Unknown. Direct final rule
4,493 words·~20 min read·
/register/2010/04/21/2010-9072A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2010-04-21.xml --- 75 76 Wednesday, April 21, 2010 Contents Agency Agency for Healthcare Research and Quality NOTICES Meetings: Health Care Policy and Research Special Emphasis Panel, 20852, 20854 2010-9034 2010-9035 Agricultural Agricultural Research Service NOTICES Intent to Grant Exclusive License, 2010-9107 2010-9108 20806-20807 2010-9109 Agriculture Agriculture Department See Agricultural Research Service See Animal and Plant Health Inspection Service See Forest Service Animal Animal and Plant Health Inspection Service RULES Viruses, Serums, Toxins, and Analogous Products and Patent Term Restoration;
Nonsubstantive Amendments, 20771-20773 2010-9072 Army Army Department See Engineers Corps NOTICES Meetings: Board of Visitors, United States Military Academy, 20827-20828 2010-9148 Non-Exclusive, Exclusive, or Partially Exclusive Licensing of U.S. Patent Application: Active Topical Skin Protectants, 20828 2010-9149 Chimeric Ebola and Marburg Virus Glycoproteins Virus Like Particle Vaccine to Protect Against Diverse Ebola and Marburg Viruses, 20828 2010-9150 Non-Exclusive, Exclusive, or Partially Exclusive Licensing of U.S.
Provisional Patent Application: Perfactant Pulmonary Lavage, 20828-20829 2010-9151 Centers Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20849-20850 2010-9202 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cross-Site Evaluation of the Children's Bureau Grantee, 20850-20851 2010-9038 Coast Guard Coast Guard RULES Drawbridge Operation Regulations:
Hampton River, Hampton, NH, Maintenance, 20775-20776 2010-9128 Shaw Cove, New London, CT, Maintenance, 20776 2010-9124 Security Zones: Portland Rose Festival Fleet Week, Willamette River, Portland, OR, 20778-20780 2010-9185 Potomac River, Washington Channel, Washington, DC, 20776-20778 2010-9193 PROPOSED RULES Safety Zones: AVI July Fireworks Display, Laughlin, NV, 20799-20802 2010-9126 New York Air Show at Jones Beach State Park, Atlantic Ocean off of Jones Beach, Wantagh, NY, 20802-20805 2010-9127 NOTICES Towing Safety Advisory Committee;
Vacancies, 20856-20857 2010-9121 Commerce Commerce Department See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Commodity Futures Trading Commission NOTICES Meetings; Sunshine Act, 20824-20825 2010-9372 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20883-20884 2010-8825 Defense Defense Acquisition Regulations System NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Defense Federal Acquisition Regulation Supplement; DoD Pilot Mentor-Protege Program, 20825-20826 2010-9140 Defense Federal Acquisition Regulation Supplement; Part 211, Describing Agency Needs, 20825 2010-9139 Defense Defense Department See Army Department See Defense Acquisition Regulations System See Engineers Corps Department of Transportation See Pipeline and Hazardous Materials Safety Administration Education Education Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20829-20830 2010-9146 2010-9147 Meetings: Early Learning, 20830-20832 2010-9276 Energy Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission NOTICES Meetings: Environmental Management Site-Specific Advisory Board, Nevada Test Site, 20832 2010-9153 National Coal Council, 20832-20833 2010-9154 Energy Energy Efficiency and Renewable Energy Office NOTICES Building Energy Codes, 20833-20834 2010-9152 Engineers Engineers Corps NOTICES Environmental Impact Statements;
Availability, etc.: Beach and Dune Restoration in St. Lucie County, FL, 20826-20827 2010-9204 EPA Environmental Protection Agency RULES Approval and Promulgation of Implementation Plans: Revisions to the Kentucky State Implementation Plan, 20780-20782 2010-8933 Tennessee; Visibility Impairment Prevention for Federal Class I Areas; Removal of Federally Promulgated Provisions, 20783-20785 2010-8935 Exemption from the Requirement of a Tolerance: Polyglyceryl Phthalate Ester of Coconut Oil Fatty Acids;
Technical Correction, 20785-20786 2010-9194 PROPOSED RULES Approval and Promulgation of Implementation Plans: Tennessee; Visibility Impairment Prevention for Federal Class I Areas; Removal of Federally Promulgated Provisions, 20805 2010-8936 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: NESHAP for Magnetic Tape Manufacturing Operations, 20837-20838 2010-9171 NESHAP for Wood Furniture Manufacturing Operations, 20838-20839 2010-9168 NSPS for Flexible Vinyl and Urethane Coating and Printing (Renewal), 20836-20837 2010-9170 Amendments to Terminate Uses:
