dreamproit/uscode huggingface dataset:
21 U.S.C. § 387l (FOOD AND DRUGS)
§ 387l. Judicial review
(a) Right to review
(1) In general
Not later than 30 days after—
(A) the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or
(B) a denial of an application under section 387j(c) of this title,
any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.
(2) Requirements
(A) Copy of petition
A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary.
(B) Record of proceedings
On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—
(i) the record of the proceedings on which the regulation or order was based; and
(ii) a statement of the reasons for the issuance of such a regulation or order.
(C) Definition of record
In this section, the term “record” means—
(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;
(ii) all information submitted to the Secretary with respect to such regulation or order;
(iii) proceedings of any panel or advisory committee with respect to such regulation or order;
(iv) any hearing held with respect to such regulation or order; and
(v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.
(b) Standard of review
Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with section 706(2)(A) of title 5.
(c) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any regulation or order 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.
(d) Other remedies
The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law.
(e) Regulations and orders must recite basis in record
To facilitate judicial review, a regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p of this title shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.
(June 25, 1938, ch. 675, § 912, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1819.)
21 U.S.C. § 387m (FOOD AND DRUGS)
§ 387m. Equal treatment of retail outlets
The Secretary shall issue regulations to require that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restrictions applicable to retail establishments accessible to individuals under the age of 18.
(June 25, 1938, ch. 675, § 913, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.)
21 U.S.C. § 387n (FOOD AND DRUGS)
§ 387n. Jurisdiction of and coordination with the Federal Trade Commission
(a) Jurisdiction
(1) In general
Except where expressly provided in this subchapter, nothing in this subchapter shall be construed as limiting or diminishing the authority of the Federal Trade Commission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products.
(2) Enforcement
Any advertising that violates this subchapter or a provision of the regulations referred to in section 387a–1 of this title, is an unfair or deceptive act or practice under section 45(a) of title 15 and shall be considered a violation of a rule promulgated under section 57a of title 15.
(b) Coordination
With respect to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act [15 U.S.C. 1333] and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 [15 U.S.C. 4402]—
(1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and
(2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections.
(June 25, 1938, ch. 675, § 914, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.)
heading: References in Text
text: The Federal Cigarette Labeling and Advertising Act, referred to in subsec. (b), is Pub. L. 89–92, July 27, 1965, 79 Stat. 282, which is classified generally to chapter 36 (§ 1331 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 1331 of Title 15 and Tables.
The Comprehensive Smokeless Tobacco Health Education Act of 1986, referred to in subsec. (b), is Pub. L. 99–252, Feb. 27, 1986, 100 Stat. 30, which is classified principally to chapter 70 (§ 4401 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 4401 of Title 15 and Tables.
21 U.S.C. § 387p (FOOD AND DRUGS)
§ 387p. Preservation of State and local authority
(a) In general
(1) Preservation
Except as provided in paragraph (2)(A), nothing in this subchapter, or rules promulgated under this subchapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this subchapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this subchapter shall limit or otherwise affect any State, tribal, or local taxation of tobacco products.
(2) Preemption of certain State and local requirements
(A) In general
No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products.
(B) Exception
Subparagraph (A) does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under subparagraph (A) that is exempt from disclosure under section 552(b)(4) of title 5 shall be treated as a trade secret and confidential information by the State.
(b) Rule of construction regarding product liability
No provision of this subchapter relating to a tobacco product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.
(June 25, 1938, ch. 675, § 916, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1823.)
21 U.S.C. § 387r (FOOD AND DRUGS)
§ 387r. Drug products used to treat tobacco dependence
(a) In general
The Secretary shall—
(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title;
(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and
(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.
(b) Report on innovative products
(1) In general
Not later than 3 years after June 22, 2009, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health—
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with continued tobacco use.
(2) Recommendations
The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.
(June 25, 1938, ch. 675, § 918, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1825.)
heading: Modification of Deadlines for Secretarial Action
text: With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.
21 U.S.C. § 391 (FOOD AND DRUGS)
§ 391. Separability clause
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.
(June 25, 1938, ch. 675, § 1001, formerly § 901, 52 Stat. 1059; renumbered § 1001, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 393a (FOOD AND DRUGS)
§ 393a. Office of Pediatric Therapeutics
(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, including increasing pediatric access to medical devices.
(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;
(2) subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under section 355a of this title or an assessment under section 355c of this title;
(3) one or more additional individuals with expertise in pediatric epidemiology; and
(4) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b) of this section.
(d) Neonatology expertise
For the 5-year period beginning on July 9, 2012, at least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
(Pub. L. 107–109, § 6, Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, § 306(a), Sept. 27, 2007, 121 Stat. 864; Pub. L. 112–144, title V, § 511, July 9, 2012, 126 Stat. 1050.)
heading: Codification
text: 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.
heading: Amendments
text: 2012—Subsec. (c)(2) to (4). Pub. L. 112–144, § 511(1), added pars. (2) and (3) and redesignated former par. (2) as (4).
Subsec. (d). Pub. L. 112–144, § 511(2), added subsec. (d).
2007—Subsec. (b). Pub. L. 110–85 inserted “, including increasing pediatric access to medical devices” before period at end.
21 U.S.C. § 394 (FOOD AND DRUGS)
§ 394. Scientific review groups
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.
(June 25, 1938, ch. 675, § 1004, formerly § 903, as added Pub. L. 101–635, title III, § 301, Nov. 28, 1990, 104 Stat. 4584; renumbered § 904, Pub. L. 103–43, title XX, § 2006(1), June 10, 1993, 107 Stat. 209; renumbered § 1004, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 395 (FOOD AND DRUGS)
§ 395. Loan repayment program
(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.
(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.)
heading: References in Text
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 [§ 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.
21 U.S.C. § 396 (FOOD AND DRUGS)
§ 396. Practice of medicine
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.
(June 25, 1938, ch. 675, § 1006, formerly § 906, as added Pub. L. 105–115, title II, § 214, Nov. 21, 1997, 111 Stat. 2348; renumbered § 1006, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
heading: Effective Date
text: 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.
21 U.S.C. § 397 (FOOD AND DRUGS)
§ 397. Contracts for expert review
(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.).
(June 25, 1938, ch. 675, § 1007, formerly § 907, as added Pub. L. 105–115, title IV, § 415, Nov. 21, 1997, 111 Stat. 2377; renumbered § 1007, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
heading: References in Text
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 (§ 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.
heading: Effective Date
text: 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.
21 U.S.C. § 398 (FOOD AND DRUGS)
§ 398. Notices to States regarding imported food
(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.
(June 25, 1938, ch. 675, § 1008, formerly § 908, as added Pub. L. 107–188, title III, § 310, June 12, 2002, 116 Stat. 673; renumbered § 1008, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)