[Federal Register Volume 59, Number 150 (Friday, August 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19096]
[[Page Unknown]]
[Federal Register: August 5, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Nominations for Voting Members on Public Advisory
Committees; Device Good Manufacturing Practice Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee in FDA's Center for Devices
and Radiological Health. Nominations will be accepted for current
vacancies and vacancies that will or may occur through May 31, 1995.
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 for
appropriately qualified female, minority, or disabled candidates.
DATES: Nominations should be received by September 6, 1994.
ADDRESSES: All nominations and curricula vitae for health
professionals, industry representatives, and government representatives
shall be submitted in writing to Sharon M. Kalokerinos (address below).
All nominations and curricula vitae for general public representatives
(consumer representatives) shall be submitted in writing to Susan K.
Meadows (address below).
FOR FURTHER INFORMATION CONTACT:
Regarding health professionals, industry representatives, and
government representatives: Sharon M. Kalokerinos, Center for Devices
and Radiological Health (HFZ-300), Food and Drug Administration, 2098
Gaither Rd., Gaithersburg, MD 20850, 301-594-4613.
Regarding general public representatives (consumer
representatives): Susan K. Meadows, Office of Consumer Affairs (HFE-
20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-5006.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members for the following vacancies: Two vacancies immediately, three
vacancies occurring June 1, 1995. There are immediate openings for one
industry and one government representative; as of June 1, 1995,
vacancies will exist for a general public representative, a health
professional, and a government representative.
Function
The function of the Device Good Manufacturing Practice Advisory
Committee is to review regulations for promulgation regarding current
good manufacturing practices (CGMP's) governing the methods used in,
and the facilities and controls used for, the design, manufacture,
packaging, storage, installation, and servicing of devices, and make
recommendations regarding the feasibility and reasonableness of those
proposed regulations. The committee also reviews and makes
recommendations on proposed guidelines (e.g., ``Guideline on General
Principles of Process Validation'') developed to assist the medical
device industry in meeting the CGMP requirements, and provides advice
with regard to any petition submitted by a manufacturer for an
exemption or variance from CGMP regulations.
Section 520 of the act, as amended by the Medical Device Amendments
of 1976 (2l U.S.C. 360(j)), provides that the Device Good Manufacturing
Practice Advisory Committee shall be composed of nine members as
follows: (1) Three of the members shall be appointed from persons who
are officers or employees of any Federal, State, or local government;
(2) two shall be representatives of interests of the device
manufacturing industry; (3) two shall be representatives of the
interests of physicians and other health professionals; and (4) two
shall be representatives of the interests of the general public.
Criteria for Members
Government Representatives and Health Professionals
Persons nominated for membership should have knowledge of or
expertise in any one or more of the following areas: Quality assurance
concerning the design, manufacture, and use of medical devices.
General Public and Industry Representatives
To be eligible for selection as a representative of the general
public and industry, candidates should possess appropriate
qualifications to understand and contribute to the committee's work.
Nomination Procedures
Any interested person may nominate one or more qualified persons as
a member of the advisory committee. Self-nominations are also accepted.
Nominations shall include a complete curriculum vitae of each nominee,
as well as current business address and telephone number. 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. Industry representatives are included specifically for the
purpose of representing industry interests and any financial interest
covered by 18 U.S.C. 208(a) in the class which the member represents is
irrelevant and is exempted under 18 U.S.C. 208(b). The term of office
is up to 4 years, depending on the appointment date.
Selection Procedures
Selection of members representing general public interests is
conducted through procedures which include use of a consortium of
consumer organizations which has the responsibility for screening,
interviewing, and recommending candidates for the agency's selection.
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: August 1, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-19096 Filed 8-4-94; 8:45 am]
BILLING CODE 4160-01-F
