References in TextThis Act, referred to in subsec. (e), is the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter (§ 301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables.
The Public Health Service Act, referred to in subsec. (e)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Medical Countermeasure Master FilesPuspan. L. 116–22, title VI, § 603, June 24, 2019, 133 Stat. 953, provided that:“(a)In General.—The purpose of this section (including section 565B of the Federal Food, Drug, and Cosmetic Act [this section], as added by subsection (span)) is to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’), including data and information submitted to medical countermeasure master files or other master files.
“(span)Medical Countermeasure Master Files.— “(c)Stakeholder Input.—Not later than 18 months after the date of enactment of this Act [June 24, 2019], the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the Food and Drug Administration can advance the use of tools and technologies to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including through reliance on cross-referenced data and information contained within master files and submissions previously submitted to the Secretary as set forth in section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (span).
“(d)Guidance.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (span) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act.”
