[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Notices]
[Pages 41052-41053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20080]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Members on Public Advisory 
Committees; Blood Products Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations to fill upcoming vacancies on the Blood Products Advisory 
Committee.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on 
advisory committees and, therefore, extends particular encouragement to 
nominations for appropriately qualified female, minority, or disabled 
candidates.

DATES: Nominations should be received on or before August 15, 1997.

ADDRESSES: All nominations for membership should be sent to the 
appropriate contact person (address below).

FOR FURTHER INFORMATION CONTACT: 
    All nominations and curricula vitae except for consumer 
representatives should be submitted in writing to Linda A. Smallwood, 
Office of Blood Research and Review (HFM-350), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-827-3514.
    All nominations and curricula vitae for consumer representatives 
should be submitted in writing to Annette J. Funn, Office of Consumer 
Affairs (HFE-88), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-5006.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations to fill 
upcoming vacancies on the Blood Products Advisory Committee. The 
function of the committee is to review and evaluate available data 
concerning the safety, effectiveness, appropriate use of blood products 
derived from blood and serum or biotechnology which are intended for 
use in the diagnosis, prevention, or treatment of human diseases, and, 
as required, any other product for which FDA has regulatory 
responsibility. Persons nominated for membership should be among 
authorities knowledgeable in the fields of clinical and administrative 
medicine, infectious disease, hematology, immunology, transfusion 
medicine, surgery, internal medicine, biochemistry, biostatistics, 
epidemiology, biological and physical sciences, biotechnology, computer 
technology, sociology/ethics, and other related professions. The 
membership will also include representatives of consumer organizations, 
product recipients, and health care providers. The committee will 
function at times as a medical device panel under the Federal Food, 
Drug, and Cosmetic Act Medical Device Amendments of 1976.

Nonvoting Consumer and Industry Representation

    Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360j(f)(3)), as amended by the Medical Device 
Amendments of 1976, provides that each medical device panel include as 
members one nonvoting representative of consumer interests and one 
nonvoting representative of interests of the manufacturing industry.

Nomination Procedures

    Interested persons may nominate one or more qualified persons for 
membership on the committee. Self nominations are also accepted. A 
current curriculum vitae of each nominee should accompany the letter of 
nomination and include the following information: Full name and title, 
business address and phone number, home address and phone number, date 
and place of birth. Nominations shall state that the nominee is willing 
to serve as a member of the committee and appears to have no conflict 
of interest that would preclude advisory committee membership. The 
Commissioner of Food and Drugs will ask the potential candidates to 
provide detailed information concerning such matters as financial 
holdings, consultancies, and research grants or contracts to permit 
evaluation of possible sources of conflict of interest. The term of 
office may not exceed 4 years, depending on the appointment date.
    The nomination procedures for the nonvoting consumer representative 
and industry representative are the same as stated previously with the 
following exceptions:

Consumer Representatives

    To be eligible for selection, the applicant's experience and/or 
education will be evaluated against Federal civil service criteria for 
the position to which the person will be appointed. The term of office 
is up to 4 years.

Industry Representatives

    Any organization representing industry interests wishing to 
participate in the selection of representatives may nominate one or 
more qualified persons to represent industry interests. Persons who 
nominate themselves as industry representatives will not participate in 
the selection process. It is, therefore, recommended that all 
nominations be made by someone with an organization, trade association, 
or firm who is willing to participate in the selection process. 
Nominees shall be full-time employees of firms that manufacture 
products that would come before the committee, or consulting firms that 
represent manufacturers. The term of office is up to 4 years.

Selection Procedures

Consumer Representatives

    Selection of members representing consumers interests is conducted 
through procedures which include use of a consortium of consumer 
organizations which has the responsibility for recommending candidates 
for the agency's selection. Candidates should possess appropriate 
qualifications to understand and contribute to the committee's work.

Industry Representatives

    Regarding nominations for members representing the interests of 
industry, a letter will be sent to each person that has made a 
nomination, and to those organizations indicating an interest in 
participating in the selection process, together with a complete list 
of all such organizations and the nominees. This letter will state that 
it is the responsibility of each nominator or

[[Page 41053]]

organization indicating an interest in participating in the selection 
process to consult with the others in selecting a single member 
representing industry interests for the committee within 60 days after 
receipt of the letter. If no individual is selected within 60 days, the 
agency will select the nonvoting member representing industry 
interests.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2), relating to advisory committees.

    Dated: July 24, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-20080 Filed 7-30-97; 8:45 am]
BILLING CODE 4160-01-F