[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Page 49695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25128]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0319]
Interim Recommendations for Deferral of Donors at Increased Risk
for HIV-1 Group O Infection; Guidance Document; 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 guidance document entitled ``Interim Recommendations
for Deferral of Donors at Increased Risk for HIV-1 Group O Infection,''
dated December 11, 1996. The guidance document, which discusses the
appearance in 1996 of two cases of HIV-1 Group O infection in the
United States, is intended to provide interim measures to reduce the
risk of HIV-1 Group O transmission by blood and blood products pending
the licensure of test kits specifically labeled for detection of
antibodies to HIV-1 Group O viruses. The guidance document recommends
adding three questions to screening questionnaires used to exclude
donors at high risk of HIV-1 infection.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of ``Interim
Recommendations for Deferral of Donors at Increased Risk for HIV-1
Group O Infection'' to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance document to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857. The guidance document may also be obtained by mail by calling
the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or
by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-
827-3844.
FOR FURTHER INFORMATION CONTACT: Joseph Wilczek, Center for Biologics
Evaluation and Research (HFM-350), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-3514.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance document entitled ``Interim Recommendations for Deferral of
Donors at Increased Risk for HIV-1 Group O Infection.'' It was dated
December 11, 1996, and sent to all registered blood and plasma
establishments. The guidance document, which discusses the appearance
in 1996 of two cases of HIV-1 Group O infection in the United States,
recommends adding three questions to screening questionnaires used to
exclude donors at high risk for HIV-1 infection. These recommendations
are intended to be interim measures to reduce the risk of HIV-1 Group O
transmission by blood and blood products pending the licensure of test
kits specifically labeled for detection of antibodies to HIV-1 Group O
viruses.
As with other guidance documents, FDA does not intend this guidance
document to be all-inclusive and cautions that not all information may
be applicable to all situations. It is intended to provide
recommendations and does not set forth requirements. In response to
public comment, development of suitable alternatives or other new
information, FDA may revise this guidance document at any time to
improve its usefulness. Any revisions to this document will be
announced in the Federal Register. The recommendations in the document
represent the agency's current thinking on screening and deferral of
donors at increased risk for HIV-1 Group O infection. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute,
regulations, or both.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance
document. 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. Any
comments previously submitted to the Division of Blood Applications
(HFM-370), CBER, FDA, do not have to be resubmitted. Comments
previously submitted will be filed with the Dockets Management Branch
(address above) under the docket number in the heading of this
document. The document 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 revision is
warranted.
Persons with access to the Internet may obtain the document by
using the World Wide Web (WWW). For WWW access, connect to CBER's site
at ``http://www.fda.gov/cber/memo.htm''.
Dated: September 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25128 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F
