1–24–06 Tuesday Vol. 71 No. 15 Jan. 24, 2006
Pages 3753–4032
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i II Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006
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Contents Federal Register Vol. 71, No. 15
Tuesday, January 24, 2006
Advisory Council on Historic Preservation NOTICES See Historic Preservation, Advisory Council Reports and guidance documents; availability, etc.: Vessels arriving to United States; entry conditions imposition notification; policy enforcement, 3873– Agency for Healthcare Research and Quality 3874 NOTICES Vessel inspection: Meetings: Certificates of inspection and compliance; temporary Health Services Research Initial Review Group extension authorization, 3874–3875 Committee, 3850–3851 Primary and secondary health; topics nominations, 3849– 3850 Commerce Department See Industry and Security Bureau See International Trade Administration Agricultural Marketing Service See National Oceanic and Atmospheric Administration NOTICES NOTICES Fresh asparagus; grade standards, 3815–3816 Committees; establishment, renewal, termination, etc.: Globe artichokes; grade standards, 3816 Sea Grant Review Panel, 3821 Mixed commodities; grade standards, 3816–3817 Pea pods; grade standards, 3817–3818 Strawberries; grade standards, 3818 Commodity Credit Corporation Table grapes (European or Vinifera type); grade standards, PROPOSED RULES 3818–3819 Export programs: Supplier Credit Guarantee Program, 3790–3791 Agriculture Department Customs and Border Protection Bureau See Agricultural Marketing Service See Commodity Credit Corporation NOTICES Automation program test: See Food and Nutrition Service Automated Commercial Environment— See Forest Service Truck carrier accounts; automated truck manifest data; deployment schedule, 3875 Air Force Department NOTICES Defense Department Environmental statements; notice of intent: See Air Force Department Nevada Test and Training Range, NV; depleted uranium See Army Department use increase, 3825–3826 See Engineers Corps NOTICES Army Department Federal Acquisition Regulation (FAR): See Engineers Corps Agency information collection activities; proposals, NOTICES submissions, and approvals, 3826 Environmental statements; availability, etc.: Fort Irwin, CA; maneuver training land addition; Education Department correction, 3919 NOTICES Agency information collection activities; proposals, Centers for Disease Control and Prevention submissions, and approvals, 3826–3829 NOTICES Grants and cooperative agreements; availability, etc.: Agency information collection activities; proposals, Elementary and secondary education— submissions, and approvals, 3851–3852 Early Reading First Program; correction, 3829 Energy Employees Occupational Illness Compensation Postsecondary education— Program Act of 2000: Developing Hispanic-Serving Institutions Program, Special Exposure Cohort; employee class designations— 3830–3834 Linde Ceramics Plant, Tonawanda, NY, 3852 Employment and Training Administration Centers for Medicare & Medicaid Services NOTICES NOTICES Adjustment assistance; applications, determinations, etc.: Medicaid: Hewlett Packard et al., 3886–3888 State plan amendments, reconsideration; hearings— OBG Manufacturing Co., 3888 Ohio, 3853–3854 Plasti-Coil, Inc., 3888–3889 Polyvision Corp., 3889 Coast Guard TexStyle, Inc., 3889 RULES Drawbridge operations: Energy Department Virginia, 3763–3764 See Federal Energy Regulatory Commission
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NOTICES Reports and guidance documents; availability, etc.: Environmental statements; record of decision: Advisory circulars, other policy documents, and Savannah River Site, SC; salt processing alternatives, proposed technical standard orders; availability on 3834–3838 agency website, 3918 Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005; Section 3116 determinations: Federal Energy Regulatory Commission Savannah River Site, SC; salt waste disposal, 3838–3839 NOTICES Complaints filed: Engineers Corps Tucson Electric Power Co., 3839 NOTICES Electric rate and corporate regulation combined filings, Environmental statements; notice of intent: 3839–3841 Yuba County, CA; Yuba River Basin Project; correction, Environmental statements; availability, etc.: 3919 Alaska Power & Telephone Co., 3841 Environmental Protection Agency Hydroelectric applications, 3841–3842 RULES Air quality implementation plans; approval and Federal Maritime Commission promulgation; various States: NOTICES Colorado, 3773–3776 Investigations, hearings, petitions, etc.: Montana, 3770–3773, 3776–3779 Worldwide Relocations, Inc., et al., 3844 North Dakota, 3764–3768 Oregon, 3768–3770 Federal Reserve System Solid waste: NOTICES State municipal solid waste landfill permit programs— Agency information collection activities; proposals, Maine, 3779–3781 submissions, and approvals, 3844–3846 PROPOSED RULES Banks and bank holding companies: Air quality implementation plans; approval and Change in bank control, 3846–3847 promulgation; various States: Formations, acquisitions, and mergers, 3847 Colorado, 3796–3797 Meetings; Sunshine Act, 3847 Montana, 3796 North Dakota, 3795–3796 Fish and Wildlife Service Solid waste: NOTICES State municipal solid waste landfill permit programs— Comprehensive conservation plans; availability, etc.: Maine, 3797 Choctaw National Wildlife Refuge, AL, 3878–3882 NOTICES Endangered and threatened species: Grants and cooperative agreements; availability, etc.: Survival enhancement permits— Conferences, workshops, and/or meetings; planning, Florida red-cockaded woodpecker; safe harbor arranging, administering, and conducting, 3842–3843 agreement, 3882–3883 Water pollution control: Total maximum daily loads— Food and Drug Administration Arkansas, 3843–3844 RULES Human drugs and biological products: Executive Office of the President Prescription drug products; labeling requirements, 3922– See Trade Representative, Office of United States 3997 Federal Aviation Administration NOTICES Agency information collection activities; proposals, RULES Airworthiness directives: submissions, and approvals, 3854–3860 Airbus, 3757–3759 Reports and guidance documents; availability, etc.: Turbomeca S.A., 3754–3757 Labeling for human prescription drug and biological Airworthiness standards: products— Special conditions— Content and format; clinical studies and adverse Airbus Model A380-800 airplane, 3753–3754 reactions sections; industry guidance, 3999–4000 Class E airspace, 3759–3762 New content and format requirements; warnings and PROPOSED RULES precautions, contraindications, etc.; industry Airworthiness directives: guidance, 3998–3999 Fokker, 3792–3794 Class E airspace, 3794–3795 Food and Nutrition Service NOTICES NOTICES Agency information collection activities; proposals, Child nutrition programs: submissions, and approvals, 3915 Summer Food Service Program— Environmental statements; availability, etc.: Reimbursement rates, 3819–3820 Las Vegas McCarran International Airport, NV, 3915 Environmental statements; notice of intent: Forest Service Upham, NM; commercial launch site development and NOTICES operation; scoping meetings, 3915–3917 Meetings: Exemption petitions; summary and disposition, 3917 Resource Advisory Committees— Meetings: Lincoln County, 3821 RTCA, Inc., 3917–3918 Southwest Mississippi, 3820–3821
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Reports and guidance documents; availability, etc.: International Trade Administration National Environmental Policy Act; implementation— NOTICES Oil and gas exploration and development activities; Antidumping: documentation; categorical exclusion; correction, Carbon and alloy steel wire rod from— 3919 Canada, 3822–3824 Uranium from— General Services Administration Russian Federation, 3824 RULES Welded carbon steel pipe and tube from— Privacy Act; implementation, 3781–3786 Turkey, 3824–3825 NOTICES Agency information collection activities; proposals, Justice Department submissions, and approvals, 3847–3848 NOTICES Federal Acquisition Regulation (FAR): Agency information collection activities; proposals, Agency information collection activities; proposals, submissions, and approvals, 3885–3886 submissions, and approvals, 3826 Pollution control; consent judgments: Cascade Cooperage, Inc., 3886 Health and Human Services Department See Agency for Healthcare Research and Quality Labor Department See Centers for Disease Control and Prevention See Employment and Training Administration See Centers for Medicare & Medicaid Services See Mine Safety and Health Administration See Food and Drug Administration NOTICES See National Institutes of Health Organization, functions, and authority delegations: NOTICES Emergency Management Center et al., 4028–4030 Poverty income guidelines; annual update, 3848–3849 Government Accountability Office, 4032
Historic Preservation, Advisory Council Land Management Bureau NOTICES NOTICES National Historic Preservation Act: Resource management plans, etc.: Mount Graham, AZ; microwave communications system Anchorage Field Office-administered lands from Dixon replacement, 3815 Entrance to Attu Island, AK; Ring of Fire Resource Area, 3884 Homeland Security Department See Coast Guard Mine Safety and Health Administration See Customs and Border Protection Bureau NOTICES See U.S. Citizenship and Immigration Services Petitions for safety standards modification; summary of NOTICES affirmative decisions; correction, 3889–3891 United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT): National Aeronautics and Space Administration Biometrically enabled travel documents; privacy impact NOTICES assessment, 3873 Federal Acquisition Regulation (FAR): Housing and Urban Development Department Agency information collection activities; proposals, NOTICES submissions, and approvals, 3826 Agency information collection activities; proposals, National Archives and Records Administration submissions, and approvals, 3877–3878 NOTICES Indian Affairs Bureau Privacy Act; systems of records, 3891–3893 NOTICES Agency information collection activities; proposals, National Highway Traffic Safety Administration submissions, and approvals, 3883–3884 RULES Motor vehicle safety standards: Industry and Security Bureau Controls, telltales, and indicators; effective date delay, NOTICES 3786–3789 Meetings: Transportation and Related Equipment Technical National Institutes of Health Advisory Committee, 3821–3822 NOTICES Meetings: Interior Department Fogarty International Center Advisory Board, 3860 See Fish and Wildlife Service National Cancer Institute, 3860–3862 See Indian Affairs Bureau National Center for Research Resources, 3862–3863 See Land Management Bureau National Heart, Lung, and Blood Institute, 3863 See National Park Service National Institute of Allergy and Infectious Diseases, See Reclamation Bureau 3866–3867 National Institute of Child Health and Human Internal Revenue Service Development, 3865 RULES National Institute of Dental and Craniofacial Research, Income taxes: 3867 Widely held fixed investment trusts; reporting National Institute of Environmental Health Sciences, requirements, 4002–4025 3863
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National Institute of Mental Health, 3864 State Department National Institute of Neurological Disorders and Stroke, RULES 3864–3865 International Traffic in Arms regulations: National Institute on Alcohol Abuse and Alcoholism, Registration fee change, 3762–3763 3864 NOTICES National Institute on Deafness and Other Communication Meetings: Disorders, 3867–3868 Arms Control and Nonproliferation Advisory Board, National Institute on Drug Abuse, 3865–3866 3913–3914 National Library of Medicine, 3868 Reports and guidance documents; availability, etc.: Scientific Review Center, 3868–3873 Exchange Visitor Program— J-1 agriculture training programs; policy statement, National Oceanic and Atmospheric Administration 3914 PROPOSED RULES J-1 flight training programs; policy statement, 3913 Fish and seafood promotion: Species-specific seafood marketing councils, 3797–3814 Trade Representative, Office of United States National Park Service NOTICES NOTICES Generalized System of Preferences: Meetings: Pakistan; intellectual property protection; 2005 annual Route 66 Corridor Preservation Program Advisory country practice review; case closure, 3914 Council, 3884–3885 Transportation Department Nuclear Regulatory Commission See Federal Aviation Administration PROPOSED RULES See National Highway Traffic Safety Administration Plants and materials; physical protection: Design basis threat, 3791–3792 NOTICES Treasury Department Meetings; Sunshine Act, 3893–3894 See Internal Revenue Service
Office of United States Trade Representative U.S. Citizenship and Immigration Services See Trade Representative, Office of United States NOTICES Agency information collection activities; proposals, Postal Rate Commission submissions, and approvals, 3875–3877 NOTICES Practice and procedure: Repositionable notes; minor classification changes, 3894– Veterans Affairs Department 3895 NOTICES Meetings: Reclamation Bureau National Research Advisory Council, 3918 NOTICES Environmental statements; availability, etc.: San Luis Unit of Central Valley Project, CA; long-term Separate Parts In This Issue contract renewal, 3885 Securities and Exchange Commission Part II NOTICES Health and Human Services Department, Food and Drug Agency information collection activities; proposals, Administration, 3922–4000 submission, and approvals, 3895–3896 Joint Industry Plan: Part III Pacific Exchange, Inc., et al., 3896–3906 Treasury Department, Internal Revenue Service, 4002–4025 Meetings; Sunshine Act, 3906–3907 Privacy Act; systems of records, 3907–3908 Part IV Self-regulatory organizations; proposed rule changes: Chicago Board Options Exchange, Inc., 3908–3909 Labor Department, 4028–4030 National Association of Securities Dealers, Inc., 3909– 3910 Part V Pacific Exchange, Inc., 3910–3911 Labor Department, 4032 Small Business Administration NOTICES Disaster loan areas: Reader Aids Oklahoma, 3911–3912 Consult the Reader Aids section at the end of this issue for Puerto Rico, 3912 phone numbers, online resources, finding aids, reminders, Texas, 3912 and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents Social Security Administration LISTSERV electronic mailing list, go to http:// NOTICES listserv.access.gpo.gov and select Online mailing list Foreign insurance or pension systems: archives, FEDREGTOC-L, Join or leave the list (or change Japan, 3913 settings); then follow the instructions.
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CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.
7 CFR Proposed Rules: 1493...... 3790 10 CFR Proposed Rules: 73...... 3791 14 CFR 25...... 3753 39 (2 documents) ....3754, 3757 71 (3 documents) ...3759, 3760, 3761 Proposed Rules: 39...... 3792 71...... 3794 21 CFR 201...... 3922 314...... 3922 601...... 3922 22 CFR 122...... 3762 129...... 3762 26 CFR 1...... 4002 301...... 4002 602...... 4002 33 CFR 117...... 3763 40 CFR 52 (5 documents) ...3764, 3768, 3770, 3773, 3776 60...... 3776 239...... 3779 257...... 3779 258...... 3779 Proposed Rules: 52 (3 documents) ....3795, 3796 239...... 3797 257...... 3797 258...... 3797 41 CFR 105...... 3781 49 CFR 571...... 3786 50 CFR Proposed Rules: 270...... 3797
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Rules and Regulations Federal Register Vol. 71, No. 15
Tuesday, January 24, 2006
This section of the FEDERAL REGISTER telephone (425) 227–1357; facsimile safety standards for the Airbus A380– contains regulatory documents having general (425) 227–1149. 800 airplane because of novel or applicability and legal effect, most of which SUPPLEMENTARY INFORMATION: unusual design features, special are keyed to and codified in the Code of conditions are prescribed under the Federal Regulations, which is published under Background provisions of 14 CFR 21.16. 50 titles pursuant to 44 U.S.C. 1510. Airbus applied for FAA certification/ In addition to the applicable The Code of Federal Regulations is sold by validation of the provisionally- airworthiness regulations and special the Superintendent of Documents. Prices of designated Model A3XX–100 in its conditions, the Airbus Model A380–800 new books are listed in the first FEDERAL letter AI/L 810.0223/98, dated August airplane must comply with the fuel vent REGISTER issue of each week. 12, 1998, to the FAA. Application for and exhaust emission requirements of certification by the Joint Aviation 14 CFR part 34 and the noise Authorities (JAA) of Europe had been certification requirements of 14 CFR DEPARTMENT OF TRANSPORTATION made on January 16, 1998, reference AI/ part 36. In addition, the FAA must issue L 810.0019/98. In its letter to the FAA, a finding of regulatory adequacy Federal Aviation Administration Airbus requested an extension to the 5- pursuant to section 611 of Public Law year period for type certification in 93–574, the ‘‘Noise Control Act of 14 CFR Part 25 accordance with 14 CFR 21.17(c). 1972.’’ [Docket No. NM316; Special Conditions No. The request was for an extension to a Special conditions, as defined in 14 25–312–SC] 7-year period, using the date of the CFR 11.19, are issued in accordance initial application letter to the JAA as with 14 CFR 11.38 and become part of Special Conditions: Airbus Model the reference date. The reason given by the type certification basis in A380–800 Airplane, Discrete Gust Airbus for the request for extension is accordance with 14 CFR 21.17(a)(2). Requirements related to the technical challenges, Special conditions are initially applicable to the model for which they AGENCY: Federal Aviation complexity, and the number of new and Administration (FAA), DOT. novel features on the airplane. On are issued. Should the type certificate November 12, 1998, the Manager, for that model be amended later to ACTION: Final special conditions. Aircraft Engineering Division, AIR–100, include any other model that SUMMARY: These special conditions are granted Airbus’ request for the 7-year incorporates the same novel or unusual issued for the Airbus A380–800 period, based on the date of application design feature, the special conditions airplane. This airplane will have novel to the JAA. would also apply to the other model or unusual design features when In its letter AI/LE–A 828.0040/99 under the provisions of 14 CFR 21.101. Issue 3, dated July 20, 2001, Airbus compared to the state of technology Discussion of Novel or Unusual Design stated that its target date for type envisioned in the airworthiness Features standards for transport category certification of the Model A380–800 has airplanes. Many of these novel or been moved from May 2005, to January In terms of requirements pertaining to unusual design features are associated 2006, to match the delivery date of the discrete gusts, the size of the Airbus with the complex systems and the first production airplane. In accordance Model A380 is a novel or unusual configuration of the airplane, including with 14 CFR 21.17(d)(2), Airbus chose a design feature. These requirements are its full-length double deck. For these new application date of April 20, 1999, found in 14 CFR 25.341 (Amendment design features, the applicable and requested that the 7-year 25–86) which specifies that the gust airworthiness regulations do not contain certification period which had already loads acting on the airplane are to be adequate or appropriate safety standards been approved be continued. The part determined by dynamic analysis, regarding discrete gust requirements. 25 certification basis for the Model considering the dynamic and rigid body These special conditions contain the A380–800 airplane was adjusted to responses of the airplane. Section additional safety standards that the reflect the new application date. 25.341(a)(3) requires that a sufficient Administrator considers necessary to The Model A380–800 airplane will be number of gust gradient distances in the establish a level of safety equivalent to an all-new, four-engine jet transport range of 30 feet to 350 feet be that established by the existing airplane with a full double-deck, two- investigated to find the critical response airworthiness standards. Additional aisle cabin. The maximum takeoff for each load quantity. For large special conditions will be issued for weight will be 1.235 million pounds airplanes, the longer gust gradient other novel or unusual design features with a typical three-class layout of 555 distances are vital to assess the rigid of the Airbus Model A380–800 airplane. passengers. body response. At the time § 25.341 was adopted, the EFFECTIVE DATE: The effective date of Type Certification Basis value of the upper end of the range of these special conditions is January 10, Under the provisions of 14 CFR 21.17, gust gradient distances to be 2006. Airbus must show that the Model A380– investigated was determined from the FOR FURTHER INFORMATION CONTACT: 800 airplane meets the applicable largest commercial airplane then in Holly Thorson, FAA, International provisions of 14 CFR part 25, as existence, the Boeing Model 747. This Branch, ANM–116, Transport Airplane amended by Amendments 25–1 through value was calculated to be the mean Directorate, Aircraft Certification 25–98. If the Administrator finds that geometric chord of the Boeing 747 Service, 1601 Lind Avenue SW., the applicable airworthiness regulations (which is 28 feet) multiplied by 12.5, Renton, Washington 98055–4056; do not contain adequate or appropriate which equals 350 feet.
