I 
114TH CONGRESS 
2D SESSION 
H. R. 5414 
To amend the Federal Food, Drug, and Cosmetic Act to provide for establish-
ment 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 Representa-
tives 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’’. 
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SEC. 2. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRA-
TION INTERCENTER INSTITUTES. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 1014. ESTABLISHMENT OF FOOD AND DRUG ADMINIS-
TRATION 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 ‘Insti-
tute’) for a major disease area or areas. With respect to 
the major disease area of focus of an Institute, such Insti-
tute shall develop and implement processes for coordina-
tion of activities, as applicable to such major disease area 
or areas, between the Center for Drug Evaluation and Re-
search, the Center for Biologics Evaluation and Research, 
and the Center for Devices and Radiological Health (re-
ferred 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, miti-
gation, treatment, or prevention of the specific dis-
eases 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 diag-
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nose, cure, mitigate, treat, or prevent the major dis-
ease 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 Cen-
ters 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 relation-
ships of the Centers with other agencies within the 
Department of Health and Human Services regard-
ing the major disease area of focus of the Institute. 
‘‘(b) PUBLIC PROCESS.—Prior to establishing an In-
stitute under subsection (a), the Secretary shall provide 
for a period of public comment on the proposed Institute. 
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‘‘(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-Cen-
ter 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. 
Æ 
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