dreamproit/uscode huggingface dataset:
21 U.S.C. § 379d–5 (FOOD AND DRUGS)
§ 379d–5. Guidance document regarding product promotion using the Internet
Not later than 2 years after July 9, 2012, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.
(Pub. L. 112–144, title XI, § 1121, July 9, 2012, 126 Stat. 1112.)
heading: Codification
text: Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 379f (FOOD AND DRUGS)
§ 379f. Recovery and retention of fees for freedom of information requests
(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.
(June 25, 1938, ch. 675, § 731, formerly § 711, as added Pub. L. 101–635, title II, § 201, Nov. 28, 1990, 104 Stat. 4584; renumbered § 731, Pub. L. 102–571, title I, § 106(6), Oct. 29, 1992, 106 Stat. 4499.)
heading: Codification
text: Section was formerly classified to section 379c of this title prior to renumbering by Pub. L. 102–571.
21 U.S.C. § 379k (FOOD AND DRUGS)
§ 379k. Information system
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.
(June 25, 1938, ch. 675, § 745, formerly § 741, as added Pub. L. 105–115, title IV, § 407(a), Nov. 21, 1997, 111 Stat. 2370; renumbered § 745, Pub. L. 110–316, title II, § 202(a), Aug. 14, 2008, 122 Stat. 3515.)
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.
heading: Report on Status of System
text: Pub. L. 105–115, title IV, § 407(b), Nov. 21, 1997, 111 Stat. 2370, 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.
21 U.S.C. § 379k–1 (FOOD AND DRUGS)
§ 379k–1. Electronic format for submissions
(a) Drugs and biologics
(1) In general
Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.
(2) Guidance contents
In the guidance under paragraph (1), the Secretary may—
(A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and
(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
(3) Exception
This subsection shall not apply to submissions described in section 360bbb of this title.
(b) Devices
(1) In general
Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.
(2) Guidance contents
In the guidance under paragraph (1), the Secretary may—
(A) provide standards for the electronic copy required under such paragraph; and
(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
(June 25, 1938, ch. 675, § 745A, as added Pub. L. 112–144, title XI, § 1136, July 9, 2012, 126 Stat. 1123.)
21 U.S.C. § 379l (FOOD AND DRUGS)
§ 379l. Education
(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. Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.
(June 25, 1938, ch. 675, § 746, formerly § 742, as added Pub. L. 105–115, title IV, § 408(a), Nov. 21, 1997, 111 Stat. 2371; amended Pub. L. 110–85, title VI, § 601(c), Sept. 27, 2007, 121 Stat. 897; renumbered § 746, Pub. L. 110–316, title II, § 202(a), Aug. 14, 2008, 122 Stat. 3515.)
heading: Prior Provisions
text: A prior section 746 of act June 25, 1938, was renumbered section 749 and is classified to section 379o of this title.
heading: Amendments
text: 2007—Subsec. (b). Pub. L. 110–85 inserted at end “Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.”
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. § 379o (FOOD AND DRUGS)
§ 379o. Environmental impact
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.
(June 25, 1938, ch. 675, § 749, formerly § 746, as added Pub. L. 105–115, title IV, § 411, Nov. 21, 1997, 111 Stat. 2373; renumbered § 749, Pub. L. 110–316, title II, § 202(a), Aug. 14, 2008, 122 Stat. 3515.)
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. § 379s (FOOD AND DRUGS)
§ 379s. Preemption for labeling or packaging of cosmetics
(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.
(June 25, 1938, ch. 675, § 752, as added Pub. L. 105–115, title IV, § 412(d), Nov. 21, 1997, 111 Stat. 2376.)
heading: References in Text
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 (§ 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 (§ 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.
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. § 379v (FOOD AND DRUGS)
§ 379v. Safety report disclaimers
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.
(June 25, 1938, ch. 675, § 756, as added Pub. L. 105–115, title IV, § 420, Nov. 21, 1997, 111 Stat. 2379.)
