[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22693-22694]
From the Federal Register Online via the Government Publishing 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: [email protected].
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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