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Since the mean geometric chord of the Issued in Renton, Washington, on January Room PL–401, Washington, DC 20590– A380 is larger than that of the Boeing 10, 2006. 0001. 747, a special condition is necessary to Ali Bahrami, • Fax: (202) 493–2251. define an appropriate upper value for Manager, Transport Airplane Directorate, • Hand Delivery: Room PL–401 on the range of gust gradient distances to be Aircraft Certification Service. the plaza level of the Nassif Building, investigated. That value would be the [FR Doc. 06–598 Filed 1–23–06; 8:45 am] 400 Seventh Street, SW., Washington, mean geometric chord of the A380 BILLING CODE 4910–13–M DC, between 9 a.m. and 5 p.m., Monday (which is 34.8 feet) multiplied by 12.5, through Friday, except Federal holidays. which equals 435 feet. Increasing the Contact Turbomeca, 40220 Tarnos, range of gust gradient distances to be DEPARTMENT OF TRANSPORTATION France; telephone +33 05 59 74 40 00, investigated to 435 feet will ensure an fax +33 05 59 74 45 15, for the service appropriate analysis of the critical rigid Federal Aviation Administration information identified in this AD. body response of the A380. FOR FURTHER INFORMATION CONTACT: 14 CFR Part 39 Christopher Spinney, Aerospace Discussion of Comments [Docket No. FAA–2005–21242; Directorate Engineer, Engine Certification Office, Notice of Proposed Special Identifier 2005–NE–09–AD; Amendment 39– FAA, Engine and Propeller Directorate, Conditions No. 25–05–11–C, pertaining 14460; AD 2006–02–08] 12 New England Executive Park, Burlington, MA 01803–5299; telephone to discrete gust requirements for the RIN 2120–AA64 Airbus A380 airplane, was published in (781) 238–7175, fax (781) 238–7199. the Federal Register on August 9, 2005 Airworthiness Directives; Turbomeca SUPPLEMENTARY INFORMATION: The FAA (70 FR 46113). A single comment was Arriel 1B, 1D, 1D1, and 1S1 Turboshaft proposed to amend 14 CFR part 39 with received which supports the intent and Engines a proposed airworthiness directive (AD). the language of the special condition, as The proposed AD applies to Turbomeca proposed. AGENCY: Federal Aviation Arriel 1B engines fitted with 2nd stage Administration (FAA), Department of turbine modification TU 148, and Arriel Applicability Transportation (DOT). 1D, 1D1, and 1S1 engines. We published As discussed above, these special ACTION: Final rule; request for the proposed AD in the Federal Register conditions are applicable to the Airbus comments. on June 28, 2005 (70 FR 37063). That A380–800 airplane. Should Airbus action proposed to require initial and apply at a later date for a change to the SUMMARY: The FAA is adopting a new repetitive position checks of the 2nd type certificate to include another airworthiness directive (AD) for certain stage turbine blades on Turbomeca model incorporating the same novel or Turbomeca Arriel 1B, 1D, 1D1, and 1S1 Arriel 1B, 1D, 1D1, and 1S1 turboshaft unusual design features, these special turboshaft engines. This AD requires engines, and replacement of 2nd stage conditions would apply to that model as initial and repetitive position checks of turbines on 1B and 1D1 engines only. the gas generator 2nd stage turbine well under the provisions of § 21.101. Examining the AD Docket blades on all Turbomeca Arriel 1B, 1D, Conclusion 1D1, and 1S1 turboshaft engines, and You may examine the docket that contains the AD, any comments This action affects only certain novel initial and repetitive replacements of received, and any final disposition in or unusual design features of the Airbus 2nd stage turbines on 1B, 1D, and 1D1 person at the Docket Management A380–800 airplane. It is not a rule of engines only. This AD results from Facility Docket Office between 9 a.m. general applicability. reports of the release of gas generator 2nd stage turbine blades while in and 5 p.m., Monday through Friday, List of Subjects in 14 CFR Part 25 service, with full containment of debris. except Federal holidays. The Docket We are issuing this AD to prevent Office (telephone (800) 647–5227) is Aircraft, Aviation safety, Reporting located on the plaza level of the and recordkeeping requirements. inflight engine shutdown and subsequent forced autorotation landing Department of Transportation Nassif I The authority citation for these or accident. Building at the street address stated in ADDRESSES. special conditions is as follows: DATES: This AD becomes effective Comments will be available Authority: 49 U.S.C. 106(g), 40113, 44701, February 28, 2006. The Director of the in the AD docket shortly after the DMS 44702, 44704. Federal Register approved the receives them. The Special Conditions incorporation by reference of certain Comments publications listed in the regulations as We provided the public the I Accordingly, pursuant to the authority of February 28, 2006. opportunity to participate in the delegated to me by the Administrator, We must receive any comments on development of this AD. We have the Federal Aviation Administration this AD by March 27, 2006. considered the comments received. (FAA), the following special conditions ADDRESSES: Use one of the following are issued as part of the type addresses to comment on this AD: Request To Change the Compliance certification basis for the Airbus A380– • DOT Docket Web site: Go to http:// Time 800 airplane. dms.dot.gov and follow the instructions One commenter, Turbomeca, requests In lieu of the requirements of for sending your comments we change the compliance time for § 25.341(a)(3), the following special electronically. replacing 2nd stage turbines to, conditions apply: • Government-wide rulemaking Web immediately upon receipt of a A sufficient number of gust gradient site: Go to http://www.regulations.gov replacement 2nd stage turbine from distances in the range of 30 feet to 435 and follow the instructions for sending Turbomeca, and at least by August 31, feet (12.5 times the Geometric Chord of your comments electronically. 2006. The commenter states that the Model A380) must be investigated to • Mail: Docket Management Facility; without this requirement, operators will find the critical response for each load U.S. Department of Transportation, 400 incur unacceptable and unnecessary quantity. Seventh Street, SW., Nassif Building, risk for engines operating past the
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hourly life limit. The commenter further received, and determined that air safety (1) Is not a ‘‘significant regulatory states that an unacceptable number of and the public interest require adopting action’’ under Executive Order 12866; engines will require replacement 2nd the AD with the changes described (2) Is not a ‘‘significant rule’’ under stage turbines at the compliance end- previously. We have determined that DOT Regulatory Policies and Procedures date, causing grounding of aircraft these changes will neither increase the (44 FR 11034, February 26, 1979); and because of a lack of replacement parts. economic burden on any operator nor (3) Will not have a significant We partially agree. There is a need to increase the scope of the AD. economic impact, positive or negative, replace the 2nd stage turbines as they on a substantial number of small entities reach the hourly life limit, and to strive Interim Action under the criteria of the Regulatory to not allow them to stay installed until These actions are interim actions and Flexibility Act. the compliance end-date. However, we may take further rulemaking actions We prepared a summary of the costs replacing them immediately upon in the future. to comply with this AD and placed it in receipt could unnecessarily create the AD Docket. You may get a copy of compliance problems for operators. An Costs of Compliance this summary at the address listed example would be if a helicopter is at There are about 2,557 Turbomeca under ADDRESSES. a remote site the day an operator Arriel 1B, 1D, 1D1 and 1S1 turboshaft List of Subjects in 14 CFR Part 39 receives a replacement 2nd stage engines of the affected design in the turbine. We changed the compliance to worldwide fleet. We estimate that this Air transportation, Aircraft, Aviation read ‘‘After accumulating 1,500 hours AD will affect 721 engines installed on safety, Incorporation by reference, TSN or TSO for Arriel 1D and 1D1 helicopters of U.S. registry. We estimate Safety. engines, and 2,200 hours TSN or TSO that it will take about 2 work hours per Adoption of the Amendment for Arriel 1B engines, initially replace engine to inspect all 721 engines and 40 I the 2nd stage turbine with a new or hours per engine to replace about 571 Accordingly, under the authority overhauled 2nd stage turbine as soon as 2nd stage turbines on 1B and 1D1 delegated to me by the Administrator, practicable, but no later than August 31, engines, and that the average labor rate the Federal Aviation Administration 2006.’’ This change prevents is $65 per work hour. Required parts amends 14 CFR part 39 as follows: compliance problems associated with will cost about $3,200 per engine. Based PART 39—AIRWORTHINESS the commenter’s phrase ‘‘immediately on these figures, we estimate the total DIRECTIVES upon receipt’’ yet still requires prompt cost of the AD to U.S. operators to be replacement of 2nd stage turbines after $3,405,530. I 1. The authority citation for part 39 one becomes available. continues to read as follows: Authority for This Rulemaking NPRM Not Clear About Ongoing Authority: 49 U.S.C. 106(g), 40113, 44701. Requirement Title 49 of the United States Code specifies the FAA’s authority to issue § 39.13 [Amended] The same commenter states that the rules on aviation safety. Subtitle I, I 2. The FAA amends § 39.13 by adding NPRM is not clear that replacing the section 106, describes the authority of the following new airworthiness 2nd stage turbines is an ongoing the FAA Administrator. Subtitle VII, directive: requirement. We agree. We changed the Aviation Programs, describes in more 2006–02–08 Turbomeca: Amendment 39– compliance in this AD to address initial detail the scope of the Agency’s and repetitive replacements of 2nd stage 14460; Docket No. FAA–2005–21242; authority. Directorate Identifier. 2005–NE–09–AD. turbines. We are issuing this rulemaking under Effective Date Inspection and Replacement the authority described in subtitle VII, Requirements Changed for Arriel 1D part A, subpart III, section 44701, (a) This airworthiness directive (AD) becomes effective February 28, 2006. Turboshaft Engines ‘‘General requirements.’’ Under that The same commenter states that the section, Congress charges the FAA with Affected ADs requirements for inspecting and promoting safe flight of civil aircraft in (b) None. replacing Arriel 1D turboshaft engines air commerce by prescribing regulations Applicability have changed since we issued the for practices, methods, and procedures the Administrator finds necessary for (c) This AD applies to Turbomeca Arriel 1B NPRM. Those requirements are now the engines fitted with 2nd stage turbine same as for Arriel 1D1 turboshaft safety in air commerce. This regulation modification TU 148, and Arriel 1D, 1D1, engines. We agree. We changed the is within the scope of that authority and 1S1 engines. Arriel 1B engines are compliance in this AD to shorten the because it addresses an unsafe condition installed on, but not limited to, Eurocopter repetitive inspection interval and add that is likely to exist or develop on France AS–350B and AS–350A ‘‘Ecureuil’’ the requirement to replace the 2nd stage products identified in this rulemaking helicopters; 1D engines are installed on, but turbine. However, since many of the action. not limited to, Eurocopter France AS–350B1 ‘‘Ecureuil’’ helicopters; 1D1 engines are Arriel 1D turboshaft engines may be at Regulatory Findings installed on, but not limited to, Eurocopter or near the compliance time for France AS–350B2 ‘‘Ecureuil’’ helicopters; replacing the 2nd stage turbine, we have We have determined that this AD will and Arriel 1S1 engines are installed on, but found that notice and opportunity for not have federalism implications under not limited to, Sikorsky Aircraft S–76A and further comment before issuing this AD, Executive Order 13132. This AD will S–76C helicopters. not have a substantial direct effect on are impracticable. We are issuing this Unsafe Condition AD as a final rule; request for the States, on the relationship between the national government and the States, (d) This AD results from reports of the comments, allowing operators to release of gas generator 2nd stage turbine comment after the AD publishes. or on the distribution of power and responsibilities among the various blades while in service, with full Conclusion containment of debris. We are issuing this levels of government. AD to prevent inflight engine shutdown and We have carefully reviewed the For the reasons discussed above, I subsequent forced autorotation landing or available data, including the comments certify that this AD: accident.
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Compliance Initial Relative Position Check of 2nd Stage (ASBs) specified in the following Table 1 (e) You are responsible for having the Turbine Blades before reaching any of the intervals specified actions required by this AD performed within (f) Do an initial relative position check of in Table 1 or within 50 hours time-in-service the compliance times specified unless the the 2nd stage turbine blades using the after the effective date of this AD, whichever actions have already been done. Turbomeca mandatory alert service bulletins occurs later.
TABLE 1.—INITIAL AND REPETITIVE RELATIVE POSITION CHECK INTERVALS OF 2ND STAGE TURBINE BLADE
Turbomeca engine Mandatory alert service model Initial relative position check interval Repetitive interval bulletin
Arriel 1B (modified per Within 1,200 hours time-since-new (TSN) or time-since-overhaul Within 200 hours time-in- A292 72 0807, dated TU 148). (TSO) or 3,500 cycles-since-new (CSN) or cycles-since-over- service-since-last-rel- March 24, 2004. haul (CSO), whichever occurs earlier. ative-position-check (TSLRPC). Arriel 1D1 and Arriel Within 1,200 hours TSN or TSO or 3,500 hours CSN or CSO, Within 150 hours A292 72 0809, Update 1D. whichever occurs earlier. TSLRPC. No. 1, dated October 4, 2005. Arriel 1S1 ...... Within 1,200 hours TSN or TSO or 3,500 hours CSN or CSO, Within 150 hours A292 72 0810, dated whichever occurs earlier. TSLRPC. March 24, 2004.
Repetitive Relative Position Check of 2nd within every 1,500 hours TSN or TSO for Related Information Stage Turbine Blades Arriel 1D and 1D1 engines, and within every (n) DGAC airworthiness directive F–2004– (g) Recheck the relative position of 2nd 2,200 hours TSN or TSO for Arriel 1B engines. 047 R1, dated October 26, 2005, also stage turbine blades at the TSLRPC intervals addresses the subject of this AD. specified in Table 1 of this AD, using the Criteria for Overhauled 2nd Stage Turbines Material Incorporated by Reference mandatory ASBs indicated. (k) Do the following to overhauled 2nd Credit for Previous Relative Position Checks stage turbines, referenced in paragraphs (i) (o) You must use the service information and (j) of this AD: specified in Table 2 of this AD to perform the (h) Relative position checks of 2nd stage (1) You must install new blades in the 2nd actions required by this AD. The Director of turbine blades done using Turbomeca Service stage turbines of overhauled Arriel 1D and the Federal Register approved the Bulletin A292 72 0263, Update 1, 2, 3, or 4, 1D1 engines. may be used to show compliance with the incorporation by reference of the documents (2) You may install either overhauled or listed in Table 2 of this AD in accordance initial requirements of paragraph (f) of this new blades in the 2nd stage turbines of with 5 U.S.C. 552(a) and 1 CFR part 51. AD. overhauled Arriel 1B engines. Contact Turbomeca, 40220 Tarnos, France; Initial Replacement of 2nd Stage Turbines Relative Position Check Continuing telephone +33 05 59 74 40 00, fax +33 05 59 on Arriel 1B, 1D, and 1D1 Engines Compliance Requirements 74 45 15, for a copy of this service (i) After accumulating 1,500 hours TSN or (l) All 2nd stage turbines, including those information. You may review copies at the TSO for Arriel 1D and 1D1 engines, and that are new or overhauled, must continue to Docket Management Facility; U.S. 2,200 hours TSN or TSO for Arriel 1B comply with relative position check Department of Transportation, 400 Seventh engines, initially replace the 2nd stage requirements of paragraphs (f) and (j) of this Street, SW., Nassif Building, Room PL–401, turbine with a new or overhauled 2nd stage AD. Washington, DC 20590–0001, on the Internet turbine as soon as practicable, but no later than August 31, 2006. Alternative Methods of Compliance at http://dms.dot.gov, or at the National (m) The Manager, Engine Certification Archives and Records Administration Repetitive Replacements of 2nd Stage Office, has the authority to approve (NARA). For information on the availability Turbines on Arriel 1B, 1D, and 1D1 Engines alternative methods of compliance for this of this material at NARA, call 202–741–6030, (j) Thereafter, replace the 2nd stage turbine AD if requested using the procedures found or go to: http://www.archives.gov/federal- with a new or overhauled 2nd stage turbine in 14 CFR 39.19. register/cfr/ibr-locations.html.
TABLE 2.—INCORPORATION BY REFERENCE
Turbomeca mandatory alert service bulletin No. Page Update No. Date
A292 72 0807 ...... ALL ...... Original ...... March 24, 2004. Total Pages: 17 A292 72 0809 ...... ALL ...... 1 ...... October 4, 2005. Total Pages: 18 A292 72 0810 ...... ALL ...... Original ...... March 24, 2004. Total Pages: 14
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Issued in Burlington, Massachusetts, on SUPPLEMENTARY INFORMATION: A330 fleet was delivered with P/N January 12, 2006. FRH010041 actuators installed, its first Examining the Docket Peter A. White, A330 was delivered July 2003, and no Acting Manager, Engine and Propeller You may examine the airworthiness P/N HTE190021 or P/N HTE190026 Directorate, Aircraft Certification Service. directive (AD) docket on the Internet at actuators have been purchased. Airbus [FR Doc. 06–522 Filed 1–23–06; 8:45 am] http://dms.dot.gov or in person at the Service Bulletins A330–28–3083 and BILLING CODE 4910–13–P Docket Management Facility office A340–28–4098, both dated March 25, between 9 a.m. and 5 p.m., Monday 2003, limit their effectivity to airplanes through Friday, except Federal holidays. delivered up to May 2003, but the DEPARTMENT OF TRANSPORTATION The Docket Management Facility office proposed AD would not so limit the (telephone (800) 647–5227) is located on applicability. The commenter requests Federal Aviation Administration the plaza level of the Nassif Building at that we revise the applicability of the the street address stated in the proposed AD to match that of the 14 CFR Part 39 ADDRESSES section. service bulletins. As stated in the preamble to the [Docket No. FAA–2004–18565; Directorate Discussion Identifier 2003–NM–168–AD; Amendment proposed AD, ‘‘the French airworthiness 39–14461; AD 2006–02–09] The FAA issued a notice of proposed directives specify that Model A330 and rulemaking (NPRM) to amend 14 CFR A340 series airplanes are affected if they RIN 2120–AA64 part 39 to include an AD that would are equipped with LPSOV actuators apply to all Airbus Model A330, A340– Airworthiness Directives; Airbus Model having certain part numbers.’’ The 200, and A340–300 series airplanes; and A330–200, A330–300, A340–200, and Airbus service bulletins, which are A340–541 and -642 airplanes. That A340–300 Series Airplanes mandated by the French airworthiness NPRM was published in the Federal directives, specify that operators first AGENCY: Federal Aviation Register on July 8, 2004 (69 FR 41211). identify the part numbers of the Administration (FAA), Department of That NPRM proposed to require actuators. This AD therefore applies to Transportation (DOT). inspecting for damage to certain all Model A330 and A340 series ACTION: Final rule. actuators of the low-pressure shut-off airplanes and requires part number valve (LPSOV), and related investigative identification. Because the part is SUMMARY: The FAA is adopting a new and corrective actions if necessary. interchangeable, this AD further ensures airworthiness directive (AD) for all that affected LPSOVs are not installed in Comments Airbus Model Airbus Model A330–200, the future, as required by paragraph (g) A330–300, A340–200, and A340–300 We provided the public the of this AD. However, we agree to revise series airplanes. This AD requires opportunity to participate in the paragraph (f) of this final rule to also inspecting for damage to certain development of this AD. We have allow an airplane records review to actuators of the low-pressure shut-off considered the comments received. determine the part number of the valve (LPSOV), and related investigative Requests To Limit Applicability actuator. and corrective actions if necessary. This One commenter, on behalf of Airbus, Request To Allow Additional Service AD results from a report of damage to Information the LPSOV pedestal. We are issuing this requests that we revise the proposed AD to ensure that, in the event of an applicability to match that of the French The proposed AD would require engine fire, the LPSOV actuator airworthiness directive, which is operators to inspect certain LPSOV functions properly to delay or block the limited to airplanes equipped with actuators, and would prohibit fuel flow to the engine and prevent an certain LPSOV part numbers (P/Ns). The installation of affected actuators on or uncontrollable fire. commenter adds that Model A330–301 after the effective date of the AD. One airplanes (among others) receive Airbus commenter, on behalf of an operator of DATES: This AD becomes effective Modification 48225/48223 in Model A330 airplanes, notes that Task February 28, 2006. production, and Model A340–541 and 28–00–00–200–80 of the A330 Aircraft The Director of the Federal Register –642 airplanes receive Airbus Maintenance Manual (AMM), task 28– approved the incorporation by reference Modification 48552 in production. 00–00–200–801, revised July 1, 2004, of certain publications listed in the AD These modifications involve installing provides new installation procedures for as of February 28, 2006. actuator P/N FRH010041. measuring the dowel in each LPSOV ADDRESSES: You may examine the AD We infer that the commenter would location. According to the commenter, docket on the Internet at http:// like us to remove Model A330–301, the AMM should provide sufficient dms.dot.gov or in person at the Docket A340–541, and A340–642 airplanes instructions to meet the parts Management Facility, U.S. Department from the applicability of the proposed installation requirement (paragraph (g) of Transportation, 400 Seventh Street AD. Since we issued the proposed AD, of the proposed AD); however, as SW., Nassif Building, room PL–401, French airworthiness directive F–2003– written, paragraph (g) would prohibit Washington, DC. 360 R1, dated May 26, 2004, was issued installing an affected actuator unless it Contact Airbus, 1 Rond Point Maurice to limit the applicability to A340–200 has been measured specifically in Bellonte, 31707 Blagnac Cedex, France, and –300 series airplanes. We have accordance with Airbus Service Bulletin for service information identified in this revised this final rule accordingly. A330–28–3083. The commenter AD. There has been no corresponding requests that we revise paragraph (g) to FOR FURTHER INFORMATION CONTACT: Tim revision to French airworthiness also consider the AMM task acceptable Backman, Aerospace Engineer, directive F–2003–359 to exclude Model for measuring the dowel during International Branch, ANM–116, FAA, A330–301 airplanes. installation of the actuator. The Transport Airplane Directorate, 1601 Another commenter, a Model A330 commenter asserts that this change will Lind Avenue, SW., Renton, Washington operator, also requests that we limit the also prevent the inadvertent installation 98055–4056; telephone (425) 227–2797; applicability. The commenter reports of an actuator that had not been fax (425) 227–1149. the following: This operator’s entire measured, since actuators that have
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been inspected in accordance with (such as measurement) were done. We have revised this action to clarify Airbus Service Bulletin A330–28–3083 Paragraph (e) of this AD allows for the appropriate procedure for notifying are not so marked or identified. The compliance when the required actions the principal inspector before using any commenter also requests that we allow have already been done. We have not approved AMOC on any airplane to actuators previously installed in changed the final rule regarding these which the AMOC applies. accordance with the AMM after the references. revision date that added the new Conclusion Additional Changes to Proposed AD measurement task be given credit for the We have carefully reviewed the Paragraph (f)(1) of the proposed AD requirements of paragraph (f) of the available data, including the comments stated that no further action would be proposed AD. received, and determined that air safety The Accomplishment Instructions in required for airplanes with LPSOV part and the public interest require adopting the referenced service bulletins refer to number FRH010041. However, the the appropriate AMM sections as requirements of paragraph (g) remain in the AD with the changes described additional sources of service effect for all airplanes. We have changed previously. We have determined that information. It is not necessary to cite paragraph (f)(1) in this final rule to refer these changes will neither increase the the specific AMM references in this AD. only to the requirements of paragraph (f) economic burden on any operator nor Furthermore, the service bulletin does for those airplanes. increase the scope of the AD. not refer to a specific revision level of We have revised the applicability of Costs of Compliance the AMM. Compliance with any the proposed AD to identify model revision of the AMM is acceptable for designations as published in the most The following table provides the compliance with the requirements of recent type certificate data sheet for the estimated costs for U.S. operators to this AD, as long as the required actions affected models. comply with this AD.
ESTIMATED COSTS
Number of Average Cost per U.S.-reg- Action Work hours labor rate Parts airplane istered Fleet cost per hour airplanes
Inspection ...... 1 $65 No parts $65 15 $975
Currently, there are no U.S.-registered the States, on the relationship between PART 39—AIRWORTHINESS Model A340–200 or –300 series the national government and the States, DIRECTIVES airplanes; however, if any are imported or on the distribution of power and I and placed on the U.S. Register in the responsibilities among the various 1. The authority citation for part 39 future, the estimated costs in the above levels of government. continues to read as follows: table would apply. For the reasons discussed above, I Authority: 49 U.S.C. 106(g), 40113, 44701. Authority for This Rulemaking certify that this AD: § 39.13 [Amended] Title 49 of the United States Code (1) Is not a ‘‘significant regulatory I 2. The Federal Aviation specifies the FAA’s authority to issue action’’ under Executive Order 12866; Administration (FAA) amends § 39.13 rules on aviation safety. Subtitle I, (2) Is not a ‘‘significant rule’’ under by adding the following new section 106, describes the authority of DOT Regulatory Policies and Procedures airworthiness directive (AD): the FAA Administrator. Subtitle VII, Aviation Programs, describes in more (44 FR 11034, February 26, 1979); and 2006–02–09 Airbus: Amendment 39–14461. detail the scope of the Agency’s (3) Will not have a significant Docket No. FAA–2004–18565; Directorate Identifier 2003–NM–168–AD. authority. economic impact, positive or negative, We are issuing this rulemaking under on a substantial number of small entities Effective Date the authority described in subtitle VII, under the criteria of the Regulatory (a) This AD becomes effective February 28, part A, subpart III, section 44701, Flexibility Act. 2006. ‘‘General requirements.’’ Under that We prepared a regulatory evaluation Affected ADs section, Congress charges the FAA with promoting safe flight of civil aircraft in of the estimated costs to comply with (b) None. this AD and placed it in the AD docket. air commerce by prescribing regulations Applicability for practices, methods, and procedures See the ADDRESSES section for a location to examine the regulatory evaluation. (c) This AD applies to all Airbus Model the Administrator finds necessary for A330–201, –202, –203, –223, –243, –301, safety in air commerce. This regulation List of Subjects in 14 CFR Part 39 –321, –322, –323, –341, –342, and –343 is within the scope of that authority airplanes; and Model A340–211, –212, –213, because it addresses an unsafe condition Air transportation, Aircraft, Aviation –311, –312, and –313 airplanes; certificated that is likely to exist or develop on safety, Incorporation by reference, in any category. products identified in this rulemaking Safety. Unsafe Condition action. Adoption of the Amendment (d) This AD results from a report of damage Regulatory Findings to the pedestal of the low-pressure shut-off I Accordingly, under the authority valve (LPSOV). We are issuing this AD to We have determined that this AD will ensure that, in the event of an engine fire, the not have federalism implications under delegated to me by the Administrator, LPSOV actuator functions properly to delay Executive Order 13132. This AD will the FAA amends 14 CFR part 39 as or block the fuel flow to the engine and not have a substantial direct effect on follows: prevent an uncontrollable fire.
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Compliance Part Number Identification this inspection if the P/N is conclusively (e) You are responsible for having the (f) At the applicable time specified in Table determined from that review. actions required by this AD performed within 1 of this AD, identify the part number (P/N) the compliance times specified, unless the of the LPSOV actuator. A review of airplane actions have already been done. maintenance records is acceptable in lieu of
TABLE 1.—COMPLIANCE TIMES
Do the actions specified in paragraph (f) of this AD at the earlier of the For model— following times:
A330–201, –202, –203, –223, –243, –301, –321, –322, –323, –341, Within 16,000 flight hours after the effective date of this AD; or Within –342, and –343 airplanes. 53 months after the effective date of this AD. A340–211, –212, –213, –311, –312, and –313 airplanes ...... Within 12,000 flight hours after the effective date of this AD; or Within 39 months after the effective date of this AD.