Dimethyldithiocarbamate Salts, 20839-20840 2010-8759 Pesticide Products; Registration Applications, 20841-20842 2010-9190 Product Cancellation Order for Certain Pesticide Registrations: Pirimicarb, 20842-20843 2010-8931 Workshop: EPA's Integrated Plan for Review of Lead National Ambient Air Quality Standards; Policy-Relevant Science, 20843-20844 2010-9172 Executive Office of the President See Presidential Documents FAA Federal Aviation Administration RULES Establishment of Class E Airspace:
Fort A.P. Hill, VA, 20774 2010-8839 Jackson, AL, 20773-20774 2010-8838 Mountain City, TN, 20774 2010-8840 Modification of Jet Routes J-37 and J-55: Northeast United States, 20774-20775 2010-8830 PROPOSED RULES Airworthiness Directives: Boeing Company Model 747-100, 747-100B, 747-0100B SUD, et al., Series Airplanes, 20792-20794 2010-9112 Bombardier, Inc. Model DHC-8-400, -401, and -402 Airplanes, 20787-20790 2010-9110 McDonnell Douglas Corp. Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), et al.
Airplanes, 20790-20792 2010-9111 Proposed Amendment of Class E Airspace: Hamilton, TX, 20794-20795 2010-9174 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20874-20875 2010-9173 Intent to Rule on Request to Release Airport Property: Eagle County Regional Airport, Eagle, CO, 20879 2010-8841 Petition for Exemption; Summary of Petition Received, 20881 2010-9135 FCC Federal Communications Commission NOTICES Meetings: Advisory Committee on Diversity for Communications in the Digital Age, 20844 2010-9179 Suspension and Initiation of Debarment Proceedings:
Schools and Libraries Universal Service Support Mechanism, 20844-20848 2010-9181 2010-9187 Federal Emergency Federal Emergency Management Agency NOTICES Major Disaster Declaration: Virginia, 20856 2010-9122 Federal Energy Federal Energy Regulatory Commission PROPOSED RULES Market-Based Rate Affiliate Restrictions, 20796-20799 2010-9083 NOTICES Combined Filings, 20834-20836 2010-9129 2010-9130 2010-9131 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20875 2010-9106 Environmental Impact Statements; Availability, etc.: State Route 374 from State Route 149 West of River Road to State Route 76 in Clarksville, Montgomery County, TN, 20878-20879 2010-8721 FMC Federal Maritime Commission NOTICES Agreements Filed, 20849 2010-9200 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers: Exemption Applications; Vision, 20881-20883 2010-9117 Federal Railroad Federal Railroad Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20875-20877 2010-9105 Federal Reserve Federal Reserve System NOTICES Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies, 20848 2010-9166 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 20848-20849 2010-9164 Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities, 20849 2010-9165 Fish Fish and Wildlife Service NOTICES Endangered Species Recovery Permit Applications, 20857-20859 2010-9157 Food Food and Drug Administration NOTICES Public Workshop:
Medical Device Use in the Home Environment; Implications for the Safe and Effective Use, etc., 20854-20856 2010-9287 Forest Forest Service NOTICES Newspapers to be Used for Publication of Legal Notice of Appealable Decisions, etc.: Alabama, Kentucky, Georgia, et al., 20807-20809 2010-8742 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Industry Industry and Security Bureau NOTICES Meetings:
Information Systems Technical Advisory Committee, 20817 2010-9155 Transportation and Related Equipment Technical Advisory Committee, 20816-20817 2010-9156 Interior Interior Department See Fish and Wildlife Service See Minerals Management Service See National Park Service International International Trade Administration NOTICES Amended Final Results of Administrative Review Pursuant to Court Decision: Silicon Metal from Brazil, 20812-20813 2010-9175 Amended Preliminary Determination of Sales at Less Than Fair Value:
Certain Magnesia Carbon Bricks from the People's Republic of China, 20813-20815 2010-9186 Extension of Time Limit for the Final Results of Antidumping Duty Administrative Review: Certain Cased Pencils From the People's Republic of China, 20815-20816 2010-9176 Preliminary Results of the 2008-2009 Antidumping Duty Administrative Review: Magnesium Metal from the People's Republic of China, 20817-20824 2010-9178 International International Trade Commission NOTICES Investigations:
Certain Digital Set-Top Boxes and Components, 20861-20862 2010-9205 Certain Display Devices Including Digital Televisions and Monitors, 20860-20861 2010-9201 Glyphosate from China, 20862 2010-9206 Hand Trucks and Certain Parts from China, 20862 2010-9207 Justice Justice Department See National Institute of Corrections NOTICES Lodging of Consent Decree, 20862-20863 2010-9132 2010-9192 Labor Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20865-20866 2010-9182 Minerals Minerals Management Service NOTICES Meetings:
