[Federal Register Volume 59, Number 110 (Thursday, June 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14016]
[[Page Unknown]]
[Federal Register: June 9, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee Meeting; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration is announcing an amendment to
the notice of a meeting of the Blood Products Advisory Committee, which
is scheduled for June 21 and 22, 1994. This meeting was announced in
the Federal Register of May 20, 1994 (59 FR 26506). The amendment is
being made to announce the agenda for June 22, 1994. There are no other
changes. This amendment will be announced at the beginning of the open
portion of the meeting.
FOR FURTHER INFORMATION CONTACT: Linda A. Smallwood, Center for
Biologics Evaluation and Research (HFM-300), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
6700.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 1994, FDA
announced that a meeting of the Blood Products Advisory Committee would
be held on June 21 and 22, 1994. On page 26507, column 1, the ``Type of
meeting and contact person'' and the ``Open committee discussion''
portions of this meeting are amended to read as follows:
Type of meeting and contact person. Open committee discussion, June
21, 1994, 8 a.m. to 8:30 a.m.; open public hearing, 8:30 a.m. to 9:30
a.m., unless public participation does not last that long; open
committee discussion, 9:30 a.m. to 5:30 p.m.; open committee
discussion, June 22, 1994, 8 a.m. to 8:45 a.m.; open public hearing,
8:45 a.m. to 9:45 a.m., unless public participation does not last that
long; open committee discussion, 9:45 a.m. to 1:30 p.m.; open public
hearing, 1:30 p.m. to 3:30 p.m., unless public participation does not
last that long; open committee discussion, 3:30 p.m. to 6 p.m.
Open committee discussion. On June 21, 1994, the committee will
discuss and provide recommendations on plasma collected by apheresis,
particularly with regard to infrequent donations of different
frequencies, and on autologous blood donation, and in the afternoon,
will discuss and provide recommendations on red cell loss during source
plasma collection and plateletpheresis, and will hear an informational
summary of regulatory issues concerning stem cells. On June 22, 1994,
the committee will discuss and provide recommendations on issues
related to sample collection kits labeled for detection of human
immunodeficiency virus (HIV) infection. The discussion will reexamine
the approach described in Federal Register notices of February 17, 1989
(54 FR 7279), and July 30, 1990 (55 FR 30982), to evaluate the safety
and effectiveness of collection kits. The notices provided guidance as
to FDA's concerns at that time. However, in light of subsequent
scientific and technological developments and the changing nature of
the HIV epidemic, FDA has been reconsidering the information provided
in those notices and recognizes that other approaches may be useful in
reviewing HIV collection kits. The committee will also consider and
make recommendations on appropriate post-marketing studies of novel
sample (e.g. dried blood spots, urine, oral fluid) collection systems
intended for professional use only. Additionally, the discussion will
focus on specimen collection systems intended for over-the-counter
purchase and home use, which provide test results anonymously, along
with telephone counseling and medical referral. The question whether
approval of an HIV home collection test would create a precedent
applicable to over-the-counter (OTC) testing for other serious medical
conditions also may be raised.
Dated: June 3, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-14016 Filed 6-6-94; 11:44 am]
BILLING CODE 4160-01-F