(1) For P/N FRH010041: No further action Related Information adequate controlled airspace to contain is required by this paragraph. (i) French airworthiness directives 2003– aircraft executing a new Standard (2) For P/N HTE190021 or HTE190026: 359(B), dated October 1, 2003, and F–2003– Instrument Approach Procedure (SIAP) Before further flight, do a detailed inspection 360 R1, dated May 26, 2004, also address the at the airport. This rule results in new for damage to the LPSOV pedestal, and subject of this AD. Class E airspace upward from 700 ft. measure the distance between the face of the mounting flange and the top of the locating Material Incorporated by Reference and 1,200 ft. above the surface at the pin (dowel). Do the actions in accordance (j) You must use Airbus Service Bulletin Toksook Bay Airport, Toksook Bay AK. with the Accomplishment Instructions of A330–28–3083, dated March 25, 2003; or EFFECTIVE DATE: 0901 UTC, April 13, Airbus Service Bulletin A330–28–3083 or Airbus Service Bulletin A340–28–4098, 2006. dated March 25, 2003; as applicable, to A340–28–4098, both dated March 25, 2003, FOR FURTHER INFORMATION CONTACT: Gary perform the actions that are required by this as applicable. Do all related investigative and Rolf, AAL–538G, Federal Aviation corrective actions before further flight in AD, unless the AD specifies otherwise. The accordance with the service bulletin, as Director of the Federal Register approved the Administration, 222 West 7th Avenue, applicable. incorporation by reference of these Box 14, Anchorage, AK 99513–7587; documents in accordance with 5 U.S.C. Note 1: For the purposes of this AD, a telephone number (907) 271–5898; fax: 552(a) and 1 CFR part 51. Contact Airbus, 1 detailed inspection is defined as: ‘‘An (907) 271–2850; e-mail: Rond Point Maurice Bellonte, 31707 Blagnac intensive visual examination of a specific [email protected]. Internet address: Cedex, France, for a copy of this service structural area, system, installation, or http://www.alaska.faa.gov/at. information. You may review copies at the assembly to detect damage, failure, or Docket Management Facility, U.S. SUPPLEMENTARY INFORMATION: irregularity. Available lighting is normally Department of Transportation, 400 Seventh History supplemented with a direct source of good Street SW., room PL–401, Nassif Building, lighting at intensity deemed appropriate by Washington, DC; on the Internet at http:// On Thursday, November 17, 2005, the the inspector. Inspection aids such as mirror, dms.dot.gov; or at the National Archives and FAA proposed to amend part 71 of the magnifying lenses, etc., may be used. Surface Records Administration (NARA). For Federal Aviation Regulations (14 CFR cleaning and elaborate access procedures information on the availability of this part 71) to modify Class E airspace may be required.’’ material at the NARA, call (202) 741–6030, upward from 700 ft. and 1,200 ft. above Note 2: Airbus Service Bulletins A330–28– or go to http://www.archives.gov/federal- the surface at Toksook Bay, AK (70 FR 3083 and A340–28–4098 refer to FR–HiTEMP register/cfr/ibr-locations.html. 69709). The action was proposed in Service Bulletin HTE190021–28–2, dated Issued in Renton, Washington, on January order to create Class E airspace March 17, 2003, as an additional source of 9, 2006. sufficient in size to contain aircraft service information for measuring the flange- Ali Bahrami, to-pin distance. while executing one new SIAP for the Manager, Transport Airplane Directorate, Toksook Bay Airport. The new approach Parts Installation Aircraft Certification Service. is the Area Navigation (Global (g) As of the effective date of this AD: No [FR Doc. 06–559 Filed 1–23–06; 8:45 am] Positioning System) (RNAV (GPS)) person may install an actuator P/N BILLING CODE 4910–13–P Runway (RWY) 34, original. Class E HTE190021 or HTE190026 on any airplane controlled airspace extending upward unless the actuator has been measured, and from 700 ft. and 1,200 ft. above the all applicable related investigative and DEPARTMENT OF TRANSPORTATION surface in the Toksook Bay Airport area corrective actions have been done, in is created by this action. Airspace more accordance with the requirements of Federal Aviation Administration than 12 Nautical Miles (NM) from the paragraph (f)(2) of this AD. shoreline will be excluded from this Alternative Methods of Compliance 14 CFR Part 71 action. That controlled airspace outside (AMOCs) [Docket No. FAA–2005–22856; Airspace 12 NM from the shoreline within 35 NM (h)(1) The Manager, International Branch, Docket No. 05–AAL–36] of the geographic point located at ANM–116, Transport Airplane Directorate, 60°21′17″ North latitude, 165°04′01″ FAA, has the authority to approve AMOCs Establishment of Class E Airspace; West longitude will be created in for this AD, if requested using the procedures Toksook Bay, AK coordination with HQ FAA ATA–400 by found in 14 CFR 39.19. modifying existing Offshore Airspace (2) Before using any AMOC approved in AGENCY: Federal Aviation accordance with 14 CFR 39.19 on any Administration (FAA), DOT. Areas in accordance with FAA Order airplane to which the AMOC applies, notify ACTION: Final rule. 7400.2. That NPRM is currently the appropriate principal inspector in the published as Docket # FAA–2005– FAA Flight Standards Certificate Holding SUMMARY: This action creates Class E 22024, 05–AAL–38. The NPRM District Office. airspace at Toksook Bay, AK to provide originally listed the airfield coordinates
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differently than this final rule. There This rulemaking is promulgated Issued in Anchorage, AK, on January 13, has been a subsequent airfield survey under the authority described in 2006. conducted since the NPRM was Subtitle VII, Part A, Subpart 1, Section Anthony M. Wylie, published, which has revised these 40103, Sovereignty and use of airspace. Manager, Safety, Area Flight Service coordinates. Those listed in the rule Under that section, the FAA is charged Operations. below are correct. Interested parties with prescribing regulations to ensure [FR Doc. 06–601 Filed 1–23–06; 8:45 am] were invited to participate in this the safe and efficient use of the BILLING CODE 4910–13–P rulemaking proceeding by submitting navigable airspace. This regulation is written comments on the proposal to the within the scope of that authority DEPARTMENT OF TRANSPORTATION FAA. No public comments have been because it creates Class E airspace received; thus the rule is adopted as sufficient in size to contain aircraft proposed. Federal Aviation Administration The area will be depicted on executing the instrument procedure for aeronautical charts for pilot reference. the Toksook Bay Airport and represents 14 CFR Part 71 The coordinates for this airspace docket the FAA’s continuing effort to safely and efficiently use the navigable [Docket No. FAA–2005–22111; Airspace are based on North American Datum 83. Docket No. 05–AAL–14] The Class E airspace areas designated as airspace. 700/1,200 ft. transition areas are List of Subjects in 14 CFR Part 71 Revision of Class E Airspace; Koyuk published in paragraph 6005 of FAA Alfred Adams, AK Order 7400.9N, Airspace Designations Airspace, Incorporation by reference, and Reporting Points, dated September Navigation (air). AGENCY: Federal Aviation 1, 2005, and effective September 15, Administration (FAA), DOT. 2005, which is incorporated by Adoption of the Amendment ACTION: Final rule. reference in 14 CFR 71.1. The Class E airspace designation listed in this I In consideration of the foregoing, the SUMMARY: This action modifies Class E document will be published Federal Aviation Administration airspace at Koyuk, AK to provide subsequently in the Order. amends 14 CFR part 71 as follows: adequate controlled airspace to contain aircraft executing one new Standard The Rule PART 71—DESIGNATION OF CLASS A, Instrument Approach Procedure (SIAP) This amendment to 14 CFR part 71 CLASS B, CLASS C, CLASS D, AND and two new SIAPs. This rule results in creates Class E airspace at Toksook Bay, CLASS E AIRSPACE AREAS; revised Class E airspace upward from Alaska. This Class E airspace is created AIRWAYS; ROUTES; AND REPORTING 1,200 ft. above the surface at the Koyuk to accommodate aircraft executing one POINTS Alfred Adams Airport, Koyuk, AK. new SIAP and will be depicted on EFFECTIVE DATE: 0901 UTC, April 13, aeronautical charts for pilot reference. I 1. The authority citation for 14 CFR 2006. The intended effect of this rule is to part 71 continues to read as follows: provide adequate controlled airspace for FOR FURTHER INFORMATION CONTACT: Gary Authority: 49 U.S.C. 106(g), 40103, 40113, Instrument Flight Rule (IFR) operations Rolf, AAL–538G, Federal Aviation 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– at Toksook Bay Airport, Toksook Bay, Administration, 222 West 7th Avenue, 1963 Comp., p. 389. Alaska. Box 14, Anchorage, AK 99513–7587; The FAA has determined that this § 71.1 [Amended] telephone number (907) 271–5898; fax: regulation only involves an established (907) 271–2850; e-mail: body of technical regulations for which I 2. The incorporation by reference in [email protected]. Internet address: frequent and routine amendments are 14 CFR 71.1 of Federal Aviation http://www.alaska.faa.gov/at. necessary to keep them operationally Administration Order 7400.9N, SUPPLEMENTARY INFORMATION: current. It, therefore—(1) is not a Airspace Designations and Reporting History ‘‘significant regulatory action’’ under Points, dated September 1, 2005, and Executive Order 12866; (2) is not a effective September 15, 2005, is On Thursday, November 17, 2005, the ‘‘significant rule’’ under DOT amended as follows: FAA proposed to amend part 71 of the Regulatory Policies and Procedures (44 Federal Aviation Regulations (14 CFR FR 11034; February 26, 1979); and (3) * * * * * part 71) to modify Class E airspace upward from 1,200 ft. above the surface does not warrant preparation of a Paragraph 6005 Class E airspace extending regulatory evaluation as the anticipated upward from 700 feet or more above the at Koyuk, AK (70 FR 69713). The action impact is so minimal. Since this is a surface of the earth. was proposed in order to create Class E routine matter that will only affect air airspace sufficient in size to contain * * * * * traffic procedures and air navigation, it aircraft while executing one new and is certified that this rule will not have AAL AK E5 Toksook Bay, AK [New] two revised SIAPs for the Koyuk a significant economic impact on a Toksook Bay Airport, AK Airport. The new approach is the Area substantial number of small entities (Lat. 60°32′29″ N., long. 165°05′14″ W.) Navigation (Global Positioning System) under the criteria of the Regulatory (RNAV (GPS)) Runway (RWY) 01, That airspace extending upward from 700 Flexibility Act. original. The two revised approaches feet above the surface within a 6.3-mile The FAA’s authority to issue rules are: (1) Non Directional Beacon (NDB) radius of the Toksook Bay Airport and that regarding aviation safety is found in Distance Measuring Equipment (DME) airspace extending upward from 1,200 feet Title 49 of the United States Code. RWY 01, amendment 1, (2) NDB RWY above the surface within a 35-mile radius of Subtitle 1, Section 106 describes the 01, amendment 1. Class E controlled lat. 60°21′17″ N., long. 165°04′01″ W., authority of the FAA Administrator. excluding that airspace more than 12 miles airspace extending upward from 1,200 Subtitle VII, Aviation Programs, from the shoreline. ft. above the surface in the Koyuk describes in more detail the scope of the Airport area is modified by this action. agency’s authority. * * * * * Additionally, one small area of Class G
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airspace surrounded by Class E airspace authority of the FAA Administrator. of the Koyuk NDB 210° bearing extending is being converted to Class E airspace. Subtitle VII, Aviation Programs, from the NDB to 30 miles southwest of the The airspace is thus simplified in this describes in more detail the scope of the NDB and 4.5 miles either side of the line area, reducing possible confusion. The agency’s authority. between the Norton Bay NDB and the Koyuk NPRM also simply listed this action This rulemaking is promulgated NDB, and the area within 20 miles of the Koyuk Airport extending clockwise from the taking place at Koyuk Airport. The more under the authority described in subtitle Koyuk NDB 140° bearing to the 187° bearing, correct designation is Koyuk Alfred VII, part A, subpart 1, section 40103, and the area within 25 miles of the Koyuk Adams and updates in this rule have Sovereignty and use of airspace. Under Airport extending clockwise from the Koyuk been made accordingly. Interested that section, the FAA is charged with NDB 220° bearing to the 230° bearing. parties were invited to participate in prescribing regulations to ensure the * * * * * this rulemaking proceeding by safe and efficient use of the navigable submitting written comments on the airspace. This regulation is within the Issued in Anchorage, AK, on January 13, 2006. proposal to the FAA. No public scope of that authority because it creates comments have been received; thus the Class E airspace sufficient in size to Anthony M. Wylie, rule is adopted as proposed. contain aircraft executing instrument Manager, Safety, Area Flight Service The area will be depicted on procedures for the Koyuk Alfred Adams Operations. aeronautical charts for pilot reference. Airport and represents the FAA’s [FR Doc. 06–600 Filed 1–23–06; 8:45 am] The coordinates for this airspace docket continuing effort to safely and BILLING CODE 4910–13–P are based on North American Datum 83. efficiently use the navigable airspace. The Class E airspace areas designated as 700/1,200 ft. transition areas are List of Subjects in 14 CFR Part 71 DEPARTMENT OF TRANSPORTATION published in paragraph 6005 of FAA Airspace, Incorporation by reference, Order 7400.9N, Airspace Designations Navigation (air). Federal Aviation Administration and Reporting Points, dated September Adoption of the Amendment 1, 2005, and effective September 15, 14 CFR Part 71 2005, which is incorporated by I In consideration of the foregoing, the [Docket No. FAA–2005–22854; Airspace reference in 14 CFR 71.1. The Class E Federal Aviation Administration Docket No. 05–AAL–34] airspace designation listed in this amends 14 CFR part 71 as follows: document will be published Revision of Class E Airspace; Holy subsequently in the Order. PART 71—DESIGNATION OF CLASS A, Cross, AK CLASS B, CLASS C, CLASS D, AND AGENCY: Federal Aviation The Rule CLASS E AIRSPACE AREAS; Administration (FAA), DOT. This amendment to 14 CFR part 71 AIRWAYS; ROUTES; AND REPORTING modifies Class E airspace at Koyuk, POINTS ACTION: Final rule. Alaska. This Class E airspace is I SUMMARY: This action modifies Class E modified to accommodate aircraft 1. The authority citation for 14 CFR part 71 continues to read as follows: airspace at Holy Cross, AK to provide executing one new SIAP, and two adequate controlled airspace to contain Authority: 49 U.S.C. 106(g), 40103, 40113, revised SIAPs and will be depicted on aircraft executing two new Standard aeronautical charts for pilot reference. 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. Instrument Approach Procedures The intended effect of this rule is to (SIAPs) and revised the Departure provide adequate controlled airspace for § 71.1 [Amended] Procedure (DP). This rule results in Instrument Flight Rule (IFR) operations I revised Class E airspace upward from at Koyuk Alfred Adams Airport, Koyuk, 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation 700 ft. above the surface at the Holy Alaska. Cross Airport, Holy Cross AK. The FAA has determined that this Administration Order 7400.9N, regulation only involves an established Airspace Designations and Reporting EFFECTIVE DATE: 0901 UTC, April 13, body of technical regulations for which Points, dated September 1, 2005, and 2006. frequent and routine amendments are effective September 15, 2005, is FOR FURTHER INFORMATION CONTACT: Gary necessary to keep them operationally amended as follows: Rolf, AAL–538G, Federal Aviation current. It, therefore: (1) Is not a * * * * * Administration, 222 West 7th Avenue, ‘‘significant regulatory action’’ under Paragraph 6005 Class E airspace extending Box 14, Anchorage, AK 99513–7587; Executive Order 12866; (2) is not a upward from 700 feet or more above the telephone number (907) 271–5898; fax: surface of the earth. ‘‘significant rule’’ under DOT (907) 271–2850; email: Regulatory Policies and Procedures (44 * * * * * [email protected]. Internet address: FR 11034; February 26, 1979); and (3) AAL AK E5 Koyuk Alfred Adams, AK http://www.alaska.faa.gov/at. does not warrant preparation of a [Revised] SUPPLEMENTARY INFORMATION: regulatory evaluation as the anticipated Koyuk Alfred Adams Airport, AK History impact is so minimal. Since this a (Lat. 64°56′22″ N., long. 161°09′15″ W.) routine matter that will only affect air Koyuk NDB, AK On Thursday, November 17, 2005, the traffic procedures and air navigation, it (Lat. 64°55′55″ N., long. 161°08′52″ W.) FAA proposed to amend part 71 of the Norton Bay NDB, AK Federal Aviation Regulations (14 CFR is certified that this rule will not have ° ′ ″ ° ′ ″ a significant economic impact on a (Lat. 64 41 46 N., long. 162 03 47 W.) part 71) to modify Class E airspace substantial number of small entities That airspace extending upward from 700 upward from 700 ft. above the surface under the criteria of the Regulatory feet above the surface within a 9-mile radius at Holy Cross, AK (70 FR 69710). The of the Koyuk Airport and 4 miles west and action was proposed in order to create Flexibility Act. 8 miles east of the Koyuk NDB 210° bearing The FAA’s authority to issue rules extending from the 9-mile radius to 17 miles Class E airspace sufficient in size to regarding aviation safety is found in southwest of the airport; and that airspace contain aircraft while executing two Title 49 of the United States Code. extending upward from 1,200 feet above the new SIAPs and one revised DP for the Subtitle 1, section 106 describes the surface within 5 miles west and 11 miles east Holy Cross Airport. The new
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approaches are the Area Navigation Title 49 of the United States Code. Issued in Anchorage, AK, on January 13, (Global Positioning System) (RNAV Subtitle 1, section 106 describes the 2006. (GPS)) Runway (RWY) 01, original, (2) authority of the FAA Administrator. Anthony M. Wylie, RNAV (GPS) RWY 19, original. The Subtitle VII, Aviation Programs, Manager, Safety, Area Flight Service unnamed revised DP is published in the describes in more detail the scope of the Operations. front of the U.S. Terminal Procedures agency’s authority. [FR Doc. 06–592 Filed 1–23–06; 8:45 am] Alaska Vol 1. Class E controlled BILLING CODE 4910–13–P airspace extending upward from 700 ft. This rulemaking is promulgated above the surface in the Holy Cross under the authority described in Airport area is modified by this action. Subtitle VII, Part A, Subpart 1, Section Interested parties were invited to 40103, Sovereignty and use of airspace. DEPARTMENT OF STATE participate in this rulemaking Under that section, the FAA is charged proceeding by submitting written with prescribing regulations to ensure 22 CFR Parts 122 and 129 comments on the proposal to the FAA. the safe and efficient use of the No public comments have been navigable airspace. This regulation is [Public Notice: 5278] received; thus the rule is adopted as within the scope of that authority proposed. because it creates Class E airspace RIN 1400–AB97 The area will be depicted on sufficient in size to contain aircraft aeronautical charts for pilot reference. executing instrument procedures for the Rule Title: Amendment to the The coordinates for this airspace docket Holy Cross Airport and represents the International Traffic in Arms are based on North American Datum 83. FAA’s continuing effort to safely and Regulations: Registration Fee Change The Class E airspace areas designated as efficiently use the navigable airspace. 700/1,200 ft. transition areas are AGENCY: Department of State. published in paragraph 6005 of FAA List of Subjects in 14 CFR Part 71 Order 7400.9N, Airspace Designations ACTION: Final rule. and Reporting Points, dated September Airspace, Incorporation by reference, 1, 2005, and effective September 15, Navigation (air). SUMMARY: This rule makes final the 2005, which is incorporated by Adoption of the Amendment interim rule that amended the reference in 14 CFR 71.1. The Class E International Traffic in Arms airspace designation listed in this I In consideration of the foregoing, the Regulations (ITAR) (22 CFR Parts 122 document will be published Federal Aviation Administration and 129) by increasing the registration subsequently in the Order. amends 14 CFR part 71 as follows: fees, changing the registration renewal period, and making other minor The Rule PART 71—DESIGNATION OF CLASS A, administrative changes. Comments This amendment to 14 CFR part 71 CLASS B, CLASS C, CLASS D, AND received on the interim rule are modifies Class E airspace at Holy Cross, CLASS E AIRSPACE AREAS; analyzed in the SUPPLEMENTARY Alaska. This Class E airspace is AIRWAYS; ROUTES; AND REPORTING INFORMATION section. No changes were modified to accommodate aircraft POINTS made to the interim rule. executing two new SIAPs, and one DATES: Effective Date: The interim rule revised DP and will be depicted on I 1. The authority citation for 14 CFR aeronautical charts for pilot reference. is adopted as final February 23, 2006. part 71 continues to read as follows: The intended effect of this rule is to FOR FURTHER INFORMATION CONTACT: provide adequate controlled airspace for Authority: 49 U.S.C. 106(g), 40103, 40113, David Trimble, Office of Defense Trade Instrument Flight Rule (IFR) operations 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– Controls Compliance, Bureau of at Holy Cross Airport, Holy Cross, 1963 Comp., p. 389. Political-Military Affairs, Department of Alaska. § 71.1 [Amended] State, Washington, DC 20522–0112, The FAA has determined that this 202–663–2807 or FAX 202–261–8199. regulation only involves an established I 2. The incorporation by reference in ATTN: ITAR Regulatory Change, 22 CFR body of technical regulations for which 14 CFR 71.1 of Federal Aviation part 122 and part 129. frequent and routine amendments are Administration Order 7400.9N, SUPPLEMENTARY INFORMATION: necessary to keep them operationally Airspace Designations and Reporting current. It, therefore—(1) is not a Points, dated September 1, 2005, and Background ‘‘significant regulatory action’’ under effective September 15, 2005, is Executive Order 12866; (2) is not a On December 8, 2004, the Department amended as follows: ‘‘significant rule’’ under DOT of State published an interim rule Regulatory Policies and Procedures (44 * * * * * (Public Notice 4920; 69 FR 70888), with FR 11034; February 26, 1979); and (3) a request for comments, amending the does not warrant preparation of a Paragraph 6005 Class E airspace extending ITAR (22 CFR parts 122 and 129) by regulatory evaluation as the anticipated upward from 700 feet or more above the increasing the registration fees, surface of the earth. impact is so minimal. Since this a changing the registration renewal routine matter that will only affect air * * * * * period, and making other minor traffic procedures and air navigation, it AAL AK E5 Holy Cross, AK [Revised] administrative changes. The is certified that this rule will not have administration of the Arms Export Holy Cross Airport, AK a significant economic impact on a Control Act (22 U.S.C. 2751 et seq.), (Lat. 62°11′18″ N., long. 159°46′30″ W.) substantial number of small entities regulations for which are set forth in the under the criteria of the Regulatory That airspace extending upward from 700 ITAR, is a foreign affairs function. The Flexibility Act. feet above the surface within a 6.4-mile Department received 43 comments from The FAA’s authority to issue rules radius of the Holy Cross Airport. ITAR registrants and defense-related regarding aviation safety is found in * * * * * associations.
