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21 U.S.C. § 356–1 — Accelerated approval of priority countermeasures
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to [section 356 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356&num=0&edition=prelim) or as a device granted review priority pursuant to section 360e(d)(5) 11 See References in Text note below. of this title. Such a designation may be made prior to the submission of—
(1) a request for designation by the sponsor or applicant; or
(2) an application for the investigation of the drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or [section 262(a)(3) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim).
Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.
**(b) Use of animal trials** A drug for which approval is sought under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 1 may be designated as a fast track product for purposes of this section.
**(c) Priority review of drugs and biological products** A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.
**(d) Definitio
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356–1
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Stable record: federal_law:legal_authorities:record_usc_c3a8f3e66b6287acfa90c2df
Source file: Laws/federal/codes/united-states-code/title-21/section-3561-accelerated-approval-of-priority-countermeasures--cfcb89c22d.md
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Source location: Title 21, Chapter 9, § 356–1; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to [section 356 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356&num=0&edition=prelim) or as a device granted review priority pursuant to section 360e(d)(5) 11 See References in Text note below. of this title. Such a designation may be made prior to the submission of—
(1) a request for designation by the sponsor or applicant; or
(2) an application for the investigation of the drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or [section 262(a)(3) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim).
Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.
**(b) Use of animal trials** A drug for which approval is sought under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 1 may be designated as a fast track product for purposes of this section.
**(c) Priority review of drugs and biological products** A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.
**(d) Definitions** For purposes of this title: 1
(1) The term “priority countermeasure” has the meaning given such term in section 247d–6(h)(4) 1 of title 42.
(2) The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.
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Federal law — U.S. Code and appendices · legal_authorities
The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the National Institute of Occupational Safety and Health, shall enhance and expand research as deemed appropriate on the health and safety of workers who are at risk for bioterrorist threats or attacks in the workplace, including research on the health effects of measures taken to treat or protect such workers for diseases or disorders resulting from a bioterrorist threat or attack. Nothing in this section may be construed as establishing new regulatory authority for the Secretary or the Director to issue or modify any occupational safety and health rule or regulation.
Source: Supplied U.S. Code snapshot — release unconfirmed · 29 U.S.C. § 669a
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Federal law — U.S. Code and appendices · legal_authorities
For purposes of this subpart:
(1) The term “human drug application” means an application for—
(A) approval of a new drug submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim), or
(B) licensure of a biological product under subsection (a) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distribute
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379g
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this subchapter:
(1) The term “alter”, with respect to a medical facility, means to repair, remodel, improve, or extend such medical facility.
(2) The terms “construct” and “alter”, with respect to a medical facility, include such engineering, architectural, legal, fiscal, and economic investigations and studies and such surveys, designs, plans, construction documents, specifications, procedures, and other similar actions as are necessary for the construction or alteration, as the case may be, of such medical facility and as are carried out after the completion of the advanced planning (including the development of project requirements and design development) for such facility.
(3) The term “medical facility” means any facility or part thereof which is, or will be, under the jurisdiction of the Secretary, or as otherwise authorized by law, for the provision of health-care services (including hospital, outpatient clinic, nursing home, or domiciliary care or medical services), including any necessary building and auxiliary structure, garage, parking facility, mechanical equipment, trackage facilities leading thereto, abutting sidewalks, accommodations for attending personnel, and recreation facilities associated therewith.
(4) The term “committee” means the Committee on Veterans’ Affairs of the House of Representatives or the Committee on Veterans’ Affairs of the Senate, and the term “committees” means both such committees.
Source: Supplied U.S. Code snapshot — release unconfirmed · 38 U.S.C. § 8101
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Designation of a drug as a breakthrough therapy**
(1) **In general** — The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a “breakthrough therapy”.)
(2) **Request for designation** — The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)].
(3) **Designation**
(A) *In general* — Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.
(B) *Actions* — The actions to
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
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