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Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is requesting nominations for nonvoting representatives of industry interests to serve on the Blood Products Advisory Committee, in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will or may occur through September 30, 2003.
FDA has a special interest in ensuring that women, minority groups, individuals with disabilities, and small businesses are adequately represented on advisory committees and, therefore, encourages nominations for appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the biologics and/or drug industry.
Nominations should be received by July 30, 2002.
All nominations and curricula vitae should be sent to Linda A. Smallwood (see FOR FURTHER INFORMATION CONTACT).Start Further Info
FOR FURTHER INFORMATION CONTACT:
Linda A. Smallwood, Office of Blood Research and Review, Center for Biologics Evaluation and Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6128.End Further Info End Preamble Start Supplemental Information
Section 120 of the FDA Modernization Act (FDAMA) of 1997 (21 U.S.C. 355) requires that newly formed FDA advisory committees include representatives from the biologics and/or drug manufacturing industries. This announcement is soliciting nominations for the committee listed below:
Blood Products Advisory Committee: One vacancy occurring in September 30, 2002; clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, statistics, biological and physical sciences, and other related scientific fields.
Reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood and products intended for use in the diagnosis, prevention, or treatment of human diseases.
II. Nomination Procedures
Any organization in the blood, medical device and/or biologics manufacturing industry wishing to participate in the selection of an appropriate nonvoting industry representative for the Blood Products Advisory Committee should notify the contact person of their interest in nominating one or more qualified persons. Persons who nominate themselves as representatives of industry interests for a certain advisory committee may not participate in the overall selection process.
Nominees should be familiar with firms that manufacture products regulated by the agency including biologics and/or drug manufacturers. Nomination packages should include the name of the committee and the nominee's willingness to serve on the committee. To ensure that the nomination process continues within the set timelines, submitters are strongly encouraged to include a complete curriculum vitae for each nominee with the letter of nomination. The term of office is up to 4 years.
III. Selection Procedure
A letter will be sent to each nominating organization that submitted a nomination package to FDA for a particular advisory committee. The letter will provide the complete list of all nominees. It is the responsibility of each nominating organization to consult with one another to select a single member to represent the industry interests for the advisory committee. This must be completed within 60 calendar days. If no individual is selected, the Commissioner of Food and Drugs will select a nonvoting member to represent the industry interests.
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.Start Signature
Dated: July 18, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-18775 Filed 7-24-02; 8:45 am]
BILLING CODE 4160-01-S