Sec. 4. Establishment of food and drug administration intercenter institutes
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Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following: The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an Institute ) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, between the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the Centers ).
Such activities may include— coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute; streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the major disease area of focus of the Institute, applying relevant standards under sections 505, 510(k), and 515 of this Act and section 351 of the Public Health Service Act, and other applicable authorities; promotion of scientific programs within the Centers related to the major disease area of focus of the Institute; development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute; enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute.
Prior to establishing an Institute under subsection (a), and not later than 1 year after the date of enactment of the FDA and NIH Workforce Authorities Modernization Act , the Secretary shall publish a draft implementation plan for such Institute, and provide for not less than 60 calendar days for public comment on such plan. The Secretary shall establish at least one Institute under subsection
(a)within 1 year of the closing of the public comment period under subsection (b), unless the Secretary determines that establishing such Institute would not be feasible or would not benefit the public health, and publishes such determination on the public Internet website of the Food and Drug Administration. The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination. . Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended— by redesignating section 1012 as section 1013; and by redesignating the second section 1011 (with respect to improving the training of State, local, territorial, and tribal food safety officials), as added by section 209(a) of the FDA Food Safety Modernization Act ( Public Law 111–353 ), as section 1012.
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- Pub. L. 111-353
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Sec. 4
Establishment of food and drug administration intercenter institutes
Pub. L.Pub. L. 111-353
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