dreamproit/uscode huggingface dataset:
21 U.S.C. § 360bbb–2 (FOOD AND DRUGS)
§ 360bbb–2. Classification of products
(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), the Secretary shall determine the classification of the product under subsection (a), 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), the recommendation made by the person under subsection (a) 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.
(June 25, 1938, ch. 675, § 563, as added Pub. L. 105–115, title IV, § 416, Nov. 21, 1997, 111 Stat. 2378.)
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. § 379b (FOOD AND DRUGS)
§ 379b. Consolidated administrative and laboratory facility
(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) 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.
(June 25, 1938, ch. 675, § 710, as added Pub. L. 101–635, title I, § 101, Nov. 28, 1990, 104 Stat. 4583.)
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). 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. § 379s (FOOD AND DRUGS)
§ 379s. Preemption for labeling or packaging of cosmetics
(a) In general
Except as provided in subsection (b), (d), or (e), 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), 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), 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. § 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).
(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. § 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) 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) 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.)
21 U.S.C. § 849 (FOOD AND DRUGS)
§ 849. Transportation safety offenses
(a) Definitions
In this section—
“safety rest area” means a roadside facility with parking facilities for the rest or other needs of motorists.
“truck stop” means a facility (including any parking lot appurtenant thereto) that—
(A) has the capacity to provide fuel or service, or both, to any commercial motor vehicle (as defined in section 31301 of title 49), operating in commerce (as defined in that section); and
(B) is located within 2,500 feet of the National System of Interstate and Defense Highways or the Federal-Aid Primary System.
(b) First offense
A person who violates section 841(a)(1) of this title or section 856 of this title by distributing or possessing with intent to distribute a controlled substance in or on, or within 1,000 feet of, a truck stop or safety rest area is (except as provided in subsection (b) 1) subject to—
(1) twice the maximum punishment authorized by section 841(b) of this title; and
(2) twice any term of supervised release authorized by section 841(b) of this title for a first offense.
(c) Subsequent offense
A person who violates section 841(a)(1) of this title or section 856 of this title by distributing or possessing with intent to distribute a controlled substance in or on, or within 1,000 feet of, a truck stop or a safety rest area after a prior conviction or convictions under subsection (a) 2 have become final is subject to—
(1) 3 times the maximum punishment authorized by section 841(b) of this title; and
(2) 3 times any term of supervised release authorized by section 841(b) of this title for a first offense.
(Pub. L. 91–513, title II, § 409, as added Pub. L. 103–322, title XVIII, § 180201(b)(1), Sept. 13, 1994, 108 Stat. 2046.)
heading: Prior Provisions
text: A prior section 849, Pub. L. 91–513, title II, § 409, Oct. 27, 1970, 84 Stat. 1266; Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat. 2095, related to dangerous special drug offender sentencing, prior to repeal by Pub. L. 98–473, title II, §§ 219(a), 235(a)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, eff. Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such repeal.
21 U.S.C. § 850 (FOOD AND DRUGS)
§ 850. Information for sentencing
Except as otherwise provided in this subchapter or section 242a(a) 1 of title 42, no limitation shall be placed on the information concerning the background, character, and conduct of a person convicted of an offense which a court of the United States may receive and consider for the purpose of imposing an appropriate sentence under this subchapter or subchapter II.
(Pub. L. 91–513, title II, § 410, Oct. 27, 1970, 84 Stat. 1269.)
heading: References in Text
text: Section 242a of title 42, referred to in text, was repealed by Pub. L. 106–310, div. B, title XXXII, § 3201(b)(1), Oct. 17, 2000, 114 Stat. 1190.
21 U.S.C. § 854 (FOOD AND DRUGS)
§ 854. Investment of illicit drug profits
(a) Prohibition
It shall be unlawful for any person who has received any income derived, directly or indirectly, from a violation of this subchapter or subchapter II punishable by imprisonment for more than one year in which such person has participated as a principal within the meaning of section 2 of title 18, to use or invest, directly or indirectly, any part of such income, or the proceeds of such income, in acquisition of any interest in, or the establishment or operation of, any enterprise which is engaged in, or the activities of which affect interstate or foreign commerce. A purchase of securities on the open market for purposes of investment, and without the intention of controlling or participating in the control of the issuer, or of assisting another to do so, shall not be unlawful under this section if the securities of the issuer held by the purchaser, the members of his immediate family, and his or their accomplices in any violation of this subchapter or subchapter II after such purchase do not amount in the aggregate to 1 per centum of the outstanding securities of any one class, and do not confer, either in law or in fact, the power to elect one or more directors of the issuer.
