80_FR_20027 80 FR 19956 - Availability of an Environmental Assessment for Field Testing a Marek's Disease Vaccine, Serotype 1, Live Virus

80 FR 19956 - Availability of an Environmental Assessment for Field Testing a Marek's Disease Vaccine, Serotype 1, Live Virus

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

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

Page Range19956-19957
FR Document2015-08604

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 vaccine, serotype 1, live virus. 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 19956-19957]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08604]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0003]


Availability of an Environmental Assessment for Field Testing a 
Marek's Disease Vaccine, Serotype 1, Live Virus

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 vaccine, serotype 1, live 
virus. 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-2015-0003.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0003, 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://

[[Page 19957]]

www.regulations.gov/#!docketDetail;D=APHIS-2015-0003 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 Vaccine, Serotype 1, Live Virus.
    Possible Field Test Locations: Arkansas, Georgia, Kentucky, North 
Carolina, Tennessee, and Texas.
    The above-mentioned product is a live Marek's Disease serotype 1 
vaccine virus containing the long terminal repeat of the 
reticuloendotheliosis virus. The attenuated vaccine is intended for use 
in healthy day-old chickens, as an aid in the prevention of Marek's 
disease caused by very virulent Marek's disease virus.
    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 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. 2015-08604 Filed 4-13-15; 8:45 am]
 BILLING CODE 3410-34-P