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Comment Analysis who do not engage in exporting must DEPARTMENT OF HOMELAND Impact on Small Business and Fee nevertheless register. In addition, 22 SECURITY Relief CFR 129.1 states that section 38(b)(1)(A)(ii) of the Arms Export Coast Guard The majority of comments received Control Act (22 U.S.C. 2778) provides concerned the fee increase’s impact on that persons engaged in the business of 33 CFR Part 117 small businesses. The comments brokering activities shall register and provided noted the burden the fee [CGD05–06–004] pay a registration fee. Furthermore, 22 increase would place on small RIN 1625–AA–09 businesses, and some sought relief from CFR 129.2 states that, inter alia, the increase. Prior to the publication of brokering activities include activities by Drawbridge Operation Regulations; the interim rule, the Department fully U.S. persons who are located inside or Elizabeth River, Eastern Branch, VA considered the financial burden the fee outside of the United States or foreign AGENCY: Coast Guard, DHS. increase would place on industry and persons subject to U.S. jurisdiction ACTION: small businesses when it decided upon involving defense articles or defense Notice of temporary deviation the new fee structure, and concluded services of U.S. or foreign origin, which from regulations. that the impact would be minimal for are located inside or outside of the SUMMARY: The Commander, Fifth Coast the majority of the registrants. In United States. Guard District, has approved a addition, as noted in the Regulatory Rationale for Two-Year Registration temporary deviation from the Findings and Notice section, the regulations governing the operation of Department has found that this fee Two comments were received the Berkley Bridge, at mile 0.4, across increase will not result in an annual requesting the retention of the option to the Eastern Branch of the Elizabeth effect on the economy of $100 million register up to a maximum period of four River in Norfolk, Virginia. To facilitate or more; a major increase in costs or years. DDTC has reduced the maximum electrical repairs, this deviation allows prices for consumers, individual registration period to two years because the drawbridge to remain closed-to- industries, Federal, State, or local the increased volume of mergers and navigation from 7 a.m. on February 7, government agencies, or geographic 2006, to 7 a.m. on February 8, 2006 and regions; or significant adverse effects on acquisitions by regulated companies has made it more difficult to maintain from 7 a.m. on February 14, 2006, to 7 competition, employment, investment, a.m. on February 15, 2006. productivity, innovation, or on the accurate information on registrants. DATES: This deviation is effective from ability of United States-based Also, DDTC encountered problems with 7 a.m. on February 7, 2006, to 7 a.m. on enterprises to compete with foreign- companies not updating their February 15, 2006. based enterprises in domestic and registration, except at the time of their export markets. renewal, as required by 22 CFR 129.4(c). FOR FURTHER INFORMATION CONTACT: Gary The change from a four-year to a two- Heyer, Bridge Management Specialist, Rational for Increasing Registration Fees year maximum registration period will Fifth Coast Guard District, at (757) 398– Ten comments were received improve the currency and accuracy of 6629. regarding the rationale for increasing the the registrants’ information, which is SUPPLEMENTARY INFORMATION: The registration fee. The Department has critical to all licensing decisions. Berkley Bridge, a lift-type drawbridge, increased the ITAR registration fee to has a vertical clearance in the closed help fund the activities of its Directorate List of Subjects position to vessels of 48 feet, at mean of Defense Trade Controls (DDTC), as set 22 CFR Part 122 high water. forth in 22 U.S.C. 2717. In particular, The bridge owner, the Virginia the additional revenue will assist DDTC Arms and munitions, Exports. Department of Transportation, has in achieving its goals of expanded requested a temporary deviation from automation, compliance, training, and 22 CFR Part 129 the current operating regulation set out in 33 CFR 117.1007, to effect electrical quality assurance. The additional Arms and munitions, Exports, repairs of the draw span. resources will enable DDTC to serve the Technical assistance. export community with greater To facilitate the repairs, the efficiency. This increase in registration Accordingly, for the reasons set forth drawbridge will be closed to navigation fees is the first increase since 1997. above, the interim rule published at 69 from 7 a.m. on February 7, 2006, to 7 FR 70888 is adopted as final. a.m. on February 8, 2006 and from 7 Registration Requirements Dated: Decemher 21, 2005. a.m. on February 14, 2006, to 7 a.m. on Three comments were received February 15, 2006. During these periods, Robert G. Joseph, regarding whether particular entities the repairs require immobilizing the must register with DDTC. The interim Under Secretary, Arms Control and operation of the lift span in the closed- rule and this final rule address an International Security, Department of State. to-navigation position. At all other increase in the registration fee, the [FR Doc. 06–667 Filed 1–23–06; 8:45 am] times, the drawbridge will operate in registration renewal period, and other BILLING CODE 4710–25–P accordance with the current operating minor administrative changes. The regulations outlined in 33 CFR regulations pertaining to who must 117.1007. register with DDTC remain unchanged. The Coast Guard has informed the Pursuant to 22 CFR 122.1, any person known users of the waterway so that who engages in the United States in the they can arrange their transits to business of either manufacturing or minimize any impact caused by the exporting defense articles or furnishing temporary deviation. defense services is required to register In accordance with 33 CFR 117.35(c), with the Office (now Directorate) of this work will be performed with all due Defense Trade Controls. Manufacturers speed in order to return the bridge to
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normal operation as soon as possible. replaced by an enhanced federal-wide comment. Electronic files should avoid This deviation from the operating electronic docket management and the use of special characters, any form regulations is authorized under 33 CFR comment system located at http:// of encryption, and be free of any defects 117.35. www.regulations.gov. Therefore, you or viruses. For additional information Dated: January 17, 2006. will be redirected to that site to access about EPA’s public docket visit the docket EPA–R08–OAR–2005–ND– EDOCKET online or see the Federal Waverly W. Gregory, Jr., 0002 and submit comments. Follow the Register of May 31, 2002 (67 FR 38102). Chief, Bridge Administration Branch, Fifth on-line instructions for submitting For additional instructions on Coast Guard District. comments. submitting comments, go to Section I. [FR Doc. 06–584 Filed 1–23–06; 8:45 am] • E-mail: [email protected] and General Information of the BILLING CODE 4910–15–P [email protected]. SUPPLEMENTARY INFORMATION section of • Fax: (303) 312–6064 (please alert this document. the individual listed in the FOR FURTHER Docket: All documents in the docket ENVIRONMENTAL PROTECTION INFORMATION CONTACT if you are faxing are listed in the Regional Materials in AGENCY comments). EDOCKET index at http:// • Mail: Richard R. Long, Director, Air 40 CFR Part 52 docket.epa.gov/rmepub/index.jsp. and Radiation Program, Environmental Although listed in the index, some [EPA–R08–OAR–2005–ND–0002; FRL– Protection Agency (EPA), Region 8, information is not publicly available, 8011–1] Mailcode 8P–AR, 999 18th Street, Suite i.e., CBI or other information whose 200, Denver, Colorado 80202–2466. disclosure is restricted by statute. Clean Air Act Approval and • Hand Delivery: Richard R. Long, Certain other material, such as Promulgation of Air Quality Director, Air and Radiation Program, copyrighted material, is not placed on Implementation Plan Revision for Environmental Protection Agency the Internet and will be publicly North Dakota; Revisions to the Air (EPA), Region 8, Mailcode 8P–AR, 999 available only in hard copy form. Pollution Control Rules; Delegation of 18th Street, Suite 200, Denver, Colorado Publicly available docket materials are Authority for New Source Performance 80202–2466. Such deliveries are only available either electronically in Standards accepted Monday through Friday, 8 a.m. Regional Materials in EDOCKET or in to 4:55 p.m., excluding Federal AGENCY: Environmental Protection hard copy at the Air and Radiation holidays. Special arrangements should Agency (EPA). Program, Environmental Protection be made for deliveries of boxed Agency (EPA), Region 8, 999 18th ACTION: Direct final rule and delegation information. Street, Suite 200, Denver, Colorado of authority. Instructions: Direct your comments to 80202–2466. EPA requests that if at all Docket ID No. R08–OAR–2005–ND– SUMMARY: EPA is taking direct final possible, you contact the individual 0002. EPA’s policy is that all comments action approving certain revisions to the listed in the FOR FURTHER INFORMATION received will be included in the public State Implementation Plan (SIP) as CONTACT section to view the hard copy docket without change and may be of the docket. You may view the hard submitted by the Governor of North made available at http://docket.epa.gov/ Dakota with a letter dated April 11, copy of the docket Monday through rmepub/index.jsp, including any Friday, 8 a.m. to 4 p.m., excluding 2003. The revisions affect certain personal information provided, unless portions of air pollution control rules Federal holidays. the comment includes information FOR FURTHER INFORMATION CONTACT: regarding permitting. This action is claimed to be Confidential Business being taken under section 110 of the Amy Platt, Environmental Protection Information (CBI) or other information Agency, Region 8, (303) 312–6449, Clean Air Act. whose disclosure is restricted by statute. [email protected]. EPA is also providing notice that on Do not submit information that you July 27, 2005, North Dakota was consider to be CBI or otherwise SUPPLEMENTARY INFORMATION: delegated authority to implement and protected through EDOCKET, enforce certain New Source Table of Contents regulations.gov, or e-mail. The EPA’s I. General Information Performance Standards, as of January Regional Materials in EDOCKET and 31, 2004. II. Background Federal regulations.gov Web site are III. Revisions in the April 11, 2003 Submittal DATES: This rule is effective on March ‘‘anonymous access’’ systems, which That Are the Subject of This Document 27, 2006 without further notice, unless means EPA will not know your identity IV. Delegation of Authority EPA receives adverse comment by or contact information unless you V. Section 110(l) February 23, 2006. If adverse comment provide it in the body of your comment. VI. Final Action VII. Statutory and Executive Order Reviews is received, EPA will publish a timely If you send an e-mail comment directly withdrawal of the direct final rule in the to EPA, without going through Definitions Federal Register informing the public EDOCKET or regulations.gov, your e- For the purpose of this document, we that the rule will not take effect. mail address will be automatically are giving meaning to certain words or ADDRESSES: Submit your comments, captured and included as part of the initials as follows: identified by Docket ID No. R08–OAR– comment that is placed in the public (i) The words or initials Act or CAA 2005–ND–0002, by one of the following docket and made available on the mean or refer to the Clean Air Act, methods: Internet. If you submit an electronic unless the context indicates otherwise. • Federal eRulemaking Portal: http:// comment, EPA recommends that you (ii) The words EPA, we, us or our www.regulations.gov. Follow the on-line include your name and other contact mean or refer to the United States instructions for submitting comments. information in the body of your Environmental Protection Agency. • Agency Web site: http:// comment and with any disk or CD–ROM (iii) The initials SIP mean or refer to docket.epa.gov/rmepub/. On November you submit. If EPA cannot read your State Implementation Plan. 28, 2005, Regional Material in comment due to technical difficulties (iv) The words State or ND mean the EDOCKET (RME), EPA’s electronic and cannot contact you for clarification, State of North Dakota, unless the public docket and comment system, was EPA may not be able to consider your context indicates otherwise.
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(v) The initials NDDH mean or refer To provide for public comment, the construction and minor source to the North Dakota Department of North Dakota Department of Health permitting). Health. (NDDH), after providing notice, held a A. Chapter 33–15–14, N.D.A.C., Section public hearing on April 19, 2002 to I. General Information 33–15–14–02, Permit To Construct address the revisions to the State A. What Should I Consider as I Prepare Implementation Plan (SIP) and Air In the Permit to Construct section, 33– My Comments for EPA? Pollution Control Rules. Following the 15–14–02, subsection 33–15–14–02.19, 1. Submitting CBI. Do not submit this public hearing, comment period, and Amendment of Permits, was revised to information to EPA through Regional legal review by the North Dakota clarify how the NDDH can amend a Materials in EDOCKET, regulations.gov Attorney General’s Office, the North construction permit. Specifically, in the or e-mail. Clearly mark the part or all of Dakota State Health Council adopted the event that a modification would be a the information that you claim to be revisions, which became effective on ‘‘major modification’’ as defined in the CBI. For CBI information in a disk or March 1, 2003. The North Dakota State’s prevention of significant CD–ROM that you mail to EPA, mark Governor submitted the SIP revisions to deterioration (PSD) regulations, then the the outside of the disk or CD ROM as us with a letter dated April 11, 2003. procedures established in Chapter 33– CBI and then identify electronically On October 21, 2004, EPA published 15–15, N.D.A.C., must be followed. a notice of final rulemaking for the State within the disk or CD–ROM the specific B. Chapter 33–15–14, N.D.A.C., Section, information that is claimed as CBI. In of North Dakota (see 69 FR 61762). In that final rulemaking, we approved 33–15–14–03, Minor Source Permit To addition to one complete version of the Operate comment that includes information portions of the SIP revision submitted claimed as CBI, a copy of the comment by the Governor of North Dakota on Subsection 33–15–14–03.16, that does not contain the information April 11, 2003. The portions of the SIP Amendment of Permits, was similarly claimed as CBI must be submitted for revision that we approved affected the revised to clarify how the NDDH can inclusion in the public docket. North Dakota Air Pollution Control amend a minor source permit to operate. Information so marked will not be Rules regarding general provisions and Specifically, in the event that a disclosed except in accordance with emissions of particulate matter and modification would be a ‘‘major sulfur compounds. procedures set forth in 40 CFR part 2. modification’’ as defined in the State’s As we discussed in our October 21, 2. Tips for Preparing Your Comments. prevention of significant deterioration 2004 notice of final rulemaking, we When submitting comments, remember (PSD) regulations, then the procedures were handling separately the revisions to: established in Chapter 33–15–15, i. Identify the rulemaking by docket in the April 11, 2003 submittal N.D.A.C., must be followed. number and other identifying addressing North Dakota Air Pollution The revisions discussed above are information (subject heading, Federal Control Rules Section 33–15–01–13, simply clarifying in nature and are Register date and page number). regarding shutdown and malfunction of approvable. an installation, certain portions of ii. Follow directions—The agency IV. Delegation of Authority may ask you to respond to specific Chapter 33–15–14, regarding questions or organize comments by construction and minor source With a February 10, 2005 submittal, referencing a Code of Federal permitting, and certain portions of the Governor of North Dakota requested Regulations (CFR) part or section Chapter 33–15–15, regarding prevention delegation of authority for revisions to number. of significant deterioration. the New Source Performance Standards iii. Explain why you agree or disagree; On August 8, 2005, EPA published a (NSPS), promulgated in Chapter 33–15– suggest alternatives and substitute direct final rulemaking for the State of 12, N.D.A.C. On July 27, 2005, language for your requested changes. North Dakota (see 70 FR 45539). In that delegation was given with the following iv. Describe any assumptions and final rulemaking, we approved letter: additional portions of the SIP revision provide any technical information and/ Ref: 8P–AR or data that you used. submitted by the Governor of North v. If you estimate potential costs or Dakota on April 11, 2003. Those Honorable John Hoeven, Governor of North Dakota State Capitol, 600 burdens, explain how you arrived at portions of the SIP revision that we approved affected certain section of the E Boulevard Avenue, Bismarck, North your estimate in sufficient detail to Dakota 58505–0001 allow for it to be reproduced. North Dakota Air Pollution Control Rules regarding permitting and Re: Delegation of Clean Air Act New Source vi. Provide specific examples to Performance Standards illustrate your concerns, and suggest prevention of significant deterioration of air quality. Dear Governor Hoeven: alternatives. In a February 10, 2005, letter from you and vii. Explain your views as clearly as III. Revisions in the April 11, 2003 a February 15, 2005, letter from David Glatt, possible, avoiding the use of profanity Submittal That Are the Subject of This North Dakota Department of Health (NDDH), or personal threats. Document the State of North Dakota submitted revisions viii. Make sure to submit your to its Air Pollution Control Rules and comments by the comment period The revisions in the April 11, 2003 requested direct delegation to implement and deadline identified. submittal to be addressed in this enforce the Federal New Source Performance document pertain to certain portions of Standards (NSPS). Specifically, North Dakota II. Background the North Dakota Air Pollution Control Administrative Code Chapter 33–15–12, The Act requires States to follow Rules regarding permitting, which Standards of Performance for New Stationary certain procedures in developing involve sections of the following Sources, was revised to update the citation implementation plans and plan chapter of the North Dakota for the incorporated Federal NSPS in 40 CFR Part 60 as those in effect on January 31, 2004, revisions for submission to us. Sections Administrative Code (N.D.A.C.): 33–15– with the exception of subpart Eb, which the 110(a)(2) and 110(l) of the Act provide 14 Designated Air Contaminant Sources, State has not adopted. that each implementation plan must be Permit to Construct, Minor Source Subsequent to States adopting NSPS adopted after reasonable notice and Permit to Operate, Title V Permit to regulations, EPA delegates the authority for public hearing. Operate (certain sections specific to the implementation and enforcement of those
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NSPS, so long as the State’s regulations are compliance with NSPS regulations. Should outlined in 40 CFR 60.13(i), may be approved equivalent to the Federal regulations. EPA the NDDH grant such a variance or waiver, by the State only if the specific NSPS grants reviewed the pertinent statutes and EPA will consider the source receiving such that authority. Otherwise, EPA retains the regulations of the State of North Dakota and relief to be in violation of the applicable authority to review and approve such determined that they provide an adequate Federal regulation and initiate enforcement alternatives. and effective procedure for the action against the source pursuant to section (N) If a source proposes to modify its implementation and enforcement of the 113 of the Act. The granting of such relief by operation or facility which may cause the NSPS by the State. Therefore, pursuant to the NDDH shall also constitute grounds for source to be subject to NSPS requirements, Section 111(c) of the Clean Air Act (Act), as revocation of delegation by EPA. amended, and 40 CFR Part 60, EPA hereby (F) If at anytime there is a conflict between the State shall notify EPA Region 8 and delegates its authority for the implementation a State regulation and a Federal regulation obtain a determination on the applicability of and enforcement of the NSPS to the State of (40 CFR Part 60), the Federal regulation must the NSPS regulations. North Dakota as follows: be applied if it is more stringent than that of (O) Information shall be made available to (A) Responsibility for all sources located, the State. If the State does not have the the public in accordance with 40 CFR 60.9. or to be located, in the State of North Dakota authority to enforce the more stringent Any records, reports, or information subject to the standards of performance for Federal regulation, this portion of the provided to, or otherwise obtained by, the new stationary sources promulgated in 40 delegation may be revoked. State in accordance with the provisions of CFR Part 60. The categories of new stationary (G) If the Regional Administrator these regulations shall be made available to sources covered by this delegation are all determines that a State procedure for the designated representatives of EPA upon NSPS subparts in 40 CFR Part 60, as in effect enforcing or implementing the NSPS is request. on January 31, 2004, with the exception of inadequate, or is not being effectively carried (P) All reports required pursuant to the subpart Eb, which the State has not adopted. out, this delegation may be revoked in whole delegated NSPS should not be submitted to Note this delegation does not include the or part. Any such revocation shall be the EPA Region 8 office, but rather to the emission guidelines in subparts Cb, Cc, Cd, effective as of the date specified in a Notice NDDH. Ce, BBBB, and DDDD. These subparts require of Revocation to the NDDH. state plans which are approved under a (H) Acceptance of this delegation of (Q) As 40 CFR Part 60 is updated, North separate process pursuant to Section 111(d) presently promulgated NSPS does not Dakota should revise its regulations of the Act. commit the State of North Dakota to accept accordingly and in a timely manner and (B) Not all authorities of NSPS can be delegation of future standards and submit to EPA requests for updates to its delegated to States under Section 111(c) of requirements. A new request for delegation delegation of authority. the Act, as amended. The EPA Administrator will be required for any standards not EPA is approving North Dakota’s request retains authority to implement those sections included in the State’s requests of February for NSPS delegation for all areas within the of the NSPS that require: (1) Approving 10, and 15, 2005. State except for the following: Lands within equivalency determinations and alternative (I) Upon approval of the Regional the exterior boundaries of the Fort Berthold, test methods, (2) decision making to ensure Administrator of EPA Region 8, the Director Fort Totten, Standing Rock and Turtle national consistency, and (3) EPA rulemaking of the NDDH may subdelegate his authority Mountain Indian Reservations; and any other to implement. Therefore, of the NSPS of 40 to implement and enforce the NSPS to local areas which are ‘‘Indian Country’’ within the CFR Part 60 being delegated in this letter, the air pollution control authorities in the State meaning of 18 U.S.C. 1151. enclosure lists examples of sections in 40 when such authorities have demonstrated Since this delegation is effective CFR Part 60 that cannot be delegated to the that they have equivalent or more stringent immediately, there is no need for the State State of North Dakota. Please note that the programs in force. enclosed list has been updated since our (J) The State of North Dakota must require to notify the EPA of its acceptance. Unless November 6, 2003, delegation of authority to reporting of all excess emissions from any we receive written notice of objections from implement and enforce the NSPS to the State NSPS source in accordance with 40 CFR you within ten days of the date on which you of North Dakota. 60.7(c). receive this letter, the State of North Dakota (C) The North Dakota Department of Health (K) Performance tests shall be scheduled will be deemed to accept all the terms of this (NDDH) and EPA will continue a system of and conducted in accordance with the delegation. EPA will publish an information communication sufficient to guarantee that procedures set forth in 40 CFR Part 60 unless notice in the Federal Register to inform the each office is always fully informed and alternate methods or procedures are public of this delegation, in which this letter current regarding compliance status of the approved by the EPA Administrator. will appear in its entirety. subject sources and interpretation of the Although the Administrator retains the If you have any questions on this matter, regulations. exclusive right to approve equivalent and please contact me or have your staff contact (D) Enforcement of the NSPS in the State alternate test methods as specified in 40 CFR Richard Long, Director of our Air and will be the primary responsibility of the 60.8(b)(2) and (3), the State may approve Radiation Program, at (303) 312–6005. NDDH. If the NDDH determines that such minor changes in methodology provided Sincerely yours, enforcement is not feasible and so notifies these changes are reported to EPA Region 8. EPA, or where the NDDH acts in a manner The Administrator also retains the right to Robert E. Roberts inconsistent with the terms of this change the opacity standard as specified in Regional Administrator. delegation, EPA may exercise its concurrent 40 CFR 60.11(e). Enclosure enforcement authority pursuant to section (L) Determinations of applicability such as 113 of the Act, as amended, with respect to those specified in 40 CFR 60.5 and 60.6 shall cc: David Glatt, NDDH sources within the State of North Dakota be consistent with those which have already Terry O’Clair, NDDH subject to NSPS. been made by the EPA. Enclosure to Letter Delegating NSPS in 40 (E) The State of North Dakota will at no (M) Alternatives to continuous monitoring CFR Part 60, Effective Through January time grant a variance or waiver from procedures or reporting requirements, as 31, 2004, to the State of North Dakota
EXAMPLES OF AUTHORITIES IN 40 CFR PART 60 WHICH CANNOT BE DELEGATED
40 CFR subparts Section(s)
A ...... 60.8(b)(2) and (b)(3), and those sections throughout the standards that reference 60.8(b)(2) and (b)(3); 60.11(b) and (e); and 60.13(i). Da ...... 60.45a. Db ...... 60.44b(f), 60.44b(g) and 60.49b(a)(4). Dc ...... 60.48c(a)(4). Ec ...... 60.56c(i), 60.8. J ...... 60.105(a)(13)(iii) and 60.106(i)(12).
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EXAMPLES OF AUTHORITIES IN 40 CFR PART 60 WHICH CANNOT BE DELEGATED—Continued
40 CFR subparts Section(s)
Ka ...... 60.114a. Kb ...... 60.111b(f)(4), 60.114b, 60.116b(e)(3)(iii), 60.116b(e)(3)(iv), and 60.116b(f)(2)(iii). O ...... 60.153(e). S ...... 60.195(b). DD ...... 60.302(d)(3). GG ...... 60.332(a)(3) and 60.335(a). VV ...... 60.482–1(c)(2) and 60.484. WW ...... 60.493(b)(2)(i)(A) and 60.496(a)(1). XX ...... 60.502(e)(6). AAA ...... 60.531, 60.533, 60.534, 60.535, 60.536(i)(2), 60.537, 60.538(e) and 60.539. BBB ...... 60.543(c)(2)(ii)(B). DDD ...... 60.562–2(c). GGG ...... 60.592(c). III ...... 60.613(e). JJJ ...... 60.623. KKK ...... 60.634. NNN ...... 60.663(f). QQQ ...... 60.694. RRR ...... 60.703(e). SSS ...... 60.711(a)(16), 60.713(b)(1)(i) and (ii), 60.713(b)(5)(i), 60.713(d), 60.715(a) and 60.716. TTT ...... 60.723(b)(1), 60.723(b)(2)(i)(C), 60.723(b)(2)(iv), 60.724(e) and 60.725(b). VVV ...... 60.743(a)(3)(v)(A) and (B), 60.743(e), 60.745(a) and 60.746. WWW ...... 60.754(a)(5). CCCC ...... 60.2030(c).
