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H.R. 5414 (114th): FDA Cross-Center Collaboration Act of 2016

The text of the bill below is as of Jun 8, 2016 (Introduced).


I

114th CONGRESS

2d Session

H. R. 5414

IN THE HOUSE OF REPRESENTATIVES

June 8, 2016

(for himself and Mr. Pallone) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of one or more Intercenter Institutes within the Food and Drug Administration for a major disease area or areas, and for other purposes.

1.

Short title

This Act may be cited as the FDA Cross-Center Collaboration Act of 2016.

2.

Establishment of Food and Drug Administration Intercenter Institutes

(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:

1014.

Establishment of 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, between the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (referred to in this section 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, of the processes for the review of medical products to diagnose, cure, mitigate, treat, or prevent 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, 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

Prior to establishing an Institute under subsection (a), the Secretary shall provide for a period of public comment on the proposed Institute.

(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 FDA Cross-Center Collaboration Act of 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 benefiting the public health. Not less than 60 days prior to terminating such Institute, the Secretary shall provide public notice of such termination, including the rationale for such termination.

.

(b)

Technical amendments

Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended—

(1)

by redesignating section 1012 as section 1013; and

(2)

by redesignating the second section 1011 (with respect to improving the training of State, local, territorial, and tribal food safety officials), as added by section 209(a) of the FDA Food Safety Modernization Act (Public Law 111–353), as section 1012.