2010-5377. Food and Drug Administration Transparency Task Force; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is soliciting comments from interested persons on ways in which FDA can increase transparency between FDA and regulated industry.

DATES:

Submit electronic or written comments by April 12, 2010.

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 in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Afia Asamoah, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 2220, Silver Spring, MD 20993-0002, 301-796-4625, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

Transparency promotes accountability and provides information to the public about government activities and initiatives. For FDA, providing information to the public in a timely, user-friendly manner is important to enhance the work of the agency.

Government transparency and accountability is a priority for the Obama Administration. On January 21, 2009, President Obama instructed executive departments and agencies to take appropriate action, consistent with law and policy, to disclose information to the public rapidly, and in a form that is easily accessible and user friendly. Executive departments and agencies have been charged with harnessing new technologies to make information about agency operations and decisions available online and readily available to the public. Executive departments and agencies have been asked to solicit public input to identify information of greatest use to the public.

The Open Government Directive, issued by the Director of the Office of Management and Budget on December 8, 2009, further instructed executive departments and agencies to take specific actions to implement a transparent, collaborative, and participatory government.

FDA has formed an internal Transparency Task Force to develop recommendations for making useful and understandable information about FDA activities and decisionmaking more readily available to the public. The recommendations will focus on disclosing relevant information in a timely manner and in a user-friendly format, and in a manner compatible with the agency's goal of protecting confidential information, as appropriate. As a part of this transparency initiative, the Task Force has held two public meetings, on June 24, 2009, and November 3, 2009, and established a public docket to seek public input on these issues. As a result of the input the Task Force has received thus far, it has decided to separate the Transparency Initiative into three phases: (1) Creating a Web-based resource called “FDA Basics,” that provides information about commonly misunderstood agency activities and frequently asked questions; (2) improving FDA's disclosure of information to the public; and (3) improving FDA's transparency to regulated industry.

The first two phases are complete or well underway. “FDA Basics” was launched on FDA's Web site on January 12, 2010. The two public meetings held in 2009 and prior specific requests for comments focused on how FDA can improve its disclosure to the public. The Task Force soon plans to issue draft proposals related to those issues for public comment. This document focuses on the third phase of the transparency initiative.

II. Scope of the Meeting

The Task Force is collecting information on how to improve FDA's transparency to regulated industry. It held three listening sessions with members of regulated industry on January 21, 27, and 28, 2010. FDA is making available transcripts and summaries of those listening sessions (see section IV of this document), and seeks public comment related to the issues raised in those sessions or other suggestions related to FDA's transparency to regulated industry. FDA is particularly interested in comments on how FDA can make improvements in the following areas:

1. Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements.

2. The guidance development process.

3. Maintaining open channels of communication with industry routinely and during crises.

4. Providing useful and timely answers to industry questions about specific regulatory issues.

5. Communicating with sponsors during review of applications.

III. Request for Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. To permit time for interested persons to submit data, information, or views on this subject, submit comments by (see DATES). Where relevant, you should annotate and organize your comments to identify the specific question addressed by the question number referenced in the previous text. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

IV. Transcripts

Transcripts and summaries are accessible at http://www.regulations.gov and on the Transparency Task Force Web site at http://www.fda.gov/​transparency. Transcripts and summaries may be viewed at the Division of Dockets Management (see ADDRESSES). They will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

Dated: March 5, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.