82_FR_37711 82 FR 37557 - Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Canine Lymphoma

82 FR 37557 - Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Canine Lymphoma

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 154 (August 11, 2017)

Page Range37557-37558
FR Document2017-16977

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.

Federal Register, Volume 82 Issue 154 (Friday, August 11, 2017) 
[Federal Register Volume 82, Number 154 (Friday, August 11, 2017)]
[Notices]
[Pages 37557-37558]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16977]


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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.

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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

37557 Notices Federal Register Vol. 82, No. 154 Friday, August 11, 2017 This section of the FEDERAL REGISTER the USDA South Building, 14th Street APHIS’ authorization to ship the contains documents other than rules or and Independence Avenue SW., product for field testing. proposed rules that are applicable to the Washington, DC. Normal reading room To determine whether to authorize public. Notices of hearings and investigations, hours are 8 a.m. to 4:30 p.m., Monday shipment and grant approval for the committee meetings, agency decisions and through Friday, except holidays. To be field testing of the unlicensed product rulings, delegations of authority, filing of petitions and applications and agency sure someone is there to help you, referenced in this notice, APHIS statements of organization and functions are please call (202) 7997039 before coming. considers the potential effects of this examples of documents appearing in this FOR FURTHER INFORMATION CONTACT: Dr. product on the safety of animals, public section. Donna Malloy, Operational Support health, and the environment. Based Section, Center for Veterinary Biologics, upon a risk analysis and other relevant Policy, Evaluation, and Licensing, VS, data, APHIS has prepared an DEPARTMENT OF AGRICULTURE APHIS, 4700 River Road Unit 148, environmental assessment (EA) Riverdale, MD 20737–1231; phone (301) concerning the field testing of the Animal and Plant Health Inspection following unlicensed veterinary 851–3426, fax (301) 734–4314. Service biological product: For information regarding the [Docket No. APHIS–2017–0054] environmental assessment or the risk Requester: Antelope Valley Bios, Inc. analysis, or to request a copy of the Product: Canine Lymphoma Vaccine, Availability of an Environmental environmental assessment (as well as Live Listeria Vector. Assessment for Field Testing of a the risk analysis with confidential Possible Field Test Locations: Vaccine for Use Against Canine business information redacted), contact Arizona, California, Connecticut, Lymphoma Dr. Patricia L. Foley, Risk Manager, Delaware, Kansas, Maryland, Center for Veterinary Biologics, Policy, Massachusetts, Missouri, Nevada, New AGENCY: Animal and Plant Health Jersey, New Mexico, New York, Inspection Service, USDA. Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, P.O. Box 844, Pennsylvania, Rhode Island, and Texas. ACTION: Notice of availability. This list of possible field test Ames, IA 50010; phone (515) 337–6100, fax (515) 337–6120. locations includes States with SUMMARY: We are advising the public veterinary clinics or oncology centers that the Animal and Plant Health SUPPLEMENTARY INFORMATION: Under the that will treat dogs, as well as States Inspection Service has prepared an Virus-Serum-Toxin Act (21 U.S.C. 151 with resident dogs that receive environmental assessment concerning et seq.), the Animal and Plant Health treatment in another State then return authorization to ship for the purposes of Inspection Service (APHIS) is home. field testing, and then to field test, an authorized to promulgate regulations The above-mentioned product unlicensed Canine Lymphoma Vaccine, designed to ensure that veterinary consists of a highly attenuated Listeria Live Listeria Vector. Based on the biological products are pure, safe, monocytogenes strain that expresses a environmental assessment, risk analysis, potent, and efficacious before a human survivin fusion protein. It and other relevant data, we have veterinary biological product license induces a strong cell-mediated immune reached a preliminary determination may be issued. Veterinary biological response as an aid in the treatment of that field testing this veterinary vaccine products include viruses, serums, dogs with lymphomas. It will be will not have a significant impact on the toxins, and analogous products of administered only in a veterinary clinic quality of the human environment. We natural or synthetic origin, such as or veterinary oncology center by trained are making the documents available to vaccines, antitoxins, or the immunizing personnel. the public for review and comment. components of microorganisms The EA has been prepared in DATES: We will consider all comments intended for the diagnosis, treatment, or accordance with: (1) The National that we receive on or before September prevention of diseases in domestic Environmental Policy Act of 1969 11, 2017. animals. (NEPA), as amended (42 U.S.C. 4321 et ADDRESSES: You may submit comments APHIS issues licenses to qualified seq.), (2) regulations of the Council on by either of the following methods: establishments that produce veterinary Environmental Quality for • Federal eRulemaking Portal: Go to biological products and issues permits implementing the procedural provisions http://www.regulations.gov/#!docket to importers of such products. APHIS of NEPA (40 CFR parts 1500–1508), (3) Detail;D=APHIS-2017-0054. also enforces requirements concerning USDA regulations implementing NEPA • Postal Mail/Commercial Delivery: production, packaging, labeling, and (7 CFR part 1b), and (4) APHIS’ NEPA Send your comment to Docket No. shipping of these products and sets Implementing Procedures (7 CFR part APHIS–2017–0054, Regulatory Analysis standards for the testing of these 372). products. Regulations concerning asabaliauskas on DSKBBXCHB2PROD with NOTICES and Development, PPD, APHIS, Station We are publishing this notice to 3A–03.8, 4700 River Road Unit 118, veterinary biological products are inform the public that we will accept Riverdale, MD 20737–1238. contained in 9 CFR parts 101 to 124. written comments regarding the EA Supporting documents and any A field test is generally necessary to from interested or affected persons for a comments we receive on this docket satisfy pre-licensing requirements for period of 30 days from the date of this may be viewed at http:// veterinary biological products. Prior to notice. Unless substantial issues with www.regulations.gov/#!docketDetail;D= conducting a field test on an unlicensed adverse environmental impacts are APHIS-2017-0054 or in our reading product, an applicant must obtain raised in response to this notice, APHIS room, which is located in room 1141 of approval from APHIS, as well as obtain intends to issue a finding of no VerDate Sep<11>2014 17:18 Aug 10, 2017 Jkt 241001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1

