Document ID: FDA-2013-N-0745-0053
Agency: fda
Document Type: Notice
Title: Reopening of Docket and Request for Comments on the Food and Drug
Administration Safety and Innovation Act Action Plan
Posted Date: 2014-08-22T04:00Z

[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49781-49782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19881]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Reopening of Docket and Request for Comments on the Food and Drug 
Administration Safety and Innovation Act Action Plan

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the action plan issued as required by section 907 of 
the Food and Drug Administration Safety and Innovation Act (FDASIA) and 
the reopening of a public docket for comments pertaining to the action 
plan.

DATES: Submit electronic or written comments by October 21, 2014.

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: Jonca Bull, Office of Minority Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 
4239, Silver Spring, MD, 20993-0002, 301-796-8000, 
jonca.bull@fda.hhs.gov.

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,'' 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

[[Page 49782]]

``FDA Action Plan to Enhance the Collection and Availability of 
Demographic Subgroup Data'' is being issued with this notice and is 
available at http://www.fda.gov/RegulatoryInformation/;Legislation/
FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/
FDASIA/ucm356316.htm.
    FDA is reopening the docket for 60 days to provide an opportunity 
for interested individuals to submit comments on the action plan. When 
submitting comments please reference the section of the action plan 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. How to Submit 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 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19881 Filed 8-21-14; 8:45 am]
BILLING CODE 4164-01-P