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

Federal Register / Vol. 80, No. 71 / Tuesday, April 14, 2015 / Notices 19957 www.regulations.gov/ The attenuated vaccine is intended for Paperwork Reduction Act (44 U.S.C. #!docketDetail;D=APHIS–2015–0003 or use in healthy day-old chickens, as an chapter 35). in our reading room, which is located in aid in the prevention of Marek’s disease Agency: U.S. Census Bureau. room 1141 of the USDA South Building, caused by very virulent Marek’s disease Title: Comparing Health Insurance 14th Street and Independence Avenue virus. Measurement Error (CHIME). SW., Washington, DC. Normal reading The EA has been prepared in OMB Control Number: 0607–XXXX. room hours are 8 a.m. to 4:30 p.m., accordance with: (1) The National Form Number(s): No forms; Monday through Friday, except Environmental Policy Act of 1969 respondent information collected by holidays. To be sure someone is there to (NEPA), as amended (42 U.S.C. 4321 et telephone interview. help you, please call (202) 799–7039 seq.), (2) regulations of the Council on Type of Request: Regular submission. before coming. Environmental Quality for Number of Respondents: 5,000 implementing the procedural provisions Households. FOR FURTHER INFORMATION CONTACT: Dr. of NEPA (40 CFR parts 1500–1508), (3) Average Hours per Response: 13 Donna Malloy, Operational Support minutes. Section, Center for Veterinary Biologics, USDA regulations implementing NEPA Burden Hours: 3,028 hours. Policy, Evaluation, and Licensing, VS, (7 CFR part 1b), and (4) APHIS’ NEPA Needs and Uses: The goal of the study APHIS, 4700 River Road Unit 148, Implementing Procedures (7 CFR part is to assess measurement error in health Riverdale, MD 20737–1231; phone (301) 372). coverage estimates that is ascribable to 851–3426, fax (301) 734–4314. Unless substantial issues with adverse the questionnaire across the CPS and For information regarding the environmental impacts are raised in ACS health insurance modules using environmental assessment or the risk response to this notice, APHIS intends administrative records as a truth source. analysis, or to request a copy of the to issue a finding of no significant Both ‘‘absolute’’ reporting accuracy (the environmental assessment (as well as impact (FONSI) based on the EA and survey report compared to the the risk analysis with confidential authorize shipment of the above product administrative record data) and business information removed), contact for the initiation of field tests following ‘‘relative’’ reporting accuracy Dr. Patricia L. Foley, Risk Manager, the close of the comment period for this (comparing absolute accuracy across Center for Veterinary Biologics, Policy, notice. questionnaire treatments) will be Evaluation, and Licensing, VS, APHIS, Because the issues raised by field evaluated. The analysis will be used to 1920 Dayton Avenue, P.O. Box 844, testing and by issuance of a license are understand the magnitude, direction Ames, IA 50010; phone (515) 337–6100, identical, APHIS has concluded that the and patterns of misreporting for three fax (515) 337–6120. EA that is generated for field testing main purposes: (1) To provide Census SUPPLEMENTARY INFORMATION: would also be applicable to the program staff with empirical data to Under the Virus-Serum-Toxin Act (21 proposed licensing action. Provided that develop and refine edits and/or to U.S.C. 151 et seq.), a veterinary the field test data support the include research notes for data users so biological product must be shown to be conclusions of the original EA and the they can make their own adjustments pure, safe, potent, and efficacious before issuance of a FONSI, APHIS does not for misreporting; (2) to equip the wider a veterinary biological product license intend to issue a separate EA and FONSI research community with information may be issued. A field test is generally to support the issuance of the product that could serve as a guide for deciding necessary to satisfy prelicensing license, and would determine that an which among the various surveys best requirements for veterinary biological environmental impact statement need suits their needs; and (3) to contribute products. Prior to conducting a field test not be prepared. APHIS intends to issue to the general survey methods research on an unlicensed product, an applicant a veterinary biological product license literature on measurement error. must obtain approval from the Animal for this vaccine following completion of Analysis will also inform reporting and Plant Health Inspection Service the field test provided no adverse accuracy of health coverage related to (APHIS), as well as obtain APHIS’ impacts on the human environment are the Affordable Care Act (ACA). authorization to ship the product for identified and provided the product Specifically, for coverage that is known field testing. meets all other requirements for to be obtained from the marketplace, we To determine whether to authorize licensing. will explore whether respondents report shipment and grant approval for the Authority: 21 U.S.C. 151–159. that coverage, the source they cite field testing of the unlicensed product Done in Washington, DC, this 8th day of (direct-purchase, government, etc.), and referenced in this notice, APHIS April 2015. the accuracy with which they answer a considers the potential effects of this Kevin Shea, question on subsidized premiums. product on the safety of animals, public Affected Public: Individuals or Administrator, Animal and Plant Health health, and the environment. Using the Inspection Service. households. risk analysis and other relevant data, Frequency: One time. [FR Doc. 2015–08604 Filed 4–13–15; 8:45 am] APHIS has prepared an environmental Respondent’s Obligation: Voluntary. BILLING CODE 3410–34–P assessment (EA) concerning the field Legal Authority: Title 13, United testing of the following unlicensed States Code, sections 141, 182 and 193. veterinary biological product: This information collection request Requester: Merial, Inc. may be viewed at www.reginfo.gov. DEPARTMENT OF COMMERCE Product: Marek’s Disease Vaccine, Follow the instructions to view asabaliauskas on DSK5VPTVN1PROD with NOTICES Serotype 1, Live Virus. Submission for OMB Review; Department of Commerce collections Possible Field Test Locations: Comment Request currently under review by OMB. Arkansas, Georgia, Kentucky, North Written comments and Carolina, Tennessee, and Texas. The Department of Commerce will recommendations for the proposed The above-mentioned product is a submit to the Office of Management and information collection should be sent live Marek’s Disease serotype 1 vaccine Budget (OMB) for clearance the within 30 days of publication of this virus containing the long terminal following proposal for collection of notice to OIRA_Submission@ repeat of the reticuloendotheliosis virus. information under the provisions of the omb.eop.gov or fax to (202)395–5806. VerDate Sep<11>2014 17:42 Apr 13, 2015 Jkt 235001 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 E:\FR\FM\14APN1.SGM 14APN1


Document Created: 2015-12-18 11:10:04
Document Modified: 2015-12-18 11:10:04
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 19956 
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