Availability of an Environmental Assessment for Field Testing Marek's Disease Vaccine, Serotype 1, Live Herpesvirus Chimera, 54453-54454 [E6-15326]

Download as PDF 54453 Notices Federal Register Vol. 71, No. 179 Friday, September 15, 2006 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2006–0146] Availability of an Environmental Assessment for Field Testing Marek’s Disease Vaccine, Serotype 1, Live Herpesvirus Chimera Animal and Plant Health Inspection Service, USDA. AGENCY: jlentini on PROD1PC65 with NOTICES 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 Marek’s Disease Vaccine, Serotype 1, Live Herpesvirus Chimera. 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. VerDate Aug<31>2005 16:24 Sep 14, 2006 Jkt 205001 We will consider all comments that we receive on or before October 16, 2006. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov, select ‘‘Animal and Plant Health Inspection Service’’ from the agency drop-down menu, then click ‘‘Submit.’’ In the Docket ID column, select APHIS–2006– 0146 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site’s ‘‘User Tips’’ link. • Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS–2006–0146, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Please state that your comment refers to Docket No. APHIS– 2006–0146. Reading Room: You may read environmental assessment, the risk analysis (with confidential business information removed), and any comments that we receive on this docket in our reading room. The reading room 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) 690–2817 before coming. Other Information: Additional information about APHIS and its programs is available on the Internet at https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737– 1231; phone (301) 734–8245, 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 DATES: PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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, 510 South 17th Street, Suite 104, Ames, IA 50010; phone (515) 232–5785, fax (515) 232–7120. 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: Schering-Plough Corporation. Product: Marek’s Disease Vaccine, Serotype 1, Live Herpesvirus Chimera. Field Test Locations: Alabama, Georgia, Missouri. The above-mentioned product is a live recombinant chimera, i.e., a hybrid of two parental organisms, consisting of certain sequences of the avirulent herpesvirus of turkeys (HVT) and certain sequences of a strain of Marek’s disease virus. The vaccine is for use in 18-day-old embryos or day-of-age chicks as an aid in the prevention of losses due to 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 provision of NEPA (40 CFR parts 1500–1508), (3) USDA regulations implementing NEPA E:\FR\FM\15SEN1.SGM 15SEN1 54454 Federal Register / Vol. 71, No. 179 / Friday, September 15, 2006 / Notices (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; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 11th day of September 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–15326 Filed 9–14–06; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Outfitting and Guiding Land Use Fees in the Alaska Region Forest Service, USDA. Notice of proposed policy; request for comment. AGENCY: jlentini on PROD1PC65 with NOTICES ACTION: SUMMARY: The Alaska Region is proposing to adopt a long-term flat fee policy for outfitters and guides operating in the Alaska Region. Under the flat fee policy, a single land use fee would be charged for each type of service provided by outfitters and guides in the Alaska Region. DATES: Comments must be received in writing by December 14, 2006. ADDRESSES: Send comments to Regional Forester, Attention: Recreation, Lands and Minerals, P.O. Box 21628, Juneau, VerDate Aug<31>2005 16:24 Sep 14, 2006 Jkt 205001 Alaska 99802–1628; via electronic mail to comments-alaska-regionaloffice@fs.fed.us; or via facsimile to (907) 586–7866. All comments, including names and addresses when provided, will be placed in the record and will be available for public inspection and copying. The public may inspect comments received on this proposed policy in the Recreation, Lands and Minerals Staff, Room 519D, Federal Office Building, 709 West 9th Street, Juneau, Alaska, between 9 a.m. and 4 p.m. FOR FURTHER INFORMATION CONTACT: Trish Clabaugh, (907) 586–8855, or Neil Hagadorn, (907) 586–9336. SUPPLEMENTARY INFORMATION: The Forest Service issues special use authorizations for a variety of uses of National Forest System (NFS) lands, including outfitting and guiding. Outfitting is defined as ‘‘renting on or delivering to National Forest System lands for pecuniary remuneration or other gain any saddle or pack animal, vehicle, boat, camping gear, or similar supplies or equipment. The term ‘outfitter’ includes the holder’s employees and agents’’ (36 CFR 251.51). Guiding is defined as ‘‘providing services or assistance (such as supervision, protection, education, training, packing, touring, subsistence, transporting people, or interpretation) for pecuniary remuneration or other gain to individuals or groups on National Forest System lands. The term ‘guide’ includes the holder’s employees and agents’’ (36 CFR 251.51). The Forest Service charges a land use fee for special use authorizations, including outfitting and guiding permits. Applicable Law The Independent Offices Appropriations Act of 1952 (IOAA) authorizes each Federal agency to collect a fee ‘‘for a service or thing of value provided by the agency’’ (31 U.S.C. 9701(b)). The IOAA requires that each fee charged to fair and be based on factors such as the costs to the Government, the value of the service or thing to the recipient, the public policy or interest served, and other relevant facts (31 U.S.C. 9701(b)). Pursuant to the IOAA, the Office of Management and Budget (OMB) issued a circular which ‘‘establish[es] guidelines for Federal agencies to assess fees for Governmental services and for the sale or use of Government property or resources’’ (OMB Circular No. A–25, 58 FR 38142 (September 23, 1959, as amended July 15, (1993)). Paragraph 6a(2)(b) of OMB circular No. A–25 instructs agencies that when the Federal government is not acting in the capacity PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 of a sovereign, but rather is acting in a proprietary capacity, as it is here in authorizing the use of Federal land for commercial purposes, user charges or fees are to be ‘‘based on market prices.’’ OMB Circular No. A–25 further provides that under such conditions, user charges need not be limited to the recovery of full costs, but may yield net revenues (OMB Circular No. A–25, ¶ 6a(2) (a) and (b)). The Circular directs that ‘‘[i]n the absence of substantial competitive demand, market price will be determined by taking into account the prevailing prices for goods, resources, or services that are the same or substantially similar to those provided by the Government, and then adjusting the supply made available and/or price of the good, resource, or service so that there will be neither a shortage nor a surplus’’ (OMB Circular No. A–25, ¶ 6d(2)(b)). Consistent with the IOAA and OMB Circular No. A–25, Forest Service regulations at 36 CFR 251.57(a) provide that special use permit fees ‘‘will be based upon the fair market value of the rights and privileges authorized by appraisal or other sound business management principles.’’ Development of the Alaska Region’s Interim Flat Fee Policy In general, the gross revenues of a business conducted on NFS lands are an accurate reflection of the value of the business’s use of those lands. However, in Alaska many outfitters and guides base a significant percentage of their client charges on activities that occur off NFS lands. Thus, flat land use fees that are based on an average of the revenues generated by outfitters and guides conducting activities on NFS lands more accurately reflect the value of the use of NFS lands for outfitting and guiding in the Alaska Region. Consistent with this assessment, in 1997, the Alaska Region issued for public comment a proposed flat fee schedule for outfitting and guiding in the Alaska Region. This fee schedule was recommended for consideration in the development of an outfitting and guiding fee system by a working group from Federal and State agencies assisting the Alaska Land Use Council (ALUC). See Final Fee Recommendations of the Alaska Land Use Council Outfitter and Guide Working Group (May 15, 1985). Based on comments received on the proposed fee schedule, the Alaska Region revised some fee categories and added others to accommodate all outfitting and guiding activities authorized on NFS lands in Alaska. The Alaska Region incorporated some of E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 71, Number 179 (Friday, September 15, 2006)]
[Notices]
[Pages 54453-54454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15326]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

