[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: [email protected].

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]
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