|OC||April 30, 2010||8:15 a.m. - 4:30 p.m.||Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee
Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
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.
Meeting Location Information:
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.
All correspondence should be mailed to:
Office of the Commissioner, (HF-4)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
**After April 15, 2010, the contact person's location and contact information will change.**
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 32, rm. 5103
Silver Spring, MD 20993–0002
FAX: 301–847–8640E-mail: Doreen.Brandes@fda.hhs.gov.
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.
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.)
Voting and NonVoting Consumer Representative Members Public Meeting Agenda - April 30, 2010(PDF - 34KB) Public Meeting Agenda - April 30, 2010(DOC - 37KB) Mini Bio's of Public Meeting Speakers(DOC - 41KB) Presentation - Advisory Committee 101(PDF - 51KB) Presentation - Consumer Representative Process(PDF - 163KB) Presentation - Qualities of a Consumer Representative(PDF - 12KB) Presentation - Patient Representatives(PDF - 56KB)