========================================================================


Federal Register / Vol. 71, No. 179 / Friday, September 15, 2006 / 
Notices

[[Page 54453]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0146]


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

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 Marek's Disease Vaccine, Serotype 1, Live 
Herpesvirus Chimera. 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 
October 16, 2006.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0146 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0146, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0146.
    Reading Room: You may read environmental assessment, the risk 
analysis (with confidential business information removed), and any 
comments that we receive on this docket in our reading room. The 
reading room 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) 
690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, 
Operational Support Section, Center for Veterinary Biologics, Policy, 
Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1231; phone (301) 734-8245, 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, 510 South 17th 
Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-
7120.

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: Schering-Plough Corporation.
    Product: Marek's Disease Vaccine, Serotype 1, Live Herpesvirus 
Chimera.
    Field Test Locations: Alabama, Georgia, Missouri.
    The above-mentioned product is a live recombinant chimera, i.e., a 
hybrid of two parental organisms, consisting of certain sequences of 
the avirulent herpesvirus of turkeys (HVT) and certain sequences of a 
strain of Marek's disease virus. The vaccine is for use in 18-day-old 
embryos or day-of-age chicks as an aid in the prevention of losses due 
to 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 provision of NEPA (40 CFR parts 1500-1508), 
(3) USDA regulations implementing NEPA

[[Page 54454]]

(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; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 11th day of September 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-15326 Filed 9-14-06; 8:45 am]
BILLING CODE 3410-34-P
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