37558 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Notices significant impact (FONSI) based on the continued operation and maintenance Federal Advisory Committee Act. The EA and authorize shipment of the above and improvements to the facilities purpose of the committee is to improve product for the initiation of field tests within the recreation areas. collaborative relationships and to following the close of the comment An analysis of nearby recreation provide advice and recommendations to period for this notice. facilities with similar amenities shows the Forest Service concerning projects Because the issues raised by field that the proposed fees are reasonable and funding consistent with Title II of testing and by issuance of a license are and typical of similar sites in the area. the Act. RAC information can be found identical, APHIS has concluded that the DATES: Comments will be accepted at the following Web site: http:// EA that is generated for field testing through September 5. New fees would cloudapps-usda-gov.force.com/FSSRS/ would also be applicable to the begin May 2018. RAC_Page?id=001t0000002JcwUAAS. proposed licensing action. Provided that ADDRESSES: Paul I.V. Strong, Forest DATES: The meeting will be held on the field test data support the Supervisor, Chequamegon-Nicolet Thursday, August 24, 2017, at 9:00 a.m. conclusions of the original EA and the National Forest, 500 Hanson Lake Road All RAC meetings are subject to issuance of a FONSI, APHIS does not Rhinelander, WI 54501 cancellation. For status of meeting prior intend to issue a separate EA and FONSI to attendance, please contact the person FOR FURTHER INFORMATION CONTACT: to support the issuance of the associated listed under FOR FURTHER INFORMATION product license, and would determine Hilary Markin, Public Affairs Officer, 715–362–1354. Information about these CONTACT. that an environmental impact statement need not be prepared. APHIS intends to and other proposed fee changes can also ADDRESSES: The meeting will be held at issue a veterinary biological product be found on the Chequamegon-Nicolet the Truckee Ranger Station, Conference license for this vaccine following National Forest Web site: https:// Room, 10811 Stockrest Springs Road, satisfactory completion of the field test, www.fs.usda.gov/CNNF Truckee, California. provided no adverse impacts on the SUPPLEMENTARY INFORMATION: The Written comments may be submitted human environment are identified and Federal Recreation Lands Enhancement as described under SUPPLEMENTARY provided the product meets all other Act (Title VII, P.L. 108–447) directed the INFORMATION. All comments, including requirements for licensing. Secretary of Agriculture to publish a six names and addresses when provided, month advance notice in the Federal are placed in the record and are Authority: 21 U.S.C. 151–159. available for public inspection and Register whenever new recreation fee Done in Washington, DC, this 7th day of areas are established. copying. The public may inspect August 2017. All proposed day-use sites have the comments received at Truckee Ranger Michael C. Gregoire, six amenities required under the Federal Station. Acting Administrator, Animal and Plant Lands Recreation Enhancement Act and FOR FURTHER INFORMATION CONTACT: Health Inspection Service. are similar to other fee sites on the Michael Woodbridge, RAC Coordinator, [FR Doc. 2017–16977 Filed 8–10–17; 8:45 am] Chequamegon-Nicolet National