dreamproit/uscode huggingface dataset:
21 U.S.C. § 399a (FOOD AND DRUGS)
§ 399a. Office of the Chief Scientist
(a) Establishment; appointment
The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.
(b) Duties of the Office
The Office of the Chief Scientist shall—
(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;
(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;
(3) develop and advocate for a budget to support intramural research;
(4) develop a peer review process by which intramural research can be evaluated;
(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—
(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and
(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and
(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.
(June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 399b (FOOD AND DRUGS)
§ 399b. Office of Women’s Health
(a) Establishment
There is established within the Office of the Commissioner, an office to be known as the Office of Women’s Health (referred to in this section as the “Office”). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.
(b) Purpose
The Director of the Office shall—
(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the “Administration”) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;
(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women’s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;
(3) provide information to women and health care providers on those areas in which differences between men and women exist;
(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women’s issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;
(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and
(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of title 42).
(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 2010 through 2014.
(June 25, 1938, ch. 675, § 1011, as added Pub. L. 111–148, title III, § 3509(g), Mar. 23, 2010, 124 Stat. 536.)
heading: Codification
text: Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, § 209(a), Jan. 4, 2011, 124 Stat. 3945, and is classified to section 399c of this title.
21 U.S.C. § 399f (FOOD AND DRUGS)
§ 399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
(a) Communication plan
The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall review and modify, as necessary, the Food and Drug Administration’s communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.
(b) Content
The communication plan described under subsection (a)—
(1) shall take into account—
(A) the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the Department of Health and Human Services;
(B) the nature of the medical product; and
(C) health and disease information available from other agencies within such Department, as well as any new means of communicating health and safety benefits and risks related to medical products;
(2) taking into account the nature of the medical product, shall address the best strategy for communicating safety alerts, labeled indications for the medical products, changes to the label or labeling of medical products (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and
(3) shall include a process for implementation of any improvements or other modifications determined to be necessary.
(c) Issuance and posting of communication plan
(1) Communication plan
Not later than 1 year after July 9, 2012, the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section.
(2) Posting of communication plan on the office of minority health web site
The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan.
(Pub. L. 112–144, title XI, § 1138, July 9, 2012, 126 Stat. 1125.)
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. § 452 (FOOD AND DRUGS)
§ 452. Congressional declaration of policy
It is hereby declared to be the policy of the Congress to provide for the inspection of poultry and poultry products and otherwise regulate the processing and distribution of such articles as hereinafter prescribed to prevent the movement or sale in interstate or foreign commerce of, or the burdening of such commerce by, poultry products which are adulterated or misbranded. It is the intent of Congress that when poultry and poultry products are condemned because of disease, the reason for condemnation in such instances shall be supported by scientific fact, information, or criteria, and such condemnation under this chapter shall be achieved through uniform inspection standards and uniform applications thereof.
(Pub. L. 85–172, § 3, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90–492, § 3, Aug. 18, 1968, 82 Stat. 792.)
heading: Amendments
text: 1968—Pub. L. 90–492 inserted provisions declaring the policy of Congress to be to otherwise regulate the processing and distribution of poultry and poultry products as hereinafter prescribed so as to prevent the movement or sale in interstate commerce of, or the burdening of such commerce by poultry products which are adulterated or misbranded, and provisions that declared the policy of Congress to be that condemnation of diseased poultry and poultry products shall be achieved through uniform inspection standards and supported by scientific fact or criteria, and struck out provisions that declared the policy of Congress to be to provide for inspection by the inspection service to prevent the movement in interstate commerce or foreign commerce or in a designated major consuming area of poultry products which are un­wholesome, adulterated, or otherwise unfit for human food.
heading: Effective Date of 1968 Amendment
text: Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 456 (FOOD AND DRUGS)
§ 456. Operation of premises, facilities and equipment
(a) Sanitary practices
Each official establishment slaughtering poultry or processing poultry products for commerce or otherwise subject to inspection under this chapter shall have such premises, facilities, and equipment, and be operated in accordance with such sanitary practices, as are required by regulations promulgated by the Secretary for the purpose of preventing the entry into or flow or movement in commerce or burdensome effect upon commerce, of poultry products which are adulterated.
(b) Refusal of inspection
The Secretary shall refuse to render inspection to any establishment whose premises, facilities, or equipment, or the operation thereof, fail to meet the requirements of this section.
(Pub. L. 85–172, § 7, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90–492, § 7, Aug. 18, 1968, 82 Stat. 799.)
heading: Amendments
text: 1968—Par. (a). Pub. L. 90–492 substituted “otherwise subject to inspection under this chapter” for “in or for marketing in a designated major consuming area”, “burdensome effect upon commerce” for “in a designated major consuming area”, and “which are adulterated” for “which are unwholesome or adulterated”.
heading: Effective Date of 1968 Amendment
text: Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 459 (FOOD AND DRUGS)
§ 459. Compliance by all establishments
(a) In general
No establishment processing poultry or poultry products for commerce otherwise subject to this chapter shall process any poultry or poultry product except in compliance with the requirements of this chapter.