Outer Continental Shelf Policy Committee, 20859 2010-9104 National Highway National Highway Traffic Safety Administration NOTICES Petition for Decision of Inconsequential Noncompliance: Tireco, Inc., 20879-20881 2010-9162 National Institute National Institute of Corrections NOTICES Solicitation for Cooperative Agreement: Development of Two Documents - Inmate Behavior Management; A Guide to Meeting Inmates' Basic Needs, etc., 20863-20865 2010-9102 NIH National Institutes of Health NOTICES Meetings:
Center for Scientific Review, 20852-20853 2010-9199 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 20853 2010-8851 National Eye Institute, 20853-20854 2010-8846 National Institute of Nursing Research, 20853 2010-8847 National Institute on Alcohol Abuse and Alcoholism, 20852 2010-8843 NOAA National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Scup Fishery; Reduction of Winter I Commercial Possession Limit, 20786 2010-9180 NOTICES Additional Membership Solicitation:
Hydrographic Services Review Panel, 20809-20810 2010-9138 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Northwest Region Pacific Whiting Shoreside Fishery Monitoring and Catch Accounting Program, 20812 2010-9113 Produce Processor Profiles of Fish Processing Plants in Alaska, 20811-20812 2010-9114 Statement of Financial Interests, Regional Fishery Management Councils, 20810-20811 2010-9191 Environmental Assessments; Availability, etc.: Proposed Reintroduction of Spring-run Chinook Salmon to the Mainstem of the San Joaquin River;
Scoping Meeting, 20815 2010-9188 Meetings: Hydrographic Services Review Panel, 20816 2010-9137 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20857 2010-9123 Proposed Award: Temporary Concession Contract for Blue Ridge Parkway, NC/VA, 20859 2010-9036 Realty Action: Independence National Historical Park, PA and Valley Forge National Historical Park, PA, 20859-20860 2010-9119 National Transportation National Transportation Safety Board NOTICES Meetings;
Sunshine Act, 20866-20867 2010-9189 Nuclear Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: DTE Energy; Enrico Fermi Atomic Power Plant (Unit 1), 20867 2010-9160 Environmental Impact Statements; Availability, etc.: Calvert Cliffs Nuclear Power Plant (Unit 3), 20867-20868 2010-9159 Issuance of Regulatory Guide, 20868-20869 2010-9161 Meetings: Advisory Committee on the Medical Uses of Isotopes, 20869 2010-9158 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Application for Special Permits, 20877-20878 2010-9037 Presidential Presidential Documents PROCLAMATIONS Special Observances:
National Crime Victims' Rights Week (Proc. 8499), 20889-20890 2010-9414 National Day of Service and Remembrance for Victims and Survivors of Terrorism (Proc. 8501), 20893-20894 2010-9416 National Park Week (Proc. 8498), 20885-20888 2010-9413 National Volunteer Week (Proc. 8500), 20891-20892 2010-9415 SEC Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: NASDAQ OMX PHLX, Inc., 20871-20873 2010-9115 SBA Small Business Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20870 2010-9141 Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest: Montreux Equity Partners II SBIC, L.P., et al., 20870 2010-9145 Small Business Size Standards: Waiver of the Nonmanufacturer Rule, 20870-20871 2010-9142 State State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: DS-2020 Retail Price Schedule, 20873 2010-9183 Culturally Significant Objects Imported for Exhibition Determinations:
The Glory of Ukraine: Golden Treasures and Lost Civilizations, 20873-20874 2010-9184 Substance Substance Abuse and Mental Health Services Administration NOTICES Fiscal Year 2010 Funding Opportunity, 20851 2010-9103 Surface Surface Transportation Board NOTICES Abandonment Exemption: Union Pacific Railroad Co., Orange County, CA, 20874 2010-9143 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration See Surface Transportation Board Treasury Treasury Department See Comptroller of the Currency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20883 2010-9120 Separate Parts In This Issue Part II Presidential Documents, 20885-20894 2010-9414 2010-9416 2010-9413 2010-9415 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 75 76 Wednesday, April 21, 2010 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 102, 103, 104, 108, 112, 113, 114, 116, and 124 [Docket No.
