[Federal Register Volume 75, Number 48 (Friday, March 12, 2010)]
[Pages 11893-11894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5377]



Food and Drug Administration

[Docket No. FDA-2009-N-0247]

Food and Drug Administration Transparency Task Force; Request for 

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.

Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, rm. 2220, Silver Spring, MD 20993-0002, 301-796-4625, FAX: 
301-847-3531, e-mail: [email protected].


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

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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.
[FR Doc. 2010-5377 Filed 3-11-10; 8:45 am]