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.
(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.)
heading: Amendments
text: 2016—Subsecs. (a), (b). Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted “the first application” for “any application”, and added subsec. (b).
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. § 360bbb–0 (FOOD AND DRUGS)
§ 360bbb–0. Expanded access policy required for investigational drugs
(a) In general
The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 360bbb(b) of this title for provision of such a drug.
(b) Public availability of expanded access policy
The policies under subsection (a) shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor.
(c) Content of policy
A policy described in subsection (a) shall include—
(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);
(2) procedures for making such requests;
(3) the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests;
(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and
(5) a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 282(j)(2)(A)(ii)(II)(gg) of title 42.
(d) No guarantee of access
The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
(e) Revised policy
Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time.
(f) Application
This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of—
(1) the date that is 60 calendar days after December 13, 2016; or
(2) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug.
(June 25, 1938, ch. 675, § 561A, as added Pub. L. 114–255, div. A, title III, § 3032, Dec. 13, 2016, 130 Stat. 1100.)
21 U.S.C. § 360bbb–3b (FOOD AND DRUGS)
§ 360bbb–3b. Products held for emergency use
It is not a violation of any section of this chapter or of the Public Health Service Act [42 U.S.C. 201 et seq.] for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 360bbb–3(a)(4) of this title) intended for emergency use, if that product—
(1) is intended to be held and not used; and
(2) is held and not used, unless and until that product—
(A) is approved, cleared, or licensed under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title;
(B) is authorized for investigational use under section 355 1 360b, or 360j of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or
(C) is authorized for use under section 360bbb–3 of this title.
(June 25, 1938, ch. 675, § 564B, as added Pub. L. 113–5, title III, § 302(d), Mar. 13, 2013, 127 Stat. 185; amended Pub. L. 114–255, div. A, title III, § 3088(d), Dec. 13, 2016, 130 Stat. 1149.)
heading: References in Text
text: The Public Health Service Act, referred to in text, is act July 1, 1944, ch. 373, 58 Stat. 682, 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: Amendments
text: 2016—Par. (2)(A). Pub. L. 114–255, § 3088(d)(1), substituted “360b, or 360e of this title” for “or 360e of this title” and inserted “or conditionally approved under section 360ccc of this title” after “Public Health Service Act”.
Par. (2)(B). Pub. L. 114–255, § 3088(d)(2), substituted “360b, or 360j of this title” for “or 360j of this title”.
21 U.S.C. § 360bbb–8a (FOOD AND DRUGS)
§ 360bbb–8a. Optimizing global clinical trials
(a) In general
The Secretary shall—
(1) work with other regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; and
(2) enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—
(A) enhance medical product development;
(B) facilitate the use of foreign data; and
(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.
(b) Medical product
In this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].
(c) Savings clause
Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].
(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(P), Dec. 13, 2016, 130 Stat. 1154.)
heading: References in Text
text: The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, 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: Amendments
text: 2016—Subsec. (c). Pub. L. 114–255 inserted “or under the Public Health Service Act” before period at end.
21 U.S.C. § 360bbb–8b (FOOD AND DRUGS)
§ 360bbb–8b. Use of clinical investigation data from outside the United States
(a) In general
In determining whether to approve, license, or clear a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug, biological product, or device in the United States.
(b) Notice to sponsor
If the Secretary finds under subsection (a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding.
(June 25, 1938, ch. 675, § 569B, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(Q), Dec. 13, 2016, 130 Stat. 1155.)
heading: Amendments
text: 2016—Pub. L. 114–255 substituted “drug, biological product, or device” for “drug or device” wherever appearing.
21 U.S.C. § 360ddd–2 (FOOD AND DRUGS)
§ 360ddd–2. Inapplicability of drug fees to designated medical gases
A designated medical gas, alone or in combination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval.
(June 25, 1938, ch. 675, § 577, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1111; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(T), Dec. 13, 2016, 130 Stat. 1155.)
heading: Amendments
text: 2016—Pub. L. 114–255 inserted “or 379j–12(a)” after “section 379h(a)”.
21 U.S.C. § 379d–3a (FOOD AND DRUGS)
§ 379d–3a. Hiring authority for scientific, technical, and professional personnel
(a) In general
The Secretary may, notwithstanding title 5, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Such positions shall be within the competitive service.
