80_FR_20026 80 FR 19955 - Availability of an Environmental Assessment for Field Testing a Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease Vector

80 FR 19955 - Availability of an Environmental Assessment for Field Testing a Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease Vector

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 71 (April 14, 2015)

Page Range19955-19956
FR Document2015-08602

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 Marek's disease-Newcastle disease vaccine, 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 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, 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.

Federal Register, Volume 80 Issue 71 (Tuesday, April 14, 2015) 
[Federal Register Volume 80, Number 71 (Tuesday, April 14, 2015)]
[Notices]
[Pages 19955-19956]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08602]


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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. 80, No. 71 / Tuesday, April 14, 2015 / 
Notices

[[Page 19955]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0002]


Availability of an Environmental Assessment for Field Testing a 
Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's 
Disease Vector

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

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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 Marek's disease-Newcastle disease vaccine, 
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 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, 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 May 
14, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0002.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0002, 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-2015-
0002 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.

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 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, 
APHIS considers 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 
veterinary biological product:
    Requester: Merial, Inc.
    Product: Marek's Disease-Newcastle Disease Vaccine, Serotype 3, 
Live Marek's Disease Vector.
    Possible Field Test Locations: Arkansas, Georgia, Indiana, Iowa, 
Missouri, Ohio, Oklahoma, Pennsylvania, and Virginia.
    The above-mentioned product is a live Marek's disease serotype 3 
vaccine virus containing a gene from the Newcastle disease virus. The 
attenuated vaccine is intended for use in healthy 18-day-old or older 
embryonated eggs or day-old chickens, as an aid in the prevention of 
Marek's disease and Newcastle disease.
    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

[[Page 19956]]

to support the issuance of the 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 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 8th day of April 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-08602 Filed 4-13-15; 8:45 am]
 BILLING CODE 3410-34-P

