[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1180-1181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-71]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


FDA Transparency Initiative: Improving Transparency to Regulated 
Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: As part of the third phase of the Transparency Initiative, the 
Food and Drug Administration (FDA) is announcing the availability of a 
report entitled ``FDA Transparency Initiative: Improving Transparency 
to Regulated Industry.'' The report includes 19 action items and 5 
draft proposals to improve transparency to regulated industry. FDA is 
seeking public comment on the content of the draft proposals, as well 
as on which draft proposals should be given priority.

DATES: Submit electronic or written comments by March 8, 2011.

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 at the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ann Witt, Office of Policy, Planning, 
and Budget, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg 32, rm. 4226, Silver Spring, MD 20993, 301-796-7463, FAX: 301-847-
8616, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background on the FDA Transparency Initiative

    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 
December 8, 2009. Under the leadership of Secretary of Health and Human 
Services, Kathleen Sebelius, the U.S. Department of Health and Human 
Services has also prioritized transparency and openness. In June 2009, 
the Commissioner of Food and Drugs (the 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 FDA and includes five of the Agency's

[[Page 1181]]

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.
    The Task Force has held two public meetings,\1\ launched an online 
blog (http://fdatransparencyblog.fda.gov/), and opened a docket. The 
online blog and the docket received over 1,500 comments. The blog, 
which is ongoing, has offered an opportunity for exchange about 
specific ideas for transparency at the Agency.
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    \1\ Transcripts and the webcast from both public meetings are 
available on the FDA Web site, http://www.fda.gov/transparency.
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    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. In early January 2010, FDA 
launched a Web-based resource called FDA Basics (http://www.fda.gov/fdabasics). The resource now includes (1) 158 questions and answers 
about FDA and the products that the Agency regulates, (2) 9 short 
videos that explain various FDA activities, and (3) 14 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 public about that 
topic. FDA uses the feedback provided by the public to update this 
resource.
    Phase II relates to FDA's proactive disclosure of information the 
Agency has in its possession, and how to make information about Agency 
activities and decisionmaking more transparent, useful, and 
understandable to the public, while appropriately protecting 
confidential information. On May 19, 2010, FDA released a report that 
contains 21 draft proposals about expanding the disclosure of 
information by FDA while maintaining confidentiality for trade secrets 
and individually identifiable patient information.
    The Task Force solicited comment on the content of the proposals, 
as well as on which draft proposals should be given priority, for 60 
days. The Task Force is reviewing the comments received and will 
recommend specific proposals to the Commissioner for consideration. The 
Task Force's recommendations will consider feasibility and priority, 
considering other Agency priorities that require resources. Not all of 
these proposals will necessarily be implemented. Some may require 
changes in law or regulation; some may require a substantial amount of 
resources.
    Phase III is the subject of this document and is described in more 
detail in section II of this document.

II. Phase III: Transparency to Regulated Industry

    The third phase of the Transparency Initiative addresses ways FDA 
can become more transparent to regulated industry to foster a more 
efficient and cost-effective regulatory process.
    Regulated industry provides the public with food, drugs, medical 
devices, cosmetics, and other widely used and important consumer 
products. FDA's mission is to protect and promote the public health 
through oversight of these products.
    In order to succeed, FDA must clearly communicate standards and 
expectations to industry. Communicating requirements and expectations 
to industry in a more accessible manner promotes understanding of, and 
compliance with, rules set up to protect the supply of food and medical 
products.
    In response to a request for input from FDA on this topic in March 
2010 (75 FR 11893, March 12, 2010), regulated companies requested 
additional transparency about the standards to which their products are 
held, the process for soliciting guidance from the Agency, and the 
progress of regulatory efforts at the Agency. In the report, FDA 
outlines 19 action items and 5 draft proposals to improve transparency 
to regulated industry.
    The Task Force is soliciting comment on the content of the five 
draft proposals, as well as on which draft proposals should be given 
priority, for 60 days. After considering public comment on the draft 
proposals, the Task Force will recommend specific proposals to the 
Commissioner for consideration. FDA will begin to implement the action 
items in the report in 2011.

III. Request for Comments

    FDA is interested in receiving comments from the public about the 
content of the five 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 comments with the docket number found in brackets in 
the heading of this document. Identify the draft proposal which your 
comment addresses by the number assigned to that proposal. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: January 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-71 Filed 1-6-11; 8:45 am]
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