APHIS-2009-0069] Viruses, Serums, Toxins, and Analogous Products and Patent Term Restoration; Nonsubstantive Amendments AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Direct final rule. SUMMARY: We are amending the Virus-Serum-Toxin Act regulations concerning veterinary biological products to update the addresses provided for units within the Center for Veterinary Biologics. We are also making several nonsubstantive technical changes to the regulations to update information concerning the number of copies of Outlines of Production and labeling to submit, and to provide information concerning using the Internet to obtain forms and apply for veterinary biologics permits.
DATES: This rule will be effective on June 21, 2010, unless we receive written adverse comments or written notice of intent to submit adverse comments on or before May 21, 2010. If we receive written adverse comments or written notice of intent to submit adverse comments, we will publish a document in the **Federal Register** withdrawing this rule before the effective date. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to ( *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0069* ) to submit or view comments and to view supporting and related materials available electronically. • Postal Mail/Commercial Delivery:
Please send one copy of your comment to Docket No. APHIS-2009-0069, 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-2009-0069. *Reading Room:* You may read 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 ( *http://www.aphis.usda.gov* ). FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief of Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231;
(301)734-8245. SUPPLEMENTARY INFORMATION: Background The regulations in Title 9, Code of Federal Regulations (9 CFR), parts 101 through 118 (referred to below as the regulations), contain provisions implementing the Virus-Serum-Toxin Act, as amended (21 U.S.C. 151-159). The regulations in 9 CFR part 124 contain procedural requirements for patent extensions for veterinary biologics under 35 U.S.C. 156. In accordance with the procedures explained below under “Dates,” this final rule makes several nonsubstantive technical changes to those regulations to update their provisions. Specifically: • We will amend the addresses throughout the regulations to reflect the relocation of the Center for Veterinary Biologics to new facilities in Ames, IA. • We will amend 9 CFR part 102, § 102.3(b)(2)(i), 9 CFR part 104, § 104.5(a)(4), and 9 CFR part 114, §§ 114.8(c) and 114.9(a)(1), (a)(5), and (a)(7) regarding the number of copies of the Outline of Production or revised pages of an Outline of Production, or special outline that are required to be submitted in support of an application for veterinary biological product license or permit. • We will amend 9 CFR part 103, § 103.3(d), and 9 CFR part 112, § 112.5(d)(1)(iii) and (d)(1)(iv) regarding the number of copies of finished labels that are required to be submitted for review and filing. • We will amend 9 CFR part 103, § 104.3(a), and 9 CFR part 112, § 112.5(a), to indicate that the Internet may be used to obtain forms and apply for certain veterinary biologics permits. • We will amend 9 CFR part 104, § 104.5(a)(1), and 9 CFR part 108, § 108.7, regarding the number of copies of all plot plans, blueprints, and legends required to be submitted for review and filing. Dates We are publishing this rule without a prior proposal because we view this action as noncontroversial and anticipate no adverse public comment. This rule will be effective, as published in this document, on June 21, 2010, unless we receive written adverse comments or written notice of intent to submit adverse comments on or before May 21, 2010. Adverse comments are comments that suggest the rule should not be adopted or that suggest the rule should be changed. If we receive written adverse comments or written notice of intent to submit adverse comments, we will publish a document in the **Federal Register** withdrawing this rule before the effective date. We will then