19955 Notices Federal Register Vol. 80, No. 71 Tuesday, April 14, 2015 This section of the FEDERAL REGISTER DATES: We will consider all comments authorization to ship the product for contains documents other than rules or that we receive on or before May 14, field testing. proposed rules that are applicable to the 2015. To determine whether to authorize public. Notices of hearings and investigations, shipment and grant approval for the committee meetings, agency decisions and ADDRESSES: You may submit comments by either of the following methods: field testing of the unlicensed product rulings, delegations of authority, filing of referenced in this notice, APHIS petitions and applications and agency • Federal eRulemaking Portal: Go to statements of organization and functions are considers the potential effects of this http://www.regulations.gov/ examples of documents appearing in this product on the safety of animals, public #!docketDetail;D=APHIS-2015-0002. section. health, and the environment. Using the • Postal Mail/Commercial Delivery: risk analysis and other relevant data, Send your comment to Docket No. APHIS has prepared an environmental APHIS–2015–0002, Regulatory Analysis DEPARTMENT OF AGRICULTURE assessment (EA) concerning the field and Development, PPD, APHIS, Station testing of the following unlicensed Animal and Plant Health Inspection 3A–03.8, 4700 River Road Unit 118, veterinary biological product: Service Riverdale, MD 20737–1238. Requester: Merial, Inc. Supporting documents and any [Docket No. APHIS–2015–0002] Product: Marek’s Disease-Newcastle comments we receive on this docket Disease Vaccine, Serotype 3, Live may be viewed at http:// Availability of an Environmental Marek’s Disease Vector. www.regulations.gov/ Assessment for Field Testing a Possible Field Test Locations: #!docketDetail;D=APHIS-2015-0002 or Marek’s Disease-Newcastle Disease Arkansas, Georgia, Indiana, Iowa, Vaccine, Serotype 3, Live Marek’s in our reading room, which is located in Missouri, Ohio, Oklahoma, Disease Vector room 1141 of the USDA South Building, Pennsylvania, and Virginia. 14th Street and Independence Avenue The above-mentioned product is a AGENCY: Animal and Plant Health SW., Washington, DC. Normal reading live Marek’s disease serotype 3 vaccine Inspection Service, USDA. room hours are 8 a.m. to 4:30 p.m., virus containing a gene from the ACTION: Notice of availability. Monday through Friday, except Newcastle disease virus. The attenuated holidays. To be sure someone is there to SUMMARY: We are advising the public vaccine is intended for use in healthy help you, please call (202) 799–7039 that the Animal and Plant Health 18-day-old or older embryonated eggs or before coming. Inspection Service has prepared an day-old chickens, as an aid in the FOR FURTHER INFORMATION CONTACT: Dr. prevention of Marek’s disease and environmental assessment concerning authorization to ship for the purpose of Donna Malloy, Operational Support Newcastle disease. field testing, and then to field test, an Section, Center for Veterinary Biologics, The EA has been prepared in unlicensed Marek’s disease-Newcastle Policy, Evaluation, and Licensing, VS, accordance with: (1) The National disease vaccine, serotype 3, live Marek’s APHIS, 4700 River Road Unit 148, Environmental Policy Act of 1969 disease vector. The environmental Riverdale, MD 20737–1231; phone (301) (NEPA), as amended (42 U.S.C. 4321 et assessment, which is based on a risk 851–3426, fax (301) 734–4314. seq.), (2) regulations of the Council on analysis prepared to assess the risks For information regarding the Environmental Quality for associated with the field testing of this environmental assessment or the risk implementing the procedural provisions vaccine, examines the potential effects analysis, or to request a copy of the of NEPA (40 CFR parts 1500–1508), (3) that field testing this veterinary vaccine environmental assessment (as well as USDA regulations implementing NEPA could have on the quality of the human the risk analysis with confidential (7 CFR part 1b), and (4) APHIS’ NEPA environment. Based on the risk analysis business information removed), contact Implementing Procedures (7 CFR part and other relevant data, we have Dr. Patricia L. Foley, Risk Manager, 372). reached a preliminary determination Center for Veterinary Biologics, Policy, Unless substantial issues with adverse that field testing this veterinary vaccine Evaluation, and Licensing, VS, APHIS, environmental impacts are raised in will not have a significant impact on the 1920 Dayton Avenue, P.O. Box 844, response to this notice, APHIS intends quality of the human environment, and Ames, IA 50010; phone (515) 337–6100, to issue a finding of no significant that an environmental impact statement fax (515) 337–6120. impact (FONSI) based on the EA and need not be prepared. We intend to SUPPLEMENTARY INFORMATION: Under the authorize shipment of the above product authorize shipment of this vaccine for Virus-Serum-Toxin Act (21 U.S.C. 151 for the initiation of field tests following field testing following the close of the et seq.), a veterinary biological product the close of the comment period for this comment period for this notice unless must be shown to be pure, safe, potent, notice. new substantial issues bearing on the and efficacious before a veterinary Because the issues raised by field effects of this action are brought to our biological product license may be testing and by issuance of a license are asabaliauskas on DSK5VPTVN1PROD with NOTICES attention. We also intend to issue a U.S. issued. A field test is generally identical, APHIS has concluded that the Veterinary Biological Product license for necessary to satisfy prelicensing EA that is generated for field testing this vaccine, provided the field test data requirements for veterinary biological would also be applicable to the support the conclusions of the products. Prior to conducting a field test proposed licensing action. Provided that environmental assessment and the on an unlicensed product, an applicant the field test data support the issuance of a finding of no significant must obtain approval from the Animal conclusions of the original EA and the impact and the product meets all other and Plant Health Inspection Service issuance of a FONSI, APHIS does not requirements for licensing. (APHIS), as well as obtain APHIS’ intend to issue a separate EA and FONSI VerDate Sep<11>2014 18:49 Apr 13, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\14APN1.SGM 14APN1

