I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Cross-Center 

5 Collaboration Act of 2016’’. 


rfrederick on DSK6VPTVN1PROD with BILLS
2 

•HR 5414 IH

1 SEC. 2. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRA2 TION INTERCENTER INSTITUTES. 

3 (a) IN GENERAL.—Chapter X of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend5 ed by adding at the end the following: 

6 ‘‘SEC. 1014. ESTABLISHMENT OF FOOD AND DRUG ADMINIS7 TRATION INTERCENTER INSTITUTES. 

8 ‘‘(a) IN GENERAL.—The Secretary shall establish one 

9 or more Intercenter Institutes within the Food and Drug 

10 Administration (referred to in this section as an ‘Insti11 tute’) for a major disease area or areas. With respect to 

12 the major disease area of focus of an Institute, such Insti13 tute shall develop and implement processes for coordina14 tion of activities, as applicable to such major disease area 

15 or areas, between the Center for Drug Evaluation and Re16 search, the Center for Biologics Evaluation and Research, 

17 and the Center for Devices and Radiological Health (re18 ferred to in this section as the ‘Centers’). Such activities 

19 may include— 

20 ‘‘(1) coordination of staff from the Centers with 

21 diverse product expertise in the diagnosis, cure, miti22 gation, treatment, or prevention of the specific dis23 eases relevant to the major disease area of focus of 

24 the Institute; 

25 ‘‘(2) streamlining, where appropriate, of the 

26 processes for the review of medical products to diagVerDate Sep 11 2014 05:23 Jun 09, 2016 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5414.IH H5414

rfrederick on DSK6VPTVN1PROD with BILLS
3 

•HR 5414 IH

1 nose, cure, mitigate, treat, or prevent the major dis2 ease area of focus of the Institute applying relevant 

3 standards under sections 505, 510(k), 513(f)(2), 

4 and 515 of this Act, section 351 of the Public 

5 Health Service Act, and other applicable authorities; 

6 ‘‘(3) promotion of scientific programs within 

7 the Centers related to the major disease area of 

8 focus of the Institute; 

9 ‘‘(4) development of programs and enhancement 

10 of strategies to recruit, train, and provide continuing 

11 education opportunities for the personnel of the Cen12 ters with expertise related to the major disease area 

13 of focus of the Institute; 

14 ‘‘(5) enhancement of the interactions of the 

15 Centers with patients, sponsors, and the external 

16 biomedical community regarding the major disease 

17 area of focus of the Institute; and 

18 ‘‘(6) facilitation of the collaborative relation19 ships of the Centers with other agencies within the 

20 Department of Health and Human Services regard21 ing the major disease area of focus of the Institute. 

22 ‘‘(b) PUBLIC PROCESS.—Prior to establishing an In23 stitute under subsection (a), the Secretary shall provide 

24 for a period of public comment on the proposed Institute. 


rfrederick on DSK6VPTVN1PROD with BILLS
4 

•HR 5414 IH

1 ‘‘(c) TIMING.—The Secretary shall establish at least 

2 one Institute under subsection (a) before the date that is 

3 1 year after the date of enactment of the FDA Cross-Cen4 ter Collaboration Act of 2016. 

5 ‘‘(d) TERMINATION OF INSTITUTES.—The Secretary 

6 may terminate any Institute established pursuant to this 

7 section if the Secretary determines such Institute is no 

8 longer benefiting the public health. Not less than 60 days 

9 prior to terminating such Institute, the Secretary shall 

10 provide public notice of such termination, including the 

11 rationale for such termination.’’. 

12 (b) TECHNICAL AMENDMENTS.—Chapter X of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 

14 et seq.) is amended— 

15 (1) by redesignating section 1012 as section 

16 1013; and 

17 (2) by redesignating the second section 1011 

18 (with respect to improving the training of State, 

19 local, territorial, and tribal food safety officials), as 

20 added by section 209(a) of the FDA Food Safety 

21 Modernization Act (Public Law 111–353), as section 

22 1012. 

Æ 


rfrederick on DSK6VPTVN1PROD with BILLS