Document ID: FDA-2009-N-0247-0281
Agency: fda
Document Type: Notice
Title: 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; Availability
Posted Date: 2011-10-04T04:00Z

[Federal Register Volume 76, Number 192 (Tuesday, October 4, 2011)]
[Notices]
[Pages 61366-61367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25354]

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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: Draft 
Proposals for Public Comment to Increase Transparency By Promoting 
Greater Access to the Agency's Compliance and Enforcement Data; 
Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 61367]]

ACTION: Notice of availability; request for comments.

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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: Draft 
Proposals for Public Comment to Increase Transparency By Promoting 
Greater Access to the Agency's Compliance and Enforcement Data.'' This 
report includes eight draft proposals to make FDA's publicly available 
compliance and enforcement data more accessible and user-friendly. FDA 
is seeking public comment on these draft proposals. The Transparency 
Task Force will ultimately recommend specific draft proposals to the 
Commissioner of Food and Drugs (the Commissioner) for consideration 
based on the comments it receives, the feasibility of the draft 
proposal, relative priority, and available resources.

DATES: Submit either electronic or written comments by December 2, 
2011.

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 at the heading of this document and the draft 
proposal(s) that the comments address.

FOR FURTHER INFORMATION CONTACT: Lisa M. Dwyer, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4228, Silver Spring, MD 20993, 301-796-4709, FAX: 301-
847-8616, e-mail: lisa.dwyer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a report entitled ``FDA 
Transparency Initiative: Draft Proposals for Public Comment to Increase 
Transparency By Promoting Greater Access to the Food and Drug 
Administration's Compliance and Enforcement Data.'' FDA is responsible 
for a broad range of compliance and enforcement activities. Increasing 
the transparency of these activities allows the public to better 
understand the Agency's decisions, and it promotes accountability of 
the Agency and the regulated industry.
    On January 18, 2011, President Obama issued a Presidential 
Memorandum on Regulatory Compliance, 76 FR 3825 (January 21, 2011), 
requiring Federal Agencies to make publicly available compliance 
information easily accessible, downloadable, and searchable online. In 
that memorandum, the President highlighted the achievements of the 
Environmental Protection Agency (EPA) and the Department of Labor (DOL) 
in developing Web sites (http://www.epa-echo.gov and http://ogesdw.dol.gov, respectively) that make their regulatory compliance 
information more accessible to the public.
    FDA responded to the Presidential Memorandum on Regulatory 
Compliance in a memorandum to the Department of Health and Human 
Services (HHS), on May 6, 2011 (FDA Response). The FDA Response 
summarized the actions that the Agency already had implemented, as well 
as those that were underway or proposed, to make its regulatory 
compliance and enforcement information more accessible to the public. 
FDA took those actions in response to the Presidential Memorandum on 
Transparency and Open Government, 74 FR 4685 (January 26, 2009), which 
the President issued in January 2009, and as part of FDA's own 
Transparency Initiative, which the Commissioner, Dr. Margaret A. 
Hamburg, launched in June 2009.
    In the FDA response, the Agency also committed to examining the 
manner in which EPA and DOL disclose compliance and enforcement 
information to determine whether there are additional steps FDA could 
take to make comparable information more accessible. Specifically, FDA 
stated that it would: (1) Within 150 days (by October 3, 2011), issue 
proposals for public comment, if it concluded that there were 
additional opportunities to increase the transparency of its compliance 
and enforcement data and (2) within 270 days (January 31, 2012), 
determine whether to adopt those proposals.
    After meeting with EPA and DOL to discuss their methods for making 
compliance and enforcement data more accessible, FDA has determined 
that there are additional steps that it could take to make its own 
information more transparent and accessible to the public. This report 
contains FDA's draft proposals for public comment.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify the 
draft proposal(s) which your comment addresses by the number assigned 
to the proposal. 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.

    Dated: September 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25354 Filed 10-3-11; 8:45 am]
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