Sec. 4. Improving critical infrastructure by requiring risk management plans
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Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ), as amended by section 2(b), is further amended by adding at the end the following: The Secretary may require a manufacturer of a drug described in subsection
(a)to conduct periodic risk assessments— to identify vulnerabilities in the manufacturing supply chain of such manufacturer; and to develop plans to mitigate the risks associated with any vulnerabilities so identified. . Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize guidance implementing subsection
(l)of section 506C of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). Such guidance shall include guidance on— examples of what may be considered a vulnerability in the manufacturing supply chain in conducting a risk assessment pursuant to such subsection; the timeframe within which a manufacturer must conduct such an assessment and provide a response to the Food and Drug Administration; expectations of the Secretary of Health and Human Services for a manufacturer to mitigate in a reasonable manner any risks associated with vulnerabilities in the manufacturing supply chain identified in such an assessment; and how the Secretary will coordinate with other Federal agencies to communicate and resolve any such vulnerabilities.
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Sec. 4
Improving critical infrastructure by requiring risk management plans
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