Sec. 2012. Enhancing intra-agency coordination and public health assessment with regard to compliance activities
365 words·~2 min read·
/bill/116/hr/14/ih/section-2012A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Paragraph
(2)of section 704(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(b) ) is amended by adding at the end the following: The Secretary shall ensure timely and effective coordination among such offices regarding the reviews of such report and the alignment of any feedback regarding such report, and any corrective or preventive actions in response to such report, after consideration of the benefits and risks to the public health, patient safety, the drug supply and drug supply chain, and timely patient access to drugs. . Subsection
(b)of section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ) is amended by adding at the end the following new paragraph: On an annual basis, the Secretary shall prepare a report on the utilization of the framework described in paragraph
(2)and post such report on the public website of the Food and Drug Administration. . The amendments made by paragraphs
(1)and
(2)shall take effect on the effective date described in section 3112 of the CARES Act ( Public Law 116–136 ), after executing the amendments made by such section 3112, and shall apply beginning on the date that is 1 year after the date of enactment of this Act. The Secretary of Health and Human Services shall publish in the Federal Register a notice of a public meeting to be held no later than six months after the date of enactment of this Act to discuss and obtain input and recommendations from public stakeholders, including patient advocates, consumers, regulated industry, and health care providers, regarding the contents of a benefit/risk framework described in section 704(b)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a), that supports a safe, stable, redundant drug supply chain. The Secretary of Health and Human Services shall— not later than one year after the date on which the public meeting described in subsection
(b)is held, issue draft guidance regarding the goals and implementation of a benefit/risk framework described in subsection (b); and not later than two years after such date of enactment, issue final guidance with respect to the implementation of such a framework.
Connectionstraces to 2
Traces to 2 documents
U.S. Code
public-private-law
Citation graph
cites case law
Sec. 2012
Enhancing intra-agency coordination and public health assessment with regard to compliance activities
Cites 2Cited by 0 across 0 sources