[Federal Register Volume 75, Number 98 (Friday, May 21, 2010)]
[Notices]
[Pages 28622-28623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12314]


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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: [email protected].

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

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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]
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