Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Newcastle Disease and Marek's Disease, 5410-5411 [2019-02854]

Download as PDF 5410 Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses. Estimate of burden: The public burden for this collection of information is estimated to average 3.13 hours per response. Respondents: Irradiation facilities in the United States, State governments, importers, and foreign government and national plant protection organization officials. Estimated annual number of respondents: 19. Estimated annual number of responses per respondent: 16.6. Estimated annual number of responses: 315. Estimated total annual burden on respondents: 987 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) 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. 2019–02848 Filed 2–20–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2018–0069] Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Newcastle Disease and Marek’s Disease Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. amozie on DSK3GDR082PROD with NOTICES1 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 SUMMARY: VerDate Sep<11>2014 17:08 Feb 20, 2019 Jkt 247001 unlicensed 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-2018-0069. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0069, 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-2018-0069 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 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 PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 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: Zoetis Inc. Product: Marek’s Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. Possible Field Test Locations: Alabama, Arkansas, Delaware, Georgia, Maryland, North Carolina, Pennsylvania, South Carolina, and Virginia. The above-mentioned product is a live Marek’s disease serotype 3 vaccine virus containing 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 1-day-old chicks against 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 E:\FR\FM\21FEN1.SGM 21FEN1 Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices 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 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. 2019–02854 Filed 2–20–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2018–0094] Notice of Request for Reinstatement of an Information Collection; Importation of Swine Hides, Bird Trophies, and Deer Hides Animal and Plant Health Inspection Service, USDA. ACTION: Reinstatement of an information collection; comment request. amozie on DSK3GDR082PROD with NOTICES1 AGENCY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service’s intention to SUMMARY: VerDate Sep<11>2014 17:08 Feb 20, 2019 Jkt 247001 request the reinstatement of an information collection associated with the regulations for the importation of swine hides, bird trophies, and deer hides. We will consider all comments that we receive on or before April 22, 2019. DATES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docket Detail;D=APHIS-2018-0094. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2018–0094, 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-2018-0094 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. ADDRESSES: For information on the regulations for the importation of swine hides, bird trophies, and deer hides, contact Dr. Lisa Dixon, Animal Products Import Director, NIES, VS, APHIS, 4700 River Road, Unit 40, Riverdale, MD 20737; (301) 851–3373. For more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS’ Information Collection Coordinator, at (301) 851–2483. SUPPLEMENTARY INFORMATION: Title: Importation of Swine Hides, Bird Trophies, and Deer Hides. OMB Control Number: 0579–0307. Type of Request: Reinstatement of an information collection. Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture is authorized, among other things, to prohibit or restrict the importation and interstate movement of animals and animal products to prevent the introduction into and dissemination within the United States of livestock diseases and pests. To carry out this mission, APHIS regulates the importation of animals and animal products into the United States. The regulations are contained in 9 CFR parts 92 through 99. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 5411 The regulations in 9 CFR part 95 (referred to below as the regulations) prohibit or restrict the importation of specified animal products into the United States to prevent the introduction of certain contagious animal diseases into the U.S. livestock population. Section 95.16 of the regulations contains, among other things, specific processing, recordkeeping, and certification requirements for untanned hides and skins and bird trophies. The regulations require that shipments of hides be accompanied by certificates showing their origin and certifying that the hides are from areas free of certain animal diseases. Shipments of ruminant hides from Mexico must be accompanied by written statements indicating that the hides were frozen for 24 hours and treated for ticks. Shipments of bird trophies must be accompanied by certificates of origin certifying that the trophies are from regions free of Newcastle disease and highly pathogenic avian influenza. These activities help ensure that the products do not harbor disease or ticks. We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses. Estimate of burden: Public burden for this collection of information is estimated to average 0.385 hours per response. Respondents: National government officials, owners of bird trophies and untanned ruminant and swine hides, and importers of bird trophies and untanned ruminant and swine hides. Estimated number of respondents: 264. E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5410-5411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02854]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0069]


Availability of an Environmental Assessment for Field Testing of 
a Vaccine for Use Against Newcastle Disease and Marek's 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 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-2018-0069.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0069, 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-
0069 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 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: Zoetis Inc.
    Product: Marek's Disease-Newcastle Disease Vaccine, Serotype 3, 
Live Marek's Disease Vector.
    Possible Field Test Locations: Alabama, Arkansas, Delaware, 
Georgia, Maryland, North Carolina, Pennsylvania, South Carolina, and 
Virginia.
    The above-mentioned product is a live Marek's disease serotype 3 
vaccine virus containing 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 1-
day-old chicks against 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

[[Page 5411]]

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 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. 2019-02854 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.