Availability of an Environmental Assessment for Field Testing of a DNA Immunostimulant, 58514-58515 [2013-23175]
Download as PDF
<![CDATA[
58514
Federal Register / Vol. 78, No. 185 / Tuesday, September 24, 2013 / Notices
We will consider all comments
that we receive on or before November
25, 2013.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!document
Detail;D=APHIS–2013–0072–0001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2013–0072, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://www.
regulations.gov/#!docketDetail;D=
APHIS–2013–0072 or in our reading
room, which is located in room 1141 of
the USDA South Building, 14th Street
and Independence Avenue SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 799–7039 before
coming.
DATES:
For
information on the regulations for the
interstate movement of horses that have
tested positive for equine infectious
anemia, contact Dr. Rory Carolan,
Equine Specialist, Aquaculture, Swine,
Equine, and Poultry Programs, VS,
APHIS, 4700 River Road Unit 46,
Riverdale, MD 20737; (301) 851–3558.
For copies of more detailed information
on the information collection, contact
Mrs. Celeste Sickles, APHIS’
Information Collection Coordinator, at
(301) 851–2908.
SUPPLEMENTARY INFORMATION:
Title: Communicable Diseases in
Horses.
OMB Number: 0579–0127.
Type of Request: Extension of
approval of an information collection.
Abstract: Under the authority of the
Animal Health Protection Act (7 U.S.C.
8301 et seq.), the Animal and Plant
Health Inspection Service (APHIS) of
the U.S. Department of Agriculture
(USDA) regulates the importation and
interstate movement of animals and
animal products, and conducts various
other activities to protect the health of
U.S. livestock and poultry.
Equine infectious anemia (EIA) is an
infectious and potentially fatal viral
disease of equines. There is no vaccine
or treatment for the disease. It is often
difficult to differentiate from other
fever-producing diseases, including
anthrax, influenza, and equine
encephalitis.
The regulations in 9 CFR 75.4 govern
the interstate movement of equines that
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
19:49 Sep 23, 2013
Jkt 229001
have tested positive to an official test for
EIA (EIA reactors) and provide for the
approval of laboratories, diagnostic
facilities, and research facilities.
Ensuring the safe movement of these
horses requires the use of information
collection activities, including an EIA
laboratory test form, a certificate or
permit for the interstate movement of an
EIA reactor, a supplemental
investigation form if a horse tests
positive for EIA, agreements, request for
hearing, and written notification of
withdrawal of approval.
Since the last approval of these
collection activities, APHIS has adjusted
the estimates of burden, responses, and
respondents. We have decreased the
estimated total annual burden hours
from 163,949 to 139,547 based on
refinements to our calculations. For
instance, as part of the last approval, we
instituted the use of a permit for the
movement of EIA-positive horses.
However, we discovered that we
overcalculated the number of
respondents who would use the form.
Similarly, the estimated number of
respondents and responses per
respondent for the EIA laboratory test
form have been adjusted to more
accurately reflect the use of the form.
Lastly, we decreased our estimates as to
the use of the supplemental
investigation form, agreements, requests
for hearing, and written notification of
approval withdrawal because we have
received fewer requests than we
estimated for these processes.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities for an additional 3
years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
Estimate of burden: The public
reporting burden for this collection of
information is estimated to average
0.083 hours per response.
Respondents: Accredited and State
veterinarians; laboratory, diagnostic,
and research facility personnel;
stockyard personnel; and owners and
shippers of horses.
Estimated annual number of
respondents: 253,785.
Estimated annual number of
responses per respondent: 6.6.
Estimated annual number of
responses: 1,681,142.
Estimated total annual burden on
respondents: 139,547 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 18th day of
September 2013.
Michael C. Gregoire,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2013–23192 Filed 9–23–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2013–0077]
Availability of an Environmental
Assessment for Field Testing of a DNA
Immunostimulant
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of availability.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared an
environmental assessment concerning
authorization to ship for the purpose of
field testing, and then to field test, an
unlicensed DNA Immunostimulant
recommended for reduction in
morbidity and mortality due to
Escherichia coli in chickens and
reduction in bovine respiratory disease
due to Mannheimia haemolytica in
cattle. The environmental assessment,
which is based on a risk analysis
prepared to assess the risks associated
with the field testing of this veterinary
biological product and related
information, examines the potential
effects that field testing this product
could have on the quality of the human
environment. Based on the risk analysis
SUMMARY:
E:\FR\FM\24SEN1.SGM
24SEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 185 / Tuesday, September 24, 2013 / Notices
and other relevant data, we have
reached a preliminary determination
that field testing this product will not
have a significant impact on the quality
of the human environment, and that an
environmental impact statement need
not be prepared. We intend to authorize
shipment of this product for field testing
following the close of the comment
period for this notice unless new
substantial issues bearing on the effects
of this action are brought to our
attention. We also intend to issue a U.S.
