Title 21 — Food and DrugsRelease 119-73not60

§399g Food and Drug Administration Intercenter Institutes

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS › § 399g

Last updated Apr 5, 2026|Official source

Summary

The Secretary must create one or more Intercenter Institutes inside the FDA to focus on major disease areas. Each Institute must coordinate work among the FDA’s drug, biologics, and device centers for its disease area. That coordination can include bringing together staff with different product skills; making product reviews smoother under the rules in sections 355, 360(k), 360c(f)(2), and 360e of Title 21 and section 262 of Title 42; supporting scientific programs; improving hiring, training, and continuing education for staff; improving contact with patients, sponsors, and the biomedical community; and working with other HHS agencies. The public must be allowed to comment while each Institute is set up. At least one Institute had to be created within 1 year after December 13, 2016. The Secretary may close an Institute if it no longer helps public health but must give at least 60 days’ public notice and explain why before doing so.

Full Legal Text

Title 21, §399g

Food and Drugs — Source: USLM XML via OLRC

(a)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 section 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)The Secretary shall provide a period for public comment during the time that each Institute is being implemented.

(c)The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after December 13, 2016.

(d)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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 399g

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60