[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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