[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52202-52203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0745]


Request for Comments on the Food and Drug Administration Safety 
and Innovation Act Section 907 Report

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for comments pertaining to the report 
issued as required by section 907 of the Food and Drug Administration 
Safety and Innovation Act (FDASIA). This notice is intended to solicit 
input from all relevant stakeholders before FDA issues an action plan 
to address issues raised in the report and to announce that such 
information submitted to FDA is available to all interested persons in 
a timely fashion.

DATES: Submit electronic or written comments by November 20, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Pamela E. Scott, Office of Women's 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 2320, Silver Spring, MD 20903,

[[Page 52203]]

301-796-9441, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the President signed FDASIA (Pub. L. 112-144) into 
law. Section 907 of FDASIA requires that FDA report on and address 
certain information regarding clinical trial participation by 
demographic subgroups and subset analysis of the resulting data. 
Specifically, section 907(a) of FDASIA requires the Secretary of Health 
and Human Services (the Secretary), acting through the FDA 
Commissioner, to publish on FDA's Internet Web site a report 
``addressing the extent to which clinical trial participation and the 
inclusion of safety and effectiveness data by demographic subgroups 
including sex, age, race, and ethnicity, is included in applications 
submitted to the FDA,'' and provide such publication to Congress. The 
report entitled ``Reporting of Inclusion of Demographic Subgroups in 
Clinical Trials and Data Analysis in Applications for Drugs, Biologics, 
and Devices'' is available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm356316.htm.
    Section 907(b) of FDASIA further requires the Secretary, again 
acting through the Commissioner, to publish an action plan on the 
Internet Web site of FDA and provide such publication to Congress. The 
action plan is to contain recommendations, as appropriate, to improve 
the completeness and quality of analyses of data on demographic 
subgroups in summaries of product safety and effectiveness and in 
labeling; on the inclusion of such data, or the lack of availability of 
such data in labeling; and on ways to improve public availability of 
such data to patients, health care providers, and researchers. These 
recommendations are to include, as appropriate, a determination that 
distinguishes between product types and applicability. The action plan 
is due not later than 1 year after the publication of the report 
described previously.
    FDA is opening a docket for 90 days to provide an opportunity for 
interested individuals to submit comments on the report for use in the 
development of the action plan. When submitting comments please 
reference the section of the report to which your comments pertain. 
This docket is intended to ensure that stakeholders have an opportunity 
to provide comments and that such information submitted to FDA is 
available to all interested persons in a timely fashion.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20352 Filed 8-20-13; 11:15 am]
BILLING CODE 4160-01-P