Availability of an Environmental Assessment for Field Testing Avian Influenza-Marek's Disease Vaccine, H5 Subtype, Serotype 3, Live Marek's Disease Vector, 66032-66033 [2011-27555]
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66032
Notices
Federal Register
Vol. 76, No. 206
Tuesday, October 25, 2011
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2011–0094]
Availability of an Environmental
Assessment for Field Testing Avian
Influenza-Marek’s Disease Vaccine, H5
Subtype, Serotype 3, Live Marek’s
Disease Vector
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
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 Avian Influenza-Marek’s
Disease Vaccine, H5 Subtype, Serotype
3, Live Marek’s Disease Vector. The
environmental assessment, which is
based on a risk analysis prepared to
assess the risks associated with the field
testing of this vaccine, examines the
potential effects that field testing this
veterinary vaccine could have on the
quality of the human environment.
Based on the risk analysis, we have
reached a preliminary determination
that field testing this veterinary vaccine
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 vaccine 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 vaccine, 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.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:10 Oct 24, 2011
Jkt 226001
We will consider all comments
that we receive on or before November
25, 2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS–2011–
0094–0001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2011–0094, 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–2011–0094 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) 690–2817
before coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Donna Malloy, Operational Support
Section, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing, VS,
APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737–1231; phone (301)
734–8245, fax (301) 734–4314.
For information regarding the
environmental assessment or the risk
analysis, or to request a copy of the
environmental assessment (as well as
the risk analysis with confidential
business information removed), contact
Dr. Patricia L. 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’
DATES:
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
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, a risk analysis
has been prepared to assess the
potential effects of this product on the
safety of animals, public health, and the
environment. Based on the risk analysis,
APHIS has prepared an environmental
assessment (EA) concerning the field
testing of the following unlicensed
veterinary biological product:
Requester: Biomune Company.
Product: Avian Influenza-Marek’s
Disease Vaccine, H5 Subtype, Serotype
3, Live Marek’s Disease Vector.
Field Test Locations: Delaware and
Kansas.
The above-mentioned product
consists of a live recombinant Marek’s
disease virus vector expressing an avian
influenza virus protein. The vaccine is
for in ovo vaccination of 18-day-old
chick embryos or for the subcutaneous
vaccination of healthy day-of-age chicks
as an aid in the prevention of Marek’s
Disease and avian influenza.
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 provision
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 product
license, and would determine that an
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 / Notices
environmental impact statement need
not be prepared. APHIS intends to issue
a veterinary biological product license
for this vaccine 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
October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–27555 Filed 10–24–11; 8:45 am]
BILLING CODE 3410–34–P
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-2011-0072 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) 690–2817
before coming.
Dr.
Arnold Tschanz, Senior Plant
Pathologist/Senior Risk Manager, Plants
for Planting Policy, RPM, PPQ, APHIS,
4700 River Road Unit 133, Riverdale,
MD 20737–1236; (301) 734–0627.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2011–0072]
Plants for Planting Whose Importation
Is Not Authorized Pending Pest Risk
Analysis; Notice of Availability of Data
Sheets for Taxa of Plants for Planting
That Are Quarantine Pests or Hosts of
Quarantine Pests
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice; reopening of comment
period.
AGENCY:
We are reopening the
comment period for a notice that
advised the public that we have
determined that 41 taxa of plants for
planting are quarantine pests and 107
taxa of plants for planting are hosts of
13 quarantine pests and therefore
should be added to our lists of taxa of
plants for planting whose importation is
not authorized pending pest risk
analysis. The notice also made available
to the public for review and comment
data sheets that detail the scientific
evidence we evaluated in making the
determination that the taxa are
quarantine pests or hosts of quarantine
pests. This action will allow interested
persons additional time to prepare and
submit comments.
DATES: We will consider all comments
that we receive on or before November
25, 2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2011-00720001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2011–0072, Regulatory Analysis
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:10 Oct 24, 2011
Jkt 226001
SUPPLEMENTARY INFORMATION:
On July 26, 2011, we published in the
Federal Register (76 FR 44572–44573,
Docket No. APHIS–2011–0072) a notice
advising the public that we have
determined that 41 taxa of plants for
planting are quarantine pests and 107
taxa of plants for planting are hosts of
13 quarantine pests and therefore
should be added to our lists of taxa of
plants for planting whose importation is
not authorized pending pest risk
analysis. The notice also made available
to the public for review and comment
data sheets that detail the scientific
evidence we evaluated in making the
determination that the taxa are
quarantine pests or hosts of quarantine
pests.
Comments on the notice were
required to be received on or before
September 26, 2011. We are reopening
the comment period on Docket No.
