Availability of an Environmental Assessment for Field Testing of a Pseudogymnoascus destructans Vaccine, Live Raccoon Poxvirus Vector (RCN-CAL/SP/ASPF2/PD-ENG2), 37827-37828 [2019-16579]

Download as PDF Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices 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; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 30th day of July 2019. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2019–16580 Filed 8–1–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2019–0044] Availability of an Environmental Assessment for Field Testing of a Pseudogymnoascus destructans Vaccine, Live Raccoon Poxvirus Vector (RCN–CAL/SP/ASPF2/PD– ENG2) Animal and Plant Health Inspection Service, USDA. ACTION: Notice. 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 Pseudogymnoascus destructans Vaccine, Live Raccoon Poxvirus Vector (RCN–CAL/SP/ASPF2/ PD–ENG2). 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, 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 jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:02 Aug 01, 2019 Jkt 247001 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 September 3, 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-2019-0044. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2019–0044, 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-2019-0044 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. Barbara J. Sheppard, Senior Staff Veterinary Medical Officer, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, Ames, IA 50010; phone (515) 337–6100; fax (515) 337–6120. 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. Mathew Erdman, Senior Staff Veterinary Medical Officer, 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 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 37827 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 conducted a risk analysis to assess the potential effects of this product on the safety of animals, public health, and the environment. Based on the risk analysis, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: U.S. Geological Survey, National Wildlife Health Center. Product: Pseudogymnoascus destructans Vaccine, Live Raccoon Poxvirus Vector (RCN–CAL/SP/ASPF2/ PD–ENG2). Possible Field Test Locations: Colorado, Iowa, Minnesota, Nebraska, Oklahoma, Texas, or Wisconsin, among others. The above-mentioned product consists of a live recombinant raccoon poxvirus vector expressing four Pseudogymnoascus destructans proteins. The vaccine is for the oral vaccination of bats as an aid in the prevention and control of White-Nose Syndrome. 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 E:\FR\FM\02AUN1.SGM 02AUN1 37828 Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices 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; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 30th day of July 2019. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2019–16579 Filed 8–1–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Senior Farmers’ Market Nutrition Program (SFMNP) Food and Nutrition Service (FNS), U.S. Department of Agriculture (USDA). ACTION: Notice. AGENCY: In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection of information relating to the reporting and recordkeeping burden associated with the Senior Farmers’ Market Nutrition Program (SFMNP). DATES: Written comments must be received on or before October 1, 2019. ADDRESSES: Comments may be sent to: Kurtria Watson, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 524, Alexandria, VA 22302. Comments may also be submitted via email to kurtria.watson@usda.gov. Comments will also be accepted through the Federal eRulemaking Portal. Go to https://www.regulations.gov, and follow the online instructions for submitting comments electronically. All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record. jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:02 Aug 01, 2019 Jkt 247001 FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of this information collection should be directed to Kurtria Watson at (703) 605–4387. SUPPLEMENTARY INFORMATION: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Title: Senior Farmers’ Market Nutrition Program (SFMNP). Form Number: Annual Financial and Program Data Report, FNS–683A. OMB Number: 0584–0541. Expiration Date: October 31, 2019. Type of Request: Revision of a currently approved collection. Abstract: The U.S. Department of Agriculture (USDA), Food and Nutrition Service (FNS), created the Senior Farmers’ Market Nutrition Program (SFMNP) in 2000 as a pilot program awarding grants to State agencies (including geographic States, U.S. Territories, and federally recognized Indian Tribal Organizations (ITOs)) on a competitive basis. The Farm Security and Rural Investment Act of 2002 (2002 Farm Bill), Public Law 107–171, authorized the SFMNP, beginning Fiscal Year (FY) 2003, and gave USDA the authority to develop regulations for the SFMNP. These regulations are published at 7 Code of Federal Regulations (CFR) part 249. The Agriculture Improvement Act of 2018 (2018 Farm Bill), Public Law 115–334, reauthorized the SFMNP through fiscal year 2023. The purpose of the SFMNP is to provide resources in the form of fresh, nutritious, unprepared, locally grown fruits, vegetables, herbs, and honey from farmers’ markets, roadside stands, and community supported agriculture (CSA) programs to low income seniors; to increase the domestic consumption of agricultural commodities by expanding or aiding in the expansion of domestic farmers’ markets, roadside stands, and CSA programs; and to develop or aid in PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 the development of new and additional farmers’ markets, roadside stands, and CSA programs. The 2018 Farm Bill and SFMNP regulations at 7 CFR part 249 require that certain program-related information be collected and that full and complete records concerning SFMNP operations are maintained. The information reporting and recordkeeping requirements are necessary to ensure appropriate and efficient management of the SFMNP program. Information reporting and recordkeeping includes, but is not limited to, the authorization and monitoring of State agencies; the certification of SFMNP recipients; nutrition education that is provided to recipients; farmer, farmers’ market, roadside stand, and CSA program authorization, monitoring, and management; and reporting on the financial management and operational aspects of program administration. This information collection is used by USDA to manage, plan, evaluate, and provide oversight to SFMNP program operations. Likewise, this information is used for reporting to Congress, as needed. This information collection is requesting a revision to the previously approved burden hours due to program adjustments that primarily reflect expected changes in the number of SFMNP State agencies, individual/ households (program recipients), and the number of farmers, farmers’ markets, roadside stands, and CSA programs, from year to year. Additionally, the burden hours associated with State agency financial and program recipient reporting on the Annual Financial and Program Data Report (FNS–683A), are now included in the information collection for the Food Programs Reporting System (FPRS), OMB #0584– 0594, expiration date of 9/30/2019. As such, with this revision we are removing the burden associated with the FNS–683A from this information collection, a decrease of 2,080 hours. Overall, program adjustments have increased the net annual burden from 427,280 to 449,090 burden hours (difference of 21,810 burden hours). Likewise, there is an increase in the total annual responses from 2,408,659 to 2,549,454 (difference of 140,795 annual responses). Affected Public Respondents Include: State agencies (including geographic States, U.S. Territories, and Indian Tribal Organizations (ITOs)); local agencies; individuals/households (program recipients); and authorized farmers, farmers’ markets, roadside stands, and CSA programs participating in the SFMNP. E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37827-37828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16579]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0044]


