I,

Sec. 102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99-91, Sec.

2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103-80, Sec.

3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, Sec.

125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281,

Sec. 4, Nov. 6, 2002, 116 Stat. 1993.)

-MISC1-

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-281, in concluding provisions,

struck out '', of such certification,'' after ''such approved

application'' and '', the issuance of the certification,'' after

''approval of the approved application''.

1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(J), struck

out '', issue another certification under section 357 of this

title,'' before ''or issue another license'' in closing provisions,

inserted ''or'' at end of par. (1), redesignated par. (3) as (2),

and struck out former par. (2) which read as follows: ''issues a

certification under section 357 of this title, or''.

Subsec. (b). Pub. L. 105-115, Sec. 125(b)(2)(K), in introductory

provisions, struck out '', if a certification is issued under

section 357 of this title for such a drug,'' after ''rare disease

or condition'', '', of the issuance of the certification under

section 357 of this title,'' after ''application approval'', '',

issue another certification under section 357 of this title,''

after ''application under section 355 of this title'', and '', of

such certification,'' after ''approved application''.

Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out

'', of the certification,'' after ''holder of the approved

application''.

Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out

'', issuance of other certifications,'' after ''approval of other

applications''.

1993 - Subsec. (b). Pub. L. 103-80 struck out extraneous comma

before ''or issue a license under section 262'' in introductory

provisions and substituted ''the'' for ''The'' at beginning of par.

(1).

1985 - Pub. L. 99-91, Sec. 2(3), struck out ''unpatented'' before

''drugs'' in section catchline.

Subsec. (a). Pub. L. 99-91, Sec. 2(1), 3(a)(3)(A)-(D), struck out

''or'' at end of par. (1), added par. (2), redesignated former par.

(2) as (3), struck out ''and for which a United States Letter of

Patent may not be issued'' after ''rare disease or condition'',

inserted in first sentence '', issue another certification under

section 357 of this title,'' after ''section 355 of this title''

the second time it appeared, inserted '', of such certification,''

after ''holder of such approved application'', and inserted '', the

issuance of the certification,'' after ''approval of the approved

application''.

Subsec. (b). Pub. L. 99-91, Sec. 2(2), 3(a)(3)(E)-(K), struck out

''and if a United States Letter of Patent may not be issued for the

drug'' after ''such a drug'', substituted '', if a certification is

issued under section 357 of this title for such a drug, or if a

license'' for ''or a license'', inserted '', of the issuance of the

certification under section 357 of this title,'' after

''application approval'', struck out '', if the drug is a

biological product,'' before ''issue a license'', inserted '',

issue another certification under section 357 of this title,''

after ''section 355 of this title'', inserted '', of such

certification,'' after ''holder of such approved application'',

inserted '', of such certification,'' after ''application'' in par.

(1), and inserted '', issuance of other certifications,'' after

''other applications'' in par. (2).

1984 - Subsecs. (a), (b). Pub. L. 98-417 substituted ''section

355'' for ''section 355(b)'' wherever appearing.

EFFECTIVE DATE OF 1985 AMENDMENT

Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section

8(b) of Pub. L. 99-91, set out as a note under section 360aa of

this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 355a of this title.

-CITE-

21 USC Sec. 360dd 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part B - Drugs for Rare Diseases or Conditions

-HEAD-

Sec. 360dd. Open protocols for investigations of drugs for rare

diseases or conditions

-STATUTE-

If a drug is designated under section 360bb of this title as a

drug for a rare disease or condition and if notice of a claimed

exemption under section 355(i) of this title or regulations issued

thereunder is filed for such drug, the Secretary shall encourage

the sponsor of such drug to design protocols for clinical

investigations of the drug which may be conducted under the

exemption to permit the addition to the investigations of persons

with the disease or condition who need the drug to treat the

disease or condition and who cannot be satisfactorily treated by

available alternative drugs.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 528, as added Pub. L. 97-414, Sec.

2(a), Jan. 4, 1983, 96 Stat. 2051.)

-CITE-

21 USC Sec. 360ee 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part B - Drugs for Rare Diseases or Conditions

-HEAD-

Sec. 360ee. Grants and contracts for development of drugs for rare

diseases and conditions

-STATUTE-

(a) Authority of Secretary

The Secretary may make grants to and enter into contracts with

public and private entities and individuals to assist in (1)

defraying the costs of qualified testing expenses incurred in

connection with the development of drugs for rare diseases and

conditions, (2) defraying the costs of developing medical devices

for rare diseases or conditions, and (3) defraying the costs of

developing medical foods for rare diseases or conditions.

(b) Definitions

For purposes of subsection (a) of this section:

(1) The term ''qualified testing'' means -

(A) human clinical testing -

(i) which is carried out under an exemption for a drug for

a rare disease or condition under section 355(i) of this

title (or regulations issued under such section); and

(ii) which occurs after the date such drug is designated

under section 360bb of this title and before the date on

which an application with respect to such drug is submitted

under section 355(b) of this title or under section 262 of

title 42; and

(B) preclinical testing involving a drug for a rare disease

or condition which occurs after the date such drug is

designated under section 360bb of this title and before the

date on which an application with respect to such drug is

submitted under section 355(b) of this title or under section

262 of title 42.

(2) The term ''rare disease or condition'' means (1) in the

case of a drug, any disease or condition which (A) affects less

than 200,000 persons in the United States, or (B) affects more

than 200,000 in the United States and for which there is no

reasonable expectation that the cost of developing and making

available in the United States a drug for such disease or

condition will be recovered from sales in the United States of

such drug, (2) in the case of a medical device, any disease or

condition that occurs so infrequently in the United States that

there is no reasonable expectation that a medical device for such

disease or condition will be developed without assistance under

subsection (a) of this section, and (3) in the case of a medical

food, any disease or condition that occurs so infrequently in the

United States that there is no reasonable expectation that a

medical food for such disease or condition will be developed

without assistance under subsection (a) of this section.

Determinations under the preceding sentence with respect to any

drug shall be made on the basis of the facts and circumstances as

of the date the request for designation of the drug under section

360bb of this title is made.

(3) The term ''medical food'' means a food which is formulated

to be consumed or administered enterally under the supervision of

a physician and which is intended for the specific dietary

management of a disease or condition for which distinctive

nutritional requirements, based on recognized scientific

principles, are established by medical evaluation.

(c) Authorization of appropriations

For grants and contracts under subsection (a) of this section,

there are authorized to be appropriated such sums as already have

been appropriated for fiscal year 2002, and $25,000,000 for each of

the fiscal years 2003 through 2006.

-SOURCE-

(Pub. L. 97-414, Sec. 5, Jan. 4, 1983, 96 Stat. 2056; Pub. L.

98-551, Sec. 4(b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91,

Sec. 5, Aug. 15, 1985, 99 Stat. 391; Pub. L. 100-290, Sec.

3(a)-(c), Apr. 18, 1988, 102 Stat. 90, 91; Pub. L. 105-115, title

I, Sec. 125(b)(2)(N), Nov. 21, 1997, 111 Stat. 2326; Pub. L.

107-281, Sec. 3, Nov. 6, 2002, 116 Stat. 1993.)

-COD-

CODIFICATION

Section was enacted as part of the Orphan Drug Act, and not as

part of the Federal Food, Drug, and Cosmetic Act which comprises

this chapter.

-MISC3-

AMENDMENTS

2002 - Subsec. (c). Pub. L. 107-281 amended subsec. (c)

generally. Prior to amendment, subsec. (c) read as follows: ''For

grants and contracts under subsection (a) of this section there are

authorized to be appropriated $10,000,000 for fiscal year 1988,

$12,000,000 for fiscal year 1989, $14,000,000 for fiscal year

1990.''

1997 - Subsec. (b)(1)(A)(ii), (B). Pub. L. 105-115 struck out

''or 357'' after ''355(b)''.

1988 - Subsec. (a). Pub. L. 100-290, Sec. 3(a)(1), (b)(1),

inserted ''(1)'' after ''assist in'' and added cls. (2) and (3).

Subsec. (b)(2). Pub. L. 100-290, Sec. 3(a)(2), (b)(2), inserted

''(1) in the case of a drug,'' after ''means'', added cls. (2) and

(3), and substituted ''under section 360bb of this title'' for

''under this subsection'' in last sentence.

Subsec. (b)(3). Pub. L. 100-290, Sec. 3(b)(3), added par. (3).

Subsec. (c). Pub. L. 100-290, Sec. 3(c), amended subsec. (c)

generally. Prior to amendment, subsec. (c) read as follows: ''For

grants and contracts under subsection (a) of this section there are

authorized to be appropriated $4,000,000 for fiscal year 1986,

$4,000,000 for fiscal year 1987, and $4,000,000 for fiscal year

1988.''

1985 - Subsec. (a). Pub. L. 99-91, Sec. 5(a)(1), struck out

''clinical'' before ''testing''.

Subsec. (b)(1). Pub. L. 99-91, Sec. 5(a)(2), substituted

provisions defining ''qualified testing'' for provisions defining

''qualified clinical testing''.

Subsec. (c). Pub. L. 99-91, Sec. 5(b), substituted provisions

authorizing appropriations for fiscal years 1986 to 1988, for

provisions authorizing appropriations for fiscal years 1983 and the

two succeeding fiscal years.

1984 - Subsec. (b)(2). Pub. L. 98-551 substituted ''which (A)

affects less than 200,000 persons in the United States, or (B)

affects more than 200,000 in the United States and for which'' for

''which occurs so infrequently in the United States that''.

EFFECTIVE DATE OF 1985 AMENDMENT

Amendment by Pub. L. 99-91 effective Oct. 1, 1985, see section

8(a) of Pub. L. 99-91, set out as a note under section 360aa of

this title.

FINDINGS AND PURPOSES

Pub. L. 107-281, Sec. 2, Nov. 6, 2002, 116 Stat. 1992, provided

that:

''(a) Findings. - Congress makes the following findings:

''(1) Rare diseases and disorders are those which affect small

patient populations, typically populations smaller than 200,000

individuals in the United States. Such diseases and conditions

include Huntington's disease, amyotrophic lateral sclerosis (Lou

Gehrig's disease), Tourette syndrome, Crohn's disease, cystic

fibrosis, cystinosis, and Duchenne muscular dystrophy.

''(2) For many years, the 25,000,000 Americans suffering from

the over 6,000 rare diseases and disorders were denied access to

effective medicines because prescription drug manufacturers could

rarely make a profit from marketing drugs for such small groups

of patients. The prescription drug industry did not adequately

fund research into such treatments. Despite the urgent health

need for these medicines, they came to be known as 'orphan drugs'

because no companies would commercialize them.

''(3) During the 1970s, an organization called the National

Organization for Rare Disorders (NORD) was founded to provide

services and to lobby on behalf of patients with rare diseases

and disorders. NORD was instrumental in pressing Congress for

legislation to encourage the development of orphan drugs.

''(4) The Orphan Drug Act (see Short Title of 1983 Amendments

note set out under section 301 of this title) created financial

incentives for the research and production of such orphan drugs.

New Federal programs at the National Institutes of Health and the

Food and Drug Administration encouraged clinical research and

commercial product development for products that target rare

diseases. An Orphan Products Board was established to promote

the development of drugs and devices for rare diseases or

disorders.

''(5) Before 1983, some 38 orphan drugs had been developed.

Since the enactment of the Orphan Drug Act (Jan. 4, 1983), more

than 220 new orphan drugs have been approved and marketed in the

United States and more than 800 additional drugs are in the

research pipeline.

''(6) Despite the tremendous success of the Orphan Drug Act,

rare diseases and disorders deserve greater emphasis in the

national biomedical research enterprise.

''(7) The Food and Drug Administration supports small clinical

trials through Orphan Products Research Grants. Such grants

embody successful partnerships of government and industry, and

have led to the development of at least 23 drugs and four medical

devices for rare diseases and disorders. Yet the appropriations

in fiscal year 2001 for such grants were less than in fiscal year

1995.

''(b) Purposes. - The purpose of this Act (see Short Title of

2002 Amendments note set out under section 301 of this title) is to

increase the national investment in the development of diagnostics

and treatments for patients with rare diseases and disorders.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 343 of this title; title

42 section 236.

-CITE-

21 USC Part C - Electronic Product Radiation Control 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

.

-HEAD-

Part C - Electronic Product Radiation Control

-COD-

CODIFICATION

This part was classified to subpart 3 (Sec. 263c et seq.) of part

F of subchapter II of chapter 6A of Title 42, The Public Health and

Welfare, prior to its renumbering by Pub. L. 101-629, Sec.

19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L.

103-80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat. 779.

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in title 15 section 2080.

-CITE-

21 USC Sec. 360hh 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360hh. Definitions

-STATUTE-

As used in this part -

(1) the term ''electronic product radiation'' means -

(A) any ionizing or non-ionizing electromagnetic or

particulate radiation, or

(B) any sonic, infrasonic, or ultrasonic wave, which is

emitted from an electronic product as the result of the

operation of an electronic circuit in such product;

(2) the term ''electronic product'' means (A) any manufactured

or assembled product which, when in operation, (i) contains or

acts as part of an electronic circuit and (ii) emits (or in the

absence of effective shielding or other controls would emit)

electronic product radiation, or (B) any manufactured or

assembled article which is intended for use as a component, part,

or accessory of a product described in clause (A) and which when

in operation emits (or in the absence of effective shielding or

other controls would emit) such radiation;

(3) the term ''manufacturer'' means any person engaged in the

business of manufacturing, assembling, or importing of electronic

products;

(4) the term ''commerce'' means (A) commerce between any place

in any State and any place outside thereof; and (B) commerce

wholly within the District of Columbia; and

(5) the term ''State'' includes the District of Columbia, the

Commonwealth of Puerto Rico, the Northern Mariana Islands, the

Virgin Islands, Guam, and American Samoa.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 531, formerly act July 1, 1944, ch.

373, title III, Sec. 531, formerly Sec. 355, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L.

94-484, title IX, Sec. 905(b)(1), Oct. 12, 1976, 90 Stat. 2325;

renumbered Sec. 531 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),

(3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263c of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263c of Title 42,

The Public Health and Welfare, as this section.

1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted ''this

part'' for ''this subpart'' in introductory provisions.

1976 - Par. (5). Pub. L. 94-484 defined ''State'' to include

Northern Mariana Islands.

SHORT TITLE

For short title of Pub. L. 90-602, which enacted provisions now

comprising this part (Sec. 360hh to 360ss), as the ''Radiation

Control for Health and Safety Act of 1968'', see section 1 of Pub.

L. 90-602, set out as a Short Title of 1968 Amendments note under

section 301 of this title.

TRANSFER OF SUBPART; CONSTRUCTION

Section 19(c) of Pub. L. 101-629 provided that: ''The transfer of

subpart 3 of part F of title III of the Public Health Service Act

(42 U.S.C. 263b et seq.) to the Federal Food, Drug, and Cosmetic

Act (this chapter) does not change the application of the

requirements of such subpart and such Act to electronic products

which were in effect on the date of the enactment of this Act (Nov.

28, 1990).''

-CROSS-

DEFINITION OF ''SECRETARY'' AND ''DEPARTMENT''

Section 3 of Pub. L. 90-602, as amended Pub. L. 96-88, title V,

Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: ''As used

in the amendments made by section 2 of this Act (enacting

provisions now comprising sections 360hh to 360ss of this title),

except when otherwise specified, the term 'Secretary' means the

Secretary of Health and Human Services, and the term 'Department'

means the Department of Health and Human Services.''

-MISC7-

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Section 4 of Pub. L. 90-602 provided that: ''The amendments made

by section 2 of this Act (enacting provisions now comprising

sections 360hh to 360ss of this title) shall not be construed as

superseding or limiting the functions, under any other provision of

law, of any officer or agency of the United States.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360kk of this title; title

15 section 2080.

-CITE-

21 USC Sec. 360ii 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360ii. Program of control

-STATUTE-

(a) Establishment

The Secretary shall establish and carry out an electronic product

radiation control program designed to protect the public health and

safety from electronic product radiation. As a part of such

program, he shall -

(1) pursuant to section 360kk of this title, develop and

administer performance standards for electronic products;

(2) plan, conduct, coordinate, and support research,

development, training, and operational activities to minimize the

emissions of and the exposure of people to, unnecessary

electronic product radiation;

(3) maintain liaison with and receive information from other

Federal and State departments and agencies with related

interests, professional organizations, industry, industry and

labor associations, and other organizations on present and future

potential electronic product radiation;

(4) study and evaluate emissions of, and conditions of exposure

to, electronic product radiation and intense magnetic fields;

(5) develop, test, and evaluate the effectiveness of procedures

and techniques for minimizing exposure to electronic product

radiation; and

(6) consult and maintain liaison with the Secretary of

Commerce, the Secretary of Defense, the Secretary of Labor, the

Atomic Energy Commission, and other appropriate Federal

departments and agencies on (A) techniques, equipment, and

programs for testing and evaluating electronic product radiation,

and (B) the development of performance standards pursuant to

section 360kk of this title to control such radiation emissions.

(b) Powers of Secretary

In carrying out the purposes of subsection (a) of this section,

the Secretary is authorized to -

(1)(A) collect and make available, through publications and

other appropriate means, the results of, and other information

concerning, research and studies relating to the nature and

extent of the hazards and control of electronic product

radiation; and (B) make such recommendations relating to such

hazards and control as he considers appropriate;

(2) make grants to public and private agencies, organizations,

and institutions, and to individuals for the purposes stated in

paragraphs (2), (4), and (5) of subsection (a) of this section;

(3) contract with public or private agencies, institutions, and

organizations, and with individuals, without regard to section

3324 of title 31 and section 5 of title 41; and

(4) procure (by negotiation or otherwise) electronic products

for research and testing purposes, and sell or otherwise dispose

of such products.

(c) Record keeping

(1) Each recipient of assistance under this part pursuant to

grants or contracts entered into under other than competitive

bidding procedures shall keep such records as the Secretary shall

prescribe, including records which fully disclose the amount and

disposition by such recipient of the proceeds of such assistance,

the total cost of the project or undertaking in connection with

which such assistance is given or used, and the amount of that

portion of the cost of the project or undertaking supplied by other

sources, and such other records as will facilitate an effective

audit.

(2) The Secretary and the Comptroller General of the United

States, or any of their duly authorized representatives, shall have

access for the purpose of audit and examination to any books,

documents, papers, and records of the recipients that are pertinent

to the grants or contracts entered into under this part under other

than competitive bidding procedures.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 532, formerly act July 1, 1944, ch.

373, title III, Sec. 532, formerly Sec. 356, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered Sec.

532 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(A), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263d of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263d of Title 42,

The Public Health and Welfare, as this section.

1990 - Subsec. (a)(1), (6). Pub. L. 101-629, Sec. 19(a)(2)(A)(i),

substituted ''section 360kk'' for ''section 263f''.

Subsec. (b)(3). Pub. L. 101-629, Sec. 19(a)(2)(A)(ii),

substituted reference to section 3324 of title 31 for reference to

section 3648 of the Revised Statutes (31 U.S.C. 529).

Subsec. (c)(1), (2). Pub. L. 101-629, Sec. 19(a)(1)(B),

substituted ''this part'' for ''this subpart''.

-TRANS-

TRANSFER OF FUNCTIONS

Atomic Energy Commission abolished and functions transferred by

sections 5814 and 5841 of Title 42, The Public Health and Welfare.

See also Transfer of Functions notes set out under those sections.

-MISC5-

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law or any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-CITE-

21 USC Sec. 360jj 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360jj. Studies by Secretary

-STATUTE-

(a) Report to Congress

The Secretary shall conduct the following studies, and shall make

a report or reports of the results of such studies to the Congress

on or before January 1, 1970, and from time to time thereafter as

he may find necessary, together with such recommendations for

legislation as he may deem appropriate:

(1) A study of present State and Federal control of health

hazards from electronic product radiation and other types of

ionizing radiation, which study shall include, but not be limited

to -

(A) control of health hazards from radioactive materials other

than materials regulated under the Atomic Energy Act of 1954 (42

U.S.C. 2011 et seq.);

(B) any gaps and inconsistencies in present controls;

(C) the need for controlling the sale of certain used

electronic products, particularly antiquated X-ray equipment,

without upgrading such products to meet the standards for new

products or separate standards for used products;

(D) measures to assure consistent and effective control of the

aforementioned health hazards;

(E) measures to strengthen radiological health programs of

State governments; and

(F) the feasibility of authorizing the Secretary to enter into

arrangements with individual States or groups of States to define

their respective functions and responsibilities for the control

of electronic product radiation and other ionizing radiation;

(2) A study to determine the necessity for the development of

standards for the use of nonmedical electronic products for

commercial and industrial purposes; and

(3) A study of the development of practicable procedures for the

detection and measurement of electronic product radiation which may

be emitted from electronic products manufactured or imported prior

to the effective date of any applicable standard established

pursuant to this part.

(b) Participation of other Federal agencies

In carrying out these studies, the Secretary shall invite the

participation of other Federal departments and agencies having

related responsibilities and interests, State governments -

particularly those of States which regulate radioactive materials

under section 274 of the Atomic Energy Act of 1954, as amended (42

U.S.C. 2021), and interested professional, labor, and industrial

organizations. Upon request from congressional committees

interested in these studies, the Secretary shall keep these

committees currently informed as to the progress of the studies and

shall permit the committees to send observers to meetings of the

study groups.

(c) Organization of studies and participation

The Secretary or his designee shall organize the studies and the

participation of the invited participants as he deems best. Any

dissent from the findings and recommendations of the Secretary

shall be included in the report if so requested by the dissenter.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 533, formerly act July 1, 1944, ch.

373, title III, Sec. 533, formerly Sec. 357, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered Sec.

533 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov.

28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug.

13, 1993, 107 Stat. 779.)

-REFTEXT-

REFERENCES IN TEXT

The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A),

is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch.

1073, Sec. 1, 68 Stat. 921, and amended, which is classified

generally to chapter 23 (Sec. 2011 et seq.) of Title 42, The Public

Health and Welfare. For complete classification of this Act to the

Code, see Short Title note set out under section 2011 of Title 42

and Tables.

-COD-

CODIFICATION

Section was classified to section 263e of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263e of Title 42,

The Public Health and Welfare, as this section.

1990 - Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B),

substituted ''this part'' for ''this subpart''.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-CITE-

21 USC Sec. 360kk 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360kk. Performance standards for electronic products

-STATUTE-

(a) Promulgation of regulations

(1) The Secretary shall by regulation prescribe performance

standards for electronic products to control the emission of

electronic product radiation from such products if he determines

that such standards are necessary for the protection of the public

health and safety. Such standards may include provisions for the

testing of such products and the measurement of their electronic

product radiation emissions, may require the attachment of warning

signs and labels, and may require the provision of instructions for

the installation, operation, and use of such products. Such

standards may be prescribed from time to time whenever such

determinations are made, but the first of such standards shall be

prescribed prior to January 1, 1970. In the development of such

standards, the Secretary shall consult with Federal and State

departments and agencies having related responsibilities or

interests and with appropriate professional organizations and

interested persons, including representatives of industries and

labor organizations which would be affected by such standards, and

shall give consideration to -

(A) the latest available scientific and medical data in the

field of electronic product radiation;

(B) the standards currently recommended by (i) other Federal

agencies having responsibilities relating to the control and

measurement of electronic product radiation, and (ii) public or

private groups having an expertise in the field of electronic

product radiation;

(C) the reasonableness and technical feasibility of such

standards as applied to a particular electronic product;

(D) the adaptability of such standards to the need for

uniformity and reliability of testing and measuring procedures

and equipment; and

(E) in the case of a component, or accessory described in

paragraph (2)(B) of section 360hh of this title, the performance

of such article in the manufactured or assembled product for

which it is designed.

(2) The Secretary may prescribe different and individual

performance standards, to the extent appropriate and feasible, for

different electronic products so as to recognize their different

operating characteristics and uses.

(3) The performance standards prescribed under this section shall

not apply to any electronic product which is intended solely for

export if (A) such product and the outside of any shipping

container used in the export of such product are labeled or tagged

to show that such product is intended for export, and (B) such

product meets all the applicable requirements of the country to

which such product is intended for export.

(4) The Secretary may by regulation amend or revoke any

performance standard prescribed under this section.

(5) The Secretary may exempt from the provisions of this section

any electronic product intended for use by departments or agencies

of the United States provided such department or agency has

prescribed procurement specifications governing emissions of

electronic product radiation and provided further that such product

is of a type used solely or predominantly by departments or

agencies of the United States.

(b) Administrative procedure

The provisions of subchapter II of chapter 5 of title 5 (relating

to the administrative procedure for rulemaking), and of chapter 7

of title 5 (relating to judicial review), shall apply with respect

to any regulation prescribing, amending, or revoking any standard

prescribed under this section.

(c) Publication in Federal Register

Each regulation prescribing, amending, or revoking a standard

shall specify the date on which it shall take effect which, in the

case of any regulation prescribing, or amending any standard, may

not be sooner than one year or not later than two years after the

date on which such regulation is issued, unless the Secretary

finds, for good cause shown, that an earlier or later effective

date is in the public interest and publishes in the Federal

Register his reason for such finding, in which case such earlier or

later date shall apply.

(d) Judicial review

(1) In a case of actual controversy as to the validity of any

regulation issued under this section prescribing, amending, or

revoking a performance standard, any person who will be adversely

affected by such regulation when it is effective may at any time

prior to the sixtieth day after such regulation is issued file a

petition with the United States court of appeals for the circuit

wherein such person resides or has his principal place of business,

for a judicial review of such regulation. A copy of the petition

shall be forthwith transmitted by the clerk of the court to the

Secretary or other officer designated by him for that purpose. The

Secretary thereupon shall file in the court the record of the

proceedings on which the Secretary based the regulation, as

provided in section 2112 of title 28.

(2) If the petitioner applies to the court for leave to adduce

additional evidence, and shows to the satisfaction of the court

that such additional evidence is material and that there were

reasonable grounds for the failure to adduce such evidence in the

proceeding before the Secretary, the court may order such

additional evidence (and evidence in rebuttal thereof) to be taken

before the Secretary, and to be adduced upon the hearing, in such

manner and upon such terms and conditions as to the court may seem

proper. The Secretary may modify his findings, or make new

findings, by reason of the additional evidence so taken, and he

shall file such modified or new findings, and his recommendations,

if any, for the modification or setting aside of his original

regulation, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1)

of this subsection, the court shall have jurisdiction to review the

regulation in accordance with chapter 7 of title 5 and to grant

appropriate relief as provided in such chapter.

(4) The judgment of the court affirming or setting aside, in

whole or in part, any such regulation of the Secretary shall be

final, subject to review by the Supreme Court of the United States

upon certiorari or certification as provided in section 1254 of

title 28.

(5) Any action instituted under this subsection shall survive,

notwithstanding any change in the person occupying the office of

Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in

addition to and not in substitution for any other remedies provided

by law.

(e) Availability of record

A certified copy of the transcript of the record and

administrative proceedings under this section shall be furnished by

the Secretary to any interested party at his request, and payment

of the costs thereof, and shall be admissible in any criminal,

exclusion of imports, or other proceeding arising under or in

respect of this part irrespective of whether proceedings with

respect to the regulation have previously been initiated or become

final under this section.

(f) Technical Electronic Product Radiation Safety Standards

Committee

(1)(A) The Secretary shall establish a Technical Electronic

Product Radiation Safety Standards Committee (hereafter in this

part referred to as the ''Committee'') which he shall consult

before prescribing any standard under this section. The Committee

shall be appointed by the Secretary, after consultation with public

and private agencies concerned with the technical aspect of

electronic product radiation safety, and shall be composed of

fifteen members each of whom shall be technically qualified by

training and experience in one or more fields of science or

engineering applicable to electronic product radiation safety, as

follows:

(i) Five members shall be selected from governmental agencies,

including State and Federal Governments;

(ii) Five members shall be selected from the affected

industries after consultation with industry representatives; and

(iii) Five members shall be selected from the general public,

of which at least one shall be a representative of organized

labor.

(B) The Committee may propose electronic product radiation safety

standards to the Secretary for his consideration. All proceedings

of the Committee shall be recorded and the record of each such

proceeding shall be available for public inspection.

(2) Payments to members of the Committee who are not officers or

employees of the United States pursuant to subsection (c) of

section 210 of title 42 shall not render members of the Committee

officers or employees of the United States for any purpose.

(g) Review and evaluation

The Secretary shall review and evaluate on a continuing basis

testing programs carried out by industry to assure the adequacy of

safeguards against hazardous electronic product radiation and to

assure that electronic products comply with standards prescribed

under this section.

(h) Product certification

Every manufacturer of an electronic product to which is

applicable a standard in effect under this section shall furnish to

the distributor or dealer at the time of delivery of such product,

in the form of a label or tag permanently affixed to such product

or in such manner as approved by the Secretary, the certification

that such product conforms to all applicable standards under this

section. Such certification shall be based upon a test, in

accordance with such standard, of the individual article to which

it is attached or upon a testing program which is in accord with

good manufacturing practice and which has not been disapproved by

the Secretary (in such manner as he shall prescribe by regulation)

on the grounds that it does not assure the adequacy of safeguards

against hazardous electronic product radiation or that it does not

assure that electronic products comply with the standards

prescribed under this section.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 534, formerly act July 1, 1944, ch.

373, title III, Sec. 534, formerly Sec. 358, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L.

91-515, title VI, Sec. 601(b)(2), (3), Oct. 30, 1970, 84 Stat.

1311; renumbered Sec. 534 and amended Pub. L. 101-629, Sec.

19(a)(1)(B), (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530;

Pub. L. 103-80, Sec. 3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778,

779.)

-COD-

CODIFICATION

Section was classified to section 263f of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80, Sec. 4(a)(2), amended directory language

of Pub. L. 101-629, Sec. 19(a)(4), which renumbered section 263f of

Title 42, The Public Health and Welfare, as this section.

Subsec. (f)(2). Pub. L. 103-80, Sec. 3(w), made technical

amendment to reference to section 210 of title 42 to reflect

correction of corresponding provision of original act.

1990 - Subsec. (a)(1)(E). Pub. L. 101-629, Sec. 19(a)(2)(B),

substituted ''section 360hh'' for ''section 263c''.

Subsecs. (e), (f)(1)(A). Pub. L. 101-629, Sec. 19(a)(1)(B),

substituted ''this part'' for ''this subpart''.

1970 - Subsec. (f)(2). Pub. L. 91-515 struck out provisions

related to payment of compensation and travel expenses of members

of the Committee who are not officers or employees of the United

States, and substituted ''to members of the Committee who are not

officers or employees of the United States pursuant to subsection

(c) of section 210 of title 42'' for ''under this subsection''.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360ii, 360ll, 360mm,

360nn, 360oo, 360pp, 360ss of this title.

-CITE-

21 USC Sec. 360ll 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360ll. Notification of defects in and repair or replacement of

electronic products

-STATUTE-

(a) Notification; exemption

(1) Every manufacturer of electronic products who discovers that

an electronic product produced, assembled, or imported by him has a

defect which relates to the safety of use of such product by reason

of the emission of electronic product radiation, or that an

electronic product produced, assembled, or imported by him on or

after the effective date of an applicable standard prescribed

pursuant to section 360kk of this title fails to comply with such

standard, shall immediately notify the Secretary of such defect or

failure to comply if such product has left the place of manufacture

and shall (except as authorized by paragraph (2)) with reasonable

promptness furnish notification of such defect or failure to the

persons (where known to the manufacturer) specified in subsection

(b) of this section.

(2) If, in the opinion of such manufacturer, the defect or

failure to comply is not such as to create a significant risk of

injury, including genetic injury, to any person, he may, at the

time of giving notice to the Secretary of such defect or failure to

comply, apply to the Secretary for an exemption from the

requirement of notice to the persons specified in subsection (b) of

this section. If such application states reasonable grounds for

such exemption, the Secretary shall afford such manufacturer an

opportunity to present his views and evidence in support of the

application, the burden of proof being on the manufacturer. If,

after such presentation, the Secretary is satisfied that such

defect or failure to comply is not such as to create a significant

risk of injury, including genetic injury, to any person, he shall

exempt such manufacturer from the requirement of notice to the

persons specified in subsection (b) of this section and from the

requirements of repair or replacement imposed by subsection (f) of

this section.

(b) Method of notification

The notification (other than to the Secretary) required by

paragraph (1) of subsection (a) of this section shall be

accomplished -

(1) by certified mail to the first purchaser of such product

for purposes other than resale, and to any subsequent transferee

of such product; and

(2) by certified mail or other more expeditious means to the

dealers or distributors of such manufacturer to whom such product

was delivered.

(c) Requisite elements of notification

The notifications required by paragraph (1) of subsection (a) of

this section shall contain a clear description of such defect or

failure to comply with an applicable standard, an evaluation of the

hazard reasonably related to such defect or failure to comply, and

a statement of the measures to be taken to repair such defect. In

the case of a notification to a person referred to in subsection

(b) of this section, the notification shall also advise the person

of his rights under subsection (f) of this section.

(d) Copies to Secretary of communications by manufacturers to

dealers or distributors regarding defects

Every manufacturer of electronic products shall furnish to the

Secretary a true or representative copy of all notices, bulletins,

and other communications to the dealers or distributors of such

manufacturer or to purchasers (or subsequent transferees) of

electronic products of such manufacturer regarding any such defect

in such product or any such failure to comply with a standard

applicable to such product. The Secretary shall disclose to the

public so much of the information contained in such notice or other

information obtained under section 360nn of this title as he deems

will assist in carrying out the purposes of this part, but he shall

not disclose any information which contains or relates to a trade

secret or other matter referred to in section 1905 of title 18

unless he determines that it is necessary to carry out the purposes

of this part.

(e) Notice from Secretary to manufacturer of defects or failure to

comply with standards

If through testing, inspection, investigation, or research

carried out pursuant to this part, or examination of reports

submitted pursuant to section 360nn of this title, or otherwise,

the Secretary determines that any electronic product -

(1) does not comply with an applicable standard prescribed

pursuant to section 360kk of this title; or

(2) contains a defect which relates to the safety of use of

such product by reason of the emission of electronic product

radiation;

he shall immediately notify the manufacturer of such product of

such defect or failure to comply. The notice shall contain the

findings of the Secretary and shall include all information upon

which the findings are based. The Secretary shall afford such

manufacturer an opportunity to present his views and evidence in

support thereof, to establish that there is no failure of

compliance or that the alleged defect does not exist or does not

relate to safety of use of the product by reason of the emission of

such radiation hazard. If after such presentation by the

manufacturer the Secretary determines that such product does not

comply with an applicable standard prescribed pursuant to section

360kk of this title, or that it contains a defect which relates to

the safety of use of such product by reason of the emission of

electronic product radiation, the Secretary shall direct the

manufacturer to furnish the notification specified in subsection

(c) of this section to the persons specified in paragraphs (1) and

(2) of subsection (b) of this section (where known to the

manufacturer), unless the manufacturer has applied for an exemption

from the requirement of such notification on the ground specified

in paragraph (2) of subsection (a) of this section and the

Secretary is satisfied that such noncompliance or defect is not

such as to create a significant risk of injury, including genetic

injury, to any person.

(f) Correction of defects

If any electronic product is found under subsection (a) or (e) of

this section to fail to comply with an applicable standard

prescribed under this part or to have a defect which relates to the

safety of use of such product, and the notification specified in

subsection (c) of this section is required to be furnished on

account of such failure or defect, the manufacturer of such product

shall (1) without charge, bring such product into conformity with

such standard or remedy such defect and provide reimbursement for

any expenses for transportation of such product incurred in

connection with having such product brought into conformity or

having such defect remedied, (2) replace such product with a like

or equivalent product which complies with each applicable standard

prescribed under this part and which has no defect relating to the

safety of its use, or (3) make a refund of the cost of such

product. The manufacturer shall take the action required by this

subsection in such manner, and with respect to such persons, as the

Secretary by regulations shall prescribe.

(g) Effective date

This section shall not apply to any electronic product that was

manufactured before October 18, 1968.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 535, formerly act July 1, 1944, ch.

373, title III, Sec. 535, formerly Sec. 359, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered Sec.

535 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263g of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263g of Title 42,

The Public Health and Welfare, as this section.

1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(C)(i),

substituted ''section 360kk'' for ''section 263f''.

Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C)(ii),

substituted ''section 360nn'' for ''section 263i'' and ''this

part'' for ''this subpart'' in two places.

Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C),

substituted ''this part'' for ''this subpart'' and ''section

360nn'' for ''section 263i'' in introductory provisions and

''section 360kk'' for ''section 263f'' in par. (1) and concluding

provisions.

Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted

''this part'' for ''this subpart'' in two places.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360nn, 360oo of this

title.

-CITE-

21 USC Sec. 360mm 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360mm. Imports

-STATUTE-

(a) Refusal of admission to noncomplying electronic products

Any electronic product offered for importation into the United

States which fails to comply with an applicable standard prescribed

under this part, or to which is not affixed a certification in the

form of a label or tag in conformity with section 360kk(h) of this

title shall be refused admission into the United States. The

Secretary of the Treasury shall deliver to the Secretary of Health

and Human Services, upon the latter's request, samples of

electronic products which are being imported or offered for import

into the United States, giving notice thereof to the owner or

consignee, who may have a hearing before the Secretary of Health

and Human Services. If it appears from an examination of such

samples or otherwise that any electronic product fails to comply

with applicable standards prescribed pursuant to section 360kk of

this title, then, unless subsection (b) of this section applies and

is complied with, (1) such electronic product shall be refused

admission, and (2) the Secretary of the Treasury shall cause the

destruction of such electronic product unless such article is

exported, under regulations prescribed by the Secretary of the

Treasury, within 90 days after the date of notice of refusal of

admission or within such additional time as may be permitted by

such regulations.

(b) Bond

If it appears to the Secretary of Health and Human Services that

any electronic product refused admission pursuant to subsection (a)

of this section can be brought into compliance with applicable

standards prescribed pursuant to section 360kk of this title, final

determination as to admission of such electronic product may be

deferred upon filing of timely written application by the owner or

consignee and the execution by him of a good and sufficient bond

providing for the payment of such liquidated damages in the event

of default as the Secretary of Health and Human Services may by

regulation prescribe. If such application is filed and such bond

is executed the Secretary of Health and Human Services may, in

accordance with rules prescribed by him, permit the applicant to

perform such operations with respect to such electronic product as

may be specified in the notice of permission.

(c) Liability of owner or consignee for expenses connected with

refusal of admission

All expenses (including travel, per diem or subsistence, and

salaries of officers or employees of the United States) in

connection with the destruction provided for in subsection (a) of

this section and the supervision of operations provided for in

subsection (b) of this section, and all expenses in connection with

the storage, cartage, or labor with respect to any electronic

product refused admission pursuant to subsection (a) of this

section, shall be paid by the owner or consignee, and, in event of

default, shall constitute a lien against any future importations

made by such owner or consignee.

(d) Designation of agent for purposes of service

It shall be the duty of every manufacturer offering an electronic

product for importation into the United States to designate in

writing an agent upon whom service of all administrative and

judicial processes, notices, orders, decisions, and requirements

may be made for and on behalf of said manufacturer, and to file

such designation with the Secretary, which designation may from

time to time be changed by like writing, similarly filed. Service

of all administrative and judicial processes, notices, orders,

decisions, and requirements may be made upon said manufacturer by

service upon such designated agent at his office or usual place of

residence with like effect as if made personally upon said

manufacturer, and in default of such designation of such agent,

service of process, notice, order, requirement, or decision in any

proceeding before the Secretary or in any judicial proceeding for

enforcement of this part or any standards prescribed pursuant to

this part may be made by posting such process, notice, order,

requirement, or decision in the Office of the Secretary or in a

place designated by him by regulation.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 536, formerly act July 1, 1944, ch.

373, title III, Sec. 536, formerly Sec. 360, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered Sec.

536 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102-300, Sec.

6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263h of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263h of Title 42,

The Public Health and Welfare, as this section.

1992 - Subsecs. (a), (b). Pub. L. 102-300 substituted ''Health

and Human Services'' for ''Health, Education, and Welfare''

wherever appearing.

1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D),

substituted ''this part'' for ''this subpart'', ''section

360kk(h)'' for ''section 263f(h)'', and ''section 360kk'' for

''section 263f''.

Subsec. (b). Pub. L. 101-629, Sec. 19(a)(2)(D), substituted

''section 360kk'' for ''section 263f''.

Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted

''this part'' for ''this subpart'' in two places.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-CITE-

21 USC Sec. 360nn 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360nn. Inspection, records, and reports

-STATUTE-

(a) Inspection of premises

If the Secretary finds for good cause that the methods, tests, or

programs related to electronic product radiation safety in a

particular factory, warehouse, or establishment in which electronic

products are manufactured or held, may not be adequate or reliable,

officers or employees duly designated by the Secretary, upon

presenting appropriate credentials and a written notice to the

owner, operator, or agent in charge, are thereafter authorized (1)

to enter, at reasonable times, any area in such factory, warehouse,

or establishment in which the manufacturer's tests (or testing

programs) required by section 360kk(h) of this title are carried

out, and (2) to inspect, at reasonable times and within reasonable

limits and in a reasonable manner, the facilities and procedures

within such area which are related to electronic product radiation

safety. Each such inspection shall be commenced and completed with

reasonable promptness. In addition to other grounds upon which

good cause may be found for purposes of this subsection, good cause

will be considered to exist in any case where the manufacturer has

introduced into commerce any electronic product which does not

comply with an applicable standard prescribed under this part and

with respect to which no exemption from the notification

requirements has been granted by the Secretary under section

360ll(a)(2) or 360ll(e) of this title.

(b) Record keeping

Every manufacturer of electronic products shall establish and

maintain such records (including testing records), make such

reports, and provide such information, as the Secretary may

reasonably require to enable him to determine whether such

manufacturer has acted or is acting in compliance with this part

and standards prescribed pursuant to this part and shall, upon

request of an officer or employee duly designated by the Secretary,

permit such officer or employee to inspect appropriate books,

papers, records, and documents relevant to determining whether such

manufacturer has acted or is acting in compliance with standards

prescribed pursuant to this part.

(c) Disclosure of technical data

Every manufacturer of electronic products shall provide to the

Secretary such performance data and other technical data related to

safety as may be required to carry out the purposes of this part.

The Secretary is authorized to require the manufacturer to give

such notification of such performance and technical data at the

time of original purchase to the ultimate purchaser of the

electronic product, as he determines necessary to carry out the

purposes of this part after consulting with the affected industry.

(d) Public nature of reports

Accident and investigation reports made under this part by any

officer, employee, or agent of the Secretary shall be available for

use in any civil, criminal, or other judicial proceeding arising

out of such accident. Any such officer, employee, or agent may be

required to testify in such proceedings as to the facts developed

in such investigations. Any such report shall be made available to

the public in a manner which need not identify individuals. All

reports on research projects, demonstration projects, and other

related activities shall be public information.

(e) Trade secrets

The Secretary or his representative shall not disclose any

information reported to or otherwise obtained by him, pursuant to

subsection (a) or (b) of this section, which concerns any

information which contains or relates to a trade secret or other

matter referred to in section 1905 of title 18, except that such

information may be disclosed to other officers or employees of the

Department and of other agencies concerned with carrying out this

part or when relevant in any proceeding under this part. Nothing

in this section shall authorize the withholding of information by

the Secretary, or by any officers or employees under his control,

from the duly authorized committees of the Congress.

(f) Information required to identify and locate first purchasers of

electronic products

The Secretary may by regulation (1) require dealers and

distributors of electronic products, to which there are applicable

standards prescribed under this part and the retail prices of which

is not less than $50, to furnish manufacturers of such products

such information as may be necessary to identify and locate, for

purposes of section 360ll of this title, the first purchasers of

such products for purposes other than resale, and (2) require

manufacturers to preserve such information. Any regulation

establishing a requirement pursuant to clause (1) of the preceding

sentence shall (A) authorize such dealers and distributors to

elect, in lieu of immediately furnishing such information to the

manufacturer, to hold and preserve such information until advised

by the manufacturer or Secretary that such information is needed by

the manufacturer for purposes of section 360ll of this title, and

(B) provide that the dealer or distributor shall, upon making such

election, give prompt notice of such election (together with

information identifying the notifier and the product) to the

manufacturer and shall, when advised by the manufacturer or

Secretary, of the need therefor for the purposes of section 360ll

of this title, immediately furnish the manufacturer with the

required information. If a dealer or distributor discontinues the

dealing in or distribution of electronic products, he shall turn

the information over to the manufacturer. Any manufacturer

receiving information pursuant to this subsection concerning first

purchasers of products for purposes other than resale shall treat

it as confidential and may use it only if necessary for the purpose

of notifying persons pursuant to section 360ll(a) of this title.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 537, formerly act July 1, 1944, ch.

373, title III, Sec. 537, formerly Sec. 360A, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered Sec.

537 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263i of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263i of Title 42,

The Public Health and Welfare, as this section.

1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E),

substituted ''section 360kk(h)'' for ''section 263f(h)'', ''this

part'' for ''this subpart'', and ''section 360ll(a)(2) or

360ll(e)'' for ''section 263g(a)(2) or 263g(e)''.

Subsecs. (b) to (e). Pub. L. 101-629, Sec. 19(a)(1)(B),

substituted ''this part'' for ''this subpart'' wherever appearing.

Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E)(ii),

substituted ''this part'' for ''this subpart'', ''section 360ll''

for ''section 263g'' in three places, and ''section 360ll(a)'' for

''section 263g(a)''.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360ll, 360oo of this

title.

