Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Canine Lymphoma, 37557-37558 [2017-16977]

Download as PDF 37557 Notices Federal Register Vol. 82, No. 154 Friday, August 11, 2017 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–2017–0054] Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Canine Lymphoma 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 purposes of field testing, and then to field test, an unlicensed Canine Lymphoma Vaccine, Live Listeria Vector. Based on the environmental assessment, risk analysis, and other relevant data, 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. We are making the documents available to the public for review and comment. DATES: We will consider all comments that we receive on or before September 11, 2017. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docket Detail;D=APHIS-2017-0054. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2017–0054, 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 http:// www.regulations.gov/#!docketDetail;D= APHIS-2017-0054 or in our reading room, which is located in room 1141 of asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:18 Aug 10, 2017 Jkt 241001 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, 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. 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 redacted), 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.), the Animal and Plant Health Inspection Service (APHIS) is authorized to promulgate regulations designed to ensure that veterinary biological products are pure, safe, potent, and efficacious before a veterinary biological product license may be issued. Veterinary biological products include viruses, serums, toxins, and analogous products of natural or synthetic origin, such as vaccines, antitoxins, or the immunizing components of microorganisms intended for the diagnosis, treatment, or prevention of diseases in domestic animals. APHIS issues licenses to qualified establishments that produce veterinary biological products and issues permits to importers of such products. APHIS also enforces requirements concerning production, packaging, labeling, and shipping of these products and sets standards for the testing of these products. Regulations concerning veterinary biological products are contained in 9 CFR parts 101 to 124. A field test is generally necessary to satisfy pre-licensing requirements for veterinary biological products. Prior to conducting a field test on an unlicensed product, an applicant must obtain approval from APHIS, as well as obtain PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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 considers the potential effects of this product on the safety of animals, public health, and the environment. Based upon a risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: Antelope Valley Bios, Inc. Product: Canine Lymphoma Vaccine, Live Listeria Vector. Possible Field Test Locations: Arizona, California, Connecticut, Delaware, Kansas, Maryland, Massachusetts, Missouri, Nevada, New Jersey, New Mexico, New York, Pennsylvania, Rhode Island, and Texas. This list of possible field test locations includes States with veterinary clinics or oncology centers that will treat dogs, as well as States with resident dogs that receive treatment in another State then return home. The above-mentioned product consists of a highly attenuated Listeria monocytogenes strain that expresses a human survivin fusion protein. It induces a strong cell-mediated immune response as an aid in the treatment of dogs with lymphomas. It will be administered only in a veterinary clinic or veterinary oncology center by trained personnel. 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). We are publishing this notice to inform the public that we will accept written comments regarding the EA from interested or affected persons for a period of 30 days from the date of this notice. Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no E:\FR\FM\11AUN1.SGM 11AUN1 37558 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Notices 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 associated 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 vaccine following satisfactory 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 7th day of August 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2017–16977 Filed 8–10–17; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Notice of Proposed New Fee Sites Chequamegon-Nicolet National Forest, Forest Service, Department of Agriculture. ACTION: Notice of Proposed New Fee Sites. AGENCY: The Chequamegon-Nicolet National Forest is proposing new recreation fee sites. The ChequamegonNicolet’s proposal includes: A $75 nightly fee for the Franklin Lake Caretaker Cabin, and adding nine dayuse sites to the Forest’s day-use fee program. Sites proposed are: Ada Lake Beach, Bear Lake Beach, Bear Lake Boat Landing, Beck Road Trailhead, Block House Boat Landing, Gordon Lake Beach, Mondeaux Pines Picnic Site, Smith Rapids Picnic Area and Wanoka Trailhead. Fees are assessed based on the level of amenities and services provided, cost of operations and maintenance and market assessment. These fees are proposed and will be determined upon further analysis and public comment. Funds from fees would be used for the asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:18 Aug 10, 2017 Jkt 241001 continued operation and maintenance and improvements to the facilities within the recreation areas. An analysis of nearby recreation facilities with similar amenities shows that the proposed fees are reasonable and typical of similar sites in the area. DATES: Comments will be accepted through September 5. New fees would begin May 2018. ADDRESSES: Paul I.V. Strong, Forest Supervisor, Chequamegon-Nicolet National Forest, 500 Hanson Lake Road Rhinelander, WI 54501 FOR FURTHER INFORMATION CONTACT: Hilary Markin, Public Affairs Officer, 715–362–1354. Information about these and other proposed fee changes can also be found on the Chequamegon-Nicolet National Forest Web site: https:// www.fs.usda.gov/CNNF SUPPLEMENTARY INFORMATION: The Federal Recreation Lands Enhancement Act (Title VII, P.L. 108–447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established. All proposed day-use sites have the six amenities required under the Federal Lands Recreation Enhancement Act and are similar to other fee sites on the Chequamegon-Nicolet National Forest. Franklin Lake Caretakers Cabin is a unique overnight opportunity not provided elsewhere on the forest. These proposed new fees are part of a larger fee proposal that includes campground increases and a change in the price of the annual day-use fee. For more information on these sites and the full proposal, visit https://www.fs.usda.gov/ CNNF/. Dated: July 18, 2017. Jeanne M. Higgins, Acting Associate Deputy Chief, National Forest System. [FR Doc. 2017–16941 Filed 8–10–17; 8:45 am] BILLING CODE 3411–15–P DEPARTMENT OF AGRICULTURE Forest Service Nevada and Placer Counties Resource Advisory Committee Forest Service, USDA. Notice of meeting. AGENCY: ACTION: The Nevada and Placer Counties Resource Advisory Committee (RAC) will meet in Truckee, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act of 2000 (the Act) and operates in compliance with the SUMMARY: PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http:// cloudapps-usda-gov.force.com/FSSRS/ RAC_Page?id=001t0000002JcwUAAS. DATES: The meeting will be held on Thursday, August 24, 2017, at 9:00 a.m. All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT. The meeting will be held at the Truckee Ranger Station, Conference Room, 10811 Stockrest Springs Road, Truckee, California. Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Truckee Ranger Station. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Michael Woodbridge, RAC Coordinator, by phone at 530–478–6205 or via email at mjwoodbridge@fs.fed.us. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday. SUPPLEMENTARY INFORMATION: The purpose of the meeting is to: 1. Welcome and oriententation of members, 2. Federal Advisory Committee Act overview, 3. Development of project ranking citeria and voting process, 4. Elect a RAC chairperson, 5. Project proponent presentations, and 6. Review and selection of project proposals. The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing at least one week prior to the meeting to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 82, Number 154 (Friday, August 11, 2017)]
[Notices]
[Pages 37557-37558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16977]