(b) Notification
Any establishment subject to inspection under this chapter that believes, or has reason to believe, that an adulterated or misbranded poultry or poultry product received by or originating from the establishment has entered into commerce shall promptly notify the Secretary with regard to the type, amount, origin, and destination of the poultry or poultry product.
(c) Plans and reassessments
The Secretary shall require that each establishment subject to inspection under this chapter shall, at a minimum—
(1) prepare and maintain current procedures for the recall of all poultry or poultry products produced and shipped by the establishment;
(2) document each reassessment of the process control plans of the establishment; and
(3) upon request, make the procedures and reassessed process control plans available to inspectors appointed by the Secretary for review and copying.
(Pub. L. 85–172, § 10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, § 10, Aug. 18, 1968, 82 Stat. 801; Pub. L. 110–234, title XI, § 11017(b), May 22, 2008, 122 Stat. 1370; Pub. L. 110–246, § 4(a), title XI, § 11017(b), June 18, 2008, 122 Stat. 1664, 2132.)
heading: Codification
text: Pub. L. 110–234 and Pub. L. 110–246 made identical amendments to this section. The amendments by Pub. L. 110–234 were repealed by section 4(a) of Pub. L. 110–246.
heading: Amendments
text: 2008—Pub. L. 110–246, § 11017(b), inserted section catchline, designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).
1968—Pub. L. 90–492 substituted “otherwise subject to this chapter” for “in or for marketing in a designated major consuming area”.
heading: Effective Date of 2008 Amendment
text: Amendment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture.
heading: Effective Date of 1968 Amendment
text: Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 462 (FOOD AND DRUGS)
§ 462. Reporting of violations; notice; opportunity to present views
Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to pre­sent his views orally or in writing with regard to such contemplated proceeding. Nothing in this chapter shall be construed as requiring the Secretary to report for criminal prosecution violations of this chapter whenever he believes that the public interest will be adequately served and compliance with the chapter obtained by a suitable written notice or warning.
(Pub. L. 85–172, § 13, Aug. 28, 1957, 71 Stat. 447.)
21 U.S.C. § 463 (FOOD AND DRUGS)
§ 463. Rules and regulations
(a) Storage and handling of poultry products; violation of regulations
The Secretary may by regulations prescribe conditions under which poultry products capable of use as human food, shall be stored or otherwise handled by any person engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, or importing, such articles, whenever the Secretary deems such action necessary to assure that such articles will not be adulterated or misbranded when delivered to the consumer. Violation of any such regulation is prohibited.
(b) Other necessary rules and regulations
The Secretary shall promulgate such other rules and regulations as are necessary to carry out the provisions of this chapter.
(c) Oral presentation of views
In applying the provisions of section 553(c) of title 5 to proposed rule making under this chapter, an opportunity for the oral presentation of views shall be accorded all interested persons.
(Pub. L. 85–172, § 14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, § 13, Aug. 18, 1968, 82 Stat. 803.)
heading: Amendments
text: 1968—Pub. L. 90–492 designated existing provisions as par. (b), added pars. (a) and (c), and in par. (b), as so designated, substituted “such other rules” for “such rules”.
heading: Effective Date of 1968 Amendment
text: Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 465 (FOOD AND DRUGS)
§ 465. Limitations upon entry of poultry products and other materials into official establishments
The Secretary may limit the entry of poultry products and other materials into any official establishment, under such conditions as he may prescribe to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this chapter.
(Pub. L. 85–172, § 16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90–492, § 15, Aug. 18, 1968, 82 Stat. 805.)
heading: Amendments
text: 1968—Pub. L. 90–492 substituted provisions authorizing the Secretary to limit the entry of poultry products and other materials into any official establishment for provisions that any person distributing unwholesome or adulterated exempted poultry or poultry products intended for human consumption shall be guilty of a misdemeanor and subject to penalties upon conviction thereof.
heading: Effective Date of 1968 Amendment
text: Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 467a (FOOD AND DRUGS)
§ 467a. Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks
Whenever any poultry product, or any product exempted from the definition of a poultry product, or any dead, dying, disabled, or diseased poultry is found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in, commerce or otherwise subject to this chapter, and there is reason to believe that any such article is adulterated or misbranded and is capable of use as human food, or that it has not been inspected, in violation of the provisions of this chapter or of any other Federal law or the laws of any State or Territory, or the District of Columbia, or that it has been or is intended to be, distributed in violation of any such provisions, it may be detained by such representative for a period not to exceed twenty days, pending action under section 467b of this title or notification of any Federal, State, or other governmental authorities having jurisdiction over such article or poultry, and shall not be moved by any person, from the place at which it is located when so detained, until released by such representative. All official marks may be required by such representative to be removed from such article or poultry before it is released unless it appears to the satisfaction of the Secretary that the article or poultry is eligible to retain such marks.