-CITE-

21 USC Sec. 360oo 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360oo. Prohibited acts

-STATUTE-

(a) It shall be unlawful -

(1) for any manufacturer to introduce, or to deliver for

introduction, into commerce, or to import into the United States,

any electronic product which does not comply with an applicable

standard prescribed pursuant to section 360kk of this title;

(2) for any person to fail to furnish any notification or other

material or information required by section 360ll or 360nn of

this title; or to fail to comply with the requirements of section

360ll(f) of this title;

(3) for any person to fail or to refuse to establish or

maintain records required by this part or to permit access by the

Secretary or any of his duly authorized representatives to, or

the copying of, such records, or to permit entry or inspection,

as required by or pursuant to section 360nn of this title;

(4) for any person to fail or to refuse to make any report

required pursuant to section 360nn(b) of this title or to furnish

or preserve any information required pursuant to section 360nn(f)

of this title; or

(5) for any person (A) to fail to issue a certification as

required by section 360kk(h) of this title, or (B) to issue such

a certification when such certification is not based upon a test

or testing program meeting the requirements of section 360kk(h)

of this title or when the issuer, in the exercise of due care,

would have reason to know that such certification is false or

misleading in a material respect.

(b) The Secretary may exempt any electronic product, or class

thereof, from all or part of subsection (a) of this section, upon

such conditions as he may find necessary to protect the public

health or welfare, for the purpose of research, investigations,

studies, demonstrations, or training, or for reasons of national

security.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 538, formerly act July 1, 1944, ch.

373, title III, Sec. 538, formerly Sec. 360B, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec.

538 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263j of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263j of Title 42,

The Public Health and Welfare, as this section.

1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(F)(i),

substituted ''section 360kk'' for ''section 263f''.

Subsec. (a)(2). Pub. L. 101-629, Sec. 19(a)(2)(F)(ii), (iii),

substituted ''section 360ll or 360nn'' for ''section 263g or 263i''

and ''section 360ll(f)'' for ''section 263g(f)''.

Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F)(iii),

substituted ''this part'' for ''this subpart'' and ''section

360nn'' for ''section 263i''.

Subsec. (a)(4). Pub. L. 101-629, Sec. 19(a)(2)(F)(iii),

substituted ''section 360nn(b)'' for ''section 263i(b)'' and

''section 360nn(f)'' for ''section 263i(f)''.

Subsec. (a)(5). Pub. L. 101-629, Sec. 19(a)(2)(F)(i), substituted

''section 360kk(h)'' for ''section 263f(h)'' in two places.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360pp of this title.

-CITE-

21 USC Sec. 360pp 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360pp. Enforcement

-STATUTE-

(a) Jurisdiction of courts

The district courts of the United States shall have jurisdiction,

for cause shown, to restrain violations of section 360oo of this

title and to restrain dealers and distributors of electronic

products from selling or otherwise disposing of electronic products

which do not conform to an applicable standard prescribed pursuant

to section 360kk of this title except when such products are

disposed of by returning them to the distributor or manufacturer

from whom they were obtained. The district courts of the United

States shall also have jurisdiction in accordance with section 1355

of title 28 to enforce the provisions of subsection (b) of this

section.

(b) Penalties

(1) Any person who violates section 360oo of this title shall be

subject to a civil penalty of not more than $1,000. For purposes of

this subsection, any such violation shall with respect to each

electronic product involved, or with respect to each act or

omission made unlawful by section 360oo of this title, constitute a

separate violation, except that the maximum civil penalty imposed

on any person under this subsection for any related series of

violations shall not exceed $300,000.

(2) Any such civil penalty may on application be remitted or

mitigated by the Secretary. In determining the amount of such

penalty, or whether it should be remitted or mitigated and in what

amount, the appropriateness of such penalty to the size of the

business of the person charged and the gravity of the violation

shall be considered. The amount of such penalty, when finally

determined, may be deducted from any sums owing by the United

States to the person charged.

(c) Venue; process

Actions under subsections (a) and (b) of this section may be

brought in the district court of the United States for the district

wherein any act or omission or transaction constituting the

violation occurred, or in such court for the district where the

defendant is found or transacts business, and process in such cases

may be served in any other district of which the defendant is an

inhabitant or wherever the defendant may be found.

(d) Warnings

Nothing in this part shall be construed as requiring the

Secretary to report for the institution of proceedings minor

violations of this part whenever he believes that the public

interest will be adequately served by a suitable written notice or

warning.

(e) Compliance with regulations

Except as provided in the first sentence of section 360ss of this

title, compliance with this part or any regulations issued

thereunder shall not relieve any person from liability at common

law or under statutory law.

(f) Additional remedies

The remedies provided for in this part shall be in addition to

and not in substitution for any other remedies provided by law.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 539, formerly act July 1, 1944, ch.

373, title III, Sec. 539, formerly Sec. 360C, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec.

539 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263k of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263k of Title 42,

The Public Health and Welfare, as this section.

1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(2)(G)(i), (ii),

substituted ''section 360oo'' for ''section 263j'' and ''section

360kk'' for ''section 263f''.

Subsec. (b)(1). Pub. L. 101-629, Sec. 19(a)(2)(G)(ii),

substituted ''section 360oo'' for ''section 263j'' in two places.

Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted

''this part'' for ''this subpart'' in two places.

Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G)(iii),

substituted ''section 360ss'' for ''section 263n'' and ''this

part'' for ''this subpart''.

Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted

''this part'' for ''this subpart''.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-CITE-

21 USC Sec. 360qq 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360qq. Repealed. Pub. L. 105-362, title VI, Sec. 601(a)(2)(A),

Nov. 10, 1998, 112 Stat. 3285

-MISC1-

Section, act June 25, 1938, ch. 675, Sec. 540, formerly act July

1, 1944, ch. 373, title III, Sec. 540, formerly Sec. 360D, as added

Pub. L. 90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1185; renumbered

Sec. 540 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4),

Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),

Aug. 13, 1993, 107 Stat. 779, related to annual report on

administration of electronic product radiation control program.

-CITE-

21 USC Sec. 360rr 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360rr. Federal-State cooperation

-STATUTE-

The Secretary is authorized (1) to accept from State and local

authorities engaged in activities related to health or safety or

consumer protection, on a reimbursable basis or otherwise, any

assistance in the administration and enforcement of this part which

he may request and which they may be able and willing to provide

and, if so agreed, may pay in advance or otherwise for the

reasonable cost of such assistance, and (2) he may, for the purpose

of conducting examinations, investigations, and inspections,

commission any officer or employee of any such authority as an

officer of the Department.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 541, formerly act July 1, 1944, ch.

373, title III, Sec. 541, formerly Sec. 360E, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec.

541 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov.

28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug.

13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263m of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263m of Title 42,

The Public Health and Welfare, as this section.

1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted ''this

part'' for ''this subpart''.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-CITE-

21 USC Sec. 360ss 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part C - Electronic Product Radiation Control

-HEAD-

Sec. 360ss. State standards

-STATUTE-

Whenever any standard prescribed pursuant to section 360kk of

this title with respect to an aspect of performance of an

electronic product is in effect, no State or political subdivision

of a State shall have any authority either to establish, or to

continue in effect, any standard which is applicable to the same

aspect of performance of such product and which is not identical to

the Federal standard. Nothing in this part shall be construed to

prevent the Federal Government or the government of any State or

political subdivision thereof from establishing a requirement with

respect to emission of radiation from electronic products procured

for its own use if such requirement imposes a more restrictive

standard than that required to comply with the otherwise applicable

Federal standard.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 542, formerly act July 1, 1944, ch.

373, title III, Sec. 542, formerly Sec. 360F, as added Pub. L.

90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec.

542 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), (3),

(4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.

4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was classified to section 263n of Title 42, The Public

Health and Welfare, prior to renumbering by Pub. L. 101-629.

-MISC3-

AMENDMENTS

1993 - Pub. L. 103-80 amended directory language of Pub. L.

101-629, Sec. 19(a)(4), which renumbered section 263n of Title 42,

The Public Health and Welfare, as this section.

1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), substituted

''section 360kk'' for ''section 263f'' and ''this part'' for ''this

subpart''.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES

Enactment of this section not to be construed to supersede or

limit the functions under any other provision of law of any officer

or agency of the United States, see section 4 of Pub. L. 90-602,

set out as a note under section 360hh of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360pp of this title.

-CITE-

21 USC Part D - Dissemination of Treatment Information 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

.

-HEAD-

Part D - Dissemination of Treatment Information

-MISC1-

TERMINATION OF PART

For termination of part by section 401(e) of Pub. L. 105-115,

see Effective and Termination Dates note set out under section

360aaa of this title.

-CITE-

21 USC Sec. 360aaa 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa. Requirements for dissemination of treatment

information on drugs or devices

-STATUTE-

(a) In general

Notwithstanding sections 331(d), 352(f), and 355 of this title,

and section 262 of title 42, a manufacturer may disseminate to -

(1) a health care practitioner;

(2) a pharmacy benefit manager;

(3) a health insurance issuer;

(4) a group health plan; or

(5) a Federal or State governmental agency;

written information concerning the safety, effectiveness, or

benefit of a use not described in the approved labeling of a drug

or device if the manufacturer meets the requirements of subsection

(b) of this section.

(b) Specific requirements

A manufacturer may disseminate information under subsection (a)

of this section on a new use only if -

(1)(A) in the case of a drug, there is in effect for the drug

an application filed under subsection (b) or (j) of section 355

of this title or a biologics license issued under section 262 of

title 42; or

(B) in the case of a device, the device is being commercially

distributed in accordance with a regulation under subsection (d)

or (e) of section 360c of this title, an order under subsection

(f) of such section, or the approval of an application under

section 360e of this title;

(2) the information meets the requirements of section 360aaa-1

of this title;

(3) the information to be disseminated is not derived from

clinical research conducted by another manufacturer or if it was

derived from research conducted by another manufacturer, the

manufacturer disseminating the information has the permission of

such other manufacturer to make the dissemination;

(4) the manufacturer has, 60 days before such dissemination,

submitted to the Secretary -

(A) a copy of the information to be disseminated; and

(B) any clinical trial information the manufacturer has

relating to the safety or effectiveness of the new use, any

reports of clinical experience pertinent to the safety of the

new use, and a summary of such information;

(5) the manufacturer has complied with the requirements of

section 360aaa-3 of this title (relating to a supplemental

application for such use);

(6) the manufacturer includes along with the information to be

disseminated under this subsection -

(A) a prominently displayed statement that discloses -

(i) that the information concerns a use of a drug or device

that has not been approved or cleared by the Food and Drug

Administration;

(ii) if applicable, that the information is being

disseminated at the expense of the manufacturer;

(iii) if applicable, the name of any authors of the

information who are employees of, consultants to, or have

received compensation from, the manufacturer, or who have a

significant financial interest in the manufacturer;

(iv) the official labeling for the drug or device and all

updates with respect to the labeling;

(v) if applicable, a statement that there are products or

treatments that have been approved or cleared for the use

that is the subject of the information being disseminated

pursuant to subsection (a)(1) of this section; and

(vi) the identification of any person that has provided

funding for the conduct of a study relating to the new use of

a drug or device for which such information is being

disseminated; and

(B) a bibliography of other articles from a scientific

reference publication or scientific or medical journal that

have been previously published about the use of the drug or

device covered by the information disseminated (unless the

information already includes such bibliography).

(c) Additional information

If the Secretary determines, after providing notice of such

determination and an opportunity for a meeting with respect to such

determination, that the information submitted by a manufacturer

under subsection (b)(3)(B) of this section, with respect to the use

of a drug or device for which the manufacturer intends to

disseminate information, fails to provide data, analyses, or other

written matter that is objective and balanced, the Secretary may

require the manufacturer to disseminate -

(1) additional objective and scientifically sound information

that pertains to the safety or effectiveness of the use and is

necessary to provide objectivity and balance, including any

information that the manufacturer has submitted to the Secretary

or, where appropriate, a summary of such information or any other

information that the Secretary has authority to make available to

the public; and

(2) an objective statement of the Secretary, based on data or

other scientifically sound information available to the

Secretary, that bears on the safety or effectiveness of the new

use of the drug or device.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 551, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2356.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note below.

-MISC1-

EFFECTIVE AND TERMINATION DATES

Section 401(d) of Pub. L. 105-115 provided that: ''The amendments

made by this section (enacting this part and amending section 331

of this title) shall take effect 1 year after the date of enactment

of this Act (Nov. 21, 1997), or upon the Secretary's issuance of

final regulations pursuant to subsection (c) (section 401(c) of

Pub. L. 105-115 set out below), whichever is sooner.''

Section 401(e) of Pub. L. 105-115 provided that: ''The amendments

made by this section (enacting this part and amending section 331

of this title) cease to be effective September 30, 2006, or 7 years

after the date on which the Secretary promulgates the regulations

described in subsection (c) (section 401(c) of Pub. L. 105-115 set

out below), whichever is later.''

REGULATIONS

Section 401(c) of Pub. L. 105-115 provided that: ''Not later than

1 year after the date of enactment of this Act (Nov. 21, 1997), the

Secretary of Health and Human Services shall promulgate regulations

to implement the amendments made by this section (enacting this

part and amending section 331 of this title).''

STUDIES AND REPORTS

Section 401(f) of Pub. L. 105-115 provided that:

''(1) General accounting office. -

''(A) In general. - The Comptroller General of the United

States shall conduct a study to determine the impact of

subchapter D of chapter V of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360aaa et seq.), as added by this section, on the

resources of the Department of Health and Human Services.

''(B) Report. - Not later than January 1, 2002, the Comptroller

General of the United States shall prepare and submit to the

Committee on Labor and Human Resources of the Senate and the

Committee on Commerce (now Committee on Energy and Commerce) of

the House of Representatives a report of the results of the

study.

''(2) Department of health and human services. -

''(A) In general. - In order to assist Congress in determining

whether the provisions of such subchapter should be extended

beyond the termination date specified in subsection (e) (section

401(e) of Pub. L. 105-115, set out above), the Secretary of

Health and Human Services shall, in accordance with subparagraph

(B), arrange for the conduct of a study of the scientific issues

raised as a result of the enactment of such subchapter including

issues relating to -

''(i) the effectiveness of such subchapter with respect to

the provision of useful scientific information to health care

practitioners;

''(ii) the quality of the information being disseminated

pursuant to the provisions of such subchapter;

''(iii) the quality and usefulness of the information

provided, in accordance with such subchapter, by the Secretary

or by the manufacturer at the request of the Secretary; and

''(iv) the impact of such subchapter on research in the area

of new uses, indications, or dosages, particularly the impact

on pediatric indications and rare diseases.

''(3) Procedure for study. -

''(A) In general. - The Secretary shall request the Institute

of Medicine of the National Academy of Sciences to conduct the

study required by paragraph (2), and to prepare and submit the

report required by subparagraph (B), under an arrangement by

which the actual expenses incurred by the Institute of Medicine

in conducting the study and preparing the report will be paid by

the Secretary. If the Institute of Medicine is unwilling to

conduct the study under such an arrangement, the Comptroller

General of the United States shall conduct such study.

''(B) Report. - Not later than September 30, 2005, the

Institute of Medicine or the Comptroller General of the United

States, as appropriate, shall prepare and submit to the Committee

on Labor and Human Resources of the Senate, the Committee on

Commerce (now Committee on Energy and Commerce) of the House of

Representatives, and the Secretary a report of the results of the

study required by paragraph (2). The Secretary, after the receipt

of the report, shall make the report available to the public.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 360aaa-1, 360aaa-2,

360aaa-3, 360aaa-4, 360aaa-6 of this title.

-CITE-

21 USC Sec. 360aaa-1 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa-1. Information authorized to be disseminated

-STATUTE-

(a) Authorized information

A manufacturer may disseminate information under section 360aaa

of this title on a new use only if the information -

(1) is in the form of an unabridged -

(A) reprint or copy of an article, peer-reviewed by experts

qualified by scientific training or experience to evaluate the

safety or effectiveness of the drug or device involved, which

was published in a scientific or medical journal (as defined in

section 360aaa-5(5) of this title), which is about a clinical

investigation with respect to the drug or device, and which

would be considered to be scientifically sound by such experts;

or

(B) reference publication, described in subsection (b) of

this section, that includes information about a clinical

investigation with respect to the drug or device that would be

considered to be scientifically sound by experts qualified by

scientific training or experience to evaluate the safety or

effectiveness of the drug or device that is the subject of such

a clinical investigation; and

(2) is not false or misleading and would not pose a significant

risk to the public health.

(b) Reference publication

A reference publication referred to in subsection (a)(1)(B) of

this section is a publication that -

(1) has not been written, edited, excerpted, or published

specifically for, or at the request of, a manufacturer of a drug

or device;

(2) has not been edited or significantly influenced by such a

manufacturer;

(3) is not solely distributed through such a manufacturer but

is generally available in bookstores or other distribution

channels where medical textbooks are sold;

(4) does not focus on any particular drug or device of a

manufacturer that disseminates information under section 360aaa

of this title and does not have a primary focus on new uses of

drugs or devices that are marketed or under investigation by a

manufacturer supporting the dissemination of information; and

(5) presents materials that are not false or misleading.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 552, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2358.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note set out under

section 360aaa of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360aaa of this title.

-CITE-

21 USC Sec. 360aaa-2 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa-2. Establishment of list of articles and publications

disseminated and list of providers that received articles and

reference publications

-STATUTE-

(a) In general

A manufacturer may disseminate information under section 360aaa

of this title on a new use only if the manufacturer prepares and

submits to the Secretary biannually -

(1) a list containing the titles of the articles and reference

publications relating to the new use of drugs or devices that

were disseminated by the manufacturer to a person described in

section 360aaa(a) of this title for the 6-month period preceding

the date on which the manufacturer submits the list to the

Secretary; and

(2) a list that identifies the categories of providers (as

described in section 360aaa(a) of this title) that received the

articles and reference publications for the 6-month period

described in paragraph (1).

(b) Records

A manufacturer that disseminates information under section 360aaa

of this title shall keep records that may be used by the

manufacturer when, pursuant to section 360aaa-4 of this title, such

manufacturer is required to take corrective action and shall be

made available to the Secretary, upon request, for purposes of

ensuring or taking corrective action pursuant to such section.

Such records, at the Secretary's discretion, may identify the

recipient of information provided pursuant to section 360aaa of

this title or the categories of such recipients.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 553, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note set out under

section 360aaa of this title.

-CITE-

21 USC Sec. 360aaa-3 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa-3. Requirement regarding submission of supplemental

application for new use; exemption from requirement

-STATUTE-

(a) In general

A manufacturer may disseminate information under section 360aaa

of this title on a new use only if -

(1)(A) the manufacturer has submitted to the Secretary a

supplemental application for such use; or

(B) the manufacturer meets the condition described in

subsection (b) or (c) of this section (relating to a

certification that the manufacturer will submit such an

application); or

(2) there is in effect for the manufacturer an exemption under

subsection (d) of this section from the requirement of paragraph

(1).

(b) Certification on supplemental application; condition in case of

completed studies

For purposes of subsection (a)(1)(B) of this section, a

manufacturer may disseminate information on a new use if the

manufacturer has submitted to the Secretary an application

containing a certification that -

(1) the studies needed for the submission of a supplemental

application for the new use have been completed; and

(2) the supplemental application will be submitted to the

Secretary not later than 6 months after the date of the initial

dissemination of information under section 360aaa of this title.

(c) Certification on supplemental application; condition in case of

planned studies

(1) In general

For purposes of subsection (a)(1)(B) of this section, a

manufacturer may disseminate information on a new use if -

(A) the manufacturer has submitted to the Secretary an

application containing -

(i) a proposed protocol and schedule for conducting the

studies needed for the submission of a supplemental

application for the new use; and

(ii) a certification that the supplemental application will

be submitted to the Secretary not later than 36 months after

the date of the initial dissemination of information under

section 360aaa of this title (or, as applicable, not later

than such date as the Secretary may specify pursuant to an

extension under paragraph (3)); and

(B) the Secretary has determined that the proposed protocol

is adequate and that the schedule for completing such studies

is reasonable.

(2) Progress reports on studies

A manufacturer that submits to the Secretary an application

under paragraph (1) shall submit to the Secretary periodic

reports describing the status of the studies involved.

(3) Extension of time regarding planned studies

The period of 36 months authorized in paragraph (1)(A)(ii) for

the completion of studies may be extended by the Secretary if -

(A) the Secretary determines that the studies needed to

submit such an application cannot be completed and submitted

within 36 months; or

(B) the manufacturer involved submits to the Secretary a

written request for the extension and the Secretary determines

that the manufacturer has acted with due diligence to conduct

the studies in a timely manner, except that an extension under

this subparagraph may not be provided for more than 24

additional months.

(d) Exemption from requirement of supplemental application

(1) In general

For purposes of subsection (a)(2) of this section, a

manufacturer may disseminate information on a new use if -

(A) the manufacturer has submitted to the Secretary an

application for an exemption from meeting the requirement of

subsection (a)(1) of this section; and

(B)(i) the Secretary has approved the application in

accordance with paragraph (2); or

(ii) the application is deemed under paragraph (3)(A) to have

been approved (unless such approval is terminated pursuant to

paragraph (3)(B)).

(2) Conditions for approval

The Secretary may approve an application under paragraph (1)

for an exemption if the Secretary makes a determination described

in subparagraph (A) or (B), as follows:

(A) The Secretary makes a determination that, for reasons

defined by the Secretary, it would be economically prohibitive

with respect to such drug or device for the manufacturer to

incur the costs necessary for the submission of a supplemental

application. In making such determination, the Secretary shall

consider (in addition to any other considerations the Secretary

finds appropriate) -

(i) the lack of the availability under law of any period

during which the manufacturer would have exclusive marketing

rights with respect to the new use involved; and

(ii) the size of the population expected to benefit from

approval of the supplemental application.

(B) The Secretary makes a determination that, for reasons

defined by the Secretary, it would be unethical to conduct the

studies necessary for the supplemental application. In making

such determination, the Secretary shall consider (in addition

to any other considerations the Secretary finds appropriate)

whether the new use involved is the standard of medical care

for a health condition.

(3) Time for consideration of application; deemed approval

(A) In general

The Secretary shall approve or deny an application under

paragraph (1) for an exemption not later than 60 days after the

receipt of the application. If the Secretary does not comply

with the preceding sentence, the application is deemed to be

approved.

(B) Termination of deemed approval

If pursuant to a deemed approval under subparagraph (A) a

manufacturer disseminates written information under section

360aaa of this title on a new use, the Secretary may at any

time terminate such approval and under section 360aaa-4(b)(3)

of this title order the manufacturer to cease disseminating the

information.

(e) Requirements regarding applications

Applications under this section shall be submitted in the form

and manner prescribed by the Secretary.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 554, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note set out under

section 360aaa of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360aaa, 360aaa-4 of this

title.

-CITE-

21 USC Sec. 360aaa-4 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa-4. Corrective actions; cessation of dissemination

-STATUTE-

(a) Postdissemination data regarding safety and effectiveness

(1) Corrective actions

With respect to data received by the Secretary after the

dissemination of information under section 360aaa of this title

by a manufacturer has begun (whether received pursuant to

paragraph (2) or otherwise), if the Secretary determines that the

data indicate that the new use involved may not be effective or

may present a significant risk to public health, the Secretary

shall, after consultation with the manufacturer, take such action

regarding the dissemination of the information as the Secretary

determines to be appropriate for the protection of the public

health, which may include ordering that the manufacturer cease

the dissemination of the information.

(2) Responsibilities of manufacturers to submit data

After a manufacturer disseminates information under section

360aaa of this title, the manufacturer shall submit to the

Secretary a notification of any additional knowledge of the

manufacturer on clinical research or other data that relate to

the safety or effectiveness of the new use involved. If the

manufacturer is in possession of the data, the notification shall

include the data. The Secretary shall by regulation establish

the scope of the responsibilities of manufacturers under this

paragraph, including such limits on the responsibilities as the

Secretary determines to be appropriate.

(b) Cessation of dissemination

(1) Failure of manufacturer to comply with requirements

The Secretary may order a manufacturer to cease the

dissemination of information pursuant to section 360aaa of this

title if the Secretary determines that the information being

disseminated does not comply with the requirements established in

this part. Such an order may be issued only after the Secretary

has provided notice to the manufacturer of the intent of the

Secretary to issue the order and (unless paragraph (2)(B)

applies) has provided an opportunity for a meeting with respect

to such intent. If the failure of the manufacturer constitutes a

minor violation of this part, the Secretary shall delay issuing

the order and provide to the manufacturer an opportunity to

correct the violation.

(2) Supplemental applications

The Secretary may order a manufacturer to cease the

dissemination of information pursuant to section 360aaa of this

title if -

(A) in the case of a manufacturer that has submitted a

supplemental application for a new use pursuant to section

360aaa-3(a)(1) of this title, the Secretary determines that the

supplemental application does not contain adequate information

for approval of the new use for which the application was

submitted;

(B) in the case of a manufacturer that has submitted a

certification under section 360aaa-3(b) of this title, the

manufacturer has not, within the 6-month period involved,

submitted the supplemental application referred to in the

certification; or

(C) in the case of a manufacturer that has submitted a

certification under section 360aaa-3(c) of this title but has

not yet submitted the supplemental application referred to in

the certification, the Secretary determines, after an informal

hearing, that the manufacturer is not acting with due diligence

to complete the studies involved.

(3) Termination of deemed approval of exemption regarding

supplemental applications

If under section 360aaa-3(d)(3) of this title the Secretary

terminates a deemed approval of an exemption, the Secretary may

order the manufacturer involved to cease disseminating the

information. A manufacturer shall comply with an order under the

preceding sentence not later than 60 days after the receipt of

the order.

(c) Corrective actions by manufacturers

(1) In general

In any case in which under this section the Secretary orders a

manufacturer to cease disseminating information, the Secretary

may order the manufacturer to take action to correct the

information that has been disseminated, except as provided in

paragraph (2).

(2) Termination of deemed approval of exemption regarding

supplemental applications

In the case of an order under subsection (b)(3) of this section

to cease disseminating information, the Secretary may not order

the manufacturer involved to take action to correct the

information that has been disseminated unless the Secretary

determines that the new use described in the information would

pose a significant risk to the public health.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 555, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2361.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note set out under

section 360aaa of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360aaa-2, 360aaa-3 of

this title.

-CITE-

21 USC Sec. 360aaa-5 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa-5. Definitions

-STATUTE-

For purposes of this part:

(1) The term ''health care practitioner'' means a physician, or

other individual who is a provider of health care, who is

licensed under the law of a State to prescribe drugs or devices.

(2) The terms ''health insurance issuer'' and ''group health

plan'' have the meaning given such terms under section 300gg-91

of title 42.

(3) The term ''manufacturer'' means a person who manufactures a

drug or device, or who is licensed by such person to distribute

or market the drug or device.

(4) The term ''new use'' -

(A) with respect to a drug, means a use that is not included

in the labeling of the approved drug; and

(B) with respect to a device, means a use that is not

included in the labeling for the approved or cleared device.

(5) The term ''scientific or medical journal'' means a

scientific or medical publication -

(A) that is published by an organization -

(i) that has an editorial board;

(ii) that utilizes experts, who have demonstrated expertise

in the subject of an article under review by the organization

and who are independent of the organization, to review and

objectively select, reject, or provide comments about

proposed articles; and

(iii) that has a publicly stated policy, to which the

organization adheres, of full disclosure of any conflict of

interest or biases for all authors or contributors involved

with the journal or organization;

(B) whose articles are peer-reviewed and published in

accordance with the regular peer-review procedures of the

organization;

(C) that is generally recognized to be of national scope and

reputation;

(D) that is indexed in the Index Medicus of the National

Library of Medicine of the National Institutes of Health; and

(E) that is not in the form of a special supplement that has

been funded in whole or in part by one or more manufacturers.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 556, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2362.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note set out under

section 360aaa of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360aaa-1, 360aaa-6 of

this title.

-CITE-

21 USC Sec. 360aaa-6 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part D - Dissemination of Treatment Information

-HEAD-

Sec. 360aaa-6. Rules of construction

-STATUTE-

(a) Unsolicited request

Nothing in section 360aaa of this title shall be construed as

prohibiting a manufacturer from disseminating information in

response to an unsolicited request from a health care practitioner.

(b) Dissemination of information on drugs or devices not evidence

of intended use

Notwithstanding subsection (a), (f), or (o) of section 352 of

this title, or any other provision of law, the dissemination of

information relating to a new use of a drug or device, in

accordance with section 360aaa of this title, shall not be

construed by the Secretary as evidence of a new intended use of the

drug or device that is different from the intended use of the drug

or device set forth in the official labeling of the drug or

device. Such dissemination shall not be considered by the

Secretary as labeling, adulteration, or misbranding of the drug or

device.

(c) Patent protection

Nothing in section 360aaa of this title shall affect patent

rights in any manner.

(d) Authorization for dissemination of articles and fees for

reprints of articles

Nothing in section 360aaa of this title shall be construed as

prohibiting an entity that publishes a scientific journal (as

defined in section 360aaa-5(5) of this title) from requiring

authorization from the entity to disseminate an article published

by such entity or charging fees for the purchase of reprints of

published articles from such entity.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 557, as added Pub. L. 105-115, title

IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2363.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates note set out under

section 360aaa of this title.

-CITE-

21 USC Part E - General Provisions Relating to Drugs and

Devices 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part E - General Provisions Relating to Drugs and Devices

.

-HEAD-

Part E - General Provisions Relating to Drugs and Devices

-CITE-

21 USC Sec. 360bbb 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part E - General Provisions Relating to Drugs and Devices

-HEAD-

Sec. 360bbb. Expanded access to unapproved therapies and

diagnostics

-STATUTE-

(a) Emergency situations

The Secretary may, under appropriate conditions determined by the

Secretary, authorize the shipment of investigational drugs or

investigational devices for the diagnosis, monitoring, or treatment

of a serious disease or condition in emergency situations.

(b) Individual patient access to investigational products intended

for serious diseases

Any person, acting through a physician licensed in accordance

with State law, may request from a manufacturer or distributor, and

any manufacturer or distributor may, after complying with the

provisions of this subsection, provide to such physician an

investigational drug or investigational device for the diagnosis,

monitoring, or treatment of a serious disease or condition if -

(1) the licensed physician determines that the person has no

comparable or satisfactory alternative therapy available to

diagnose, monitor, or treat the disease or condition involved,

and that the probable risk to the person from the investigational

drug or investigational device is not greater than the probable

risk from the disease or condition;

(2) the Secretary determines that there is sufficient evidence

of safety and effectiveness to support the use of the

investigational drug or investigational device in the case

described in paragraph (1);

(3) the Secretary determines that provision of the

investigational drug or investigational device will not interfere

with the initiation, conduct, or completion of clinical

investigations to support marketing approval; and

(4) the sponsor, or clinical investigator, of the

investigational drug or investigational device submits to the

Secretary a clinical protocol consistent with the provisions of

section 355(i) or 360j(g) of this title, including any

regulations promulgated under section 355(i) or 360j(g) of this

title, describing the use of the investigational drug or

investigational device in a single patient or a small group of

patients.

(c) Treatment investigational new drug applications and treatment

investigational device exemptions

Upon submission by a sponsor or a physician of a protocol

intended to provide widespread access to an investigational drug or

investigational device for eligible patients (referred to in this

subsection as an ''expanded access protocol''), the Secretary shall

permit such investigational drug or investigational device to be

made available for expanded access under a treatment

investigational new drug application or treatment investigational

device exemption if the Secretary determines that -

(1) under the treatment investigational new drug application or

treatment investigational device exemption, the investigational

drug or investigational device is intended for use in the

diagnosis, monitoring, or treatment of a serious or immediately

life-threatening disease or condition;

(2) there is no comparable or satisfactory alternative therapy

available to diagnose, monitor, or treat that stage of disease or

condition in the population of patients to which the

investigational drug or investigational device is intended to be

administered;

(3)(A) the investigational drug or investigational device is

under investigation in a controlled clinical trial for the use

described in paragraph (1) under an investigational drug

application in effect under section 355(i) of this title or

investigational device exemption in effect under section 360j(g)

of this title; or

(B) all clinical trials necessary for approval of that use of

the investigational drug or investigational device have been

completed;

(4) the sponsor of the controlled clinical trials is actively

pursuing marketing approval of the investigational drug or

investigational device for the use described in paragraph (1)

with due diligence;

(5) in the case of an investigational drug or investigational

device described in paragraph (3)(A), the provision of the

investigational drug or investigational device will not interfere

with the enrollment of patients in ongoing clinical

investigations under section 355(i) or 360j(g) of this title;

(6) in the case of serious diseases, there is sufficient

evidence of safety and effectiveness to support the use described

in paragraph (1); and

(7) in the case of immediately life-threatening diseases, the

available scientific evidence, taken as a whole, provides a

reasonable basis to conclude that the investigational drug or

investigational device may be effective for its intended use and

would not expose patients to an unreasonable and significant risk

of illness or injury.

A protocol submitted under this subsection shall be subject to the

provisions of section 355(i) or 360j(g) of this title, including

regulations promulgated under section 355(i) or 360j(g) of this

title. The Secretary may inform national, State, and local medical

associations and societies, voluntary health associations, and

other appropriate persons about the availability of an

investigational drug or investigational device under expanded

access protocols submitted under this subsection. The information

provided by the Secretary, in accordance with the preceding

sentence, shall be the same type of information that is required by

section 282(j)(3) of title 42.

(d) Termination

The Secretary may, at any time, with respect to a sponsor,

physician, manufacturer, or distributor described in this section,

terminate expanded access provided under this section for an

investigational drug or investigational device if the requirements

under this section are no longer met.

(e) Definitions

In this section, the terms ''investigational drug'',

''investigational device'', ''treatment investigational new drug

application'', and ''treatment investigational device exemption''

shall have the meanings given the terms in regulations prescribed

by the Secretary.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 561, as added Pub. L. 105-115, title

IV, Sec. 402, Nov. 21, 1997, 111 Stat. 2365.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in title 42 section 282.

-CITE-

21 USC Sec. 360bbb-1 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part E - General Provisions Relating to Drugs and Devices

-HEAD-

Sec. 360bbb-1. Dispute resolution

-STATUTE-

If, regarding an obligation concerning drugs or devices under

this Act or section 351 of the Public Health Service Act (42 U.S.C.

262), there is a scientific controversy between the Secretary and a

person who is a sponsor, applicant, or manufacturer and no specific

provision of the Act involved, including a regulation promulgated

under such Act, provides a right of review of the matter in

controversy, the Secretary shall, by regulation, establish a

procedure under which such sponsor, applicant, or manufacturer may

request a review of such controversy, including a review by an

appropriate scientific advisory panel described in section 355(n)

of this title or an advisory committee described in section

360e(g)(2)(B) of this title. Any such review shall take place in a

timely manner. The Secretary shall promulgate such regulations

within 1 year after November 21, 1997.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 562, as added Pub. L. 105-115, title

IV, Sec. 404, Nov. 21, 1997, 111 Stat. 2368.)

-REFTEXT-

REFERENCES IN TEXT

This Act, referred to in text, is the Federal Food, Drug, and

Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as

amended, which is classified generally to this chapter. For

complete classification of this Act to the Code, see section 301 of

this title and Tables.

-MISC2-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360l of this title.

-CITE-

21 USC Sec. 360bbb-2 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part E - General Provisions Relating to Drugs and Devices

-HEAD-

Sec. 360bbb-2. Classification of products

-STATUTE-

(a) Request

A person who submits an application or submission (including a

petition, notification, and any other similar form of request)

under this chapter for a product, may submit a request to the

Secretary respecting the classification of the product as a drug,

biological product, device, or a combination product subject to

section 353(g) of this title or respecting the component of the

Food and Drug Administration that will regulate the product. In

submitting the request, the person shall recommend a classification

for the product, or a component to regulate the product, as

appropriate.

(b) Statement

Not later than 60 days after the receipt of the request described

in subsection (a) of this section, the Secretary shall determine

the classification of the product under subsection (a) of this

section, or the component of the Food and Drug Administration that

will regulate the product, and shall provide to the person a

written statement that identifies such classification or such

component, and the reasons for such determination. The Secretary

may not modify such statement except with the written consent of

the person, or for public health reasons based on scientific

evidence.

(c) Inaction of Secretary

If the Secretary does not provide the statement within the 60-day

period described in subsection (b) of this section, the

recommendation made by the person under subsection (a) of this

section shall be considered to be a final determination by the

Secretary of such classification of the product, or the component

of the Food and Drug Administration that will regulate the product,

as applicable, and may not be modified by the Secretary except with

the written consent of the person, or for public health reasons

based on scientific evidence.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 563, as added Pub. L. 105-115, title

IV, Sec. 416, Nov. 21, 1997, 111 Stat. 2378.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC SUBCHAPTER VI - COSMETICS 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VI - COSMETICS

.

-HEAD-

SUBCHAPTER VI - COSMETICS

-CITE-

21 USC Sec. 361 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VI - COSMETICS

-HEAD-

Sec. 361. Adulterated cosmetics

-STATUTE-

A cosmetic shall be deemed to be adulterated -

(a) If it bears or contains any poisonous or deleterious

substance which may render it injurious to users under the

conditions of use prescribed in the labeling thereof, or under such

conditions of use as are customary or usual, except that this

provision shall not apply to coal-tar hair dye, the label of which

bears the following legend conspicuously displayed thereon:

''Caution - This product contains ingredients which may cause skin

irritation on certain individuals and a preliminary test according

to accompanying directions should first be made. This product must

not be used for dyeing the eyelashes or eyebrows; to do so may

cause blindness.'', and the labeling of which bears adequate

directions for such preliminary testing. For the purposes of this

paragraph and paragraph (e) the term ''hair dye'' shall not include

eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or

decomposed substance.

(c) If it has been prepared, packed, or held under insanitary

conditions whereby it may have become contaminated with filth, or

whereby it may have been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any

poisonous or deleterious substance which may render the contents

injurious to health.

(e) If it is not a hair dye and it is, or it bears or contains, a

color additive which is unsafe within the meaning of section

379e(a) of this title.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 601, 52 Stat. 1054; Pub. L. 86-618,

title I, Sec. 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L.

102-571, title I, Sec. 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub.

L. 103-80, Sec. 3(x), Aug. 13, 1993, 107 Stat. 778.)

-MISC1-

AMENDMENTS

1993 - Subsec. (a). Pub. L. 103-80 substituted ''usual, except

that this'' for ''usual: Provided, That this''.

1992 - Par. (e). Pub. L. 102-571 substituted ''379e(a)'' for

''376(a)''.

1960 - Par. (e). Pub. L. 86-618 substituted ''and it is, or it

bears or contains, a color additive which is unsafe within the

meaning of section 376(a) of this title'' for ''and it bears or

contains a coal-tar color other than one from a batch that has been

certified in accordance with regulations as provided by section 364

of this title''.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE; POSTPONEMENT

Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,

53 Stat. 853, set out as an Effective Date; Postponement in Certain

Cases note under section 301 of this title.

EFFECTIVE DATE

Section effective twelve months after June 25, 1938, except par.

(a), which, with certain exceptions, became effective on June 25,

1938, see section 902(a) of act June 25, 1938, set out as a note

under section 301 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 334, 379e of this title.

-CITE-

21 USC Sec. 362 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VI - COSMETICS

-HEAD-

Sec. 362. Misbranded cosmetics

-STATUTE-

A cosmetic shall be deemed to be misbranded -

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing (1) the

name and place of business of the manufacturer, packer, or

distributor; and (2) an accurate statement of the quantity of the

contents in terms of weight, measure, or numerical count: Provided,

That under clause (2) of this paragraph reasonable variations shall

be permitted, and exemptions as to small packages shall be

established, by regulations prescribed by the Secretary.

(c) If any word, statement, or other information required by or

under authority of this chapter to appear on the label or labeling

is not prominently placed thereon with such conspicuousness (as

compared with other words, statements, designs, or devices, in the

labeling) and in such terms as to render it likely to be read and

understood by the ordinary individual under customary conditions of

purchase and use.

(d) If its container is so made, formed, or filled as to be

misleading.

(e) If it is a color additive, unless its packaging and labeling

are in conformity with such packaging and labeling requirements,

applicable to such color additive, as may be contained in

regulations issued under section 379e of this title. This

paragraph shall not apply to packages of color additives which,

with respect to their use for cosmetics, are marketed and intended

for use only in or on hair dyes (as defined in the last sentence of

section 361(a) of this title).

(f) If its packaging or labeling is in violation of an applicable

regulation issued pursuant to section 1472 or 1473 of title 15.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 602, 52 Stat. 1054; Pub. L. 86-618,

title I, Sec. 102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L.

91-601, Sec. 6(f), formerly Sec. 7(f), Dec. 30, 1970, 84 Stat.

1673, renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13,

1981, 95 Stat. 716; Pub. L. 102-571, title I, Sec. 107(12), Oct.

29, 1992, 106 Stat. 4499.)

-MISC1-

AMENDMENTS

1992 - Par. (e). Pub. L. 102-571 substituted ''379e'' for

''376''.

1970 - Par. (f). Pub. L. 91-601 added par. (f).

1960 - Par. (e). Pub. L. 86-618 added par. (e).

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and

regulations establishing special packaging standards effective no

sooner than 180 days or later than one year from date regulations

are final, or an earlier date published in Federal Register, see

section 8 of Pub. L. 91-601, set out as an Effective Date note

under section 1471 of Title 15, Commerce and Trade.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE; POSTPONEMENT

Par. (b) effective Jan. 1, 1940, and such subsection effective

July 1, 1940, as provided by regulations for certain lithographed

labeling and containers bearing certain labeling, see act June 23,

1939, ch. 242, 53 Stat. 853, set out as an Effective Date;

Postponement in Certain Cases note under section 301 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 321 of this title.

-CITE-

21 USC Sec. 363 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VI - COSMETICS

-HEAD-

Sec. 363. Regulations making exemptions

-STATUTE-

The Secretary shall promulgate regulations exempting from any

labeling requirement of this chapter cosmetics which are, in

accordance with the practice of the trade, to be processed,

labeled, or repacked in substantial quantities at establishments

other than those where originally processed or packed, on condition

that such cosmetics are not adulterated or misbranded under the

provisions of this chapter upon removal from such processing,

labeling, or repacking establishment.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 603, 52 Stat. 1054.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-CITE-

21 USC Sec. 364 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VI - COSMETICS

-HEAD-

Sec. 364. Repealed. Pub. L. 86-618, title I, Sec. 103(a)(3), July

12, 1960, 74 Stat. 398

-MISC1-

Section, act June 25, 1938, ch. 675, Sec. 604, 52 Stat. 1055,

directed Secretary to promulgate regulations for listing of

coal-tar colors for cosmetics. See section 379e of this title.

EFFECTIVE DATE OF REPEAL

Repeal effective July 12, 1960, subject to the provisions of

section 203 of Pub. L. 86-618, see section 202 of Pub. L. 86-618,

set out as an Effective Date of 1960 Amendment note under section

379e of this title.

-CITE-

21 USC SUBCHAPTER VII - GENERAL AUTHORITY 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

.

-HEAD-

SUBCHAPTER VII - GENERAL AUTHORITY

-CITE-

21 USC Part A - General Administrative Provisions 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

.

-HEAD-

Part A - General Administrative Provisions

-CITE-

21 USC Sec. 371 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 371. Regulations and hearings

-STATUTE-

(a) Authority to promulgate regulations

The authority to promulgate regulations for the efficient

enforcement of this chapter, except as otherwise provided in this

section, is vested in the Secretary.

(b) Regulations for imports and exports

The Secretary of the Treasury and the Secretary of Health and

Human Services shall jointly prescribe regulations for the

efficient enforcement of the provisions of section 381 of this

title, except as otherwise provided therein. Such regulations

shall be promulgated in such manner and take effect at such time,

after due notice, as the Secretary of Health and Human Services

shall determine.

(c) Conduct of hearings

Hearings authorized or required by this chapter shall be

conducted by the Secretary or such officer or employee as he may

designate for the purpose.

(d) Effectiveness of definitions and standards of identity

The definitions and standards of identity promulgated in

accordance with the provisions of this chapter shall be effective

for the purposes of the enforcement of this chapter,

notwithstanding such definitions and standards as may be contained

in other laws of the United States and regulations promulgated

thereunder.

(e) Procedure for establishment

(1) Any action for the issuance, amendment, or repeal of any

regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or

(h) of this title, and any action for the amendment or repeal of

any definition and standard of identity under section 341 of this

title for any dairy product (including products regulated under

parts 131, 133 and 135 of title 21, Code of Federal Regulations)

shall be begun by a proposal made (A) by the Secretary on his own

initiative, or (B) by petition of any interested person, showing

reasonable grounds therefor, filed with the Secretary. The

Secretary shall publish such proposal and shall afford all

interested persons an opportunity to present their views thereon,

orally or in writing. As soon as practicable thereafter, the

Secretary shall by order act upon such proposal and shall make such

order public. Except as provided in paragraph (2), the order shall

become effective at such time as may be specified therein, but not

prior to the day following the last day on which objections may be

filed under such paragraph.

(2) On or before the thirtieth day after the date on which an

order entered under paragraph (1) is made public, any person who

will be adversely affected by such order if placed in effect may

file objections thereto with the Secretary, specifying with

particularity the provisions of the order deemed objectionable,

stating the grounds therefor, and requesting a public hearing upon

such objections. Until final action upon such objections is taken

by the Secretary under paragraph (3), the filing of such objections

shall operate to stay the effectiveness of those provisions of the

order to which the objections are made. As soon as practicable

after the time for filing objections has expired the Secretary

shall publish a notice in the Federal Register specifying those

parts of the order which have been stayed by the filing of

objections and, if no objections have been filed, stating that

fact.

