Page:United States Statutes at Large Volume 116 Part 1.djvu/639

 PUBLIC LAW 107-188-JUNE 12, 2002 116 STAT. 613 (1) STRATEGIC NATIONAL STOCKPILE.— For the purpose of carrying out subsection (a), there are authorized to be appropriated $640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. (2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTER- 21 USC 356-1. MEASURES. (a) IN GENERAL.— The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) or as a device granted review priority pursuant to section 515(d)(5) of such Act (21 U.S.C. 360e(d)(5)). Such a designation may he 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 505(i) of such Act or section 351(a)(3) of the Public Health Service Act. 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 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 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) The term "priority countermeasure" has the meaning given such term in section 319F(h)(4) of the Public Health Service Act. (2) The term "priority drugs or biological products" means a drug or biological product that is the subject of a drug or biologies application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997. SEC 123. ISSUANCE OF RULE ON ANIMAL TRIALS. Not later than 90 days after the date of the enactment of Deadline, this Act, the Secretary of Health and Human Services shall complete the process of rulemaking that was commenced under authority of section 505 of the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act with the issuance of the proposed rule entitled "New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot be Conducted" published in the Federal Register on October 5, 1999 (64 Fed. Reg. 53960), and shall promulgate a final rule.

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