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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. STREAMLINED DATA REVIEW PROGRAM. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505F of such Act (21 U.S.C. 355f) the following: 
‘‘SEC. 505F. STREAMLINED DATA REVIEW PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
streamlined data review program under which a holder of 
an 
approved 
application 
submitted 
under 
section 
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505(b)(1) or under section 351(a) of the Public Health 
Service Act may, to support the approval or licensure (as 
applicable) of the use of the drug that is the subject of 
such approved application for a new qualified indication, 
submit qualified data summaries. 
‘‘(b) ELIGIBILITY.—In carrying out the streamlined 
data review program under subsection (a), the Secretary 
may authorize the holder of the approved application to 
include one or more qualified data summaries described 
in subsection (a) in a supplemental application if— 
‘‘(1) the drug has been approved under section 
505(c) of this Act or licensed under section 351(a) 
of the Public Health Service Act for one or more in-
dications, and such approval or licensure remains in 
effect; 
‘‘(2) the supplemental application is for ap-
proval or licensure (as applicable) under such section 
505(c) or 351(a) of the use of the drug for a new 
qualified indication under such section 505(c) or 
351(a); 
‘‘(3) there is an existing database acceptable to 
the Secretary regarding the safety of the drug devel-
oped for one or more indications of the drug ap-
proved under such section 505(c) or licensed under 
such section 351(a); 
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‘‘(4) the supplemental application incorporates 
or supplements the data submitted in the application 
for approval or licensure referred to in paragraph 
(1); and 
‘‘(5) the full data sets used to develop the quali-
fied data summaries are submitted, unless the Sec-
retary determines that the full data sets are not re-
quired. 
‘‘(c) PUBLIC AVAILABILITY
OF INFORMATION
ON 
PROGRAM.—The Secretary shall post on the public website 
of the Food and Drug Administration and update annu-
ally— 
‘‘(1) the number of applications reviewed under 
the streamlined data review program; 
‘‘(2) the average time for completion of review 
under the streamlined data review program versus 
other review of applications for new indications; and 
‘‘(3) the number of applications reviewed under 
the streamlined data review program for which the 
Food and Drug Administration made use of full 
data sets in addition to the qualified data summary. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘qualified indication’ means— 
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‘‘(A) an indication for the treatment of 
cancer, as determined appropriate by the Sec-
retary; or 
‘‘(B) such other types of indications as the 
Secretary determines to be subject to the 
streamlined data review program under this 
section. 
‘‘(2) The term ‘qualified data summary’ means 
a summary of clinical data intended to demonstrate 
safety and effectiveness with respect to a qualified 
indication for use of a drug.’’. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that the streamlined data review program under sec-
tion 505F of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), should enable the Food and 
Drug Administration to make approval decisions for cer-
tain supplemental applications based on qualified data 
summaries (as defined in such section 505F). 
(c) GUIDANCE; REGULATIONS.—The Commissioner 
of Food and Drugs— 
(1) shall— 
(A) issue final guidance for implementation 
of the streamlined data review program estab-
lished under section 505F of the Federal Food, 
Drug, and Cosmetic Act, as added by sub-
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section (a), not later than 24 months after the 
date of enactment of this Act; and 
(B) include in such guidance the process 
for expanding the types of indications to be 
subject to the streamlined data review program, 
as authorized by section 505F(c)(1)(B) of such 
Act; and 
(2) in addition to issuing guidance under para-
graph (1), may issue such regulations as may be 
necessary for implementation of the program. 
Æ 
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