[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