V. Section 110(l) delegated to the states, as defined in 40 this reason, this action is also not CFR part 60. subject to Executive Order 13211, Section 110(l) of the Clean Air Act EPA is publishing this rule without ‘‘Actions Concerning Regulations That states that a SIP revision cannot be prior proposal because the Agency Significantly Affect Energy Supply, approved if the revision would interfere views this as a noncontroversial Distribution, or Use’’ (66 FR 28355, May with any applicable requirement amendment and anticipates no adverse 22, 2001). This action merely approves concerning attainment and reasonable comments. However, in the ‘‘Proposed state law as meeting Federal further progress towards attainment of Rules’’ section of today’s Federal requirements and imposes no additional the National Ambient Air Quality Register publication, EPA is publishing requirements beyond those imposed by Standards (NAAQS) or any other a separate document that will serve as state law. Accordingly, the applicable requirements of the Act. the proposal to approve the SIP revision Administrator certifies that this rule There are no nonattainment areas in if adverse comments are filed. This rule will not have a significant economic North Dakota. The revisions to the will be effective March 27, 2006 without impact on a substantial number of small permitting provisions were clarifying in further notice unless the Agency entities under the Regulatory Flexibility nature, will not affect emissions, and receives adverse comments by February Act (5 U.S.C. 601 et seq.). Because this will not interfere with requirements of 23, 2006. If the EPA receives adverse rule approves pre-existing requirements the Act related to administrative or comments, EPA will publish a timely under state law and does not impose procedural provisions. Therefore, these withdrawal in the Federal Register any additional enforceable duty beyond revisions do not interfere with informing the public that the rule will that required by state law, it does not attainment or maintenance of the not take effect. EPA will address all contain any unfunded mandate or NAAQS or other applicable public comments in a subsequent final significantly or uniquely affect small requirements of the Act. rule based on the proposed rule. The governments, as described in the EPA will not institute a second Unfunded Mandates Reform Act of 1995 VI. Final Action comment period on this action. Any (Pub. L. 104–4). parties interested in commenting must We reviewed the adequacy of these do so at this time. Please note that if This rule also does not have tribal certain revisions submitted by the North EPA receives adverse comment on an implications because it will not have a Dakota Governor with a letter dated amendment, paragraph, or section of substantial direct effect on one or more April 11, 2003, and find them this rule and if that provision may be Indian tribes, on the relationship approvable. In addition, as requested by severed from the remainder of the rule, between the Federal Government and the North Dakota Governor with his EPA may adopt as final those provisions Indian tribes, or on the distribution of February 10, 2005 submittal, we are of the rule that are not the subject of an power and responsibilities between the providing notice that we granted adverse comment. Federal Government and Indian tribes, delegation of authority to North Dakota as specified by Executive Order 13175 on July 27, 2005, to implement and VII. Statutory and Executive Order (65 FR 67249, November 9, 2000). This enforce the NSPS promulgated in 40 Reviews action also does not have federalism CFR part 60, promulgated as of January Under Executive Order 12866 (58 FR implications because it does not have 31, 2004 (except subpart Eb, which the 51735, October 4, 1993), this action is substantial direct effects on the States, State has not adopted). However, the not a ‘‘significant regulatory action’’ and on the relationship between the State’s NSPS authorities do not include therefore is not subject to review by the National Government and the States, or those authorities which cannot be Office of Management and Budget. For on the distribution of power and
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responsibilities among the various such rule or action. This action may not ENVIRONMENTAL PROTECTION levels of government, as specified in be challenged later in proceedings to AGENCY Executive Order 13132 (64 FR 43255, enforce its requirements. (See section August 10, 1999). This action merely 307(b)(2)). 40 CFR Part 52 approves a state rule implementing a List of Subjects in 40 CFR Part 52 [Docket No.: EPA–R10–OAR–2005–OR– Federal standard, and does not alter the 0001; FRL–8015–3] relationship or the distribution of power Environmental protection, Air and responsibilities established in the Approval and Promulgation of State pollution control, Carbon monoxide, Clean Air Act. This rule also is not Implementation Plans: Oregon; Incorporation by reference, subject to Executive Order 13045 Portland Carbon Monoxide Second 10- Intergovernmental relations, Nitrogen ‘‘Protection of Children from Year Maintenance Plan Environmental Health Risks and Safety dioxide, Ozone, Particulate matter, Risks’’ (62 FR 19885, April 23, 1997), Reporting and recordkeeping AGENCY: Environmental Protection because it is not economically requirements, Sulfur oxides, Volatile Agency (EPA). significant. organic compounds. ACTION: Final rule. In reviewing SIP submissions, EPA’s Dated: December 7, 2005. role is to approve state choices, SUMMARY: This action finalizes our Kerrigan G. Clough, provided that they meet the criteria of approval of the State Implementation the Clean Air Act. In this context, in the Acting Regional Administrator, Region 8. Plan (SIP) revisions submitted by the Oregon Department of Environmental absence of a prior existing requirement I 40 CFR part 52 is amended to read as Quality on January 3, 2005. EPA is for the State to use voluntary consensus follows: standards (VCS), EPA has no authority approving the State of Oregon’s second 10-year carbon monoxide (CO) to disapprove a SIP submission for PART 52—[AMENDED] failure to use VCS. It would thus be maintenance plan for the Portland inconsistent with applicable law for I 1. The authority citation for part 52 maintenance area. Specifically, EPA is approving the following: Oregon’s EPA, when it reviews a SIP submission, continues to read as follows: to use VCS in place of a SIP submission demonstration that the Portland CO that otherwise satisfies the provisions of Authority: 42 U.S.C. 7401 et seq. Attainment Area will maintain air the Clean Air Act. Thus, the quality standards for CO through the Subpart JJ—North Dakota requirements of section 12(d) of the year 2017; a revised CO motor vehicle National Technology Transfer and emissions budget for transportation Advancement Act of 1995 (15 U.S.C. I 2. Section 52.1820 is amended by conformity purposes using the 272 note) do not apply. This rule does adding paragraph (c)(35) to read as MOBILE6.2 emissions model and latest not impose an information collection follows: growth and planning assumptions; and burden under the provisions of the revised state implementation plan (SIP) § 52.1820 Identification of plan. Paperwork Reduction Act of 1995 (44 control strategies and contingency U.S.C. 3501 et seq.). * * * * * measures. The Congressional Review Act, 5 (c) * * * DATES: This final rule is effective on U.S.C. 801 et seq., as added by the Small (35) Certain revisions to the North February 23, 2006. Business Regulatory Enforcement ADDRESSES: Fairness Act of 1996, generally provides Dakota State Implementation Plan and EPA has established a that before a rule may take effect, the Air Pollution Control Rules as docket for this action under Docket ID agency promulgating the rule must submitted by the Governor with a letter No. EPA–R10–OAR–2005–OR–0001. All submit a rule report, which includes a dated April 11, 2003. The revisions documents in the docket are listed on copy of the rule, to each House of the affect portions of North Dakota the http://www.regulations.gov Web Congress and to the Comptroller General Administrative Code (N.D.A.C.) site. Although listed in the index, some of the United States. EPA will submit a regarding construction and minor information is not publicly available, report containing this rule and other source permitting. e.g., CBI or other information whose disclosure is restricted by statute. required information to the U.S. Senate, (i) Incorporation by reference. the U.S. House of Representatives, and Certain other material, such as (A) Revisions to the North Dakota Air the Comptroller General of the United copyrighted material, is not placed on States prior to publication of the rule in Pollution Control Rules as follows: the Internet and will be publicly the Federal Register. A major rule (1) In Chapter 33–15–14, N.D.A.C., available only in hard copy form. cannot take effect until 60 days after it Designated Air Contaminant Sources, Publicly available docket materials are is published in the Federal Register. Permit to Construct, Minor Source available either electronically through This action is not a ‘‘major rule’’ as Permit to Operate, Title V Permit to http://www.regulations.gov or in hard defined by 5 U.S.C. 804(2). Operate, the sentence in each first copy at the EPA, Region 10, Office of Under section 307(b)(1) of the Clean paragraph of subsections 33–15–14– Air, Waste and Toxics (AWT–107), 1200 Air Act, petitions for judicial review of 02.19 and 33–15–14–03.16 that reads as Sixth Avenue, Seattle WA. EPA requests this action must be filed in the United follows, ‘‘In the event that the that if all possible, you contact the FOR FURTHER States Court of Appeals for the modification would be a major contact listed in the INFORMATION CONTACT section to appropriate circuit by March 27, 2006. modification as defined in chapter 33– schedule your inspection. The Regional Filing a petition for reconsideration by 15–15, the department shall follow the Office’s official hours of business are the Administrator of this final rule does procedures established in chapter 33– not affect the finality of this rule for the Monday through Friday, 8:30 to 4:30 15–15.’’ These revisions were effective excluding legal holidays. purposes of judicial review nor does it March 1, 2003. extend the time within which a petition FOR FURTHER INFORMATION CONTACT: Gina for judicial review may be filed, and [FR Doc. 06–629 Filed 1–23–06; 8:45 am] Bonifacino, Office of Air, Waste and shall not postpone the effectiveness of BILLING CODE 6560–50–P Toxics (AWT–107), EPA Region 10,
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1200 Sixth Avenue, Seattle WA 98101; and Emission Factors, and Compilation the published proposal. A Technical telephone number: (206) 553–2970; fax of Air Pollutant Emission Factors (AP– Support Document on file at the EPA number: (206) 553–0110; e-mail address: 42). Region 10 office contains a detailed [email protected]. By letter dated November 15, 2005, as analysis and rationale in support of the SUPPLEMENTARY INFORMATION: corrected on November 21, 2005, the plan. Throughout this document, wherever Oregon Department of Environmental Quality (ODEQ) provided specific IV. Statutory and Executive Order ‘‘awe,’’ ‘‘aus,’’ or ‘‘aour’’ is used, we Reviews mean the EPA. Information is organized information in response to the as follows: comment. As part of the Portland carbon Under Executive Order 12866 (58 FR monoxide maintenance plan, 51735, October 4, 1993), this action is I. What Is the Background of This agricultural activity was inventoried per Rulemaking? not a ‘‘significant regulatory action’’ and II. What Comments Did We Receive on the EPA guidance. The types of agricultural therefore is not subject to review by the Proposed Action? activity inventoried by ODEQ were Office of Management and Budget. For III. What Is Our Final Action? orchard pruning burning (11 tons/year), this reason, this action is also not IV. Statutory and Executive Order Reviews agriculture field burning (61 tons/year) subject to Executive Order 13211, and non-road agriculture equipment I. What Is the Background of This ‘‘Actions Concerning Regulations That (298.9 tons/year) for a total of 370.8 Rulemaking? Significantly Affect Energy Supply, tons/year. The 370.8 tons of CO that Distribution, or Use’’ (66 FR 28355, May On September 6, 2005, EPA published ODEQ calculates are generated by 22, 2001). This action merely approves in the Federal Register, a detailed agriculture in the Portland area state law as meeting Federal description of our proposed action to represents .07% of the region’s total. requirements and imposes no additional approve the Portland, Oregon, CO ODEQ informed EPA that there are no requirements beyond those imposed by Second 10-year maintenance plan. See Concentrated Animal Feeding state law. Accordingly, the 70 FR 52956. Operations (CAFOs) within the Administrator certifies that this rule The air quality data shows that the boundary of the Portland CO will not have a significant economic Portland CO maintenance area has not Maintenance Area. impact on a substantial number of small recorded a violation of the primary or CO is not a pollutant where transport entities under the Regulatory Flexibility secondary CO air quality standards is a concern and there is no information Act (5 U.S.C. 601 et seq.). Because this since 1989. EPA believes the area will to suggest that CO emissions from rule approves pre-existing requirements continue to meet the National Ambient CAFOs outside of the Portland CO under state law and does not impose Air Quality Standards (NAAQS or Maintenance Area impact CO levels any additional enforceable duty beyond standards) until at least 2017 as required within the maintenance area. For these that required by state law, it does not by the Clean Air Act. reasons, EPA finds the State of Oregon’s contain any unfunded mandate or second 10-year CO maintenance plan for II. What Comments Did We Receive on significantly or uniquely affect small the Portland CO Maintenance Area the Proposed Action? governments, as described in the adequately accounts for emissions from Unfunded Mandates Reform Act of 1995 EPA provided a 30-day review and agricultural sources. comment period to solicit comments on Comment: The commenter states (Public Law 104–4). our proposal published in the ODEQ cannot properly implement the This rule also does not have tribal September 6, 2005 Federal Register. We maintenance plan as a result of budget implications because it will not have a received one comment letter on the cuts. Specifically, the commenter is substantial direct effect on one or more proposed rulemaking. This comment concerned because the ODEQ air Indian tribes, on the relationship letter was from Pacific Environmental program is expected to lose nearly 20 between the Federal Government and Advocacy Center on behalf of the staff members and 4 of the 5 air quality Indian tribes, or on the distribution of Northwest Environmental Defense monitors that were installed in the power and responsibilities between the Center. In general, the letter opposed the Portland area several years ago are being Federal Government and Indian tribes, proposed SIP revision. The comments decommissioned. as specified by Executive Order 13175 and our responses are summarized as Response: ODEQ has informed EPA (65 FR 67249, November 9, 2000). This follows: that the four air quality monitors which action also does not have federalism Comment: The commenter states that are to be decommissioned by ODEQ due implications because it does not have EPA cannot approve Oregon’s proposed to budget cuts are part of a temporary substantial direct effects on the States, CO Maintenance Plan because it does effort to investigate toxic air pollutants on the relationship between the not account for agricultural sources’ in the Portland airshed. The monitors to National Government and the States, or contributions to CO in the Portland area. be removed do not measure CO and are on the distribution of power and Response: The Portland Area Carbon not required by EPA for monitoring of responsibilities among the various Monoxide Maintenance Plan Emission CO. As stated in the maintenance plan levels of government, as specified in Inventory and Forecast was prepared submitted by ODEQ, three CO monitors Executive Order 13132 (64 FR 43255, using current and applicable EPA operating in the Portland CO August 10, 1999). This action merely procedure and guidance documents and maintenance area will continue to approves a state rule implementing a computer software programs. The operate throughout the second 10-year Federal standard, and does not alter the primary procedure and guidance period. For these reasons, EPA believes relationship or the distribution of power documents are Procedures for the that ODEQ will continue to fulfill the and responsibilities established in the Preparation of Emission Inventories for monitoring commitments set forth in the Clean Air Act. This rule also is not Carbon Monoxide and Precursors of Maintenance Plan. subject to Executive Order 13045 Ozone, Volume I, and Emission ‘‘Protection of Children from Inventory Requirements for Carbon III. What Is Our Final Action? Environmental Health Risks and Safety Monoxide State Implementation Plans. EPA is taking final action to approve Risks’’ (62 FR 19885, April 23, 1997), Emission factors were taken from the the Portland, Oregon CO Second 10- because it is not economically supplemental Short List of AMS SCCS Year Maintenance Plan consistent with significant.
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In reviewing SIP submissions, EPA’s Dated: December 8, 2005. SUMMARY: EPA is taking direct final role is to approve state choices, L. Michael Bogert, action approving State Implementation provided that they meet the criteria of Regional Administrator, EPA Region 10. Plan (SIP) revisions submitted by the the Clean Air Act. In this context, in the I Part 52, chapter I, title 40 of the Code State of Montana on August 25, 2004. absence of a prior existing requirement of Federal Regulations is amended as The revisions are to the Administrative for the State to use voluntary consensus follows: Rules of Montana and correct internal standards (VCS), EPA has no authority references to state documents; correct to disapprove a SIP submission for PART 52—[AMENDED] references to, or update citations of, failure to use VCS. It would thus be Federal documents; and make minor I 1. The authority citation for part 52 editorial changes. The intended effect of inconsistent with applicable law for continues to read as follows: EPA, when it reviews a SIP submission, this action is to make federally to use VCS in place of a SIP submission Authority: 42 U.S.C. 7401 et seq. enforceable those provisions that EPA is approving. This action is being taken that otherwise satisfies the provisions of Subpart MM—Oregon under section 110 of the Clean Air Act. the Clean Air Act. Thus, the DATES: This rule is effective on March requirements of section 12(d) of the I 2. Section 52.1970 is amended by 27, 2006 without further notice, unless National Technology Transfer and adding paragraph (c)(145) to read as EPA receives adverse comment by Advancement Act of 1995 (15 U.S.C. follows: February 23, 2006. If adverse comment 272 note) do not apply. This rule does § 52.1970 Identification of plan. is received, EPA will publish a timely not impose an information collection withdrawal of the direct final rule in the burden under the provisions of the * * * * * (c) * * * Federal Register informing the public Paperwork Reduction Act of 1995 (44 that the rule will not take effect. U.S.C. 3501 et seq.). (145) On December 27, 2004, the Oregon Department of Environmental ADDRESSES: Submit your comments, The Congressional Review Act, 5 Quality submitted to the Regional identified by Docket ID No. EPA–R08– U.S.C. 801 et seq., as added by the Small Administrator of EPA, the Second OAR–2005–MT–0001, by one of the Business Regulatory Enforcement Portland Area Carbon Monoxide following methods: Fairness Act of 1996, generally provides Maintenance Plan that demonstrates • http://www.regulations.gov. Follow that before a rule may take effect, the continued attainment of the NAAQS for the on-line instructions for submitting agency promulgating the rule must carbon monoxide through the year 2017. comments. submit a rule report, which includes a (i) Incorporation by reference. • E-mail: [email protected] and copy of the rule, to each House of the (A) Oregon Administrative Rules, [email protected]. • Congress and to the Comptroller General Chapter 340: 200–0040, 204–0090 and Fax: (303) 312–6064 (please alert of the United States. EPA will submit a 242–0440, as effective December 15, the individual listed in the FOR FURTHER report containing this rule and other 2004. INFORMATION CONTACT if you are faxing required information to the U.S. Senate, I 3. Paragraph (a) of § 52.1973 is revised comments). • Mail: Richard R. Long, Director, Air the U.S. House of Representatives, and to read as follows: the Comptroller General of the United and Radiation Program, Environmental § 52.1973 Approval of plans. Protection Agency (EPA), Region 8, States prior to publication of the rule in Mailcode 8P–AR, 999 18th Street, Suite the Federal Register. A major rule (a) Carbon monoxide. (1) EPA approves as a revision to the 200, Denver, Colorado 80202–2466. cannot take effect until 60 days after it • Hand Delivery: Richard R. Long, is published in the Federal Register. Oregon State Implementation Plan, the Second Portland Area Carbon Monoxide Director, Air and Radiation Program, This action is not a ‘‘major rule’’ as Environmental Protection Agency defined by 5 U.S.C. 804(2). Maintenance Plan, effective December 15, 2004, and submitted to EPA on (EPA), Region 8, Mailcode 8P–AR, 999 Under section 307(b)(1) of the Clean December 27, 2004. 18th Street, Suite 300, Denver, Colorado Air Act, petitions for judicial review of (2) [Reserved] 80202–2466. Such deliveries are only accepted Monday through Friday, 8 a.m. this action must be filed in the United * * * * * States Court of Appeals for the to 4:55 p.m., excluding Federal [FR Doc. 06–636 Filed 1–23–06; 8:45 am] appropriate circuit by March 27, 2006. holidays. Special arrangements should BILLING CODE 6560–50–P Filing a petition for reconsideration by be made for deliveries of boxed the Administrator of this final rule does information. Instructions: Direct your comments to not affect the finality of this rule for the ENVIRONMENTAL PROTECTION Docket ID No. EPA–R08–OAR–2005– purposes of judicial review nor does it AGENCY extend the time within which a petition MT–0001. EPA’s policy is that all for judicial review may be filed, and 40 CFR Part 52 comments received will be included in the public docket without change and shall not postpone the effectiveness of [EPA–R08–OAR–2005–MT–0001, FRL–8012– may be made available online at such rule or action. This action may not 5] http://www.regulations.gov including be challenged later in proceedings to any personal information provided, enforce its requirements. (See section Approval and Promulgation of Air unless the comment includes 307(b)(2).) Quality Implementation Plans; information claimed to be Confidential Montana; Revisions to the List of Subjects in 40 CFR Part 52 Business Information (CBI) or other Administrative Rules of Montana; information whose disclosure is Environmental protection, Air Direct Final Rule restricted by statute. Do not submit pollution control, Carbon monoxide, AGENCY: Environmental Protection information that you consider to be CBI Incorporation by reference, Agency (EPA). or otherwise protected through http:// Intergovernmental relations, Reporting www.regulations.gov or e-mail. The ACTION: Direct final rule. and recordkeeping requirements. http://www.regulations.gov Web site is
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an ‘‘anonymous access’’ system, which III. EPA’s Review of the State of Montana’s g. Explain your views as clearly as means EPA will not know your identity August 25, 2004 Submittal possible, avoiding the use of profanity or contact information unless you IV. Final Action or personal threats. provide it in the body of your comment. V. Statutory and Executive Order Reviews h. Make sure to submit your If you send an e-mail comment directly Definitions comments by the comment period to EPA, without going through http:// For the purpose of this document, we deadline identified. www.regulations.gov, your e-mail are giving meaning to certain words or II. Background address will be automatically captured initials as follows: On August 25, 2004, the Governor and included as part of the comment (i) The words or initials Act or CAA submitted a SIP revision that contains that is placed in the public docket and mean or refer to the Clean Air Act, amendments to the following sections of made available on the Internet. If you unless the context indicates otherwise. submit an electronic comment, EPA (ii) The words EPA, we, us or our the Administrative Rules of Montana recommends that you include your mean or refer to the United States (ARM) 17.8.102, 17.8.103, 17.8.106, name and other contact information in Environmental Protection Agency. 17.8.130, 17.8.316, 17.8.320, 17.8.401, the body of your comment and with any (iii) The initials SIP mean or refer to 17.8.801, 17.8.819 and 17.8.822. The disk or CD–ROM you submit. If EPA State Implementation Plan. amendments correct internal references cannot read your comment due to (iv) The words State or Montana to state documents; correct references technical difficulties and cannot contact mean the State of Montana, unless the to, or update citations of, federal you for clarification, EPA may not be context indicates otherwise. documents; and make minor editorial able to consider your comment. changes. The Board of Environmental Electronic files should avoid the use of I. General Information Review adopted the amendments on special characters, any form of A. What Should I Consider as I Prepare March 26, 2004. encryption, and be free of any defects or My Comments for EPA? On December 22, 2004, the Governor viruses. For additional information of Montana rescinded the submission of about EPA’s public docket visit the EPA 1. Submitting CBI. Do not submit this the changes to ARM 17.8.102. Docket Center homepage at http:// information to EPA through http:// www.regulations.gov or e-mail. Clearly III. EPA’s Review of the State of www.epa.gov/epahome/dockets.htm. Montana’s August 25, 2004 Submittal For additional instructions on mark the part or all of the information submitting comments, go to Section I. that you claim to be CBI. For CBI A. Changes to Sub-Chapter 1—General General Information of the information in a disk or CD ROM that Provisions you mail to EPA, mark the outside of the SUPPLEMENTARY INFORMATION section of disk or CD ROM as CBI and then 1. Review of changes to ARM this document. identify electronically within the disk or 17.8.102—Incorporation by Reference— Docket: All documents in the docket CD ROM the specific information that is EPA is not acting on these changes since are listed in the http:// claimed as CBI. In addition to one the Governor rescinded them. www.regulations.gov index. Although complete version of the comment that 2. Review of changes to ARM listed in the index, some information is includes information claimed as CBI, a 17.8.103—Incorporation by Reference not publicly available, e.g., CBI or other copy of the comment that does not and Availability of Referenced information whose disclosure is contain the information claimed as CBI Documents. The state is correcting a restricted by statute. Certain other must be submitted for inclusion in the reference to the Montana Source Test material, such as copyrighted material, public docket. Information so marked Protocol and Procedures Manual (July will be publicly available only in hard will not be disclosed except in 1994 ed.). We are not acting on these copy. Publicly available docket accordance with procedures set forth in changes at this time. materials are available either 40 CFR part 2. 3. Review of changes to ARM electronically in http:// 2. Tips for Preparing Your Comments. 17.8.106—Source Testing Protocol. The www.regulations.gov or in hard copy at When submitting comments, remember state is correcting a reference to the the Air and Radiation Program, to: Montana Source Test Protocol and Environmental Protection Agency a. Identify the rulemaking by docket Procedures Manual (July 1994 ed.). We (EPA), Region 8, 999 18th Street, Suite number and other identifying are not acting on these changes at this 300, Denver, Colorado 80202–2466. EPA information (subject heading, Federal time. requests that if at all possible, you Register date and page number). 4. Review of changes to ARM contact the individual listed in the FOR b. Follow directions—The agency may 17.8.130—Enforcement Procedures— FURTHER INFORMATION CONTACT section to ask you to respond to specific questions Notice of Violation Order to Take view the hard copy of the docket. You or organize comments by referencing a Corrective Action. The state is updating may view the hard copy of the docket Code of Federal Regulations (CFR) part language and making minor editorial Monday through Friday, 8 a.m. to 4 or section number. changes necessary to conform to the p.m., excluding Federal holidays. c. Explain why you agree or disagree; Montana Code Annotated. We are FOR FURTHER INFORMATION CONTACT: suggest alternatives and substitute approving all of ARM 17.8.130 as in Laurie Ostrand, Air and Radiation language for your requested changes. effect on April 9, 2004. d. Describe any assumptions and Program, Mailcode 8P–AR, B. Changes to Sub-Chapter 3—Emission provide any technical information and/ Environmental Protection Agency Standards (EPA), Region 8, 999 18th Street, Suite or data that you used. 200, Denver, Colorado 80202–2466, e. If you estimate potential costs or 1. Review of changes to ARM (303) 312–6437, [email protected]. burdens, explain how you arrived at 17.8.316—Incinerators. We are not your estimate in sufficient detail to acting on the changes to ARM 17.8.316 SUPPLEMENTARY INFORMATION: allow for it to be reproduced. because of other pending changes to this Table of Contents f. Provide specific examples to section that we have not acted on yet. I. General Information illustrate your concerns, and suggest We will address both changes in a II. Background alternatives. separate action.
