[Federal Register Volume 62, Number 186 (Thursday, September 25, 1997)]
[Notices]
[Page 50285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25484]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-098-1]
In Vitro Testing of Veterinary Biologics; Public Meeting
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of public meeting.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service is hosting a public meeting to discuss the
implementation of guidelines for the in vitro testing of veterinary
biologics.
PLACE, DATE, AND TIME OF MEETING: The meeting will be held in the main
auditorium of the National Animal Disease Center, 2300 Dayton Road,
Ames, IA. The meeting will be held from 8 a.m. until noon on Thursday,
October 16, 1997.
FOR FURTHER INFORMATION CONTACT: Dr. Jeanette Greenberg, Center for
Veterinary Biologics, Licensing and Policy Development, VS, APHIS, 4700
River Road Unit 148, Riverdale, MD 20737-1231; telephone (301) 734-
8400; fax (301) 734-8910; or E-mail: jgreenberg@aphis.usda.gov.
SUPPLEMENTARY INFORMATION: In a final rule published on April 18, 1997
(62 FR 19033-19039, Docket No. 94-051-3), we amended our regulations in
9 CFR part 113 to provide for the use of in vitro potency tests when
conducting immunoassays to determine the relative antigen content
(potency) of a serial of inactivated veterinary biological product once
immunogenicity is established using host animal tests. The amended
regulations provide that such tests are to be conducted using unexpired
immunogenic reference preparations and parallel line assay or another
method that is at least equivalent to the parallel line assay in terms
of its linearity, specificity, and reproducibility.
The purpose of the public meeting announced in this notice is to
present and discuss draft guidelines pertaining to the qualification
and requalification of reference preparations used in in vitro
immunoassays affected by the change in the regulations.
The meeting on October 16, 1997, will begin at 8 a.m. and end at
noon; however, the meeting may end earlier if all persons desiring to
speak have been heard. No advance registration is necessary to attend
this meeting.
Done in Washington, DC, this 22nd day of September 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-25484 Filed 9-24-97; 8:45 am]
BILLING CODE 3410-34-P
