[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Notices]
[Pages 13326-13327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5375]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

[[Page 13327]]

recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 15, 2001, from 
8:30 a.m. to 6 p.m. and on March 16, 2001, from 8:30 a.m. to 12 noon.
    Location: Hilton, 620 Perry Pkwy., Gaithersburg, MD.
    Contact: Linda A. Smallwood, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 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 March 15, 2001, the committee will hear presentations, 
discuss and make recommendations on the comparative sensitivity of 
Hepatitis B Virus nucleic acid testing versus Hepatitis B Surface 
Antigen testing. In the afternoon, the committee will hear 
presentations, discuss and make recommendations on the implementation 
of nucleic acid testing for Hepatitis C Virus and human 
immunodeficiency virus, testing donor and product management, and blood 
bags for diversion of the initial collection. On March 16, 2001, the 
committee will hear updates on the following topics: (1) Summaries of 
the Transmissible Spongiform Encephalopathies Advisory Committee 
Meeting and the Public Health Service Advisory Committee Meeting on 
blood safety and availability, and (2) The Office of Inspector 
General's report on tissue and organ regulation. The committee will 
additionally hear presentations, discuss and make recommendations on 
the topic of guidance on malaria, applicability to plasma.
    Procedure: On March 15, 2001, from 8:30 a.m. to 6 p.m. and on March 
16, 2001, from 8:30 a.m. to 12 noon, the meeting is open to the public. 
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 March 9, 2001. Oral presentations 
from the public will be scheduled between approximately 9:30 a.m. and 
10:30 a.m., 1:30 p.m. and 2:30 p.m., and 4:30 p.m. and 5:30 p.m. on 
March 15, 2001, and 10:15 a.m. and 10:30 a.m. on March 16, 2001. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before March 
9, 2001, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 15 to 16, 2001, 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: February 28, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-5375 Filed 3-1-01; 11:53 am]
BILLING CODE 4160-01-S