United States Code

21 U.S.C. § 399g

Food and Drug Administration Intercenter Institutes

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Bills that would change it 19

  • HR 8646 Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 Amends its part · introduced · 119th Congress
  • HR 8432 To provide the Food and Drug Administration needed authorities to carry out its regulatory mission with respect to human foods, to provid... Amends its part · introduced · 119th Congress
  • HR 7148 Consolidated Appropriations Act, 2026 Amends its part · enacted · 119th Congress
  • HR 1262 Mikaela Naylon Give Kids a Chance Act Amends its part · introduced · 119th Congress
  • S 891 Bipartisan Health Care Act Amends its part · introduced · 119th Congress
  • HR 1794 United States-Abraham Accords Cooperation and Security Act of 2025 Amends its part · introduced · 119th Congress
  • HR 1768 Lower Costs for Everyday Americans Act Amends its part · introduced · 119th Congress
  • HR 597 PURR Act of 2025 Amends its part · introduced · 119th Congress
  • HR 3433 Give Kids a Chance Act of 2024 Amends its part · introduced · 118th Congress
  • HR 7380 PURR Act of 2024 Amends its part · introduced · 118th Congress
  • HR 7155 United States-Abraham Accords Cooperation and Security Act of 2024 Amends its part · introduced · 118th Congress
  • HR 6288 Data for Pediatric Brain Cancer Act of 2023 Amends its part · introduced · 118th Congress
  • HR 6000 Cures 2.0 Act Amends 399g(c) · introduced · 117th Congress
  • S 3427 Neuroscience Center of Excellence Act of 2021 Amends 399g(a), 399g(c) · introduced · 117th Congress
  • HR 5435 BRAIN Act of 2021 Amends · introduced · 117th Congress
  • HR 1730 Speeding Therapy Access Today Act of 2021 Amends 399g(a) · introduced · 117th Congress
  • S 670 Speeding Therapy Access Today Act of 2021 Amends 399g(a) · introduced · 117th Congress
  • HR 70 Securing America’s Medicine Cabinet Act of 2021 Amends its part · introduced · 117th Congress
  • HR 5228 SCREEN Act Amends its part · introduced · 115th Congress

The law today

From the official United States Code, current through Public Law 119-121.

(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”) 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, among 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— (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, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 355, 360(k), 360c(f)(2), and 360e of this title and section 262 of title 42, 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 The Secretary shall provide a period for public comment during the time that each Institute is being implemented. (c) Timing The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after December 13, 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 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.
Official text at uscode.house.gov ↗