Veterinary Biological Product license for
this product, provided the field test data
support the conclusions of the
environmental assessment and the
issuance of a finding of no significant
impact and the product meets all other
requirements for licensing.
DATES: We will consider all comments
that we receive on or before October 24,
2013.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2013-00770001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2013–0077, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://
www.regulations.gov/
#!docketDetail;D=APHIS-2013-0077 or
in our reading room, which is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue
SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 7997039
before coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Donna Malloy, Section Leader,
Operational Support Section, Center for
Veterinary Biologics, Policy, Evaluation,
and Licensing, VS, APHIS, 4700 River
Road Unit 148, Riverdale, MD 20737–
1231; phone (301) 851–3426, fax (301)
734–4314; email:
Donna.L.Malloy@aphis.usda.gov. For
information regarding the
environmental assessment or the risk
analysis, or to request a copy of the
environmental assessment or the risk
analysis (with confidential business
information redacted), contact Dr.
Patricia Foley, Risk Manager, Center for
Veterinary Biologics, Policy, Evaluation,
and Licensing, VS, APHIS, 1920 Dayton
Avenue, P.O. Box 844, Ames, IA 50010;
VerDate Mar<15>2010
19:49 Sep 23, 2013
Jkt 229001
phone (515) 337–6100, fax (515) 337–
6120
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. A field test is generally
necessary to satisfy prelicensing
requirements for veterinary biological
products. Prior to conducting a field test
on an unlicensed product, an applicant
must obtain approval from the Animal
and Plant Health Inspection Service
(APHIS), as well as obtain APHIS’
authorization to ship the product for
field testing.
To determine whether to authorize
shipment and grant approval for the
field testing of the unlicensed product
referenced in this notice, APHIS
conducted a risk analysis to evaluate the
potential effects of this product on the
safety of animals, public health, and the
environment. Using the risk analysis
and other relevant data, APHIS has
prepared an environmental assessment
(EA) concerning the field testing of the
following unlicensed product:
Requester: Bayer HealthCare LLC,
Animal Health Division.
Product: DNA Immunostimulant.
Possible Field Test Locations: Texas,
Mississippi, and Georgia for poultry;
Nebraska, Indiana, and Missouri for
cattle.
The above mentioned product
consists of non-replicating plasmid
DNA in an immunogenic complex for
use as an immunostimulant. This
product will be recommended for the
reduction in morbidity and mortality
due to Escherichia coli in chickens and
reduction in bovine respiratory disease
due to Mannheimia haemolytica in
cattle.
The EA has been prepared in
accordance with: (1) The National
Environmental Policy Act of 1969
(NEPA), as amended (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 issues with adverse
environmental impacts are raised in
response to this notice, APHIS intends
to issue a finding of no significant
impact (FONSI) based on the EA and
authorize shipment of the above product
for the initiation of field tests following
the close of the comment period for this
notice.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
58515
Because the issues raised by field
testing and by issuance of a license are
identical, APHIS has concluded that the
EA that is generated for field testing
would also be applicable to the
proposed licensing action. Provided that
the field test data support the
conclusions of the original EA and the
issuance of a FONSI, APHIS does not
intend to issue a separate EA and FONSI
to support the issuance of the veterinary
biological product license, and would
determine that an environmental impact
statement need not be prepared. APHIS
intends to issue a veterinary biological
product license for this product
following completion of the field test
provided no adverse impacts on the
human environment are identified and
provided the product meets all other
requirements for licensing.
Authority: 21 U.S.C. 151–159.
Done in Washington, DC, this 19th day of
September 2013.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2013–23175 Filed 9–23–13; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2013–0063]
Supplemental Environmental Impact
Statement for the Bird Hazard
Reduction Program at John F.
Kennedy International Airport
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of intent and public
scoping process.
AGENCY:
We are advising the public
that a supplemental environmental
impact statement will be prepared by
the Animal and Plant Health Inspection
Service to analyze a proposed method
for managing hazards to aircraft at John
F. Kennedy International Airport
associated with non-native mute swans
in the Gateway National Recreation
Area. This action is a supplement to the
Gull Hazard Reduction Program at John
F. Kennedy International Airport Final
Environmental Impact Statement (EIS),
May 1994, and the Supplemental EIS,
June 2012.
