[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