I 114th CONGRESS 1st Session H. R. 3299 IN THE HOUSE OF REPRESENTATIVES July 29, 2015 Mrs. Brooks of Indiana (for herself and Ms. Eshoo ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to ensure preparedness for chemical, radiological, biological, and nuclear threats, and for other purposes.

1. Short title This Act may be cited as the Strengthening Public Health Emergency Response Act of 2015 . 2. Hospital preparedness program Subsection (j) of section 319C–2 of the Public Health Service Act ( 42 U.S.C. 247d–3b ) is amended by adding at the end the following: (5) Minimum funding level for awards Of the amounts appropriated to carry out this section for a fiscal year, not less than 97 percent shall be awarded to eligible entities as described in subsection (a). . 3. GAO report on State, local, and hospital preparedness programs (a) In general Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit a report to the Congress on the programs for awarding cooperative agreements and grants under section 319C–1 of the Public Health Service Act (42 U.S.C. 247d–3a; improving State and local public health security) and section 319C–2 of such Act (42 U.S.C. 247d–3b; partnerships for State and regional hospital preparedness to improve surge capacity). (b) Contents The report under subsection (a) shall address each of the following: (1) The goals of the programs specified in subsection (a). (2) The extent to which such goals are being met, including performance metrics that could help assess whether such programs are succeeding. (3) How such programs could be improved. (4) How such programs complement other preparedness programs of the Department of Health and Human Services. (5) How funds awarded through such programs should be allocated and whether that allocation should be based on risk. (6) Progress made toward State and local preparedness entities being self-sustaining. (7) Whether the level of funding for such programs is sufficient. 4. Strategic national stockpile Section 319F–2(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(2)) is amended— (1) in subparagraph (G), by striking and at the end; (2) in subparagraph (H), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (I) ensure procedures are in place to coordinate the ongoing stockpiling by the Biomedical Advanced Research and Development Authority and Centers for Disease Control and Prevention of qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in this section), and qualified pandemic or epidemic products (as defined in section 319F–3) for which funds have been made available under section 319L in order to avoid any gaps in preparedness. . 5. Project Bioshield procurement process Section 319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is amended— (1) in paragraph (4)(A)(ii), by striking make a recommendation under paragraph (6) that the special reserve fund as defined in subsection (h) be made available for the procurement of such countermeasure and inserting make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure ; (2) in paragraph (6)— (A) by striking subparagraphs (A), (B), (C), and (E); and (B) by striking (6) Recommendations for president’s approval and all that follows through (D) Subsequent specific countermeasures .— and inserting (6) Subsequent specific countermeasures .—Procurement under ; and (3) in paragraph (7)— (A) by striking subparagraph (A); (B) by redesignating subparagraph (B) as subparagraph (A) and amending such subparagraph (A), as redesignated, to read as follows: (A) Payments from special reserve fund The special reserve fund as defined in subsection (h) shall be available for payments made by the Secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph. ; and (C) by redesignating subparagraph (C) as subparagraph (B). 6. BARDA transaction authorities Section 319L(c)(5) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)) is amended by adding at the end the following: (H) Contracting authority The Secretary shall delegate authority for negotiating and entering into any contracts, grants, or cooperative agreements under this section to the Director. . 7. Public health emergency medical countermeasures enterprise strategy and implementation plan Section 2811(d)(2) of the Public Health Service Act ( 42 U.S.C. 300hh–10(d)(2) ) is amended— (1) in subparagraph (A), by inserting after describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation the following: (which shall include pandemic influenza) ; (2) by striking and at the end of subparagraph (J); (3) by redesignating subparagraph (K) as subparagraph (L); and (4) by inserting after subparagraph (J) the following: (K) report on the amount of time between the issuance of each request for proposal or task order from the Biomedical Advanced Research and Development Authority and the award of a contract pursuant to such request for proposal or task order; and . 8. Priority review to encourage treatments for national security threats Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(a)(3) ) is amended— (1) by redesignating subparagraph (R) as subparagraph (S); and (2) by inserting after subparagraph (Q) the following: (R) Any disease or other agent that is determined to be a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act. .