APHIS–2011–0072 for an additional 30
days. This action will allow interested
persons additional time to prepare and
submit comments. We will also consider
all comments received between
September 27, 2011, and the date of this
notice.
66033
DEPARTMENT OF AGRICULTURE
Forest Service
Madera County Resource Advisory
Committee
Forest Service, USDA.
Notice of meeting.
AGENCY:
ACTION:
The Madera County Resource
Advisory Committee will be meeting in
North Fork, California on November 15,
2011. The purpose of the meeting will
be to to update the committee on the
status and monitoring of projects that
were recommended for funding at the
March 30, 2011 meeting, as authorized
under the Secure Rural Schools and
Community Self-Determination Act of
2000 (Pub. L.110–343) for expenditure
of Payments to States Madera County
Title II funds.
DATES: The meeting will be held on
November 15, 2011.
ADDRESSES: The meeting will be held at
the Bass Lake Ranger District, 57003
Road 225, North Fork, California, 93643.
Send written comments to Julie Roberts,
Madera County Resource Advisory
Committee Coordinator, c/o Sierra
National Forest, Bass Lake Ranger
District, at the above address, or
electronically to jaroberts@fs.fed.us.
FOR FURTHER INFORMATION CONTACT: Julie
Roberts, Madera County Resource
Advisory Committee Coordinator, (559)
877–2218 ext. 3159.
SUPPLEMENTARY INFORMATION: The
meeting is open to the public.
Committee discussion is limited to
Forest Service staff and Committee
members. However, persons who wish
to bring Payments to States Madera
County Title II project matters to the
attention of the Committee may file
written statements with the Committee
staff before or after the meetings.
SUMMARY:
Dated: October 18, 2011.
Dave Martin,
District Ranger.
[FR Doc. 2011–27608 Filed 10–24–11; 8:45 am]
BILLING CODE 3410–11–P
DEPARTMENT OF AGRICULTURE
Authority: 7 U.S.C. 450, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
Forest Service
Done in Washington, DC, this 19th day of
October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
AGENCY:
[FR Doc. 2011–27559 Filed 10–24–11; 8:45 am]
BILLING CODE 3410–34–P
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
Sabine Resource Advisory Committee
ACTION:
Forest Service, USDA.
Notice of meeting cancellation.
The Sabine-Angelina
Resource Advisory Committee was
scheduled to meet October 20, 2011 in
Hemphill, Texas. The committee is
authorized under the Secure Rural
SUMMARY:
E:\FR\FM\25OCN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Notices]
[Pages 66032-66033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27555]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 /
Notices
[[Page 66032]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0094]
Availability of an Environmental Assessment for Field Testing
Avian Influenza-Marek's Disease Vaccine, H5 Subtype, Serotype 3, Live
Marek's Disease Vector
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 environmental assessment concerning
authorization to ship for the purpose of field testing, and then to
field test, an unlicensed Avian Influenza-Marek's Disease Vaccine, H5
Subtype, Serotype 3, Live Marek's Disease Vector. The environmental
assessment, which is based on a risk analysis prepared to assess the
risks associated with the field testing of this vaccine, examines the
potential effects that field testing this veterinary vaccine could have
on the quality of the human environment. Based on the risk analysis, we
have reached a preliminary determination that field testing this
veterinary vaccine 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 vaccine 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 vaccine, 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
November 25, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2011-0094-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2011-0094, 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-2011-
0094 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) 690-2817 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support
Section, Center for Veterinary Biologics, Policy, Evaluation, and
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; phone (301) 734-8245, fax (301) 734-4314.
For information regarding the environmental assessment or the risk
analysis, or to request a copy of the environmental assessment (as well
as the risk analysis with confidential business information removed),
contact Dr. Patricia L. 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,
a risk analysis has been prepared to assess the potential effects of
this product on the safety of animals, public health, and the
environment. Based on the risk analysis, APHIS has prepared an
environmental assessment (EA) concerning the field testing of the
following unlicensed veterinary biological product:
Requester: Biomune Company.
Product: Avian Influenza-Marek's Disease Vaccine, H5 Subtype,
Serotype 3, Live Marek's Disease Vector.
Field Test Locations: Delaware and Kansas.
The above-mentioned product consists of a live recombinant Marek's
disease virus vector expressing an avian influenza virus protein. The
vaccine is for in ovo vaccination of 18-day-old chick embryos or for
the subcutaneous vaccination of healthy day-of-age chicks as an aid in
the prevention of Marek's Disease and avian influenza.
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 provision 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 product license, and would determine that an
[[Page 66033]]
environmental impact statement need not be prepared. APHIS intends to
issue a veterinary biological product license for this vaccine
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 October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-27555 Filed 10-24-11; 8:45 am]
BILLING CODE 3410-34-P
