[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Notices]
[Pages 3042-3043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1657]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0369]
Memorandum on the Recommendations for Donor Screening With a
Licensed Test for HIV-1 Antigen; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a memorandum to all registered blood and plasma
establishments, dated August 8, 1995. In the memorandum, the Center for
Biologics Evaluation and Research (CBER) recommends the implementation
of donor screening tests for human immunodeficiency virus, type 1 (HIV-
1) antigen(s) using licensed tests that are approved for donor
screening. FDA is recommending the implementation of HIV-1 antigen
screening because of the benefit that it will provide to a small number
of blood product recipients, as a partial preventive measure against
the possibility of any increase in HIV-1 ``window period'' donations
and to decrease the virus burden in plasma pools for fractionation. FDA
expects HIV-1 antigen testing will reduce, but not eliminate, the
residual risk of HIV-1 from transfusion and, therefore, regards such
screening as only an interim measure pending the availability of more
advanced test methodology.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the memorandum
to the Congressional and Consumer Affairs Branch (HFM-12), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, or call FDA's automated
information system at 800-835-4709. Send one self-addressed adhesive
label to assist that office in processing your requests. Submit written
comments on the memorandum to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Requests and comments should be
identified with the docket number found in brackets in the heading of
this document. A copy of the memorandum and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to INTERNET may request the memorandum be sent
by return E-mail by sending a message to
``[email protected]''. The memorandum may also be obtained
through INTERNET via File Transfer Protocol (FTP). Requestors should
connect to the Center for Drug Evaluation and Research (CDER) using the
FTP. CBER documents are maintained in a subdirectory called CBER on the
server, ``CDVS2.CDER.FDA.GOV'' (150.148.24.202). The ``READ.ME'' file
in that subdirectory describes the available documents which may be
available as an ASCII text file (*.TXT), or a WordPerfect 5.1 document
(*.w51), or both. A sample dialogue for obtaining the ``READ.ME'' file
with a text-based FTP program would be:
FTP CDVS2.CDER.FDA.GOV
LOGIN: ANONYMOUS
<``your e-mail="" address''="">
BINARY
CD CBER
GET READ.ME
EXIT
The memorandum may also be obtained by calling the CBER FAX
Information System (FAX--ON--DEMAND) at 301-594-1939 from a touch tone
telephone.
FOR FURTHER INFORMATION CONTACT: Paul A. Mied, Center for Biologics
Evaluation and Research (HFM-310), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-3008.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
memorandum to all registered blood and plasma establishments, dated
August 8, 1995, recommending the implementation of donor screening for
HIV-1 antigen with a licensed test approved for this use. As of August
8, 1995, there were no tests for HIV-1 antigen(s) approved for donor
screening. However, FDA issued these recommendations in advance of the
availability of such tests in order to provide blood and plasma
establishments with maximum time to prepare for implementation of this
testing. These recommendations supersede some of the rationale/
recommendations provided in a previous FDA memorandum dated October 4,
1989, following licensure of the first test for HIV-1 antigen(s).
Based on the data available in 1989, FDA did not approve HIV-1
antigen testing for routine donor screening. Recently, however, the
role of HIV-1 antigen testing in the donor setting has been
reconsidered for several reasons. For instance, there have been four
documented instances of HIV-1 transmission by HIV-1 antigen positive
blood donations from three HIV-1 antibody negative donors. Also, based
on recent estimates of the antibody negative infectious ``window
period,'' the residual risk of HIV transmission by screened blood, and
the efficacy of antigen testing to detect seronegative, infectious
donations, it has been estimated that donor screening by HIV-1 antigen
can be expected to prevent up to 25 percent of the current ``window
period'' cases or about 5 to 10 cases of transfusion associated HIV
infection per year.
In September 1994, FDA sponsored a ``Conference on the Feasibility
of Genetic Technology to Close the HIV Window in Donor Screening.''
Although the majority of participating experts expressed the opinion
that genetic techniques were not ready for use in mass screening, the
meeting did spark renewed interest in considering other direct viral
detection methods for donor screening, such as HIV-1 antigen testing as
an interim measure to further reduce current low risk of
[[Page 3043]]
HIV-1 transmission through transfusions of blood and blood products. To
further address direct viral detection methods, FDA brought the issue
of donor screening for HIV-1 antigen to a public meeting of the Blood
Products Advisory Committee (BPAC) in June 1995. After hearing the most
recent available data on HIV-1 risk in the blood supply, the estimated
efficacy of antigen screening, and other issues bearing on a risk/
benefit assessment, 9 of the 15 BPAC members present were of the
opinion that donor screening for HIV-1 antigen by candidate test kits
is not likely to provide a significant public health benefit which
outweighs the potential risks. After considering the available
information and the opinions of the BPAC members, FDA recommended that
blood establishments should implement donor screening for HIV-1 antigen
using licensed tests that are approved for this indication. FDA
recommended implementation of HIV-1 antigen screening because of the
benefit that it will provide to a small number of blood product
recipients, as a partial preventive measure against the possibility of
any increase in HIV-1 ``window period'' donations and to decrease the
virus burden in plasma pools for fractionation.
FDA recommended that the screening for HIV-1 antigen(s) be
implemented within 3 months of the commercial availability of the first
such test approved for donor screening for all donations of Whole
Blood, blood components, Source Leukocytes and Source Plasma, and all
such inventoried units available for release. FDA also recommended that
consigned within-date units intended for transfusion and still in the
consignee's inventory be either replaced with screened units or tested
for HIV-1 antigen(s) as soon as feasible. The memorandum included
additional recommendations and information on the following: (1)
Disposition and labeling of units; (2) donor deferral; (3) Public
Health Service recommendations for donor notification and counseling;
(4) exclusion/retrieval of potentially contaminated units from prior
collections and notification of consignees; and (5) notification of
consignees of neutralization test results.
Because HIV-1 antigen testing will reduce, but not eliminate, the
residual risk of HIV-1 from transfusion, FDA regards such screening as
an interim measure pending the availability of better technology for
this purpose. FDA encourages continued development of new methods to
further reduce the risk of HIV transmissions in the ``window period.''
As with other memoranda, FDA does not intend this document to be
all-inclusive and cautions that not all information may be applicable
to all situations. The memorandum is intended to provide information
and does not set forth new requirements. The procedures cited in the
memorandum are recommendations. FDA anticipates that blood and plasma
establishments may develop alternative procedures and discuss them with
FDA. FDA may find those alternative procedures acceptable. FDA
recognizes that the scientific technology for controlling the risk of
transmission of HIV by blood and blood products may continue to advance
and that this document may become outdated as those advances occur. The
memorandum does not bind FDA and does not create or confer any rights,
privileges, or benefits on or for any private person, but is intended
merely for guidance.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the memorandum.
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
memorandum and received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Received comments will be considered in determining whether further
revisions to the memorandum are warranted.
Dated: January 22, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-1657 Filed 1-29-96; 8:45 am]
BILLING CODE 4160-01-F
