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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5414 Introduced in House (IH)]

<DOC>

114th CONGRESS
  2d Session
                                H. R. 5414

   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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              June 8, 2016

Mr. Upton (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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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:

``SEC. 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.
                                 <all>
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