19956 Federal Register / Vol. 80, No. 71 / Tuesday, April 14, 2015 / Notices to support the issuance of the product • Follow-on discussion of DEPARTMENT OF AGRICULTURE license, and would determine that an antimicrobial resistance, mitigations, environmental impact statement need and the U.S. Department of Agriculture Animal and Plant Health Inspection not be prepared. APHIS intends to issue (USDA) action plan, Service a veterinary biological product license • Comprehensive discussion on [Docket No. APHIS–2015–0003] for this vaccine following completion of porcine epidemic diarrhea, the field test provided no adverse Availability of an Environmental impacts on the human environment are • Follow-on discussion on foot-and- Assessment for Field Testing a identified and provided the product mouth disease, Marek’s Disease Vaccine, Serotype 1, meets all other requirements for • USDA draft framework for emerging Live Virus licensing. diseases, AGENCY: Animal and Plant Health Authority: 21 U.S.C. 151–159. • Proposed national list of reportable Inspection Service, USDA. Done in Washington, DC, this 8th day of animal diseases, ACTION: Notice of availability. April 2015. • Avian influenza, and Kevin Shea, SUMMARY: We are advising the public • Bovine tuberculosis program— that the Animal and Plant Health Administrator, Animal and Plant Health Inspection Service. understanding the disease. Inspection Service has prepared an [FR Doc. 2015–08602 Filed 4–13–15; 8:45 am] A final agenda will be posted on the environmental assessment concerning BILLING CODE 3410–34–P Committee Web site by April 13, 2015. authorization to ship for the purpose of Those wishing to attend the meeting field testing, and then to field test, an in person must complete a brief unlicensed Marek’s disease vaccine, DEPARTMENT OF AGRICULTURE registration form by clicking on the serotype 1, live virus. The ‘‘SACAH Meeting Sign-Up’’ button on environmental assessment, which is Animal and Plant Health Inspection based on a risk analysis prepared to Service the Committee’s Web site (http:// assess the risks associated with the field www.aphis.usda.gov/animalhealth/ [Docket No. APHIS–2015–0025] testing of this vaccine, examines the sacah). Members of the public may also potential effects that field testing this join the meeting via teleconference in veterinary vaccine could have on the Secretary’s Advisory Committee on Animal Health; Meeting ‘‘listen-only’’ mode. Participants who quality of the human environment. wish to listen in on the teleconference Based on the risk analysis and other AGENCY: Animal and Plant Health may do so by dialing 1–888–469–3079 relevant data, we have reached a Inspection Service, USDA. and then entering the public passcode, preliminary determination that field ACTION: Notice of meeting. 2061888#. testing this veterinary vaccine will not Due to time constraints, members of have a significant impact on the quality SUMMARY: This is a notice to inform the of the human environment, and that an public of an upcoming meeting of the the public will not have an opportunity to participate in the Committee’s environmental impact statement need Secretary’s Advisory Committee on not be prepared. We intend to authorize Animal Health. The meeting is being discussions. However, questions and written statements for the Committee’s shipment of this vaccine for field testing organized by the Animal and Plant following the close of the comment Health Inspection Service to discuss consideration may be submitted up to 5 working days before the meeting. They period for this notice unless new matters of animal health. substantial issues bearing on the effects DATES: The meeting will be held on may be sent to SACAH.Management@ aphis.usda.gov or mailed to the person of this action are brought to our April 28 and 29, 2015, from 9 a.m. to 5 attention. We also intend to issue a U.S. p.m. each day. listed on the notice under FOR FURTHER Veterinary Biological Product license for INFORMATION CONTACT. Statements filed ADDRESSES: The meeting will be held at this vaccine, provided the field test data the Bethesda Marriott, 5151 Pooks Hill with the Committee should specify that support the conclusions of the Road, Bethesda, MD 20814. they pertain to the April 2015 environmental assessment and the Committee meeting. issuance of a finding of no significant FOR FURTHER INFORMATION CONTACT: Mrs. R.J. Cabrera, Designated Federal Officer, This notice of meeting is given impact and the product meets all other VS, APHIS, 4700 River Road Unit 34, pursuant to section 10 of the Federal requirements for licensing. Riverdale, MD 20737; phone (301) 851– Advisory Committee Act (5 U.S.C. App. DATES: We will consider all comments 3478, email SACAH.Management@ 2). that we receive on or before May 14, aphis.usda.gov. Done in Washington, DC, this 8th day of 2015. SUPPLEMENTARY INFORMATION: April 2015. ADDRESSES: You may submit comments The Secretary’s Advisory Committee Kevin Shea, by either of the following methods: on Animal Health (the Committee) Administrator, Animal and Plant Health • Federal eRulemaking Portal: Go to advises the Secretary of Agriculture on Inspection Service. http://www.regulations.gov/ matters of animal health, including [FR Doc. 2015–08603 Filed 4–13–15; 8:45 am] #!docketDetail;D=APHIS–2015–0003. means to prevent, conduct surveillance • Postal Mail/Commercial Delivery: asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 3410–34–P on, monitor, control, or eradicate animal Send your comment to Docket No. diseases of national importance. In APHIS–2015–0003, Regulatory Analysis doing so, the Committee will consider and Development, PPD, APHIS, Station public health, conservation of natural 3A–03.8, 4700 River Road Unit 118, resources, and the stability of livestock Riverdale, MD 20737–1238. economies. Supporting documents and any Tentative topics for discussion at the comments we receive on this docket meeting include: may be viewed at http:// VerDate Sep<11>2014 17:42 Apr 13, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\14APN1.SGM 14APN1


Document Created: 2015-12-18 11:09:28
Document Modified: 2015-12-18 11:09:28
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 May 14, 2015.
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 Citation80 FR 19955 
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