[Federal Register Volume 74, Number 105 (Wednesday, June 3, 2009)]
[Notices]
[Pages 26712-26713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12902]
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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; Public
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to solicit recommendations from interested persons on ways in
which FDA can make useful and understandable information about FDA
activities and decisionmaking more readily available to the public.
Dates and Times: The public meeting will be held on June 24, 2009,
from 8 a.m. to 5 p.m. Persons interested in attending the meeting must
register by June 17, 2009. Submit written or electronic comments by
August 7, 2009.
Location: The public meeting will be held at the National
Transportation Safety Board (NTSB) Conference Center, 429 L'Enfant
Plaza, SW., Washington, DC 20594.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document. Submit
electronic registration via e-mail to [email protected]
by close of business on June 17, 2009. Transcripts of the meeting will
be available for review at the Division of Dockets Management and on
the Internet at http://www.regulations.gov approximately 30 days after
the meeting.
For Registration to Attend and/or to Participate in the Meeting: If
you wish to attend public meeting and/or make an oral presentation at
the meeting, you must register by e-mail (see ADDRESSES) by close of
business on June 17, 2009. When registering, you must provide the
following information: (1) Your name, title, company or organization
(if applicable), address, phone number, and e-mail address and (2) if
you wish to make a presentation, the specific topic or issue to be
addressed and the approximate desired length of your presentation.
There is no fee to register for the public meeting and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited. Registration on the day of the
public meeting will be permitted on a space-available basis beginning
at 7:30 a.m.
We will do our best to accommodate all persons who wish to make a
presentation at the meeting. FDA encourages persons and groups having
similar interests to consolidate their information for presentation
through a single representative. After reviewing the requests to
present, we will contact each participant prior to the meeting with the
amount of time available and the approximate time the participant's
presentation is scheduled to begin. Presenters must then send the final
electronic copies of their presentations in Microsoft PowerPoint,
Microsoft Word, or Adobe Portable Document Format (PDF) to
[email protected] by June 22, 2009.
If you need special accommodations due to a disability, please
inform the contact person (see FOR FURTHER INFORMATION CONTACT) by June
17, 2009.
FOR FURTHER INFORMATION CONTACT: Afia Asamoah, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
rm. 2208, Silver Spring, MD 20993, 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 issued two
memoranda to the heads of executive departments and agencies regarding
openness in government.\1\ In the memorandum on Transparency and Open
Government (``Transparency and Open Government memorandum''), the
Administration has pledged 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. Further, executive departments and
agencies have been instructed to solicit public input to identify
information of greatest use to the public.
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\1\ Presidential Documents, Memorandum for the Heads of
Executive Departments and Agencies on Transparency and Open
Government (January 21, 2009) (74 FR 4685, January 26, 2009),
available at http://www.whitehouse.gov/open/; Presidential
Documents, Memorandum for the Heads of Executive Departments and
Agencies on Freedom of Information Act (January 21, 2009) (74 FR
4683, January 26, 2009), available at http://www.gpo.gov/fdsys/pkg/FR-2009-01-26/pdf/E9-1773.pdf.
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In the Transparency and Open Government memorandum, President Obama
directed the Chief Technology Officer, in coordination with the
Director of the Office of Management and Budget (OMB) and the
Administrator of General Services, to coordinate the development of
recommendations for an Open Government Directive. This Directive, to be
issued by the Director of the OMB, is to instruct executive departments
and agencies to take specific actions implementing the principles set
forth in this memorandum.
In the memorandum on the Freedom of Information Act (FOIA) (``FOIA
memorandum''), the Administration noted that principles embodied in the
FOIA express our Nation's commitment to an open government. Executive
agencies were instructed to adopt a presumption in favor of disclosure
with respect to all decisions involving the FOIA. The Attorney General
was directed to issue new guidelines governing the FOIA to the heads of
executive departments and agencies. On March 19, 2009, the Attorney
General issued guidelines for implementing the FOIA in a memorandum for
heads of executive departments and agencies.\2\ Regarding the
presumption of openness, the Attorney General strongly encouraged
agencies to make discretionary disclosures, but also noted
[[Page 26713]]
that the FOIA's disclosure obligation is not absolute and provides
exemptions to protect, for example, national security, personal
privacy, privileged records, and law enforcement interests.
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\2\ Office of the Attorney General, Memorandum for the Heads of
Executive Departments and Agencies on The Freedom of Information Act
(March 19, 2009), available at http://www.usdoj.gov/ag/foia-memo-march2009.pdf.
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In response to both Presidential memoranda, 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 in a timely manner
and in a user-friendly format, in a manner compatible with the agency's
goal of protecting confidential information, as appropriate. As a part
of this process, the Task Force is holding two public meetings and
establishing a public docket to seek public input on these issues. The
first public meeting to solicit input from interested stakeholders on
improving agency transparency, the subject of this meeting notice, will
be held on June 24, 2009. The Task Force is exploring additional ways
to seek input through the Internet, and is planning to hold a second
public meeting in the fall of 2009. A meeting announcement describing
the scope of the second meeting will be published in the Federal
Register.
II. Scope of Meeting
FDA is interested in receiving comments from the public on issues
related to transparency. The comments should focus on ways in which the
agency should provide information to the public about what FDA is
doing, the bases for the agency's decisions, and the processes used to
make agency decisions. In addition to general suggestions about the
ways the agency can inform the public, we are specifically interested
in soliciting input on the following questions:
1. How can the agency better explain its operations, activities,
processes, and decisionmaking?
2. What specific information should FDA provide about agency
operations, activities, processes, and decisionmaking, including:
a. Enforcement actions?
b. Product approvals?
c. Recalls?
d. Other actions?
3. What tools, techniques, processes, or other mechanisms should FDA
use to be more effective in providing useful and understandable
information?
a. Internet tools?
b. Tools to improve targeting and effectiveness of communications,
including risk communication?
c. Improvements to the Freedom of Information Act processes?
d. Other?
4. What, if any, legislative or regulatory changes are needed to
improve FDA's ability to provide useful and understandable information
to the public?
5. As FDA becomes more transparent, what information should remain
confidential in order to promote key internal and external policy
goals, such as preserving patient privacy, and how, in these cases,
should FDA explain the importance of confidentiality?
6. What metrics should FDA use to gauge the effectiveness of its
transparency efforts?
III. Request for Comments
Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments (see ADDRESSES). 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 August 7, 2009. Where relevant, you
should annotate and organize your comments to identify the specific
question addressed by the question number referenced in the previous
text. Please identify comments with the docket number assigned to this
notice, which is found at 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. FDA is
also exploring additional electronic means for the public to provide
comments and feedback on this topic.
IV. Transcripts
Transcripts of the meeting will be available for review
approximately 30 days after the meeting at http://www.regulations.gov
and at the Division of Dockets Management (see ADDRESSES).
Dated: May 29, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12902 Filed 6-2-09; 8:45 am]
BILLING CODE 4160-01-S