[Federal Register: July 1, 2005 (Volume 70, Number 126)]
[Notices]
[Page 38182-38183]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy05-104]
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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.
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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
outlets.
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]
BILLING CODE 4160-01-S