Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Bursal Disease, Marek's Disease, and Newcastle Disease, 5412-5413 [2019-02855]

Download as PDF 5412 Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices Estimated number of responses per respondent: 2.8. Estimated annual number of responses: 738. Estimated total annual burden on respondents: 284. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Done in Washington, DC, this 14th day of February 2019. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2019–02856 Filed 2–20–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2018–0082] Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Bursal Disease, Marek’s Disease, and Newcastle Disease 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 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 March 25, 2019. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docket Detail;D=APHIS-2018-0082. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0082, 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 amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:08 Feb 20, 2019 Jkt 247001 may be viewed at https:// www.regulations.gov/#!docketDetail; D=APHIS-2018-0082 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; (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. PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 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: Merial, Inc. Product: Bursal Disease-Marek’s Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. Possible Field Test Locations: Alabama, Arkansas, Georgia, Mississippi, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Virginia. The above-mentioned product is a live Marek’s disease serotype 3 vaccine virus containing a gene from the infectious bursal disease virus and a gene from the Newcastle disease virus. It has been shown to be effective for the vaccination of 18 to 19-day-old embryonated chicken eggs or the subcutaneous vaccination of healthy day-old chickens against 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. 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 E:\FR\FM\21FEN1.SGM 21FEN1 Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices 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; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 14th day of February 2019. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2019–02855 Filed 2–20–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Eastern Region Recreation Resource Advisory Committee Forest Service, USDA. ACTION: Notice of meeting. AGENCY: The Eastern Region Recreation Resource Advisory Committee (Recreation RAC) will meet in Milwaukee, Wisconsin. The Recreation RAC is established consistent with the Federal Advisory Committee Act of 1972, and the Federal Lands Recreation Enhancement Act. Additional information concerning the Recreation RAC, including details on all fee proposals, can be found by visiting the Recreation RAC’s website at: https:// www.fs.usda.gov/main/r9/recreation/ racs. SUMMARY: The meeting will be held on the following dates: • Thursday, March 14, 2019, from 1:00 p.m. to 5:00 p.m., and • Friday, March 15, 2019, from 8:00 a.m. to 12:00 p.m. All Recreation RAC meetings are subject to cancellation. For updated status of the meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT. DATES: The meeting will be held at the Forest Service—Eastern Regional Office, 626 East Wisconsin Avenue, Milwaukee, Wisconsin. The meeting will be available via teleconference. Visit the Recreation RAC’s website at: https://www.fs.usda.gov/main/r9/ recreation/racs for call-in information. Written comments may be submitted as described under SUPPLEMENTARY amozie on DSK3GDR082PROD with NOTICES1 ADDRESSES: VerDate Sep<11>2014 17:08 Feb 20, 2019 Jkt 247001 INFORMATION. All comments, including names and addresses, when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received at the Forest Service—Eastern Regional Office. Please call ahead at 541–860– 8048 to facilitate entry into the building. FOR FURTHER INFORMATION CONTACT: Joanna Wilson, Eastern Region Recreation RAC Coordinator, by phone at 541–860–8048 or by email at jwilson08@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) Review the following fee proposals: a. Regional streamline fee proposal by the Recreation Resource Advisory Committee, b. Monongahela National Forest fee proposals which includes fee increases for Bear Heaven Campground, Laurel Fork Campground, and Red Creek Campground. The proposal also includes a proposed new fee for a daily reservation at Seneca Rocks Picnic Shelter; and c. Huron Manistee National Forest fee proposal for new fees Red Bridge Access, Sulak Recreation Area, McKinley Horse Trail Campsites, Buttercup Backcountry Campsites, Cathedral Pines Backcountry Group Campsite, Meadow Springs Backcountry Campsites, Bear Island Backcountry Campsites, River Dune Backcountry Campsites, Luzerne Horse Trail Campground, Government Landing Access Campsites, and Upper Manistee River Backcountry Campsites. New group campground fees are proposed for the group sites at AuSable Loop Recreation Area Campground, Mack Lake ORV Campground, Kneff Lake Recreation Area, Gabions Campground, McKinley Horse Trail Campground, Luzerne Horse Trail Campground, and River Road Horse Trail Camp. 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 request in writing by March 1, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Recreation RAC may file written statements with the Recreation RAC’s staff before or after the meeting. Written comments and time requests for oral PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 5413 comments must be sent to Joanna Wilson, Eastern Region Recreation RAC Coordinator, 221 North 780 East, Salem, Utah 84653; or by email to jwilson08@ fs.fed.us. Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case-by case basis. Dated: February 4, 2019. Allen Rowley, Acting Associate Deputy Chief, National Forest System. [FR Doc. 2019–02981 Filed 2–20–19; 8:45 am] BILLING CODE 3411–15–P COMMISSION ON CIVIL RIGHTS Notice of Public Meetings of the Oklahoma Advisory Committee to the U.S. Commission on Civil Rights U.S. Commission on Civil Rights. ACTION: Announcement of meeting. AGENCY: Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Oklahoma Advisory Committee (Committee) will hold a meeting on Tuesday, April 2, 2019 at 2:00 p.m. Central time. The Committee will discuss the implementation stage of their study of the state’s 2012 ‘‘Civil Rights Initiative,’’ which prohibited preferential treatment or discrimination based on race, color, sex, ethnicity or national origin in public employment, education, and contracting. DATES: The meeting will take place on Tuesday, April 2, 2019 at 2:00 p.m. Central. Public Call Information: Dial: 855– 719–5012, Conference ID: 1821716. FOR FURTHER INFORMATION CONTACT: Alejandro Ventura, DFO, at aventura@ usccr.gov or (213) 894–3437. SUPPLEMENTARY INFORMATION: Members of the public may listen to this discussion through the above call in number. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with SUMMARY: E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5412-5413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02855]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0082]


Availability of an Environmental Assessment for Field Testing of 
a Vaccine for Use Against 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 March 
25, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2018-0082.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0082, 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 https://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0082 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; (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: Merial, Inc.
    Product: Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, 
Serotype 3, Live Marek's Disease Vector.
    Possible Field Test Locations: Alabama, Arkansas, Georgia, 
Mississippi, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, 
Tennessee, Texas, and Virginia.
    The above-mentioned product is a live Marek's disease serotype 3 
vaccine virus containing a gene from the infectious bursal disease 
virus and a gene from the Newcastle disease virus. It has been shown to 
be effective for the vaccination of 18 to 19-day-old embryonated 
chicken eggs or the subcutaneous vaccination of healthy day-old 
chickens against 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.
    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 5413]]

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; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 14th day of February 2019.
 Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-02855 Filed 2-20-19; 8:45 am]
 BILLING CODE 3410-34-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.