I 

114TH CONGRESS 

1ST SESSION H. R. 2415 

To amend the Federal Food, Drug, and Cosmetic Act to provide for 

establishment of a streamlined data review program. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 19, 2015 

Mr. BURGESS (for himself and Mr. ENGEL) 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 a streamlined data review 

program. 

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

3 SECTION 1. STREAMLINED DATA REVIEW PROGRAM. 

4 (a) IN GENERAL.—Chapter V of the Federal Food, 

5 Drug, and Cosmetic Act is amended by inserting after sec6 tion 505F of such Act (21 U.S.C. 355f) the following: 

7 ‘‘SEC. 505F. STREAMLINED DATA REVIEW PROGRAM. 

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

9 streamlined data review program under which a holder of 

10 an approved application submitted under section 


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1 505(b)(1) or under section 351(a) of the Public Health 

2 Service Act may, to support the approval or licensure (as 

3 applicable) of the use of the drug that is the subject of 

4 such approved application for a new qualified indication, 

5 submit qualified data summaries. 

6 ‘‘(b) ELIGIBILITY.—In carrying out the streamlined 

7 data review program under subsection (a), the Secretary 

8 may authorize the holder of the approved application to 

9 include one or more qualified data summaries described 

10 in subsection (a) in a supplemental application if— 

11 ‘‘(1) the drug has been approved under section 

12 505(c) of this Act or licensed under section 351(a) 

13 of the Public Health Service Act for one or more in14 dications, and such approval or licensure remains in 

15 effect; 

16 ‘‘(2) the supplemental application is for ap17 proval or licensure (as applicable) under such section 

18 505(c) or 351(a) of the use of the drug for a new 

19 qualified indication under such section 505(c) or 

20 351(a); 

21 ‘‘(3) there is an existing database acceptable to 

22 the Secretary regarding the safety of the drug devel23 oped for one or more indications of the drug ap24 proved under such section 505(c) or licensed under 

25 such section 351(a); 


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1 ‘‘(4) the supplemental application incorporates 

2 or supplements the data submitted in the application 

3 for approval or licensure referred to in paragraph 

4 (1); and 

5 ‘‘(5) the full data sets used to develop the quali6 fied data summaries are submitted, unless the Sec7 retary determines that the full data sets are not re8 quired. 

9 ‘‘(c) PUBLIC AVAILABILITY OF INFORMATION ON

10 PROGRAM.—The Secretary shall post on the public website 

11 of the Food and Drug Administration and update annu12 ally— 

13 ‘‘(1) the number of applications reviewed under 

14 the streamlined data review program; 

15 ‘‘(2) the average time for completion of review 

16 under the streamlined data review program versus 

17 other review of applications for new indications; and 

18 ‘‘(3) the number of applications reviewed under 

19 the streamlined data review program for which the 

20 Food and Drug Administration made use of full 

21 data sets in addition to the qualified data summary. 

22 ‘‘(d) DEFINITIONS.—In this section: 

23 ‘‘(1) The term ‘qualified indication’ means— 


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1 ‘‘(A) an indication for the treatment of 

2 cancer, as determined appropriate by the Sec3 retary; or 

4 ‘‘(B) such other types of indications as the 

5 Secretary determines to be subject to the 

6 streamlined data review program under this 

7 section. 

8 ‘‘(2) The term ‘qualified data summary’ means 

9 a summary of clinical data intended to demonstrate 

10 safety and effectiveness with respect to a qualified 

11 indication for use of a drug.’’. 

12 (b) SENSE OF CONGRESS.—It is the sense of Con13 gress that the streamlined data review program under sec14 tion 505F of the Federal Food, Drug, and Cosmetic Act, 

15 as added by subsection (a), should enable the Food and 

16 Drug Administration to make approval decisions for cer17 tain supplemental applications based on qualified data 

18 summaries (as defined in such section 505F). 

19 (c) GUIDANCE; REGULATIONS.—The Commissioner 

20 of Food and Drugs— 

21 (1) shall— 

22 (A) issue final guidance for implementation 

23 of the streamlined data review program estab24 lished under section 505F of the Federal Food, 

25 Drug, and Cosmetic Act, as added by subVerDate Sep 11 2014 02:15 May 27, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2415.IH H2415

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1 section (a), not later than 24 months after the 

2 date of enactment of this Act; and 

3 (B) include in such guidance the process 

4 for expanding the types of indications to be 

5 subject to the streamlined data review program, 

6 as authorized by section 505F(c)(1)(B) of such 

7 Act; and 

8 (2) in addition to issuing guidance under para9 graph (1), may issue such regulations as may be 

10 necessary for implementation of the program. 

Æ 


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