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2. Review of changes to ARM Montana. Therefore, section 110(l) substantial direct effect on one or more 17.8.320(9)—Wood-Waste Burners. The requirements are satisfied. Indian tribes, on the relationship state is correcting internal citations to EPA is publishing this rule without between the Federal Government and other state regulations. We are prior proposal because the Agency Indian tribes, or on the distribution of approving ARM 17.8.320(9) as in effect views this as a noncontroversial power and responsibilities between the on April 9, 2004. amendment and anticipates no adverse Federal Government and Indian tribes, comments; we are merely approving as specified by Executive Order 13175 C. Changes to Sub-Chapter 4—Stack administrative changes to Montana’s air (65 FR 67249, November 9, 2000). This Heights and Dispersion Techniques rules. However, in the ‘‘Proposed Rules’’ action also does not have Federalism 1. Review of changes to ARM section of today’s Federal Register implications because it does not have 17.8.401—Definitions. The state is publication, EPA is publishing a substantial direct effects on the States, making minor clerical changes. We are separate document that will serve as the on the relationship between the national not acting on these changes at this time proposal to approve the SIP revision if government and the States, or on the for the same reasons stated on our adverse comments are filed. This rule distribution of power and August 13, 2001 action (66 FR 42427 at will be effective March 27, 2006 without responsibilities among the various 42434). further notice unless the Agency levels of government, as specified in receives adverse comments by February Executive Order 13132 (64 FR 43255, D. Changes to Sub-Chapter 8— 23, 2006. If the EPA receives adverse August 10, 1999). This action merely Prevention of Significant Deterioration comments, EPA will publish a timely approves a state rule implementing a of Air Quality withdrawal in the Federal Register Federal standard, and does not alter the 1. Review of changes to ARM informing the public that the rule will relationship or the distribution of power 17.8.801—Definitions. The state is not take effect. EPA will address all and responsibilities established in the making minor clerical changes to how public comments in a subsequent final Clean Air Act. This rule also is not federal documents are cited in the rule based on the proposed rule. The subject to Executive Order 13045 definitions. We are approving the EPA will not institute a second ‘‘Protection of Children from revisions to ARM 17.8.801(22) as in comment period on this action. Any Environmental Health Risks and Safety effect on April 9, 2004. parties interested in commenting must Risks’’ (62 FR 19885, April 23, 1997), 2. Review of changes to ARM do so at this time. Please note that if because it is not economically 17.8.819—Control Technology Review. EPA receives adverse comment on an significant. The state is making minor clerical amendment, paragraph, or section of In reviewing SIP submissions, EPA’s changes to how federal documents are this rule and if that provision may be role is to approve state choices, cited. We are approving all of ARM severed from the remainder of the rule, provided that they meet the criteria of 17.8.819 as in effect on April 9, 2004. EPA may adopt as final those provisions the Clean Air Act. In this context, in the 3. Review of changes to ARM of the rule that are not the subject of an absence of a prior existing requirement 17.8.822—Air Quality Analysis. The adverse comment. for the State to use voluntary consensus state is correcting internal citations to standards (VCS), EPA has no authority V. Statutory and Executive Order other state regulations and making other to disapprove a SIP submission for Reviews minor clerical changes. We are failure to use VCS. It would thus be approving all of ARM 17.8.822 as in Under Executive Order 12866 (58 FR inconsistent with applicable law for effect on April 9, 2004. 51735, October 4, 1993), this action is EPA, when it reviews a SIP submission, not a ‘‘significant regulatory action’’ and to use VCS in place of a SIP submission IV. Final Action therefore is not subject to review by the that otherwise satisfies the provisions of EPA is approving the following Office of Management and Budget. For the Clean Air Act. Thus, the changes to the ARM that were submitted this reason, this action is also not requirements of section 12(d) of the on August 25, 2004 and effective on subject to Executive Order 13211, National Technology Transfer and April 9, 2004: ARM 17.8.130; ‘‘Actions Concerning Regulations That Advancement Act of 1995 (15 U.S.C. 17.8.320(9); 17.8.801(22); 17.8.819; and Significantly Affect Energy Supply, 272 note) do not apply. This rule does 17.8.822. Distribution, or Use’’ (66 FR 28355, May not impose an information collection EPA is not acting on the following 22, 2001). This action merely approves burden under the provisions of the changes to the ARM that were submitted state law as meeting Federal Paperwork Reduction Act of 1995 (44 on August 25, 2004 and effective on requirements and imposes no additional U.S.C. 3501 et seq.). April 9, 2004: ARM 17.8.103, 17.8.106, requirements beyond those imposed by The Congressional Review Act, 5 17.8.316 and 17.8.401. These revisions state law. Accordingly, the U.S.C. 801 et seq., as added by the Small will be addressed in separate actions. Administrator certifies that this rule Business Regulatory Enforcement Section 110(l) of the Clean Air Act will not have a significant economic Fairness Act of 1996, generally provides states that a SIP revision cannot be impact on a substantial number of small that before a rule may take effect, the approved if the revision would interfere entities under the Regulatory Flexibility agency promulgating the rule must with any applicable requirement Act (5 U.S.C. 601 et seq.). Because this submit a rule report, which includes a concerning attainment and reasonable rule approves pre-existing requirements copy of the rule, to each House of the further progress towards attainment of under state law and does not impose Congress and to the Comptroller General the NAAQS or any other applicable any additional enforceable duty beyond of the United States. EPA will submit a requirements of the Act. The Montana that required by state law, it does not report containing this rule and other SIP revisions that are the subject of this contain any unfunded mandate or required information to the U.S. Senate, document do not interfere with the significantly or uniquely affect small the U.S. House of Representatives, and maintenance of the NAAQS or any other governments, as described in the the Comptroller General of the United applicable requirement of the Act. The Unfunded Mandates Reform Act of 1995 States prior to publication of the rule in August 25, 2004 submittal merely makes (Pub. L. 104–4). the Federal Register. A major rule administrative amendments to the This rule also does not have tribal cannot take effect until 60 days after it State’s Administrative Rules of implications because it will not have a is published in the Federal Register.
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This action is not a ‘‘major rule’’ as ENVIRONMENTAL PROTECTION Mailcode 8P–AR, 999 18th Street, Suite defined by 5 U.S.C. 804(2). AGENCY 200, Denver, Colorado 80202–2466. • Under section 307(b)(1) of the Clean Hand Delivery: Richard R. Long, 40 CFR Part 52 Air Act, petitions for judicial review of Director, Air and Radiation Program, Environmental Protection Agency this action must be filed in the United [EPA–R08–OAR–2005–CO–0002; FRL– (EPA), Region 8, Mailcode 8P–AR, 999 States Court of Appeals for the 8010–2] 18th Street, Suite 200, Denver, Colorado appropriate circuit by March 27, 2006. 80202–2466. Such deliveries are only Filing a petition for reconsideration by Clean Air Act Approval and Promulgation of Air Quality accepted Monday through Friday, 8 a.m. the Administrator of this final rule does to 4:55 p.m., excluding Federal not affect the finality of this rule for the Implementation Plan Revision for Colorado; Long-Term Strategy of State holidays. Special arrangements should purposes of judicial review nor does it be made for deliveries of boxed extend the time within which a petition Implementation Plan for Class I Visibility Protection information. for judicial review may be filed, and Instructions: Direct your comments to shall not postpone the effectiveness of AGENCY: Environmental Protection Docket ID No. R08–OAR–2005–CO– such rule or action. This action may not Agency (EPA). 0002. EPA’s policy is that all comments be challenged later in proceedings to ACTION: Direct final rule. received will be included in the public enforce its requirements. (See section docket without change and may be 307(b)(2).) SUMMARY: EPA is taking direct final made available at http://docket.epa.gov/ List of Subjects in 40 CFR Part 52 action approving a State rmepub/index.jsp, including any Implementation Plan (SIP) revision personal information provided, unless Environmental protection, Air submitted by the Governor of Colorado the comment includes information pollution control, Carbon monoxide, with a letter dated March 24, 2005. This claimed to be Confidential Business Incorporation by reference, revision updates the Long-Term Strategy Information (CBI) or other information Intergovernmental relations, Lead, of the Visibility SIP to establish whose disclosure is restricted by statute. Nitrogen dioxide, Ozone, Particulate strategies, activities, and monitoring Do not submit information that you matter, Reporting and recordkeeping plans that constitute reasonable progress consider to be CBI or otherwise requirements, Sulfur oxides, Volatile toward the National visibility goal. This protected through EDOCKET, organic compounds. action is being taken under section 110 regulations.gov, or e-mail. The EPA’s of the Clean Air Act. Regional Materials in EDOCKET and Dated: December 7, 2005. Federal regulations.gov Web site are DATES: This rule is effective on March Kerrigan G. Clough, ‘‘anonymous access’’ systems, which 27, 2006 without further notice, unless means EPA will not know your identity Acting Regional Administrator, Region 8. EPA receives adverse comment by or contact information unless you I February 23, 2006. If adverse comment 40 CFR part 52 is amended to read as provide it in the body of your comment. is received, EPA will publish a timely follows: If you send an e-mail comment directly withdrawal of the direct final rule in the to EPA, without going through PART 52—[AMENDED] Federal Register informing the public EDOCKET or regulations.gov, your e- that the rule will not take effect. mail address will be automatically I 1. The authority citation for part 52 ADDRESSES: Submit your comments, captured and included as part of the continues to read as follows: identified by Docket ID No. R08–OAR– comment that is placed in the public Authority: 42 U.S.C. 7401 et seq. 2005–CO–0002, by one of the following docket and made available on the methods: Internet. If you submit an electronic • Subpart BB—Montana Federal eRulemaking Portal: http:// comment, EPA recommends that you www.regulations.gov. Follow the on-line include your name and other contact I 2. Section 52.1370 is amended by instructions for submitting comments. information in the body of your adding paragraph (c)(62) to read as • Agency Web site: http:// comment and with any disk or CD–ROM follows: docket.epa.gov/rmepub/. On November you submit. If EPA cannot read your 28, 2005, Regional Material in comment due to technical difficulties § 52.1370 Identification of plan. EDOCKET (RME), EPA’s electronic and cannot contact you for clarification, * * * * * public docket and comment system, was EPA may not be able to consider your replaced by an enhanced Federal-wide (c) * * * comment. Electronic files should avoid electronic docket management and the use of special characters, any form (62) Revisions to State comment system located at http:// of encryption, and be free of any defects Implementation Plan were submitted by www.regulations.gov. Therefore, you or viruses. For additional information the State of Montana on August 25, will be redirected to that site to access about EPA’s public docket visit 2004. The revisions correct internal the docket EPA–R08–OAR–2005–CO– EDOCKET online or see the Federal references to state documents; correct 0002 and submit comments. Follow the Register of May 31, 2002 (67 FR 38102). references to, or update citations of, on-line instructions for submitting For additional instructions on Federal documents; and make minor comments. submitting comments, go to section I. editorial changes. • E-mail: [email protected] and General Information of the (i) Incorporation by reference. [email protected]. SUPPLEMENTARY INFORMATION section of • (A) Administrative Rules of Montana Fax: (303) 312–6064 (please alert this document. FOR FURTHER (ARM) sections: ARM 17.8.130; the individual listed in the Docket: All documents in the docket 17.8.320(9); 17.8.801(22); 17.8.819; and INFORMATION CONTACT if you are faxing are listed in the Regional Materials in 17.8.822, effective April 9, 2004. comments). EDOCKET index at http:// • Mail: Richard R. Long, Director, Air docket.epa.gov/rmepub/index.jsp. [FR Doc. 06–633 Filed 1–23–06; 8:45 am] and Radiation Program, Environmental Although listed in the index, some BILLING CODE 6560–50–P Protection Agency (EPA), Region 8, information is not publicly available,
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i.e., CBI or other information whose claimed as CBI, a copy of the comment reasonable progress toward meeting the disclosure is restricted by statute. that does not contain the information National goal (see CAA section Certain other material, such as claimed as CBI must be submitted for 169A(b)(2)). Section 110(a)(2)(J) of the copyrighted material, is not placed on inclusion in the public docket. CAA, 42 U.S.C. 7410(a)(2)(J), similarly the Internet and will be publicly Information so marked will not be requires SIPs to meet the visibility available only in hard copy form. disclosed except in accordance with protection requirements of the CAA. Publicly available docket materials are procedures set forth in 40 CFR part 2. We promulgated regulations that available either electronically in 2. Tips for Preparing Your Comments. required affected States to, among other Regional Materials in EDOCKET or in When submitting comments, remember things, (1) coordinate development of hard copy at the Air and Radiation to: SIPs with appropriate FLMs; (2) develop Program, Environmental Protection i. Identify the rulemaking by docket a program to assess and remedy Agency (EPA), Region 8, 999 18th number and other identifying visibility impairment from new and Street, Suite 200, Denver, Colorado information (subject heading, Federal existing sources; and (3) develop a long- 80202–2466. EPA requests that if at all Register date and page number). term (10–15 years) strategy to assure possible, you contact the individual ii. Follow directions—The agency reasonable progress toward the National listed in the FOR FURTHER INFORMATION may ask you to respond to specific visibility goal. See 45 FR 80084, CONTACT section to view the hard copy questions or organize comments by December 2, 1980 (codified at 40 CFR of the docket. You may view the hard referencing a Code of Federal 51.300–51.307). The regulations provide copy of the docket Monday through Regulations (CFR) part or section for the remedying of visibility Friday, 8 a.m. to 4 p.m., excluding number. impairment that is reasonably Federal holidays. iii. Explain why you agree or disagree; attributable to a single existing FOR FURTHER INFORMATION CONTACT: suggest alternatives and substitute stationary facility or small group of Amy Platt, Environmental Protection language for your requested changes. existing stationary facilities. These Agency, Region 8, (303) 312–6449, iv. Describe any assumptions and regulations require that the SIPs provide [email protected]. provide any technical information and/ for periodic review, and revision as or data that you used. appropriate, of the Long-Term Strategy SUPPLEMENTARY INFORMATION: v. If you estimate potential costs or not less frequently than every three Table of Contents burdens, explain how you arrived at years, that the review process include I. General Information your estimate in sufficient detail to consultation with the appropriate FLMs, II. Background allow for it to be reproduced. and that the State provide a report to the III. March 24, 2005 Submittal vi. Provide specific examples to public and EPA that includes an IV. Section 110(l) illustrate your concerns, and suggest assessment of the State’s progress V. Final Action alternatives. toward the National visibility goal. See VI. Statutory and Executive Order Reviews vii. Explain your views as clearly as 40 CFR 51.306(c). Definitions possible, avoiding the use of profanity On July 12, 1985 (50 FR 28544) and or personal threats. November 24, 1987 (52 FR 45132), we For the purpose of this document, we viii. Make sure to submit your disapproved the SIPs of states, are giving meaning to certain words or comments by the comment period including Colorado, that failed to initials as follows: deadline identified. comply with the requirements of the (i) The word Act or initials CAA mean provisions of 40 CFR 51.302 (visibility II. Background the Clean Air Act, unless the context general plan requirements), 51.305 indicates otherwise. Section 169A of the Clean Air Act (visibility monitoring), and 51.306 (ii) The word we or initials EPA mean (CAA),1 42 U.S.C. 7491, establishes as a (visibility long-term strategy). We also the United States Environmental National goal the prevention of any incorporated corresponding Federal Protection Agency. future, and the remedying of any plans and regulations into the SIPs of (iii) The initials SIP mean State existing, anthropogenic visibility these states pursuant to section 110(c)(1) Implementation Plan. impairment in mandatory Class I of the CAA, 42 U.S.C. 7410(c)(1). (iv) The word State or initials CO Federal areas 2 (referred to herein as the The Governor of Colorado submitted mean the State of Colorado, unless the ‘‘National goal’’ or ‘‘National visibility a SIP revision for visibility protection context indicates otherwise. goal’’). Section 169A called for EPA to, on December 21, 1987, which met the (v) The initials FLM mean Federal among other things, issue regulations to criteria of 40 CFR 51.302, 51.305, and Land Manager. assure reasonable progress toward 51.306 for general plan requirements, I. General Information meeting the National visibility goal, monitoring strategy, and long-term including requiring each State with a strategies. We approved this SIP A. What Should I Consider as I Prepare mandatory Class I Federal area to revise revision in the August 12, 1988 Federal My Comments for EPA? its SIP to contain such emission limits, Register (53 FR 30428), and this 1. Submitting CBI. Do not submit this schedules of compliance and other revision replaced the Federal plans and information to EPA through Regional measures as may be necessary to make regulations in the Colorado Visibility Materials in EDOCKET, regulations.gov SIP. The Governor of Colorado or e-mail. Clearly mark the part or all of 1 The Clean Air Act is codified, as amended, in submitted a subsequent SIP revision for the information that you claim to be the U.S. Code at 42 U.S.C. 7401, et seq. visibility protection with a letter dated CBI. For CBI information in a disk or CD 2 Mandatory class I Federal areas include November 18, 1992, which we approved international parks, national wilderness areas, and ROM that you mail to EPA, mark the national memorial parks greater than five thousand on October 11, 1994 (59 FR 51376). outside of the disk or CD ROM as CBI acres in size, and national parks greater than six After Colorado’s 1992 Long-Term and then identify electronically within thousand acres in size, as described in section Strategy review, the U.S. Forest Service the disk or CD ROM the specific 162(a) of the Act (42 U.S.C. 7472(a)). Each (USFS) certified visibility impairment at mandatory Class I Federal area is the responsibility information that is claimed as CBI. In of a ‘‘Federal land manager’’ (FLM), the Secretary Mt. Zirkel Wilderness Area (MZWA) addition to one complete version of the of the department with authority over such lands. and named the Hayden and Craig comment that includes information See section 302(i) of the Act, 42 U.S.C. 7602(i). generating stations in the Yampa Valley
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of Northwest Colorado as suspected incorporates by reference requirements VI. Final Action sources. The USFS is the FLM for for the Hayden and Craig Generating We have reviewed the adequacy of the MZWA. This certification was issued on Stations, including emissions limits and State’s revision to the Long-Term July 14, 1993. Emissions from the schedules of compliance, as previously Strategy of Colorado’s SIP for Class I Hayden Station were addressed in the approved by EPA on January 16, 1997 Visibility Protection, contained in Part II State’s August 23, 1996 Long-Term (see 62 FR 2305) and July 5, 2001 (see of the November 18, 2004 document Strategy review and revision (see 62 FR 66 FR 35374). Part II also contains entitled ‘‘Long-Term Strategy Review 2305, January 16, 1997). Emissions from provisions that are explanatory and and Revision of Colorado’s State the Craig Generating Station were analyses that are required by section Implementation Plan for Class I addressed in the State’s April 19, 2001 169A of the CAA, Federal visibility Visibility Protection,’’ as submitted by Long-Term Strategy review and revision regulations (40 CFR 51.300 to 51.307), the Governor with a letter dated March (see 66 FR 35374, July 5, 2001). and/or the Colorado Visibility SIP. 24, 2005. We are approving the revision The State conducted its next complete periodic review and revision of the These requirements address existing as demonstrating reasonable further long-term strategy in 2002. With an impairment, ongoing air pollution progress toward the National visibility April 12, 2004, letter, the Governor of programs, smoke management practices, goal as required by 40 CFR 51.306. Colorado submitted that revision to the prevention of future impairment, and EPA is publishing this rule without Long-Term Strategy of Colorado’s SIP FLM consultation and communication. prior proposal because the Agency for Class I Visibility Protection, which These revisions are consistent with views this as a noncontroversial we approved on August 1, 2005 (70 FR Federal requirements and demonstrate amendment and anticipates no adverse 44052). reasonable further progress toward the comments. However, in the ‘‘Proposed National visibility goal as required by 40 Rules’’ section of today’s Federal III. March 24, 2005 Submittal CFR 51.306. Therefore, they are Register publication, EPA is publishing With a March 24, 2005 letter, the approvable. a separate document that will serve as Governor of Colorado submitted a the proposal to approve the SIP revision In addition, Appendix B of Part II of revision to the Long-Term Strategy of if adverse comments are filed. This rule the November 18, 2004 document Colorado’s SIP for Class I Visibility will be effective March 27, 2006 without entitled ‘‘Long-Term Strategy Review Protection, contained in Part II of the further notice unless the Agency November 18, 2004 document entitled and Revision of Colorado’s State receives adverse comments by February ‘‘Long-Term Strategy Review and Implementation Plan for Class I 23, 2006. If the EPA receives adverse Revision of Colorado’s State Visibility Protection,’’ contains an comments, EPA will publish a timely Implementation Plan for Class I update of section XIV, Visibility, of Part withdrawal in the Federal Register Visibility Protection.’’ This revision was D of the Colorado Air Quality Control informing the public that the rule will made to fulfill the requirements to Commission Regulation No. 3 not take effect. EPA will address all periodically review and, as appropriate, (Stationary Source Permitting and Air public comments in a subsequent final revise the Long-Term Strategy. Pollutant Emission Notice rule based on the proposed rule. The The CAA requires States to observe Requirements). Although this section EPA will not institute a second certain procedural requirements in has not changed substantively since it comment period on this action. Any developing implementation plans and was last incorporated into the Visibility parties interested in commenting must plan revisions for submission to EPA. SIP (see 53 FR 30431, August 12, 1988, do so at this time. Please note that if Section 110(a)(2) of the CAA provides and 59 FR 51379, October 11, 1994), it EPA receives adverse comment on an that each implementation plan has been recodified. Therefore, for amendment, paragraph, or section of submitted by a State must be adopted clarification purposes, we are also this rule and if that provision may be after reasonable notice and public approving this recodified version of the severed from the remainder of the rule, hearing. Section 110(l) of the CAA State’s visibility regulations in order to EPA may adopt as final those provisions similarly provides that each revision to update the version incorporated into the of the rule that are not the subject of an an implementation plan submitted by a Visibility SIP. adverse comment. State under the CAA must be adopted VII. Statutory and Executive Order by such State after reasonable notice V. Section 110(l) Reviews and public hearing. After providing adequate notice, the Section 110(l) of the Clean Air Act Under Executive Order 12866 (58 FR Colorado Air Quality Control states that a SIP revision cannot be 51735, October 4, 1993), this action is Commission (AQCC) held a public approved if the revision would interfere not a ‘‘significant regulatory action’’ and hearing on November 18, 2004 to with any applicable requirement therefore is not subject to review by the consider the proposed revision to the concerning attainment and reasonable Office of Management and Budget. For Long-Term Strategy of the Colorado further progress towards attainment of this reason, this action is also not Visibility SIP and adopted the revision. the National Ambient Air Quality subject to Executive Order 13211, We have reviewed the SIP revision and Standards (NAAQS) or any other ‘‘Actions Concerning Regulations That have determined that it adequately applicable requirements of the Act. The Significantly Affect Energy Supply, demonstrates that the State is making Colorado SIP revisions that are the Distribution, or Use’’ (66 FR 28355, May reasonable progress toward the National subject of this document are consistent 22, 2001). This action merely approves visibility goal. with Federal requirements and rules. state law as meeting Federal The SIP revision is contained in Part These revisions were made to requirements and imposes no additional II of the November 18, 2004 document demonstrate reasonable further progress requirements beyond those imposed by entitled ‘‘Long-Term Strategy Review toward the National visibility goal, as state law. Accordingly, the and Revision of Colorado’s State required by the Act. They do not Administrator certifies that this rule Implementation Plan for Class I interfere with the attainment or will not have a significant economic Visibility Protection.’’ Part II, ‘‘Revision maintenance of the NAAQS or other impact on a substantial number of small of the Long-Term Strategy,’’ applicable requirements of the Act. entities under the Regulatory Flexibility
