[Federal Register: March 30, 2010 (Volume 75, Number 60)]
[Notices]
[Page 15714]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr10-80]
[[Page 15714]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Voting and Nonvoting Consumer Representative Members on Public
Advisory Committees and Panels; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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The Food and Drug Administration (FDA) is announcing a public
meeting for individuals and groups interested in nominating voting and
nonvoting consumer representatives to FDA advisory committees and
panels. This public meeting also is for individuals interested in
serving as voting and nonvoting representatives of FDA advisory
committees and panels. The purpose of the public meeting is to inform
individuals and groups with consumer interests on how to participate in
the nomination and selection process for members representing consumer
interests on advisory committees, provide information on the structure
and function of advisory committees seeking individuals to serve as
consumer representatives, and update individuals and consumer groups
and individuals on current committee vacancies.
Date and Time: The public meeting will be held on April 30, 2010,
from 8:15 a.m. to approximately 4:30 p.m.
Location: The public meeting will be held at the Food and Drug
Administration, Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Please use the lower entrance, which faces Parklawn Drive. Visitor
badges will be held at the guard station at the entrance to the
building. Participants will need a picture identification to pick up
their badge. Public parking is not available at the 5630 Fishers Lane
location. A public parking lot is available on Fishers Lane across from
the Parklawn Building at 5600 Fishers Lane, and additional public
parking is available at the Twinbrook Metro Station located several
blocks west of the meeting location.
Contact Person: Doreen Brandes, Office of the Commissioner (HF-4),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-8858, FAX: 301-827-1041, or e-mail: Doreen.Brandes@fda.hhs.gov.
After April 15, 2010, the contact person's location and contact
information will change. All correspondence should be mailed to Doreen
Brandes, Office of the Commissioner, 10903 New Hampshire Ave., Bldg.
32, rm. 5103, Silver Spring, MD 20993-0002, 301-796-8858, FAX: 301-847-
8640, or e-mail: Doreen.Brandes@fda.hhs.gov.
Registration: Register by e-mail or fax to the contact person no
later than April 23, 2010. Provide complete information for each
attendee, including name, title, organization's name, address, e-mail,
and telephone and fax numbers
If you need special accommodations due to a disability, please
contact Doreen Brandes (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
I. Criteria for Members
FDA believes that persons nominated for membership as a consumer
representative on the committee/panels should meet the following
criteria: (1) Demonstrate ties to consumer and community-based
organizations, (2) be able to analyze technical data, (3) understand
research design, (4) be able to discuss benefits and risks, and (5) be
able to evaluate the safety and efficacy of products under review. The
consumer representative represents the consumer perspective on issues
and actions before the advisory committee; serves as a liaison between
the committee and interested consumers, associations, coalitions, and
consumer organizations; and facilitates dialogue with the advisory
committees on scientific issues that affect consumers.
II. Nomination Procedures
When individuals are nominated to serve as consumer representatives
on FDA advisory committee and panels, all nominations should include a
cover letter, a curriculum vita or resume (that includes the nominee's
office address, telephone number, and e-mail address), and a list of
consumer or community-based organizations for which the candidate can
demonstrate active participation. Nominations will specify the advisory
committee(s)or panel(s) for which the nominee is recommended. Any
interested person or organization may nominate one or more qualified
persons for membership as consumer representatives on the advisory
committee/panels. Self-nominations are also accepted. Potential
candidates will be required to provide detailed information concerning
such matters as financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of a conflict
of interest. The nomination should specify the committees/panels of
interest. The term of office is up to 4 years, depending on the
appointment date.
Additional background information regarding the topics for the
public meeting will be available 5 days before the meeting and may be
found at: http://www.fda.gov/AdvisoryCommittees/default.htm (look for
link to Advisory Committee Public Meeting for Consumer
Representatives.)
Dated: March 24, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-6967 Filed 3-29-10; 8:45 am]
BILLING CODE 4160-01-S