94-1334. Antibody to Human T-Lymphotropic Virus Type I (HTLV-I) Reference Panel 3; Availability
[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
Document Information
- Published:
- 01/20/1994
- Department:
- Food and Drug Administration
- Entry Type:
- Uncategorized Document
- Action:
- Notice.
- Document Number:
- 94-1334
- 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.
- Pages:
- 0-0 (1 pages)
- Docket Numbers:
- Federal Register: January 20, 1994