(3) As soon as practicable after such request for a public

hearing, the Secretary, after due notice, shall hold such a public

hearing for the purpose of receiving evidence relevant and material

to the issues raised by such objections. At the hearing, any

interested person may be heard in person or by representative. As

soon as practicable after completion of the hearing, the Secretary

shall by order act upon such objections and make such order

public. Such order shall be based only on substantial evidence of

record at such hearing and shall set forth, as part of the order,

detailed findings of fact on which the order is based. The

Secretary shall specify in the order the date on which it shall

take effect, except that it shall not be made to take effect prior

to the ninetieth day after its publication unless the Secretary

finds that emergency conditions exist necessitating an earlier

effective date, in which event the Secretary shall specify in the

order his findings as to such conditions.

(f) Review of order

(1) In a case of actual controversy as to the validity of any

order under subsection (e) of this section, any person who will be

adversely affected by such order if placed in effect may at any

time prior to the ninetieth day after such order is issued file a

petition with the United States court of appeals for the circuit

wherein such person resides or has his principal place of business,

for a judicial review of such order. A copy of the petition shall

be forthwith transmitted by the clerk of the court to the Secretary

or other officer designated by him for that purpose. The Secretary

thereupon shall file in the court the record of the proceedings on

which the Secretary based his order, as provided in section 2112 of

title 28.

(2) If the petitioner applies to the court for leave to adduce

additional evidence, and shows to the satisfaction of the court

that such additional evidence is material and that there were

reasonable grounds for the failure to adduce such evidence in the

proceeding before the Secretary, the court may order such

additional evidence (and evidence in rebuttal thereof) to be taken

before the Secretary, and to be adduced upon the hearing, in such

manner and upon such terms and conditions as to the court may seem

proper. The Secretary may modify his findings as to the facts, or

make new findings, by reason of the additional evidence so taken,

and he shall file such modified or new findings, and his

recommendation, if any, for the modification or setting aside of

his original order, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1)

of this subsection, the court shall have jurisdiction to affirm the

order, or to set it aside in whole or in part, temporarily or

permanently. If the order of the Secretary refuses to issue,

amend, or repeal a regulation and such order is not in accordance

with law the court shall by its judgment order the Secretary to

take action, with respect to such regulation, in accordance with

law. The findings of the Secretary as to the facts, if supported

by substantial evidence, shall be conclusive.

(4) The judgment of the court affirming or setting aside, in

whole or in part, any such order of the Secretary shall be final,

subject to review by the Supreme Court of the United States upon

certiorari or certification as provided in section 1254 of title

28.

(5) Any action instituted under this subsection shall survive

notwithstanding any change in the person occupying the office of

Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in

addition to and not in substitution for any other remedies provided

by law.

(g) Copies of records of hearings

A certified copy of the transcript of the record and proceedings

under subsection (e) of this section shall be furnished by the

Secretary to any interested party at his request, and payment of

the costs thereof, and shall be admissible in any criminal, libel

for condemnation, exclusion of imports, or other proceeding arising

under or in respect to this chapter, irrespective of whether

proceedings with respect to the order have previously been

instituted or become final under subsection (f) of this section.

(h) Guidance documents

(1)(A) The Secretary shall develop guidance documents with public

participation and ensure that information identifying the existence

of such documents and the documents themselves are made available

to the public both in written form and, as feasible, through

electronic means. Such documents shall not create or confer any

rights for or on any person, although they present the views of the

Secretary on matters under the jurisdiction of the Food and Drug

Administration.

(B) Although guidance documents shall not be binding on the

Secretary, the Secretary shall ensure that employees of the Food

and Drug Administration do not deviate from such guidances without

appropriate justification and supervisory concurrence. The

Secretary shall provide training to employees in how to develop and

use guidance documents and shall monitor the development and

issuance of such documents.

(C) For guidance documents that set forth initial interpretations

of a statute or regulation, changes in interpretation or policy

that are of more than a minor nature, complex scientific issues, or

highly controversial issues, the Secretary shall ensure public

participation prior to implementation of guidance documents, unless

the Secretary determines that such prior public participation is

not feasible or appropriate. In such cases, the Secretary shall

provide for public comment upon implementation and take such

comment into account.

(D) For guidance documents that set forth existing practices or

minor changes in policy, the Secretary shall provide for public

comment upon implementation.

(2) In developing guidance documents, the Secretary shall ensure

uniform nomenclature for such documents and uniform internal

procedures for approval of such documents. The Secretary shall

ensure that guidance documents and revisions of such documents are

properly dated and indicate the nonbinding nature of the

documents. The Secretary shall periodically review all guidance

documents and, where appropriate, revise such documents.

(3) The Secretary, acting through the Commissioner, shall

maintain electronically and update and publish periodically in the

Federal Register a list of guidance documents. All such documents

shall be made available to the public.

(4) The Secretary shall ensure that an effective appeals

mechanism is in place to address complaints that the Food and Drug

Administration is not developing and using guidance documents in

accordance with this subsection.

(5) Not later than July 1, 2000, the Secretary after evaluating

the effectiveness of the Good Guidance Practices document,

published in the Federal Register at 62 Fed. Reg. 8961, shall

promulgate a regulation consistent with this subsection specifying

the policies and procedures of the Food and Drug Administration for

the development, issuance, and use of guidance documents.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 701, 52 Stat. 1055; June 25, 1948,

ch. 646, Sec. 32, 62 Stat. 991; Apr. 15, 1954, ch. 143, Sec. 2, 68

Stat. 55; Aug. 1, 1956, ch. 861, Sec. 2, 70 Stat. 919; Pub. L.

85-791, Sec. 21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86-618, title

I, Sec. 103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101-535,

Sec. 8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102-300, Sec.

6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Sec. 3(y),

(dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103-396,

Sec. 3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105-115, title

IV, Sec. 405, Nov. 21, 1997, 111 Stat. 2368.)

-MISC1-

AMENDMENTS

1997 - Subsec. (h). Pub. L. 105-115 added subsec. (h).

1994 - Subsec. (e)(1). Pub. L. 103-396 which directed the

amendment of par. (1) by striking out ''or maple syrup (regulated

under section 168.140 of title 21, Code of Federal Regulations).'',

was executed by striking out ''or maple sirup (regulated under

section 168.140 of title 21, Code of Federal Regulations)'' before

''shall be begun by a proposal'', to reflect the probable intent of

Congress.

1993 - Subsec. (b). Pub. L. 103-80, Sec. 3(dd)(1), substituted

''Health and Human Services'' for ''Agriculture'' in two places.

Subsec. (e)(1). Pub. L. 103-80, Sec. 4(c), made technical

correction to directory language of Pub. L. 101-535, Sec. 8. See

1990 Amendment note below.

Pub. L. 103-80, Sec. 3(y)(1), struck out period after second

reference to ''Regulations)''.

Subsec. (f)(4). Pub. L. 103-80, Sec. 3(y)(2), substituted

reference to section 1254 of title 28 for ''sections 239 and 240 of

the Judicial Code, as amended''.

1992 - Subsec. (b). Pub. L. 102-300, which directed the

substitution of ''Health and Human Services'' for ''Health,

Education, and Welfare'', could not be executed because such words

did not appear in the original statutory text. See 1993 Amendment

note above and Transfer of Functions note below.

1990 - Subsec. (e)(1). Pub. L. 101-535, Sec. 8, as amended by

Pub. L. 103-80, Sec. 4(c), substituted ''Any action for the

issuance, amendment, or repeal of any regulation under section

343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and

any action for the amendment or repeal of any definition and

standard of identity under section 341 of this title for any dairy

product (including products regulated under parts 131, 133 and 135

of title 21, Code of Federal Regulations) or maple sirup (regulated

under section 168.140 of title 21, Code of Federal Regulations)''

for ''Any action for the issuance, amendment, or repeal of any

regulation under section 341, 343(j), 344(a), 346, 351(b), or

352(d) or (h) of this title''.

1960 - Subsec. (e). Pub. L. 86-618 substituted ''section 341,

343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title'' for

''section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or

(h), 354 or 364 of this title''.

1958 - Subsec. (f)(1). Pub. L. 85-791, Sec. 21(a), substituted

provisions requiring transmission of a copy of the petition by

clerk to Secretary, and filing of the record by Secretary, for

provisions which permitted service of summons and petition any

place in United States and required Secretary to certify and file

transcript of the proceedings and record upon service.

Subsec. (f)(3). Pub. L. 85-791, Sec. 21(b), inserted ''Upon the

filing of the petition referred to in paragraph (1) of this

subsection''.

1956 - Subsec. (e). Act Aug. 1, 1956, simplified procedures

governing prescribing of regulations under certain provisions of

this chapter.

1954 - Subsec. (e). Act Apr. 15, 1954, struck out reference to

section 341 of this title, before ''343(j)'', such section 341 now

containing its own provisions with respect to hearings regarding

the establishment of food standards.

-CHANGE-

CHANGE OF NAME

Circuit Court of Appeals of the United States changed to United

States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.

-MISC4-

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535

Amendments by Pub. L. 101-535 not to be construed to alter the

authority of the Secretary of Health and Human Services and the

Secretary of Agriculture under the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21

U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.

451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031

et seq.), see section 9 of Pub. L. 101-535, set out as a note under

section 343 of this title.

SAVINGS PROVISION

Savings clause of act Aug. 1, 1956, see note set out under

section 341 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

Secretary and Department of Health, Education, and Welfare

redesignated Secretary and Department of Health and Human Services

by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.

695, which is classified to section 3508(b) of Title 20, Education.

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS

Section 403 of Pub. L. 105-115 provided that:

''(a) Standards. - Not later than 180 days after the date of

enactment of this Act (Nov. 21, 1997), the Secretary of Health and

Human Services shall publish in the Federal Register standards for

the prompt review of supplemental applications submitted for

approved articles under the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 301 et seq.) or section 351 of the Public Health Service

Act (42 U.S.C. 262).

''(b) Guidance to Industry. - Not later than 180 days after the

date of enactment of this Act (Nov. 21, 1997), the Secretary shall

issue final guidances to clarify the requirements for, and

facilitate the submission of data to support, the approval of

supplemental applications for the approved articles described in

subsection (a). The guidances shall -

''(1) clarify circumstances in which published matter may be

the basis for approval of a supplemental application;

''(2) specify data requirements that will avoid duplication of

previously submitted data by recognizing the availability of data

previously submitted in support of an original application; and

''(3) define supplemental applications that are eligible for

priority review.

''(c) Responsibilities of Centers. - The Secretary shall

designate an individual in each center within the Food and Drug

Administration (except the Center for Food Safety and Applied

Nutrition) to be responsible for -

''(1) encouraging the prompt review of supplemental

applications for approved articles; and

''(2) working with sponsors to facilitate the development and

submission of data to support supplemental applications.

''(d) Collaboration. - The Secretary shall implement programs and

policies that will foster collaboration between the Food and Drug

Administration, the National Institutes of Health, professional

medical and scientific societies, and other persons, to identify

published and unpublished studies that may support a supplemental

application, and to encourage sponsors to make supplemental

applications or conduct further research in support of a

supplemental application based, in whole or in part, on such

studies.''

HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS

Provisions of this chapter in effect prior to Apr. 15, 1954, as

applicable with respect to hearings begun prior to such date under

subsection (e) of this section, regarding food standards, see

Savings Provisions note set out under section 341 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 346a, 352, 379e of this

title; title 15 sections 1261, 1262, 1455, 1474.

-CITE-

21 USC Sec. 372 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 372. Examinations and investigations

-STATUTE-

(a) Authority to conduct

(1) The Secretary is authorized to conduct examinations and

investigations for the purposes of this chapter through officers

and employees of the Department or through any health, food, or

drug officer or employee of any State, Territory, or political

subdivision thereof, duly commissioned by the Secretary as an

officer of the Department.

(2)(A) In addition to the authority established in paragraph (1),

the Secretary, pursuant to a memorandum of understanding between

the Secretary and the head of another Federal department or agency,

is authorized to conduct examinations and investigations for the

purposes of this chapter through the officers and employees of such

other department or agency, subject to subparagraph (B). Such a

memorandum shall include provisions to ensure adequate training of

such officers and employees to conduct the examinations and

investigations. The memorandum of understanding shall contain

provisions regarding reimbursement. Such provisions may, at the

sole discretion of the head of the other department or agency,

require reimbursement, in whole or in part, from the Secretary for

the examinations or investigations performed under this section by

the officers or employees of the other department or agency.

(B) A memorandum of understanding under subparagraph (A) between

the Secretary and another Federal department or agency is effective

only in the case of examinations or inspections at facilities or

other locations that are jointly regulated by the Secretary and

such department or agency.

(C) For any fiscal year in which the Secretary and the head of

another Federal department or agency carries out one or more

examinations or inspections under a memorandum of understanding

under subparagraph (A), the Secretary and the head of such

department or agency shall with respect to their respective

departments or agencies submit to the committees of jurisdiction

(authorizing and appropriating) in the House of Representatives and

the Senate a report that provides, for such year -

(i) the number of officers or employees that carried out one or

more programs, projects, or activities under such memorandum;

(ii) the number of additional articles that were inspected or

examined as a result of such memorandum; and

(iii) the number of additional examinations or investigations

that were carried out pursuant to such memorandum.

(3) In the case of food packed in the Commonwealth of Puerto Rico

or a Territory the Secretary shall attempt to make inspection of

such food at the first point of entry within the United States

when, in his opinion and with due regard to the enforcement of all

the provisions of this chapter, the facilities at his disposal will

permit of such inspection.

(4) For the purposes of this subsection, the term ''United

States'' means the States and the District of Columbia.

(b) Availability to owner of part of analysis samples

Where a sample of a food, drug, or cosmetic is collected for

analysis under this chapter the Secretary shall, upon request,

provide a part of such official sample for examination or analysis

by any person named on the label of the article, or the owner

thereof, or his attorney or agent; except that the Secretary is

authorized, by regulations, to make such reasonable exceptions

from, and impose such reasonable terms and conditions relating to,

the operation of this subsection as he finds necessary for the

proper administration of the provisions of this chapter.

(c) Records of other departments and agencies

For purposes of enforcement of this chapter, records of any

department or independent establishment in the executive branch of

the Government shall be open to inspection by any official of the

Department duly authorized by the Secretary to make such

inspection.

(d) Information on patents for drugs

The Secretary is authorized and directed, upon request from the

Under Secretary of Commerce for Intellectual Property and Director

of the United States Patent and Trademark Office, to furnish full

and complete information with respect to such questions relating to

drugs as the Director may submit concerning any patent

application. The Secretary is further authorized, upon receipt of

any such request, to conduct or cause to be conducted, such

research as may be required.

(e) Powers of enforcement personnel

Any officer or employee of the Department designated by the

Secretary to conduct examinations, investigations, or inspections

under this chapter relating to counterfeit drugs may, when so

authorized by the Secretary -

(1) carry firearms;

(2) execute and serve search warrants and arrest warrants;

(3) execute seizure by process issued pursuant to libel under

section 334 of this title;

(4) make arrests without warrant for offenses under this

chapter with respect to such drugs if the offense is committed in

his presence or, in the case of a felony, if he has probable

cause to believe that the person so arrested has committed, or is

committing, such offense; and

(5) make, prior to the institution of libel proceedings under

section 334(a)(2) of this title, seizures of drugs or containers

or of equipment, punches, dies, plates, stones, labeling, or

other things, if they are, or he has reasonable grounds to

believe that they are, subject to seizure and condemnation under

such section 334(a)(2). In the event of seizure pursuant to this

paragraph (5), libel proceedings under section 334(a)(2) of this

title shall be instituted promptly and the property seized be

placed under the jurisdiction of the court.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 702, 52 Stat. 1056; Pub. L. 87-781,

title III, Sec. 307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L.

89-74, Sec. 8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91-513,

title II, Sec. 701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L.

102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L.

103-80, Sec. 3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L.

106-113, div. B, Sec. 1000(a)(9) (title IV, Sec. 4732(b)(12)),

Nov. 29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 107-188, title

III, Sec. 314, June 12, 2002, 116 Stat. 674.)

-MISC1-

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-188 inserted ''(1)'' before ''The

Secretary is authorized to conduct'', added par. (2), inserted

''(3)'' before ''In the case of food packed'', and substituted

''(4) For the purposes of this subsection,'' for ''For the purposes

of this subsection''.

1999 - Subsec. (d). Pub. L. 106-113, in first sentence,

substituted ''Under Secretary of Commerce for Intellectual Property

and Director of the United States Patent and Trademark Office'' for

''Commissioner of Patents'' and ''Director'' for ''Commissioner''.

1993 - Subsec. (c). Pub. L. 103-80 struck out ''of Agriculture''

after ''Department''.

1992 - Subsec. (c). Pub. L. 102-300, which directed the amendment

of subsec. (c) by striking out ''of Health, Education, and

Welfare'', could not be executed because such words did not appear

in the original statutory text. See 1993 Amendment note above and

Transfer of Functions note below.

1970 - Subsec. (e). Pub. L. 91-513 struck out reference to

depressant or stimulant drugs.

1965 - Subsec. (e). Pub. L. 89-74 added subsec. (e).

1962 - Subsec. (a). Pub. L. 87-781, Sec. 307(b), inserted ''the

Commonwealth of Puerto Rico or'' before ''a Territory the

Secretary''.

Subsec. (d). Pub. L. 87-781, Sec. 308, added subsec. (d).

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,

1999, see section 1000(a)(9) (title IV, Sec. 4731) of Pub. L.

106-113, set out as a note under section 1 of Title 35, Patents.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-513 effective on first day of seventh

calendar month that begins after Oct. 26, 1970, see section 704 of

Pub. L. 91-513, set out as an Effective Date note under section 801

of this title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-74 effective July 15, 1965, see section

11 of Pub. L. 89-74, set out as a note under section 321 of this

title.

SAVINGS PROVISION

Amendment by Pub. L. 91-513 not to affect or abate any

prosecutions for any violation of law or any civil seizures or

forfeitures and injunctive proceedings commenced prior to the

effective date of such amendment, and all administrative

proceedings pending before the Bureau of Narcotics and Dangerous

Drugs (now Drug Enforcement Administration) on Oct. 27, 1970, to be

continued and brought to final determination in accord with laws

and regulations in effect prior to Oct. 27, 1970, see section 702

of Pub. L. 91-513, set out as a note under section 321 of this

title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 399 of this title.

-CITE-

21 USC Sec. 372a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 372a. Transferred

-COD-

CODIFICATION

Section, act June 25, 1938, ch. 675, Sec. 702A, formerly June 30,

1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712, 48 Stat.

1204, and amended, which related to examination of sea food, was

renumbered section 706 of act June 25, 1938, by Pub. L. 102-571,

title I, Sec. 106(3), Oct. 29, 1992, 106 Stat. 4498, and

transferred to section 376 of this title.

-CITE-

21 USC Sec. 373 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 373. Records of interstate shipment

-STATUTE-

For the purpose of enforcing the provisions of this chapter,

carriers engaged in interstate commerce, and persons receiving

food, drugs, devices, or cosmetics in interstate commerce or

holding such articles so received, shall, upon the request of an

officer or employee duly designated by the Secretary, permit such

officer or employee, at reasonable times, to have access to and to

copy all records showing the movement in interstate commerce of any

food, drug, device, or cosmetic, or the holding thereof during or

after such movement, and the quantity, shipper, and consignee

thereof; and it shall be unlawful for any such carrier or person to

fail to permit such access to and copying of any such record so

requested when such request is accompanied by a statement in

writing specifying the nature or kind of food, drug, device, or

cosmetic to which such request relates, except that evidence

obtained under this section, or any evidence which is directly or

indirectly derived from such evidence, shall not be used in a

criminal prosecution of the person from whom obtained, and except

that carriers shall not be subject to the other provisions of this

chapter by reason of their receipt, carriage, holding, or delivery

of food, drugs, devices, or cosmetics in the usual course of

business as carriers.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 703, 52 Stat. 1057; Pub. L. 91-452,

title II, Sec. 230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103-80,

Sec. 3(z), Aug. 13, 1993, 107 Stat. 778.)

-MISC1-

AMENDMENTS

1993 - Pub. L. 103-80 substituted '', except that'' for '':

Provided, That'' and '', and except that'' for '': Provided

further, That''.

1970 - Pub. L. 91-452 inserted '', or any evidence which is

directly or indirectly derived from such evidence,'' after ''under

this section''.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-452 effective on sixtieth day following

Oct. 15, 1970, and not to affect any immunity to which any

individual is entitled under this section by reason of any

testimony given before sixtieth day following Oct. 15, 1970, see

section 260 of Pub. L. 91-452, set out as an Effective Date;

Savings Provision note under section 6001 of Title 18, Crimes and

Criminal Procedure.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 331 of this title.

-CITE-

21 USC Sec. 374 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 374. Inspection

-STATUTE-

(a) Right of agents to enter; scope of inspection; notice;

promptness; exclusions

(1) For purposes of enforcement of this chapter, officers or

employees duly designated by the Secretary, upon presenting

appropriate credentials and a written notice to the owner,

operator, or agent in charge, are authorized (A) to enter, at

reasonable times, any factory, warehouse, or establishment in which

food, drugs, devices, or cosmetics are manufactured, processed,

packed, or held, for introduction into interstate commerce or after

such introduction, or to enter any vehicle being used to transport

or hold such food, drugs, devices, or cosmetics in interstate

commerce; and (B) to inspect, at reasonable times and within

reasonable limits and in a reasonable manner, such factory,

warehouse, establishment, or vehicle and all pertinent equipment,

finished and unfinished materials, containers, and labeling

therein. In the case of any person (excluding farms and

restaurants) who manufactures, processes, packs, transports,

distributes, holds, or imports foods, the inspection shall extend

to all records and other information described in section 350c of

this title when the Secretary has a reasonable belief that an

article of food is adulterated and presents a threat of serious

adverse health consequences or death to humans or animals, subject

to the limitations established in section 350c(d) of this title.

In the case of any factory, warehouse, establishment, or consulting

laboratory in which prescription drugs, nonprescription drugs

intended for human use, or restricted devices are manufactured,

processed, packed, or held, the inspection shall extend to all

things therein (including records, files, papers, processes,

controls, and facilities) bearing on whether prescription drugs,

nonprescription drugs intended for human use, or restricted devices

which are adulterated or misbranded within the meaning of this

chapter, or which may not be manufactured, introduced into

interstate commerce, or sold, or offered for sale by reason of any

provision of this chapter, have been or are being manufactured,

processed, packed, transported, or held in any such place, or

otherwise bearing on violation of this chapter. No inspection

authorized by the preceding sentence or by paragraph (3) shall

extend to financial data, sales data other than shipment data,

pricing data, personnel data (other than data as to qualification

of technical and professional personnel performing functions

subject to this chapter), and research data (other than data

relating to new drugs, antibiotic drugs, and devices and subject to

reporting and inspection under regulations lawfully issued pursuant

to section 355(i) or (k) (FOOTNOTE 1) section 360i, or 360j(g) of

this title, and data relating to other drugs or devices which in

the case of a new drug would be subject to reporting or inspection

under lawful regulations issued pursuant to section 355(j) of this

title). A separate notice shall be given for each such inspection,

but a notice shall not be required for each entry made during the

period covered by the inspection. Each such inspection shall be

commenced and completed with reasonable promptness.

(FOOTNOTE 1) So in original. Probably should be followed by a

comma.

(2) The provisions of the third sentence of paragraph (1) shall

not apply to -

(A) pharmacies which maintain establishments in conformance

with any applicable local laws regulating the practice of

pharmacy and medicine and which are regularly engaged in

dispensing prescription drugs or devices, upon prescriptions of

practitioners licensed to administer such drugs or devices to

patients under the care of such practitioners in the course of

their professional practice, and which do not, either through a

subsidiary or otherwise, manufacture, prepare, propagate,

compound, or process drugs or devices for sale other than in the

regular course of their business of dispensing or selling drugs

or devices at retail;

(B) practitioners licensed by law to prescribe or administer

drugs, or prescribe or use devices, as the case may be, and who

manufacture, prepare, propagate, compound, or process drugs, or

manufacture or process devices, solely for use in the course of

their professional practice;

(C) persons who manufacture, prepare, propagate, compound, or

process drugs or manufacture or process devices, solely for use

in research, teaching, or chemical analysis and not for sale;

(D) such other classes of persons as the Secretary may by

regulation exempt from the application of this section upon a

finding that inspection as applied to such classes of persons in

accordance with this section is not necessary for the protection

of the public health.

(3) An officer or employee making an inspection under paragraph

(1) for purposes of enforcing the requirements of section 350a of

this title applicable to infant formulas shall be permitted, at all

reasonable times, to have access to and to copy and verify any

records -

(A) bearing on whether the infant formula manufactured or held

in the facility inspected meets the requirements of section 350a

of this title, or

(B) required to be maintained under section 350a of this title.

(b) Written report to owner; copy to Secretary

Upon completion of any such inspection of a factory, warehouse,

consulting laboratory, or other establishment, and prior to leaving

the premises, the officer or employee making the inspection shall

give to the owner, operator, or agent in charge a report in writing

setting forth any conditions or practices observed by him which, in

his judgment, indicate that any food, drug, device, or cosmetic in

such establishment (1) consists in whole or in part of any filthy,

putrid, or decomposed substance, or (2) has been prepared, packed,

or held under insanitary conditions whereby it may have become

contaminated with filth, or whereby it may have been rendered

injurious to health. A copy of such report shall be sent promptly

to the Secretary.

(c) Receipt for samples taken

If the officer or employee making any such inspection of a

factory, warehouse, or other establishment has obtained any sample

in the course of the inspection, upon completion of the inspection

and prior to leaving the premises he shall give to the owner,

operator, or agent in charge a receipt describing the samples

obtained.

(d) Analysis of samples furnished owner

Whenever in the course of any such inspection of a factory or

other establishment where food is manufactured, processed, or

packed, the officer or employee making the inspection obtains a

sample of any such food, and an analysis is made of such sample for

the purpose of ascertaining whether such food consists in whole or

in part of any filthy, putrid, or decomposed substance, or is

otherwise unfit for food, a copy of the results of such analysis

shall be furnished promptly to the owner, operator, or agent in

charge.

(e) Accessibility of records

Every person required under section 360i or 360j(g) of this title

to maintain records and every person who is in charge or custody of

such records shall, upon request of an officer or employee

designated by the Secretary, permit such officer or employee at all

reasonable times to have access to, and to copy and verify, such

records.

(f) Recordkeeping

(1) An accredited person described in paragraph (3) shall

maintain records documenting the training qualifications of the

person and the employees of the person, the procedures used by the

person for handling confidential information, the compensation

arrangements made by the person, and the procedures used by the

person to identify and avoid conflicts of interest. Upon the

request of an officer or employee designated by the Secretary, the

person shall permit the officer or employee, at all reasonable

times, to have access to, to copy, and to verify, the records.

(2) Within 15 days after the receipt of a written request from

the Secretary to an accredited person described in paragraph (3)

for copies of records described in paragraph (1), the person shall

produce the copies of the records at the place designated by the

Secretary.

(3) For purposes of paragraphs (1) and (2), an accredited person

described in this paragraph is a person who -

(A) is accredited under subsection (g) of this section; or

(B) is accredited under section 360m of this title.

(g) Inspections by accredited persons

(1) Not later than one year after October 26, 2002, the Secretary

shall, subject to the provisions of this subsection, accredit

persons for the purpose of conducting inspections of establishments

that manufacture, prepare, propagate, compound, or process class II

or class III devices that are required in section 360(h) of this

title, or inspections of such establishments required to register

pursuant to section 360(i) of this title. The owner or operator of

such an establishment that is eligible under paragraph (6) may,

from the list published under paragraph (4), select an accredited

person to conduct such inspections.

(2) Not later than 180 days after October 26, 2002, the Secretary

shall publish in the Federal Register criteria to accredit or deny

accreditation to persons who request to perform the duties

specified in paragraph (1). Thereafter, the Secretary shall inform

those requesting accreditation, within 60 days after the receipt of

such request, whether the request for accreditation is adequate for

review, and the Secretary shall promptly act on the request for

accreditation. Any resulting accreditation shall state that such

person is accredited to conduct inspections at device

establishments identified in paragraph (1). The accreditation of

such person shall specify the particular activities under this

subsection for which such person is accredited. In the first year

following the publication in the Federal Register of criteria to

accredit or deny accreditation to persons who request to perform

the duties specified in paragraph (1), the Secretary shall accredit

no more than 15 persons who request to perform duties specified in

paragraph (1).

(3) An accredited person shall, at a minimum, meet the following

requirements:

(A) Such person may not be an employee of the Federal

Government.

(B) Such person shall be an independent organization which is

not owned or controlled by a manufacturer, supplier, or vendor of

articles regulated under this chapter and which has no

organizational, material, or financial affiliation (including a

consultative affiliation) with such a manufacturer, supplier, or

vendor.

(C) Such person shall be a legally constituted entity permitted

to conduct the activities for which it seeks accreditation.

(D) Such person shall not engage in the design, manufacture,

promotion, or sale of articles regulated under this chapter.

(E) The operations of such person shall be in accordance with

generally accepted professional and ethical business practices,

and such person shall agree in writing that at a minimum the

person will -

(i) certify that reported information accurately reflects

data reviewed, inspection observations made, other matters that

relate to or may influence compliance with this chapter, and

recommendations made during an inspection or at an inspection's

closing meeting;

(ii) limit work to that for which competence and capacity are

available;

(iii) treat information received, records, reports, and

recommendations as confidential commercial or financial

information or trade secret information, except such

information may be made available to the Secretary;

(iv) promptly respond and attempt to resolve complaints

regarding its activities for which it is accredited; and

(v) protect against the use, in carrying out paragraph (1),

of any officer or employee of the accredited person who has a

financial conflict of interest regarding any product regulated

under this chapter, and annually make available to the public

disclosures of the extent to which the accredited person, and

the officers and employees of the person, have maintained

compliance with requirements under this clause relating to

financial conflicts of interest.

(4) The Secretary shall publish on the Internet site of the Food

and Drug Administration a list of persons who are accredited under

paragraph (2). Such list shall be updated to ensure that the

identity of each accredited person, and the particular activities

for which the person is accredited, is known to the public. The

updating of such list shall be no later than one month after the

accreditation of a person under this subsection or the suspension

or withdrawal of accreditation, or the modification of the

particular activities for which the person is accredited.

(5)(A) To ensure that persons accredited under this subsection

continue to meet the standards of accreditation, the Secretary

shall (i) audit the performance of such persons on a periodic basis

through the review of inspection reports and inspections by persons

designated by the Secretary to evaluate the compliance status of a

device establishment and the performance of accredited persons, and

(ii) take such additional measures as the Secretary determines to

be appropriate.

(B) The Secretary may withdraw accreditation of any person

accredited under paragraph (2), after providing notice and an

opportunity for an informal hearing, when such person is

substantially not in compliance with the standards of

accreditation, or poses a threat to public health or fails to act

in a manner that is consistent with the purposes of this

subsection. The Secretary may suspend the accreditation of such

person during the pendency of the process under the preceding

sentence.

(6)(A) Subject to subparagraphs (B) and (C), a device

establishment is eligible for inspections by persons accredited

under paragraph (2) if the following conditions are met:

(i) The Secretary classified the results of the most recent

inspection of the establishment pursuant to subsection (h) or (i)

of section 360 of this title as ''no action indicated'' or

''voluntary action indicated''.

(ii) With respect to each inspection to be conducted by an

accredited person -

(I) the owner or operator of the establishment submits to the

Secretary a notice requesting clearance to use such a person to

conduct the inspection, and the Secretary provides such

clearance; and

(II) such notice identifies the accredited person whom the

establishment has selected to conduct the inspection, and the

Secretary agrees to the selected accredited person.

(iii) With respect to the devices that are manufactured,

prepared, propagated, compounded, or processed by the

establishment, at least one of such devices is marketed in the

United States, and the following additional conditions are met:

(I) At least one of such devices is marketed, or is intended

to be marketed, in one or more foreign countries, one of which

countries certifies, accredits, or otherwise recognizes the

person accredited under paragraph (2) and identified under

subclause (II) of this clause.

(II) The owner or operator of the establishment submits to

the Secretary a statement that the law of a country in which

such a device is marketed, or is intended to be marketed,

recognizes an inspection of the establishment by the Secretary,

and not later than 30 days after receiving such statement, the

Secretary informs the owner or operator of the establishment

that the owner or operator may submit a notice requesting

clearance under clause (ii).

(iv)(I) In the case of an inspection to be conducted pursuant

to 360(h) of this title, persons accredited under paragraph (2)

did not conduct the two immediately preceding inspections of the

establishment, except that the establishment may petition the

Secretary for a waiver of such condition. Such a waiver may be

granted only if the petition states a commercial reason for the

waiver; the Secretary determines that the public health would be

served by granting the waiver; and the Secretary has conducted an

inspection of the establishment during the four-year period

preceding the date on which the notice under clause (ii) is

submitted to the Secretary. Such a waiver is deemed to be granted

only if the petition states a commercial reason for the waiver;

the Secretary has not determined that the public health would be

served by granting the waiver; and the owner or operator of the

device establishment has requested in writing, not later than 18

months following the most recent inspection of such establishment

by a person accredited under paragraph (2), that the Secretary

inspect the establishment and the Secretary has not conducted an

inspection within 30 months after the most recent inspection.

With respect to such a waiver that is granted or deemed to be

granted, no additional such waiver may be granted until after the

Secretary has conducted an inspection of the establishment.

(II) In the case of an inspection to be conducted pursuant to

360(i) of this title, the Secretary periodically conducts

inspections of the establishment.

(B)(i) The Secretary shall respond to a notice under subparagraph

(A) from a device establishment not later than 30 days after the

Secretary receives the notice. Through such response, the

Secretary shall (I) provide clearance under such subparagraph, and

agree to the selection of an accredited person, or (II) make a

request under clause (ii). If the Secretary fails to respond to the

notice within such 30-day period, the establishment is deemed to

have such clearance, and to have the agreement of the Secretary for

such selection.

(ii) The request referred to in clause (i)(II) is -

(I) a request to the device establishment involved to submit to

the Secretary compliance data in accordance with clause (iii); or

(II) a request to the establishment, or to the accredited

person identified in the notice under subparagraph (A), for

information concerning the relationship between the establishment

and such accredited person, including information about the

number of inspections of the establishment, or other

establishments owned or operated by the owner or operator of the

establishment, that have been conducted by the accredited person.

The Secretary may make both such requests.

(iii) The compliance data to be submitted by a device

establishment under clause (ii) are data describing whether the

quality controls of the establishment have been sufficient for

ensuring consistent compliance with current good manufacturing

practice within the meaning of section 351(h) of this title, and

data otherwise describing whether the establishment has

consistently been in compliance with sections 351 and 352 of this

title and other applicable provisions of this chapter. Such data

shall include complete reports of inspections regarding good

manufacturing practice or other quality control audits that, during

the preceding two-year period, were conducted at the establishment

by persons other than the owner or operator of the establishment,

together with all other compliance data the Secretary deems

necessary. Data under the preceding sentence shall demonstrate to

the Secretary whether the establishment has facilitated consistent

compliance by promptly correcting any compliance problems

identified in such inspections.

(iv) Not later than 60 days after receiving compliance data under

clause (iii) from a device establishment, the Secretary shall

provide or deny clearance under subparagraph (A). The Secretary may

deny clearance if the Secretary determines that the establishment

has failed to demonstrate consistent compliance for purposes of

clause (iii). The Secretary shall provide to the establishment a

statement of such reasons for such determination. If the Secretary

fails to provide such statement to the establishment within such

60-day period, the establishment is deemed to have such clearance.

(v)(I) A request to an accredited person under clause (ii)(II)

may not seek any information that is not required to be maintained

by such person in records under subsection (f)(1) of this section.

Not later than 60 days after receiving the information sought by

the request, the Secretary shall agree to, or reject, the selection

of such person by the device establishment involved. The Secretary

may reject the selection if the Secretary provides to the

establishment a statement of the reasons for such rejection.

Reasons for the rejection may include that the establishment or the

accredited person, as the case may be, has failed to fully respond

to the request, or that the Secretary has concerns regarding the

relationship between the establishment and such accredited person.

If within such 60-day period the Secretary fails to agree to or

reject the selection in accordance with this subclause, the

Secretary is deemed to have agreed to the selection.

(II) If the Secretary rejects the selection of an accredited

person by a device establishment, the establishment may make an

additional selection of an accredited person by submitting to the

Secretary a notice that identifies the additional selection.

Clauses (i) and (ii), and subclause (I) of this clause, apply to

the selection of an accredited person through a notice under the

preceding sentence in the same manner and to the same extent as

such provisions apply to a selection of an accredited person

through a notice under subparagraph (A).

(vi) In the case of a device establishment that under clause (iv)

is denied clearance under subparagraph (A), or whose selection of

an accredited person is rejected under clause (v), the Secretary

shall designate a person to review the findings of the Secretary

under such clause if, during the 30-day period beginning on the

date on which the establishment receives the findings, the

establishment requests the review. The review shall commence not

later than 30 days after the establishment requests the review,

unless the Secretary and the establishment otherwise agree.

(C)(i) In the case of a device establishment for which the

Secretary classified the results of the most recent inspection of

the establishment by a person accredited under paragraph (2) as

''official action indicated'', the establishment, if otherwise

eligible under subparagraph (A), is eligible for further

inspections by persons accredited under such paragraph if (I) the

Secretary issues a written statement to the owner or operator of

the establishment that the violations leading to such

classification have been resolved, and (II) the Secretary, either

upon the Secretary's own initiative or a petition of the owner or

operator of the establishment, notifies the establishment that it

has clearance to use an accredited person for the inspections. The

Secretary shall respond to such petition within 30 days after the

receipt of the petition.

(ii) If the Secretary denies a petition under clause (i), the

device establishment involved may, after the expiration of one year

after such denial, again petition the Secretary for a determination

of eligibility for inspection by persons accredited by the

Secretary under paragraph (2). If the Secretary denies such

petition, the Secretary shall provide the establishment with such

reasons for such denial within 60 days after the denial. If, as of

the expiration of 48 months after the receipt of the first

petition, the establishment has not been inspected by the Secretary

in accordance with section 360(h) of this title, or has not during

such period been inspected pursuant to section 360(i) of this

title, as applicable, the establishment is eligible for further

inspections by accredited persons.

(7)(A) Persons accredited under paragraph (2) to conduct

inspections shall record in writing their inspection observations

and shall present the observations to the device establishment's

designated representative and describe each observation.

Additionally, such accredited person shall prepare an inspection

report (including for inspections classified as ''no action

indicated'') in a form and manner consistent with such reports

prepared by employees and officials designated by the Secretary to

conduct inspections.

(B) At a minimum, an inspection report under subparagraph (A)

shall identify the persons responsible for good manufacturing

practice compliance at the inspected device establishment, the

dates of the inspection, the scope of the inspection, and shall

describe in detail each observation identified by the accredited

person, identify other matters that relate to or may influence

compliance with this chapter, and describe any recommendations

during the inspection or at the inspection's closing meeting.

(C) An inspection report under subparagraph (A) shall be sent to

the Secretary and to the designated representative of the inspected

device establishment at the same time, but under no circumstances

later than three weeks after the last day of the inspection. The

report to the Secretary shall be accompanied by all written

inspection observations previously provided to the designated

representative of the establishment.

(D) Any statement or representation made by an employee or agent

of a device establishment to a person accredited under paragraph

(2) to conduct inspections shall be subject to section 1001 of

title 18.

(E) If at any time during an inspection by an accredited person

the accredited person discovers a condition that could cause or

contribute to an unreasonable risk to the public health, the

accredited person shall immediately notify the Secretary of the

identification of the device establishment subject to inspection

and such condition.

(8) Compensation for an accredited person shall be determined by

agreement between the accredited person and the person who engages

the services of the accredited person, and shall be paid by the

person who engages such services.

(9) Nothing in this subsection affects the authority of the

Secretary to inspect any device establishment pursuant to this

chapter.

(10)(A) For fiscal year 2005 and each subsequent fiscal year, no

device establishment may be inspected during the fiscal year

involved by a person accredited under paragraph (2) if -

(i) of the amounts appropriated for salaries and expenses of

the Food and Drug Administration for the preceding fiscal year

(referred to in this subparagraph as the ''first prior fiscal

year''), the amount obligated by the Secretary for inspections of

device establishments by the Secretary was less than the adjusted

base amount applicable to such first prior fiscal year; and

(ii) of the amounts appropriated for salaries and expenses of

the Food and Drug Administration for the fiscal year preceding

the first prior fiscal year (referred to in this subparagraph as

the ''second prior fiscal year''), the amount obligated by the

Secretary for inspections of device establishments by the

Secretary was less than the adjusted base amount applicable to

such second prior fiscal year.

(B)(i) Subject to clause (ii), the Comptroller General of the

United States shall determine the amount that was obligated by the

Secretary for fiscal year 2002 for compliance activities of the

Food and Drug Administration with respect to devices (referred to

in this subparagraph as the ''compliance budget''), and of such

amount, the amount that was obligated for inspections by the

Secretary of device establishments (referred to in this

subparagraph as the ''inspection budget'').

(ii) For purposes of determinations under clause (i), the

Comptroller General shall not include in the compliance budget or

the inspection budget any amounts obligated for inspections of

device establishments conducted as part of the process of reviewing

applications under section 360e of this title.

(iii) Not later than March 31, 2003, the Comptroller General

shall complete the determinations required in this subparagraph and

submit to the Secretary and the Congress a reporting describing the

findings made through such determinations.

(C) For purposes of this paragraph:

(i) The term ''base amount'' means the inspection budget

determined under subparagraph (B) for fiscal year 2002.

(ii) The term ''adjusted base amount'', in the case of

applicability to fiscal year 2003, means an amount equal to the

base amount increased by 5 percent.

(iii) The term ''adjusted base amount'', with respect to

applicability to fiscal year 2004 or any subsequent fiscal year,

means the adjusted based amount applicable to the preceding year

increased by 5 percent.

(11) The authority provided by this subsection terminates on

October 1, 2012.

(12) No later than four years after October 26, 2002, the

Comptroller General shall report to the Committee on Energy and

Commerce of the House of Representatives and the Committee on

Health, Education, Labor and Pensions of the Senate -

(A) the number of inspections pursuant to subsections (h) and

(i) of section 360 of this title conducted by accredited persons

and the number of inspections pursuant to such subsections

conducted by Federal employees;

(B) the number of persons who sought accreditation under this

subsection, as well as the number of persons who were accredited

under this subsection;

(C) the reasons why persons who sought accreditation, but were

denied accreditation, were denied;

(D) the number of audits conducted by the Secretary of

accredited persons, the quality of inspections conducted by

accredited persons, whether accredited persons are meeting their

obligations under this chapter, and whether the number of audits

conducted is sufficient to permit these assessments;

(E) whether this subsection is achieving the goal of ensuring

more information about device establishment compliance is being

presented to the Secretary, and whether that information is of a

quality consistent with information obtained by the Secretary

pursuant to subsection (h) or (i) of section 360 of this title;

(F) whether this subsection is advancing efforts to allow

device establishments to rely upon third-party inspections for

purposes of compliance with the laws of foreign governments; and

(G) whether the Congress should continue, modify, or terminate

the program under this subsection.

(13) The Secretary shall include in the annual report required

under section 393(g) of this title the names of all accredited

persons and the particular activities under this subsection for

which each such person is accredited and the name of each

accredited person whose accreditation has been withdrawn during the

year.

(14) Notwithstanding any provision of this subsection, this

subsection does not have any legal effect on any agreement

described in section 383(b) of this title between the Secretary and

a foreign country.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 704, 52 Stat. 1057; Aug. 7, 1953, ch.

350, Sec. 1, 67 Stat. 476; Pub. L. 87-781, title II, Sec. 201(a),

(b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, Sec. 6, May

28, 1976, 90 Stat. 581; Pub. L. 96-359, Sec. 4, Sept. 26, 1980, 94

Stat. 1193; Pub. L. 103-80, Sec. 3(aa), Aug. 13, 1993, 107 Stat.

778; Pub. L. 105-115, title I, Sec. 125(b)(2)(L), title II, Sec.

210(b), title IV, Sec. 412(b), Nov. 21, 1997, 111 Stat. 2326, 2344,

2375; Pub. L. 107-188, title III, Sec. 306(b), June 12, 2002, 116

Stat. 670; Pub. L. 107-250, title II, Sec. 201(a), (b), Oct. 26,

2002, 116 Stat. 1602, 1609.)

-MISC1-

AMENDMENTS

2002 - Subsec. (a)(1). Pub. L. 107-188, Sec. 306(b)(1), inserted

after first sentence ''In the case of any person (excluding farms

and restaurants) who manufactures, processes, packs, transports,

distributes, holds, or imports foods, the inspection shall extend

to all records and other information described in section 350c of

this title when the Secretary has a reasonable belief that an

article of food is adulterated and presents a threat of serious

adverse health consequences or death to humans or animals, subject

to the limitations established in section 350c(d) of this title.''

Subsec. (a)(2). Pub. L. 107-188, Sec. 306(b)(2), substituted

''third sentence'' for ''second sentence'' in introductory

provisions.

Subsec. (f)(1). Pub. L. 107-250, Sec. 201(b)(1), in first

sentence, substituted ''An accredited person described in paragraph

(3) shall maintain records'' for ''A person accredited under

section 360m of this title to review reports made under section

360(k) of this title and make recommendations of initial

classifications of devices to the Secretary shall maintain

records''.

Subsec. (f)(2). Pub. L. 107-250, Sec. 201(b)(2), substituted ''an

accredited person described in paragraph (3)'' for ''a person

accredited under section 360m of this title''.

Subsec. (f)(3). Pub. L. 107-250, Sec. 201(b)(3), added par. (3).

Subsec. (g). Pub. L. 107-250, Sec. 201(a), added subsec. (g).

1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 412(b), substituted

''prescription drugs, nonprescription drugs intended for human

use,'' for ''prescription drugs'' in two places.