(b) Compensation
(1) In general
Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, and consistent with the requirements of paragraph (2), the Commissioner of Food and Drugs may determine and set—
(A) the annual rate of pay of any individual appointed under subsection (a); and
(B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before December 13, 2016.
(2) Limitation
The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3.
(3) Public availability
The annual rate of pay provided to an individual in accordance with this section shall be publicly available information.
(c) Rule of construction
The authorities under this section shall not be construed to affect the authority provided under section 379d–3 of this title.
(d) Report on workforce planning
(1) In general
Not later than 18 months after December 13, 2016, the Secretary shall submit a report on workforce planning to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that examines the extent to which the Food and Drug Administration has a critical need for qualified individuals for scientific, technical, or professional positions, including—
(A) an analysis of the workforce needs at the Food and Drug Administration and the Secretary’s strategic plan for addressing such needs, including through use of the authority under this section; and
(B) a recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of—
(i) recruitment through nongovernmental recruitment or placement agencies;
(ii) recruitment through academic institutions;
(iii) recruitment or hiring bonuses, if applicable;
(iv) recruitment using targeted direct hiring authorities; and
(v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary.
(2) Recommendations
The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency.
(June 25, 1938, ch. 675, § 714A, as added Pub. L. 114–255, div. A, title III, § 3072(a), Dec. 13, 2016, 130 Stat. 1134.)
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 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.
(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.)
heading: Amendments
text: 2016—Subsec. (a)(2). Pub. L. 114–255 substituted “conducting” for “conduction”.
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 subsequently renumbered section 1012 by Pub. L. 114–255, div. A, title III, § 3073(b)(2), Dec. 13, 2016, 130 Stat. 1137, and is classified to section 399c of this title.
21 U.S.C. § 399g (FOOD AND DRUGS)
§ 399g. Food and Drug Administration Intercenter Institutes
(a) In general
The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an “Institute”) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, among the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the “Centers”). Such activities may include—
(1) coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute;
(2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 355, 360(k), 360c(f)(2), and 360e of this title and section 262 of title 42, and other applicable authorities;
(3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute;
(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute;
(5) enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and
(6) facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute.
(b) Public process
The Secretary shall provide a period for public comment during the time that each Institute is being implemented.
(c) Timing
The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after December 13, 2016.
(d) Termination of Institutes
The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination.
(June 25, 1938, ch. 675, § 1014, as added Pub. L. 114–255, div. A, title III, § 3073(a), Dec. 13, 2016, 130 Stat. 1136.)
21 U.S.C. § 399h (FOOD AND DRUGS)
§ 399h. Grants for studying continuous drug manufacturing
(a) In general
The Secretary of Health and Human Services may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
(b) Definitions
In this section—
(1) the term “drug” has the meaning given such term in section 321 of this title;
(2) the term “biological product” has the meaning given such term in section 262(i) of title 42; and
(3) the term “institution of higher education” has the meaning given such term in section 1001(a) of title 20.
(Pub. L. 114–255, div. A, title III, § 3016, Dec. 13, 2016, 130 Stat. 1095.)
heading: Codification
text: Section was enacted as part of the 21st Century Cures Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
38 U.S.C. § 5501A (VETERANS’ BENEFITS)
§ 5501A. Beneficiaries’ rights in mental competence determinations
The Secretary may not make an adverse determination concerning the mental capacity of a beneficiary to manage monetary benefits paid to or for the beneficiary by the Secretary under this title unless such beneficiary has been provided all of the following, subject to the procedures and timelines prescribed by the Secretary for determinations of incompetency:
(1) Notice of the proposed adverse determination and the supporting evidence.
(2) An opportunity to request a hearing.
(3) An opportunity to present evidence, including an opinion from a medical professional or other person, on the capacity of the beneficiary to manage monetary benefits paid to or for the beneficiary by the Secretary under this title.
(4) An opportunity to be represented at no expense to the Government (including by counsel) at any such hearing and to bring a medical professional or other person to provide relevant testimony at any such hearing.
(Added Pub. L. 114–255, div. B, title XIV, § 14017(a), Dec. 13, 2016, 130 Stat. 1307.)
heading: Effective Date
text: Pub. L. 114–255, div. B, title XIV, § 14017(c), Dec. 13, 2016, 130 Stat. 1307, provided that: “Section 5501A of title 38, United States Code, as added by subsection (a), shall apply to determinations made by the Secretary of Veterans Affairs on or after the date of the enactment of this Act [Dec. 13, 2016].”