Sec. 4. GAO report on intra-agency coordination
220 words·~1 min read·
/bill/116/s/2723/is/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report examining the Food and Drug Administration's intra-agency coordination, communication, and decision making in assessing drug shortage risks, and taking corrective action. The report shall include— consideration of— risks associated with violations of current good manufacturing practices; corrective and preventative actions with respect to such violations requested by the Food and Drug Administration; the effects of potential manufacturing slow-downs or shut-downs on potential drug shortages, including the discontinuance of drug manufacturing and marketing; efforts to prioritize review of applications for drugs that the Secretary has determined under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ) to be in shortage; and efforts to prioritize inspections of facilities necessary for approval of applications for drugs described in subparagraph (D); a description of how the Food and Drug Administration proactively coordinates strategies to mitigate the consequences of the violations, slow-downs, and shut-downs described in paragraph
(1)across agencies; and an evaluation of changes in relevant Food and Drug Administration practices that such agency has proposed but not yet implemented.
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 4
GAO report on intra-agency coordination
Cites 1Cited by 0 across 0 sources