Pub. L. 105-115, Sec. 125(b)(2)(L), struck out '', section 357(d)

or (g),'' before ''section 360i''.

Subsec. (f). Pub. L. 105-115, Sec. 210(b), added subsec. (f).

1993 - Subsec. (a)(1). Pub. L. 103-80 substituted a comma for

semicolon after ''finished and unfinished materials'' and ''section

355(i) or (k)'' for ''section 355(i) or (j)''.

1980 - Subsec. (a)(1). Pub. L. 96-359, Sec. 4(1), (2),

restructured first five sentences of former subsec. (a) as par. (1)

and, as so restructured, inserted reference to paragraph (3) and

substituted ''(A)'' and ''(B)'' for ''(1)'' and ''(2)'',

respectively.

Subsec. (a)(2). Pub. L. 96-359, Sec. 4(3), redesignated sixth

sentence of former subsec. (a) as par. (2) and, as so redesignated,

substituted reference to second sentence of paragraph (1) for

reference to former second sentence of this subsection, and

''(A)'', ''(B)'', ''(C)'', and ''(D)'', for ''(1)'', ''(2)'',

''(3)'', and ''(4)'', respectively.

Subsec. (a)(3). Pub. L. 96-359, Sec. 4(4), added par. (3).

1976 - Subsec. (a). Pub. L. 94-295, Sec. 6(a)-(c), expanded

existing provisions to encompass medical devices by inserting

references to factories, warehouses, establishments, and consulting

laboratories in which restricted devices are manufactured,

processed, packed, or held, inspections relating to devices,

reporting and inspection regulations issued pursuant to sections

360i and 360j(g) of this title, and the manufacture and processing

of devices.

Subsec. (e). Pub. L. 94-295, Sec. 6(d), added subsec. (e).

1962 - Subsec. (a). Pub. L. 87-781, Sec. 201(a), extended the

inspection, where prescription drugs are manufactured, processed,

packed, or held, to all things bearing on whether adulterated or

misbranded drugs, or any which may not be manufactured, introduced

in interstate commerce, or sold or offered for sale under any

provision of this chapter, have been or are being manufactured,

processed, packed, transported or held in any such place, or

otherwise bearing on violation of this chapter, but excluded from

such inspection, data concerning finance, sales other than

shipment, pricing, personnel other than qualifications of technical

and professional personnel, research other than relating to new

drugs subject to reporting, provided that provisions of second

sentence of this subsection shall be inapplicable to pharmacies,

practitioners and other persons enumerated in pars. (1) to (4), and

struck out ''are held'' before ''after such introduction''.

Subsec. (b). Pub. L. 87-781, Sec. 201(b), inserted ''consulting

laboratory'' after ''warehouse''.

1953 - Act Aug. 7, 1953, designated existing provisions as

subsec. (a) and amended them by substituting provisions permitting

entry and inspection upon presentation of appropriate credentials

and a written notice to the owner, operator, or agent in charge for

provisions which authorized entry and inspection only after making

a request and obtaining permission from the owner, operator, or

custodian, and inserting provisions requiring a separate written

notice for each inspection but not for each entry made during the

period covered by the inspection, and directing that the inspection

shall be conducted within reasonable limits, in a reasonable manner

and completed with reasonable promptness, and added subsecs. (b) to

(d).

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by sections 210(b) and 412(b) of Pub. L. 105-115

effective 90 days after Nov. 21, 1997, except as otherwise

provided, see section 501 of Pub. L. 105-115, set out as a note

under section 321 of this title.

EFFECTIVE DATE OF 1962 AMENDMENT

Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section

203 of Pub. L. 87-781, set out as a note under section 332 of this

title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

AUTHORITY OF SECRETARY PRIOR TO OCTOBER 10, 1962

Section 201(d) of Pub. L. 87-781 provided that: ''Nothing in the

amendments made by subsections (a) and (b) of this section

(amending this section) shall be construed to negate or derogate

from any authority of the Secretary existing prior to the enactment

of this Act (Oct. 10, 1962).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 333, 334, 335a, 360,

360e, 360j, 379l of this title.

-CITE-

21 USC Sec. 375 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 375. Publicity

-STATUTE-

(a) Reports

The Secretary shall cause to be published from time to time

reports summarizing all judgments, decrees, and court orders which

have been rendered under this chapter, including the nature of the

charge and the disposition thereof.

(b) Information regarding certain goods

The Secretary may also cause to be disseminated information

regarding food, drugs, devices, or cosmetics in situations

involving, in the opinion of the Secretary, imminent danger to

health or gross deception of the consumer. Nothing in this section

shall be construed to prohibit the Secretary from collecting,

reporting, and illustrating the results of the investigations of

the Department.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 705, 52 Stat. 1057.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360h of this title.

-CITE-

21 USC Sec. 376 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 376. Examination of sea food on request of packer; marking

food with results; fees; penalties

-STATUTE-

The Secretary, upon application of any packer of any sea food for

shipment or sale within the jurisdiction of this chapter, may, at

his discretion, designate inspectors to examine and inspect such

food and the production, packing, and labeling thereof. If on such

examination and inspection compliance is found with the provisions

of this chapter and regulations promulgated thereunder, the

applicant shall be authorized or required to mark the food as

provided by regulation to show such compliance. Services under

this section shall be rendered only upon payment by the applicant

of fees fixed by regulation in such amounts as may be necessary to

provide, equip, and maintain an adequate and efficient inspection

service. Receipts from such fees shall be covered into the

Treasury and shall be available to the Secretary for expenditures

incurred in carrying out the purposes of this section, including

expenditures for salaries of additional inspectors when necessary

to supplement the number of inspectors for whose salaries Congress

has appropriated. The Secretary is authorized to promulgate

regulations governing the sanitary and other conditions under which

the service herein provided shall be granted and maintained, and

for otherwise carrying out the purposes of this section. Any

person who forges, counterfeits, simulates, or falsely represents,

or without proper authority uses any mark, stamp, tag, label, or

other identification devices authorized or required by the

provisions of this section or regulations thereunder, shall be

guilty of a misdemeanor, and shall on conviction thereof be subject

to imprisonment for not more than one year or a fine of not less

than $1,000 nor more than $5,000, or both such imprisonment and

fine.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 706, formerly Sec. 702A, formerly

June 30, 1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712,

48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June

25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059; renumbered Sec. 702A

of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat.

500; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;

renumbered Sec. 706, Pub. L. 102-571, title I, Sec. 106(3), Oct.

29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(dd)(2), Aug. 13,

1993, 107 Stat. 779.)

-COD-

CODIFICATION

Section was formerly classified to section 372a of this title

prior to renumbering by Pub. L. 102-571.

Section, which formerly was not a part of the Federal Food, Drug,

and Cosmetic Act, originally was classified to section 14a of this

title. Section 902(a) of act June 25, 1938, set out as an

Effective Date note under section 301 of this title, provided that

the section should remain in force and effect and be applicable to

the provisions of this chapter. Act July 12, 1943, renumbered this

section as 702A of the Federal Food, Drug, and Cosmetic Act.

-MISC3-

PRIOR PROVISIONS

A prior section 376, act June 25, 1938, ch. 675, Sec. 706, 52

Stat. 1058, as amended, which related to listing and certification

of color additives for foods, drugs, devices, and cosmetics, was

renumbered section 721 of act June 25, 1938, by Pub. L. 102-571,

title I, Sec. 106(4), Oct. 29, 1992, 106 Stat. 4498, and

transferred to section 379e of this title.

AMENDMENTS

1993 - Pub. L. 103-80 struck out ''of Agriculture'' after

''Secretary'' in two places.

1992 - Pub. L. 102-300, which directed the amendment of the

section by striking out ''of Health, Education, and Welfare''

wherever appearing, could not be executed because such words did

not appear in the original statutory text. See 1993 Amendment note

above and Transfer of Functions note below.

-TRANS-

TRANSFER OF FUNCTIONS

Secretary and Department of Health, Education, and Welfare

redesignated Secretary and Department of Health and Human Services

by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.

695, which is classified to section 3508(b) of Title 20, Education.

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-CITE-

21 USC Sec. 377 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 377. Revision of United States Pharmacopoeia; development of

analysis and mechanical and physical tests

-STATUTE-

The Secretary, in carrying into effect the provisions of this

chapter, is authorized on and after July 12, 1943, to cooperate

with associations and scientific societies in the revision of the

United States Pharmacopoeia and in the development of methods of

analysis and mechanical and physical tests necessary to carry out

the work of the Food and Drug Administration.

-SOURCE-

(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan

No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

-COD-

CODIFICATION

Section was enacted as part of the Labor-Federal Security

Appropriation Act, 1944, and not as part of the Federal Food, Drug,

and Cosmetic Act which comprises this chapter.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-CITE-

21 USC Sec. 378 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 378. Advertising of foods

-STATUTE-

(a) Determination of misbranding; notification of Federal Trade

Commission by Secretary; contents

(1) Except as provided in subsection (c) of this section, before

the Secretary may initiate any action under subchapter III of this

chapter -

(A) with respect to any food which the Secretary determines is

misbranded under section 343(a)(2) of this title because of its

advertising, or

(B) with respect to a food's advertising which the Secretary

determines causes the food to be so misbranded,

the Secretary shall, in accordance with paragraph (2), notify in

writing the Federal Trade Commission of the action the Secretary

proposes to take respecting such food or advertising.

(2) The notice required by paragraph (1) shall -

(A) contain (i) a description of the action the Secretary

proposes to take and of the advertising which the Secretary has

determined causes a food to be misbranded, (ii) a statement of

the reasons for the Secretary's determination that such

advertising has caused such food to be misbranded, and

(B) be accompanied by the records, documents, and other written

materials which the Secretary determines supports his

determination that such food is misbranded because of such

advertising.

(b) Action by Federal Trade Commission precluding action by

Secretary; exception

(1) If the Secretary notifies the Federal Trade Commission under

subsection (a) of this section of action proposed to be taken under

subchapter III of this chapter with respect to a food or food

advertising and the Commission notifies the Secretary in writing,

within the 30-day period beginning on the date of the receipt of

such notice, that -

(A) it has initiated under the Federal Trade Commission Act (15

U.S.C. 41 et seq.) an investigation of such advertising to

determine if it is prohibited by such Act or any order or rule

under such Act,

(B) it has commenced (or intends to commence) a civil action

under section 5, 13, or 19 (15 U.S.C. 45, 53, or 57b) with

respect to such advertising or the Attorney General has commenced

(or intends to commence) a civil action under section 5 (15

U.S.C. 45) with respect to such advertising,

(C) it has issued and served (or intends to issue and serve) a

complaint under section 5(b) of such Act (15 U.S.C. 45(b))

respecting such advertising, or

(D) pursuant to section 16(b) of such Act (15 U.S.C. 56(b)) it

has made a certification to the Attorney General respecting such

advertising,

the Secretary may not, except as provided by paragraph (2),

initiate the action described in the Secretary's notice to the

Federal Trade Commission.

(2) If, before the expiration of the 60-day period beginning on

the date the Secretary receives a notice described in paragraph (1)

from the Federal Trade Commission in response to a notice of the

Secretary under subsection (a) of this section -

(A) the Commission or the Attorney General does not commence a

civil action described in subparagraph (B) of paragraph (1) of

this subsection respecting the advertising described in the

Secretary's notice,

(B) the Commission does not issue and serve a complaint

described in subparagraph (C) of such paragraph respecting such

advertising, or

(C) the Commission does not (as described in subparagraph (D)

of such paragraph) make a certification to the Attorney General

respecting such advertising, or, if the Commission does make such

a certification to the Attorney General respecting such

advertising, the Attorney General, before the expiration of such

period, does not cause appropriate criminal proceedings to be

brought against such advertising,

the Secretary may, after the expiration of such period, initiate

the action described in the notice to the Commission pursuant to

subsection (a) of this section. The Commission shall promptly

notify the Secretary of the commencement by the Commission of such

a civil action, the issuance and service by it of such a complaint,

or the causing by the Attorney General of criminal proceedings to

be brought against such advertising.

(c) Secretary's determination of imminent hazard to health as

suspending applicability of provisions

The requirements of subsections (a) and (b) of this section do

not apply with respect to action under subchapter III of this

chapter with respect to any food or food advertising if the

Secretary determines that such action is required to eliminate an

imminent hazard to health.

(d) Coordination of action by Secretary with Federal Trade

Commission

For the purpose of avoiding unnecessary duplication, the

Secretary shall coordinate any action taken under subchapter III of

this chapter because of advertising which the Secretary determines

causes a food to be misbranded with any action of the Federal Trade

Commission under the Federal Trade Commission Act (15 U.S.C. 41 et

seq.) with respect to such advertising.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 707, as added Pub. L. 94-278, title

V, Sec. 502(b), Apr. 22, 1976, 90 Stat. 412.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Trade Commission Act, referred to in subsecs. (b) and

(d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, as amended,

which is classified generally to subchapter I (Sec. 41 et seq.) of

chapter 2 of Title 15, Commerce and Trade. For complete

classification of this Act to the Code, see section 58 of Title 15

and Tables.

-CITE-

21 USC Sec. 379 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 379. Confidential information

-STATUTE-

The Secretary may provide any information which is exempt from

disclosure pursuant to subsection (a) of section 552 of title 5 by

reason of subsection (b)(4) of such section to a person other than

an officer or employee of the Department if the Secretary

determines such other person requires the information in connection

with an activity which is undertaken under contract with the

Secretary, which relates to the administration of this chapter, and

with respect to which the Secretary (or an officer or employee of

the Department) is not prohibited from using such information. The

Secretary shall require as a condition to the provision of

information under this section that the person receiving it take

such security precautions respecting the information as the

Secretary may by regulation prescribe.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 708, as added Pub. L. 94-295, Sec. 8,

May 28, 1976, 90 Stat. 582.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 397 of this title.

-CITE-

21 USC Sec. 379a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 379a. Presumption of existence of jurisdiction

-STATUTE-

In any action to enforce the requirements of this chapter

respecting a device, food, drug, or cosmetic the connection with

interstate commerce required for jurisdiction in such action shall

be presumed to exist.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 709, as added Pub. L. 94-295, Sec. 8,

May 28, 1976, 90 Stat. 583; amended Pub. L. 105-115, title IV, Sec.

419, Nov. 21, 1997, 111 Stat. 2379.)

-MISC1-

AMENDMENTS

1997 - Pub. L. 105-115 substituted ''a device, food, drug, or

cosmetic'' for ''a device''.

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

-CITE-

21 USC Sec. 379b 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 379b. Consolidated administrative and laboratory facility

-STATUTE-

(a) Authority

The Secretary, in consultation with the Administrator of the

General Services Administration, shall enter into contracts for the

design, construction, and operation of a consolidated Food and Drug

Administration administrative and laboratory facility.

(b) Awarding of contract

The Secretary shall solicit contract proposals under subsection

(a) of this section from interested parties. In awarding contracts

under such subsection, the Secretary shall review such proposals

and give priority to those alternatives that are the most cost

effective for the Federal Government and that allow for the use of

donated land, federally owned property, or lease-purchase

arrangements. A contract under this subsection shall not be

entered into unless such contract results in a net cost savings to

the Federal Government over the duration of the contract, as

compared to the Government purchase price including borrowing by

the Secretary of the Treasury.

(c) Donations

In carrying out this section, the Secretary shall have the power,

in connection with real property, buildings, and facilities, to

accept on behalf of the Food and Drug Administration gifts or

donations of services or property, real or personal, as the

Secretary determines to be necessary.

(d) Authorization of appropriations

There are authorized to be appropriated to carry out this section

$100,000,000 for fiscal year 1991, and such sums as may be

necessary for each of the subsequent fiscal years, to remain

available until expended.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 710, as added Pub. L. 101-635, title

I, Sec. 101, Nov. 28, 1990, 104 Stat. 4583.)

-CITE-

21 USC Sec. 379c 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 379c. Transferred

-COD-

CODIFICATION

Section, act June 25, 1938, ch. 675, Sec. 711, as added Nov. 28,

1990, Pub. L. 101-635, title II, Sec. 201, 104 Stat. 4584, which

related to recovery and retention of fees for freedom of

information requests, was renumbered section 731 of act June 25,

1938, by Pub. L. 102-571, title I, Sec. 106(6), Oct. 29, 1992, 106

Stat. 4499, and transferred to section 379f of this title.

-CITE-

21 USC Sec. 379d 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part A - General Administrative Provisions

-HEAD-

Sec. 379d. Automation of Food and Drug Administration

-STATUTE-

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs,

shall automate appropriate activities of the Food and Drug

Administration to ensure timely review of activities regulated

under this chapter.

(b) Authorization of appropriations

There are authorized to be appropriated each fiscal year such

sums as are necessary to carry out this section.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 711, formerly Sec. 712, as added Pub.

L. 101-635, title IV, Sec. 401, Nov. 28, 1990, 104 Stat. 4585;

renumbered Sec. 711, Pub. L. 102-571, title I, Sec. 106(3), Oct.

29, 1992, 106 Stat. 4498.)

-MISC1-

PRIOR PROVISIONS

A prior section 711 of act June 25, 1938, was renumbered section

731 by Pub. L. 102-571 and is classified to section 379f of this

title.

-CITE-

21 USC Part B - Colors 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part B - Colors

.

-HEAD-

Part B - Colors

-CITE-

21 USC Sec. 379e 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part B - Colors

-HEAD-

Sec. 379e. Listing and certification of color additives for foods,

drugs, devices, and cosmetics

-STATUTE-

(a) Unsafe color additives

A color additive shall, with respect to any particular use (for

which it is being used or intended to be used or is represented as

suitable) in or on food or drugs or devices or cosmetics, be deemed

unsafe for the purposes of the application of section 342(c),

351(a)(4), or 361(e) of this title, as the case may be, unless -

(1)(A) there is in effect, and such additive and such use are

in conformity with, a regulation issued under subsection (b) of

this section listing such additive for such use, including any

provision of such regulation prescribing the conditions under

which such additive may be safely used, and (B) such additive

either (i) is from a batch certified, in accordance with

regulations issued pursuant to subsection (c) of this section,

for such use, or (ii) has, with respect to such use, been

exempted by the Secretary from the requirement of certification;

or

(2) such additive and such use thereof conform to the terms of

an exemption which is in effect pursuant to subsection (f) of

this section.

While there are in effect regulations under subsections (b) and (c)

of this section relating to a color additive or an exemption

pursuant to subsection (f) of this section with respect to such

additive, an article shall not, by reason of bearing or containing

such additive in all respects in accordance with such regulations

or such exemption, be considered adulterated within the meaning of

clause (1) of section 342(a) of this title if such article is a

food, or within the meaning of section 361(a) of this title if such

article is a cosmetic other than a hair dye (as defined in the last

sentence of section 361(a) of this title). A color additive for

use in or on a device shall be subject to this section only if the

color additive comes in direct contact with the body of man or

other animals for a significant period of time. The Secretary may

by regulation designate the uses of color additives in or on

devices which are subject to this section.

(b) Listing of colors; regulations; issuance, amendment or repeal;

referral to advisory committee; report and recommendations;

appointment and compensation of advisory committee

(1) The Secretary shall, by regulation, provide for separately

listing color additives for use in or on food, color additives for

use in or on drugs, or devices, and color additives for use in or

on cosmetics, if and to the extent that such additives are suitable

and safe for any such use when employed in accordance with such

regulations.

(2)(A) Such regulations may list any color additive for use

generally in or on food, or in or on drugs or devices, or in or on

cosmetics, if the Secretary finds that such additive is suitable

and may safely be employed for such general use.

(B) If the data before the Secretary do not establish that the

additive satisfies the requirements for listing such additive on

the applicable list pursuant to subparagraph (A) of this paragraph,

or if the proposal is for listing such additive for a more limited

use or uses, such regulations may list such additive only for any

more limited use or uses for which it is suitable and may safely be

employed.

(3) Such regulations shall, to the extent deemed necessary by the

Secretary to assure the safety of the use or uses for which a

particular color additive is listed, prescribe the conditions under

which such additive may be safely employed for such use or uses

(including, but not limited to, specifications, hereafter in this

section referred to as tolerance limitations, as to the maximum

quantity or quantities which may be used or permitted to remain in

or on the article or articles in or on which it is used;

specifications as to the manner in which such additive may be added

to or used in or on such article or articles; and directions or

other labeling or packaging requirements for such additive).

(4) The Secretary shall not list a color additive under this

section for a proposed use unless the data before him establish

that such use, under the conditions of use specified in the

regulations, will be safe: Provided, however, That a color additive

shall be deemed to be suitable and safe for the purpose of listing

under this subsection for use generally in or on food, while there

is in effect a published finding of the Secretary declaring such

substance exempt from the term ''food additive'' because of its

being generally recognized by qualified experts as safe for its

intended use, as provided in section 321(s) of this title.

(5)(A) In determining, for the purposes of this section, whether

a proposed use of a color additive is safe, the Secretary shall

consider, among other relevant factors -

(i) the probable consumption of, or other relevant exposure

from, the additive and of any substance formed in or on food,

drugs or devices, or cosmetics because of the use of the

additive;

(ii) the cumulative effect, if any, of such additive in the

diet of man or animals, taking into account the same or any

chemically or pharmacologically related substance or substances

in such diet;

(iii) safety factors which, in the opinion of experts qualified

by scientific training and experience to evaluate the safety of

color additives for the use or uses for which the additive is

proposed to be listed, are generally recognized as appropriate

for the use of animal experimentation data; and

(iv) the availability of any needed practicable methods of

analysis for determining the identity and quantity of (I) the

pure dye and all intermediates and other impurities contained in

such color additive, (II) such additive in or on any article of

food, drug or device, or cosmetic, and (III) any substance formed

in or on such article because of the use of such additive.

(B) A color additive (i) shall be deemed unsafe, and shall not be

listed, for any use which will or may result in ingestion of all or

part of such additive, if the additive is found by the Secretary to

induce cancer when ingested by man or animal, or if it is found by

the Secretary, after tests which are appropriate for the evaluation

of the safety of additives for use in food, to induce cancer in man

or animal, and (ii) shall be deemed unsafe, and shall not be

listed, for any use which will not result in ingestion of any part

of such additive, if, after tests which are appropriate for the

evaluation of the safety of additives for such use, or after other

relevant exposure of man or animal to such additive, it is found by

the Secretary to induce cancer in man or animal: Provided, That

clause (i) of this subparagraph (B) shall not apply with respect to

the use of a color additive as an ingredient of feed for animals

which are raised for food production, if the Secretary finds that,

under the conditions of use and feeding specified in proposed

labeling and reasonably certain to be followed in practice, such

additive will not adversely affect the animals for which such feed

is intended, and that no residue of the additive will be found (by

methods of examination prescribed or approved by the Secretary by

regulations, which regulations shall not be subject to subsection

(d) of this section) in any edible portion of such animals after

slaughter or in any food yielded by or derived from the living

animal.

(C)(i) In any proceeding for the issuance, amendment, or repeal

of a regulation listing a color additive, whether commenced by a

proposal of the Secretary on his own initiative or by a proposal

contained in a petition, the petitioner, or any other person who

will be adversely affected by such proposal or by the Secretary's

order issued in accordance with paragraph (1) of section 371(e) of

this title if placed in effect, may request, within the time

specified in this subparagraph, that the petition or order thereon,

or the Secretary's proposal, be referred to an advisory committee

for a report and recommendations with respect to any matter arising

under subparagraph (B) of this paragraph, which is involved in such

proposal or order and which requires the exercise of scientific

judgment. Upon such request, or if the Secretary within such time

deems such a referral necessary, the Secretary shall forthwith

appoint an advisory committee under subparagraph (D) of this

paragraph and shall refer to it, together with all the data before

him, such matter arising under subparagraph (B) for study thereof

and for a report and recommendations on such matter. A person who

has filed a petition or who has requested the referral of a matter

to an advisory committee pursuant to this subparagraph (C), as well

as representatives of the Department, shall have the right to

consult with such advisory committee in connection with the matter

referred to it. The request for referral under this subparagraph,

or the Secretary's referral on his own initiative, may be made at

any time before, or within thirty days after, publication of an

order of the Secretary acting upon the petition or proposal.

(ii) Within sixty days after the date of such referral, or within

an additional thirty days if the committee deems such additional

time necessary, the committee shall, after independent study of the

data furnished to it by the Secretary and other data before it,

certify to the Secretary a report and recommendations, together

with all underlying data and a statement of the reasons or basis

for the recommendations. A copy of the foregoing shall be promptly

supplied by the Secretary to any person who has filed a petition,

or who has requested such referral to the advisory committee.

Within thirty days after such certification, and after giving due

consideration to all data then before him, including such report,

recommendations, underlying data, and statement, and to any prior

order issued by him in connection with such matter, the Secretary

shall by order confirm or modify any order theretofore issued or,

if no such prior order has been issued, shall by order act upon the

petition or other proposal.

(iii) Where -

(I) by reason of subparagraph (B) of this paragraph, the

Secretary has initiated a proposal to remove from listing a color

additive previously listed pursuant to this section; and

(II) a request has been made for referral of such proposal to

an advisory committee;

the Secretary may not act by order on such proposal until the

advisory committee has made a report and recommendations to him

under clause (ii) of this subparagraph and he has considered such

recommendations, unless the Secretary finds that emergency

conditions exist necessitating the issuance of an order

notwithstanding this clause.

(D) The advisory committee referred to in subparagraph (C) of

this paragraph shall be composed of experts selected by the

National Academy of Sciences, qualified in the subject matter

referred to the committee and of adequately diversified

professional background, except that in the event of the inability

or refusal of the National Academy of Sciences to act, the

Secretary shall select the members of the committee. The size of

the committee shall be determined by the Secretary. Members of any

advisory committee established under this chapter, while attending

conferences or meetings of their committees or otherwise serving at

the request of the Secretary, shall be entitled to receive

compensation at rates to be fixed by the Secretary but at rates not

exceeding the daily equivalent of the rate specified at the time of

such service for grade GS-18 of the General Schedule, including

traveltime; and while away from their homes or regular places of

business they may be allowed travel expenses, including per diem in

lieu of subsistence, as authorized by section 5703 of title 5 for

persons in the Government service employed intermittently. The

members shall not be subject to any other provisions of law

regarding the appointment and compensation of employees of the

United States. The Secretary shall furnish the committee with

adequate clerical and other assistance, and shall by rules and

regulations prescribe the procedure to be followed by the

committee.

(6) The Secretary shall not list a color additive under this

subsection for a proposed use if the data before him show that such

proposed use would promote deception of the consumer in violation

of this chapter or would otherwise result in misbranding or

adulteration within the meaning of this chapter.

(7) If, in the judgment of the Secretary, a tolerance limitation

is required in order to assure that a proposed use of a color

additive will be safe, the Secretary -

(A) shall not list the additive for such use if he finds that

the data before him do not establish that such additive, if used

within a safe tolerance limitation, would achieve the intended

physical or other technical effect; and

(B) shall not fix such tolerance limitation at a level higher

than he finds to be reasonably required to accomplish the

intended physical or other technical effect.

(8) If, having regard to the aggregate quantity of color additive

likely to be consumed in the diet or to be applied to the human

body, the Secretary finds that the data before him fail to show

that it would be safe and otherwise permissible to list a color

additive (or pharmacologically related color additives) for all the

uses proposed therefor and at the levels of concentration proposed,

the Secretary shall, in determining for which use or uses such

additive (or such related additives) shall be or remain listed, or

how the aggregate allowable safe tolerance for such additive or

additives shall be allocated by him among the uses under

consideration, take into account, among other relevant factors (and

subject to the paramount criterion of safety), (A) the relative

marketability of the articles involved as affected by the proposed

uses of the color additive (or of such related additives) in or on

such articles, and the relative dependence of the industries

concerned on such uses; (B) the relative aggregate amounts of such

color additive which he estimates would be consumed in the diet or

applied to the human body by reason of the various uses and levels

of concentration proposed; and (C) the availability, if any, of

other color additives suitable and safe for one or more of the uses

proposed.

(c) Certification of colors

The Secretary shall further, by regulation, provide (1) for the

certification, with safe diluents or without diluents, of batches

of color additives listed pursuant to subsection (b) of this

section and conforming to the requirements for such additives

established by regulations under such subsection and this

subsection, and (2) for exemption from the requirement of

certification in the case of any such additive, or any listing or

use thereof, for which he finds such requirement not to be

necessary in the interest of the protection of the public health:

Provided, That, with respect to any use in or on food for which a

listed color additive is deemed to be safe by reason of the proviso

to paragraph (4) of subsection (b), the requirement of

certification shall be deemed not to be necessary in the interest

of public health protection.

(d) Procedure for issuance, amendment, or repeal of regulations

The provisions of section 371(e), (f), and (g) of this title

shall, subject to the provisions of subparagraph (C) of subsection

(b)(5) of this section, apply to and in all respects govern

proceedings for the issuance, amendment, or repeal of regulations

under subsection (b) or (c) of this section (including judicial

review of the Secretary's action in such proceedings) and the

admissibility of transcripts of the record of such proceedings in

other proceedings, except that -

(1) if the proceeding is commenced by the filing of a petition,

notice of the proposal made by the petition shall be published in

general terms by the Secretary within thirty days after such

filing, and the Secretary's order (required by paragraph (1) of

section 371(e) of this title) acting upon such proposal shall, in

the absence of prior referral (or request for referral) to an

advisory committee, be issued within ninety days after the date

of such filing, except that the Secretary may (prior to such

ninetieth day), by written notice to the petitioner, extend such

ninety-day period to such time (not more than one hundred and

eighty days after the date of filing of the petition) as the

Secretary deems necessary to enable him to study and investigate

the petition;

(2) any report, recommendations, underlying data, and reasons

certified to the Secretary by an advisory committee appointed

pursuant to subparagraph (D) of subsection (b)(5) of this

section, shall be made a part of the record of any hearing if

relevant and material, subject to the provisions of section

556(d) of title 5. The advisory committee shall designate a

member to appear and testify at any such hearing with respect to

the report and recommendations of such committee upon request of

the Secretary, the petitioner, or the officer conducting the

hearing, but this shall not preclude any other member of the

advisory committee from appearing and testifying at such hearing;

(3) the Secretary's order after public hearing (acting upon

objections filed to an order made prior to hearing) shall be

subject to the requirements of section 348(f)(2) of this title;

and

(4) the scope of judicial review of such order shall be in

accordance with the fourth sentence of paragraph (2), and with

the provisions of paragraph (3), of section 348(g) of this title.

(e) Fees

The admitting to listing and certification of color additives, in

accordance with regulations prescribed under this chapter, shall be

performed only upon payment of such fees, which shall be specified

in such regulations, as may be necessary to provide, maintain, and

equip an adequate service for such purposes.

(f) Exemptions

The Secretary shall by regulations (issued without regard to

subsection (d) of this section) provide for exempting from the

requirements of this section any color additive or any specific

type of use thereof, and any article of food, drug, or device, or

cosmetic bearing or containing such additive, intended solely for

investigational use by qualified experts when in his opinion such

exemption is consistent with the public health.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 721, formerly Sec. 706, 52 Stat.

1058; Pub. L. 86-618, title I, Sec. 103(b), July 12, 1960, 74 Stat.

399; Pub. L. 87-781, title I, Sec. 104(f)(2), Oct. 10, 1962, 76

Stat. 785; Pub. L. 91-515, title VI, Sec. 601(d)(2), Oct. 30, 1970,

84 Stat. 1311; Pub. L. 94-295, Sec. 9(a), May 28, 1976, 90 Stat.

583; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.

695; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;

renumbered Sec. 721, Pub. L. 102-571, title I, Sec. 106(4), Oct.

29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(bb), Aug. 13,

1993, 107 Stat. 778.)

-COD-

CODIFICATION

Section was formerly classified to section 376 of this title

prior to renumbering by Pub. L. 102-571.

In subsec. (d)(2), ''section 556(d) of title 5'' substituted for

''section 7(c) of the Administrative Procedure Act (5 U.S.C., sec.

1006(c))'' on authority of Pub. L. 89-554, Sec. 7(b), Sept. 6,

1966, 80 Stat. 631, the first section of which enacted Title 5,

Government Organization and Employees.

-MISC3-

AMENDMENTS

1993 - Subsec. (b)(5)(D). Pub. L. 103-80 substituted ''section

5703'' for ''section 5703(b)''.

1992 - Subsec. (b)(5)(C)(i). Pub. L. 102-300 struck out ''of

Health, Education, and Welfare'' after ''representatives of the

Department''.

1976 - Subsec. (a). Pub. L. 94-295, Sec. 9(a)(2), (3), inserted

reference to devices and inserted provisions directing that color

additives for use in or on devices be subject to this section only

if the color additives come in direct contact with the body of man

or other animals for a significant period of time and authorizing

the Secretary to designate by regulation the uses of color

additives in or on devices which are subject to this section.

Subsec. (b). Pub. L. 94-295, Sec. 9(a)(1), (2), substituted

''drug or device'' for ''drug'' and ''drugs or devices'' for

''drugs'' wherever appearing.

Subsec. (f). Pub. L. 94-295, Sec. 9(a)(1), substituted ''drug or

device'' for ''drug''.

1970 - Subsec. (b)(5)(D). Pub. L. 91-515 substituted provisions

authorizing members of an advisory committee to receive

compensation at rates fixed by the Secretary, with a specific

maximum amount, and travel expenses, including per diem in lieu of

subsistence, as authorized by section 5703(b) of Title 5, for

provisions authorizing such members to receive as compensation a

reasonable per diem for time actually spent on committee work, and

necessary traveling and subsistence expenses while serving away

from their places of residence.

1962 - Subsec. (b)(5)(B). Pub. L. 87-781 provided that clause (i)

of this subparagraph shall not apply to a color additive in feed of

animals raised for food production, if under the conditions of use

specified in proposed labeling, and which conditions are reasonably

certain to be followed in practice, such additive will not

adversely affect the animals and no residue will be found in any

edible portion of such animal after slaughter or in any food from

the living animal.

1960 - Pub. L. 86-618 amended section generally. Prior to

amendment, section read as follows: ''The admitting to listing and

certification of coal-tar colors, in accordance with regulations

prescribed under this chapter, shall be performed only upon payment

of such fees, which shall be specified in such regulations, as may

be necessary to provide, maintain, and equip an adequate service

for such purposes.''

EFFECTIVE DATE OF 1962 AMENDMENT

Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section

107 of Pub. L. 87-781, set out as a note under section 321 of this

title.

EFFECTIVE DATE OF 1960 AMENDMENT, TRANSITIONAL PROVISIONS, AND

EFFECT ON OTHER LAWS

Title II of Pub. L. 86-618 provided that:

''Sec. 201. (Definitions.) As used in this title, the term 'basic

Act' means the Federal Food, Drug, and Cosmetic Act (this chapter);

the term 'enactment date' means the date of enactment of this Act

(July 12, 1960); and other terms, insofar as also used in the basic

Act (whether before or after enactment of this Act) shall have the

same meaning as they have, or had when in effect, under the basic

Act.

''Sec. 202. (Effective Date.) This Act (amending this section and

sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371

of this title and repealing sections 354 and 364 of this title)

shall, subject to the provisions of section 203, take effect on the

enactment date (July 12, 1960).

''Sec. 203. (Provisional Listings of Commercially Established

Colors.) (a)(1) The purpose of this section is to make possible, on

an interim basis for a reasonable period, through provisional

listings, the use of commercially established color additives to

the extent consistent with the public health, pending the

completion of the scientific investigations needed as a basis for

making determinations as to listing of such additives under the

basic Act as amended by this Act. A provisional listing (including

a deemed provisional listing) of a color additive under this

section for any use shall, unless sooner terminated or expiring

under the provisions of this section, expire (A) on the closing

date (as defined in paragraph (2) of this subsection) or (B) on the

effective date of a listing of such additive for such use under

section 706 (now 721) of the basic Act, (this section), whichever

date first occurs.

''(2) For the purposes of this section, the term 'closing date'

means (A) the last day of the two and one-half year period

beginning on the enactment date (July 12, 1960) or (B), with

respect to a particular provisional listing (or deemed provisional

listing) of a color additive or use thereof, such later closing

date as the Secretary may from time to time establish pursuant to

the authority of this paragraph. The Secretary may by regulation,

upon application of an interested person or on his own initiative,

from time to time postpone the original closing date with respect

to a provisional listing (or deemed provisional listing) under this

section of a specified color additive, or of a specified use or

uses of such additive, for such period or periods as he finds

necessary to carry out the purpose of this section, if in the

Secretary's judgment such action is consistent with the objective

of carrying to completion in good faith, as soon as reasonably

practicable, the scientific investigations necessary for making a

determination as to listing such additive, or such specified use or

uses thereof, under section 706 (now 721) of the basic Act (this

section). The Secretary may terminate a postponement of the

closing date at any time if he finds that such postponement should

not have been granted, or that by reason of a change in

circumstances the basis for such postponement no longer exists, or

that there has been a failure to comply with a requirement for

submission of progress reports or with other conditions attached to

such postponement.

''(b) Subject to the other provisions of this section -

''(1) any color additive which, on the day preceding the

enactment date (July 12, 1960), was listed and certifiable for

any use or uses under section 406(b), 504, or 604 (section

346(b), 354, or 364 of this title), or under the third proviso of

section 402(c) (section 342(c) of this title), of the basic Act,

and of which a batch or batches had been certified for such use

or uses prior to the enactment date (July 12, 1960), and

''(2) any color additive which was commercially used or sold

prior to the enactment date (July 12, 1960) for any use or uses

in or on any food, drug, or cosmetic, and which either, (A), on

the day preceding the enactment date (July 12, 1960), was not a

material within the purview of any of the provisions of the basic

Act enumerated in paragraph (1) of this subsection, or (B) is the

color additive known as synthetic beta-carotene,

shall, beginning on the enactment date (July 12, 1960), be deemed

to be provisionally listed under this section as a color additive

for such use or uses.

''(c) Upon request of any person, the Secretary, by regulations

issued under subsection (d), shall without delay, if on the basis

of the data before him he deems such action consistent with the

protection of the public health, provisionally list a material as a

color additive for any use for which it was listed, and for which a

batch or batches of such material had been certified, under section

406(b), 504, or 604 of the basic Act (section 346(b), 354, or 364

of this title) prior to the enactment date (July 12, 1960),

although such color was no longer listed and certifiable for such

use under such sections on the day preceding the enactment date.

Such provisional listing shall take effect on the date of

publication.

''(d)(1) The Secretary shall, by regulations issued or amended

from time to time under this section -

''(A) insofar as practicable promulgate and keep current a list

or lists of the color additives, and of the particular uses

thereof, which he finds are deemed provisionally listed under

subsection (b), and the presence of a color additive on such a

list with respect to a particular use shall, in any proceeding

under the basic Act, be conclusive evidence that such provisional

listing is in effect;

''(B) provide for the provisional listing of the color

additives and particular uses thereof specified in subsection

(c);

''(C) provide, with respect to particular uses for which color

additives are or are deemed to be provisionally listed, such

temporary tolerance limitations (including such limitations at

zero level) and other conditions of use and labeling or packaging

requirements, if any, as in his judgment are necessary to protect

the public health pending listing under section 706 (now 721) of

the basic Act (this section);

''(D) provide for the certification of batches of such color

additives (with or without diluents) for the uses for which they

are so listed or deemed to be listed under this section, except

that such an additive which is a color additive deemed

provisionally listed under subsection (b)(2) of this section

shall be deemed exempt from the requirement of such certification

while not subject to a tolerance limitation; and

''(E) provide for the termination of a provisional listing (or

deemed provisional listing) of a color additive or particular use

thereof forthwith whenever in his judgment such action is

necessary to protect the public health.

''(2)(A) Except as provided in subparagraph (C) of this

paragraph, regulations under this section shall, from time to time,

be issued, amended, or repealed by the Secretary without regard to

the requirements of the basic Act (subsec. (e) of this section),

but for the purposes of the application of section 706(e) (now

721(e)) of the basic Act (relating to fees) and of determining the

availability of appropriations of fees (and of advance deposits to

cover fees), proceedings, regulations, and certifications under

this section shall be deemed to be proceedings, regulations, and

certifications under such section 706 (now 721, this section).

Regulations providing for fees (and advance deposits to cover

fees), which on the day preceding the enactment date (July 12,

1960) were in effect pursuant to section 706 (now 721) of the basic

Act (this section), shall be deemed to be regulations under such

section 706 (now 721, this section) as amended by this Act, and

appropriations of fees (and advance deposits) available for the

purposes specified in such section 706 (now 721) as in effect prior

to the enactment date (July 12, 1960) shall be available for the

purposes specified in such section 706 (now 721, this section) as

so amended.

''(B) If the Secretary, by regulation -

''(i) has terminated a provisional listing (or deemed

provisional listing) of a color additive or particular use

thereof pursuant to paragraph (1)(E) of this subsection; or

''(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of

this subsection, initially established or rendered more

restrictive a tolerance limitation or other restriction or

requirement with respect to a provisional listing (or deemed

provisional listing) which listing had become effective prior to

such action,

any person adversely affected by such action may, prior to the

expiration of the period specified in clause (A) of subsection

(a)(2) of this section, file with the Secretary a petition for

amendment of such regulation so as to revoke or modify such action

of the Secretary, but the filing of such petition shall not operate

to stay or suspend the effectiveness of such action. Such petition

shall, in accordance with regulations, set forth the proposed

amendment and shall contain data (or refer to data which are before

the Secretary or of which he will take official notice), which show

that the revocation or modification proposed is consistent with the

protection of the public health. The Secretary shall, after

publishing such proposal and affording all interested persons an

opportunity to present their views thereon orally or in writing,

act upon such proposal by published order.

''(C) Any person adversely affected by an order entered under

subparagraph (B) of this paragraph may, within thirty days after

its publication, file objections thereto with the Secretary,

specifying with particularity the provisions of the order deemed

objectionable, stating reasonable grounds for such objections, and

requesting a public hearing upon such objections. The Secretary

shall hold a public hearing on such objections and shall, on the

basis of the evidence adduced at such hearing, act on such

objections by published order. Such order may reinstate a

terminated provisional listing, or increase or dispense with a

previously established temporary tolerance limitation, or make less

restrictive any other limitation established by him under paragraph

(1) or (3) of this subsection, only if in his judgment the evidence

so adduced shows that such action will be consistent with the

protection of the public health. An order entered under this

subparagraph shall be subject to judicial review in accordance with

section 701(f) of the basic Act (section 371(f) of this title)

except that the findings and order of the Secretary shall be

sustained only if based upon a fair evaluation of the entire record

at such hearing. No stay or suspension of such order shall be

ordered by the court pending conclusion of such judicial review.

''(D) On and after the enactment date (July 12, 1960),

regulations, provisional listings, and certifications (or

exemptions from certification) in effect under this section shall,

for the purpose of determining whether an article is adulterated or

misbranded within the meaning of the basic Act by reason of its

being, bearing, or containing a color additive, have the same

effect as would regulations, listings, and certifications (or

exemptions from certification) under section 706 (now 721) of the

basic Act (this section). A regulation, provisional listing or

termination thereof, tolerance limitation, or certification or

exemption therefrom, under this section shall not be the basis for

any presumption or inference in any proceeding under section 706(b)

or (c) (now 721(b), (c)) of the basic Act (subsec. (b) or (c) of

this section).

''(3) For the purpose of enabling the Secretary to carry out his

functions under paragraphs (1)(A) and (C) of this subsection with

respect to color additives deemed provisionally listed, he shall,

as soon as practicable after enactment of this Act (July 12, 1960),

afford by public notice a reasonable opportunity to interested

persons to submit data relevant thereto. If the data so submitted

or otherwise before him do not, in his judgment, establish a

reliable basis for including such a color additive or particular

use or uses thereof in a list or lists promulgated under paragraph

(1)(A), or for determining the prevailing level or levels of use

thereof prior to the enactment date (July 12, 1960) with a view to

prescribing a temporary tolerance or tolerances for such use or

uses under paragraph (1)(C), the Secretary shall establish a

temporary tolerance limitation at zero level for such use or uses

until such time as he finds that it would not be inconsistent with

the protection of the public health to increase or dispense with

such temporary tolerance limitation.

''Sec. 204. (Effect on Meat Inspection and Poultry Products

Inspection Acts.) Nothing in this Act (amending this section and

sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371

of this title and repealing sections 354 and 364 of this title)

shall be construed to exempt any meat or meat food product, poultry

or poultry product, or any person from any requirement imposed by

or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat.

1260, as amended or extended (21 U.S.C. 71 and the following) (see

section 601 et seq. of this title) or the Poultry Products

Inspection Act (21 U.S.C. 451 and the following).''

EFFECTIVE DATE; ACCELERATION

This section was made ''immediately effective'' by act May 2,

1939, ch. 107, title I, Sec. 1, 53 Stat. 631.

TERMINATION OF ADVISORY COMMITTEES

Advisory committees in existence on Jan. 5, 1973, to terminate

not later than the expiration of the 2-year period following Jan.

5, 1973, and advisory committees established after Jan. 5, 1973, to

terminate not later than the expiration of the 2-year period

beginning on the date of their establishment, unless in the case of

a committee established by the President or an officer of the

Federal Government, such committee is renewed by appropriate action

prior to the expiration of such 2-year period, or in the case of a

committee established by Congress, its duration is otherwise

provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972,

86 Stat. 776, set out in the Appendix to Title 5, Government

Organization and Employees.

REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES

References in laws to the rates of pay for GS-16, 17, or 18, or

to maximum rates of pay under the General Schedule, to be

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

(title I, Sec. 101(c)(1)) of Pub. L. 101-509, set out in a note

under section 5376 of Title 5.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 331, 342, 343, 351,

352, 360j, 361, 362, 453, 601, 1033 of this title.