publish a proposed rule for public comment. As discussed above, if we receive no written adverse comments or written notice of intent to submit adverse comments within 30 days of publication of this direct final rule, this direct final rule will become effective 60 days following its publication. We will publish a document in the **Federal Register** , before the effective date of this direct final rule, confirming that it is effective on the date indicated in this document. Executive Order 12866 and Regulatory Flexibility Act This rule is subject to Executive Order 12866. However, for this action, the Office of Management and Budget has waived its review under Executive Order 12866. This direct final rule will affect all licensed manufacturers of veterinary biologics. Currently, there are approximately 125 veterinary biologics manufacturers, including permittees. According to the standards of the Small Business Administration, most veterinary biologics establishments are small entities. The provisions of this direct final rule that update addresses and indicate the availability of forms on the Internet will have no economic effect on any entities, large or small. The provisions that reduce from three to two the number of copies of certain forms, labels, plot plans, blueprints, and legends that regulated entities are required to submit in specific cases may result in some cost savings to those entities, but those savings will be inconsequential. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This direct final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any State or local laws, regulations, or policies where they are necessary to address local disease conditions or eradication programs. However, where safety, efficacy, purity, and potency of biological products are concerned, it is the Agency’s intent to occupy the field. This includes, but is not limited to, the regulation of labeling. Under the Act, Congress clearly intended that there be national uniformity in the regulation of these products. There are no administrative proceedings which must be exhausted prior to a judicial challenge to the regulations under this rule. Paperwork Reduction Act This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq* .). Further, this rule will reduce information collection or recordkeeping requirements in 9 CFR parts 102, 103, 104, 108, 112, and 114. List of Subjects 9 CFR Parts 102, 103, 114, and 116 Animal biologics, Reporting and recordkeeping requirements. 9 CFR Part 104 Animal biologics, Imports, Reporting and recordkeeping requirements, Transportation. 9 CFR Part 108 Animal biologics 9 CFR Part 112 Animal biologics, Exports, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements. 9 CFR Part 113 Animal biologics, Exports, Imports, Reporting and recordkeeping requirements. 9 CFR Part 124 Animal biologics, Patents. Accordingly, we are amending 9 CFR parts 102, 103, 104, 108, 112, 113, 114, 116, and 124 as follows: PART 102—LICENSES FOR BIOLOGICAL PRODUCTS 1. The authority citation for part 102 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. § 102.3 [Amended] 2. In § 102.3, paragraph (b)(2)(i) is amended by removing the words “four copies” and adding the word “two copies” in their place. § 102.5 [Amended] 3. In § 102.5, paragraph (e), the second sentence is amended by removing the words “Licensing and Policy Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197” and adding the words “Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. PART 103—EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING 4. The authority citation for part 103 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. § 103.3 [Amended] 5. In § 103.3, paragraph (d), the first sentence is amended by removing the words “Three copies” and adding the words “Two copies” in their place. PART 104—PERMITS FOR BIOLOGICAL PRODUCTS 6. The authority citation for part 104 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. 7. In § 104.3, paragraph
(a)is amended by revising the second sentence to read as follows: § 104.3 Permit application.
