[Federal Register: May 30, 2002 (Volume 67, Number 104)]
[Page 37843-37844]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Blood Products Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 13, 2002, from 8 
a.m. to 5:30 p.m., and on June 14, 2000, from 8 a.m. to 1:30 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Linda A. Smallwood, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-3514, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 19516. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On June 13, 2002, the following committee updates are 
tentatively scheduled: (1) End user notification, and (2) human 
immunodeficiency virus (HIV) rapid tests. The committee will hear an 
informational presentation on the shortage of western blot tests for 
HIV and electronic submission of biological

[[Page 37844]]

license applications (BLAs), and discuss and provide recommendations on 
standards for recovered plasma. In the afternoon, the committee will 
hear presentations, discuss, and make recommendations on the uniform 
donor history questionnaire. On June 14, 2002, the following committee 
updates are tentatively scheduled: (1) Summaries of FDA/Plasma Protein 
Therapeutic Association workshop on comparability of plasma 
derivatives, and (2) the American Association of Blood Bank conference 
on oxygen therapeutics. The committee will hear an informational 
presentation on premarket submissions: In-vitro diagnostic software and 
instruments. The committee will hear presentations, discuss, and make 
recommendations on the warning label for hetastarch and bleeding.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by June 3, 2002. 
Oral presentations from the public will be scheduled between 
approximately 12:30 p.m. and 1 p.m. and between approximately 4 p.m. 
and 4:30 p.m. on June 13, 2002; and between approximately 12 noon and 
12:30 p.m. on June 14, 2002. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before June 3, 2002, and submit a brief statement of 
the general nature of the evidence or arguments they wish to present, 
the names and addresses of proposed participants, and an indication of 
the approximate time requested to make their presentation.
    Persons attending FDA advisory committee meetings are advised that 
the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Linda A. Smallwood 
or Pearline K. Muckelvene at 301-827-1281 at least 7 days in advance of 
the meeting.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the June 13 and 14, 2002, Blood Products Advisory Committee meeting. 
Because the agency believes there is some urgency to bring these issues 
to public discussion and qualified members of the Blood Products 
Advisory Committee were available at this time, the Commissioner of 
Food and Drugs concluded that it was in the public interest to hold 
this meeting even if there was not sufficient time for the customary 
15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 23, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
[FR Doc. 02-13586 Filed 5-29-02; 8:45 am]