§ 399g. Food and Drug Administration Intercenter Institutes

421 words·~2 min read·/usc/title-21/section-399g

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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.)

Connections12 cite this · traces to 2

Cited by 12 sections · top 9

public-private-law