[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Page 61352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29351]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Members on Public Advisory Panels or 
Committees; Medical Devices Dispute Resolution Panel of the Medical 
Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of the Medical Devices Dispute Resolution Panel of the 
Medical Devices Advisory Committee (the Panel) in the Center for 
Devices and Radiological Health (CDRH). In this document, FDA is also 
requesting nominations for members to serve on the newly formed Panel.
     FDA has a special interest in ensuring that women, minority 
groups, and individuals with disabilities are adequately represented on 
advisory committees and, therefore, encourages nominations of qualified 
candidates from these groups. Final selection from among qualified 
candidates for each vacancy will be determined by the expertise 
required to meet specific agency needs and in a manner to ensure 
appropriate balance of membership.
DATES: Nominations should be received by January 10, 2000.
ADDRESSES: All nominations and curricula vitae, except for consumer-
nominated and industry-nominated members, should be sent to Nancy J. 
Pluhowski (address below). All nominations and curricula vitae for the 
consumer-nominated members should be sent to Annette J. Funn (address 
below). All nominations for the industry-nominated members should be 
sent to Kathleen L. Walker (address below).

FOR FURTHER INFORMATION CONTACT:
     Regarding all nominations for membership, except consumer-
nominated and industry-nominated members: Nancy J. Pluhowski, Office of 
Device Evaluation (HFZ-400), CDRH, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2022.
     Regarding all nominations for consumer-nominated members: Annette 
J. Funn, Office of Consumer Affairs (HFE-88), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5006.
     Regarding all nominations for industry-nominated members: Kathleen 
L. Walker, Office of Systems and Management (HFZ-17), CDRH, Food and 
Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-
1283, ext. 114.
SUPPLEMENTARY INFORMATION: The Panel was created on August 18, 1999. 
FDA is requesting nominations for members to serve on the new advisory 
panel. Persons nominated for membership should have expertise in the 
activity of the Panel as identified below.

 Function

     The function of the Medical Devices Dispute Resolution Panel is to 
provide advice to the Commissioner of Food and Drugs on complex or 
contested scientific issues between FDA and medical device sponsors, 
applicants, or manufacturers relating to specific products, marketing 
applications, regulatory decisions and actions by FDA, and agency 
guidance and policies. The Panel makes recommendations on issues that 
are lacking resolution, are highly complex in nature, or result from 
challenges to regular advisory panel proceedings or agency decisions or 
actions.

 Criteria for Members

     Persons nominated for membership on the Panel shall be experts 
with broad, cross-cutting scientific, clinical, analytical or mediation 
skills. The term of office is up to 4 years.
     The Panel will also include technically qualified members who are 
identified with consumer interests and representatives of industry 
interests.

 Nomination Procedures

     Any interested person may nominate one or more qualified persons 
for membership on the Panel. Self-nominations are also accepted. 
Nominations shall include a complete curriculum vitae of each nominee, 
current business address and telephone number, and shall state that the 
nominee is aware of the nomination, is willing to serve as a member, 
and appears to have no conflict of interest that would preclude Panel 
membership. FDA will ask the potential candidates to provide detailed 
information concerning such matters as financial holdings, employment, 
and research grants and/or contracts to permit evaluation of possible 
sources of conflict of interest.

 Criteria for Consumer-Nominated Members

     Selection of members representing consumer interests is conducted 
through procedures that include use of a consortium of consumer 
organizations which has the responsibility for screening, interviewing 
and recommending candidates for the agency's selection. Candidates from 
this group, like all other candidates for membership on the Panel, 
should possess appropriate qualifications to understand and contribute 
to the Panel's work.

 Industry Representatives

     Regarding nominations for members representing industry interests, 
a letter will be sent to each person or organization that has made a 
nomination and to other organizations that have expressed an interest 
in participating in the selection process together with a complete list 
of all such organizations and the nominees. The letter will state that 
it is the responsibility of each nominator or organization that has 
expressed an interest in participating in the selection process to 
consult with the others to provide a consensus slate of possible 
members representing industry interests within 60 days. In the event 
that a slate of nominees has not been provided within 60 days, the 
agency will select an industry representative for each such vacancy 
from the entire list of industry nominees to avoid delay or disruption 
of the work of the Panel. The agency is particularly interested in 
nominees that possess the essential scientific credentials needed to 
participate fully and knowledgeably in the Panel's deliberations. In 
addition to this expertise, the agency believes that it would be an 
advantage to the Panel's work if the individual had special insight and 
direct experience into specific industry-wide issues, practices, and 
concerns that might not otherwise be available to others not similarly 
situated.
     This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.

    Dated: November 2, 1999.
Linda S. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-29351 Filed 11-9-99; 8:45 am]
BILLING CODE 4160-01-F