[Federal Register Volume 62, Number 59 (Thursday, March 27, 1997)]
[Notices]
[Page 14666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7809]


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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-022-1]


Intent to Issue Veterinary Biological Product Licenses

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service intends to issue veterinary biological product 
licenses to Rhone Merieux, Inc., for four veterinary vaccines intended 
for use in dogs. This proposed action is consistent with the 
conclusions of a risk analysis that formed the basis of an 
environmental assessment and finding of no significant impact prepared 
prior to the authorization of field trials for those vaccines. With 
this notice, we are stating our intention to issue veterinary 
biological product licenses for those vaccines after 14 days from the 
date of this notice unless new substantial issues bearing on the 
effects of the action contemplated here are brought to our attention.

ADDRESSES: Copies of the environmental assessment and finding of no 
significant impact prepared for the field testing of the products may 
be obtained by writing to the person listed under FOR FURTHER 
INFORMATION CONTACT. Please refer to the docket number of this notice 
when requesting copies. Copies of the environmental assessment and 
finding of no significant impact (as well as the risk analysis with 
confidential business information removed) are also available for 
public inspection at USDA, room 1141, South Building, 14th Street and 
Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., 
Monday through Friday, except holidays. Persons wishing to inspect 
those documents are requested to call ahead on (202) 690-2817 to 
facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Jeanette Greenberg, Technical 
Writer-Editor, Center for Veterinary Biologics-Licensing and Policy 
Development, VS, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 
20737-1231; telephone (301) 734-5338; fax (301) 734-8910.

SUPPLEMENTARY INFORMATION: We are advising the public that the Animal 
and Plant Health Inspection Service (APHIS) intends to issue veterinary 
biological product licenses to Rhone Merieux, Inc., Establishment 
License No. 298, for four veterinary vaccines intended for use in dogs. 
These vaccines each contain a canarypox-vectored canine distemper 
fraction. The true names and product codes of the four vaccines are as 
follows:
    (1) Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-
Parvovirus Vaccine, Modified Live Virus, Canarypox Vector, Leptospira 
Bacterin (Code 46J9.R1);
    (2) Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus 
Vaccine, Modified Live Virus, Canarypox Vector, Leptospira Bacterin 
(Code 4639.R1);
    (3) Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-
Parvovirus Vaccine, Modified Live Virus, Canarypox Vector (Code 
1591.R1); and
    (4) Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus 
Vaccine, Modified Live Virus, Canarypox Vector (Code 13D1.R1).
    The products numbered (1) and (3) above were field tested directly. 
The products numbered (2) and (4) above contain the same components as 
(1) and (3), respectively, except that they lack the Canine Coronavirus 
fraction; therefore, they are being licensed based on data generated 
for the products numbered (1) and (3).
    With this notice, APHIS states its intention to issue veterinary 
biological product licenses for these products after 14 days from the 
date of this notice unless new substantial issues, bearing on the 
effects of the action contemplated here, are brought to APHIS' 
attention.
    This proposed action is consistent with the conclusions of a risk 
analysis, which formed the basis for the environmental assessment (EA) 
supporting authorization of a field trial using these vaccines. Since 
the issues raised by authorization of a field trial and by issuance of 
a product license are identical, and since the field trial data have 
supported the conclusions of the original EA and finding of no 
significant impact (FONSI), APHIS has concluded that the EA and FONSI 
generated for the field trial are also applicable to the proposed 
licensing actions. Therefore, APHIS does not intend to issue a separate 
EA to support issuance of product licenses. Based on our original 
FONSI, reconfirmed here, we have determined that an environmental 
impact statement need not be prepared.

    Authority: 21 U.S.C. 151-159.

    Done in Washington, DC, this 21st day of March 1997.
Donald W. Luchsinger,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-7809 Filed 3-26-97; 8:45 am]
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