(Pub. L. 85–172, § 19, as added Pub. L. 90–492, § 17, Aug. 18, 1968, 82 Stat. 805.)
21 U.S.C. § 467c (FOOD AND DRUGS)
§ 467c. Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas
The United States district courts, the District Court of Guam, the District Court of the Virgin Islands, the highest court of American Samoa, and the United States courts of the other territories, are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of, this chapter, and shall have jurisdiction in all other kinds of cases arising under this chapter, except as provided in section 457(d) or 467 of this title. All proceedings for the enforcement or to restrain violations of this chapter shall be by and in the name of the United States. Subpenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any such proceeding.
(Pub. L. 85–172, § 21, as added Pub. L. 90–492, § 17, Aug. 18, 1968, 82 Stat. 806.)
21 U.S.C. § 467d (FOOD AND DRUGS)
§ 467d. Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts
For the efficient administration and enforcement of this chapter, the provision (including penalties) of sections 46, 48, 49 and 50 of title 15 (except paragraphs (c) through (h) of section 46 and the last paragraph of section 49 1 of title 15), and the provisions of section 409(l) 1 of title 47, are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of title 15 on the district courts of the United States may be exercised for the purposes of this chapter by any court designated in section 467c of this title.
(Pub. L. 85–172, § 22, as added Pub. L. 90–492, § 17, Aug. 18, 1968, 82 Stat. 807.)
heading: References in Text
text: The last paragraph of section 49 of title 15, and the provisions of section 409(l) of title 47, referred to in text, which related to immunity of witnesses, were repealed by sections 211 and 242, respectively, of Pub. L. 91–452, Oct. 15, 1970, title II, 84 Stat. 929, 930. For provisions relating to immunity of witnesses, see section 6001 et seq. of Title 18, Crimes and Criminal Procedure.
21 U.S.C. § 467e (FOOD AND DRUGS)
§ 467e. Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, packaging, and ingredients; recordkeeping and related requirements; concurrent jurisdiction over distribution for human food purposes of adulterated or misbranded and imported articles; other matters
Requirements within the scope of this chapter with respect to premises, facilities and operations of any official establishment which are in addition to, or different than those made under this chapter may not be imposed by any State or Territory or the District of Columbia, except that any such jurisdiction may impose recordkeeping and other requirements within the scope of paragraph (b) of section 460 of this title, if consistent therewith, with respect to any such establishment. Marking, labeling, packaging, or ingredient requirements (or storage or handling requirements found by the Secretary to unduly interfere with the free flow of poultry products in commerce) in addition to, or different than, those made under this chapter may not be imposed by any State or Territory or the District of Columbia with respect to articles prepared at any official establishment in accordance with the requirements under this chapter, but any State or Territory or the District of Columbia may, consistent with the requirements under this chapter exercise concurrent jurisdiction with the Secretary over articles required to be inspected under this chapter for the purpose of preventing the distribution for human food purposes of any such articles which are adulterated or misbranded and are outside of such an establishment, or, in the case of imported articles which are not at such an establishment, after their entry into the United States. This chapter shall not preclude any State or Territory or the District of Columbia from making requirement or taking other action, consistent with this chapter, with respect to any other matters regulated under this chapter.
(Pub. L. 85–172, § 23, as added Pub. L. 90–492, § 17, Aug. 18, 1968, 82 Stat. 807.)
21 U.S.C. § 467f (FOOD AND DRUGS)
§ 467f. Federal Food, Drug, and Cosmetic Act applications
(a) Exemptions; authorities under food, drug, and cosmetic provisions unaffected
Poultry and poultry products shall be exempt from the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] to the extent of the application or extension thereto of the provisions of this chapter, except that the provisions of this chapter shall not derogate from any authority conferred by the Federal Food, Drug, and Cosmetic Act prior to August 18, 1968.
(b) Enforcement proceedings; detainer authority of representatives of Secretary of Health and Human Services
The detainer authority conferred by section 467a of this title shall apply to any authorized representative of the Secretary of Health and Human Services for purposes of the enforcement of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with respect to any poultry carcass, or part or product thereof, that is outside any official establishment, and for such purposes the first reference to the Secretary in section 467a of this title shall be deemed to refer to the Secretary of Health and Human Services.
(Pub. L. 85–172, § 24, as added Pub. L. 90–492, § 17, Aug. 18, 1968, 82 Stat. 807; amended Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695.)
heading: References in Text
text: The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
heading: Change of Name
text: “Secretary of Health and Human Services” substituted for “Secretary of Health, Education, and Welfare” in par. (b) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.