§ 399g. Food and Drug Administration Intercenter Institutes

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 2016

   21st Century Cures Act

   Pub. L. 114–255 div. A title III § 3073(a) · 130 Stat. 1033

   Enacted · 21 U.S.C. § 399g

   (June 25, 1938, ch. 675, § 1014, as added Pub. L. 114–255, div. A, title III, § 3073(a), Dec. 13, 2016, 130 Stat. 1136.)

   Source evidence

   Code source credit
   (June 25, 1938, ch. 675, § 1014, as added Pub. L. 114–255, div. A, title III, § 3073(a), Dec. 13, 2016, 130 Stat. 1136.)

   Enacted provision · exact public law section
   (a) In General.— 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: “SEC. 1014. 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’) 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 505, 510(k), 513(f)(2), and 515 of this Act and 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.— 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 the date of enactment of the 21st Century Cures Act. “(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.” .

1 of 1 references resolved to an enrolled provision