Forest. by phone at 530–478–6205 or via email BILLING CODE 3410–34–P Franklin Lake Caretakers Cabin is a at mjwoodbridge@fs.fed.us. unique overnight opportunity not Individuals who use provided elsewhere on the forest. These telecommunication devices for the deaf DEPARTMENT OF AGRICULTURE proposed new fees are part of a larger (TDD) may call the Federal Information fee proposal that includes campground Relay Service (FIRS) at 1–800–877–8339 Forest Service increases and a change in the price of between 8:00 a.m. and 8:00 p.m., Notice of Proposed New Fee Sites the annual day-use fee. For more Eastern Standard Time, Monday information on these sites and the full through Friday. AGENCY: Chequamegon-Nicolet National proposal, visit https://www.fs.usda.gov/ Forest, Forest Service, Department of SUPPLEMENTARY INFORMATION: The CNNF/. Agriculture. purpose of the meeting is to: Dated: July 18, 2017. 1. Welcome and oriententation of ACTION: Notice of Proposed New Fee Jeanne M. Higgins, members, Sites. Acting Associate Deputy Chief, National 2. Federal Advisory Committee Act SUMMARY: The Chequamegon-Nicolet Forest System. overview, National Forest is proposing new [FR Doc. 2017–16941 Filed 8–10–17; 8:45 am] 3. Development of project ranking recreation fee sites. The Chequamegon- BILLING CODE 3411–15–P citeria and voting process, Nicolet’s proposal includes: A $75 4. Elect a RAC chairperson, nightly fee for the Franklin Lake 5. Project proponent presentations, Caretaker Cabin, and adding nine day- DEPARTMENT OF AGRICULTURE and use sites to the Forest’s day-use fee 6. Review and selection of project program. Sites proposed are: Ada Lake Forest Service proposals. Beach, Bear Lake Beach, Bear Lake Boat The meeting is open to the public. Nevada and Placer Counties Resource Landing, Beck Road Trailhead, Block The agenda will include time for people Advisory Committee House Boat Landing, Gordon Lake to make oral statements of three minutes Beach, Mondeaux Pines Picnic Site, AGENCY: Forest Service, USDA. or less. Individuals wishing to make an asabaliauskas on DSKBBXCHB2PROD with NOTICES Smith Rapids Picnic Area and Wanoka ACTION: Notice of meeting. oral statement should submit a request Trailhead. in writing at least one week prior to the Fees are assessed based on the level SUMMARY: The Nevada and Placer meeting to be scheduled on the agenda. of amenities and services provided, cost Counties Resource Advisory Committee Anyone who would like to bring related of operations and maintenance and (RAC) will meet in Truckee, California. matters to the attention of the committee market assessment. These fees are The committee is authorized under the may file written statements with the proposed and will be determined upon Secure Rural Schools and Community committee staff before or after the further analysis and public comment. Self-Determination Act of 2000 (the Act) meeting. Written comments and Funds from fees would be used for the and operates in compliance with the requests for time to make oral comments VerDate Sep<11>2014 17:18 Aug 10, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1


Document Created: 2018-10-24 11:46:16
Document Modified: 2018-10-24 11:46:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesWe will consider all comments that we receive on or before September 11, 2017.
ContactDr. 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.
FR Citation82 FR 37557 
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