[Federal Register Volume 64, Number 186 (Monday, September 27, 1999)]
[Notices]
[Pages 52098-52099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Members on Public Advisory Panels or
Committees; Molecular and Clinical Genetics 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 Molecular and Clinical Genetics 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 October 27, 1999.
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.
Functions
The functions of the medical devices panels of the Medical Devices
Advisory Committee are to: (1) Review and evaluate data on the safety
and effectiveness of marketed and investigational devices and make
recommendations for their regulation; (2) advise the Commissioner of
Food and Drugs regarding recommended classification or reclassification
of these devices into one of three regulatory categories; (3) advise on
any possible risks to health associated with the use of devices; (4)
advise on formulation of product development protocols; (5) review
premarket approval applications for medical devices; (6) review
guidelines and guidance documents; (7) recommend exemption to certain
devices from the application of portions of the Federal Food, Drug, and
Cosmetic Act (the act); (8) advise on the necessity to ban a device;
(9) respond to requests from the agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices; and (10) make recommendations on the
quality in the design of clinical studies regarding the safety and
effectiveness of marketed and investigational devices.
Specifically, the function of the Molecular and Clinical Genetics
Panel is to provide advice to the Commissioner on the appropriate
scientific criteria to diagnostically test for human genes. In addition
to the functions of the Medical Devices Advisory Committee, this panel
shall review guidance and recommend criteria and classification of
tests for human genes.
Criteria for Members
Persons nominated for membership on the Panel shall have expertise
in human genetics and in the clinical management of patients with
genetic disorders, e.g., pediatricians, obstetricians, and
neonatologists. The agency is also interested in considering
[[Page 52099]]
candidates with training in inborn errors of metabolism, biochemical
and/or molecular genetics, population genetics, epidemiology and
related statistical training. Additionally, individuals with experience
in genetic counseling, medical ethics as well as ancillary fields of
study will be considered. 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 industrywide 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: September 17, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-24980 Filed 9-24-99; 8:45 am]
BILLING CODE 4160-01-F