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Act (5 U.S.C. 601 et seq.). Because this submit a rule report, which includes a (i) Incorporation by reference. rule approves pre-existing requirements copy of the rule, to each House of the (A) ‘‘Revision of the Long-Term under state law and does not impose Congress and to the Comptroller General Strategy’’, Part II of the November 18, any additional enforceable duty beyond of the United States. EPA will submit a 2004 document entitled ‘‘Long-Term that required by state law, it does not report containing this rule and other Strategy Review and Revision of contain any unfunded mandate or required information to the U.S. Senate, Colorado’s State Implementation Plan significantly or uniquely affect small the U.S. House of Representatives, and for Class I Visibility Protection,’’ governments, as described in the the Comptroller General of the United effective November 18, 2004. Unfunded Mandates Reform Act of 1995 States prior to publication of the rule in (B) Colorado Air Quality Control (Pub. L. 104–4). the Federal Register. A major rule Commission Regulation No. 3, This rule also does not have tribal cannot take effect until 60 days after it ‘‘Stationary Source Permitting and Air implications because it will not have a is published in the Federal Register. Pollutant Emission Notice substantial direct effect on one or more This action is not a ‘‘major rule’’ as Requirements’’, 5 CCR 1001–5, Part D, Indian tribes, on the relationship defined by 5 U.S.C. 804(2). Section XIV, Visibility, Subsections A between the Federal Government and Under section 307(b)(1) of the Clean through F, effective April 16, 2004. Indian tribes, or on the distribution of Air Act, petitions for judicial review of [FR Doc. 06–630 Filed 1–23–06; 8:45 am] power and responsibilities between the this action must be filed in the United Federal Government and Indian tribes, States Court of Appeals for the BILLING CODE 6560–50–P as specified by Executive Order 13175 appropriate circuit by March 27, 2006. (65 FR 67249, November 9, 2000). This Filing a petition for reconsideration by action also does not have federalism ENVIRONMENTAL PROTECTION the Administrator of this final rule does AGENCY implications because it does not have not affect the finality of this rule for the substantial direct effects on the States, purposes of judicial review nor does it 40 CFR Parts 52 and 60 on the relationship between the national extend the time within which a petition government and the States, or on the for judicial review may be filed, and [EPA–R08–OAR–2004–MT–0001, FRL–8012– 9] distribution of power and shall not postpone the effectiveness of responsibilities among the various such rule or action. This action may not Approval and Promulgation of Air levels of government, as specified in be challenged later in proceedings to Executive Order 13132 (64 FR 43255, Quality Implementation Plans; enforce its requirements. (See section Montana; Revisions to the August 10, 1999). This action merely 307(b)(2).) approves a state rule implementing a Administrative Rules of Montana; New Federal standard, and does not alter the List of Subjects in 40 CFR Part 52 Source Performance Standards for Montana; Final Rule relationship or the distribution of power Environmental protection, Air and responsibilities established in the pollution control, Carbon monoxide, AGENCY: Environmental Protection Clean Air Act. This rule also is not Incorporation by reference, Agency (EPA). subject to Executive Order 13045 Intergovernmental relations, Nitrogen ACTION: Final rule. ‘‘Protection of Children from dioxide, Ozone, Particulate matter, Environmental Health Risks and Safety Reporting and recordkeeping SUMMARY: EPA is approving State Risks’’ (62 FR 19885, April 23, 1997), requirements, Sulfur oxides. Implementation Plan (SIP) revisions because it is not economically Dated: December 7, 2005. submitted by the State of Montana on significant. August 20, 2003, except for revisions to In reviewing SIP submissions, EPA’s Kerrigan G. Clough, Acting Regional Administrator, Region 8. three rules that EPA will act on at a later role is to approve state choices, date. The revisions modify definitions I provided that they meet the criteria of 40 CFR part 52 is amended to read as and references to federal regulations and the Clean Air Act. In this context, in the follows: other materials in the Administrative absence of a prior existing requirement PART 52—[AMENDED] Rules of Montana. The intended effect for the State to use voluntary consensus of this action is to make federally standards (VCS), EPA has no authority I 1. The authority citation for part 52 enforceable those provisions that EPA is to disapprove a SIP submission for continues to read as follows: approving. This action is being taken failure to use VCS. It would thus be under section 110 of the Clean Air Act. inconsistent with applicable law for Authority: 42 U.S.C. 7401 et seq. EFFECTIVE DATE: This final rule is EPA, when it reviews a SIP submission, Subpart G—Colorado to use VCS in place of a SIP submission effective February 23, 2006. that otherwise satisfies the provisions of I 2. Section 52.320 is amended by ADDRESSES: EPA has established a the Clean Air Act. Thus, the adding paragraph (c)(108) to read as docket for this action under Docket ID requirements of section 12(d) of the follows: No. EPA–R08–OAR–2004–MT–0001. National Technology Transfer and All documents in the docket are listed Advancement Act of 1995 (15 U.S.C. § 52.320 Identification of plan. on the www.regulations.gov Web site. 272 note) do not apply. This rule does * * * * * Although listed in the index, some not impose an information collection (c) * * * information is not publicly available, burden under the provisions of the (108) Revisions to the Long-Term e.g., Confidential Business Information Paperwork Reduction Act of 1995 (44 Strategy of Colorado’s State (CBI) or other information whose U.S.C. 3501 et seq.). Implementation Plan for Class I disclosure is restricted by statute. The Congressional Review Act, 5 Visibility Protection (Visibility SIP), as Certain other material, such as U.S.C. 801 et seq., as added by the Small submitted by the Governor on March 24, copyrighted material, is not placed on Business Regulatory Enforcement 2005. The revisions update strategies, the Internet and will be publicly Fairness Act of 1996, generally provides activities, and monitoring plans that available only in hard copy form. that before a rule may take effect, the constitute reasonable progress toward Publicly available docket materials are agency promulgating the rule must the National visibility goal. available either electronically through
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http://www.regulations.gov or in hard federal regulations and other material August 20, 2003 submittal merely makes copy at the Air and Radiation Program, into air quality rules at ARM 17.8.101, administrative amendments to the Environmental Protection Agency 17.8.102, 17.8.103, 17.8.106, 17.8.110, State’s Administrative Rules of (EPA), Region 8, 999 18th Street, Suite 17.8.302, 17.8.401, 17.8.402, 17.8.801, Montana. Therefore, section 110(l) 300, Denver, Colorado 80202–2466. EPA 17.8.802, 17.8.818, 17.8.819, 17.8.821, requirements are satisfied. requests that if at all possible, you 17.8.901, 17.8.902, 17.8.905, and III. Statutory and Executive Order contact the individual listed in the FOR 17.8.1002. The amendments update Reviews FURTHER INFORMATION CONTACT section to federal citations, make clerical view the hard copy of the docket. You amendments, and eliminate the Under Executive Order 12866 (58 FR may view the hard copy of the docket duplication of statutory language in 51735, October 4, 1993), this action is Monday through Friday, 8 a.m. to 4 definitions by citing to the definitions in not a ‘‘significant regulatory action’’ and p.m., excluding Federal holidays. the statute. therefore is not subject to review by the FOR FURTHER INFORMATION CONTACT: We proposed to approve all of the Office of Management and Budget. For Laurie Ostrand, Air and Radiation August 20, 2003 submittal, except for this reason, this action is also not Program, Mailcode 8P–AR, changes in ARM 17.8.401 and 402. In subject to Executive Order 13211, Environmental Protection Agency our proposal we indicated that we were ‘‘Actions Concerning Regulations That (EPA), Region 8, 999 18th Street, Suite not acting on the changes to ARM Significantly Affect Energy Supply, 200, Denver, Colorado 80202–2466, 17.8.401 and 402 at this time for the Distribution, or Use’’ (66 FR 28355, May (303) 312–6437, [email protected]. same reasons stated on our August 13, 22, 2001). This action merely approves 2001 action (66 FR 42427 at 42434). We SUPPLEMENTARY INFORMATION: state law as meeting Federal did not receive any comments on our requirements and imposes no additional Table of Contents proposed action of the August 20, 2003 requirements beyond those imposed by I. Background submittal. state law. Accordingly, the II. Final Action We have also decided to not act on Administrator certifies that this rule III. Statutory and Executive Order Reviews the changes to ARM 17.8.106 at this will not have a significant economic time. We will address ARM 17.8.106 at Definitions impact on a substantial number of small a later date. entities under the Regulatory Flexibility For the purpose of this document, we Act (5 U.S.C. 601 et seq.). Because this are giving meaning to certain words or II. Final Action rule approves pre-existing requirements initials as follows: EPA is approving the following under state law and does not impose (i) The words or initials Act or CAA changes to the ARM that were submitted any additional enforceable duty beyond mean or refer to the Clean Air Act, on August 20, 2003 and effective on that required by state law, it does not unless the context indicates otherwise. April 11, 2003: ARM 17.8.101(2), (8), (ii) The words EPA, we, us or our (9), (12), (19), (20), (22), (23), (30) and contain any unfunded mandate or mean or refer to the United States (36); 17.8.102; 17.8.103(1); 17.8.110(2); significantly or uniquely affect small Environmental Protection Agency. 17.8.302(1); 17.8.801(1), (3), (4), (6), governments, as described in the (iii) The initials SIP mean or refer to (20), (21), (22), (24), (27) and (28); Unfunded Mandates Reform Act of 1995 State Implementation Plan. 17.8.802(1); 17.8.818(2), (3) and (6); (Pub. L. 104–4). (iv) The words State or Montana 17.8.819(3); 17.8.821; 17.8.901(1), (11), This rule also does not have tribal mean the State of Montana, unless the (12) and (14); 17.8.902(1); 17.8.905(1)(c); implications because it will not have a context indicates otherwise. and 17.8.1002(1). We are also approving substantial direct effect on one or more Indian tribes, on the relationship I. Background the deletion of ARM 17.8.101(43) that references definitions in the Montana between the Federal Government and On July 20, 2004 (69 FR 43371), EPA Code Annotated. Indian tribes, or on the distribution of published a notice of proposed EPA is not acting on the following power and responsibilities between the rulemaking partially approving and changes to the ARM that were submitted Federal Government and Indian tribes, partially disapproving SIP revisions on August 20, 2003 and effective on as specified by Executive Order 13175 submitted by the State of Montana on April 11, 2003: ARM 17.8.106, 17.8.401 (65 FR 67249, November 9, 2000). This April 18, 2003 and August 20, 2003. The and 17.8.402. These revisions will be action also does not have federalism revisions modify the open burning addressed in a separate action. implications because it does not have rules, definitions and references to EPA is updating the table in 40 CFR substantial direct effects on the States, federal regulations and other materials 60.4(c), entitled ‘‘Delegation Status of on the relationship between the in the Administrative Rules of Montana. New Source Performance Standards National Government and the States, or At this time we are finalizing our [(NSPS) for Region VIII],’’ to indicate the on the distribution of power and proposed action on the August 20, 2003 current status of the 40 CFR part 60 responsibilities among the various submittal. We will address the April 18, NSPS that are delegated to the State of levels of government, as specified in 2003 submittal, pertaining to open Montana. Executive Order 13132 (64 FR 43255, burning rules and ARM 17.8.302(1)(f), Section 110(l) of the Clean Air Act August 10, 1999). This action merely in a separate action. In the July 20, 2004 states that a SIP revision cannot be approves a state rule implementing a proposed rulemaking notice we also approved if the revision would interfere Federal standard, and does not alter the announced that on January 9, 2004, with any applicable requirement relationship or the distribution of power pursuant to section 111(c) of the Act, we concerning attainment and reasonable and responsibilities established in the delegated the authority to the State of further progress towards attainment of Clean Air Act. This rule also is not Montana to implement and enforce the the NAAQS or any other applicable subject to Executive Order 13045 New Source Performance Standards requirements of the Act. The Montana ‘‘Protection of Children from (NSPS). SIP revisions that are the subject of this Environmental Health Risks and Safety The August 20, 2003 submittal document do not interfere with the Risks’’ (62 FR 19885, April 23, 1997), contains amendments to definitions and maintenance of the NAAQS or any other because it is not economically incorporation by reference of current applicable requirement of the Act. The significant.
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In reviewing SIP submissions, EPA’s be challenged later in proceedings to § 52.1370 Identification of plan. role is to approve state choices, enforce its requirements. (See section * * * * * provided that they meet the criteria of 307(b)(2).) (c) * * * the Clean Air Act. In this context, in the List of Subjects absence of a prior existing requirement (61) Revisions to State for the State to use voluntary consensus 40 CFR Part 52 Implementation Plan were submitted by standards (VCS), EPA has no authority Environmental protection, Air the State of Montana on August 20, to disapprove a SIP submission for pollution control, Carbon monoxide, 2003. The revisions modify definitions failure to use VCS. It would thus be Incorporation by reference, and references to federal regulations and inconsistent with applicable law for Intergovernmental relations, Lead, other materials in the Administrative EPA, when it reviews a SIP submission, Nitrogen dioxide, Ozone, Particulate Rules of Montana (ARM). The revisions to use VCS in place of a SIP submission matter, Reporting and recordkeeping also delete the definition at ARM that otherwise satisfies the provisions of requirements, Sulfur oxides, Volatile 17.8.101(43). the Clean Air Act. Thus, the organic compounds. requirements of section 12(d) of the (i) Incorporation by reference. National Technology Transfer and 40 CFR Part 60 (A) Administrative Rules of Montana Advancement Act of 1995 (15 U.S.C. Administrative practice and (ARM) sections: ARM 17.8.101(2), (8), 272 note) do not apply. This rule does procedure, Air pollution control, (9), (12), (19), (20), (22), (23), (30), and not impose an information collection Aluminum, Ammonium sulfate plants, (36); 17.8.102; 17.8.103(1); 17.8.110(2); burden under the provisions of the Beverages, Carbon monoxide, Cement 17.8.302(1); 17.8.801(1), (3), (4), (6), Paperwork Reduction Act of 1995 (44 industry, Coal, Copper, Dry cleaners, (20), (21), (22), (24), (27) and (28); U.S.C. 3501 et seq.). Electric power plants, Fertilizers, 17.8.802(1); 17.8.818(2), (3) and (6); The Congressional Review Act, 5 Fluoride, Gasoline, Glass and glass 17.8.819(3); 17.8.821; 17.8.901(1), (11), U.S.C. 801 et seq., as added by the Small products, Graphic arts industry, (12) and (14); 17.8.902(1); 17.8.905(1)(c); Business Regulatory Enforcement Household appliances, Insulation, and 17.8.1002(1) effective April 11, Fairness Act of 1996, generally provides Intergovernmental relations, Iron, Lead, 2003. that before a rule may take effect, the Lime, Metallic and nonmetallic mineral agency promulgating the rule must processing plants, Metals, Motor PART 60—[AMENDED] submit a rule report, which includes a vehicles, Natural gas, Nitric acid plants, copy of the rule, to each House of the Nitrogen dioxide, Paper and paper I 1. The authority citation for part 60 Congress and to the Comptroller General products industry, Particulate matter, continues to read as follows: of the United States. EPA will submit a Paving and roofing materials, report containing this rule and other Petroleum, Phosphate, Plastics materials Authority: 42 U.S.C. 7401, 7411, 7414, required information to the U.S. Senate, and synthetics, Reporting and 7416, and 7601 as amended by the Clean Air the U.S. House of Representatives, and recordkeeping requirements, Sewage Act Amendments of 1990, Pub. L. 101–549, the Comptroller General of the United disposal, Steel, Sulfur oxides, Tires, 104 Stat. 2399 (November 15, 1990; 402, 409, States prior to publication of the rule in Urethane, Vinyl, Waste treatment and 415 of the Clean Air Act as amended, 104 the Federal Register. A major rule disposal, Zinc. Stat. 2399, unless otherwise noted). cannot take effect until 60 days after it Dated: December 7, 2005. is published in the Federal Register. Subpart A—General Provisions This action is not a ‘‘major rule’’ as Kerrigan G. Clough, defined by 5 U.S.C. 804(2). Acting Regional Administrator, Region 8. I 2. Section 60.4 is amended by revising Under section 307(b)(1) of the Clean I 40 CFR parts 52 and 60 are amended the entries for ‘‘Eb—Large Municipal Air Act, petitions for judicial review of to read as follows: Waste Combustors’’ and ‘‘Ec—Hospital/ this action must be filed in the United Medical/Infectious Waste Incinerators’’ PART 52—[AMENDED] States Court of Appeals for the in the table in paragraph (c) entitled appropriate circuit by March 27, 2006. I 1. The authority citation for part 52 ‘‘Delegation Status of New Source Filing a petition for reconsideration by continues to read as follows: Performance Standards [(NSPS) for the Administrator of this final rule does Authority: 42 U.S.C. 7401 et seq. Region VIII]’’ to read as follows: not affect the finality of this rule for the purposes of judicial review nor does it Subpart BB—Montana § 60.4 Address. extend the time within which a petition * * * * * for judicial review may be filed, and I 2. Section 52.1370 is amended by shall not postpone the effectiveness of adding paragraph (c)(61) to read as (c) * * * such rule or action. This action may not follows:
DELEGATION STATUS OF NEW SOURCE PERFORMANCE STANDARDS [(NSPS) for Region VIII]
Subpart CO MT ND SD UT WY
******* Eb—Large Municipal Waste Combustors ...... X ...... X X X Ec—Hospital/Medical/Infectious Waste Incinerators...... X X X X X X
*******
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* * * * * New England—Region 1, One Congress of Title 40 of the Code of Federal [FR Doc. 06–634 Filed 1–23–06; 8:45 am] Street, Suite 1100, (CHW), Boston, MA Regulations (CFR) (40 CFR part 258) BILLING CODE 6560–50–P 02114–2023. which establishes the minimum criteria Instructions: We must receive your for Municipal Solid Waste Landfills comments by February 23, 2006. Do not (MSWLF’s). The criteria set out in 40 ENVIRONMENTAL PROTECTION submit information that you consider to CFR part 258 include location AGENCY be CBI or otherwise protected through restrictions and standards for design, regulations.gov, or e-mail. The Federal operation, groundwater monitoring, 40 CFR Parts 239, 257, and 258 regulations.gov website is an corrective action, financial assurance [FRL–8024–2] ‘‘anonymous access’’ system, which and closure and post-closure care for means EPA will not know your identity MSWLFs. On July 1, 1996, EPA Maine: Determination of Adequacy for or contact information unless you amended part 257 of Title 40 of the CFR the State Municipal Solid Waste provide it in the body of your comment. (40 CFR part 257) by adding Subpart B, Landfill Permit Program If you send an e-mail comment directly ‘‘Federal Disposal Standards for the to EPA without going through Receipt of CESQG Wastes at Non- AGENCY: Environmental Protection regulations.gov, your e-mail address Municipal, Non-Hazardous Waste Agency (EPA). will be automatically captured and Disposal Units’’ (61 FR 34252). The 40 ACTION: Direct final rule. included as part of the comment that is CFR part 257 criteria include location restrictions and groundwater monitoring SUMMARY: The Environmental Protection placed in the public docket and made and corrective action standards for non- Agency (EPA) is taking direct final available on the Internet. If you submit municipal, non-hazardous waste action to approve the State of Maine’s an electronic comment, EPA disposal units that receive CESQG permit program for municipal solid recommends that you include your hazardous waste. Today’s rule refers to waste landfills (MSWLFs) and to name and other contact information in the 40 CFR part 257, subpart B criteria approve the State’s approach of not the body of your comment and with any and the 40 CFR part 258 criteria together allowing conditionally exempt small disk or CD–ROM you submit. If EPA as the ‘‘Subtitle D federal revised quantity generator (CESQG) hazardous cannot read your comment due to criteria.’’ The Subtitle D federal revised waste to be sent to non-municipal, non- technical difficulties and cannot contact criteria establish minimum federal hazardous waste disposal units. Under you for clarification, EPA may not be able to consider your comment. standards that take into account the the Resource Conservation Recovery Act practical capability of owners and (RCRA), as amended by the Hazardous Electronic files should avoid the use of special characters, any form of operators of MSWLFs and non- and Solid Waste Amendments (HSWA), municipal, non-hazardous waste States may develop and implement encryption, and be free of any defects or viruses. disposal units that receive CESQG permit programs for MSWLFs and for hazardous waste while ensuring that non-municipal, non-hazardous waste You can view and copy Maine’s application and associated publicly these two types of facilities are designed disposal units that receive CESQG and managed in a manner that is hazardous waste, and submit them for available materials at the following locations: (1) Maine Department of protective of human health and the review and an adequacy determination environment. by EPA. Today’s approval documents Environmental Protection (ME DEP), State House Station 17, Hospital Street, Section 4005(c)(1)(B) of Subtitle D of EPA’s determination that Maine’s the Resource Conservation and MSWLF permit program, and the Augusta, Maine 04333, business hours: Monday through Thursday, 8:30 a.m. to Recovery Act (RCRA), as amended by manner in which the State addresses the Hazardous and Solid Waste CESQG hazardous waste with respect to 4:30 p.m. and Friday, 8:30 a.m. to 12:30 p.m.; interested persons wanting to Amendments (HSWA) of 1984, requires non-municipal, non-hazardous waste States to develop and implement permit examine documents at the state office disposal units, are adequate to ensure programs to ensure that MSWLFs and should make an appointment with the compliance with federal requirements. non-municipal, non-hazardous waste ME DEP, Bureau of Remediation and DATES: This rule is effective on March disposal units that receive CESQG Waste Management at least one day in 27, 2006 without further notice, unless hazardous waste will comply with the advance by calling (207) 287–2651; and EPA receives adverse comment by Subtitle D federal revised criteria. RCRA (2) EPA New England—Region 1 February 23, 2006. If we receive such Section 4005(c)(1)(C) requires EPA to Library, One Congress Street—11th comment, we will publish a timely determine whether the permit programs Floor, Boston, MA 02114–2023, withdrawal in the Federal Register that states develop and implement for business hours: 10 a.m. to 3 p.m., informing the public that this rule will these two types of facilities are not take effect. Monday through Thursday, telephone adequate. number: (617) 918–1990. ADDRESSES: Submit your comments To fulfill this determination (including requests for a public hearing) FOR FURTHER INFORMATION CONTACT: requirement, EPA promulgated the State by one of the following methods: Chuck Franks, EPA New England— Implementation Rule (SIR). The SIR, 1. Federal eRulemaking Portal: Region 1, One Congress Street, Suite which established part 239 of Title 40 http://www.regulations.gov. Follow the 1100 (CHW), Boston, MA 02114–2023; of the CFR (40 CFR part 239), has the on-line instructions for submitting telephone number: (617) 918–1554, e- following four purposes: (1) It spells out comments. mail: [email protected]. the requirements that State programs 2. E-mail: Chuck Franks at: SUPPLEMENTARY INFORMATION: must satisfy to be determined adequate; [email protected]. (2) it confirms the process for EPA I. Background 3. Mail: Chuck Franks, EPA New approval or partial approval of State England—Region 1, One Congress On October 9, 1991, the permit programs for MSWLFs and non- Street, Suite 1100, (Mail Code: CHW), Environmental Protection Agency (EPA) municipal, non-hazardous waste Boston, MA 02114–2023. promulgated the ‘‘Solid Waste Disposal disposal units that receive CESQG 4. Hand Delivery or Courier: Deliver Facility Criteria: Final Rule’’ (56 FR hazardous waste; (3) it provides the your comments to Chuck Franks, EPA 50978). This rule promulgates part 258 procedures for withdrawal of such
