2015 US Code
Title 21 - Food and Drugs (Sections 1 - 2252)
Chapter 9 - Federal Food, Drug, and Cosmetic Act (Sections 301 - 399f)
Subchapter V - Drugs and Devices (Sections 351 - 360fff-7)
Part A - Drugs and Devices (Sections 351 - 360n-1)
Sec. 356-1 - Accelerated approval of priority countermeasures
Publication Title | United States Code, 2012 Edition, Supplement 3, Title 21 - FOOD AND DRUGS |
Category | Bills and Statutes |
Collection | United States Code |
SuDoc Class Number | Y 1.2/5: |
Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 356-1 - Accelerated approval of priority countermeasures |
Contains | section 356-1 |
Date | 2015 |
Laws In Effect As Of Date | January 3, 2016 |
Positive Law | No |
Disposition | standard |
Source Credit | Pub. L. 107-188, title I, §122, June 12, 2002, 116 Stat. 613. |
Statutes at Large References | 116 Stat. 613, 596 120 Stat. 2861 |
Public and Private Laws | Public Law 105-115, Public Law 107-188, Public Law 109-417 |
Download PDF
The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 356 of this title or as a device granted review priority pursuant to section 360e(d)(5) 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 or section 262(a)(3) of title 42.
Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.
(b) Use of animal trialsA drug for which approval is sought under section 355(b) of this title or section 262 of title 42 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 productsA 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) DefinitionsFor 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.
(Pub. L. 107–188, title I, §122, June 12, 2002, 116 Stat. 613.)
REFERENCES IN TEXTSection 123, referred to in subsec. (b), is section 123 of Pub. L. 107–188, title I, June 12, 2002, 116 Stat. 613, which is not classified to the Code.
This title, referred to in subsec. (d), is title I of Pub. L. 107–188, June 12, 2002, 116 Stat. 596, which enacted this section, section 669a of Title 29, Labor, and sections 244, 245, 247d–3a, 247d–3b, 247d–7a to 247d–7d, 300hh, 300hh–11 to 300hh–13, 1320b–5, and 7257d of Title 42, The Public Health and Welfare, amended sections 247d to 247d–6, 264, 266, 290hh–1, and 5196b of Title 42, and enacted provisions set out as notes preceding section 8101 of Title 38, Veterans' Benefits, and under sections 201, 244, 247d, 247d–6, 300hh, 300hh–12, and 1320b–5 of Title 42. For complete classification of this title to the Code, see Tables.
Section 247d–6(h)(4) of title 42, referred to in subsec. (d)(1), was redesignated section 247d–6(e)(4) by Pub. L. 109–417, title III, §304(3), Dec. 19, 2006, 120 Stat. 2861.
Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in subsec. (d)(2), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title.
CODIFICATIONSection was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
1 See References in Text note below.
Disclaimer: These codes may not be the most recent version. The United States Government Printing Office may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the US site. Please check official sources.