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21 U.S.C. § 397 — Contracts for expert review
Federal law — U.S. Code and appendices · legal_authorities
**(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)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)) with respect to a biological product. Any such contract shall be subject to the requirements of [section 379 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379&num=0&edition=prelim) 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 technol
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Source location: Title 21, Chapter 9, § 397; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)) with respect to a biological product. Any such contract shall be subject to the requirements of [section 379 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379&num=0&edition=prelim) 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) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.).
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Contractors** The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) 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.
**(b) Ability to receive and protect confidential information obtained from foreign governments**
(1) **In general** — The Secretary shall not be required to disclose under [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) (commonly referred to as the “Freedom of Information Act”), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—
(A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;
(B) the information is provided or made available to the United States Government voluntarily on the c
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Federal law — U.S. Code and appendices · legal_authorities
Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Special rules**
(A) *Special rule for cigarettes* — Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this subparagraph.
(B) *Additional special rule* — Beginning 2 years after June 22, 2009, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
(2) **Revision of tobacco product standards** — The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (c).
(3) **Tobacco product standards**
(A) *In general* — The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health.
(B) *Determinations*
(i) *Considerations* — In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning—
(I) the risks and benefits to the population as a whole,
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387g
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Federal law — U.S. Code and appendices · legal_authorities
Page 707
TITLE 21—FOOD AND DRUGS
§ 397
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 agree-
ment with a health professional pursuant to
paragraph (1) unless such professional—
(A) has a substantial amount of edu-
cational 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 in-
consistent with subsection (a) of this section,
apply to the program established in such sub-
section in the same manner and to the same ex-
tent 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.
(June 25, 1938, ch. 675, § 1005, formerly § 905, as
added Pub. L. 103–43, title XX, § 2006(2), June 10,
1993, 107 Stat. 210; renumbered § 1005, Pub. L.
111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123
Stat. 1784.)
Editorial Notes
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsec.
(b), is act July 1, 1944, ch. 373, 58 Stat. 682. Subpart III
of part D of title III of the Act is classified generally
to subpart III [§ 254l et seq.] of part D of subchapter II
of chapter 6A of Title 42, The Public Health and Wel-
fare. For complete class
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 397
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 35
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 201
1 See References in Text note below.
Sec.
300jj–34.
Competitive grants to States and Indian
tribes for the development of loan pro-
grams to facilitate the widespread
adoption of certified EHR technology.
300jj–35.
Demonstration program to integrate in-
formation
technology
into
clinical
education.
300jj–36.
Information technology professionals in
health care.
300jj–37.
General grant and loan provisions.
300jj–38.
Authorization for appropriations.
PART C—OTHER PROVISIONS
300jj–51.
Health information technology enroll-
ment standards and protocols.
300jj–52.
Information blocking.
SUBCHAPTER XXIX—DATA COLLECTION,
ANALYSIS, AND QUALITY
300kk.
Data collection, analysis, and quality.
SUBCHAPTER XXX—COMMUNITY LIVING
ASSISTANCE SERVICES AND SUPPORTS
300ll to 300ll–9. Repealed.
SUBCHAPTER XXXI—WORLD TRADE CENTER
HEALTH PROGRAM
PART A—ESTABLISHMENT OF PROGRAM; ADVISORY
COMMITTEE
300mm.
Establishment of World Trade Center
Health Program.
300mm–1.
WTC Health Program Scientific/Tech-
nical
Advisory
Committee;
WTC
Health Program Steering Committees.
300mm–2.
Education and outreach.
300mm–3.
Uniform data collection and analysis.
300mm–4.
Clinical Centers of Excellence and Data
Centers.
300mm–5.
Definitions.
PART B—PROGRAM OF MONITORING, INITIAL HEALTH
EVALUATIONS, AND TREATMENT
SUBPART 1—WTC RESPONDERS
300mm–21.
Identification of WTC responders and
provision of WTC-related monitoring
services.
300mm–22.
Treatment of enrolled WTC responders
for WTC-related health conditions.
300mm–23.
National arrangement for benefits for el-
igible individuals outside New York.
SUBPART 2—WTC SURVIVORS
300mm–31.
Identification and initial health evalua-
tion of screening-eligible and
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
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Federal law — U.S. Code and appendices · legal_authorities
Page 456
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 258a
§ 258a. Transferred
Editorial Notes
CODIFICATION
Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat.
269, which related to transfer of balances in working
capital fund, narcotic hospitals, to surplus fund, was
transferred and is set out as a note under section 290aa
of this title.
§§ 259 to 261a. Repealed. Pub. L. 106–310, div. B,
title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat.
1221, as amended by Pub. L. 114–198, title I,
§ 110(b), July 22, 2016, 130 Stat. 710
Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58
Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct.
27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86
Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98
Stat. 2031, related to convict addicts or other persons
with drug abuse or drug dependence problems.
Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58
Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24,
1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513,
title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re-
lated to addicts and persons with drug abuse or drug
dependence problems.
Section 260a, act July 1, 1944, ch. 373, title III, § 345, as
added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July
24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L.
91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re-
lated to admission of addicts committed from District
of Columbia.
Section 261, acts July 1, 1944, ch. 373, title III, § 346,
formerly § 345, 58 Stat. 701; renumbered § 346, May 8,
1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513,
title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262
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