(a)* * * Application forms are available on the Internet at ( *http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml* ) and application for a permit to import a veterinary biologic for research and evaluation or transit shipment may be made on the Internet at ( *http://www.aphis.usda.gov/animal_health/permits/vet_bio_permits.shtml* ). § 104.5 [Amended] 8. Section 104.5 is amended as follows: a. In paragraph (a)(1), in the first sentence, by removing the words “Three copies” and adding the words “Two copies” in their place. b. In paragraph (a)(4), in the second sentence, by removing the words “Four copies” and adding the words “Two copies” in their place. PART 108—FACILITY REQUIREMENTS FOR LICENSED ESTABLISHMENTS 9. The authority citation for part 108 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. § 108.7 [Amended] 10. In § 108.7, the first sentence is amended by removing the words “Three copies” and adding the words “Two copies” in their place. PART 112—PACKAGING AND LABELING 11. The authority citation for part 112 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. § 112.5 [Amended] 12. Section 112.5 is amended as follows: a. In paragraph (a), in the first sentence, by removing the words “furnished by Animal and Plant Health inspection Service upon request” and adding the words “available on the Internet at ( *http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml* ) ” in their place. b. In paragraph (d)(1)(iii), in the first sentence, by removing the words “three copies” and adding the words “two copies” in their place and, in the second sentence, by removing the words “Two copies” and adding the words “One copy” in their place. c. In paragraph (d)(1)(iv), in the first sentence, by removing the words “three copies” and adding the words “two copies” in their place and, in the fifth sentence, by removing the words “Two copies” and adding the words “One copy” in their place. PART 113—STANDARD REQUIREMENTS 13. The authority citation for part 113 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. § 113.113 [Amended] 14. Section 113.113 is amended as follows: a. In paragraph (a)(2), in the third sentence, by removing the words “510 South 17th Street, Suite 104, Ames, IA 50010-8197” and adding the words “1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. b. In paragraph (a)(3), in the second sentence, by removing the words “510 South 17th Street, Suite 104, Ames, IA 50010-8197” and adding the words “1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. c. In paragraph (c)(1)(iv), in the first sentence, by removing the words “510 South 17th Street, Suite 104, Ames, IA 50010-8197” and adding the words “1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. d. In paragraph (c)(2)(iv)(A), in the second sentence, by removing the words “Licensing and Policy Development, 510 South 17th Street, Suite, 104, Ames, IA 50010-8197” and adding the words “Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. § 113.209 [Amended] 15. In § 113.209, paragraph (b)(1), the fifth sentence is amended by removing the words “1800 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone
(515)239-8331; fax
(515)239-8673” and adding the words “1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone
(515)337-6100; fax
(515)337-6120” in their place and, in the seventh sentence, by removing the words “Licensing, and Policy Development, 4700 River Road, Riverdale, MD” and adding the words “Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS 16. The authority citation for part 114 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. 17. In § 114.8, paragraph
(c)is revised to read as follows: § 114.8 Outline of Production required.
(c)One copy of the Outline of Production shall be retained by the Animal and Plant Health Inspection Service and one copy returned to the licensee or permittee. § 114.9 [Amended] 18. Section 114.9 is amended as follows: a. In paragraph (a)(1), in the first sentence, by removing the words “The original and not more than four” and adding the word “All” in their place. b. In paragraph (a)(5), in the first sentence, by removing the words “the original and one copy” and adding the words “both copies” in their place. c. In paragraph (a)(7), by removing the second sentence and adding the sentence “Transmittal forms are available on the Internet at ( *http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml* ) .” in its place. PART 116—RECORDS AND REPORTS 19. The authority citation for part 116 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. § 116.5 [Amended] 20. In § 116.5, paragraph (b), the second sentence is amended by removing the words “510 South 17th Street, Suite 104, Ames, IA 50010-8197; by electronic mail to ( *cvb@aphis.usda.gov* ); by fax to
(515)232-7120; or by telephone to
(515)232-5785” and adding the words “1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; by electronic mail to ( *cvb@aphis.usda.gov* ); by fax to
(515)337-6120; or by telephone to
(515)337-6100” in their place. PART 124—PATENT TERM RESTORATION 21. The authority citation for part 124 continues to read as follows: Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.4. § 124.22 [Amended] 22. In § 124.22, paragraph (a), the second sentence is amended by removing the words “Licensing, and Policy Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197” and adding the words “Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. § 124.40 [Amended] 23. In § 124.40, paragraph (b)(3) is amended by removing the words “Licensing and Policy Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197” and adding the words “Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010” in their place. Done in Washington, DC, this 14 th day of April 2010. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2010-9072 Filed 4-20-10; 10:24 am]
Connectionstraces to 5
Traces to 5 documents
11 references not yet in our index
- 21 USC 151-159
- 9 CFR 124
- 9 CFR 102
- 9 CFR 104
- 9 CFR 114
- 9 CFR 103
- 9 CFR 112
- 9 CFR 108
- 7 CFR 3015
- 9 CFR 113
- 7 CFR 2.22
Citation graph
cites case law
Unknown
Direct final rule
Cite21 USC 151-159
Cite9 CFR 124
Cite9 CFR 102
Cite9 CFR 104
Cite9 CFR 114
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