========================================================================
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. 82, No. 154 / Friday, August 11, 2017 / 
Notices

[[Page 37557]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0054]


Availability of an Environmental Assessment for Field Testing of 
a Vaccine for Use Against Canine Lymphoma

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 purposes of field testing, and then to 
field test, an unlicensed Canine Lymphoma Vaccine, Live Listeria 
Vector. Based on the environmental assessment, risk analysis, and other 
relevant data, 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. We are making the documents 
available to the public for review and comment.

DATES: We will consider all comments that we receive on or before 
September 11, 2017.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0054.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0054, 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 http://www.regulations.gov/#!docketDetail;D=APHIS-2017-
0054 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, 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.
    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 redacted), 
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.), the Animal and Plant Health Inspection Service (APHIS) is 
authorized to promulgate regulations designed to ensure that veterinary 
biological products are pure, safe, potent, and efficacious before a 
veterinary biological product license may be issued. Veterinary 
biological products include viruses, serums, toxins, and analogous 
products of natural or synthetic origin, such as vaccines, antitoxins, 
or the immunizing components of microorganisms intended for the 
diagnosis, treatment, or prevention of diseases in domestic animals.
    APHIS issues licenses to qualified establishments that produce 
veterinary biological products and issues permits to importers of such 
products. APHIS also enforces requirements concerning production, 
packaging, labeling, and shipping of these products and sets standards 
for the testing of these products. Regulations concerning veterinary 
biological products are contained in 9 CFR parts 101 to 124.
    A field test is generally necessary to satisfy pre-licensing 
requirements for veterinary biological products. Prior to conducting a 
field test on an unlicensed product, an applicant must obtain approval 
from 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 considers the potential effects of this product on the safety of 
animals, public health, and the environment. Based upon a risk analysis 
and other relevant data, APHIS has prepared an environmental assessment 
(EA) concerning the field testing of the following unlicensed 
veterinary biological product:
    Requester: Antelope Valley Bios, Inc.
    Product: Canine Lymphoma Vaccine, Live Listeria Vector.
    Possible Field Test Locations: Arizona, California, Connecticut, 
Delaware, Kansas, Maryland, Massachusetts, Missouri, Nevada, New 
Jersey, New Mexico, New York, Pennsylvania, Rhode Island, and Texas.
    This list of possible field test locations includes States with 
veterinary clinics or oncology centers that will treat dogs, as well as 
States with resident dogs that receive treatment in another State then 
return home.
    The above-mentioned product consists of a highly attenuated 
Listeria monocytogenes strain that expresses a human survivin fusion 
protein. It induces a strong cell-mediated immune response as an aid in 
the treatment of dogs with lymphomas. It will be administered only in a 
veterinary clinic or veterinary oncology center by trained personnel.
    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).
    We are publishing this notice to inform the public that we will 
accept written comments regarding the EA from interested or affected 
persons for a period of 30 days from the date of this notice. Unless 
substantial issues with adverse environmental impacts are raised in 
response to this notice, APHIS intends to issue a finding of no

[[Page 37558]]

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 associated 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 vaccine 
following satisfactory 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 7th day of August 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-16977 Filed 8-10-17; 8:45 am]
 BILLING CODE 3410-34-P