[Federal Register Volume 75, Number 48 (Friday, March 12, 2010)]
[Notices]
[Pages 11893-11894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5377]
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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 Task Force; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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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:
301-847-3531, e-mail: [email protected].
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
[[Page 11894]]
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]
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