-CITE-

21 USC Part C - Fees 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

.

-HEAD-

Part C - Fees

-CITE-

21 USC subpart 1 - freedom of information fees 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 1 - freedom of information fees

.

-HEAD-

subpart 1 - freedom of information fees

-CITE-

21 USC Sec. 379f 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 1 - freedom of information fees

-HEAD-

Sec. 379f. Recovery and retention of fees for freedom of

information requests

-STATUTE-

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs,

may -

(1) set and charge fees, in accordance with section

552(a)(4)(A) of title 5, to recover all reasonable costs incurred

in processing requests made under section 552 of title 5 for

records obtained or created under this chapter or any other

Federal law for which responsibility for administration has been

delegated to the Commissioner by the Secretary;

(2) retain all fees charged for such requests; and

(3) establish an accounting system and procedures to control

receipts and expenditures of fees received under this section.

(b) Use of fees

The Secretary and the Commissioner of Food and Drugs shall not

use fees received under this section for any purpose other than

funding the processing of requests described in subsection (a)(1)

of this section. Such fees shall not be used to reduce the amount

of funds made to carry out other provisions of this chapter.

(c) Waiver of fees

Nothing in this section shall supersede the right of a requester

to obtain a waiver of fees pursuant to section 552(a)(4)(A) of

title 5.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 731, formerly Sec. 711, as added Pub.

L. 101-635, title II, Sec. 201, Nov. 28, 1990, 104 Stat. 4584;

renumbered Sec. 731, Pub. L. 102-571, title I, Sec. 106(6), Oct.

29, 1992, 106 Stat. 4499.)

-COD-

CODIFICATION

Section was formerly classified to section 379c of this title

prior to renumbering by Pub. L. 102-571.

-CITE-

21 USC subpart 2 - fees relating to drugs 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 2 - fees relating to drugs

.

-HEAD-

subpart 2 - fees relating to drugs

-MISC1-

TERMINATION OF SUBPART

For termination of subpart by section 105 of Pub. L. 102-571,

see Termination Date note set out under section 379g of this

title.

-CITE-

21 USC Sec. 379g 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 2 - fees relating to drugs

-HEAD-

Sec. 379g. Definitions

-STATUTE-

For purposes of this part:

(1) The term ''human drug application'' means an application

for -

(A) approval of a new drug submitted under section 355(b)(1)

of this title,

(B) approval of a new drug submitted under section 355(b)(2)

of this title after September 30, 1992, which requests approval

of -

(i) a molecular entity which is an active ingredient

(including any salt or ester of an active ingredient), or

(ii) an indication for a use,

that had not been approved under an application submitted under

section 355(b) of this title, or

(C) licensure of a biological product under section 262 of

title 42.

Such term does not include a supplement to such an application,

does not include an application with respect to whole blood or a

blood component for transfusion, does not include an application

with respect to a bovine blood product for topical application

licensed before September 1, 1992, an allergenic extract product,

or an in vitro diagnostic biologic product licensed under section

262 of title 42, does not include an application with respect to

a large volume parenteral drug product approved before September

1, 1992, does not include an application for a licensure of a

biological product for further manufacturing use only, and does

not include an application or supplement submitted by a State or

Federal Government entity for a drug that is not distributed

commercially. Such term does include an application for

licensure, as described in subparagraph (C), of a large volume

biological product intended for single dose injection for

intravenous use or infusion.

(2) The term ''supplement'' means a request to the Secretary to

approve a change in a human drug application which has been

approved.

(3) The term ''prescription drug product'' means a specific

strength or potency of a drug in final dosage form -

(A) for which a human drug application has been approved,

(B) which may be dispensed only under prescription pursuant

to section 353(b) of this title, and

(C) which is on the list of products described in section

355(j)(7)(A) of this title or is on a list created and

maintained by the Secretary of products approved under human

drug applications under section 262 of title 42.

Such term does not include whole blood or a blood component for

transfusion, does not include a bovine blood product for topical

application licensed before September 1, 1992, an allergenic

extract product, or an in vitro diagnostic biologic product

licensed under section 262 of title 42. Such term does not

include a biological product that is licensed for further

manufacturing use only, and does not include a drug that is not

distributed commercially and is the subject of an application or

supplement submitted by a State or Federal Government entity.

Such term does include a large volume biological product intended

for single dose injection for intravenous use or infusion.

(4) The term ''final dosage form'' means, with respect to a

prescription drug product, a finished dosage form which is

approved for administration to a patient without substantial

further manufacturing.

(5) The term ''prescription drug establishment'' means a

foreign or domestic place of business which is at one general

physical location consisting of one or more buildings all of

which are within five miles of each other and at which one or

more prescription drug products are manufactured in final dosage

form. For purposes of this paragraph, the term ''manufactured''

does not include packaging.

(6) The term ''process for the review of human drug

applications'' means the following activities of the Secretary

with respect to the review of human drug applications and

supplements:

(A) The activities necessary for the review of human drug

applications and supplements.

(B) The issuance of action letters which approve human drug

applications or which set forth in detail the specific

deficiencies in such applications and, where appropriate, the

actions necessary to place such applications in condition for

approval.

(C) The inspection of prescription drug establishments and

other facilities undertaken as part of the Secretary's review

of pending human drug applications and supplements.

(D) Activities necessary for the review of applications for

licensure of establishments subject to section 262 of title 42

and for the release of lots of biologics under such section.

(E) Monitoring of research conducted in connection with the

review of human drug applications.

(F) In the case of drugs approved after October 1, 2002,

under human drug applications or supplements: collecting,

developing, and reviewing safety information on the drugs,

including adverse event reports, during a period of time after

approval of such applications or supplements, not to exceed

three years.

(7) The term ''costs of resources allocated for the process for

the review of human drug applications'' means the expenses

incurred in connection with the process for the review of human

drug applications for -

(A) officers and employees of the Food and Drug

Administration, contractors of the Food and Drug

Administration, advisory committees, and costs related to such

officers, employees, and committees and to contracts with such

contractors,

(B) management of information, and the acquisition,

maintenance, and repair of computer resources,

(C) leasing, maintenance, renovation, and repair of

facilities and acquisition, maintenance, and repair of

fixtures, furniture, scientific equipment, and other necessary

materials and supplies, and

(D) collecting fees under section 379h of this title and

accounting for resources allocated for the review of human drug

applications and supplements.

(8) The term ''adjustment factor'' applicable to a fiscal year

is the Consumer Price Index for all urban consumers (all items;

United States city average) for April of the preceding fiscal

year divided by such Index for April 1997.

(9) The term ''affiliate'' means a business entity that has a

relationship with a second business entity if, directly or

indirectly -

(A) one business entity controls, or has the power to

control, the other business entity; or

(B) a third party controls, or has power to control, both of

the business entities.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 735, as added Pub. L. 102-571, title

I, Sec. 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L.

105-115, title I, Sec. 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat.

2298, 2326; Pub. L. 107-188, title V, Sec. 503, June 12, 2002, 116

Stat. 688.)

-STATAMEND-

AMENDMENT OF SECTION

For termination of amendment by section 509 of Pub. L. 107-188,

see Effective and Termination Dates of 2002 Amendments note

below.

For termination of amendment by section 107 of Pub. L. 105-115,

see Effective and Termination Dates of 1997 Amendment note below.

TERMINATION OF SECTION

For termination of section by section 105 of Pub. L. 102-571,

see Termination Date note below.

-MISC1-

AMENDMENTS

2002 - Par. (1). Pub. L. 107-188, Sec. 503(1), 509, temporarily

substituted ''licensure, as described in subparagraph (C)'' for

''licensure, as described in subparagraph (D)'' in concluding

provisions. See Effective and Termination Dates of 2002 Amendment

note below.

Par. (3). Pub. L. 107-188, Sec. 503(2)(D), 509, which directed

the temporary amendment of concluding provisions of par. (3) by

striking ''section 262 of title 42'' and all that follows through

''biological product'' and inserting ''section 262 of title 42.

Such term does not include a biological product'', was executed by

striking language ending with ''biological product'' the first time

appearing, thereby making the substitution for ''section 262 of

title 42, does not include a large volume parenteral drug product

approved before September 1, 1992, does not include a biological

product'', to reflect the probable intent of Congress. See

Effective and Termination Dates of 2002 Amendment note below.

Par. (3)(C). Pub. L. 107-188, Sec. 503(2)(A)-(C), 509,

temporarily added subpar. (C). See Effective and Termination Dates

of 2002 Amendment note below.

Par. (6)(F). Pub. L. 107-188, Sec. 503(3), 509, temporarily added

subpar. (F). See Effective and Termination Dates of 2002 Amendment

note below.

Par. (8). Pub. L. 107-188, Sec. 503(4), 509, temporarily struck

out designations of subpars. (A) and (B) and text of subpar. (B)

and concluding provisions, substituting definition of ''adjustment

factor'' as the Consumer Price Index for definition of Index as the

lower of the Consumer Price Index or the total of discretionary

budget authority provided for programs in the domestic category for

the immediately preceding fiscal year divided by such budget

authority for fiscal year 1997. See Effective and Termination Dates

of 2002 Amendment note below.

1997 - Par. (1). Pub. L. 105-115, Sec. 102(1), 107, in closing

provisions, temporarily struck out ''and'' before ''does not

include an application'' and substituted ''September 1, 1992, does

not include an application for a licensure of a biological product

for further manufacturing use only, and does not include an

application or supplement submitted by a State or Federal

Government entity for a drug that is not distributed commercially.

Such term does include an application for licensure, as described

in subparagraph (D), of a large volume biological product intended

for single dose injection for intravenous use or infusion'' for

''September 1, 1992'' before period at end. See Effective and

Termination Dates of 1997 Amendment note below.

Par. (1)(B) to (D). Pub. L. 105-115, Sec. 125(b)(2)(M), inserted

''or'' at end of subpar. (B), redesignated subpar. (D) as (C), and

struck out former subpar. (C) which read as follows: ''initial

certification or initial approval of an antibiotic drug under

section 357 of this title, or''.

Par. (3). Pub. L. 105-115, Sec. 102(2), 107, in closing

provisions, temporarily struck out ''and'' before ''does not

include a large volume parenteral drug'' and substituted

''September 1, 1992, does not include a biological product that is

licensed for further manufacturing use only, and does not include a

drug that is not distributed commercially and is the subject of an

application or supplement submitted by a State or Federal

Government entity. Such term does include a large volume

biological product intended for single dose injection for

intravenous use or infusion'' for ''September 1, 1992'' before

period at end. See Effective and Termination Dates of 1997

Amendment note below.

Par. (4). Pub. L. 105-115, Sec. 102(3), 107, temporarily

substituted ''without substantial further manufacturing'' for

''without further manufacturing''. See Effective and Termination

Dates of 1997 Amendment note below.

Par. (5). Pub. L. 105-115, Sec. 102(4), 107, temporarily amended

first sentence generally. Prior to amendment, first sentence read

as follows: ''The term 'prescription drug establishment' means a

foreign or domestic place of business which is -

''(A) at one general physical location consisting of one or

more buildings all of which are within 5 miles of each other, at

which one or more prescription drug products are manufactured in

final dosage form, and

''(B) under the management of a person that is listed as the

applicant in a human drug application for a prescription drug

product with respect to at least one such product.''

See Effective and Termination Dates of 1997 Amendment note below.

Par. (7)(A). Pub. L. 105-115, Sec. 102(5), 107, temporarily

substituted ''contractors of the Food and Drug Administration,''

for ''employees under contract with the Food and Drug

Administration who work in facilities owned or leased for the Food

and Drug Administration,'' and ''and committees and to contracts

with such contractors,'' for ''and committees,''. See Effective

and Termination Dates of 1997 Amendment note below.

Par. (8)(A). Pub. L. 105-115, Sec. 102(6)(A), 107, temporarily

substituted ''April of the preceding fiscal year'' for ''August of

the preceding fiscal year'' and ''April 1997'' for ''August 1992''.

See Effective and Termination Dates of 1997 Amendment note below.

Par. (8)(B). Pub. L. 105-115, Sec. 102(6)(B), 107, temporarily

substituted ''section 254(c)'' for ''section 254(d)'', ''fiscal

year 1997'' for ''fiscal year 1992'', and ''105th Congress, 1st

Session'' for ''102d Congress, 2d Session''. See Effective and

Termination Dates of 1997 Amendment note below.

Par. (9). Pub. L. 105-115, Sec. 102(7), 107, temporarily added

par. (9). See Effective and Termination Dates of 1997 Amendment

note below.

EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT

Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section

508 of Pub. L. 107-188, set out as an Effective Date of 2002

Amendment note under section 356b of this title.

Pub. L. 107-188, title V, Sec. 509, June 12, 2002, 116 Stat. 694,

provided that: ''The amendments made by sections 503 and 504

(amending this section and section 379h of this title) cease to be

effective October 1, 2007, and section 505 (enacting provisions set

out as a note below) ceases to be effective 120 days after such

date.''

EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT

Section 106 of title I of Pub. L. 105-115 provided that: ''The

amendments made by this subtitle (subtitle A (Sec. 101-107) of

title I of Pub. L. 105-115, amending this section and section 379h

of this title) shall take effect October 1, 1997.''

Section 107 of Pub. L. 105-115 provided that: ''The amendments

made by sections 102 and 103 (amending this section and section

379h of this title) cease to be effective October 1, 2002, and

section 104 (enacting provisions set out as a note below) ceases to

be effective 120 days after such date.''

TERMINATION DATE

Section 105 of Pub. L. 102-571 provided that: ''The amendments

made by section 103 (enacting this subpart) shall not be in effect

after October 1, 1997 and section 104 (enacting provisions set out

as a note below) shall not be in effect after 120 days after such

date.''

SAVINGS PROVISION

Pub. L. 107-188, title V, Sec. 507, June 12, 2002, 116 Stat. 694,

provided that: ''Notwithstanding section 107 of the Food and Drug

Administration Modernization Act of 1997 (section 107 of Pub. L.

105-115, set out as an Effective and Termination Dates of 1997

Amendment note above), and notwithstanding the amendments made by

this subtitle (subtitle A (Sec. 501-509) of title V of Pub. L.

107-188, amending this section and sections 356b and 379h of this

title), part 2 of subchapter C of chapter VII of the Federal Food,

Drug, and Cosmetic Act (this subpart), as in effect on the day

before the date of the enactment of this Act (June 12, 2002),

continues to be in effect with respect to human drug applications

and supplements (as defined in such part as of such day) that, on

or after October 1, 1997, but before October 1, 2002, were accepted

by the Food and Drug Administration for filing and with respect to

assessing and collecting any fee required by such Act for a fiscal

year prior to fiscal year 2003.''

Section 105 of Pub. L. 105-115 provided that: ''Notwithstanding

section 105 of the Prescription Drug User Fee Act of 1992 (section

105 of Pub. L. 102-571, set out above), the Secretary shall retain

the authority to assess and collect any fee required by part 2 of

subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic

Act (this subpart) for a human drug application or supplement

accepted for filing prior to October 1, 1997, and to assess and

collect any product or establishment fee required by such Act for a

fiscal year prior to fiscal year 1998.''

ACCOUNTABILITY AND REPORTS

Pub. L. 107-188, title V, Sec. 505, June 12, 2002, 116 Stat. 692,

provided that:

''(a) Public Accountability. -

''(1) Consultation. - In developing recommendations to the

Congress for the goals and plans for meeting the goals for the

process for the review of human drug applications for the fiscal

years after fiscal year 2007, and for the reauthorization of

sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 379g, 379h), the Secretary of Health and Human

Services (referred to in this section as the 'Secretary') shall

consult with the Committee on Energy and Commerce of the House of

Representatives, the Committee on Health, Education, Labor, and

Pensions of the Senate, appropriate scientific and academic

experts, health care professionals, representatives of patient

and consumer advocacy groups, and the regulated industry.

''(2) Recommendations. - The Secretary shall publish in the

Federal Register recommendations under paragraph (1), after

negotiations with the regulated industry; shall present such

recommendations to the congressional committees specified in such

paragraph; shall hold a meeting at which the public may present

its views on such recommendations; and shall provide for a period

of 30 days for the public to provide written comments on such

recommendations.

''(b) Performance Report. - Beginning with fiscal year 2003, not

later than 60 days after the end of each fiscal year during which

fees are collected under part 2 of subchapter C of chapter VII of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.),

the Secretary of Health and Human Services shall prepare and submit

to the President, the Committee on Energy and Commerce of the House

of Representatives, and the Committee on Health, Education, Labor,

and Pensions of the Senate a report concerning the progress of the

Food and Drug Administration in achieving the goals identified in

the letters described in section 502(4) (section 502(4) of Pub. L.

107-188, set out below) during such fiscal year and the future

plans of the Food and Drug Administration for meeting the goals.

''(c) Fiscal Report. - Beginning with fiscal year 2003, not later

than 120 days after the end of each fiscal year during which fees

are collected under the part described in subsection (b), the

Secretary of Health and Human Services shall prepare and submit to

the Committee on Energy and Commerce of the House of

Representatives, and the Committee on Health, Education, Labor, and

Pensions of the Senate, a report on the implementation of the

authority for such fees during such fiscal year and the use, by the

Food and Drug Administration, of the fees collected during such

fiscal year for which the report is made.''

(Section 505 of Pub. L. 107-188, set out above, ceases to be

effective 120 days after Oct. 1, 2007, see Effective and

Termination Dates of 2002 Amendment note above.)

CONGRESSIONAL FINDINGS CONCERNING FEES RELATING TO DRUGS

Pub. L. 107-188, title V, Sec. 502, June 12, 2002, 116 Stat. 687,

provided that: ''The Congress finds that -

''(1) prompt approval of safe and effective new drugs and other

therapies is critical to the improvement of the public health so

that patients may enjoy the benefits provided by these therapies

to treat and prevent illness and disease;

''(2) the public health will be served by making additional

funds available for the purpose of augmenting the resources of

the Food and Drug Administration that are devoted to the process

for the review of human drug applications and the assurance of

drug safety;

''(3) the provisions added by the Prescription Drug User Fee

Act of 1992 (see section 101(a) of Pub. L. 102-571, set out as a

Short Title of 1992 Amendment note under section 301 of this

title), as amended by the Food and Drug Administration

Modernization Act of 1997 (see Short Title of 1997 Amendment note

set out under section 301 of this title), have been successful in

substantially reducing review times for human drug applications

and should be -

''(A) reauthorized for an additional 5 years, with certain

technical improvements; and

''(B) carried out by the Food and Drug Administration with

new commitments to implement more ambitious and comprehensive

improvements in regulatory processes of the Food and Drug

Administration, including -

''(i) strengthening and improving the review and monitoring

of drug safety;

''(ii) considering greater interaction between the agency

and sponsors during the review of drugs and biologics

intended to treat serious diseases and life-threatening

diseases; and

''(iii) developing principles for improving first-cycle

reviews; and

''(4) the fees authorized by amendments made in this subtitle

(subtitle A (Sec. 501-509) of title V of Pub. L. 107-188,

amending this section and sections 356b and 379h of this title)

will be dedicated towards expediting the drug development process

and the process for the review of human drug applications as set

forth in the goals identified for purposes of part 2 of

subchapter C of chapter VII of the Federal Food, Drug, and

Cosmetic Act (this subpart), in the letters from the Secretary of

Health and Human Services to the chairman of the Committee on

Energy and Commerce of the House of Representatives and the

chairman of the Committee on Health, Education, Labor and

Pensions of the Senate, as set forth in the Congressional

Record.''

Section 101 of title I of Pub. L. 105-115 provided that:

''Congress finds that -

''(1) prompt approval of safe and effective new drugs and other

therapies is critical to the improvement of the public health so

that patients may enjoy the benefits provided by these therapies

to treat and prevent illness and disease;

''(2) the public health will be served by making additional

funds available for the purpose of augmenting the resources of

the Food and Drug Administration that are devoted to the process

for review of human drug applications;

''(3) the provisions added by the Prescription Drug User Fee

Act of 1992 (see section 101(a) of Pub. L. 102-571, set out as a

Short Title of 1992 Amendment note under section 301 of this

title) have been successful in substantially reducing review

times for human drug applications and should be -

''(A) reauthorized for an additional 5 years, with certain

technical improvements; and

''(B) carried out by the Food and Drug Administration with

new commitments to implement more ambitious and comprehensive

improvements in regulatory processes of the Food and Drug

Administration; and

''(4) the fees authorized by amendments made in this subtitle

(subtitle A (Sec. 101-107) of title I of Pub. L. 105-115,

amending this section and section 379h of this title) will be

dedicated toward expediting the drug development process and the

review of human drug applications as set forth in the goals

identified, for purposes of part 2 of subchapter C of chapter VII

of the Federal Food, Drug, and Cosmetic Act (this subpart), in

the letters from the Secretary of Health and Human Services to

the chairman of the Committee on Commerce of the House of

Representatives and the chairman of the Committee on Labor and

Human Resources of the Senate, as set forth in the Congressional

Record.''

ANNUAL REPORTS

Section 104 of Pub. L. 105-115 provided that:

''(a) Performance Report. - Beginning with fiscal year 1998, not

later than 60 days after the end of each fiscal year during which

fees are collected under part 2 of subchapter C of chapter VII of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.),

the Secretary of Health and Human Services shall prepare and submit

to the Committee on Commerce of the House of Representatives and

the Committee on Labor and Human Resources of the Senate a report

concerning the progress of the Food and Drug Administration in

achieving the goals identified in the letters described in section

101(4) (section 101(4) of Pub. L. 105-115 set out above) during

such fiscal year and the future plans of the Food and Drug

Administration for meeting the goals.

''(b) Fiscal Report. - Beginning with fiscal year 1998, not later

than 120 days after the end of each fiscal year during which fees

are collected under the part described in subsection (a), the

Secretary of Health and Human Services shall prepare and submit to

the Committee on Commerce of the House of Representatives and the

Committee on Labor and Human Resources of the Senate a report on

the implementation of the authority for such fees during such

fiscal year and the use, by the Food and Drug Administration, of

the fees collected during such fiscal year for which the report is

made.''

CONGRESSIONAL FINDINGS CONCERNING PRESCRIPTION DRUG USER FEES

Section 102 of title I of Pub. L. 102-571 provided that: ''The

Congress finds that -

''(1) prompt approval of safe and effective new drugs is

critical to the improvement of the public health so that patients

may enjoy the benefits provided by these therapies to treat and

prevent illness and disease;

''(2) the public health will be served by making additional

funds available for the purpose of augmenting the resources of

the Food and Drug Administration that are devoted to the process

for review of human drug applications; and

''(3) the fees authorized by this title (see Short Title of

1992 Amendment note, set out under section 301 of this title)

will be dedicated toward expediting the review of human drug

applications as set forth in the goals identified in the letters

of September 14, 1992, and September 21, 1992, from the

Commissioner of Food and Drugs to the Chairman of the Energy and

Commerce Committee of the House of Representatives and the

Chairman of the Labor and Human Resources Committee of the

Senate, as set forth at 138 Cong. Rec. H9099-H9100 (daily ed.

September 22, 1992).''

ANNUAL REPORTS

Pub. L. 102-571, title I, Sec. 104, Oct. 29, 1992, 106 Stat.

4498, which provided that the Secretary of Health and Human

Services submit to Committee on Energy and Commerce of the House of

Representatives and Committee on Labor and Human Resources of the

Senate, within 60 days after the end of each fiscal year during

which fees were collected under this subpart, a report stating the

Food and Drug Administration's progress in achieving the goals

identified in section 102(3) of Pub. L. 102-571, set out as a note

above, during such fiscal year and that agency's future plans for

meeting such goals, and within 120 days after the end of each

fiscal year during which such fees were collected, a report on the

implementation of the authority for such fees during such fiscal

year and on the use the Food and Drug Administration made of the

fees collected during such fiscal year, ceased to be in effect 120

days after Oct. 1, 1997. See Termination Date note above.

ANIMAL DRUG USER FEE STUDY

Section 108 of Pub. L. 102-571 directed Secretary, in

consultation with manufacturers of animal drug products and other

interested persons, to undertake study to evaluate whether, and

under what conditions, to impose user fees to supplement

appropriated funds in order to improve process of reviewing

applications (including abbreviated and supplemental applications)

for new animal drugs under section 360b of this title, and further

provided for submission of study to Congress no later than Jan. 4,

1994.

-CITE-

21 USC Sec. 379h 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 2 - fees relating to drugs

-HEAD-

Sec. 379h. Authority to assess and use drug fees

-STATUTE-

(a) Types of fees

Beginning in fiscal year 2003, the Secretary shall assess and

collect fees in accordance with this section as follows:

(1) Human drug application and supplement fee

(A) In general

Each person that submits, on or after September 1, 1992, a

human drug application or a supplement shall be subject to a

fee as follows:

(i) A fee established under subsection (c)(4) of this

section for a human drug application for which clinical data

(other than bioavailability or bioequivalence studies) with

respect to safety or effectiveness are required for approval.

(ii) A fee established under subsection (c)(4) of this

section for a human drug application for which clinical data

with respect to safety or effectiveness are not required or a

supplement for which clinical data (other than

bioavailability or bioequivalence studies) with respect to

safety or effectiveness are required. Such fee shall be half

of the amount of the fee established under clause (i).

(B) Payment

The fee required by subparagraph (A) shall be due upon

submission of the application or supplement.

(C) Exception for previously filed application or supplement

If a human drug application or supplement was submitted by a

person that paid the fee for such application or supplement,

was accepted for filing, and was not approved or was withdrawn

(without a waiver), the submission of a human drug application

or a supplement for the same product by the same person (or the

person's licensee, assignee, or successor) shall not be subject

to a fee under subparagraph (A).

(D) Refund of fee if application refused for filing

The Secretary shall refund 75 percent of the fee paid under

subparagraph (B) for any application or supplement which is

refused for filing.

(E) Exception for designated orphan drug or indication

A human drug application for a prescription drug product that

has been designated as a drug for a rare disease or condition

pursuant to section 360bb of this title shall not be subject to

a fee under subparagraph (A), unless the human drug application

includes an indication for other than a rare disease or

condition. A supplement proposing to include a new indication

for a rare disease or condition in a human drug application

shall not be subject to a fee under subparagraph (A), if the

drug has been designated pursuant to section 360bb of this

title as a drug for a rare disease or condition with regard to

the indication proposed in such supplement.

(F) Refund of fee if application withdrawn

If an application or supplement is withdrawn after the

application or supplement was filed, the Secretary may refund

the fee or a portion of the fee if no substantial work was

performed on the application or supplement after the

application or supplement was filed. The Secretary shall have

the sole discretion to refund a fee or a portion of the fee

under this subparagraph. A determination by the Secretary

concerning a refund under this paragraph shall not be

reviewable.

(2) Prescription drug establishment fee

(A) In general

Except as provided in subparagraph (B), each person that -

(i) is named as the applicant in a human drug application;

and

(ii) after September 1, 1992, had pending before the

Secretary a human drug application or supplement,

shall be assessed an annual fee established under subsection

(c)(4) of this section for each prescription drug establishment

listed in its approved human drug application as an

establishment that manufactures the prescription drug product

named in the application. The annual establishment fee shall

be assessed in each fiscal year in which the prescription drug

product named in the application is assessed a fee under

paragraph (3) unless the prescription drug establishment listed

in the application does not engage in the manufacture of the

prescription drug product during the fiscal year. The

establishment fee shall be payable on or before October 1 of

each year. Each such establishment shall be assessed only one

fee per establishment, notwithstanding the number of

prescription drug products manufactured at the establishment.

In the event an establishment is listed in a human drug

application by more than one applicant, the establishment fee

for the fiscal year shall be divided equally and assessed among

the applicants whose prescription drug products are

manufactured by the establishment during the fiscal year and

assessed product fees under paragraph (3).

(B) Exception

If, during the fiscal year, an applicant initiates or causes

to be initiated the manufacture of a prescription drug product

at an establishment listed in its human drug application -

(i) that did not manufacture the product in the previous

fiscal year; and

(ii) for which the full establishment fee has been assessed

in the fiscal year at a time before manufacture of the

prescription drug product was begun;

the applicant will not be assessed a share of the establishment

fee for the fiscal year in which the manufacture of the product

began.

(3) Prescription drug product fee

(A) In general

Except as provided in subparagraph (B), each person who is

named as the applicant in a human drug application, and who,

after September 1, 1992, had pending before the Secretary a

human drug application or supplement, shall pay for each such

prescription drug product the annual fee established under

subsection (c)(4) of this section. Such fee shall be payable

on or before October 1 of each year. Such fee shall be paid

only once for each product for a fiscal year in which the fee

is payable.

(B) Exception

A prescription drug product shall not be assessed a fee under

subparagraph (A) if such product is identified on the list

compiled under section 355(j)(7)(A) of this title with a

potency described in terms of per 100 mL, or if such product is

the same product as another product approved under an

application filed under section 355(b) or 355(j) of this title,

under an abbreviated application filed under section 357 of

this title (as in effect on the day before November 21, 1997),

or under an abbreviated new drug application pursuant to

regulations in effect prior to the implementation of the Drug

Price Competition and Patent Term Restoration Act of 1984.

(b) Fee revenue amounts

Except as provided in subsections (c), (d), (f), and (g) of this

section, fees under subsection (a) of this section shall be

established to generate the following revenue amounts:

--------------------------------------

Type of Fee Revenue

Application/Supplement

Fiscal Year 2003: $74,300,000

Fiscal Year 2004: $77,000,000

Fiscal Year 2005: $84,000,000

Fiscal Year 2006: $86,434,000

Fiscal Year 2007: $86,434,000

Establishment

Fiscal Year 2003: $74,300,000

Fiscal Year 2004: $77,000,000

Fiscal Year 2005: $84,000,000

Fiscal Year 2006: $86,433,000

Fiscal Year 2007: $86,433,000

Product

Fiscal Year 2003: $74,300,000

Fiscal Year 2004: $77,000,000

Fiscal Year 2005: $84,000,000

Fiscal Year 2006: $86,433,000

Fiscal Year 2007: $86,433,000

Total Fee Revenue

Fiscal Year 2003: $222,900,000

Fiscal Year 2004: $231,000,000

Fiscal Year 2005: $252,000,000

Fiscal Year 2006: $259,300,000

Fiscal Year 2007: $259,300,000

--------------------------------------

If, after June 12, 2002, legislation is enacted requiring the

Secretary to fund additional costs of the retirement of Federal

personnel, fee revenue amounts shall be increased in each year by

the amount necessary to fully fund the portion of such additional

costs that are attributable to the process for the review of human

drug applications.

(c) Adjustments

(1) Inflation adjustment

The revenues established in subsection (b) of this section

shall be adjusted by the Secretary by notice, published in the

Federal Register, for a fiscal year to reflect the greater of -

(A) the total percentage change that occurred in the Consumer

Price Index for all urban consumers (all items; U.S. city

average) for the 12 month period ending June 30 preceding the

fiscal year for which fees are being established, or

(B) the total percentage change for the previous fiscal year

in basic pay under the General Schedule in accordance with

section 5332 of title 5, as adjusted by any locality-based

comparability payment pursuant to section 5304 of such title

for Federal employees stationed in the District of Columbia.

The adjustment made each fiscal year by this subsection will be

added on a compounded basis to the sum of all adjustments made

each fiscal year after fiscal year 2003 under this subsection.

(2) Workload adjustment

Beginning with fiscal year 2004, after the fee revenues

established in subsection (b) of this section are adjusted for a

fiscal year for inflation in accordance with paragraph (1), the

fee revenues shall be adjusted further for such fiscal year to

reflect changes in the workload of the Secretary for the process

for the review of human drug applications. With respect to such

adjustment:

(A) The adjustment shall be determined by the Secretary based

on a weighted average of the change in the total number of

human drug applications, commercial investigational new drug

applications, efficacy supplements, and manufacturing

supplements submitted to the Secretary. The Secretary shall

publish in the Federal Register the fee revenues and fees

resulting from the adjustment and the supporting methodologies.

(B) Under no circumstances shall the adjustment result in fee

revenues for a fiscal year that are less than the fee revenues

for the fiscal year established in subsection (b) of this

section, as adjusted for inflation under paragraph (1).

(3) Final year adjustment

For fiscal year 2007, the Secretary may, in addition to

adjustments under paragraphs (1) and (2), further increase the

fee revenues and fees established in subsection (b) of this

section if such an adjustment is necessary to provide for not

more than three months of operating reserves of carryover user

fees for the process for the review of human drug applications

for the first three months of fiscal year 2008. If such an

adjustment is necessary, the rationale for the amount of the

increase shall be contained in the annual notice establishing fee

revenues and fees for fiscal year 2007. If the Secretary has

carryover balances for such process in excess of three months of

such operating reserves, the adjustment under this paragraph

shall not be made.

(4) Annual fee setting

The Secretary shall, 60 days before the start of each fiscal

year that begins after September 30, 2002, establish, for the

next fiscal year, application, product, and establishment fees

under subsection (a) of this section, based on the revenue

amounts established under subsection (b) of this section and the

adjustments provided under this subsection.

(5) Limit

The total amount of fees charged, as adjusted under this

subsection, for a fiscal year may not exceed the total costs for

such fiscal year for the resources allocated for the process for

the review of human drug applications.

(d) Fee waiver or reduction

(1) In general

The Secretary shall grant a waiver from or a reduction of one

or more fees assessed under subsection (a) of this section where

the Secretary finds that -

(A) such waiver or reduction is necessary to protect the

public health,

(B) the assessment of the fee would present a significant

barrier to innovation because of limited resources available to

such person or other circumstances,

(C) the fees to be paid by such person will exceed the

anticipated present and future costs incurred by the Secretary

in conducting the process for the review of human drug

applications for such person, or

(D) the applicant involved is a small business submitting its

first human drug application to the Secretary for review.

(2) Use of standard costs

In making the finding in paragraph (1)(C), the Secretary may

use standard costs.

(3) Rules relating to small businesses

(A) ''Small business'' defined

In paragraph (1)(D), the term ''small business'' means an

entity that has fewer than 500 employees, including employees

of affiliates.

(B) Waiver of application fee

The Secretary shall waive under paragraph (1)(D) the

application fee for the first human drug application that a

small business or its affiliate submits to the Secretary for

review. After a small business or its affiliate is granted

such a waiver, the small business or its affiliate shall pay -

(i) application fees for all subsequent human drug

applications submitted to the Secretary for review in the

same manner as an entity that does not qualify as a small

business; and

(ii) all supplement fees for all supplements to human drug

applications submitted to the Secretary for review in the

same manner as an entity that does not qualify as a small

business.

(e) Effect of failure to pay fees

A human drug application or supplement submitted by a person

subject to fees under subsection (a) of this section shall be

considered incomplete and shall not be accepted for filing by the

Secretary until all fees owed by such person have been paid.

(f) Limitations

(1) In general

Fees under subsection (a) of this section shall be refunded for

a fiscal year beginning after fiscal year 1997 unless

appropriations for salaries and expenses of the Food and Drug

Administration for such fiscal year (excluding the amount of fees

appropriated for such fiscal year) are equal to or greater than

the amount of appropriations for the salaries and expenses of the

Food and Drug Administration for the fiscal year 1997 (excluding

the amount of fees appropriated for such fiscal year) multiplied

by the adjustment factor applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) of

this section during any portion of a fiscal year because of

paragraph (1) and if at a later date in such fiscal year the

Secretary may assess such fees, the Secretary may assess and

collect such fees, without any modification in the rate, for

human drug applications and supplements, prescription drug

establishments, and prescription drug products at any time in

such fiscal year notwithstanding the provisions of subsection (a)

of this section relating to the date fees are to be paid.

(g) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) of this section shall be

collected and available for obligation only to the extent and in

the amount provided in advance in appropriations Acts. Such fees

are authorized to remain available until expended. Such sums as

may be necessary may be transferred from the Food and Drug

Administration salaries and expenses appropriation account

without fiscal year limitation to such appropriation account for

salaries and expenses with such fiscal year limitation. The sums

transferred shall be available solely for the process for the

review of human drug applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section -

(i) shall be retained in each fiscal year in an amount not

to exceed the amount specified in appropriation Acts, or

otherwise made available for obligation, for such fiscal

year, and

(ii) shall only be collected and available to defray

increases in the costs of the resources allocated for the

process for the review of human drug applications (including

increases in such costs for an additional number of full-time

equivalent positions in the Department of Health and Human

Services to be engaged in such process) over such costs,

excluding costs paid from fees collected under this section,

for fiscal year 1997 multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the

requirements of subparagraph (A)(ii) in any fiscal year if the

costs funded by appropriations and allocated for the process

for the review of human drug applications -

(i) are not more than 3 percent below the level specified

in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified

in subparagraph (A)(ii), and fees assessed for the fiscal

year following the subsequent fiscal year are decreased by

the amount in excess of 3 percent by which such costs fell

below the level specified in such subparagraph; and

(II) such costs are not more than 5 percent below the level

specified in such subparagraph.

(3) Authorization of appropriations

There are authorized to be appropriated for fees under this

section -

(A) $222,900,000 for fiscal year 2003;

(B) $231,000,000 for fiscal year 2004;

(C) $252,000,000 for fiscal year 2005;

(D) $259,300,000 for fiscal year 2006; and

(E) $259,300,000 for fiscal year 2007;

as adjusted to reflect adjustments in the total fee revenues made

under this section and changes in the total amounts collected by

application, supplement, establishment, and product fees.

(4) Offset

Any amount of fees collected for a fiscal year under this

section that exceeds the amount of fees specified in

appropriation Acts for such fiscal year shall be credited to the

appropriation account of the Food and Drug Administration as

provided in paragraph (1), and shall be subtracted from the

amount of fees that would otherwise be authorized to be collected

under this section pursuant to appropriation Acts for a

subsequent fiscal year.

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee

assessed under subsection (a) of this section within 30 days after

it is due, such fee shall be treated as a claim of the United

States Government subject to subchapter II of chapter 37 of title

31.

(i) Written requests for waivers, reductions, and refunds

To qualify for consideration for a waiver or reduction under

subsection (d) of this section, or for a refund of any fee

collected in accordance with subsection (a) of this section, a

person shall submit to the Secretary a written request for such

waiver, reduction, or refund not later than 180 days after such fee

is due.

(j) Construction

This section may not be construed to require that the number of

full-time equivalent positions in the Department of Health and

Human Services, for officers, employers, and advisory committees

not engaged in the process of the review of human drug

applications, be reduced to offset the number of officers,

employees, and advisory committees so engaged.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 736, as added Pub. L. 102-571, title

I, Sec. 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L.

105-115, title I, Sec. 103(a)-(g), Nov. 21, 1997, 111 Stat.

2299-2304; Pub. L. 107-109, Sec. 5(a), Jan. 4, 2002, 115 Stat.

1413; Pub. L. 107-188, title V, Sec. 504, June 12, 2002, 116 Stat.

689.)

-STATAMEND-

AMENDMENT OF SECTION

For termination of amendment by section 509 of Pub. L. 107-188,

see Effective and Termination Dates of 2002 Amendments note

below.

For termination of amendment by section 107 of Pub. L. 105-115,

see Effective and Termination Dates of 1997 Amendment note below.

TERMINATION OF SECTION

For termination of section by section 105 of Pub. L. 102-571,

see Termination Date note below.

-REFTEXT-

REFERENCES IN TEXT

Section 357 of this title, referred to in subsec. (a)(3)(B), was

repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,

1997, 111 Stat. 2325.

The Drug Price Competition and Patent Term Restoration Act of

1984, referred to in subsec. (a)(3)(B), is Pub. L. 98-417, Sept.

24, 1984, 98 Stat. 1585. For complete classification of this Act to

the Code, see Short Title of 1984 Amendment note set out under

section 301 of this title and Tables.

-MISC2-

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-188, Sec. 504(a)(1), 509,

temporarily substituted ''fiscal year 2003'' for ''fiscal year

1998'' in introductory provisions. See Effective and Termination

Dates of 2002 Amendment note below.

Subsec. (a)(1)(A)(i). Pub. L. 107-188, Sec. 504(a)(2)(A), 509,

temporarily substituted ''under subsection (c)(4)'' for ''in

subsection (b)''. See Effective and Termination Dates of 2002

Amendment note below.

Subsec. (a)(1)(A)(ii). Pub. L. 107-188, Sec. 504(a)(2), 509,

temporarily substituted ''under subsection (c)(4)'' for ''in

subsection (b)'' and inserted ''Such fee shall be half of the

amount of the fee established under clause (i).'' at end. See

Effective and Termination Dates of 2002 Amendment note below.

Subsec. (a)(1)(F), (G). Pub. L. 107-109 redesignated subpar. (G)

as (F) and struck out heading and text of former subpar. (F). Text

read as follows: ''A supplement to a human drug application

proposing to include a new indication for use in pediatric

populations shall not be assessed a fee under subparagraph (A).''

Subsec. (a)(2)(A). Pub. L. 107-188, Sec. 504(a)(3), 509, in

concluding provisions, temporarily substituted ''under subsection

(c)(4)'' for ''in subsection (b)'' and ''payable on or before

October 1'' for ''payable on or before January 31''. See Effective

and Termination Dates of 2002 Amendment note below.

Subsec. (a)(3)(A). Pub. L. 107-188, Sec. 504(a)(4)(A), 509,

temporarily amended heading and text of subpar. (A) generally.

Prior to amendment, text read as follows: ''Except as provided in

subparagraph (B), each person -

''(i) who is named as the applicant in a human drug application

for a prescription drug product which has been submitted for

listing under section 360 of this title, and

''(ii) who, after September 1, 1992, had pending before the

Secretary a human drug application or supplement,

shall pay for each such prescription drug product the annual fee

established in subsection (b) of this section. Such fee shall be

payable for the fiscal year in which the product is first submitted

for listing under section 360 of this title, or is submitted for

relisting under section 360 of this title if the product has been

withdrawn from listing and relisted. After such fee is paid for

that fiscal year, such fee shall be payable on or before January 31

of each year. Such fee shall be paid only once for each product

for a fiscal year in which the fee is payable.'' See Effective and

Termination Dates of 2002 Amendment note below.

Subsec. (a)(3)(B). Pub. L. 107-188, Sec. 504(a)(4)(B), 509,

temporarily substituted ''A prescription drug product shall not be

assessed a fee under subparagraph (A) if such product is identified

on the list compiled under section 355(j)(7)(A) of this title with

a potency described in terms of per 100 mL, or if such product is

the same product as another product approved under an application

filed under section 355(b)'' for ''The listing of a prescription

drug product under section 360 of this title shall not require the

person who listed such product to pay the fee prescribed by

subparagraph (A) if such product is the same product as a product

approved under an application filed under section 355(b)(2)''. See

Effective and Termination Dates of 2002 Amendment note below.

Subsec. (b). Pub. L. 107-188, Sec. 504(b), 509, temporarily

amended heading and text of subsec. (b) generally, substituting

''Fee revenue amounts'' for ''Fee amounts'' in heading and

substituting fee schedules for fiscal years 2003 to 2007 for fee

provisions relating to fiscal years 1998 to 2002. See Effective and

Termination Dates of 2002 Amendment note below.

Subsec. (c)(1). Pub. L. 107-188, Sec. 504(c)(1)(A), (D), 509,

temporarily substituted ''revenues'' for ''fees and total fee

revenues'' in introductory provisions and ''fiscal year 2003'' for

''fiscal year 1997'' in concluding provisions. See Effective and

Termination Dates of 2002 Amendment note below.

Subsec. (c)(1)(A). Pub. L. 107-188, Sec. 504(c)(1)(B), 509,

temporarily struck out ''during the preceding fiscal year'' before

''in the Consumer Price Index'' and substituted ''for the 12 month

period ending June 30 preceding the fiscal year for which fees are

being established, or'' for '', or''. See Effective and

Termination Dates of 2002 Amendment note below.

Subsec. (c)(1)(B). Pub. L. 107-188, Sec. 504(c)(1)(C), 509,

temporarily substituted ''for the previous fiscal year'' for ''for

such fiscal year''. See Effective and Termination Dates of 2002

Amendment note below.

Subsec. (c)(2) to (5). Pub. L. 107-188, Sec. 504(c)(2)-(4), 509,

temporarily added pars. (2) and (3), redesignated former pars. (2)

and (3) as (4) and (5), respectively, and amended heading and text

of par. (4) generally. Prior to amendment, text of par. (4) read

as follows: ''Subject to the amount appropriated for a fiscal year

under subsection (g) of this section, the Secretary shall, within

60 days after the end of each fiscal year beginning after September

30, 1997, adjust the establishment and product fees described in

subsection (b) of this section for the fiscal year in which the

adjustment occurs so that the revenues collected from each of the

categories of fees described in paragraphs (2) and (3) of

subsection (b) of this section shall be set to be equal to the

revenues collected from the category of application and supplement

fees described in paragraph (1) of subsection (b) of this

section.'' See Effective and Termination Dates of 2002 Amendment

note below.

Subsec. (d)(1)(C) to (E). Pub. L. 107-188, Sec. 504(d)(1), 509,

temporarily inserted ''or'' at end of subpar. (C), redesignated

subpar. (E) as (D), and struck out former subpar. (D) which read as

follows: ''assessment of the fee for an application or a supplement

filed under section 355(b)(1) of this title pertaining to a drug

containing an active ingredient would be inequitable because an

application for a product containing the same active ingredient

filed by another person under section 355(b)(2) of this title could

not be assessed fees under subsection (a)(1) of this section,

or''. See Effective and Termination Dates of 2002 Amendment note

below.

Subsec. (d)(3)(A), (B). Pub. L. 107-188, Sec. 504(d)(2), 509,

temporarily substituted ''paragraph (1)(D)'' for ''paragraph

(1)(E)''. See Effective and Termination Dates of 2002 Amendment

note below.

