[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Notices]
[Page 28622-28623]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my10-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0247]
FDA Transparency Initiative: Draft Proposals for Public Comment
Regarding Disclosure Policies of the U.S. Food and Drug Administration;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; request for comments.
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SUMMARY: As part of the second phase of the Transparency Initiative,
the Food and Drug Administration (FDA) is announcing the availability
of a report entitled ``FDA Transparency Initiative: Draft Proposals for
Public Comment Regarding Disclosure Policies of the U.S. Food and Drug
Administration.'' The report includes 21 draft proposals about
expanding disclosure of information by the agency while maintaining
confidentiality of trade secrets and individually identifiable patient
information. FDA is seeking public comment on the draft proposals, as
well as on which draft proposals should be given priority. Some of the
draft proposals may require extensive resources to implement, and some
may require changes to regulations or legislation.
DATES: Submit either electronic or written comments by July 20, 2010.
ADDRESSES: Submit electronic comments to http://www.regulations.gov or
on the FDA Web site, www.fda.gov/transparency. 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.
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, 301-796-4625, FAX: 301-847-
3531, e-mail: Afia.Asamoah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Every day, the U.S. Food and Drug Administration (FDA) makes
important health and safety decisions about foods, drugs, medical
devices, cosmetics, and other widely used consumer products.
Transparency in FDA's activities and decisionmaking allows the public
to better understand the agency's decisions, increasing credibility and
promoting accountability. Transparency helps the agency to more
effectively protect and promote the public health.
In January 2009, President Obama issued a memorandum on
Transparency and Open Government calling for an ``unprecedented level
of openness in Government'' and directing the Director of the Office of
Management and Budget (OMB) to issue an Open Government Directive
instructing executive departments and agencies to take specific actions
to implement the principles of transparent, collaborative, and
participatory government. The Open Government Directive was issued in
December. Under the leadership of Secretary Kathleen Sebelius, the U.S.
Department of Health and Human Services has also prioritized
transparency and openness. In June 2009, FDA Commissioner Dr. Margaret
Hamburg launched FDA's Transparency Initiative to implement these
efforts at FDA.
The initiative is overseen by a Task Force representing key leaders
of FDA. The internal task force is chaired by the Principal Deputy
Commissioner of the FDA and includes five of the agency's center
directors, the Chief Counsel, the Associate Commissioner of Regulatory
Affairs, and the Chief Scientist. The Task Force is charged with
submitting a written report to the Commissioner on the Task Force's
findings and recommendations.
Over the last 11 months, the Task Force has held two public
meetings, launched an online blog (http://fdatransparencyblog.fda.gov/
), and opened a docket. The online blog and the docket have received
over 1,500 comments.
The Task Force is proceeding with the Transparency Initiative in
three phases:
Phase I: FDA Basics
Phase II: Public Disclosure
Phase III: Transparency to Regulated Industry
Phase I is intended to provide the public with basic information
about FDA and how the agency does its work. This phase was unveiled in
early January 2010 with the launch of a web-based resource called FDA
Basics (www.fda.gov/fdabasics). The resource now includes (1) 126
questions and answers about FDA and the products that the agency
regulates, (2) 9 short videos that explain various FDA activities, and
(3) 10 conversations with FDA officials about the work of their
Offices. Each month, senior officials from FDA product centers and
offices host online sessions about a specific topic and answer
questions from the
[[Page 28623]]
public about that topic. FDA uses the feedback provided by the public
to update this resource.
Phase II is the subject of this document and is described in more
detail in section II of this document.
Phase III of the Transparency Initiative will address ways FDA can
become more transparent to regulated industry, to foster a more
efficient and cost-effective regulatory process. The Task Force
solicited comments from the public on this topic in March 2010 (75 FR
11893, March 12, 2010) and draft proposals from this phase are expected
in the summer of 2010.
II. Phase II: Public Disclosure
The second phase of the Transparency Initiative relates to FDA's
policies on disclosure of information to the public about FDA
activities. FDA is releasing a report that contains 21 draft proposals
that we are issuing for public comment. The draft proposals, along with
background material, can be found on the FDA Web site at www.fda.gov/
transparency. FDA is accepting comments from the public on the draft
proposals on the FDA Web site as well as through the docket (see
section III of this notice).
The Task Force solicited comments from the public about information
FDA should provide to the public about what FDA is doing, the bases for
the agency's decisions, and the processes used to make agency
decisions. The Task Force reviewed and considered all the comments
received from a range of stakeholders. The Task Force also identified
on its own initiative ways to improve transparency that are reflected
in the report.
In the report, the Task Force makes available for public comment 21
draft proposals for changes in policy related to the disclosure of
information FDA has in its possession, while supporting the redaction
of trade secrets and individually identifiable patient information from
all documents proposed for disclosure. Other topics on which FDA plans
to make changes or on which the Task Force is not proposing policy
changes at this time are discussed in the ``Other Areas of Public
Comment'' section of the report.
After considering public comment on the draft proposals, the Task
Force will recommend specific proposals to the Commissioner for
consideration, and then FDA will announce which of the proposals it
will implement, and the projected timeframe for implementation. Some of
the draft proposals may require extensive resources to implement, and
some may require changes to regulations or legislation. Therefore, in
addition to input on the content of the proposals and whether the Task
Force has struck the right balance with respect to the draft proposals,
FDA is seeking input on how the agency should prioritize the proposals,
if it decided to implement them. The Task Force will consider
feasibility and priority, considering other agency priorities that
require resources, when developing its specific recommendations for the
Commissioner.
III. Request for Comments
FDA is interested in receiving comments from the public about the
content of the draft proposals as well as on which draft proposals
should be given priority. 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 which your comment addresses by
the number assigned to that 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. Comments can also be submitted
on each draft proposal via the FDA Web site, www.fda.gov/transparency.
Dated: May 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12314 Filed 5-19-10; 8:45 am]
BILLING CODE 4160-01-S