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

submitted 88 years ago by Pub. L. 114-255 to r/title-21-FOOD-AND-DRUGS · 399 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law requires the FDA to create Intercenter Institutes, each focused on a major disease area. Each Institute coordinates staff, product reviews, training, and outreach across three FDA centers. The Secretary must allow public comment and can later end an Institute with 60 days' notice.

(a) The Secretary must set up one or more "Intercenter Institutes" inside the FDA, each focused on one major disease area. An Institute links the work of three FDA centers. Those are the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. The Institute can pool staff who know how to find, treat, or stop the disease. It can also make product reviews faster under listed laws, push related science within the centers, and train staff on the disease. It can help the centers talk with patients, sponsors, and outside experts. It can also help the centers work with other agencies in the Department of Health and Human Services. (b) While setting up each Institute, the Secretary must allow time for public comment. (c) The Secretary must set up at least one Institute within one year of December 13, 2016. (d) The Secretary may end an Institute if the Secretary thinks it no longer helps public health. At least 60 days before ending one, the Secretary must give public notice and say why.

facts

- Codified at 21 U.S.C. § 399g, titled "Food and Drug Administration Intercenter Institutes." - Enacted as § 1014 of the Federal Food, Drug, and Cosmetic Act (ch. 675, June 25, 1938), added by Pub. L. 114–255, div. A, title III, § 3073(a), Dec. 13, 2016, 130 Stat. 1136. - Statute text contains 399 words and includes one amendment reference in the source credit. - Requires establishment of at least one Intercenter Institute within one year of December 13, 2016. - Structured into four subsections: (a) general establishment and coordination duties, (b) public comment process, (c) timing, and (d) termination procedures.

the actual law source: uscode.house.gov ↗public domain

(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.

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.

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.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 114-255 · 130 Stat. 1136

The record. The source credit indicates that this section was codified as part of the Federal Food, Drug, and Cosmetic Act (June 25, 1938, ch. 675), but that the specific provision, § 1014, was added later—by Public Law 114-255, division A, title III, § 3073(a), enacted December 13, 2016, and published at 130 Stat. 1136. The credit reflects a single enactment event with no subsequent amendments recorded. Historical context. Public Law 114-255 is commonly known as the 21st Century Cures Act, a 2016 statute generally understood to have been aimed at accelerating the discovery, development, and delivery of new medical treatments and at modernizing certain Food and Drug Administration processes. Within that broader framework, provisions establishing coordination mechanisms among the FDA's product centers—such as the Intercenter Institutes described here—are consistent with the Act's commonly cited goal of improving efficiency and cross-disciplinary collaboration in the review of drugs, biologics, and devices, particularly for complex or major disease areas that may implicate more than one FDA center. Beyond this general understanding of the Act's purpose, the record does not establish the specific legislative rationale, deliberations, or disease-area priorities that led Congress to adopt this particular provision.

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