dreamproit/uscode huggingface dataset:
21 U.S.C. § 360n–1 (FOOD AND DRUGS)
§ 360n–1. Priority review for qualified infectious disease products
(a) In general
If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 355(b) of this title, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.
(b) Construction
Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 355(b) of this title that otherwise meets the criteria for the Secretary to grant priority review.
(June 25, 1938, ch. 675, § 524A, as added Pub. L. 112–144, title VIII, § 802(a), July 9, 2012, 126 Stat. 1079; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(N), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 117–328, div. FF, title III, § 3212(b), Dec. 29, 2022, 136 Stat. 5826.)
heading: Editorial Notes
heading: Amendments
text: 2022—Subsec. (a). Pub. L. 117–328 inserted “, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness” before period at end.
2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted “the first application” for “any application”, and added subsec. (b).
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Pub. L. 112–144, title VIII, § 802(b), July 9, 2012, 126 Stat. 1079, provided that: “Section 524A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–1], as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act [July 9, 2012].”
21 U.S.C. § 364b (FOOD AND DRUGS)
§ 364b. Good manufacturing practice
(a) In general
The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with section 361 of this title. Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph 1 during an inspection conducted under section 374 of this title.
(b) Considerations
In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.
(c) Timeframe
The Secretary shall publish a notice of proposed rulemaking not later than 2 years after December 29, 2022, and shall publish a final such rule not later than 3 years after December 29, 2022.
(June 25, 1938, ch. 675, § 606, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5850.)
heading: Statutory Notes and Related Subsidiaries
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 364d (FOOD AND DRUGS)
§ 364d. Safety substantiation
(a) Substantiation of safety
A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
(b) Coal-tar hair dye
Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title. A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
(c) Definitions
For purposes of this section:
(1) Adequate substantiation of safety
The term “adequate substantiation of safety” means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
(2) Safe
The term “safe” means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.
(June 25, 1938, ch. 675, § 608, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5854.)
heading: Statutory Notes and Related Subsidiaries
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
heading: Talc-Containing Cosmetics
text: Pub. L. 117–328, div. FF, title III, § 3505, Dec. 29, 2022, 136 Stat. 5859, provided that:
“The Secretary of Health and Human Services—
“(1) not later than one year after the date of enactment of this Act [Dec. 29, 2022], shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and
“(2) not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.”
21 U.S.C. § 364e (FOOD AND DRUGS)
§ 364e. Labeling
(a) General requirement
Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
(b) Fragrance allergens
The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
(c) Cosmetic products for professional use
(1) Definition of professional
For purposes of this subsection, the term “professional” means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.
(2) Professional use labeling
A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—
(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and
(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15.
(June 25, 1938, ch. 675, § 609, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5854.)
heading: Delayed Effective Date of Subsection (a)
text: For delayed effective date of subsection (a) of this section, see Effective Date of 2022 Amendment note below.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 2022 Amendment
text: Pub. L. 117–328, div. FF, title III, § 3503(b)(2), Dec. 29, 2022, 136 Stat. 5859, provided that: “Section 609(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 364e(a)], as added by section 802 [probably should be “section 3502”], shall take effect on the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022].”
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 364f (FOOD AND DRUGS)
§ 364f. Records
(a) In general
If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
(b) Rule of construction
Nothing in this section shall be construed to limit the authority of the Secretary to inspect records or require establishment and maintenance of records under any other provision of this chapter, including section 364a or 364b of this title.
(June 25, 1938, ch. 675, § 610, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)
heading: Statutory Notes and Related Subsidiaries
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 364h (FOOD AND DRUGS)
§ 364h. Small businesses
(a) In general
Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
(b) Requirements applicable to all manufacturers and processors of cosmetics
The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:
(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
(2) Cosmetic products that are injected.
(3) Cosmetic products that are intended for internal use.
(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
(June 25, 1938, ch. 675, § 612, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)
heading: Statutory Notes and Related Subsidiaries
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 364i (FOOD AND DRUGS)
§ 364i. Exemption for certain products and facilities
(a) In general
Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.
(b) Exception
A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.