Availability of an Environmental Assessment for Field Testing of 
a Pseudogymnoascus destructans Vaccine, Live Raccoon Poxvirus Vector 
(RCN-CAL/SP/ASPF2/PD-ENG2)

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

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 Pseudogymnoascus destructans Vaccine, Live 
Raccoon Poxvirus Vector (RCN-CAL/SP/ASPF2/PD-ENG2). 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, 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 
September 3, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0044.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0044, 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-2019-
0044 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. Barbara J. Sheppard, Senior Staff 
Veterinary Medical Officer, Center for Veterinary Biologics, Policy, 
Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, Ames, IA 
50010; phone (515) 337-6100; fax (515) 337-6120.
    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. Mathew Erdman, Senior Staff Veterinary Medical Officer, 
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 conducted a risk analysis to assess the potential effects of this 
product on the safety of animals, public health, and the environment. 
Based on the risk analysis, APHIS has prepared an environmental 
assessment (EA) concerning the field testing of the following 
unlicensed veterinary biological product:
    Requester: U.S. Geological Survey, National Wildlife Health Center.
    Product: Pseudogymnoascus destructans Vaccine, Live Raccoon 
Poxvirus Vector (RCN-CAL/SP/ASPF2/PD-ENG2).
    Possible Field Test Locations: Colorado, Iowa, Minnesota, Nebraska, 
Oklahoma, Texas, or Wisconsin, among others.
    The above-mentioned product consists of a live recombinant raccoon 
poxvirus vector expressing four Pseudogymnoascus destructans proteins. 
The vaccine is for the oral vaccination of bats as an aid in the 
prevention and control of White-Nose Syndrome.
    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

[[Page 37828]]

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; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 30th day of July 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-16579 Filed 8-1-19; 8:45 am]
 BILLING CODE 3410-34-P
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