2011-25354. 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.

ACTION:

Notice of availability; request for comments.

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: [phone], e-mail: [e-mail].

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.