FDA Cross-Center Collaboration Act of 2016

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of one or more Intercenter Institutes within the Food and Drug Administration for a major disease area or areas, and for other purposes. 1. Short title This Act may be cited as the FDA Cross-Center Collaboration Act of 2016 2. Establishment of Food and Drug Administration Intercenter Institutes (a) In general Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. 1014. Establishment of Food and Drug Administration Intercenter Institutes (a) In general The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an Institute Centers (1) 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; (2) streamlining, where appropriate, of the processes for 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), 513(f)(2), and 515 of this Act, section 351 of the Public Health Service Act, and other applicable authorities; (3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute; (4) 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; (5) 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 (6) 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. (b) Public process Prior to establishing an Institute under subsection (a), the Secretary shall provide for a period of public comment on the proposed Institute. (c) Timing The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after the date of enactment of the FDA Cross-Center Collaboration Act of 2016 (d) Termination of institutes The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefiting the public health. Not less than 60 days prior to terminating such Institute, the Secretary shall provide public notice of such termination, including the rationale for such termination. . (b) Technical amendments Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. (1) by redesignating section 1012 as section 1013; and (2) 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

Summary: FDA Cross-Center Collaboration Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community.