Subsec. (f). Pub. L. 107-188, Sec. 504(e)(1), 509, temporarily

substituted ''Limitations'' for ''Assessment of fees'' in heading.

See Effective and Termination Dates of 2002 Amendment note below.

Subsec. (f)(1). Pub. L. 107-188, Sec. 504(e)(2), 509, temporarily

substituted ''In general'' for ''Limitation'' in heading and ''Fees

under subsection (a) of this section shall be refunded for a fiscal

year beginning'' for ''Fees may not be assessed under subsection

(a) of this section for a fiscal year beginning'' in text. See

Effective and Termination Dates of 2002 Amendment note below.

Subsec. (g)(1). Pub. L. 107-188, Sec. 504(f)(1), 509, which

directed the temporary amendment of par. (1) by striking ''Fees

collected for a fiscal year'' and all that follows through ''fiscal

year limitation.'' and inserting ''Fees authorized under subsection

(a) of this section shall be collected and available for obligation

only to the extent and in the amount provided in advance in

appropriations Acts. Such fees are authorized to remain available

until expended.'', was executed by striking language ending with

''fiscal year limitation.'' the first time appearing, thereby

making the substitution for ''Fees collected for a fiscal year

pursuant to subsection (a) of this section shall be credited to the

appropriation account for salaries and expenses of the Food and

Drug Administration and shall be available in accordance with

appropriation Acts until expended without fiscal year

limitation.'', to reflect the probable intent of Congress. See

Effective and Termination Dates of 2002 Amendment note below.

Subsec. (g)(2). Pub. L. 107-188, Sec. 504(f)(2), 509, temporarily

amended par. (2) by designating existing provisions as subpar. (A),

inserting subpar. (A) heading, adding subpar. (B), redesignating

former subpars. (A) and (B) as cls. (i) and (ii), respectively, of

subpar. (A), substituting ''shall be retained in each fiscal year

in an amount not to exceed the amount specified'' for ''shall be

collected in each fiscal year in an amount equal to the amount

specified'' in cl. (i), and realigning margin of cl. (ii). See

Effective and Termination Dates of 2002 Amendment note below.

Subsec. (g)(3)(A) to (E). Pub. L. 107-188, Sec. 504(f)(3), 509,

temporarily added subpars. (A) to (E) and struck out former

subpars. (A) to (E) which read as follows:

''(A) $106,800,000 for fiscal year 1998;

''(B) $109,200,000 for fiscal year 1999;

''(C) $109,200,000 for fiscal year 2000;

''(D) $114,000,000 for fiscal year 2001; and

''(E) $110,100,000 for fiscal year 2002,''.

See Effective and Termination Dates of 2002 Amendment note below.

1997 - Subsec. (a). Pub. L. 105-115, Sec. 103(a)(1), 107,

temporarily substituted ''Beginning in fiscal year 1998'' for

''Beginning in fiscal year 1993'' in introductory provisions. See

Effective and Termination Dates of 1997 Amendment note below.

Subsec. (a)(1)(B). Pub. L. 105-115, Sec. 103(a)(2)(A), 107,

temporarily amended heading and text of subpar. (B) generally.

Prior to amendment, text read as follows:

''(i) First payment. - 50 percent of the fee required by

subparagraph (A) shall be due upon submission of the application or

supplement.

''(ii) Final payment. - The remaining 50 percent of the fee

required by subparagraph (A) shall be due upon -

''(I) the expiration of 30 days from the date the Secretary

sends to the applicant a letter designated by the Secretary as an

action letter described in section 379g(6)(B) of this title, or

''(II) the withdrawal of the application or supplement after it

is filed unless the Secretary waives the fee or a portion of the

fee because no substantial work was performed on such application

or supplement after it was filed.

The designation under subclause (I) or the waiver under subclause

(II) shall be solely in the discretion of the Secretary and shall

not be reviewable.'' See Effective and Termination Dates of 1997

Amendment note below.

Subsec. (a)(1)(D). Pub. L. 105-115, Sec. 103(a)(2)(B), 107,

temporarily substituted ''refused'' for ''not accepted'' in heading

and ''75 percent'' for ''50 percent'', ''subparagraph (B)'' for

''subparagraph (B)(i)'', and ''refused'' for ''not accepted'' in

text. See Effective and Termination Dates of 1997 Amendment note

below.

Subsec. (a)(1)(E) to (G). Pub. L. 105-115, Sec. 103(a)(2)(C),

107, temporarily added subpars. (E) to (G). See Effective and

Termination Dates of 1997 Amendment note below.

Subsec. (a)(2). Pub. L. 105-115, Sec. 103(a)(3), 107, temporarily

reenacted heading without change and amended text generally. Prior

to amendment, text read as follows: ''Each person that -

''(A) owns a prescription drug establishment, at which is

manufactured at least 1 prescription drug product which is not

the, or not the same as a, product approved under an application

filed under section 355(b)(2) or 355(j) of this title, and

''(B) after September 1, 1992, had pending before the Secretary

a human drug application or supplement,

shall be subject to the annual fee established in subsection (b) of

this section for each such establishment, payable on or before

January 31 of each year.'' See Effective and Termination Dates of

1997 Amendment note below.

Subsec. (a)(3)(A). Pub. L. 105-115, Sec. 103(a)(4)(A), 107,

temporarily substituted, in cl. (i), ''has been submitted for

listing'' for ''is listed'' and, in closing provisions, ''Such fee

shall be payable for the fiscal year in which the product is first

submitted for listing under section 360 of this title, or is

submitted for relisting under section 360 of this title if the

product has been withdrawn from listing and relisted. After such

fee is paid for that fiscal year, such fee shall be payable on or

before January 31 of each year. Such fee shall be paid only once

for each product for a fiscal year in which the fee is payable.''

for ''Such fee shall be payable at the time of the first such

listing of such product in each calendar year. Such fee shall be

paid only once each year for each listed prescription drug product

irrespective of the number of times such product is listed under

section 360 of this title.'' See Effective and Termination Dates of

1997 Amendment note below.

Subsec. (a)(3)(B). Pub. L. 105-115, Sec. 103(a)(4)(B), 107,

temporarily substituted ''355(j) of this title, under an

abbreviated application filed under section 357 of this title (as

in effect on the day before November 21, 1997), or under an

abbreviated new drug application pursuant to regulations in effect

prior to the implementation of the Drug Price Competition and

Patent Term Restoration Act of 1984.'' for ''355(j) of this

title.''. See Effective and Termination Dates of 1997 Amendment

note below.

Subsec. (b). Pub. L. 105-115, Sec. 103(b), 107, temporarily

amended subsec. (b) generally. Prior to amendment, subsec. (b)

related to fee amounts, including a schedule of fees in par. (1)

and fee exceptions for certain small businesses in par. (2). See

Effective and Termination Dates of 1997 Amendment note below.

Subsec. (c). Pub. L. 105-115, Sec. 103(c)(1), 107, temporarily

substituted ''Adjustments'' for ''Increases and adjustments'' in

heading. See Effective and Termination Dates of 1997 Amendment

note below.

Subsec. (c)(1). Pub. L. 105-115, Sec. 103(c)(2), 107, temporarily

substituted ''Inflation adjustment'' for ''Revenue increase'' in

heading, ''The fees and total fee revenues established in

subsection (b) of this section shall be adjusted by the Secretary''

for ''The total fee revenues established by the schedule in

subsection (b)(1) of this section shall be increased by the

Secretary'' in introductory provisions, and ''change'' for

''increase'' after ''total percentage'' in subpars. (A) and (B),

and inserted at end ''The adjustment made each fiscal year by this

subsection will be added on a compounded basis to the sum of all

adjustments made each fiscal year after fiscal year 1997 under this

subsection.'' See Effective and Termination Dates of 1997 Amendment

note below.

Subsec. (c)(2). Pub. L. 105-115, Sec. 103(c)(3), 107, temporarily

substituted ''September 30, 1997, adjust the establishment and

product fees described in subsection (b) of this section for the

fiscal year in which the adjustment occurs so that the revenues

collected from each of the categories of fees described in

paragraphs (2) and (3) of subsection (b) of this section shall be

set to be equal to the revenues collected from the category of

application and supplement fees described in paragraph (1) of

subsection (b) of this section.'' for ''October 1, 1992, adjust the

fees established by the schedule in subsection (b)(1) of this

section for the following fiscal year to achieve the total fee

revenues, as may be increased under paragraph (1). Such fees shall

be adjusted under this paragraph to maintain the proportions

established in such schedule.'' See Effective and Termination Dates

of 1997 Amendment note below.

Subsec. (c)(3). Pub. L. 105-115, Sec. 103(c)(4), 107, temporarily

substituted ''this subsection'' for ''paragraph (2)''. See

Effective and Termination Dates of 1997 Amendment note below.

Subsec. (d). Pub. L. 105-115, Sec. 103(d), 107, temporarily

struck out introductory provisions which read ''The Secretary shall

grant a waiver from or a reduction of 1 or more fees under

subsection (a) of this section where the Secretary finds that - ''

and closing provisions which read ''In making the finding in

paragraph (3), the Secretary may use standard costs.'', inserted

designation, heading, and introductory provisions of par. (1),

redesignated former pars. (1) to (4) as subpars. (A) to (D),

respectively, of par. (1), and added pars. (1)(E), (2), and (3).

See Effective and Termination Dates of 1997 Amendment note below.

Subsec. (f)(1). Pub. L. 105-115, Sec. 103(e), 107, temporarily

substituted ''fiscal year 1997'' for ''fiscal year 1993'' and

''fiscal year 1997 (excluding the amount of fees appropriated for

such fiscal year)'' for ''fiscal year 1992''. See Effective and

Termination Dates of 1997 Amendment note below.

Subsec. (g)(1). Pub. L. 105-115, Sec. 103(f)(1), 107, temporarily

inserted at end ''Such sums as may be necessary may be transferred

from the Food and Drug Administration salaries and expenses

appropriation account without fiscal year limitation to such

appropriation account for salaries and expenses with such fiscal

year limitation. The sums transferred shall be available solely

for the process for the review of human drug applications.'' See

Effective and Termination Dates of 1997 Amendment note below.

Subsec. (g)(2)(A). Pub. L. 105-115, Sec. 103(f)(2)(A), 107,

temporarily substituted ''Acts, or otherwise made available for

obligation,'' for ''Acts''. See Effective and Termination Dates of

1997 Amendment note below.

Subsec. (g)(2)(B). Pub. L. 105-115, Sec. 103(f)(2)(B), 107,

temporarily substituted ''over such costs, excluding costs paid

from fees collected under this section, for fiscal year 1997'' for

''over such costs for fiscal year 1992''. See Effective and

Termination Dates of 1997 Amendment note below.

Subsec. (g)(3), (4). Pub. L. 105-115, Sec. 103(f)(3), 107,

temporarily added pars. (3) and (4) and struck out heading and text

of former par. (3). Text read as follows: ''There are authorized to

be appropriated for fees under this section -

''(A) $36,000,000 for fiscal year 1993,

''(B) $54,000,000 for fiscal year 1994,

''(C) $75,000,000 for fiscal year 1995,

''(D) $78,000,000 for fiscal year 1996, and

''(E) $84,000,000 for fiscal year 1997,

as adjusted to reflect increases in the total fee revenues made

under subsection (c)(1) of this section.'' See Effective and

Termination Dates of 1997 Amendment note below.

Subsecs. (i), (j). Pub. L. 105-115, Sec. 103(g), 107, temporarily

added subsec. (i) and redesignated former subsec. (i) as (j). See

Effective and Termination Dates of 1997 Amendment note below.

EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT

Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section

508 of Pub. L. 107-188, set out as an Effective Date of 2002

Amendment note under section 356b of this title.

Amendment by Pub. L. 107-188 to cease to be effective Oct. 1,

2007, see section 509 of Pub. L. 107-188, set out as a note under

section 379g of this title.

EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective Oct. 1, 1997, and ceases

to be effective Oct. 1, 2002, see sections 106 and 107 of Pub. L.

105-115, set out as notes under section 379g of this title.

TERMINATION DATE

Section not in effect after Oct. 1, 1997, see section 105 of Pub.

L. 102-571, set out as a note under section 379g of this title.

SPECIAL RULE FOR WAIVERS AND REFUNDS

Section 103(h) of Pub. L. 105-115 provided that: ''Any requests

for waivers or refunds for fees assessed under section 736 of the

Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the

date of enactment of this Act (Nov. 21, 1997) shall be submitted in

writing to the Secretary of Health and Human Services within 1 year

after the date of enactment of this Act. Any requests for waivers

or refunds pertaining to a fee for a human drug application or

supplement accepted for filing prior to October 1, 1997 or to a

product or establishment fee required by such Act for a fiscal year

prior to fiscal year 1998, shall be evaluated according to the

terms of the Prescription Drug User Fee Act of 1992 (see section

101(a) of Pub. L. 102-571, set out as a Short Title of 1992

Amendment note under section 301 of this title) (as in effect on

September 30, 1997) and part 2 of subchapter C of chapter VII of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.)

(as in effect on September 30, 1997). The term ''person'' in such

Acts shall continue to include an affiliate thereof.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 356, 379g of this title;

title 42 section 282.

-CITE-

21 USC subpart 3 - fees relating to devices 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 3 - fees relating to devices

.

-HEAD-

subpart 3 - fees relating to devices

-MISC1-

TERMINATION OF SUBPART

For termination of subpart by section 107 of Pub. L. 107-250,

see Effective and Termination Dates note set out under section

379i of this title.

-CITE-

21 USC Sec. 379i 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 3 - fees relating to devices

-HEAD-

Sec. 379i. Definitions

-STATUTE-

For purposes of this part:

(1) The term ''premarket application'' means -

(A) an application for approval of a device submitted under

section 360e(c) of this title or section 262 of title 42; or

(B) a product development protocol described in section

360e(f) of this title.

Such term does not include a supplement, a premarket report, or a

premarket notification submission.

(2) The term ''premarket report'' means a report submitted

under section 360e(c)(2) of this title.

(3) The term ''premarket notification submission'' means a

report submitted under section 360(k) of this title.

(4)(A) The term ''supplement'', with respect to a panel-track

supplement, a 180-day supplement, a real-time supplement, or an

efficacy supplement, means a request to the Secretary to approve

a change in a device for which -

(i) an application or report has been approved under section

360e(d) of this title, or an application has been approved

under section 262 of title 42; or

(ii) a notice of completion has become effective under

section 360e(f) of this title.

(B) The term ''panel-track supplement'' means a supplement to

an approved premarket application or premarket report under

section 360e of this title that requests a significant change in

design or performance of the device, or a new indication for use

of the device, and for which clinical data are generally

necessary to provide a reasonable assurance of safety and

effectiveness.

(C) The term ''180-day supplement'' means a supplement to an

approved premarket application or premarket report under section

360e of this title that is not a panel-track supplement and

requests a significant change in components, materials, design,

specification, software, color additives, or labeling.

(D) The term ''real-time supplement'' means a supplement to an

approved premarket application or premarket report under section

360e of this title that requests a minor change to the device,

such as a minor change to the design of the device, software,

manufacturing, sterilization, or labeling, and for which the

applicant has requested and the agency has granted a meeting or

similar forum to jointly review and determine the status of the

supplement.

(E) The term ''efficacy supplement'' means a supplement to an

approved premarket application under section 262 of title 42 that

requires substantive clinical data.

(5) The term ''process for the review of device applications''

means the following activities of the Secretary with respect to

the review of premarket applications, premarket reports,

supplements, and premarket notification submissions:

(A) The activities necessary for the review of premarket

applications, premarket reports, supplements, and premarket

notification submissions.

(B) The issuance of action letters that allow the marketing

of devices or which set forth in detail the specific

deficiencies in such applications, reports, supplements, or

submissions and, where appropriate, the actions necessary to

place them in condition for approval.

(C) The inspection of manufacturing establishments and other

facilities undertaken as part of the Secretary's review of

pending premarket applications, premarket reports, and

supplements.

(D) Monitoring of research conducted in connection with the

review of such applications, reports, supplements, and

submissions.

(E) Review of device applications subject to section 262 of

title 42 for an investigational new drug application under

section 355(i) of this title or for an investigational device

exemption under section 360j(g) of this title and activities

conducted in anticipation of the submission of such

applications under section 355(i) or 360j(g) of this title.

(F) The development of guidance, policy documents, or

regulations to improve the process for the review of premarket

applications, premarket reports, supplements, and premarket

notification submissions.

(G) The development of voluntary test methods, consensus

standards, or mandatory performance standards under section

360d of this title in connection with the review of such

applications, reports, supplements, or submissions and related

activities.

(H) The provision of technical assistance to device

manufacturers in connection with the submission of such

applications, reports, supplements, or submissions.

(I) Any activity undertaken under section 360c or 360e(i) of

this title in connection with the initial classification or

reclassification of a device or under section 360e(b) of this

title in connection with any requirement for approval of a

device.

(J) Evaluation of postmarket studies required as a condition

of an approval of a premarket application under section 360e of

this title or section 262 of title 42.

(K) Compiling, developing, and reviewing information on

relevant devices to identify safety and effectiveness issues

for devices subject to premarket applications, premarket

reports, supplements, or premarket notification submissions.

(6) The term ''costs of resources allocated for the process for

the review of device applications'' means the expenses incurred

in connection with the process for the review of device

applications for -

(A) officers and employees of the Food and Drug

Administration, contractors of the Food and Drug

Administration, advisory committees, and costs related to such

officers, employees, and committees and to contracts with such

contractors;

(B) management of information, and the acquisition,

maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of

facilities and acquisition, maintenance, and repair of

fixtures, furniture, scientific equipment, and other necessary

materials and supplies; and

(D) collecting fees and accounting for resources allocated

for the review of premarket applications, premarket reports,

supplements, and submissions.

(7) The term ''adjustment factor'' applicable to a fiscal year

is the Consumer Price Index for all urban consumers (all items;

United States city average) for April of the preceding fiscal

year divided by such Index for April 2002.

(8) The term ''affiliate'' means a business entity that has a

relationship with a second business entity if, directly or

indirectly -

(A) one business entity controls, or has the power to

control, the other business entity; or

(B) a third party controls, or has power to control, both of

the business entities.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 737, as added Pub. L. 107-250, title

I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1589.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 107 of Pub. L. 107-250,

see Effective and Termination Dates note set out below.

-MISC1-

EFFECTIVE AND TERMINATION DATES

Pub. L. 107-250, title I, Sec. 106, Oct. 26, 2002, 116 Stat.

1602, provided that: ''The amendments made by this title (enacting

this subpart) shall take effect on the date of the enactment of

this Act (Oct. 26, 2002), except that fees shall be assessed for

all premarket applications, premarket reports, supplements, and

premarket notification submissions received on or after October 1,

2002, regardless of the date of enactment.''

Pub. L. 107-250, title I, Sec. 107, Oct. 26, 2002, 116 Stat.

1602, provided that: ''The amendments made by this title (enacting

this subpart) cease to be effective October 1, 2007, except that

section 103 (set out as a note below) with respect to annual

reports ceases to be effective January 31, 2008.''

FINDINGS

Pub. L. 107-250, title I, Sec. 101, Oct. 26, 2002, 116 Stat.

1589, provided that: ''The Congress finds that -

''(1) prompt approval and clearance of safe and effective

devices is critical to the improvement of the public health so

that patients may enjoy the benefits of devices to diagnose,

treat, and prevent disease;

''(2) the public health will be served by making additional

funds available for the purpose of augmenting the resources of

the Food and Drug Administration that are devoted to the process

for the review of devices and the assurance of device safety and

effectiveness so that statutorily mandated deadlines may be met;

and

''(3) the fees authorized by this title (enacting this subpart

and provisions set out as notes under this section and section

379j of this title) will be dedicated to meeting the goals

identified in the letters from the Secretary of Health and Human

Services to the Committee on Energy and Commerce of the House of

Representatives and the Committee on Health, Education, Labor,

and Pensions of the Senate, as set forth in the Congressional

Record.''

ANNUAL REPORTS

Pub. L. 107-250, title I, Sec. 103, Oct. 26, 2002, 116 Stat.

1600, provided that: ''Beginning with fiscal year 2003, the

Secretary shall prepare and submit to the Committee on Energy and

Commerce of the House of Representatives and the Committee on

Health, Education, Labor and Pensions of the Senate a report

concerning -

''(1) the progress of the Food and Drug Administration in

achieving the goals identified in the letters described in

section 101(3) (set out as a note above) during such fiscal year

and the future plans of the Food and Drug Administration for

meeting the goals, not later than 60 days after the end of each

fiscal year during which fees are collected under this part

(title I of Pub. L. 107-250 does not contain parts); and

''(2) the implementation of the authority for such fees during

such fiscal year, and the use, by the Food and Drug

Administration, of the fees collected during such fiscal year,

not later than 120 days after the end of each fiscal year during

which fees are collected under the medical device user-fee

program established under the amendment made by section 102

(enacting this subpart).''

(Section 103 of Pub. L. 107-250, set out above, ceases to be

effective Jan. 31, 2008, see Effective and Termination Dates note

above.)

STUDY

Pub. L. 107-250, title I, Sec. 104(b), Oct. 26, 2002, 116 Stat.

1601, provided that:

''(1) In general. - The Secretary of Health and Human Services

(referred to in this section as the 'Secretary') shall conduct a

study for the purpose of determining the following with respect to

the medical device user-fee program established under the amendment

made by section 102 (enacting this subpart):

''(A) The impact of such program on the ability of the Food and

Drug Administration to conduct postmarket surveillance on medical

devices.

''(B) The programmatic improvements, if any, needed for

adequate postmarket surveillance of medical devices.

''(C) The amount of funds needed to conduct adequate postmarket

surveillance of medical devices.

''(D) The extent to which device companies comply with the

postmarket surveillance requirements, including postmarket study

commitments.

''(E) The recommendations of the Secretary as to whether, and

in what amounts, user fees collected under such user-fee program

should be dedicated to postmarket surveillance if the program is

extended beyond fiscal year 2007.

''(2) Report. - Not later than January 10, 2007, the Secretary

shall submit to the Committee on Energy and Commerce of the House

of Representatives, and the Committee on Health, Education, Labor,

and Pensions of the Senate, a report that describes the findings of

the study under paragraph (1).''

CONSULTATION

Pub. L. 107-250, title I, Sec. 105, Oct. 26, 2002, 116 Stat.

1601, provided that:

''(a) In General. - In developing recommendations to the Congress

for the goals and plans for meeting the goals for the process for

the review of medical device applications for fiscal years after

fiscal year 2007, and for the reauthorization of sections 737 and

738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i,

379j), the Secretary of Health and Human Services (referred to in

this section as the 'Secretary') shall consult with the Committee

on Energy and Commerce of the House of Representatives, the

Committee on Health, Education, Labor, and Pensions of the Senate,

appropriate scientific and academic experts, health care

professionals, representatives of patient and consumer advocacy

groups, and the regulated industry.

''(b) Recommendations. - The Secretary shall publish in the

Federal Register recommendations under subsection (a), after

negotiations with the regulated industry; shall present such

recommendations to the congressional committees specified in such

paragraph; shall hold a meeting at which the public may present its

views on such recommendations; and shall provide for a period of 30

days for the public to provide written comments on such

recommendations.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360e of this title.

-CITE-

21 USC Sec. 379j 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part C - Fees

subpart 3 - fees relating to devices

-HEAD-

Sec. 379j. Authority to assess and use device fees

-STATUTE-

(a) Types of fees

Beginning on October 26, 2002, the Secretary shall assess and

collect fees in accordance with this section as follows:

(1) (FOOTNOTE 1) Premarket application, premarket report,

supplement, and submission fee

(FOOTNOTE 1) So in original. No par. (2) has been enacted.

(A) In general

Except as provided in subparagraph (B) and subsection (d) of

this section, each person who submits any of the following, on

or after October 1, 2002, shall be subject to a fee established

under subsection (c)(5) of this section for the fiscal year

involved in accordance with the following:

(i) A premarket application.

(ii) For a premarket report, a fee equal to the fee that

applies under clause (i).

(iii) For a panel track supplement, a fee equal to the fee

that applies under clause (i).

(iv) For a 180-day supplement, a fee equal to 21.5 percent

of the fee that applies under clause (i), subject to any

adjustment under subsection (c)(3) of this section.

(v) For a real-time supplement, a fee equal to 7.2 percent

of the fee that applies under clause (i).

(vi) For an efficacy supplement, a fee equal to the fee

that applies under clause (i).

(vii) For a premarket notification submission, a fee equal

to 1.42 percent of the fee that applies under clause (i),

subject to any adjustment under subsection (c)(3) of this

section and any adjustment under subsection (e)(2)(C)(ii) of

this section.

(B) Exceptions

(i) Humanitarian device exemption

An application under section 360j(m) of this title is not

subject to any fee under subparagraph (A).

(ii) Further manufacturing use

No fee shall be required under subparagraph (A) for the

submission of a premarket application under section 262 of

title 42 for a product licensed for further manufacturing use

only.

(iii) State or Federal Government sponsors

No fee shall be required under subparagraph (A) for a

premarket application, premarket report, supplement, or

premarket notification submission submitted by a State or

Federal Government entity unless the device involved is to be

distributed commercially.

(iv) Premarket notifications by third parties

No fee shall be required under subparagraph (A) for a

premarket notification submission reviewed by an accredited

person pursuant to section 360m of this title.

(v) Pediatric conditions of use

(I) In general

No fee shall be required under subparagraph (A) for a

premarket application, premarket report, or premarket

notification submission if the proposed conditions of use

for the device involved are solely for a pediatric

population. No fee shall be required under such

subparagraph for a supplement if the sole purpose of the

supplement is to propose conditions of use for a pediatric

population.

(II) Subsequent proposal of adult conditions of use

In the case of a person who submits a premarket

application or premarket report for which, under subclause

(I), a fee under subparagraph (A) is not required, any

supplement to such application that proposes conditions of

use for any adult population is subject to the fee that

applies under such subparagraph for a premarket

application.

(C) Payment

The fee required by subparagraph (A) shall be due upon

submission of the premarket application, premarket report,

supplement, or premarket notification submission except that

invoices for applications submitted between October 1, 2002,

and October 26, 2002, shall be payable on October 30, 2002.

Applicants submitting portions of applications pursuant to

section 360e(c)(3) of this title shall pay such fees upon

submission of the first portion of such applications. The fees

credited to fiscal year 2003 under this section shall include

all fees payable from October 1, 2002, through September 30,

2003.

(D) Refunds

(i) Application refused for filing

The Secretary shall refund 75 percent of the fee paid under

subparagraph (A) for any application or supplement that is

refused for filing.

(ii) Application withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under

subparagraph (A) for any application or supplement that is

withdrawn prior to the filing decision of the Secretary.

(iii) Application withdrawn before first action

After receipt of a request for a refund of the fee paid

under subparagraph (A) for a premarket application, premarket

report, or supplement that is withdrawn after filing but

before a first action, the Secretary may return some or all

of the fee. The amount of refund, if any, shall be based on

the level of effort already expended on the review of such

application, report, or supplement. The Secretary shall have

sole discretion to refund a fee or portion of the fee under

this subparagraph. A determination by the Secretary

concerning a refund under this paragraph shall not be

reviewable.

(b) Fee revenue amounts

Except as provided in subsections (c), (d), (e), (g), and (h) of

this section, the fees under subsection (a) of this section shall

be established to generate the following revenue amounts:

$25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004;

$29,785,000 in fiscal year 2005; $32,615,000 in fiscal year 2006,

and $35,000,000 in fiscal year 2007. If legislation is enacted

after October 26, 2002, requiring the Secretary to fund additional

costs of the retirement of Federal personnel, fee revenue amounts

under this subsection shall be increased in each year by the amount

necessary to fully fund the portion of such additional costs that

are attributable to the process for the review of device

applications.

(c) Adjustments

(1) Inflation adjustment

The revenues established in subsection (b) of this section

shall be adjusted by the Secretary by notice, published in the

Federal Register, for a fiscal year to reflect the greater of -

(A) the total percentage change that occurred in the Consumer

Price Index for all urban consumers (all items; U.S. city

average) for the 12 month period ending June 30 preceding the

fiscal year for which fees are being established, or

(B) the total percentage change for the previous fiscal year

in basic pay under the General Schedule in accordance with

section 5332 of title 5, as adjusted by any locality-based

comparability payment pursuant to section 5304 of such title

for Federal employees stationed in the District of Columbia.

The adjustment made each fiscal year by this subsection shall be

added on a compounded basis to the sum of all adjustments made

each fiscal year after fiscal year 2003 under this subsection.

(2) Workload adjustment

After the fee revenues established in subsection (b) of this

section are adjusted for a fiscal year for inflation in

accordance with paragraph (1), the fee revenues shall, beginning

with fiscal year 2004, be adjusted further each fiscal year to

reflect changes in the workload of the Secretary for the process

for the review of device applications. With respect to such

adjustment:

(A) The adjustment shall be determined by the Secretary based

on a weighted average of the change in the total number of

premarket applications, investigational new device

applications, premarket reports, supplements, and premarket

notification submissions submitted to the Secretary. The

Secretary shall publish in the Federal Register the fee

revenues and fees resulting from the adjustment and the

supporting methodologies.

(B) Under no circumstances shall the adjustment result in fee

revenues for a fiscal year that are less than the fee revenues

for the fiscal year established in subsection (b) of this

section, as adjusted for inflation under paragraph (1).

(3) Compensating adjustment

After the fee revenues established in subsection (b) of this

section are adjusted for a fiscal year for inflation in

accordance with paragraph (1), and for workload in accordance

with paragraph (2), the fee revenues shall, beginning with fiscal

year 2004, be adjusted further each fiscal year, if necessary, to

reflect the cumulative amount by which collections for previous

fiscal years, beginning with fiscal year 2003, fell below the

cumulative revenue amounts for such fiscal years specified in

subsection (b) of this section, adjusted for such fiscal years

for inflation in accordance with paragraph (1), and for workload

in accordance with paragraph (2).

(4) Final year adjustment

For fiscal year 2007, the Secretary may, in addition to

adjustments under paragraphs (1) and (2), further increase the

fees and fee revenues established in subsection (b) of this

section if such adjustment is necessary to provide for not more

than three months of operating reserves of carryover user fees

for the process for the review of device applications for the

first three months of fiscal year 2008. If such an adjustment is

necessary, the rationale for the amount of the increase shall be

contained in the annual notice establishing fee revenues and fees

for fiscal year 2007. If the Secretary has carryover user fee

balances for such process in excess of three months of such

operating reserves, the adjustment under this paragraph shall not

be made.

(5) Annual fee setting

The Secretary shall, 60 days before the start of each fiscal

year after September 30, 2002, establish, for the next fiscal

year, and publish in the Federal Register, fees under subsection

(a) of this section, based on the revenue amounts established

under subsection (b) of this section and the adjustment provided

under this subsection and subsection (e)(2)(C)(ii) of this

section, except that the fees established for fiscal year 2003

shall be based on a premarket application fee of $154,000.

(6) Limit

The total amount of fees charged, as adjusted under this

subsection, for a fiscal year may not exceed the total costs for

such fiscal year for the resources allocated for the process for

the review of device applications.

(d) Small businesses; fee waiver and fee reduction regarding

premarket approval fees

(1) In general

The Secretary shall grant a waiver of the fee required under

subsection (a) of this section for one premarket application, or

one premarket report, where the Secretary finds that the

applicant involved is a small business submitting its first

premarket application to the Secretary, or its first premarket

report, respectively, for review. In addition, for subsequent

premarket applications, premarket reports, and supplements where

the Secretary finds that the applicant involved is a small

business, the fees specified in clauses (i) through (vi) of

subsection (a)(1)(A) of this section may be paid at a reduced

rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket approval fees

(A) Definition

(i) In general

For purposes of this subsection, the term ''small

business'' means an entity that reported $30,000,000 or less

of gross receipts or sales in its most recent Federal income

tax return for a taxable year, including such returns of all

of its affiliates, partners, and parent firms.

(ii) Adjustment

The Secretary may adjust the $30,000,000 threshold

established in clause (i) if the Secretary has evidence from

actual experience that this threshold results in a reduction

in revenues from premarket applications, premarket reports,

and supplements that is 16 percent or more than would occur

without small business exemptions and lower fee rates. To

adjust this threshold, the Secretary shall publish a notice

in the Federal Register setting out the rationale for the

adjustment, and the new threshold.

(B) Evidence of qualification

An applicant shall pay the higher fees established by the

Secretary each year unless the applicant submits evidence that

it qualifies for a waiver of the fee or the lower fee rate.

The applicant shall support its claim that it meets the

definition under subparagraph (A) by submission of a copy of

its most recent Federal income tax return for a taxable year,

and a copy of such returns of its affiliates, partners, and

parent firms. which show an amount of gross sales or receipts

that is less than the maximum established in subparagraph (A).

The applicant, and each of such affiliates, partners, and

parent firms, shall certify that the information provided is a

true and accurate copy of the actual tax forms they submitted

to the Internal Revenue Service. If no tax forms are submitted

for affiliates, partners, or parent firms, the applicant shall

certify that the applicant has no affiliates, partners, or

parent firms, respectively.

(C) Reduced fees

Where the Secretary finds that the applicant involved meets

the definition under subparagraph (A), the fees established

under subsection (c)(5) of this section may be paid at a

reduced rate of 38 percent of the fee established under such

subsection for a premarket application, a premarket report, or

a supplement.

(D) Request for fee waiver or reduction

An applicant seeking a fee waiver or reduction under this

subsection shall submit supporting information to the Secretary

at least 60 days before the fee is required pursuant to

subsection (a) of this section. The decision of the Secretary

regarding whether an entity qualifies for such a waiver or

reduction is not reviewable.

(e) Small businesses; fee reduction regarding premarket

notification submissions

(1) In general

Where the Secretary finds that the applicant involved is a

small business, the fee specified in subsection (a)(1)(A)(vii) of

this section may be paid at a reduced rate in accordance with

paragraph (2)(C).

(2) Rules relating to premarket notification submissions

(A) Definition

For purposes of this subsection, the term ''small business''

means an entity that reported $30,000,000 or less of gross

receipts or sales in its most recent Federal income tax return

for a taxable year, including such returns of all of its

affiliates, partners, and parent firms.

(B) Evidence of qualification

An applicant shall pay the higher fees established by the

Secretary each year unless the applicant submits evidence that

it qualifies for the lower fee rate. The applicant shall

support its claim that it meets the definition under

subparagraph (A) by submission of a copy of its most recent

Federal income tax return for a taxable year, and a copy of

such returns of its affiliates, partners, and parent firms.

(FOOTNOTE 2) which show an amount of gross sales or receipts

that is less than the maximum established in subparagraph (A).

The applicant, and each of such affiliates, partners, and

parent firms, shall certify that the information provided is a

true and accurate copy of the actual tax forms they submitted

to the Internal Revenue Service. If no tax forms are submitted

for affiliates, partners, or parent firms, the applicant shall

certify that the applicant has no affiliates, partners, or

parent firms, respectively.

(FOOTNOTE 2) So in original. The period probably should be a

comma.

(C) Reduced fees

(i) In general

Where the Secretary finds that the applicant involved meets

the definition under subparagraph (A), the fee for a

premarket notification submission may be paid at 80 percent

of the fee that applies under subsection (a)(1)(A)(vii) of

this section, as adjusted under clause (ii) and as

established under subsection (c)(5) of this section.

(ii) Adjustment per fee revenue amount

For fiscal year 2004 and each subsequent fiscal year, the

Secretary, in setting the revenue amount under subsection

(c)(5) of this section for premarket notification

submissions, shall determine the revenue amount that would

apply if all such submissions for the fiscal year involved

paid a fee equal to 1.42 percent of the amount that applies

under subsection (a)(1)(A)(i) of this section for premarket

applications, and shall adjust the fee under subsection

(a)(1)(A)(vii) of this section for premarket notification

submissions such that the reduced fees collected under clause

(i) of this subparagraph, when added to fees for such

submissions that are not paid at the reduced rate, will equal

such revenue amount for the fiscal year.

(D) Request for reduction

An applicant seeking a fee reduction under this subsection

shall submit supporting information to the Secretary at least

60 days before the fee is required pursuant to subsection (a)

of this section. The decision of the Secretary regarding

whether an entity qualifies for such a reduction is not

reviewable.

(f) Effect of failure to pay fees

A premarket application, premarket report, supplement, or

premarket notification submission submitted by a person subject to

fees under subsection (a) of this section shall be considered

incomplete and shall not be accepted for filing by the Secretary

until all fees owed by such person have been paid.

(g) Conditions

(1) Performance goals through fiscal year 2005; termination of

program after fiscal year 2005

With respect to the amount that, under the salaries and

expenses account of the Food and Drug Administration, is

appropriated for a fiscal year for devices and radiological

products:

(A)(i) For each of the fiscal years 2003 and 2004, the

Secretary is expected to meet all of the goals identified for

the fiscal year involved in any letter referred to in section

101(3) of the Medical Device User Fee and Modernization Act of

2002 (referred to in this paragraph as ''performance goals'')

if the amount so appropriated for such fiscal year, excluding

the amount of fees appropriated for such fiscal year, is equal

to or greater than $205,720,000 multiplied by the adjustment

factor applicable to the fiscal year.

(ii) For each of the fiscal years 2003 and 2004, if the

amount so appropriated for the fiscal year involved, excluding

the amount of fees appropriated for such fiscal year, is less

than the amount that applies under clause (i) for such fiscal

year, the following applies:

(I) The Secretary is expected to meet such goals to the

extent practicable, taking into account the amounts that are

available to the Secretary for such purpose, whether from

fees under subsection (a) of this section or otherwise.

(II) The Comptroller General of the United States shall

submit to the Congress a report describing whether and to

what extent the Secretary is meeting the performance goals

identified for such fiscal year, and whether the Secretary

will be able to meet all performance goals identified for

fiscal year 2005. A report under the preceding sentence shall

be submitted to the Congress not later than July 1 of the

fiscal year with which the report is concerned.

(B)(i) For fiscal year 2005, the Secretary is expected to

meet all of the performance goals identified for the fiscal

year if the total of the amounts so appropriated for fiscal

years 2003 through 2005, excluding the amount of fees

appropriated for such fiscal years, is equal to or greater than

the sum of -

(I) $205,720,000 multiplied by the adjustment factor

applicable to fiscal year 2003;

(II) $205,720,000 multiplied by the adjustment factor

applicable to fiscal year 2004; and

(III) $205,720,000 multiplied by the adjustment factor

applicable to fiscal year 2005.

(ii) For fiscal year 2005, if the total of the amounts so

appropriated for fiscal years 2003 through 2005, excluding the

amount of fees appropriated for such fiscal years, is less than

the sum that applies under clause (i) for fiscal year 2005, the

following applies:

(I) The Secretary is expected to meet such goals to the

extent practicable, taking into account the amounts that are

available to the Secretary for such purpose, whether from

fees under subsection (a) of this section or otherwise.

(II) The Comptroller General of the United States shall

submit to the Congress a report describing whether and to

what extent the Secretary is meeting the performance goals

identified for such fiscal year, and whether the Secretary

will be able to meet all performance goals identified for

fiscal year 2006. The report under the preceding sentence

shall be submitted to the Congress not later than July 1,

2005.

(C) For fiscal year 2006, fees may not be assessed under

subsection (a) of this section for the fiscal year, and the

Secretary is not expected to meet any performance goals

identified for the fiscal year, if the total of the amounts so

appropriated for fiscal years 2003 through 2006, excluding the

amount of fees appropriated for such fiscal years, is less than

the sum of -

(i) $205,720,000 multiplied by the adjustment factor

applicable to fiscal year 2006; and

(ii) an amount equal to the sum that applies for purposes

of subparagraph (B)(i).

(D) For fiscal year 2007, fees may not be assessed under

subsection (a) of this section for the fiscal year, and the

Secretary is not expected to meet any performance goals

identified for the fiscal year, if -

(i) the amount so appropriated for the fiscal year,

excluding the amount of fees appropriated for the fiscal

year, is less than $205,720,000 multiplied by the adjustment

factor applicable to fiscal year 2007; or

(ii) pursuant to subparagraph (C), fees were not assessed

under subsection (a) of this section for fiscal year 2006.

(2) Authority

If the Secretary does not assess fees under subsection (a) of

this section during any portion of a fiscal year because of

subparagraph (C) or (D) of paragraph (1) and if at a later date

in such fiscal year the Secretary may assess such fees, the

Secretary may assess and collect such fees, without any

modification in the rate for premarket applications, supplements,

premarket reports, and premarket notification submissions, and at

any time in such fiscal year, notwithstanding the provisions of

subsection (a) of this section relating to the date fees are to

be paid.

(h) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) of this section shall be

collected and available for obligation only to the extent and in

the amount provided in advance in appropriation Acts. Such fees

are authorized to be appropriated to remain available until

expended. Such sums as may be necessary may be transferred from

the Food and Drug Administration salaries and expenses

appropriation account without fiscal year limitation to such

appropriation account for salaries and expenses with such fiscal

year limitation. The sums transferred shall be available solely

for the process for the review of device applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section -

(i) shall be retained in each fiscal year in an amount not

to exceed the amount specified in appropriation Acts, or

otherwise made available for obligation, for such fiscal

year, and

(ii) shall only be collected and available to defray

increases in the costs of the resources allocated for the

process for the review of device applications (including

increases in such costs for an additional number of full-time

equivalent positions in the Department of Health and Human

Services to be engaged in such process) over such costs,

excluding costs paid from fees collected under this section,

for fiscal year 2002 multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the

requirements of subparagraph (A)(ii) in any fiscal year if the

costs funded by appropriations and allocated for the process

for the review of device applications -

(i) are not more than 3 percent below the level specified

in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified

in subparagraph (A)(ii), and fees assessed for a subsequent

fiscal year are decreased by the amount in excess of 3

percent by which such costs fell below the level specified in

such subparagraph; and

(II) such costs are not more than 5 percent below the level

specified in such subparagraph.

(3) Authorization of appropriations

There are authorized to be appropriated for fees under this

section -

(A) $25,125,000 for fiscal year 2003;

(B) $27,255,000 for fiscal year 2004;

(C) $29,785,000 for fiscal year 2005;

(D) $32,615,000 for fiscal year 2006; and

(E) $35,000,000 for fiscal year 2007,

as adjusted to reflect adjustments in the total fee revenues made

under this section and changes in the total amounts collected by

application fees.

(4) Offset

Any amount of fees collected for a fiscal year under this

section that exceeds the amount of fees specified in

appropriation Acts for such fiscal year shall be credited to the

appropriation account of the Food and Drug Administration as

provided in paragraph (1), and shall be subtracted from the

amount of fees that would otherwise be authorized to be collected

under this section pursuant to appropriation Acts for a

subsequent fiscal year.

(i) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee

assessed under subsection (a) of this section within 30 days after

it is due, such fee shall be treated as a claim of the United

States Government subject to subchapter II of chapter 37 of title

31.

(j) Written requests for refunds

To qualify for consideration for a refund under subsection

(a)(1)(D) of this section, a person shall submit to the Secretary a

written request for such refund not later than 180 days after such

fee is due.

(k) Construction

This section may not be construed to require that the number of

full-time equivalent positions in the Department of Health and

Human Services, for officers, employees, and advisory committees

not engaged in the process of the review of device applications, be

reduced to offset the number of officers, employees, and advisory

committees so engaged.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 738, as added Pub. L. 107-250, title

I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1591.)

-STATAMEND-

TERMINATION OF SECTION

For termination of section by section 107 of Pub. L. 107-250,

see Effective and Termination Dates note set out under section

379i of this title.

-REFTEXT-

REFERENCES IN TEXT

-MISC2-

SECTION 101(3) OF THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT

OF 2002, REFERRED TO IN SUBSEC. (G)(1)(A)(I), IS SECTION 101(3) OF

PUB. L. 107-250, WHICH IS SET OUT AS A NOTE UNDER SECTION 379I OF

THIS TITLE.

EFFECTIVE AND TERMINATION DATES

Section effective Oct. 26, 2002, except for certain premarket

fees, and ceases to be effective Oct. 1, 2007, see sections 106 and

107 of Pub. L. 107-250, set out as notes under section 379i of this

title.

FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PREMARKET REPORTS

Pub. L. 107-250, title I, Sec. 102(b), Oct. 26, 2002, 116 Stat.

1600, provided that:

''(1) In general. - A person submitting a premarket report to the

Secretary of Health and Human Services is exempt from the fee under

section 738(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 379j(a)(1)(A)(ii)) (as added by subsection (a) of

this section) if -

''(A) the premarket report is the first such report submitted

to the Secretary by the person; and

''(B) before October 1, 2002, the person submitted a premarket

application to the Secretary for the same device as the device

for which the person is submitting the premarket report.

''(2) Definitions. - For purposes of paragraph (1), the terms

'device', 'premarket application', and 'premarket report' have the

same meanings as apply to such terms for purposes of section 738 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) (as added

by subsection (a) of this section).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 360e of this title.

-CITE-

21 USC Part D - Information and Education 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part D - Information and Education

.

-HEAD-

Part D - Information and Education

-CITE-

21 USC Sec. 379k 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part D - Information and Education

-HEAD-

Sec. 379k. Information system

-STATUTE-

The Secretary shall establish and maintain an information system

to track the status and progress of each application or submission

(including a petition, notification, or other similar form of

request) submitted to the Food and Drug Administration requesting

agency action.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 741, as added Pub. L. 105-115, title

IV, Sec. 407(a), Nov. 21, 1997, 111 Stat. 2370.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

REPORT ON STATUS OF SYSTEM

Section 407(b) of Pub. L. 105-115 provided that not later than 1

year after Nov. 21, 1997, Secretary of Health and Human Services

was to submit report to Congress on status of system to be

established under this section, including projected costs of system

and concerns about confidentiality.

