[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]
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