Sec. 5. Requiring FDA to share manufacturing information with ASPR and the Assistant Secretary of Defense for Health Affairs
319 words·~1 min read·
/bill/116/s/3781/is/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Beginning as soon as practicable, but not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall provide to the Assistant Secretary for Preparedness and Response and the Assistant Secretary of Defense for Health Affairs all drug and device manufacturing data described in subsection (b), as appropriate and applicable, for any of the following purposes: Maintaining the strategic national stockpile under section 319F–2 of the Public Health Service Act ( 42 U.S.C. 247d–6b ).
Evaluating health infrastructure under the Division of Critical Infrastructure Protection of the Office of the Assistant Secretary for Preparedness and Response. Preparing for and responding to public health emergencies and national security concerns. Mitigating potential drug shortages. The drug and device manufacturing data required to be provided as described in subsection
(a)includes— information reported by any manufacturer under subsection
(a)or
(k)of section 506C(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) or subsection
(a)or
(j)of section 506J of such Act ( 21 U.S.C. 356j ); any risk management plan under section 506C(j) of such Act ( 21 U.S.C. 356c(j) ) that is made available to the Secretary pursuant to such section; records or other information provided under section 704(a)(4) of such Act ( 21 U.S.C. 374(a)(4) ); and to the extent not already provided, the locations where each drug that is a subject of a report or plan under paragraph (1), (2), or
(3)is manufactured. The Commissioner of Food and Drugs and the Assistant Secretary for Preparedness and Response, and the Commissioner of Food and Drugs and the Assistant Secretary of Defense for Health Affairs, shall enter into memoranda of understanding to set forth the manner in which data will be shared under this section and the procedures for protecting any nonpublic data from further disclosure.
Connectionstraces to 3
1 reference not yet in our index
- 42 USC 247d–6b
Citation graph
cites case law
Sec. 5
Requiring FDA to share manufacturing information with ASPR and the Assistant Secretary of Defense for Health Affairs
Cite42 USC 247d–6b
Cites 4Cited by 0 across 0 sources