(b) Penalty
Whoever violates this section shall be fined not more than $50,000 or imprisoned not more than ten years, or both.
(c) “Enterprise” defined
As used in this section, the term “enterprise” includes any individual, partnership, corporation, association, or other legal entity, and any union or group of individuals associated in fact although not a legal entity.
(d) Construction
The provisions of this section shall be liberally construed to effectuate its remedial purposes.
(Pub. L. 91–513, title II, § 414, as added Pub. L. 98–473, title II, § 303, Oct. 12, 1984, 98 Stat. 2049.)
21 U.S.C. § 856 (FOOD AND DRUGS)
§ 856. Maintaining drug-involved premises
(a) Unlawful acts
Except as authorized by this subchapter, it shall be unlawful to—
(1) knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance;
(2) manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.
(b) Criminal penalties
Any person who violates subsection (a) of this section shall be sentenced to a term of imprisonment of not more than 20 years or a fine of not more than $500,000, or both, or a fine of $2,000,000 for a person other than an individual.
(c) Violation as offense against property
A violation of subsection (a) shall be considered an offense against property for purposes of section 3663A(c)(1)(A)(ii) of title 18.
(d) Civil penalties
(1) Any person who violates subsection (a) shall be subject to a civil penalty of not more than the greater of—
(A) $250,000; or
(B) 2 times the gross receipts, either known or estimated, that were derived from each violation that is attributable to the person.
(2) If a civil penalty is calculated under paragraph (1)(B), and there is more than 1 defendant, the court may apportion the penalty between multiple violators, but each violator shall be jointly and severally liable for the civil penalty under this subsection.
(e) Declaratory and injunctive remedies
Any person who violates subsection (a) shall be subject to declaratory and injunctive remedies as set forth in section 843(f) of this title.
(Pub. L. 91–513, title II, § 416, as added Pub. L. 99–570, title I, § 1841(a), Oct. 27, 1986, 100 Stat. 3207–52; amended Pub. L. 106–310, div. B, title XXXVI, § 3613(e), Oct. 17, 2000, 114 Stat. 1230; Pub. L. 108–21, title VI, § 608(b)(1), (2), (c), Apr. 30, 2003, 117 Stat. 691.)
heading: Amendments
text: 2003—Pub. L. 108–21, § 608(b)(2), substituted “Maintaining drug-involved premises” for “Establishment of manufacturing operations” in section catchline.
Subsec. (a)(1). Pub. L. 108–21, § 608(b)(1)(A), substituted “open, lease, rent, use, or maintain any place, whether permanently or temporarily,” for “open or maintain any place”.
Subsec. (a)(2). Pub. L. 108–21, § 608(b)(1)(B), added par. (2) and struck out former par. (2) which read as follows: “manage or control any building, room, or enclosure, either as an owner, lessee, agent, employee, or mortgagee, and knowingly and intentionally rent, lease, or make available for use, with or without compensation, the building, room, or enclosure for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.”
Subsecs. (d), (e). Pub. L. 108–21, § 608(c), added subsecs. (d) and (e).
2000—Subsec. (c). Pub. L. 106–310 added subsec. (c).
21 U.S.C. § 864 (FOOD AND DRUGS)
§ 864. Anhydrous ammonia
(a) It is unlawful for any person—
(1) to steal anhydrous ammonia, or
(2) to transport stolen anhydrous ammonia across State lines,
knowing, intending, or having reasonable cause to believe that such anhydrous ammonia will be used to manufacture a controlled substance in violation of this part.
(b) Any person who violates subsection (a) shall be imprisoned or fined, or both, in accordance with section 843(d) of this title as if such violation were a violation of a provision of section 843 of this title.
(Pub. L. 91–513, title II, § 423, as added Pub. L. 106–310, div. B, title XXXVI, § 3653(a), Oct. 17, 2000, 114 Stat. 1240.)