-CITE-

21 USC Sec. 379l 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part D - Information and Education

-HEAD-

Sec. 379l. Education

-STATUTE-

(a) In general

The Secretary shall conduct training and education programs for

the employees of the Food and Drug Administration relating to the

regulatory responsibilities and policies established by this

chapter, including programs for -

(1) scientific training;

(2) training to improve the skill of officers and employees

authorized to conduct inspections under section 374 of this

title;

(3) training to achieve product specialization in such

inspections; and

(4) training in administrative process and procedure and

integrity issues.

(b) Intramural fellowships and other training programs

The Secretary, acting through the Commissioner, may, through

fellowships and other training programs, conduct and support

intramural research training for predoctoral and postdoctoral

scientists and physicians.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 742, as added Pub. L. 105-115, title

IV, Sec. 408(a), Nov. 21, 1997, 111 Stat. 2371.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Part E - Environmental Impact Review 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part E - Environmental Impact Review

.

-HEAD-

Part E - Environmental Impact Review

-CITE-

21 USC Sec. 379o 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part E - Environmental Impact Review

-HEAD-

Sec. 379o. Environmental impact

-STATUTE-

Notwithstanding any other provision of law, an environmental

impact statement prepared in accordance with the regulations

published in part 25 of title 21, Code of Federal Regulations (as

in effect on August 31, 1997) in connection with an action carried

out under (or a recommendation or report relating to) this chapter,

shall be considered to meet the requirements for a detailed

statement under section 4332(2)(C) of title 42.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 746, as added Pub. L. 105-115, title

IV, Sec. 411, Nov. 21, 1997, 111 Stat. 2373.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Part F - National Uniformity for Nonprescription

Drugs and Preemption for Labeling or

Packaging of Cosmetics 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part F - National Uniformity for Nonprescription Drugs and

Preemption for Labeling or Packaging of Cosmetics

.

-HEAD-

Part F - National Uniformity for Nonprescription Drugs and

Preemption for Labeling or Packaging of Cosmetics

-CITE-

21 USC Sec. 379r 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part F - National Uniformity for Nonprescription Drugs and

Preemption for Labeling or Packaging of Cosmetics

-HEAD-

Sec. 379r. National uniformity for nonprescription drugs

-STATUTE-

(a) In general

Except as provided in subsection (b), (c)(1), (d), (e), or (f) of

this section, no State or political subdivision of a State may

establish or continue in effect any requirement -

(1) that relates to the regulation of a drug that is not

subject to the requirements of section 353(b)(1) or 353(f)(1)(A)

of this title; and

(2) that is different from or in addition to, or that is

otherwise not identical with, a requirement under this chapter,

the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et

seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et

seq.).

(b) Exemption

(1) In general

Upon application of a State or political subdivision thereof,

the Secretary may by regulation, after notice and opportunity for

written and oral presentation of views, exempt from subsection

(a) of this section, under such conditions as may be prescribed

in such regulation, a State or political subdivision requirement

that -

(A) protects an important public interest that would

otherwise be unprotected, including the health and safety of

children;

(B) would not cause any drug to be in violation of any

applicable requirement or prohibition under Federal law; and

(C) would not unduly burden interstate commerce.

(2) Timely action

The Secretary shall make a decision on the exemption of a State

or political subdivision requirement under paragraph (1) not

later than 120 days after receiving the application of the State

or political subdivision under paragraph (1).

(c) Scope

(1) In general

This section shall not apply to -

(A) any State or political subdivision requirement that

relates to the practice of pharmacy; or

(B) any State or political subdivision requirement that a

drug be dispensed only upon the prescription of a practitioner

licensed by law to administer such drug.

(2) Safety or effectiveness

For purposes of subsection (a) of this section, a requirement

that relates to the regulation of a drug shall be deemed to

include any requirement relating to public information or any

other form of public communication relating to a warning of any

kind for a drug.

(d) Exceptions

(1) In general

In the case of a drug described in subsection (a)(1) of this

section that is not the subject of an application approved under

section 355 of this title or section 357 of this title (as in

effect on the day before November 21, 1997) or a final regulation

promulgated by the Secretary establishing conditions under which

the drug is generally recognized as safe and effective and not

misbranded, subsection (a) of this section shall apply only with

respect to a requirement of a State or political subdivision of a

State that relates to the same subject as, but is different from

or in addition to, or that is otherwise not identical with -

(A) a regulation in effect with respect to the drug pursuant

to a statute described in subsection (a)(2) of this section; or

(B) any other requirement in effect with respect to the drug

pursuant to an amendment to such a statute made on or after

November 21, 1997.

(2) State initiatives

This section shall not apply to a State requirement adopted by

a State public initiative or referendum enacted prior to

September 1, 1997.

(e) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise

affect any action or the liability of any person under the product

liability law of any State.

(f) State enforcement authority

Nothing in this section shall prevent a State or political

subdivision thereof from enforcing, under any relevant civil or

other enforcement authority, a requirement that is identical to a

requirement of this chapter.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 751, as added Pub. L. 105-115, title

IV, Sec. 412(a), Nov. 21, 1997, 111 Stat. 2373.)

-REFTEXT-

REFERENCES IN TEXT

The Poison Prevention Packaging Act of 1970, referred to in

subsec. (a)(2), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as

amended, which is classified principally to chapter 39A (Sec. 1471

et seq.) of Title 15, Commerce and Trade. For complete

classification of this Act to the Code, see Short Title note set

out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec.

(a)(2), is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended,

which is classified generally to chapter 39 (Sec. 1451 et seq.) of

Title 15, Commerce and Trade. For complete classification of this

Act to the Code, see Short Title note set out under section 1451 of

Title 15 and Tables.

-MISC2-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Sec. 379s 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part F - National Uniformity for Nonprescription Drugs and

Preemption for Labeling or Packaging of Cosmetics

-HEAD-

Sec. 379s. Preemption for labeling or packaging of cosmetics

-STATUTE-

(a) In general

Except as provided in subsection (b), (d), or (e) of this

section, no State or political subdivision of a State may establish

or continue in effect any requirement for labeling or packaging of

a cosmetic that is different from or in addition to, or that is

otherwise not identical with, a requirement specifically applicable

to a particular cosmetic or class of cosmetics under this chapter,

the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et

seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et

seq.).

(b) Exemption

Upon application of a State or political subdivision thereof, the

Secretary may by regulation, after notice and opportunity for

written and oral presentation of views, exempt from subsection (a)

of this section, under such conditions as may be prescribed in such

regulation, a State or political subdivision requirement for

labeling or packaging that -

(1) protects an important public interest that would otherwise

be unprotected;

(2) would not cause a cosmetic to be in violation of any

applicable requirement or prohibition under Federal law; and

(3) would not unduly burden interstate commerce.

(c) Scope

For purposes of subsection (a) of this section, a reference to a

State requirement that relates to the packaging or labeling of a

cosmetic means any specific requirement relating to the same aspect

of such cosmetic as a requirement specifically applicable to that

particular cosmetic or class of cosmetics under this chapter for

packaging or labeling, including any State requirement relating to

public information or any other form of public communication.

(d) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise

affect any action or the liability of any person under the product

liability law of any State.

(e) State initiative

This section shall not apply to a State requirement adopted by a

State public initiative or referendum enacted prior to September 1,

1997.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 752, as added Pub. L. 105-115, title

IV, Sec. 412(d), Nov. 21, 1997, 111 Stat. 2376.)

-REFTEXT-

REFERENCES IN TEXT

The Poison Prevention Packaging Act of 1970, referred to in

subsec. (a), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as

amended, which is classified principally to chapter 39A (Sec. 1471

et seq.) of Title 15, Commerce and Trade. For complete

classification of this Act to the Code, see Short Title note set

out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a),

is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which

is classified generally to chapter 39 (Sec. 1451 et seq.) of Title

15, Commerce and Trade. For complete classification of this Act to

the Code, see Short Title note set out under section 1451 of Title

15 and Tables.

-MISC2-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Part G - Safety Reports 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part G - Safety Reports

.

-HEAD-

Part G - Safety Reports

-CITE-

21 USC Sec. 379v 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII - GENERAL AUTHORITY

Part G - Safety Reports

-HEAD-

Sec. 379v. Safety report disclaimers

-STATUTE-

With respect to any entity that submits or is required to submit

a safety report or other information in connection with the safety

of a product (including a product that is a food, drug, device,

dietary supplement, or cosmetic) under this chapter (and any

release by the Secretary of that report or information), such

report or information shall not be construed to reflect necessarily

a conclusion by the entity or the Secretary that the report or

information constitutes an admission that the product involved

malfunctioned, caused or contributed to an adverse experience, or

otherwise caused or contributed to a death, serious injury, or

serious illness. Such an entity need not admit, and may deny, that

the report or information submitted by the entity constitutes an

admission that the product involved malfunctioned, caused or

contributed to an adverse experience, or caused or contributed to a

death, serious injury, or serious illness.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 756, as added Pub. L. 105-115, title

IV, Sec. 420, Nov. 21, 1997, 111 Stat. 2379.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC SUBCHAPTER VIII - IMPORTS AND EXPORTS 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VIII - IMPORTS AND EXPORTS

.

-HEAD-

SUBCHAPTER VIII - IMPORTS AND EXPORTS

-CITE-

21 USC Sec. 381 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-

Sec. 381. Imports and exports

-STATUTE-

(a) Imports; list of registered foreign establishments; samples

from unregistered foreign establishments; examination and

refusal of admission

The Secretary of the Treasury shall deliver to the Secretary of

Health and Human Services, upon his request, samples of food,

drugs, devices, and cosmetics which are being imported or offered

for import into the United States, giving notice thereof to the

owner or consignee, who may appear before the Secretary of Health

and Human Services and have the right to introduce testimony. The

Secretary of Health and Human Services shall furnish to the

Secretary of the Treasury a list of establishments registered

pursuant to subsection (i) of section 360 of this title and shall

request that if any drugs and devices manufactured, prepared,

propagated, compounded, or processed in an establishment not so

registered are imported or offered for import into the United

States, samples of such drugs and devices be delivered to the

Secretary of Health and Human Services, with notice of such

delivery to the owner or consignee, who may appear before the

Secretary of Health and Human Services and have the right to

introduce testimony. If it appears from the examination of such

samples or otherwise that (1) such article has been manufactured,

processed, or packed under insanitary conditions or, in the case of

a device, the methods used in, or the facilities or controls used

for, the manufacture, packing, storage, or installation of the

device do not conform to the requirements of section 360j(f) of

this title, or (2) such article is forbidden or restricted in sale

in the country in which it was produced or from which it was

exported, or (3) such article is adulterated, misbranded, or in

violation of section 355 of this title, then such article shall be

refused admission, except as provided in subsection (b) of this

section. The Secretary of the Treasury shall cause the destruction

of any such article refused admission unless such article is

exported, under regulations prescribed by the Secretary of the

Treasury, within ninety days of the date of notice of such refusal

or within such additional time as may be permitted pursuant to such

regulations. Clause (2) of the third sentence of this paragraph

(FOOTNOTE 1) shall not be construed to prohibit the admission of

narcotic drugs the importation of which is permitted under the

Controlled Substances Import and Export Act (21 U.S.C. 951 et

seq.).

(FOOTNOTE 1) So in original. Probably should be ''subsection''.

(b) Disposition of refused articles

Pending decision as to the admission of an article being imported

or offered for import, the Secretary of the Treasury may authorize

delivery of such article to the owner or consignee upon the

execution by him of a good and sufficient bond providing for the

payment of such liquidated damages in the event of default as may

be required pursuant to regulations of the Secretary of the

Treasury. If it appears to the Secretary of Health and Human

Services that an article included within the provisions of clause

(3) of subsection (a) of this section can, by relabeling or other

action, be brought into compliance with this chapter or rendered

other than a food, drug, device, or cosmetic, final determination

as to admission of such article may be deferred and, upon filing of

timely written application by the owner or consignee and the

execution by him of a bond as provided in the preceding provisions

of this subsection, the Secretary may, in accordance with

regulations, authorize the applicant to perform such relabeling or

other action specified in such authorization (including destruction

or export of rejected articles or portions thereof, as may be

specified in the Secretary's authorization). All such relabeling

or other action pursuant to such authorization shall in accordance

with regulations be under the supervision of an officer or employee

of the Department of Health and Human Services designated by the

Secretary, or an officer or employee of the Department of the

Treasury designated by the Secretary of the Treasury.

(c) Charges concerning refused articles

All expenses (including travel, per diem or subsistence, and

salaries of officers or employees of the United States) in

connection with the destruction provided for in subsection (a) of

this section and the supervision of the relabeling or other action

authorized under the provisions of subsection (b) of this section,

the amount of such expenses to be determined in accordance with

regulations, and all expenses in connection with the storage,

cartage, or labor with respect to any article refused admission

under subsection (a) of this section, shall be paid by the owner or

consignee and, in default of such payment, shall constitute a lien

against any future importations made by such owner or consignee.

(d) Reimportation

(1) Except as provided in paragraph (2) and section 384 of this

title, no drug subject to section 353(b) of this title or composed

wholly or partly of insulin which is manufactured in a State and

exported may be imported into the United States unless the drug is

imported by the manufacturer of the drug.

(2) The Secretary may authorize the importation of a drug the

importation of which is prohibited by paragraph (1) if the drug is

required for emergency medical care.

(3)(A) Subject to subparagraph (B), no component of a drug, no

component part or accessory of a device, or other article of device

requiring further processing, which is ready or suitable for use

for health-related purposes, and no article of a food additive,

color additive, or dietary supplement, including a product in bulk

form, shall be excluded from importation into the United States

under subsection (a) of this section if each of the following

conditions is met:

(i) The importer of such article of a drug or device or

importer of such article of a food additive, color additive, or

dietary supplement submits to the Secretary, at the time of

initial importation, a statement in accordance with the

following:

(I) Such statement provides that such article is intended to

be further processed by the initial owner or consignee, or

incorporated by the initial owner or consignee, into a drug,

biological product, device, food, food additive, color

additive, or dietary supplement that will be exported by the

initial owner or consignee from the United States in accordance

with subsection (e) of this section or section 382 of this

title, or with section 262(h) of title 42.

(II) The statement identifies the manufacturer of such

article and each processor, packer, distributor, or other

entity that had possession of the article in the chain of

possession of the article from the manufacturer to such

importer of the article.

(III) The statement is accompanied by such certificates of

analysis as are necessary to identify such article, unless the

article is a device or is an article described in paragraph

(4).

(ii) At the time of initial importation and before the delivery

of such article to the importer or the initial owner or

consignee, such owner or consignee executes a good and sufficient

bond providing for the payment of such liquidated damages in the

event of default as may be required pursuant to regulations of

the Secretary of the Treasury.

(iii) Such article is used and exported by the initial owner or

consignee in accordance with the intent described under clause

(i)(I), except for any portions of the article that are

destroyed.

(iv) The initial owner or consignee maintains records on the

use or destruction of such article or portions thereof, as the

case may be, and submits to the Secretary any such records

requested by the Secretary.

(v) Upon request of the Secretary, the initial owner or

consignee submits a report that provides an accounting of the

exportation or destruction of such article or portions thereof,

and the manner in which such owner or consignee complied with the

requirements of this subparagraph.

(B) Notwithstanding subparagraph (A), the Secretary may refuse

admission to an article that otherwise would be imported into the

United States under such subparagraph if the Secretary determines

that there is credible evidence or information indicating that such

article is not intended to be further processed by the initial

owner or consignee, or incorporated by the initial owner or

consignee, into a drug, biological product, device, food, food

additive, color additive, or dietary supplement that will be

exported by the initial owner or consignee from the United States

in accordance with subsection (e) of this section or section 382 of

this title, or with section 262(h) of title 42.

(C) This section may not be construed as affecting the

responsibility of the Secretary to ensure that articles imported

into the United States under authority of subparagraph (A) meet

each of the conditions established in such subparagraph for

importation.

(4) The importation into the United States of blood, blood

components, source plasma, or source leukocytes or of a component,

accessory, or part thereof is not permitted pursuant to paragraph

(3) unless the importation complies with section 262(a) of title 42

or the Secretary permits the importation under appropriate

circumstances and conditions, as determined by the Secretary. The

importation of tissue or a component or part of tissue is not

permitted pursuant to paragraph (3) unless the importation complies

with section 264 of title 42.

(e) Exports

(1) A food, drug, device, or cosmetic intended for export shall

not be deemed to be adulterated or misbranded under this chapter if

it -

(A) accords to the specifications of the foreign purchaser,

(B) is not in conflict with the laws of the country to which it

is intended for export,

(C) is labeled on the outside of the shipping package that it

is intended for export, and

(D) is not sold or offered for sale in domestic commerce.

(2) Paragraph (1) does not apply to any device -

(A) which does not comply with an applicable requirement of

section 360d or 360e of this title,

(B) which under section 360j(g) of this title is exempt from

either such section, or

(C) which is a banned device under section 360f of this title,

unless, in addition to the requirements of paragraph (1), either

(i) the Secretary has determined that the exportation of the device

is not contrary to public health and safety and has the approval of

the country to which it is intended for export or (ii) the device

is eligible for export under section 382 of this title.

(3) A new animal drug that requires approval under section 360b

of this title shall not be exported pursuant to paragraph (1) if

such drug has been banned in the United States.

(4)(A) Any person who exports a drug, animal drug, or device may

request that the Secretary -

(i) certify in writing that the exported drug, animal drug, or

device meets the requirements of paragraph (1) or section 382 of

this title; or

(ii) certify in writing that the drug, animal drug, or device

being exported meets the applicable requirements of this chapter

upon a showing that the drug or device meets the applicable

requirements of this chapter.

The Secretary shall issue such a certification within 20 days of

the receipt of a request for such certification.

(B) If the Secretary issues a written export certification within

the 20 days prescribed by subparagraph (A), a fee for such

certification may be charged but shall not exceed $175 for each

certification. Fees collected for a fiscal year pursuant to this

subparagraph shall be credited to the appropriation account for

salaries and expenses of the Food and Drug Administration and shall

be available in accordance with appropriations Acts until expended

without fiscal year limitation. Such fees shall be collected in

each fiscal year in an amount equal to the amount specified in

appropriations Acts for such fiscal year and shall only be

collected and available for the costs of the Food and Drug

Administration.

(f) Labeling of exported drugs

(1) If a drug (other than insulin, an antibiotic drug, an animal

drug, or a drug exported under section 382 of this title) being

exported in accordance with subsection (e) of this section is being

exported to a country that has different or additional labeling

requirements or conditions for use and such country requires the

drug to be labeled in accordance with those requirements or uses,

such drug may be labeled in accordance with such requirements and

conditions for use in the country to which such drug is being

exported if it also is labeled in accordance with the requirements

of this chapter.

(2) If, pursuant to paragraph (1), the labeling of an exported

drug includes conditions for use that have not been approved under

this chapter, the labeling must state that such conditions for use

have not been approved under this chapter. A drug exported under

section 382 of this title is exempt from this section.

(g) Warning notice of importation in violation of chapter

(1) With respect to a prescription drug being imported or offered

for import into the United States, the Secretary, in the case of an

individual who is not in the business of such importations, may not

send a warning notice to the individual unless the following

conditions are met:

(A) The notice specifies, as applicable to the importation of

the drug, that the Secretary has made a determination that -

(i) importation is in violation of subsection (a) of this

section because the drug is or appears to be adulterated,

misbranded, or in violation of section 355 of this title;

(ii) importation is in violation of subsection (a) of this

section because the drug is or appears to be forbidden or

restricted in sale in the country in which it was produced or

from which it was exported;

(iii) importation is or appears to be in violation of

subsection (d)(1) of this section; or

(iv) importation otherwise is or appears to be in violation

of Federal law.

(B) The notice does not specify any provision described in

subparagraph (A) that is not applicable to the importation of the

drug.

(C) The notice states the reasons underlying such determination

by the Secretary, including a brief application to the principal

facts involved of the provision of law described in subparagraph

(A) that is the basis of the determination by the Secretary.

(2) For purposes of this section, the term ''warning notice'',

with respect to the importation of a drug, means a communication

from the Secretary (written or otherwise) notifying a person, or

clearly suggesting to the person, that importing the drug for

personal use is, or appears to be, a violation of this chapter.

(h) Protection against adulteration of food

(1) The Secretary shall give high priority to increasing the

number of inspections under this section for the purpose of

enabling the Secretary to inspect food offered for import at ports

of entry into the United States, with the greatest priority given

to inspections to detect the intentional adulteration of food.

(2) The Secretary shall give high priority to making necessary

improvements to the information management systems of the Food and

Drug Administration that contain information related to foods

imported or offered for import into the United States for purposes

of improving the ability of the Secretary to allocate resources,

detect the intentional adulteration of food, and facilitate the

importation of food that is in compliance with this chapter.

(3) The Secretary shall improve linkages with other regulatory

agencies of the Federal Government that share responsibility for

food safety, and shall with respect to such safety improve linkages

with the States and Indian tribes (as defined in section 450b(e) of

title 25).

(i) Testing for rapid detection of adulteration of food

(1) For use in inspections of food under this section, the

Secretary shall provide for research on the development of tests

and sampling methodologies -

(A) whose purpose is to test food in order to rapidly detect

the adulteration of the food, with the greatest priority given to

detect the intentional adulteration of food; and

(B) whose results offer significant improvements over the

available technology in terms of accuracy, timing, or costs.

(2) In providing for research under paragraph (1), the Secretary

shall give priority to conducting research on the development of

tests that are suitable for inspections of food at ports of entry

into the United States.

(3) In providing for research under paragraph (1), the Secretary

shall as appropriate coordinate with the Director of the Centers

for Disease Control and Prevention, the Director of the National

Institutes of Health, the Administrator of the Environmental

Protection Agency, and the Secretary of Agriculture.

(4) The Secretary shall annually submit to the Committee on

Energy and Commerce of the House of Representatives, and the

Committee on Health, Education, Labor, and Pensions of the Senate,

a report describing the progress made in research under paragraph

(1), including progress regarding paragraph (2).

(j) Temporary holds at ports of entry

(1) If an officer or qualified employee of the Food and Drug

Administration has credible evidence or information indicating that

an article of food presents a threat of serious adverse health

consequences or death to humans or animals, and such officer or

qualified employee is unable to inspect, examine, or investigate

such article upon the article being offered for import at a port of

entry into the United States, the officer or qualified employee

shall request the Secretary of Treasury to hold the food at the

port of entry for a reasonable period of time, not to exceed 24

hours, for the purpose of enabling the Secretary to inspect,

examine, or investigate the article as appropriate.

(2) The Secretary shall request the Secretary of Treasury to

remove an article held pursuant to paragraph (1) to a secure

facility, as appropriate. During the period of time that such

article is so held, the article shall not be transferred by any

person from the port of entry into the United States for the

article, or from the secure facility to which the article has been

removed, as the case may be. Subsection (b) of this section does

not authorize the delivery of the article pursuant to the execution

of a bond while the article is so held.

(3) An officer or qualified employee of the Food and Drug

Administration may make a request under paragraph (1) only if the

Secretary or an official designated by the Secretary approves the

request. An official may not be so designated unless the official

is the director of the district under this chapter in which the

article involved is located, or is an official senior to such

director.

(4) With respect to an article of food for which a request under

paragraph (1) is made, the Secretary, promptly after the request is

made, shall notify the State in which the port of entry involved is

located that the request has been made, and as applicable, that

such article is being held under this subsection.

(k) Importation by debarred persons

(1) If an article of food is being imported or offered for import

into the United States, and the importer, owner, or consignee of

the article is a person who has been debarred under section

335a(b)(3) of this title, such article shall be held at the port of

entry for the article, and may not be delivered to such person.

Subsection (b) of this section does not authorize the delivery of

the article pursuant to the execution of a bond while the article

is so held. The article shall be removed to a secure facility, as

appropriate. During the period of time that such article is so

held, the article shall not be transferred by any person from the

port of entry into the United States for the article, or from the

secure facility to which the article has been removed, as the case

may be.

(2) An article of food held under paragraph (1) may be delivered

to a person who is not a debarred person under section 335a(b)(3)

of this title if such person affirmatively establishes, at the

expense of the person, that the article complies with the

requirements of this chapter, as determined by the Secretary.

(l) Failure to register

(1) (FOOTNOTE 2) If an article of food is being imported or

offered for import into the United States, and such article is from

a foreign facility for which a registration has not been submitted

to the Secretary under section 350d of this title, such article

shall be held at the port of entry for the article, and may not be

delivered to the importer, owner, or consignee of the article,

until the foreign facility is so registered. Subsection (b) of

this section does not authorize the delivery of the article

pursuant to the execution of a bond while the article is so held.

The article shall be removed to a secure facility, as appropriate.

During the period of time that such article is so held, the article

shall not be transferred by any person from the port of entry into

the United States for the article, or from the secure facility to

which the article has been removed, as the case may be.

(FOOTNOTE 2) So in original. No par. (2) has been enacted.

(m) Prior notice of imported food shipments

(1) In the case of an article of food that is being imported or

offered for import into the United States, the Secretary, after

consultation with the Secretary of the Treasury, shall by

regulation require, for the purpose of enabling such article to be

inspected at ports of entry into the United States, the submission

to the Secretary of a notice providing the identity of each of the

following: The article; the manufacturer and shipper of the

article; if known within the specified period of time that notice

is required to be provided, the grower of the article; the country

from which the article originates; the country from which the

article is shipped; and the anticipated port of entry for the

article. An article of food imported or offered for import without

submission of such notice in accordance with the requirements under

this paragraph shall be refused admission into the United States.

Nothing in this section may be construed as a limitation on the

port of entry for an article of food.

(2)(A) Regulations under paragraph (1) shall require that a

notice under such paragraph be provided by a specified period of

time in advance of the time of the importation of the article of

food involved or the offering of the food for import, which period

shall be no less than the minimum amount of time necessary for the

Secretary to receive, review, and appropriately respond to such

notification, but may not exceed five days. In determining the

specified period of time required under this subparagraph, the

Secretary may consider, but is not limited to consideration of, the

effect on commerce of such period of time, the locations of the

various ports of entry into the United States, the various modes of

transportation, the types of food imported into the United States,

and any other such consideration. Nothing in the preceding

sentence may be construed as a limitation on the obligation of the

Secretary to receive, review, and appropriately respond to any

notice under paragraph (1).

(B)(i) If an article of food is being imported or offered for

import into the United States and a notice under paragraph (1) is

not provided in advance in accordance with the requirements under

paragraph (1), such article shall be held at the port of entry for

the article, and may not be delivered to the importer, owner, or

consignee of the article, until such notice is submitted to the

Secretary, and the Secretary examines the notice and determines

that the notice is in accordance with the requirements under

paragraph (1). Subsection (b) of this section does not authorize

the delivery of the article pursuant to the execution of a bond

while the article is so held. The article shall be removed to a

secure facility, as appropriate. During the period of time that

such article is so held, the article shall not be transferred by

any person from the port of entry into the United States for the

article, or from the secure facility to which the article has been

removed, as the case may be.

(ii) In carrying out clause (i) with respect to an article of

food, the Secretary shall determine whether there is in the

possession of the Secretary any credible evidence or information

indicating that such article presents a threat of serious adverse

health consequences or death to humans or animals.

(3)(A) This subsection may not be construed as limiting the

authority of the Secretary to obtain information under any other

provision of this chapter.

(B) This subsection may not be construed as authorizing the

Secretary to impose any requirements with respect to a food to the

extent that it is within the exclusive jurisdiction of the

Secretary of Agriculture pursuant to the Federal Meat Inspection

Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act

(21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21

U.S.C. 1031 et seq.).

(n) Labeling of food refused admission

(1) If a food has been refused admission under subsection (a) of

this section, other than such a food that is required to be

destroyed, the Secretary may require the owner or consignee of the

food to affix to the container of the food a label that clearly and

conspicuously bears the statement: ''UNITED STATES: REFUSED

ENTRY''.

(2) All expenses in connection with affixing a label under

paragraph (1) shall be paid by the owner or consignee of the food

involved, and in default of such payment, shall constitute a lien

against future importations made by such owner or consignee.

(3) A requirement under paragraph (1) remains in effect until the

Secretary determines that the food involved has been brought into

compliance with this chapter.

(o) Registration statement

If an article that is a drug or device is being imported or

offered for import into the United States, and the importer, owner,

or consignee of such article does not, at the time of offering the

article for import, submit to the Secretary a statement that

identifies the registration under section 360(i) of this title of

each establishment that with respect to such article is required

under such section to register with the Secretary, the article may

be refused admission. If the article is refused admission for

failure to submit such a statement, the article shall be held at

the port of entry for the article, and may not be delivered to the

importer, owner, or consignee of the article, until such a

statement is submitted to the Secretary. Subsection (b) of this

section does not authorize the delivery of the article pursuant to

the execution of a bond while the article is so held. The article

shall be removed to a secure facility, as appropriate. During the

period of time that such article is so held, the article shall not

be transferred by any person from the port of entry into the United

States for the article, or from the secure facility to which the

article has been removed, as the case may be.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 801, 52 Stat. 1058; Oct. 18, 1949,

ch. 696, Sec. 1-3, 63 Stat. 882; Pub. L. 87-781, title III, Sec.

306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90-399, Sec. 106, July

13, 1968, 82 Stat. 353; Pub. L. 91-513, title II, Sec. 701(h), Oct.

27, 1970, 84 Stat. 1282; Pub. L. 94-295, Sec. 3(f), 4(b)(3), May

28, 1976, 90 Stat. 578, 580; Pub. L. 100-293, Sec. 3, Apr. 22,

1988, 102 Stat. 96; Pub. L. 102-300, Sec. 6(b)(1), June 16, 1992,

106 Stat. 240; Pub. L. 102-353, Sec. 5, Aug. 26, 1992, 106 Stat.

943; Pub. L. 103-80, Sec. 3(cc), (dd)(1), Aug. 13, 1993, 107 Stat.

778, 779; Pub. L. 104-134, title II, Sec. 2102(a)-(c), Apr. 26,

1996, 110 Stat. 1321-313, 1321-314; Pub. L. 104-180, title VI, Sec.

603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105-115,

title I, Sec. 125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L.

106-387, Sec. 1(a) (title VII, Sec. 745(c)(1), 746(c)), Oct. 28,

2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107-188, title

III, Sec. 302(a)-(d), 303(c), 304(e), 305(c), 307(a), 308(a),

321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667,

668, 670, 672, 676.)

-REFTEXT-

REFERENCES IN TEXT

The Controlled Substances Import and Export Act, referred to in

subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84

Stat. 1285, as amended, which is classified principally to

subchapter II (Sec. 951 et seq.) of chapter 13 of this title. For

complete classification of this Act to the Code, see Short Title

note set out under section 951 of this title and Tables.

The Federal Meat Inspection Act, referred to in subsec.

(m)(3)(B), is titles I to IV of act Mar. 4, 1907, ch. 2907, as

added Pub. L. 90-201, Dec. 15, 1967, 81 Stat. 584, and amended,

which are classified generally to subchapters I to IV (Sec. 601 et

seq.) of chapter 12 of this title. For complete classification of

this Act to the Code, see Short Title note set out under section

601 of this title and Tables.

The Poultry Products Inspection Act, referred to in subsec.

(m)(3)(B), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as

amended, which is classified generally to chapter 10 (Sec. 451 et

seq.) of this title. For complete classification of this Act to

the Code, see Short Title note set out under section 451 of this

title and Tables.

The Egg Products Inspection Act, referred to in subsec.

(m)(3)(B), is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as

amended, which is classified generally to chapter 15 (Sec. 1031 et

seq.) of this title. For complete classification of this Act to

the Code, see Short Title note set out under section 1031 of this

title and Tables.

-MISC2-

AMENDMENTS

2002 - Subsec. (d)(3). Pub. L. 107-188, Sec. 322(a), amended par.

(3) generally. Prior to amendment, par. (3) read as follows: ''No

component of a drug, no component part or accessory of a device, or

other article of device requiring further processing, which is

ready or suitable for use for health-related purposes, and no food

additive, color additive, or dietary supplement, including a

product in bulk form, shall be excluded from importation into the

United States under subsection (a) of this section if -

''(A) the importer of such article of a drug or device or

importer of the food additive, color additive, or dietary

supplement submits a statement to the Secretary, at the time of

initial importation, that such article of a drug or device, food

additive, color additive, or dietary supplement is intended to be

further processed by the initial owner or consignee, or

incorporated by the initial owner or consignee into a drug,

biological product, device, food, food additive, color additive,

or dietary supplement that will be exported by such owner or

consignee from the United States in accordance with subsection

(e) of this section or section 382 of this title or section

262(h) of title 42;

''(B) the initial owner or consignee responsible for such

imported article maintains records that identify the use of such

imported article and upon request of the Secretary submits a

report that provides an accounting of the exportation or the

disposition of the imported article, including portions that have

been destroyed, and the manner in which such person complied with

the requirements of this paragraph; and

''(C) any imported component, part, article, or accessory of a

drug or device and any food additive, color additive, or dietary

supplement not incorporated or further processed as described in

subparagraph (A) is destroyed or exported by the owner or

consignee.''

Subsec. (h). Pub. L. 107-188, Sec. 302(a)-(c), added subsec. (h).

Subsec. (i). Pub. L. 107-188, Sec. 302(d), added subsec. (i).

Subsec. (j). Pub. L. 107-188, Sec. 303(c), added subsec. (j).

Subsec. (k). Pub. L. 107-188, Sec. 304(e), added subsec. (k).

Subsec. (l). Pub. L. 107-188, Sec. 305(c), added subsec. (l).

Subsec. (m). Pub. L. 107-188, Sec. 307(a), added subsec. (m).

Subsec. (n). Pub. L. 107-188, Sec. 308(a), added subsec. (n).

Subsec. (o). Pub. L. 107-188, Sec. 321(b)(1), added subsec. (o).

2000 - Subsec. (d)(1). Pub. L. 106-387, Sec. 1(a) (title VII,

Sec. 745(c)(1)), inserted ''and section 384 of this title'' after

''paragraph (2)''.

Subsec. (g). Pub. L. 106-387, Sec. 1(a) (title VII, Sec. 746(c)),

added subsec. (g).

1997 - Subsec. (d)(1). Pub. L. 105-115 inserted ''or composed

wholly or partly of insulin'' after ''353(b) of this title''.

1996 - Subsec. (d)(3). Pub. L. 104-180, Sec. 603(a), substituted

''accessory of a device, or other article of device requiring

further processing, which is ready'' for ''accessory of a device

which is ready'' in introductory provisions, inserted ''further

processed by the initial owner or consignee, or'' after ''is

intended to be'' in subpar. (A), and inserted ''article,'' after

''part,'' and ''or further processed'' after ''incorporated'' in

subpar. (C).

Pub. L. 104-134, Sec. 2102(a)(1), added par. (3)

Subsec. (d)(4). Pub. L. 104-134, Sec. 2102(a)(1), added par. (4).

Subsec. (e)(1). Pub. L. 104-134, Sec. 2102(b)(1), struck out

concluding provisions which read as follows: ''This paragraph does

not authorize the exportation of any new animal drug, or an animal

feed bearing or containing a new animal drug, which is unsafe

within the meaning of section 360b of this title.''

Subsec. (e)(2). Pub. L. 104-134, Sec. 2102(b)(2), in concluding

provisions, substituted ''either (i) the Secretary'' for ''the

Secretary'' and added cl. (ii).

Subsec. (e)(3), (4). Pub. L. 104-134, Sec. 2102(b)(3), added

pars. (3) and (4).

Subsec. (f). Pub. L. 104-180, Sec. 603(b), inserted ''(other than

insulin, an antibiotic drug, an animal drug, or a drug exported

under section 382 of this title)'' after ''If a drug'' in par. (1)

and ''A drug exported under section 382 of this title is exempt

from this section.'' at end of par. (2).

Pub. L. 104-134, Sec. 2102(c), added subsec. (f).

1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(dd)(1), substituted

''Health and Human Services'' for ''Agriculture'' after ''Secretary

of'' in two places in first sentence.

Subsec. (b). Pub. L. 103-80, Sec. 3(cc), substituted ''Secretary

of Health and Human Services'' for ''Administrator'' after ''If it

appears to the'', ''Secretary'' for ''Administrator'' after

''provisions of this subsection, the'', ''Secretary's'' for

''Administrator's'' after ''as may be specified in the'',

''Department of Health and Human Services'' for ''Federal Security

Agency'', and ''Secretary'' for ''Administrator'' after

''designated by the''.

1992 - Subsecs. (a), (b). Pub. L. 102-300, which directed the

substitution of ''Health and Human Services'' for ''Health,

Education, and Welfare'' wherever appearing, was executed in second

sentence of subsec. (a), but could not be executed in first

sentence of subsec. (a) or in subsec. (b) because such words did

not appear. See 1993 Amendment note above and Transfer of

Functions note below.

Subsec. (d)(1). Pub. L. 102-353 substituted ''manufacturer of''

for ''person who manufactured''.

1988 - Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and

redesignated former subsec. (d) as (e).

1976 - Subsec. (a). Pub. L. 94-295, Sec. 3(f)(2), 4(b)(3),

expanded provisions requiring the Secretary of Health, Education,

and Welfare to request that the Secretary of the Treasury deliver

to the Secretary of Health, Education, and Welfare items imported

or offered for import into the United States that were

manufactured, prepared, propagated, compounded, or processed in

non-registered establishments by extending the provisions to

include devices imported or offered for import, and, in cl. (1),

inserted reference to devices which were manufactured, packed,

stored, or installed using methods, facilities, or controls not

conforming to the requirements of section 360j(f) of this title.

Subsec. (d). Pub. L. 94-295, Sec. 3(f)(1), designated existing

provisions as par. (1) and added par. (2).

1970 - Subsec. (a). Pub. L. 91-513 substituted ''Clause (2) of

the third sentence of this paragraph'' for ''This paragraph'' and

''the Controlled Substances Import and Export Act'' for ''section

173 of this title'' in last sentence.

1968 - Subsec. (d). Pub. L. 90-399 provided that nothing in

subsec. (d) shall authorize the exportation of any new animal drug,

or an animal feed bearing or containing a new animal drug, which is

unsafe within the meaning of section 360b of this title.

1962 - Subsec. (a). Pub. L. 87-781 inserted provisions requiring

the Secretary of Health, Education, and Welfare to furnish the

Secretary of the Treasury a list of establishments registered under

section 360(i) of this title, and to request that samples of any

drugs from any establishments not so registered be delivered to the

Secretary of Health, Education, and Welfare, with notice of

delivery to the consignee who may appear before the Secretary to

testify.

1949 - Subsec. (a). Act Oct. 18, 1949, Sec. 1, inserted before

period at end of second sentence '', except as provided in

subsection (b) of this section. The Secretary of the Treasury

shall cause the destruction of any such article refused admission

unless such article is exported, under regulations prescribed by

the Secretary of the Treasury within ninety days of the notice of

such refusal or within such additional time as may be permitted

pursuant to such regulations''.

Subsec. (b). Act Oct. 18, 1949, Sec. 2, provided for express

statutory authority for the long-standing administrative practice

of releasing imported articles that do not comply with the

requirements of the law so that they may be relabeled or given

appropriate treatment to bring them into compliance.

Subsec. (c). Act Oct. 18, 1949, Sec. 3, charged all costs,

including salaries and travel and subsistence expenses of officers

and employees, against importers.

EFFECTIVE DATE OF 2002 AMENDMENT

Amendment by section 321(b)(1) of Pub. L. 107-188 effective upon

the expiration of the 180-day period beginning June 12, 2002, see

section 321(c) of Pub. L. 107-188, set out as a note under section

331 of this title.

Amendment by section 322(a) of Pub. L. 107-188 effective upon the

expiration of the 90-day period beginning June 12, 2002, see

section 322(c) of Pub. L. 107-188, set out as a note under section

331 of this title.

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-293 effective upon expiration of 90 days

after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out

as a note under section 353 of this title.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-513 effective on first day of seventh

calendar month that begins after Oct. 26, 1970, see section 704 of

Pub. L. 91-513, set out as an Effective Date note under section 801

of this title.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment of subsec. (d) by Pub. L. 90-399 effective on first day

of thirteenth calendar month after July 13, 1968, see section

108(a) of Pub. L. 90-399, set out as an Effective Date and

Transitional Provisions note under section 360b of this title.

REGULATIONS

Pub. L. 107-188, title III, Sec. 307(c), June 12, 2002, 116 Stat.

672, provided that:

''(1) In general. - Not later than 18 months after the date of

the enactment of this Act (June 12, 2002), the Secretary of Health

and Human Services shall promulgate proposed and final regulations

for the requirement of providing notice in accordance with section

801(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

381(m)) (as added by subsection (a) of this section). Such

requirement of notification takes effect -

''(A) upon the effective date of such final regulations; or

''(B) upon the expiration of such 18-month period if the final

regulations have not been made effective as of the expiration of

such period, subject to compliance with the final regulations

when the final regulations are made effective.

''(2) Default; minimum period of advance notice. - If under

paragraph (1) the requirement for providing notice in accordance

with section 801(m) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 381(m)) takes effect without final regulations having been

made effective, then for purposes of such requirement, the

specified period of time that the notice is required to be made in

advance of the time of the importation of the article of food

involved or the offering of the food for import shall be not fewer

than eight hours and not more than five days, which shall remain in

effect until the final regulations are made effective.''

SAVINGS PROVISION

Amendment by Pub. L. 91-513 not to affect or abate any

prosecutions for violation of law or any civil seizure or

forfeitures and injunctive proceedings commenced prior to the

effective date of such amendment, and all administrative

proceedings pending before the Bureau of Narcotic and Dangerous

Drugs (now Drug Enforcement Administration) on Oct. 27, 1970, to be

continued and brought to final determination in accord with laws

and regulations in effect prior to Oct. 27, 1970, see section 702

of Pub. L. 91-513, set out as a note under section 321 of this

title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188

Pub. L. 107-188, title III, Sec. 308(c), June 12, 2002, 116 Stat.

673, provided that: ''With respect to articles of food that are

imported or offered for import into the United States, nothing in

this section (amending this section and section 343 of this title)

shall be construed to limit the authority of the Secretary of

Health and Human Services or the Secretary of the Treasury to

require the marking of refused articles of food under any other

provision of law.''

-TRANS-

TRANSFER OF FUNCTIONS

Secretary and Department of Health, Education, and Welfare

redesignated Secretary and Department of Health and Human Services

by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.

695, which is classified to section 3508(b) of Title 20, Education.

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

FINDINGS

Pub. L. 106-387, Sec. 1(a) (title VII, Sec. 746(b)), Oct. 28,

2000, 114 Stat. 1549, 1549A-40, provided that: ''The Congress finds

as follows:

''(1) Patients and their families sometimes have reason to

import into the United States drugs that have been approved by

the Food and Drug Administration ('FDA').

''(2) There have been circumstances in which -

''(A) an individual seeking to import such a drug has

received a notice from FDA that importing the drug violates or

may violate the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.); and

''(B) the notice failed to inform the individual of the

reasons underlying the decision to send the notice.

''(3) FDA should not send a warning notice regarding the

importation of a drug without providing to the individual

involved a statement of the underlying reasons for the notice.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 333, 334, 342, 343,

360, 371, 382, 384 of this title; title 15 section 1456; title 42

section 262.

-CITE-

21 USC Sec. 382 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-

Sec. 382. Exports of certain unapproved products

-STATUTE-

(a) Drugs or devices intended for human or animal use which require

approval or licensing

A drug or device -

(1) which, in the case of a drug -

(A)(i) requires approval by the Secretary under section 355

of this title before such drug may be introduced or delivered

for introduction into interstate commerce; or

(ii) requires licensing by the Secretary under section 262 of

title 42 or by the Secretary of Agriculture under the Act of

March 4, 1913 (21 U.S.C. 151 et seq.) (known as the Virus-Serum

Toxin Act) before it may be introduced or delivered for

introduction into interstate commerce;

(B) does not have such approval or license; and

(C) is not exempt from such sections or Act; and

(2) which, in the case of a device -

(A) does not comply with an applicable requirement under

section 360d or 360e of this title;

(B) under section 360j(g) of this title is exempt from either

such section; or

(C) is a banned device under section 360f of this title, is

adulterated, misbranded, and in violation of such sections or

Act unless the export of the drug or device is, except as

provided in subsection (f) of this section, authorized under

subsection (b), (c), (d), or (e) of this section or section

381(e)(2) of this title. If a drug or device described in

paragraphs (1) and (2) may be exported under subsection (b) of

this section and if an application for such drug or device

under section 355 or 360e of this title or section 262 of title

42 was disapproved, the Secretary shall notify the appropriate

public health official of the country to which such drug will

be exported of such disapproval.

(b) List of eligible countries for export; criteria for addition to

list; direct export; petition for exemption

(1)(A) A drug or device described in subsection (a) of this

section may be exported to any country, if the drug or device

complies with the laws of that country and has valid marketing

authorization by the appropriate authority -

(i) in Australia, Canada, Israel, Japan, New Zealand,

Switzerland, or South Africa; or

(ii) in the European Union or a country in the European

Economic Area (the countries in the European Union and the

European Free Trade Association) if the drug or device is

marketed in that country or the drug or device is authorized for

general marketing in the European Economic Area.

(B) The Secretary may designate an additional country to be

included in the list of countries described in clauses (i) and (ii)

of subparagraph (A) if all of the following requirements are met in

such country:

(i) Statutory or regulatory requirements which require the

review of drugs and devices for safety and effectiveness by an

entity of the government of such country and which authorize the

approval of only those drugs and devices which have been

determined to be safe and effective by experts employed by or

acting on behalf of such entity and qualified by scientific

training and experience to evaluate the safety and effectiveness

of drugs and devices on the basis of adequate and well-controlled

investigations, including clinical investigations, conducted by

experts qualified by scientific training and experience to

evaluate the safety and effectiveness of drugs and devices.

