[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69863-69864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27732]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1818]


New Clinical Trials Demographic Data; Availability for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of Demographic Subgroup Data for FDA 
Approved Products on FDA's Internet Web site. This new posting 
implements Action 3.1 from Priority 3 of the Food and Drug 
Administration Safety and Innovation Act (FDASIA) Section 907 Action 
Plan designed to improve the availability and transparency of clinical 
trial demographic subgroup data. FDA is requesting comments on the 
format, content, and overall usability of the site to determine whether 
this approach is user friendly to the public.

DATES: Submit electronic or written comments on the content by January 
23, 2015.

ADDRESSES: Submit electronic comments on the Web page 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.

FOR FURTHER INFORMATION CONTACT: Laurie Haughey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6511, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of clinical trial demographic 
data for consumers on FDA's Internet Web site at www.fda.gov/drugtrialssnapshot.
    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

[[Page 69864]]

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,'' was posted on FDA's 
Internet Web site in August 2013 and 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 FDA's 
Internet Web site 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. The action plan entitled ``FDA Action Plan to Enhance the 
Collection and Availability of Demographic Subgroup Data'' was 
published in August 2014 and is available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm356316.htm.
    Priority three of the action plan aims to make demographic data 
more available and transparent by, amongst other things, posting 
demographic composition and analysis by subgroup in pivotal clinical 
studies for FDA-approved medical products. The first iteration of FDA's 
publication of this data is available at www.fda.gov/drugtrialssnapshot.

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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 19, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27732 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P