[Federal Register: July 1, 2005 (Volume 70, Number 126)]
[Page 38182-38183]
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 July 21, 2005, from 8 
a.m. to 6:30 p.m.
    Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: William Freas or Pearline K. Muckelvene, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014519516. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On July 21, 2005, in the morning, the committee will hear 
updates on the following topics: (1)

[[Page 38183]]

Summary of the May 2005 meeting of the Department of Health and Human 
Services Advisory Committee on Blood Safety and Availability; (2) 
disseminated intravascular coagulation associated with acute 
hemoglobinemia following anti-D Immune Globulin Intravenous 
administration for idiopathic thrombocytopenic purpura; (4) update on 
safety of albumin; (5) summary of June 2005 workshop on Biological 
Therapeutics for Rare Plasma Protein Disorders; (6) summary of July 
2005 workshop on Leukoreduction and updates on West Nile Virus 
guidance. The committee will discuss management of donors and units 
that test positive for Hepatitis B Virus DNA by nucleic acid tests. In 
the afternoon, the committee will discuss the scientific basis for 
review of Varicella Zoster Immune Globulin and Dextran 1 pretreatment 
for safe use of Dextran 40/70.
    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 July 5, 2005. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., 2:30 p.m. and 3 p.m., and 5 p.m. 
and 5:30 p.m. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before July 13, 2005, 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's 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 William Freas or 
Pearline K. Muckelvene at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13017 Filed 6-28-05; 1:26 pm]