(ii) Statutory or regulatory requirements that the methods used

in, and the facilities and controls used for -

(I) the manufacture, processing, and packing of drugs in the

country are adequate to preserve their identity, quality,

purity, and strength; and

(II) the manufacture, preproduction design validation,

packing, storage, and installation of a device are adequate to

assure that the device will be safe and effective.

(iii) Statutory or regulatory requirements for the reporting of

adverse reactions to drugs and devices and procedures to withdraw

approval and remove drugs and devices found not to be safe or

effective.

(iv) Statutory or regulatory requirements that the labeling and

promotion of drugs and devices must be in accordance with the

approval of the drug or device.

(v) The valid marketing authorization system in such country or

countries is equivalent to the systems in the countries described

in clauses (i) and (ii) of subparagraph (A).

The Secretary shall not delegate the authority granted under this

subparagraph.

(C) An appropriate country official, manufacturer, or exporter

may request the Secretary to take action under subparagraph (B) to

designate an additional country or countries to be added to the

list of countries described in clauses (i) and (ii) of subparagraph

(A) by submitting documentation to the Secretary in support of such

designation. Any person other than a country requesting such

designation shall include, along with the request, a letter from

the country indicating the desire of such country to be designated.

(2) A drug described in subsection (a) of this section may be

directly exported to a country which is not listed in clause (i) or

(ii) of paragraph (1)(A) if -

(A) the drug complies with the laws of that country and has

valid marketing authorization by the responsible authority in

that country; and

(B) the Secretary determines that all of the following

requirements are met in that country:

(i) Statutory or regulatory requirements which require the

review of drugs for safety and effectiveness by an entity of

the government of such country and which authorize the approval

of only those drugs which have been determined to be safe and

effective by experts employed by or acting on behalf of such

entity and qualified by scientific training and experience to

evaluate the safety and effectiveness of drugs on the basis of

adequate and well-controlled investigations, including clinical

investigations, conducted by experts qualified by scientific

training and experience to evaluate the safety and

effectiveness of drugs.

(ii) Statutory or regulatory requirements that the methods

used in, and the facilities and controls used for the

manufacture, processing, and packing of drugs in the country

are adequate to preserve their identity, quality, purity, and

strength.

(iii) Statutory or regulatory requirements for the reporting

of adverse reactions to drugs and procedures to withdraw

approval and remove drugs found not to be safe or effective.

(iv) Statutory or regulatory requirements that the labeling

and promotion of drugs must be in accordance with the approval

of the drug.

(3) The exporter of a drug described in subsection (a) of this

section which would not meet the conditions for approval under this

chapter or conditions for approval of a country described in clause

(i) or (ii) of paragraph (1)(A) may petition the Secretary for

authorization to export such drug to a country which is not

described in clause (i) or (ii) of paragraph (1)(A) or which is not

described in paragraph (2). The Secretary shall permit such export

if -

(A) the person exporting the drug -

(i) certifies that the drug would not meet the conditions for

approval under this chapter or the conditions for approval of a

country described in clause (i) or (ii) of paragraph (1)(A);

and

(ii) provides the Secretary with credible scientific

evidence, acceptable to the Secretary, that the drug would be

safe and effective under the conditions of use in the country

to which it is being exported; and

(B) the appropriate health authority in the country to which

the drug is being exported -

(i) requests approval of the export of the drug to such

country;

(ii) certifies that the health authority understands that the

drug is not approved under this chapter or in a country

described in clause (i) or (ii) of paragraph (1)(A); and

(iii) concurs that the scientific evidence provided pursuant

to subparagraph (A) is credible scientific evidence that the

drug would be reasonably safe and effective in such country.

The Secretary shall take action on a request for export of a drug

under this paragraph within 60 days of receiving such request.

(c) Investigational use exemption

A drug or device intended for investigational use in any country

described in clause (i) or (ii) of subsection (b)(1)(A) of this

section may be exported in accordance with the laws of that country

and shall be exempt from regulation under section 355(i) or 360j(g)

of this title.

(d) Anticipation of market authorization

A drug or device intended for formulation, filling, packaging,

labeling, or further processing in anticipation of market

authorization in any country described in clause (i) or (ii) of

subsection (b)(1)(A) of this section may be exported for use in

accordance with the laws of that country.

(e) Diagnosis, prevention, or treatment of tropical disease

(1) A drug or device which is used in the diagnosis, prevention,

or treatment of a tropical disease or another disease not of

significant prevalence in the United States and which does not

otherwise qualify for export under this section shall, upon

approval of an application, be permitted to be exported if the

Secretary finds that the drug or device will not expose patients in

such country to an unreasonable risk of illness or injury and the

probable benefit to health from the use of the drug or device

(under conditions of use prescribed, recommended, or suggested in

the labeling or proposed labeling of the drug or device) outweighs

the risk of injury or illness from its use, taking into account the

probable risks and benefits of currently available drug or device

treatment.

(2) The holder of an approved application for the export of a

drug or device under this subsection shall report to the Secretary

-

(A) the receipt of any credible information indicating that the

drug or device is being or may have been exported from a country

for which the Secretary made a finding under paragraph (1)(A) to

a country for which the Secretary cannot make such a finding; and

(B) the receipt of any information indicating adverse reactions

to such drug.

(3)(A) If the Secretary determines that -

(i) a drug or device for which an application is approved under

paragraph (1) does not continue to meet the requirements of such

paragraph; or

(ii) the holder of an approved application under paragraph (1)

has not made the report required by paragraph (2),

the Secretary may, after providing the holder of the application an

opportunity for an informal hearing, withdraw the approved

application.

(B) If the Secretary determines that the holder of an approved

application under paragraph (1) or an importer is exporting a drug

or device from the United States to an importer and such importer

is exporting the drug or device to a country for which the

Secretary cannot make a finding under paragraph (1) and such export

presents an imminent hazard, the Secretary shall immediately

prohibit the export of the drug or device to such importer, provide

the person exporting the drug or device from the United States

prompt notice of the prohibition, and afford such person an

opportunity for an expedited hearing.

(f) Prohibition of export of drug or device

A drug or device may not be exported under this section -

(1) if the drug or device is not manufactured, processed,

packaged, and held in substantial conformity with current good

manufacturing practice requirements or does not meet

international standards as certified by an international

standards organization recognized by the Secretary;

(2) if the drug or device is adulterated under clause (1),

(2)(A), or (3) of section 351(a) or subsection (c) or (d) of

section 351 of this title;

(3) if the requirements of subparagraphs (A) through (D) of

section 381(e)(1) of this title have not been met;

(4)(A) if the drug or device is the subject of a notice by the

Secretary or the Secretary of Agriculture of a determination that

the probability of reimportation of the exported drug or device

would present an imminent hazard to the public health and safety

of the United States and the only means of limiting the hazard is

to prohibit the export of the drug or device; or

(B) if the drug or device presents an imminent hazard to the

public health of the country to which the drug or device would be

exported;

(5) if the labeling of the drug or device is not -

(A) in accordance with the requirements and conditions for

use in -

(i) the country in which the drug or device received valid

marketing authorization under subsection (b) of this section;

and

(ii) the country to which the drug or device would be

exported; and

(B) in the language and units of measurement of the country

to which the drug or device would be exported or in the

language designated by such country; or

(6) if the drug or device is not promoted in accordance with

the labeling requirements set forth in paragraph (5).

In making a finding under paragraph (4)(B), (5), or (6) the

Secretary shall consult with the appropriate public health official

in the affected country.

(g) Notification of Secretary

The exporter of a drug or device exported under subsection (b)(1)

of this section shall provide a simple notification to the

Secretary identifying the drug or device when the exporter first

begins to export such drug or device to any country listed in

clause (i) or (ii) of subsection (b)(1)(A) of this section. When

an exporter of a drug or device first begins to export a drug or

device to a country which is not listed in clause (i) or (ii) of

subsection (b)(1)A) (FOOTNOTE 1) of this section, the exporter

shall provide a simple notification to the Secretary identifying

the drug or device and the country to which such drug or device is

being exported. Any exporter of a drug or device shall maintain

records of all drugs or devices exported and the countries to which

they were exported.

(FOOTNOTE 1) So in original. Probably should be subsection

''(b)(1)(A)''.

(h) References to Secretary and term ''drug''

For purposes of this section -

(1) a reference to the Secretary shall in the case of a

biological product which is required to be licensed under the Act

of March 4, 1913 (21 U.S.C. 151 et seq.) (37 Stat. 832-833)

(commonly known as the Virus-Serum Toxin Act) be considered to be

a reference to the Secretary of Agriculture, and

(2) the term ''drug'' includes drugs for human use as well as

biologicals under section 262 of title 42 or the Act of March 4,

1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin

Act).

(i) Exportation

Insulin and antibiotic drugs may be exported without regard to

the requirements in this section if the insulin and antibiotic

drugs meet the requirements of section 381(e)(1) of this title.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 802, as added Pub. L. 99-660, title

I, Sec. 102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L.

104-134, title III, Sec. 2102(d)(1), Apr. 26, 1996, 110 Stat.

1321-315; Pub. L. 104-180, title VI, Sec. 603(c), Aug. 6, 1996, 110

Stat. 1595; Pub. L. 105-115, title I, Sec. 125(c), Nov. 21, 1997,

111 Stat. 2326.)

-REFTEXT-

REFERENCES IN TEXT

Act of March 4, 1913 (known as the Virus-Serum Toxin Act),

referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the

eighth paragraph under the heading ''Bureau of Animal Industry'' of

act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is

classified generally to chapter 5 (Sec. 151 et seq.) of this

title. For complete classification of this Act to the Code, see

Short Title note set out under section 151 of this title and

Tables.

-MISC2-

AMENDMENTS

1997 - Subsec. (i). Pub. L. 105-115 added subsec. (i).

1996 - Pub. L. 104-134 reenacted section catchline without change

and amended text generally. Prior to amendment, text related to

exports of certain unapproved products, including provisions

relating to drugs intended for human or animal use which required

approval or licensing, conditions for export, active pursuit of

drug approval or licensing, application for export, contents,

approval or disapproval, list of eligible countries for export, and

criteria for list change, report to Secretary by holder of approved

application, events requiring report, and annual report to

Secretary on pursuit of approval of drug, export of drug under

approved application prohibited under certain conditions,

determination by Secretary of noncompliance, failure of active

pursuit of drug approval, imminent hazard of drug to public health,

or exportation of drug to noneligible country, notices, hearings,

and prohibition on exportation of drug under certain circumstances,

drugs used in prevention or treatment of tropical disease, and

reference to Secretary and holder of application.

Subsec. (f)(5). Pub. L. 104-180 substituted ''if the labeling of

the drug or device is not'' for ''if the drug or device is not

labeled''.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 331, 381, 384 of

this title.

-CITE-

21 USC Sec. 383 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-

Sec. 383. Office of International Relations

-STATUTE-

(a) Establishment

There is established in the Department of Health and Human

Services an Office of International Relations.

(b) Agreements with foreign countries

In carrying out the functions of the office under subsection (a)

of this section, the Secretary may enter into agreements with

foreign countries to facilitate commerce in devices between the

United States and such countries consistent with the requirements

of this chapter. In such agreements, the Secretary shall encourage

the mutual recognition of -

(1) good manufacturing practice regulations promulgated under

section 360j(f) of this title, and

(2) other regulations and testing protocols as the Secretary

determines to be appropriate.

(c) Harmonizing regulatory requirements

(1) The Secretary shall support the Office of the United States

Trade Representative, in consultation with the Secretary of

Commerce, in meetings with representatives of other countries to

discuss methods and approaches to reduce the burden of regulation

and harmonize regulatory requirements if the Secretary determines

that such harmonization continues consumer protections consistent

with the purposes of this chapter.

(2) The Secretary shall support the Office of the United States

Trade Representative, in consultation with the Secretary of

Commerce, in efforts to move toward the acceptance of mutual

recognition agreements relating to the regulation of drugs,

biological products, devices, foods, food additives, and color

additives, and the regulation of good manufacturing practices,

between the European Union and the United States.

(3) The Secretary shall regularly participate in meetings with

representatives of other foreign governments to discuss and reach

agreement on methods and approaches to harmonize regulatory

requirements.

(4) The Secretary shall, not later than 180 days after November

21, 1997, make public a plan that establishes a framework for

achieving mutual recognition of good manufacturing practices

inspections.

(5) Paragraphs (1) through (4) shall not apply with respect to

products defined in section 321(ff) of this title.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 803, as added Pub. L. 101-629, Sec.

15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105-115,

title IV, Sec. 410(b), Nov. 21, 1997, 111 Stat. 2373.)

-MISC1-

AMENDMENTS

1997 - Subsec. (c). Pub. L. 105-115 added subsec. (c).

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

REPORT ON ACTIVITIES OF OFFICE OF INTERNATIONAL RELATIONS

Section 15(b) of Pub. L. 101-629 directed Secretary of Health and

Human Services, not later than 2 years after Nov. 28, 1990, to

prepare and submit to the appropriate committees of Congress a

report on the activities of the Office of International Relations

under 21 U.S.C. 383.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 335a, 374 of this title.

-CITE-

21 USC Sec. 384 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-

Sec. 384. Importation of covered products

-STATUTE-

(a) Regulations

The Secretary, after consultation with the United States Trade

Representative and the Commissioner of Customs, shall promulgate

regulations permitting pharmacists and wholesalers to import into

the United States covered products.

(b) Limitation

Regulations under subsection (a) of this section shall -

(1) require that safeguards be in place to ensure that each

covered product imported pursuant to such subsection complies

with section 355 of this title (including with respect to being

safe and effective for its intended use), with sections 351 and

352 of this title, and with other applicable requirements of this

chapter;

(2) require that an importer of a covered product pursuant to

subsection (a) of this section comply with the applicable

provisions of this section, including subsection (d) of this

section; and

(3) contain any additional provisions determined by the

Secretary to be appropriate as a safeguard to protect the public

health or as a means to facilitate the importation of such

products.

(c) Records

Regulations under subsection (a) of this section shall require

that records regarding the importation of covered products pursuant

to such subsection be provided to and maintained by the Secretary

for a period of time determined to be necessary by the Secretary.

(d) Importation

Regulations under subsection (a) of this section shall require an

importer of a covered product pursuant to such subsection to

provide to the Secretary the following information and records:

(1) The name and amount of the active ingredient of such

product and description of the dosage form.

(2) The date that the product is shipped and the quantity of

the product that is shipped, points of origin and destination for

the product, the price paid for the product by the importer, and

(once the product is distributed) the price for which such

product is sold by the importer.

(3) Documentation from the foreign seller specifying the

original source of the product and the amount of each lot of the

product originally received.

(4) The manufacturer's lot or control number of the product

imported.

(5) The name, address, and telephone number of the importer,

including the professional license number of the importer, if

any.

(6) For a product that is coming directly from the first

foreign recipient of the product from the manufacturer:

(A) Documentation demonstrating that such product came from

such recipient and was received by the recipient from such

manufacturer.

(B) Documentation of the amount of each lot of the product

received by such recipient to demonstrate that the amount being

imported into the United States is not more than the amount

that was received by the recipient.

(C) In the case of the initial imported shipment,

documentation demonstrating that each batch of such shipment

was statistically sampled and tested for authenticity and

degradation.

(D) In the case of all subsequent shipments from such

recipient, documentation demonstrating that a statistically

valid sample of such shipments was tested for authenticity and

degradation.

(E) Certification from the importer or manufacturer of such

product that the product is approved for marketing in the

United States and meets all labeling requirements under this

chapter.

(7) For a product that is not coming directly from the first

foreign recipient of the product from the manufacturer:

(A) Documentation demonstrating that each batch in all

shipments offered for importation into the United States was

statistically sampled and tested for authenticity and

degradation.

(B) Certification from the importer or manufacturer of such

product that the product is approved for marketing in the

United States and meets all labeling requirements under this

chapter.

(8) Laboratory records, including complete data derived from

all tests necessary to assure that the product is in compliance

with established specifications and standards.

(9) Documentation demonstrating that the testing required by

paragraphs (6) through (8) was performed at a qualifying

laboratory (as defined in subsection (k) of this section).

(10) Any other information that the Secretary determines is

necessary to ensure the protection of the public health.

(e) Testing

Regulations under subsection (a) of this section -

(1) shall require that testing referred to in paragraphs (6)

through (8) of subsection (d) of this section be conducted by the

importer of the covered product pursuant to subsection (a) of

this section, or the manufacturer of the product;

(2) shall require that if such tests are conducted by the

importer, information needed to authenticate the product being

tested, and to confirm that the labeling of such product complies

with labeling requirements under this chapter, be supplied by the

manufacturer of such product to the pharmacist or wholesaler, and

shall require that such information be kept in strict confidence

and used only for purposes of testing under this chapter; and

(3) may include such additional provisions as the Secretary

determines to be appropriate to provide for the protection of

trade secrets and commercial or financial information that is

privileged or confidential.

(f) Country limitation

Regulations under subsection (a) of this section shall provide

that covered products may be imported pursuant to such subsection

only from a country, union, or economic area that is listed in

subparagraph (A) of section 382(b)(1) of this title or designated

by the Secretary, subject to such limitations as the Secretary

determines to be appropriate to protect the public health.

(g) Suspension of importations

The Secretary shall require that importations of specific covered

products or importations by specific importers pursuant to

subsection (a) of this section be immediately suspended upon

discovery of a pattern of importation of such products or by such

importers that is counterfeit or in violation of any requirement

pursuant to this section, until an investigation is completed and

the Secretary determines that the public is adequately protected

from counterfeit and violative covered products being imported

pursuant to subsection (a) of this section.

(h) Prohibited agreements

No manufacturer of a covered product may enter into a contract or

agreement that includes a provision to prevent the sale or

distribution of covered products imported pursuant to subsection

(a) of this section.

(i) Studies; reports

(1) Study by Secretary

(A) In general

The Secretary shall conduct, or contract with an entity to

conduct, a study on the imports permitted pursuant to

subsection (a) of this section, including consideration of the

information received under subsection (d) of this section. In

conducting such study, the Secretary or entity shall -

(i) evaluate the compliance of importers with regulations

under subsection (a) of this section, and the number of

shipments pursuant to such subsection, if any, that have been

determined to be counterfeit, misbranded, or adulterated, and

determine how such compliance contrasts with the number of

shipments of prescription drugs transported within the United

States that have been determined to be counterfeit,

misbranded, or adulterated; and

(ii) consult with the United States Trade Representative

and the Commissioner of Patents and Trademarks to evaluate

the effect of importations pursuant to subsection (a) of this

section on trade and patent rights under Federal law.

(B) Report

Not later than 2 years after the effective date of final

regulations under subsection (a) of this section, the Secretary

shall prepare and submit to the Congress a report describing

the findings of the study under subparagraph (A).

(2) Study by General Accounting Office

The Comptroller General of the United States shall conduct a

study to determine the effect of this section on the price of

covered products sold to consumers at retail. Not later than 18

months after the effective date of final regulations under

subsection (a) of this section, the Comptroller General shall

prepare and submit to the Congress a report describing the

findings of such study.

(j) Construction

Nothing in this section shall be construed to limit the

statutory, regulatory, or enforcement authority of the Secretary

relating to the importation of covered products, other than with

respect to section 381(d)(1) of this title as provided in this

section.

(k) Definitions

(1) Covered product

(A) In general

For purposes of this section, the term ''covered product''

means a prescription drug, except that such term does not

include a controlled substance in schedule I, II, or III under

section 812(c) of this title or a biological product as defined

in section 262 of title 42.

(B) Charitable contributions; parenteral drugs

Notwithstanding any other provision of this section, section

381(d)(1) of this title -

(i) continues to apply to a covered product donated or

otherwise supplied for free by the manufacturer of the drug

to a charitable or humanitarian organization, including the

United Nations and affiliates, or to a government of a

foreign country; and

(ii) continues to apply to a covered product that is a

parenteral drug the importation of which pursuant to

subsection (a) of this section is determined by the Secretary

to pose a threat to the public health.

(2) Other terms

For purposes of this section:

(A) The term ''importer'' means a pharmacist or wholesaler.

(B) The term ''pharmacist'' means a person licensed by a

State to practice pharmacy, including the dispensing and

selling of prescription drugs.

(C) The term ''prescription drug'' means a drug subject to

section 353(b) of this title.

(D) The term ''qualifying laboratory'' means a laboratory in

the United States that has been approved by the Secretary for

purposes of this section.

(E) The term ''wholesaler'' means a person licensed as a

wholesaler or distributor of prescription drugs in the United

States pursuant to section 353(e)(2)(A) of this title. Such

term does not include a person authorized to import drugs under

section 381(d)(1) of this title.

(l) Conditions

This section shall become effective only if the Secretary

demonstrates to the Congress that the implementation of this

section will -

(1) pose no additional risk to the public's health and safety;

and

(2) result in a significant reduction in the cost of covered

products to the American consumer.

(m) Sunset

Effective upon the expiration of the 5-year period beginning on

the effective date of final regulations under subsection (a) of

this section, this section ceases to have any legal effect.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 804, as added Pub. L. 106-387, Sec.

1(a) (title VII, Sec. 745(c)(2)), Oct. 28, 2000, 114 Stat. 1549,

1549A-36.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions, personnel, assets, and liabilities of

the United States Customs Service of the Department of the

Treasury, including functions of the Secretary of the Treasury

relating thereto, to the Secretary of Homeland Security, and for

treatment of related references, see sections 203(1), 551(d),

552(d), and 557 of Title 6, Domestic Security, and the Department

of Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-MISC5-

FINDINGS

Pub. L. 106-387, Sec. 1(a) (title VII, Sec. 745(b)), Oct. 28,

2000, 114 Stat. 1549, 1549A-35, provided that: ''The Congress makes

the following findings:

''(1) The cost of prescription drugs for Americans continues to

rise at an alarming rate.

''(2) Millions of Americans, including Medicare beneficiaries

on fixed incomes, face a daily choice between purchasing

life-sustaining prescription drugs, or paying for other

necessities, such as food and housing.

''(3) Many life-saving prescription drugs are available in

countries other than the United States at substantially lower

prices, even though such drugs were developed and are approved

for use by patients in the United States.

''(4) Many Americans travel to other countries to purchase

prescription drugs because the medicines that they need are

unaffordable in the United States.

''(5) Americans should be able to purchase medicines at prices

that are comparable to prices for such medicines in other

countries, but efforts to enable such purchases should not

endanger the gold standard for safety and effectiveness that has

been established and maintained in the United States.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 333, 381 of this

title.

-CITE-

21 USC SUBCHAPTER IX - MISCELLANEOUS 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

.

-HEAD-

SUBCHAPTER IX - MISCELLANEOUS

-CITE-

21 USC Sec. 391 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 391. Separability clause

-STATUTE-

If any provision of this chapter is declared unconstitutional, or

the applicability thereof to any person or circumstances is held

invalid, the constitutionality of the remainder of the chapter and

the applicability thereof to other persons and circumstances shall

not be affected thereby.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 901, 52 Stat. 1059.)

-CITE-

21 USC Sec. 392 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 392. Exemption of meats and meat food products

-STATUTE-

(a) Law determinative of exemption

Meats and meat food products shall be exempt from the provisions

of this chapter to the extent of the application or the extension

thereto of the Meat Inspection Act, approved March 4, 1907, as

amended (21 U.S.C. 601 et seq.).

(b) Laws unaffected

Nothing contained in this chapter shall be construed as in any

way affecting, modifying, repealing, or superseding the provisions

of section 351 of Public Health Service Act (42 U.S.C. 262)

(relating to viruses, serums, toxins, and analogous products

applicable to man); the virus, serum, toxin, and analogous products

provisions, applicable to domestic animals, of the Act of Congress

approved March 4, 1913 (37 Stat. 832-833) (21 U.S.C. 151 et seq.);

the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26,

ch. 10), the Filled Milk Act of March 4, 1923 (21 U.S.C. 61 et

seq.); or the Import Milk Act of February 15, 1927 (21 U.S.C. 141

et seq.).

-SOURCE-

(June 25, 1938, ch. 675, Sec. 902(b), (c), 52 Stat. 1059; Pub. L.

90-399, Sec. 107, July 13, 1968, 82 Stat. 353.)

-REFTEXT-

REFERENCES IN TEXT

The Meat Inspection Act, approved March 4, 1907, as amended,

referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I

to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which

are classified generally to subchapters I to IV (Sec. 601 et seq.)

of chapter 12 of this title. For complete classification of this

Act to the Code, see Short Title note set out under section 601 of

this title and Tables.

Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4,

1913, ch. 145, 37 Stat. 828, as amended. The provisions of such

act referred to relating to viruses, etc., applicable to domestic

animals, are contained in the eighth paragraph under the heading

''Bureau of Animal Industry'', 37 Stat. 832, as amended, popularly

known as the Virus-Serum-Toxin Act, which is classified generally

to chapter 5 (Sec. 151 et seq.) of this title. For complete

classification of this Act to the Code, see Short Title note set

out under section 151 of this title and Tables.

The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title

26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch.

337, 29 Stat. 253, as amended, which had been classified to chapter

10 (Sec. 1000 et seq.) of Title 26, Internal Revenue, and included

as chapter 17 (Sec. 2350 et seq.) of Title 26, Internal Revenue

Code of 1939. Such chapter 17 was covered by section 4831 et seq.

of Title 26, Internal Revenue Code, prior to the repeal of section

4831 et seq. of Title 26 by Pub. L. 93-490, Sec. 3(a)(1), Oct. 26,

1974, 88 Stat. 1466.

The Filled Milk Act of March 4, 1923, referred to in subsec. (b),

is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, as amended, which is

classified generally to chapter 3 (Sec. 61 et seq.) of this title.

For complete classification of this Act to the Code, see Short

Title note set out under section 61 of this title and Tables.

The Import Milk Act of February 15, 1927, referred to in subsec.

(b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, as amended,

which is classified generally to subchapter IV (Sec. 141 et seq.)

of chapter 4 of this title. For complete classification of this

Act to the Code, see Short Title note set out under section 141 of

this title and Tables.

-COD-

CODIFICATION

Subsecs. (a) and (b) of this section comprise respectively

subsecs. (b) and (c) of section 902 of act June 25, 1938. Subsecs.

(a) and (d) of section 902 of act June 25, 1938, which prescribed

the effective date of this chapter and made appropriations

available, are set out as notes under section 301 of this title and

this section, respectively.

-MISC3-

AMENDMENTS

1968 - Subsec. (b). Pub. L. 90-399 substituted ''section 262 of

title 42 (relating to viruses, serums, toxins, and analogous

products applicable to man)'' for ''the virus serum, and toxin Act

of July 1, 1902'' and inserted reference to ''the virus, serum,

toxin, and analogous products provisions, applicable to domestic

animals, of the Act of Congress approved March 4, 1913''.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by Pub. L. 90-399 effective on first day of thirteenth

calendar month after July 13, 1968, see section 108(a) of Pub. L.

90-399, set out as an Effective Date and Transitional Provisions

note under section 360b of this title.

AVAILABILITY OF APPROPRIATIONS

Section 902(d) of act June 25, 1938, provided that: ''In order to

carry out the provisions of this Act which take effect (see section

902(a) of act June 25, 1938, set out as an Effective Date note

under section 301 of this title) prior to the repeal of the Food

and Drugs Act of June 30, 1906, as amended (sections 1 to 15 of

this title), appropriations available for the enforcement of such

Act of June 30, 1906, are also authorized to be made available to

carry out such provisions.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 679 of this title.

-CITE-

21 USC Sec. 393 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 393. Food and Drug Administration

-STATUTE-

(a) In general

There is established in the Department of Health and Human

Services the Food and Drug Administration (hereinafter in this

section referred to as the ''Administration'').

(b) Mission

The Administration shall -

(1) promote the public health by promptly and efficiently

reviewing clinical research and taking appropriate action on the

marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by

ensuring that -

(A) foods are safe, wholesome, sanitary, and properly

labeled;

(B) human and veterinary drugs are safe and effective;

(C) there is reasonable assurance of the safety and

effectiveness of devices intended for human use;

(D) cosmetics are safe and properly labeled; and

(E) public health and safety are protected from electronic

product radiation;

(3) participate through appropriate processes with

representatives of other countries to reduce the burden of

regulation, harmonize regulatory requirements, and achieve

appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out

paragraphs (1) through (3) in consultation with experts in

science, medicine, and public health, and in cooperation with

consumers, users, manufacturers, importers, packers,

distributors, and retailers of regulated products.

(c) Interagency collaboration

The Secretary shall implement programs and policies that will

foster collaboration between the Administration, the National

Institutes of Health, and other science-based Federal agencies, to

enhance the scientific and technical expertise available to the

Secretary in the conduct of the duties of the Secretary with

respect to the development, clinical investigation, evaluation, and

postmarket monitoring of emerging medical therapies, including

complementary therapies, and advances in nutrition and food

science.

(d) Commissioner

(1) Appointment

There shall be in the Administration a Commissioner of Food and

Drugs (hereinafter in this section referred to as the

''Commissioner'') who shall be appointed by the President by and

with the advice and consent of the Senate.

(2) General powers

The Secretary, through the Commissioner, shall be responsible

for executing this chapter and for -

(A) providing overall direction to the Food and Drug

Administration and establishing and implementing general

policies respecting the management and operation of programs

and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all

administrative entities within the Administration;

(C) research relating to foods, drugs, cosmetics, and devices

in carrying out this chapter;

(D) conducting educational and public information programs

relating to the responsibilities of the Food and Drug

Administration; and

(E) performing such other functions as the Secretary may

prescribe.

(e) Technical and scientific review groups

The Secretary through the Commissioner of Food and Drugs may,

without regard to the provisions of title 5 governing appointments

in the competitive service and without regard to the provisions of

chapter 51 and subchapter III of chapter 53 of such title relating

to classification and General Schedule pay rates, establish such

technical and scientific review groups as are needed to carry out

the functions of the Administration, including functions under this

chapter, and appoint and pay the members of such groups, except

that officers and employees of the United States shall not receive

additional compensation for service as members of such groups.

(f) Agency plan for statutory compliance

(1) In general

Not later than 1 year after November 21, 1997, the Secretary,

after consultation with appropriate scientific and academic

experts, health care professionals, representatives of patient

and consumer advocacy groups, and the regulated industry, shall

develop and publish in the Federal Register a plan bringing the

Secretary into compliance with each of the obligations of the

Secretary under this chapter. The Secretary shall review the

plan biannually and shall revise the plan as necessary, in

consultation with such persons.

(2) Objectives of agency plan

The plan required by paragraph (1) shall establish objectives

and mechanisms to achieve such objectives, including objectives

related to -

(A) maximizing the availability and clarity of information

about the process for review of applications and submissions

(including petitions, notifications, and any other similar

forms of request) made under this chapter;

(B) maximizing the availability and clarity of information

for consumers and patients concerning new products;

(C) implementing inspection and postmarket monitoring

provisions of this chapter;

(D) ensuring access to the scientific and technical expertise

needed by the Secretary to meet obligations described in

paragraph (1);

(E) establishing mechanisms, by July 1, 1999, for meeting the

time periods specified in this chapter for the review of all

applications and submissions described in subparagraph (A) and

submitted after November 21, 1997; and

(F) eliminating backlogs in the review of applications and

submissions described in subparagraph (A), by January 1, 2000.

(g) Annual report

The Secretary shall annually prepare and publish in the Federal

Register and solicit public comment on a report that -

(1) provides detailed statistical information on the

performance of the Secretary under the plan described in

subsection (f) of this section;

(2) compares such performance of the Secretary with the

objectives of the plan and with the statutory obligations of the

Secretary; and

(3) identifies any regulatory policy that has a significant

negative impact on compliance with any objective of the plan or

any statutory obligation and sets forth any proposed revision to

any such regulatory policy.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 903, as added Pub. L. 100-607, title

V, Sec. 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L.

100-690, title II, Sec. 2631, Nov. 18, 1988, 102 Stat. 4244; Pub.

L. 105-115, title IV, Sec. 406, 414, Nov. 21, 1997, 111 Stat. 2369,

2377.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 governing appointments in the

competitive service, referred to in subsec. (e), are classified

generally to section 3301 et seq. of Title 5, Government

Organization and Employees.

-COD-

CODIFICATION

Another section 903 of the Federal Food, Drug, and Cosmetic Act

was renumbered section 904 and is classified to section 394 of this

title.

-MISC3-

AMENDMENTS

1997 - Subsec. (b). Pub. L. 105-115, Sec. 406(a)(2), added

subsec. (b). Former subsec. (b) redesignated (d).

Subsec. (c). Pub. L. 105-115, Sec. 414, added subsec. (c). Former

subsec. (c) redesignated (e).

Subsecs. (d), (e). Pub. L. 105-115, Sec. 406(a)(1), redesignated

subsecs. (b) and (c) as (d) and (e), respectively.

Subsecs. (f), (g). Pub. L. 105-115, Sec. 406(b), added subsecs.

(f) and (g).

1988 - Subsec. (b)(2). Pub. L. 100-690 substituted ''shall be

responsible for executing this chapter and for ''shall be

responsible''.

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

EFFECTIVE DATE

Section 503(c) of title V of Pub. L. 100-607 provided that:

''(1) Except as provided in paragraph (2), the amendments made by

this title (enacting this section and amending sections 5315 and

5316 of Title 5, Government Organization and Employees) shall take

effect on the date of enactment of this Act (Nov. 4, 1988).

''(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 393(b)(1)) (as added by subsection (a) of this

section) shall apply to the appointments of Commissioners of Food

and Drugs made after the date of enactment of this Act.''

REGULATIONS FOR SUNSCREEN PRODUCTS

Section 129 of Pub. L. 105-115 provided that: ''Not later than 18

months after the date of enactment of this Act (Nov. 21, 1997), the

Secretary of Health and Human Services shall issue regulations for

over-the-counter sunscreen products for the prevention or treatment

of sunburn.''

FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD

Section 413 of Pub. L. 105-115 provided that:

''(a) List and Analysis. - The Secretary of Health and Human

Services shall, acting through the Food and Drug Administration -

''(1) compile a list of drugs and foods that contain

intentionally introduced mercury compounds, and

''(2) provide a quantitative and qualitative analysis of the

mercury compounds in the list under paragraph (1).

The Secretary shall compile the list required by paragraph (1)

within 2 years after the date of enactment of the Food and Drug

Administration Modernization Act of 1997 (Nov. 21, 1997) and shall

provide the analysis required by paragraph (2) within 2 years after

such date of enactment.

''(b) Study. - The Secretary of Health and Human Services, acting

through the Food and Drug Administration, shall conduct a study of

the effect on humans of the use of mercury compounds in nasal

sprays. Such study shall include data from other studies that have

been made of such use.

''(c) Study of Mercury Sales. -

''(1) Study. - The Secretary of Health and Human Services,

acting through the Food and Drug Administration and subject to

appropriations, shall conduct, or shall contract with the

Institute of Medicine of the National Academy of Sciences to

conduct, a study of the effect on humans of the use of elemental,

organic, or inorganic mercury when offered for sale as a drug or

dietary supplement. Such study shall, among other things,

evaluate -

''(A) the scope of mercury use as a drug or dietary

supplement; and

''(B) the adverse effects on health of children and other

sensitive populations resulting from exposure to, or ingestion

or inhalation of, mercury when so used.

In conducting such study, the Secretary shall consult with the

Administrator of the Environmental Protection Agency, the Chair

of the Consumer Product Safety Commission, and the Administrator

of the Agency for Toxic Substances and Disease Registry, and, to

the extent the Secretary believes necessary or appropriate, with

any other Federal or private entity.

''(2) Regulations. - If, in the opinion of the Secretary, the

use of elemental, organic, or inorganic mercury offered for sale

as a drug or dietary supplement poses a threat to human health,

the Secretary shall promulgate regulations restricting the sale

of mercury intended for such use. At a minimum, such regulations

shall be designed to protect the health of children and other

sensitive populations from adverse effects resulting from

exposure to, or ingestion or inhalation of, mercury. Such

regulations, to the extent feasible, should not unnecessarily

interfere with the availability of mercury for use in religious

ceremonies.''

MANAGEMENT ACTIVITIES STUDY

Pub. L. 102-571, title II, Sec. 205, Oct. 29, 1992, 106 Stat.

4502, directed Comptroller General to conduct a study of management

of activities of the Food and Drug Administration that are related

to dietary supplements of vitamins, minerals, herbs, or other

similar nutritional substances and submit an interim report to

Congress, not later than 6 months after Oct. 29, 1992, with a final

report to be submitted not later than 12 months after Oct. 29,

1992.

CONGRESSIONAL FINDINGS

Section 502 of Pub. L. 100-607 provided that: ''Congress finds

that -

''(1) the public health has been effectively protected by the

presence of the Food and Drug Administration during the last

eighty years;

''(2) the presence and importance of the Food and Drug

Administration must be guaranteed; and

''(3) the independence and integrity of the Food and Drug

Administration need to be enhanced in order to ensure the

continuing protection of the public health.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 360m, 374 of this title.

-CITE-

21 USC Sec. 393a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 393a. Office of Pediatric Therapeutics

-STATUTE-

(a) Establishment

The Secretary of Health and Human Services shall establish an

Office of Pediatric Therapeutics within the Food and Drug

Administration.

(b) Duties

The Office of Pediatric Therapeutics shall be responsible for

coordination and facilitation of all activities of the Food and

Drug Administration that may have any effect on a pediatric

population or the practice of pediatrics or may in any other way

involve pediatric issues.

(c) Staff

The staff of the Office of Pediatric Therapeutics shall

coordinate with employees of the Department of Health and Human

Services who exercise responsibilities relating to pediatric

therapeutics and shall include -

(1) one or more additional individuals with expertise

concerning ethical issues presented by the conduct of clinical

research in the pediatric population; and

(2) one or more additional individuals with expertise in

pediatrics as may be necessary to perform the activities

described in subsection (b) of this section.

-SOURCE-

(Pub. L. 107-109, Sec. 6, Jan. 4, 2002, 115 Stat. 1414.)

-COD-

CODIFICATION

Section was enacted as part of the Best Pharmaceuticals for

Children Act, and not as part of the Federal Food, Drug, and

Cosmetic Act which comprises this chapter.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 355b of this title.

-CITE-

21 USC Sec. 394 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 394. Scientific review groups

-STATUTE-

Without regard to the provisions of title 5 governing

appointments in the competitive service and without regard to the

provisions of chapter 51 and subchapter III of chapter 53 of such

title relating to classification and General Schedule pay rates,

the Commissioner of Food and Drugs may -

(1) establish such technical and scientific review groups as

are needed to carry out the functions of the Food and Drug

Administration (including functions prescribed under this

chapter); and

(2) appoint and pay the members of such groups, except that

officers and employees of the United States shall not receive

additional compensation for service as members of such groups.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 904, formerly Sec. 903, as added Pub.

L. 101-635, title III, Sec. 301, Nov. 28, 1990, 104 Stat. 4584;

renumbered Sec. 904, Pub. L. 103-43, title XX, Sec. 2006(1), June

10, 1993, 107 Stat. 209.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 governing appointments in the

competitive service, referred to in text, are classified generally

to section 3301 et seq. of Title 5, Government Organization and

Employees.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 355 of this title.

-CITE-

21 USC Sec. 395 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 395. Loan repayment program

-STATUTE-

(a) In general

(1) Authority for program

Subject to paragraph (2), the Secretary shall carry out a

program of entering into contracts with appropriately qualified

health professionals under which such health professionals agree

to conduct research, as employees of the Food and Drug

Administration, in consideration of the Federal Government

agreeing to repay, for each year of such service, not more than

$20,000 of the principal and interest of the educational loans of

such health professionals.

(2) Limitation

The Secretary may not enter into an agreement with a health

professional pursuant to paragraph (1) unless such professional -

(A) has a substantial amount of educational loans relative to

income; and

(B) agrees to serve as an employee of the Food and Drug

Administration for purposes of paragraph (1) for a period of

not less than 3 years.

(b) Applicability of certain provisions

With respect to the National Health Service Corps Loan Repayment

Program established in subpart III of part D of title III of the

Public Health Service Act (42 U.S.C. 254l et seq.), the provisions

of such subpart shall, except as inconsistent with subsection (a)

of this section, apply to the program established in such

subsection in the same manner and to the same extent as such

provisions apply to the National Health Service Corps Loan

Repayment Program.

(c) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 1994 through 1996.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 905, as added Pub. L. 103-43, title

XX, Sec. 2006(2), June 10, 1993, 107 Stat. 210.)

-REFTEXT-

REFERENCES IN TEXT

The Public Health Service Act, referred to in subsec. (b), is act

July 1, 1944, ch. 373, 58 Stat. 682, as amended. Subpart III of

part D of title III of the Act is classified generally to subpart

III (Sec. 254l et seq.) of part D of subchapter II of chapter 6A of

Title 42, The Public Health and Welfare. For complete

classification of this Act to the Code, see Short Title note set

out under section 201 of Title 42 and Tables.

-CITE-

21 USC Sec. 396 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 396. Practice of medicine

-STATUTE-

Nothing in this chapter shall be construed to limit or interfere

with the authority of a health care practitioner to prescribe or

administer any legally marketed device to a patient for any

condition or disease within a legitimate health care

practitioner-patient relationship. This section shall not limit

any existing authority of the Secretary to establish and enforce

restrictions on the sale or distribution, or in the labeling, of a

device that are part of a determination of substantial equivalence,

established as a condition of approval, or promulgated through

regulations. Further, this section shall not change any existing

prohibition on the promotion of unapproved uses of legally marketed

devices.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 906, as added Pub. L. 105-115, title

II, Sec. 214, Nov. 21, 1997, 111 Stat. 2348.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Sec. 397 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 397. Contracts for expert review

-STATUTE-

(a) In general

(1) Authority

The Secretary may enter into a contract with any organization

or any individual (who is not an employee of the Department) with

relevant expertise, to review and evaluate, for the purpose of

making recommendations to the Secretary on, part or all of any

application or submission (including a petition, notification,

and any other similar form of request) made under this chapter

for the approval or classification of an article or made under

section 351(a) of the Public Health Service Act (42 U.S.C.

262(a)) with respect to a biological product. Any such contract

shall be subject to the requirements of section 379 of this title

relating to the confidentiality of information.

(2) Increased efficiency and expertise through contracts

The Secretary may use the authority granted in paragraph (1)

whenever the Secretary determines that use of a contract

described in paragraph (1) will improve the timeliness of the

review of an application or submission described in paragraph

(1), unless using such authority would reduce the quality, or

unduly increase the cost, of such review. The Secretary may use

such authority whenever the Secretary determines that use of such

a contract will improve the quality of the review of an

application or submission described in paragraph (1), unless

using such authority would unduly increase the cost of such

review. Such improvement in timeliness or quality may include

providing the Secretary increased scientific or technical

expertise that is necessary to review or evaluate new therapies

and technologies.

(b) Review of expert review

(1) In general

Subject to paragraph (2), the official of the Food and Drug

Administration responsible for any matter for which expert review

is used pursuant to subsection (a) of this section shall review

the recommendations of the organization or individual who

conducted the expert review and shall make a final decision

regarding the matter in a timely manner.

(2) Limitation

A final decision by the Secretary on any such application or

submission shall be made within the applicable prescribed time

period for review of the matter as set forth in this chapter or

in the Public Health Service Act (42 U.S.C. 201 et seq.).

-SOURCE-

(June 25, 1938, ch. 675, Sec. 907, as added Pub. L. 105-115, title

IV, Sec. 415, Nov. 21, 1997, 111 Stat. 2377.)

-REFTEXT-

REFERENCES IN TEXT

The Public Health Service Act, referred to in subsec. (b)(2), is

act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is

classified generally to chapter 6A (Sec. 201 et seq.) of Title 42,

The Public Health and Welfare. For complete classification of this

Act to the Code, see Short Title note set out under section 201 of

Title 42 and Tables.

-MISC2-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Sec. 398 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 398. Notices to States regarding imported food

-STATUTE-

(a) In general

If the Secretary has credible evidence or information indicating

that a shipment of imported food or portion thereof presents a

threat of serious adverse health consequences or death to humans or

animals, the Secretary shall provide notice regarding such threat

to the States in which the food is held or will be held, and to the

States in which the manufacturer, packer, or distributor of the

food is located, to the extent that the Secretary has knowledge of

which States are so involved. In providing notice to a State, the

Secretary shall request the State to take such action as the State

considers appropriate, if any, to protect the public health

regarding the food involved.

(b) Rule of construction

Subsection (a) of this section may not be construed as limiting

the authority of the Secretary with respect to food under any other

provision of this chapter.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 908, as added Pub. L. 107-188, title

III, Sec. 310, June 12, 2002, 116 Stat. 673.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 399 of this title.

-CITE-

21 USC Sec. 399 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IX - MISCELLANEOUS

-HEAD-

Sec. 399. Grants to States for inspections

-STATUTE-

(a) In general

The Secretary is authorized to make grants to States,

territories, and Indian tribes (as defined in section 450b(e) of

title 25) that undertake examinations, inspections, and

investigations, and related activities under section 372 of this

title. The funds provided under such grants shall only be

available for the costs of conducting such examinations,

inspections, investigations, and related activities.

(b) Notices regarding adulterated imported food

The Secretary may make grants to the States for the purpose of

assisting the States with the costs of taking appropriate action to

protect the public health in response to notification under section

398 of this title, including planning and otherwise preparing to

take such action.

(c) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated $10,000,000 for fiscal year 2002, and

such sums as may be necessary for each of the fiscal years 2003

through 2006.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 909, as added Pub. L. 107-188, title

III, Sec. 311, June 12, 2002, 116 Stat. 673.)

-CITE-