82 FR 32785 - Availability of an Environmental Assessment for Field Testing a Vaccine For Use Against Infectious Bursal Disease, Marek's Disease, and Newcastle Disease

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 136 (July 18, 2017)

Page Range		32785-32786
FR Document		2017-14977

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 Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease 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 136 (Tuesday, July 18, 2017)

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32785-32786]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14977]


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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / 
Notices

[[Page 32785]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0020]


Availability of an Environmental Assessment for Field Testing a 
Vaccine For Use Against Infectious Bursal Disease, Marek's Disease, and 
Newcastle Disease

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 purpose of field testing, and then to 
field test, an unlicensed Bursal Disease-Marek's Disease-Newcastle 
Disease Vaccine, Serotype 3, Live Marek's Disease 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 
August 17, 2017.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0020.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0020, 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-
0020 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; (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 prelicensing 
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: Merck Animal Health.
    Product: Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, 
Serotype 3, Live Marek's Disease Vector.
    Possible Field Test Locations: Alabama, Arkansas, Georgia, 
Missouri, South Carolina, and Tennessee.
    The above-mentioned product is a live Marek's Disease serotype 3 
vaccine virus containing a gene from the Newcastle disease virus and a 
gene from the infectious bursal disease virus. The attenuated vaccine 
is intended for use in healthy 18-day-old chicken embryos by the in ovo 
route or day-old chicks by subcutaneous inoculation, as an aid in the 
prevention of infectious bursal disease, 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).
    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 
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.

[[Page 32786]]

    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 12th day of July 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-14977 Filed 7-17-17; 8:45 am]
 BILLING CODE 3410-34-P

