Sec. 4132. GAO report on intra-agency coordination
292 words·~1 min read·
/bill/116/s/3548/is/section-4132A 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 device shortages and risks associated with the supply of devices, and any efforts by the Food and Drug Administration to mitigate any device shortages or to take corrective actions.
The report shall include— consideration of— risks of creating, worsening, or extending a shortage of a device 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 disruptions or shut-downs on potential device shortages, which may include the discontinuance of device manufacturing and marketing, or the manufacturing of device components or parts; efforts to prioritize and expedite the review of submissions for devices that the Secretary has determined under section 506J(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ) to be in shortage; and efforts to prioritize inspections of facilities necessary for approval or clearance of devices 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. In this section, the term device has the meaning given such term under section 506J(i)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 4131.
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 4132
GAO report on intra-agency coordination
Cites 1Cited by 0 across 0 sources