Notice: Food and Drug Administration Transparency Initiative: Exploratory 
Program To Increase Access to the Agency's Compliance and Enforcement 
Data; Availability

Federal Register: Volume 77, Number 21 (Wednesday, February 1, 2012)
                  Pages 5027-5028

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Food and Drug Administration 
Transparency Initiative: Exploratory Program to

[[Page 5028]]

Increase Access to the Agency's Compliance and Enforcement Data,'' as 
part of the Transparency Initiative. This report includes eight 
initiatives adopted by the Commissioner of Food and Drugs (the 
Commissioner) to explore avenues for making FDA's publicly available 
compliance and enforcement data more accessible and user-friendly.

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 ``Food and Drug Administration Transparency Initiative: 
Exploratory Program to Increase Access to the Agency'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.
    In a May 6, 2011, memorandum to the Department of Health and Human 
Services responding to a January 18, 2011, Presidential Memorandum on 
Regulatory Compliance, (76 FR 3825, January 21, 2011), FDA recounted 
the actions it had already implemented, as well as those proposed or 
underway, to increase public accessibility of its regulatory compliance 
and enforcement information. FDA stated that it would: (1) Issue 
proposals for public comment within 150 days (by October 3, 2011) if it 
concluded that there were additional opportunities to increase the 
transparency of its compliance and enforcement data, and (2) determine 
within 270 days (by January 31, 2012) whether to adopt such proposals.
    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,'' that advanced eight draft 
proposals to make FDA's publicly available compliance and enforcement 
data more accessible and user-friendly 
(http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM273145.pdf). 
In publishing a notice of availability of this report on October 4, 2011 
(76 FR 61366), FDA sought public comment on these proposals by December 
2, 2011. The Agency stated that its Transparency Task Force would 
ultimately recommend specific draft proposals to the Commissioner for 
consideration based on the comments it received, the feasibility of 
each draft proposal, relative priority, and available resources, and 
that the Commissioner would determine whether to adopt any of these 
draft proposals by January 31, 2012.
    Based on a review of the recommendations of the Transparency Task 
Force, the Commissioner is adopting all eight of the draft proposals 
published in October 2011 as initiatives the Agency will explore, 
thereby committing the Agency to investigating numerous avenues for 
increasing the transparency and public accessibility of its compliance 
and enforcement data.

    Dated: January 27, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-2184 Filed 1-31-12; 8:45 am]
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