[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Notices]
[Pages 51942-51943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0746]


Guidance for Industry: Donor Screening for Antibodies to HTLV-II; 
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 document entitled ``Guidance for Industry: Donor 
Screening for Antibodies to HTLV-II.'' The guidance document provides 
information regarding human T-lymphotrophic virus type II (HTLV-II) 
screening tests for Whole Blood and blood components. This guidance 
document is a further effort of FDA to help ensure a safe blood supply 
for the United States of America (U.S.).

DATES: Written comments may be provided at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Guidance for Industry: Donor Screening for Antibodies to 
HTLV-II'' to

[[Page 51943]]

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 the office in 
processing your requests. The 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance. Submit written comments on the 
guidance document to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gloria J. Hicks, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Donor Screening for Antibodies to HTLV-II.'' 
This guidance document gives recommendations to manufacturers of Whole 
Blood and blood components regarding screening tests for HTLV-II. 
Issues discussed in the guidance document include but are not limited 
to: (1) Implementation of screening for antibodies to HTLV-II; (2) 
handling of donations with repeatedly reactive enzyme immunoassay test 
results; (3) quarantine and disposition of units from prior collections 
from donors who subsequently test repeatedly reactive for anti-HTLV-I 
or anti-HTLV-II; (4) donor deferral; (5) donor notification and 
counseling and; (6) blood product labeling. The guidance document is 
intended to supplement previous information provided in letters to 
registered blood establishments dated November 29, 1988, and July 19, 
1996, regarding HTLV-I and HTLV-II.
    On August 15, 1997, FDA approved a test kit to detect antibodies to 
HTLV-I and HTLV-II in human blood. FDA made this guidance document 
available via the CBER Internet World Wide Web (WWW) site on August 15, 
1997, as outlined in the agency's good guidance practices (see the 
Federal Register of February 27, 1997 (62 FR 8961)). This guidance 
document was released for immediate implementation so that blood 
establishments would have guidance at the time of licensure of the 
previous mentioned test kit. FDA believes that making this guidance 
document available as soon as possible after licensure of the test kit 
was necessary to help ensure the safety of the U.S. blood supply and 
therefore FDA did not circulate the document for comment before 
releasing it for use. However, FDA accepts comments on guidance 
documents at any time and will consider comments in future revisions of 
the document.
    This guidance document represents the agency's current thinking 
with regard to donor screening for antibodies to HTLV-II. 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 requirement of the applicable statute, 
regulations, or both. As with other guidance documents, FDA does not 
intend this document to be all-inclusive and cautions that not all 
information may be applicable to all situations. The document is 
intended to provide information and does not set forth requirements.

II. Comments

     Interested persons, may at any time, submit written comments to 
the Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document using 
the WWW. For WWW access, connect to CBER at ``http://www.fda.gov/cber/
guidelines.htm''.

    Dated: September 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-25907 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F