[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45618-45619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22930]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-055-2]
Availability of an Addendum to the Environmental Assessment and
Finding of No Significant Impact for Field Testing Vaccine Containing
Canarypox-Vectored Rabies Fraction
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared an addendum to the environmental
assessment and finding of no significant impact that were prepared for
the shipment of an unlicensed veterinary vaccine containing a
canarypox-vectored rabies fraction for field testing in cats. The
availability of the original environmental assessment and finding of no
significant impact was announced in the Federal Register on July 10,
1997. The addendum addresses the expansion of the scope of the field
trials to include veterinary clinics in two additional States.
ADDRESSES: Copies of the addendum, as well as copies of the original
environmental assessment and finding of no significant impact, may be
obtained by contacting the person listed under FOR FURTHER INFORMATION
CONTACT. Please refer to the docket number, date, and complete title of
this notice when requesting copies. Copies of the original
environmental assessment and finding of no significant impact and the
addendum (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, Veterinary Services, APHIS, USDA, 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: Under the Virus-Serum-Toxin Act (21 U.S.C.
151 et seq.), a veterinary biological product must be shown to be pure,
safe, potent, and efficacious before a veterinary biological product
license may be issued. Field trials are generally necessary to satisfy
prelicensing requirements for veterinary biological products. In order
to ship an unlicensed veterinary biological product for the purpose of
conducting field trials, a sponsor must receive authorization from the
Animal and Plant Health Inspection Service (APHIS).
On July 10, 1997, we published in the Federal Register (62 FR
37010-37011, Docket No. 97-055-1) a notice announcing the availability
of an environmental assessment (EA) that had been prepared for the
shipment of an unlicensed veterinary vaccine containing a canarypox-
vectored rabies fraction for field testing. APHIS had concluded that
such shipment would not significantly affect the quality of the human
environment. Based on that finding of no significant impact (FONSI), we
determined that there was no need to prepare an environmental impact
statement.
With this notice, APHIS is announcing that the scope of the field
trials has been expanded to include veterinary clinics in two more
States--Arkansas and Indiana--in addition to the eight States indicated
in the July 10, 1997, notice. The addition of these two States is
addressed in an addendum to the original EA and FONSI. The EA and FONSI
and the addendum were prepared by APHIS for the shipment of the
following unlicensed veterinary biological product for field testing:
Requester: Rhone Merieux, Inc., Establishment License No. 298.
Product: Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia-
Chlamydia Psittaci-Rabies Vaccine, Modified Live and Killed Virus and
Chlamydia, Canarypox Vector, (Code 16A9.R0).
[[Page 45619]]
Field test locations (including States added): Arkansas,
California, Florida, Georgia, Illinois, Indiana, New York,
Pennsylvania, Texas, and Wisconsin.
The EA and FONSI were prepared in accordance with: (1) The National
Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
Unless substantial environmental issues are raised in response to
this notice, APHIS intends to authorize the shipment of the above
product and the initiation of the field trials after 14 days from the
date of this notice. Because the issues raised by authorization of
field trials and by issuance of a license are identical, APHIS has
concluded that the EA and FONSI that were generated for the field
trials would also be applicable to the proposed licensing action.
Provided that the field trial data support the conclusions of the
original EA and FONSI and the addendum, APHIS does not intend to
generate a separate EA to support the issuance of the product license,
and would determine that an environmental impact statement need not be
prepared. Therefore, APHIS intends to issue a veterinary biological
product license for this product following the completion of the field
trials, provided no adverse impacts on the human environment are
identified as a result of field testing this product and provided the
product meets all other requirements for licensure.
Simultaneously, APHIS intends to issue licenses for three
additional combination vaccines produced by Rhone Merieux, Inc., also
for use in cats. These three vaccines--each of which contains the same
canarypox-vectored rabies fraction present in the above-mentioned
product but lacks one or two components present in that product--are as
follows:
Product: Feline Rhinotracheitis-Calici-Panleukopenia-Chlamydia
Psittaci-Rabies Vaccine, Modified Live Virus and Chlamydia, Canarypox
Vector (Code 1619.R1);
Product: Feline Rhinotracheitis-Calici-Panleukopenia-Rabies
Vaccine, Modified Live Virus, Canarypox Vector, (Code 16T9.R0); and
Product: Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia-
Rabies Vaccine, Modified Live and Killed Virus, Canarypox Vector (Code
16S9.R0).
Except for the canarypox-vectored rabies fraction, all components
of the four products discussed in this notice are represented in
currently licensed products.
Authority: 21 U.S.C. 151-159.
Done in Washington, DC, this 22nd day of August 1997.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-22930 Filed 8-27-97; 8:45 am]
BILLING CODE 3410-34-P