32786 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices

Because the issues raised by field members of the public and affected forms, certifications and required
testing and by issuance of a license are agencies have an opportunity to documentation.
identical, APHIS has concluded that the comment on information collection and Estimate of Burden: Public reporting
EA that is generated for field testing recordkeeping activities (see 5 CFR burden for this collection of information
would also be applicable to the 1320.8(d)). This notice identifies an is estimated to average 32.35 hours per
proposed licensing action. Provided that information collection that the Agency response.
the field test data support the is submitting to OMB for extension. Respondents: Non-profit institutions.
conclusions of the original EA and the Comments are invited on: (a) Whether Estimated Number of Respondents: 7.
issuance of a FONSI, APHIS does not the proposed collection of information Estimated Number of Responses per
intend to issue a separate EA and FONSI is necessary for the proper performance Respondent: 24.
to support the issuance of the associated of the functions of the Agency, Estimated Total Annual Burden on
product license, and would determine including whether the information will Respondents: 776 Hours.
that an environmental impact statement have practical utility; (b) The accuracy Copies of this information collection
need not be prepared. APHIS intends to of the Agency’s estimate of the burden can be obtained from Rebecca Hunt,
issue a veterinary biological product of the proposed collection of Management Analyst, Program
license for this vaccine following information including the validity of the Development and Regulatory Analysis,
satisfactory completion of the field test, methodology and assumptions used; (c) at (202) 205–3660; FAX: (202) 720–
provided no adverse impacts on the Ways to enhance the quality, utility and 8435.
All responses to this notice will be
human environment are identified and clarity of the information to be
summarized and included in the request
provided the product meets all other collected; and (d) Ways to minimize the
for OMB approval. All comments will
requirements for licensing. burden of the collection of information
also become a matter of public record.
Authority: 21 U.S.C. 151–159. on those who are to respond, including
through the use of appropriate Dated: June 26, 2017.
Done in Washington, DC, this 12th day of automated, electronic, mechanical, or Christopher A. McLean,
July 2017.
other technological collection Acting Administrator, Rural Utilities Service.
Michael C. Gregoire, techniques or other forms of information [FR Doc. 2017–14979 Filed 7–17–17; 8:45 am]
Acting Administrator, Animal and Plant technology. Comments may be sent to: BILLING CODE P
Health Inspection Service. Thomas P. Dickson, Acting Director,
[FR Doc. 2017–14977 Filed 7–17–17; 8:45 am] Program Development and Regulatory
BILLING CODE 3410–34–P Analysis, USDA Rural Utilities Service, DEPARTMENT OF COMMERCE
1400 Independence Avenue SW., Room
5164–S, Stop 1522, Washington, DC Bureau of the Census
DEPARTMENT OF AGRICULTURE 20250–1522. Telephone: (202) 690–
4492, Facsimile: (202) 720–8435, Email: Census Scientific Advisory Committee
Rural Utilities Service
Thomas.Dickson@wdc.usda.gov. AGENCY: Bureau of the Census,
Information Collection Activity; Title: 7 CFR part 1776, ‘‘Household Department of Commerce.
Comment Request Water Well System Grant Program’’.
ACTION: Notice of public meeting.
OMB Control Number: 0572–0139.
Rural Utilities Service, USDA.
AGENCY: Type of Request: Extension of a SUMMARY: The Bureau of the Census
Notice and request for
ACTION: currently approved information (Census Bureau) is giving notice of a
comments. collection. meeting of the Census Scientific
Abstract: The Rural Utilities Service Advisory Committee (C–SAC). The
SUMMARY: In accordance with the
supports the sound development of Committee will address policy,
Paperwork Reduction Act of 1995, the
rural communities and the growth of research, and technical issues relating to
United States Department of
our economy without endangering the a full range of Census Bureau programs
Agriculture’s Rural Utilities Service
environment. RUS provides financial and activities, including
(RUS), invites comments on this
and technical assistance to help communications, decennial,
information collection for which the
communities bring safe drinking water demographic, economic, field
Agency intends to request approval
and sanitary, environmentally sound operations, geographic, information
from the Office of Management and
waste disposal facilities to rural technology, and statistics. The C–SAC
Budget (OMB).
Americans in greatest need. will meet in a plenary session from
DATES: Comments on this notice must be The Household Water Well System September 14–15, 2017. Last minute
received by September 18, 2017. (HWWS) Grant Program makes grants to changes to the schedule are possible,
FOR FURTHER INFORMATION CONTACT: qualified private non-profit which could prevent giving advance
Thomas P. Dickson, Acting Director, organizations which will help public notice of schedule adjustments.
Program Development and Regulatory homeowners finance the cost of private Please visit the Census Advisory
Analysis, USDA Rural Utilities Service, wells. As the grant recipient, non-profit Committees Web site for the most
1400 Independence Avenue SW., Stop organizations will establish a revolving current meeting agenda at: http://
1522, Room 5164–S, Washington, DC loan fund lending program to provide www.census.gov/about/cac.html. The
20250–1522. Telephone: (202) 690– water well loans to individuals who meeting will be available via webcast at:
4492, Facsimile: (202) 720–8435. Email: own or will own private wells in rural http://www.ustream.tv/uscensusbureau.
sradovich on DSK3GMQ082PROD with NOTICES

Thomas.Dickson@wdc.usda.gov. areas. The individual loan recipients Topics of discussion will include the
SUPPLEMENTARY INFORMATION: The Office may use the funds to construct, following items:
of Management and Budget’s (OMB) refurbish, and service their household • 2020 Systems and Operations
regulation (5 CFR part 1320) well systems for an existing home. • Ranked Statistics
implementing provisions of the The collection of information consists • Privacy and Security—Issues as it
Paperwork Reduction Act of 1995 (Pub. of the materials to file a grant relates to systems and administrative
L. 104–13) requires that interested application with the agency, including records data

VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1

Document Created: 2018-10-24 11:25:28
Document Modified: 2018-10-24 11:25:28

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		We will consider all comments that we receive on or before August 17, 2017.
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; (301) 851-3426, fax (301) 734-4314.
FR Citation		82 FR 32785

82 FR 32785 - Availability of an Environmental Assessment for Field Testing a Vaccine For Use Against Infectious Bursal Disease, Marek's Disease, and Newcastle Disease

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 82, Issue 136 (July 18, 2017)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service