Sec. 4. Review and update of existing guidance
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The Secretary, acting through the Commissioner of Food and Drugs, shall— not later than 1 year after the date of the enactment of this Act, initiate an internal review of existing guidance for determining eligibility of donors of human cell and tissue products; not later than 3 years after the date of the enactment of this Act, if appropriate— update the guidance titled Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry issued August 2007; and issue or update, as applicable, any guidance for industry of the Food and Drug Administration that includes— recommendations to reduce the risk of transmission of mycobacterium tuberculosis by human cells, tissues, and cellular and tissue-based products (HCT/Ps); or recommendations to reduce the risk of transmission of disease agents associated with sepsis for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps); and if the Secretary determines that issuing or updating guidance as specified in paragraph
(2)is not appropriate, provide a written statement of explanation of that determination to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.