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. § 379dd–1 (FOOD AND DRUGS)
§ 379dd–1. Location of Foundation
The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.
(June 25, 1938, ch. 675, § 771, as added Pub. L. 110–85, title VI, § 601(b), Sept. 27, 2007, 121 Stat. 897.)
21 U.S.C. § 379dd–2 (FOOD AND DRUGS)
§ 379dd–2. Activities of the Food and Drug Administration
(a) In general
The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under section 379dd(l)(2) of this title.
(b) Report to Congress
Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under section 379dd(l)(2) of this title and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration.
(c) Extramural grants
The provisions of this part and section 360bbb–5 of this title shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity entered into before, on, or after September 27, 2007.
(June 25, 1938, ch. 675, § 772, as added Pub. L. 110–85, title VI, § 601(b), Sept. 27, 2007, 121 Stat. 897.)
21 U.S.C. § 384c (FOOD AND DRUGS)
§ 384c. Inspection of foreign food facilities
(a) Inspection
The Secretary—
(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 350d of this title; and
(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.
(b) Effect of inability to inspect
Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the Secretary and the foreign factory, warehouse, or other establishment.
(June 25, 1938, ch. 675, § 807, as added Pub. L. 111–353, title III, § 306(a), Jan. 4, 2011, 124 Stat. 3958.)
heading: Construction
text: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 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 risk-based inspections in accordance with the schedule established in section 360(h)(3) 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 conduction 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.
(June 25, 1938, ch. 675, § 809, as added Pub. L. 112–144, title VII, § 712, July 9, 2012, 126 Stat. 1072.)
21 U.S.C. § 387b (FOOD AND DRUGS)
§ 387b. Adulterated tobacco products
A tobacco product shall be deemed to be adulterated if—
(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;
(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;
(5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;
(6)
(A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or
(B) it is in violation of an order under section 387j(c)(1)(A) of this title;
(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or
(8) it is in violation of section 387k of this title.
(June 25, 1938, ch. 675, § 902, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1787.)
heading: Prior Provisions
text: A prior section 902 of act June 25, 1938, was renumbered section 1002. Subsec. (a) of section 1002 is set out as a note under section 301 of this title. Subsecs. (b) and (c) of section 1002 are classified to section 392 of this title. Subsec. (d) of section 1002 is set out as a note under section 392 of this title.
21 U.S.C. § 387f–1 (FOOD AND DRUGS)
§ 387f–1. Enforcement action plan for advertising and promotion restrictions
(a) Action plan
(1) Development
Not later than 6 months after June 22, 2009, the Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall develop and publish an action plan to enforce restrictions adopted pursuant to section 387f of this title, as added by section 101(b) of this division, or pursuant to section 387a–1(a) of this title, on promotion and advertising of menthol and other cigarettes to youth.
(2) Consultation
The action plan required by paragraph (1) shall be developed in consultation with public health organizations and other stakeholders with demonstrated expertise and experience in serving minority communities.
(3) Priority
The action plan required by paragraph (1) shall include provisions designed to ensure enforcement of the restrictions described in paragraph (1) in minority communities.
(b) State and local activities
(1) Information on authority
Not later than 3 months after June 22, 2009, the Secretary shall inform State, local, and tribal governments of the authority provided to such entities under section 1334(c) of title 15, as added by section 203 of this division, or preserved by such entities under section 387p of this title, as added by section 101(b) of this division.
(2) Community assistance
At the request of communities seeking assistance to prevent underage tobacco use, the Secretary shall provide such assistance, including assistance with strategies to address the prevention of underage tobacco use in communities with a disproportionate use of menthol cigarettes by minors.
(Pub. L. 111–31, div. A, title I, § 105, June 22, 2009, 123 Stat. 1841.)
heading: Codification
text: Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
heading: Modification of Deadlines for Secretarial Action
text: With respect to any time periods specified in 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.