Mike Rogers

“ The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection. ”

“ An assurance that the public health emergency in the geographic area of the requesting State or tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available. (ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary redeployment of personnel. (iii) An assurance that the requested temporary redeployment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 319C–1. ”

“ The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product's approved, licensed, or cleared conditions of use. ”

“ Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.; (C) in paragraph (2) — (i) in subparagraph (A) — (I) by striking “manufacturer of the product” and inserting “person”; (II) by striking “circumstances of the emergency” and inserting “applicable circumstances described in subsection (b) (1) ”; and (III) by inserting at the end before the period “or in paragraph (1) (B) ” ”

“ In general– Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided. (B) Funds contingent on achieving benchmarks– The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection (i) .. ”

“ Protection of national security– In carrying out subsections (b) (7) and (d) , the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed.. ”

“ Center-specific objectives and accomplishments; and (B) the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures; (5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 564 ”

“ National collaboration– Partnerships consisting of one or more eligible entities under this section may, to the extent practicable, collaborate with other partnerships consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness goals described under paragraphs (1) , (3) , (4) , (5) , and (6) of section 2802 (b) .; (5) in subsection (i) — (A) by striking “The requirements of” and inserting the following: (1) In general– The requirements of ”

“ Special protocol assessment Section 505 (b) (5) (B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (b) (5) (B) ) is amended by striking “size of clinical trials intended” and all that follows through “. ”