republic-os/legal/us/code/title-21/chapter-9/section-399g.md

type, title, description, jurisdiction, corpus, kind, title_number, title_name, chapter_number, chapter_name, section, citation, status, release_point, release_date, source, source_url, source_identifier, source_file, source_hash, raw_snapshot_hash, text_hash, retrieved_at, confidence, tags

type	title	description	jurisdiction	corpus	kind	title_number	title_name	chapter_number	chapter_name	section	citation	status	release_point	release_date	source	source_url	source_identifier	source_file	source_hash	raw_snapshot_hash	text_hash	retrieved_at	confidence	tags
LegalText	21 U.S.C. § 399g	Food and Drug Administration Intercenter Institutes	us	united_states_code	code_section	21	FOOD AND DRUGS	9	FEDERAL FOOD, DRUG, AND COSMETIC ACT	399g	21 U.S.C. § 399g	current	119-100	2026-06-26	official	https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip	/us/usc/t21/s399g	data/legal/raw/us/code/title-21/usc21.xml	b941d5e48b4dd66347282e6f3a758935adaadb7e89abecc80b0d12f7fdee7f6b	3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1	17b7bc1f357d8043c9ef6501de0b8fbf6d7148a94435d85a6455eec1679dd833	2026-07-04	official	legal us-code

21 U.S.C. § 399g - Food and Drug Administration Intercenter Institutes

Text

(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.

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