[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1334]


[[Page Unknown]]

[Federal Register: January 20, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 

Antibody to Human T-Lymphotropic Virus Type I (HTLV-I) Reference 
Panel 3; 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 new FDA reference panel for tests intended to detect 
antibodies to Human T-Lymphotropic Virus Type I (HTLV-I Reference Panel 
3). HTLV-I Reference Panel 3 is a regulatory test panel intended for 
lot release testing of enzyme-linked immunosorbent assay (ELISA) HTLV-I 
antibody test kits. The HTLV-I Reference Panel 3 is intended to replace 
HTLV-I Reference Panel 2F. FDA recommends that manufacturers of 
currently licensed HTLV-I test kits supplement their approved product 
license applications by amending their lot release protocols to use the 
HTLV-I Reference Panel 3.

DATES: FDA recommends that manufacturers supplement their product 
licenses and amend their lot release protocols by February 22, 1994, to 
incorporate HTLV-I Reference Panel 3. Additionally, FDA recommends that 
as of June 20, 1994, manufacturers supplement their product licences by 
incorporating a lot release testing protocol that enables lots of 
licensed HTLV-I antibody test kits to detect five panel members of 
HTLV-I Reference Panel 3, with expected reactivity of , as 
repeatedly reactive.

ADDRESSES: The HTLV-I Reference Panel 3 is available for distribution 
from the contact person listed below.

FOR FURTHER INFORMATION CONTACT: Charles O. Roberts, Center for 
Biologics Evaluation and Research (HFM-323), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
6721.

SUPPLEMENTARY INFORMATION: The HTLV-I Reference Panel 3 is intended for 
the evaluation of in vitro tests to detect antibodies to HTLV-I in 
human serum or plasma. HTLV-I Reference Panel 3 contains samples that 
were derived by diluting known reactive sera in a pool of normal human 
sera, negative for antibodies to HTLV-I. Five of the diluted samples 
have borderline ELISA reactivity. FDA recommends that currently 
produced kit lots detect antibodies in these diluted samples to be 
suitable for release. The Center for Biologics Evaluation and Research 
will limit the distribution of HTLV-I Reference Panel 3 to conserve 
these reagents when necessary. These reagents should not be used for 
experimental or other reference purposes.
    Any significant changes in kit manufacturing needed as a result of 
the new reference panel should be approved through a product amendment 
filed with the Food and Drug Administration, Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448.

    Dated: January 13, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1334 Filed 1-19-94; 8:45 am]
BILLING CODE 4160-01-F