Page:United States Statutes at Large Volume 118.djvu/890

 118 STAT. 860 PUBLIC LAW 108–276—JULY 21, 2004 SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT. (a) SECRETARY OF HEALTH AND HUMAN SERVICES.— (1) ANNUAL REPORTS ON PARTICULAR EXERCISES OF AUTHORITY.— (A) RELEVANT AUTHORITIES.—The Secretary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’) shall submit reports in accordance with subparagraph (B) regarding the exercise of authority under the following provisions of law: (i) With respect to section 319F–1 of the Public Health Service Act (as added by section 2 of this Act): (I) Subsection (b)(1) (relating to increased sim plified acquisition threshold). (II) Subsection (b)(2) (relating to procedures other than full and open competition). (III) Subsection (c) (relating to expedited peer review procedures). (ii) With respect to section 319F–2 of the Public Health Service Act (as added by section 3 of this Act): (I) Subsection (c)(7)(C)(iii) (relating to sim plified acquisition procedures). (II) Subsection (c)(7)(C)(iv) (relating to proce dures other than full and open competition). (III) Subsection (c)(7)(C)(v) (relating to pre mium provision in multiple award contracts). (iii) With respect to section 564 of the Federal Food, Drug, and Cosmetic Act (as added by section 4 of this Act): (I) Subsection (a)(1) (relating to emergency uses of certain drugs and devices). (II) Subsection (b)(1) (relating to a declaration of an emergency). (III) Subsection (e) (relating to conditions on authorization). (B) CONTENTS OF REPORTS.—The Secretary shall annually submit to the designated congressional commit tees a report that summarizes— (i) the particular actions that were taken under the authorities specified in subparagraph (A), including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used; (ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities; (iii) the number of, nature of, and other informa tion concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity; and (iv) whether, with respect to each procurement that is approved by the President under section 319F– 2(c)(6) of the Public Health Service Act (as added by 42 USC 247d–6c.

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