(June 25, 1938, ch. 675, § 613, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)
heading: Statutory Notes and Related Subsidiaries
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 364j (FOOD AND DRUGS)
§ 364j. Preemption
(a) In general
No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this subchapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.
(b) Limitation
Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in a cosmetic product.
(c) Savings
Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law.
(d) Rule of construction
Nothing in this section shall be construed to amend, expand, or limit the provisions under section 379s of this title.
(June 25, 1938, ch. 675, § 614, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)
heading: Editorial Notes
heading: References in Text
text: The amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, referred to in subsecs. (b) and (c), means the amendments made by subtitle E (§§ 3501–3508) of title III of div. FF of Pub. L. 117–328, which enacted this section and sections 364 to 364i of this title and amended sections 331, 361, 362, 374, and 381 of this title.
The time of enactment of the Modernization of Cosmetics Regulation Act of 2022, referred to in subsec. (b), probably means the date of enactment of subtitle E (§§ 3501–3508) of title III of div. FF of Pub. L. 117–328, which was approved Dec. 29, 2022.
heading: Statutory Notes and Related Subsidiaries
heading: Construction; Confidentiality
text: Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 384e (FOOD AND DRUGS)
§ 384e. Recognition of foreign government inspections
(a) Inspection
The Secretary—
(1) may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under section 360(i) of this title in order to facilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of section 360(h) of this title;
(2) may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conducting inspections that meet the applicable requirements of this chapter; and
(3) shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter.
(b) Results of inspection
The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—
(1) evidence of compliance with section 351(a)(2)(B) of this title or section 381(r) of this title; and
(2) for any other purposes as determined appropriate by the Secretary.
(c) Periodic review
(1) In general
Beginning not later than 1 year after December 29, 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate.
(2) Reports to Congress
Beginning not later than 4 years after December 29, 2022, and every 4 years thereafter, 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 describing the findings and conclusions of each review conducted under paragraph (1).
(June 25, 1938, ch. 675, § 809, as added Pub. L. 112–144, title VII, § 712, July 9, 2012, 126 Stat. 1072; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(X), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title VII, § 701(b), Aug. 18, 2017, 131 Stat. 1055; Pub. L. 117–328, div. FF, title III, § 3613(c), Dec. 29, 2022, 136 Stat. 5872.)
heading: Editorial Notes
heading: Amendments
text: 2022—Subsec. (a)(1). Pub. L. 117–328, § 3613(c)(1), inserted “preapproval or” before “risk-based inspections”.
Subsec. (c). Pub. L. 117–328, § 3613(c)(2), added subsec. (c).
2017—Subsec. (a)(1). Pub. L. 115–52 substituted “paragraph (2) or (3) of section 360(h)” for “section 360(h)(3)”.
2016—Subsec. (a)(2). Pub. L. 114–255 substituted “conducting” for “conduction”.
22 U.S.C. § 284dd (FOREIGN RELATIONS AND INTERCOURSE)
§ 284dd. Twentieth replenishment
(a) In general
The United States Governor of the International Development Association is authorized to contribute on behalf of the United States $3,500,000,000 to the twentieth replenishment of the resources of the Association, subject to obtaining the necessary appropriations.
(b) Authorization of appropriations
In order to pay for the United States contribution provided for in subsection (a), there are authorized to be appropriated, without fiscal year limitation, $3,500,000,000 for payment by the Secretary of the Treasury.
(Pub. L. 86–565, § 32, as added Pub. L. 117–328, div. K, title VII, § 7072(a), Dec. 29, 2022, 136 Stat. 5091.)
22 U.S.C. § 285hh (FOREIGN RELATIONS AND INTERCOURSE)
§ 285hh. Twelfth replenishment
(a) The United States Governor of the Bank is authorized to contribute, on behalf of the United States, $177,440,000 to the twelfth replenishment of the resources of the Fund, subject to obtaining the necessary appropriations.
(b) In order to pay for the United States contribution provided for in subsection (a), there are authorized to be appropriated, without fiscal year limitation, $177,440,000 for payment by the Secretary of the Treasury.
(Pub. L. 89–369, § 37, as added Pub. L. 117–328, div. K, title VII, § 7072(b), Dec. 29, 2022, 136 Stat. 5092.)