DATES: We will consider all comments
that we receive on or before October 24,
2013.
ADDRESSES: You may submit comments
by either of the following methods:
SUMMARY:
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58514-58515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23175]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2013-0077]
Availability of an Environmental Assessment for Field Testing of
a DNA Immunostimulant
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared an environmental assessment concerning
authorization to ship for the purpose of field testing, and then to
field test, an unlicensed DNA Immunostimulant recommended for reduction
in morbidity and mortality due to Escherichia coli in chickens and
reduction in bovine respiratory disease due to Mannheimia haemolytica
in cattle. The environmental assessment, which is based on a risk
analysis prepared to assess the risks associated with the field testing
of this veterinary biological product and related information, examines
the potential effects that field testing this product could have on the
quality of the human environment. Based on the risk analysis
[[Page 58515]]
and other relevant data, we have reached a preliminary determination
that field testing this product will not have a significant impact on
the quality of the human environment, and that an environmental impact
statement need not be prepared. We intend to authorize shipment of this
product for field testing following the close of the comment period for
this notice unless new substantial issues bearing on the effects of
this action are brought to our attention. We also intend to issue a
U.S. Veterinary Biological Product license for this product, provided
the field test data support the conclusions of the environmental
assessment and the issuance of a finding of no significant impact and
the product meets all other requirements for licensing.
DATES: We will consider all comments that we receive on or before
October 24, 2013.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2013-0077-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2013-0077, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0077 or in our reading room, which is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 7997039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Section Leader,
Operational Support Section, Center for Veterinary Biologics, Policy,
Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737-1231; phone (301) 851-3426, fax (301) 734-4314;
email: Donna.L.Malloy@aphis.usda.gov. For information regarding the
environmental assessment or the risk analysis, or to request a copy of
the environmental assessment or the risk analysis (with confidential
business information redacted), contact Dr. Patricia Foley, Risk
Manager, Center for Veterinary Biologics, Policy, Evaluation, and
Licensing, VS, APHIS, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010;
phone (515) 337-6100, fax (515) 337-6120
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. A field test is generally necessary to satisfy
prelicensing requirements for veterinary biological products. Prior to
conducting a field test on an unlicensed product, an applicant must
obtain approval from the Animal and Plant Health Inspection Service
(APHIS), as well as obtain APHIS' authorization to ship the product for
field testing.
To determine whether to authorize shipment and grant approval for
the field testing of the unlicensed product referenced in this notice,
APHIS conducted a risk analysis to evaluate the potential effects of
this product on the safety of animals, public health, and the
environment. Using the risk analysis and other relevant data, APHIS has
prepared an environmental assessment (EA) concerning the field testing
of the following unlicensed product:
Requester: Bayer HealthCare LLC, Animal Health Division.
Product: DNA Immunostimulant.
Possible Field Test Locations: Texas, Mississippi, and Georgia for
poultry; Nebraska, Indiana, and Missouri for cattle.
The above mentioned product consists of non-replicating plasmid DNA
in an immunogenic complex for use as an immunostimulant. This product
will be recommended for the reduction in morbidity and mortality due to
Escherichia coli in chickens and reduction in bovine respiratory
disease due to Mannheimia haemolytica in cattle.
The EA has been prepared in accordance with: (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (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 issues with adverse environmental impacts are
raised in response to this notice, APHIS intends to issue a finding of
no significant impact (FONSI) based on the EA and authorize shipment of
the above product for the initiation of field tests following the close
of the comment period for this notice.
Because the issues raised by field testing and by issuance of a
license are identical, APHIS has concluded that the EA that is
generated for field testing would also be applicable to the proposed
licensing action. Provided that the field test data support the
conclusions of the original EA and the issuance of a FONSI, APHIS does
not intend to issue a separate EA and FONSI to support the issuance of
the veterinary biological product license, and would determine that an
environmental impact statement need not be prepared. APHIS intends to
issue a veterinary biological product license for this product
following completion of the field test provided no adverse impacts on
the human environment are identified and provided the product meets all
other requirements for licensing.
Authority: 21 U.S.C. 151-159.
Done in Washington, DC, this 19th day of September 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-23175 Filed 9-23-13; 8:45 am]
BILLING CODE 3410-34-P
