Document ID: FDA-2009-N-0247-0310
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Transparency Initiative: Increasing
Public Access to the Food and Drug Administration’s Compliance and
Enforcement Data; Availability
Posted Date: 2014-04-23T04:00Z

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22693-22694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09188]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0247]

Food and Drug Administration Transparency Initiative: Increasing 
Public Access to the Food and Drug Administration's Compliance and 
Enforcement Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: As part of the Transparency Initiative, the Food and Drug 
Administration (FDA) is announcing the availability of a report 
entitled ``Food and Drug Administration Transparency Initiative: 
Increasing Public Access to FDA's Compliance and Enforcement

[[Page 22694]]

Data.'' This report summarizes findings and recommendations from eight 
FDA working groups established to enhance the transparency and public 
accessibility of the Agency's compliance and enforcement data.

FOR FURTHER INFORMATION CONTACT: Daniel W. Sigelman, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4254, Silver Spring, MD 20993, 301-796-4706, FAX: 301-
847-8616, email: daniel.sigelman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
report entitled ``FDA Transparency Initiative: Increasing Public Access 
to FDA's Compliance and Enforcement Data.'' FDA is responsible for a 
broad range of compliance and enforcement activities. Increasing the 
transparency of these activities enhances the public's understanding of 
the Agency's decisions and promotes accountability of the Agency and 
the regulated industry.
    On October 3, 2011, FDA issued a report entitled, ``Food and Drug 
Administration Transparency Initiative: Draft Proposals for Public 
Comment to Increase Transparency by Promoting Greater Access to the 
Agency's Compliance and Enforcement Data.'' The report advanced eight 
draft proposals for making FDA's publicly available compliance and 
enforcement data more accessible and user-friendly (available at: 
http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM273145.pdf). Following extensive public 
comment on the report and internal FDA deliberation, the FDA 
Commissioner adopted all eight draft proposals, committing FDA to 
exploring numerous avenues for increasing the transparency and public 
accessibility of its compliance and enforcement data (see 77 FR 5027, 
February 1, 2012, and http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm289638.htm).
    To develop plans for addressing the eight initiatives, FDA 
established eight working groups with representatives from all of FDA's 
centers and several of its offices. Each group was asked to draft a 
report on its initiative and to include recommendations for moving 
forward. These efforts culminated in the preparation of this report, 
which summarizes the eight initiatives and the recommendations from the 
relevant working groups for enhancing the transparency and public 
accessibility of FDA's compliance and enforcement data.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09188 Filed 4-22-14; 8:45 am]
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