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approvals; and (4) it establishes a revisions to correct errors and omissions The flexibility allowed by 40 CFR part flexible framework for modifications of or to provide greater clarity to the 257, subpart B is not applicable in approved programs. MSWLF permit program regulations Maine since, as explained above, Maine To receive a determination of were drafted, distributed for public requires CESQG hazardous waste to be adequacy under the SIR, a State must comment, adopted through formal disposed of only at hazardous waste have: (1) Enforceable standards for new rulemaking and made effective on disposal facilities. The Maine and existing MSWLFs and non- September 6, 1999. regulations generally track the federal municipal, non-hazardous waste On March 22, 2004, the EPA regulations and, therefore, generally disposal units that receive CESQG promulgated the Research Development allow the flexibility provided by 40 CFR hazardous waste that are technically and Demonstration amendments at 40 part 258. comparable to the Subtitle D federal CFR 258.4. Maine is not seeking RCRA Section 4005(a) provides that revised criteria; (2) authority to issue a approval to implement the provisions of citizens may use the citizen suit permit or other notice of prior approval the RD&D amendments in this provisions of RCRA Section 7002 to and conditions to all new and existing determination of adequacy. Adopting enforce the RCRA Subtitle D Federal MSWLFs and non-municipal, non- these provisions is optional. Maine may revised criteria independent of any State hazardous waste disposal units that apply for, and be approved to enforcement program. EPA expects that receive CESQG hazardous waste in its implement these provisions at a later any owner or operator complying with jurisdiction; (3) provisions for public time. the provisions in a State program participation in permit issuance and Based on our review, EPA has approved by EPA should be considered enforcement, as required in RCRA determined that Maine’s MSWLF permit to be in compliance with the criteria set Section 7004(b); and (4) sufficient program meets all of the criteria out in 40 CFR part 257, subpart B and compliance monitoring and necessary to qualify for full program 40 CFR part 258. enforcement authorities to take specific approval. The bases for this Maine is not applying at this time for action against any owner or operator determination are set forth in checklists the authority to carry out its federal that fails to comply with the state comparing the state program to the program in Indian country. Therefore, program. EPA expects States to meet all federal criteria, and other documents, today’s EPA action does not include of these requirements for all elements of contained in the Administrative Docket. approval for the State to carry out its a permit program before it gives full Maine has not submitted an program in Indian country within the approval to a State’s program. application for a determination of State, which includes the lands of the adequacy under Subtitle D for a permit Houlton Band of Maliseet Indians, the II. State of Maine program for non-municipal, non- Aroostook Band of Micmacs, the On September 29, 1993, Maine hazardous waste disposal units that Passamaquoddy Tribe at Pleasant Point submitted an application for a receive CESQG hazardous waste and Indian Township, and the determination of adequacy of its because it does not have such a Penobscot Nation. Today’s action has no MSWLF permit program to EPA (Region program. The State instead requires that effect on Indian country. EPA will 1). EPA reviewed the application and all hazardous waste disposal, including address any issues relating to the State’s requested additional information about CESQG hazardous waste disposal, must authority regarding Indian country only program implementation. This occur only at hazardous waste disposal if and when the State applies to be information was provided and is part of facilities that comply with the disposal authorized to carry out this federal the application record. Also, as a part of requirements of RCRA Subtitle C. program in Indian country. the application process, ME DEP Therefore, the state exceeds the initiated a process to revise portions of requirements as set out in 40 CFR part III. Public Comments and Public Maine’s statutes and the Department’s 257, subpart B for non-municipal, non- Hearing solid waste management rules as hazardous waste disposal units The public may submit written necessary to make the program receiving CESQG hazardous waste and comments on this rule. The deadline for consistent with the Federal criteria is, therefore, approved by EPA as having submitting written comments is in the under 40 CFR part 258. met or exceeded all RCRA Subtitle D DATES section of this rule. The mailing After EPA provided Maine with initial CESQG disposal requirements. The and email addresses to which comments comments regarding the application, State has no plans to revise its current should be sent are in the ADDRESSES Maine provided EPA with a copy of the CESQG hazardous waste disposal section of this rule. EPA will consider proposed draft revisions to their solid requirements and has indicated that any all public comments on this direct final waste management rules on August 28, potential future changes to Maine’s rule that it receives during the public 1995. The August 28, 1995 draft solid waste management rules that may comment period and during any public revisions were distributed to an alter these requirements will be hearing, if held. extensive list of potentially interested forwarded to EPA for approval under Although RCRA does not require EPA parties and Maine DEP received public the provisions of Subtitle D. to hold a public hearing on a comments concerning this draft which it Owners and operators located in determination to approve a State’s determined warranted additional draft States with approved permit programs MSWLF permit program and the changes and public review and may benefit from the site-specific manner in which CESQG hazardous comment. Subsequent revision drafts flexibility provided by 40 CFR part 257, waste is addressed at non-municipal, dated September 1996 and January 1998 subpart B, and 40 CFR part 258, to the non-hazardous waste disposal units, were prepared and distributed for extent the State program allows such EPA will hold a public hearing on this public review and comment and were flexibility. States with approved determination if sufficient public also forwarded to EPA for agency review programs may choose to require interest is expressed by persons either relative to the criteria under 40 CFR part facilities to comply with the Subtitle D writing to EPA at the address in the 258. The revised MSWLF permit federal revised criteria exactly, or they ADDRESSES section above or calling the program regulations were adopted by may choose to allow owners and EPA representative listed in the FOR Maine DEP and became effective on operators to use site-specific alternative FURTHER INFORMATION CONTACT section November 2, 1998. Subsequent minor approaches to meet the federal criteria. by February 23, 2006. Should EPA
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decide to hold a public hearing, this 22, 2001) ) because it is not a significant GENERAL SERVICES direct final rule will be revoked and the regulatory action under Executive Order ADMINISTRATION final deadline for submitting comments 12866. 41 CFR Part 105 will be extended. EPA will notify any Under RCRA, EPA grants a State’s persons who submit comments on this application as long as the State meets [GSPMR Amendment 2006–01; GSPMR notice if there is a public hearing. In the criteria required by RCRA. It would Case 2006–105–1] addition, anyone who wishes to learn thus be inconsistent with applicable law whether the hearing will be held may for EPA, when it reviews a State General Services Administration call the EPA representative listed in the application, to require the use of any Property Management Regulations; FOR FURTHER INFORMATION CONTACT particular voluntary consensus standard GSA Privacy Act Rules section above. Copies of Maine’s application are in place of another standard that AGENCY: Office of the Chief People available for inspection and copying at otherwise satisfies the requirements of Officer, General Services the location indicated in the ADDRESSES RCRA. Thus, the requirements of Administration (GSA). section of this direct final rule. section 12(d) of the National ACTION: Final rule. Technology Transfer and Advancement IV. Regulatory Assessments Act of 1995 (15 U.S.C. 272 note) do not SUMMARY: The General Services The Office of Management and Budget apply. Administration (GSA) is revising its has exempted this type of action from This rule does not impose an Privacy Act rules to reflect the requirements of Executive Order information collection burden under the organizational changes and to update 12866; therefore, this action is not provisions of the Paperwork Reduction policies and procedures. This revision subject to review by OMB. This action Act of 1995 (44 U.S.C. 3501 et seq.). informs individuals of procedures for approves State requirements for the obtaining personal information in GSA’s purposes of RCRA and imposes no The Congressional Review Act, 5 systems of records and provides current additional requirements beyond those U.S.C. 801 et seq., as added by the Small organizational titles and addresses of imposed by State law. Accordingly, this Business Regulatory Enforcement offices to contact about the GSA Privacy action will not have a significant Fairness Act of 1996, generally provides Program and the systems of records that economic impact on a substantial that before a rule may take effect, the are maintained by GSA. agency promulgating the rule must number of small entities under the DATES: Effective January 24, 2006. submit a rule report, which includes a Regulatory Flexibility Act (5 U.S.C. 601 FOR FURTHER INFORMATION CONTACT: copy of the rule, to each House of the GSA et seq.). Because this action authorizes Privacy Act Officer, General Services Congress and to the Comptroller General pre-existing requirements under State Administration, Office of the Chief of the United States. EPA will submit a law and does not impose any additional People Officer, 1800 F Street NW, report containing this document and enforceable duty beyond that required Washington DC 20405; telephone (202) other required information to the U.S. by State law, it does not contain any 501–1452; or e-mail at Senate, the U.S. House of unfunded mandate or significantly or [email protected]. uniquely affect small governments, as Representatives, and the Comptroller described in the Unfunded Mandates General of the United States prior to ADDRESSES: GSA Privacy Act Officer Reform Act of 1995 (Pub. L. 104–4). For publication in the Federal Register. (CIB), General Services Administration, the same reason, and because this action This action is not a ‘‘major rule’’ as 1800 F Street NW, Washington, DC has no effect in Indian country, this defined by 5 U.S.C. 804(2) and therefore 20405. action also does not significantly or is not subject to the additional SUPPLEMENTARY INFORMATION: uniquely affect the communities or requirements for major rules. Tribal governments, as specified by A. Background Executive Order 13175 (65 FR 67249, List of Subjects GSA undertook a project that focused November 9, 2000). This action will not 40 CFR Part 239 on making sure that all GSA Privacy Act have substantial direct effects on the Rules are still relevant, necessary, and States, on the relationship between the Environmental protection, covered by a legal or regulatory National Government and the States, or Administrative practice and procedure, authority and that the GSA regulations on the distribution of power and Intergovernmental relations, Waste implementing the Privacy Act Rules responsibilities among the various treatment and disposal. reflect the current GSA organization, levels of government, as specified in policies, standards, and practices. As a 40 CFR Part 257 Executive Order 13132 (64 FR 43255, result of this review GSA is publishing August 10, 1999), because it merely Waste treatment and disposal. updated Privacy Act Rules. Nothing in approves State requirements as part of the final rule indicates a change in the State RCRA program without 40 CFR Part 258 authorities or practices regarding the altering the relationship or the collection and maintenance of Reporting and recordkeeping distribution of power and information. The changes do not impact requirements, Waste treatment and responsibilities established by RCRA. individuals’ rights to access or amend disposal, Water pollution control. This action also is not subject to their records in the systems of records. Executive Order 13045 (62 FR 19885, Authority: This action is issued under the April 23, 1997), because it is not authority of the Solid Waste Disposal Act as B. Executive Order 12866 economically significant and it does not amended 42 U.S.C. 6912, 6945, 6949(a). This is not a significant regulatory make decisions based on environmental Dated: December 27, 2005. action and, therefore, was not subject to health or safety risks. This rule is not review under Section 6(b) of Executive subject to Executive Order 13211, Robert Varney, Order 12866, Regulatory Planning and ‘‘Actions Concerning Regulations That Regional Administrator, New England. Review, dated September 30, 1993. This Significantly Affect Energy Supply, [FR Doc. 06–627 Filed 1–23–06; 8:45 am] rule is not a major rule under 5 U.S.C. Distribution, or Use’’ (66 FR 28355 (May BILLING CODE 6560–50–P 804.
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C. Regulatory Flexibility Act Subpart 105–64.2—Access to Records under the Privacy Act of 1974, 5 U.S.C. 105–64.201 How do I get access to my 552a, as amended. The rules cover the The Regulatory Flexibility Act does records? GSA systems of records from which not apply to this final rule. It is not 105–64.202 How do I request access in information is retrieved by an expected to have a significant economic person? individual’s name or personal identifier. impact on small business entities within 105–64.203 How do I request access in These rules set forth GSA’s policies and the meaning of the Regulatory writing? procedures for accessing, reviewing, Flexibility Act, 5 U.S.C. 601, et seq. 105–64.204 Can parents and guardians obtain access to records? amending, and disclosing records D. Paperwork Reduction Act 105–64.205 Who will provide access to my covered by the Privacy Act. records? § 105–64.001 What terms are defined in The Paperwork Reduction Act does 105–64.206 How long will it take to get my this part? not apply because the rule imposes no record? record keeping or information collection 105–64.207 Are there any fees? GSA defines the following terms to requirements nor the collection of 105–64.208 What special conditions apply ensure consistency of use and information from offerors, contractors, to release of medical records? understanding of their meaning under 105–64.209 What special conditions apply or members of the public that would this part: to accessing law enforcement and Agency means any organization require the approval of the Office of security records? Management and Budget (OMB) under covered by the Privacy Act as defined in 44 U.S.C. 3501, et seq.; and the rule is Subpart 105–64.3—Denial of Access to 5 U.S.C. 551(1) and 5 U.S.C. 552a (a)(1). exempt from Congressional review Records GSA is such an agency. under 5 U.S.C. 801. 105–64.301 Under what conditions will I be Individual means a citizen of the denied access to a record? United States or a legal resident alien on List of Subjects in 41 CFR Part 105–64 105–64.302 How will I be denied access? whom GSA maintains Privacy Act 105–64.303 How do I appeal a denial to records. An individual may be Privacy. access a record? addressed as you when information is Dated: January 11, 2006. 105–64.304 How are administrative appeal provided for the individual’s use. decisions made? System of records means a group of June V. Huber, 105–64.305 What is my recourse to an Director,Office of Information appeal denial? records from which information is Management,Office of the Chief People retrieved by the name of an individual, Officer. Subpart 105–64.4—Amending Records or by any number, symbol, or other 105–64.401 Can I amend my records? identifier assigned to that individual. I Therefore, GSA is revising 41 CFR 105–64.402 What records are not subject to Record means any item, collection, or part 105–64 as follows: amendment? grouping of information about an 105–64.403 What happens when I submit a individual within a system of records PART 105–64—GSA PRIVACY ACT request to amend a record? which contains the individual’s name or RULES 105–64.404 How do I agree to an alternative amendment? any other personal identifier such as Sec. 105–64.405 Can I appeal a denial to amend number or symbol, fingerprint, 105–64.000 What is the purpose of this a record? voiceprint, or photograph. The part? 105–64.406 How will my appeal be information may relate to education, 105–64.001 What terms are defined in this handled? financial transactions, medical part? 105–64.407 How do I file a Statement of conditions, employment, or criminal Disagreement? Subpart 105–64.1—Policies and history collected in connection with an 105–64.408 What is my recourse to a denial individual’s interaction with GSA. Responsibilities decision? 105–64.101 Who is responsible for Request for access means a request by enforcing these rules? Subpart 105–64.5—Disclosure of Records an individual to obtain or review his or 105–64.102 What is GSA’s policy on 105–64.501 Under what conditions may a her record or information in the record. disclosure of information in a system of record be disclosed without my consent? Disclosure of information means records? 105–64.502 How do I find out if my record providing a record or the information in 105–64.103 What is GSA’s policy on has been disclosed? a record to someone other than the collecting and using information in a 105–64.503 What is an accounting of individual of record. system of records? disclosures? Exempt records means records 105–64.104 What must the system manager 105–64.504 Under what conditions will I be exempted from access by an individual denied an accounting of disclosures? tell me when soliciting information for a under the Privacy Act, subsections (j)(1), system of records? Subpart 105–64.6—Establishing or Revising Central Intelligence Agency, (j)(2) and 105–64.105 When may Social Security Systems of Records in GSA Numbers (SSNs) be collected? (k)(2), law enforcement, (k)(1), Section 105–64.106 What is GSA’s policy on 105–64.601 Procedures for establishing 552 (b)(1), (k)(3), protective services to information accuracy in a system of system of records. the President, (k)(4), statistical records, records? Subpart 105–64.7—Assistance and Referrals (k)(5), employee background 105–64.107 What standards of conduct investigations, (k)(6), federal service 105–64.701 Submittal of requests for apply to employees with privacy-related assistance and referrals. disclosure, and (k)(7), promotion in responsibilities? armed services. 105–64.108 How does GSA safeguard Appendix A to Part 105–64—Addresses for Solicitation means a request by an personal information? Geographically Dispersed Records officer or employee of GSA for an 105–64.109 How does GSA handle other agencies’ records? Authority: 5 U.S.C. 552a. individual to provide information about 105–64.110 When may GSA establish himself or herself for a specified computer matching programs? § 105–64.000 What is the purpose of this purpose. 105–64.111 What is GSA’s policy on part? directives that may conflict with these This part implements the General Routine use means disclosure of a rules? Services Administration (GSA) rules record outside GSA for the purpose for
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which it is intended, as specified in the § 105–64.105 When may Social Security § 105–64.111 What is GSA’s policy on systems of records notices. Numbers (SSNs) be collected? directives that may conflict with these Computer matching program means Statutory or regulatory authority must rules? the computerized comparison of two or exist for collecting Social Security These rules take precedence over any more Federal personnel or payroll Numbers for record systems that use the GSA directive that may conflict with the systems of records, or systems of records SSNs as a method of identification. requirements stated here. GSA officials used to establish or verify an Systems without statutory or regulatory will ensure that no such conflict exists individual’s eligibility for Federal authority implemented after January 1, in new or existing directives. benefits or to recoup delinquent debts. 1975, will not collect Social Security System manager means the GSA Numbers. Subpart 105–64.2—Access to Records associate responsible for a system of records and the information in it, as § 105–64.106 What is GSA’s policy on § 105–64.201 How do I get access to my information accuracy in a system of records? noted in the Federal Register systems of records? records notices. System managers will ensure that all You may request access to your record Subpart 105–64.1—Policies and Privacy Act records are accurate, in person or by writing to the system Responsibilities relevant, necessary, timely, and manager or, in the case of complete. geographically dispersed records, to the § 105–64.101 Who is responsible for office maintaining the records (see enforcing these rules? § 105–64.107 What standards of conduct Appendix A). Parents or guardians may GSA Heads of Services and Staff apply to employees with privacy-related obtain access to records of minors or responsibilities? Offices and Regional Administrators are when a court has determined that the responsible for ensuring that all systems Employees who design, develop, individual of record is incompetent. of records under their jurisdiction meet operate, or maintain Privacy Act record the provisions of the Privacy Act and systems will protect system security, § 105–64.202 How do I request access in these rules. System managers are avoid unauthorized disclosure of person? responsible for the system(s) of records information, both verbal and written, assigned to them. The GSA Privacy Act and ensure that no system of records is If appearing in person, you must Officer oversees the GSA Privacy maintained without public notice. All properly identify yourself through Program and establishes privacy-related such employees will follow the photographic identification such as an policy and procedures for the agency standards of conduct in 5 CFR part agency identification badge, passport, or under the direction of the GSA Senior 2635, 5 CFR part 6701, 5 CFR part 735, driver’s license. Records will be Agency Official for Privacy. and 5 CFR part 2634 to protect personal available during normal business hours information. at the offices where the records are § 105–64.102 What is GSA’s policy on maintained. You may examine the disclosure of information in a system of § 105–64.108 How is personal information record and be provided a copy on records? safeguarded? request. If you want someone else to No information contained in a Privacy System managers will establish accompany you when reviewing a Act system of records will be disclosed administrative, technical, and physical record, you must first sign a statement to third parties without the written safeguards to ensure the security and authorizing the disclosure of the record; consent of you, the individual of record, confidentiality of records, protect the the statement will be maintained with except under the conditions cited in records against possible threats or your record. § 105–64.501. hazards, and permit access only to authorized persons. Automated systems § 105–64.203 How do I request access in § 105–64.103 What is GSA’s policy on will incorporate security controls such writing? collecting and using information in a system of records? as password protection, verification of identity of authorized users, detection of If you request access in writing, mark System managers must collect break-in attempts, firewalls, or both the envelope and the request letter information that is used to determine encryption, as appropriate. ‘‘Privacy Act Request.’’ Include in the your rights, benefits, or privileges under request your full name and address; a GSA programs directly from you § 105–64.109 How does GSA handle other description of the records you seek; the whenever practical, and use the agencies’ records? title and number of the system of information only for the intended In cases where GSA has either records as published in the Federal purpose(s). permanent or temporary custody of Register; a brief description of the other agencies’ records, system nature, time, and place of your § 105–64.104 What must the system managers will coordinate with those manager tell me when soliciting personal association with GSA; and any other information? agencies on any release of information. information you believe will help in Office of Personnel Management (OPM) When soliciting information from you locating the record. records that are in GSA’s custody are or a third party for a system of records, subject to OPM’s Privacy Act rules. § 105–64.204 How do parents or guardians system managers must: cite the obtain access to records? authority for collecting the information; § 105–64.110 When may GSA establish say whether providing the information computer matching programs? If you are the parent or guardian of a is mandatory or voluntary; give the System managers will establish minor, or of a person judicially purpose for which the information will computer matching programs or determined to be incompetent, you must be used; state the routine uses of the agreements for sharing information with provide full information about the information; and describe the effect on other agencies only with the consent individual of record. You also must you, if any, of not providing the and under the direction of the GSA Data properly identify yourself and provide a information. Any information Integrity Board that will be established copy of the birth certificate of the solicitation forms will contain this when and if computer matching individual, or a court order establishing information. programs are used at GSA. guardianship, whichever applies.
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§ 105–64.205 Who will provide access to so, the system manager will notify you consulting with legal counsel and my record? of the existence of the record and appropriate officials. The Privacy Act The system manager will make a disclose the information, but only to the Officer may grant record access if the record available to you on request, extent that the information does not appeal is granted. If the decision is to unless special conditions apply, such as identify a confidential source. If reject the appeal, the Privacy Act Officer for medical, law enforcement, and disclosure of information could will provide all pertinent information security records. reasonably be expected to identify a about the case to the Deputy Administrator and ask for a final § 105–64.206 How long will it take to get confidential source, the record will not my record? be disclosed to you unless it is possible administrative decision. The Deputy to delete all such information. A Administrator may grant access to a The system manager will make a confidential source is a person or record, in which case the Privacy Act record available within 10 workdays Officer will notify you in writing, and after receipt of your request. If a delay persons who furnished information during Federal investigations with the the system manager will make the of more than 10 workdays is expected, record available to you. If the Deputy the system manager will notify you in understanding that his or her identity would remain confidential. Administrator denies the appeal, he or writing of the reason for the delay and she will notify you in writing of the when the record will be available. The Subpart 105–64.3—Denial of Access to reason for rejection and of your right to system manager may ask you for Records a judicial review. The administrative additional information to clarify your § 105–64.301 Under what conditions will I appeal review will take no longer than request. The system manager will have 30 workdays after the Privacy Act an additional 10 workdays after receipt be denied access to a record? The system manager will deny access Officer receives the appeal. The Deputy of the new information to provide the Administrator may extend the time limit record to you, or provide another to a record that is being compiled in the reasonable anticipation of a civil action by notifying you in writing of the acknowledgment letter if a delay in extension and the reason for it before locating the record is expected. or proceeding or to records that are specifically exempted from disclosure the 30 days are up. § 105–64.207 Are there any fees? by GSA in its system of records notices, § 105–64.305 What is my recourse to an No fees are charged for records when published in the Federal Register. appeal denial? the total fee is less than $25. The system Exempted systems include the You may file a civil action to have the manager may waive the fee above this Investigation Case Files, Internal GSA administrative decision overturned amount if providing records without Evaluation Case Files, and Security within two years after the decision is charge is customary or in the public Files. These systems are exempted to made. You may file in a Federal District interest. When the cost exceeds $25, the maintain the effectiveness and integrity Court where you live or have a principal fee for a paper copy is 10 cents per page, of investigations conducted by the place of business, where the records are and the fee for materials other than Office of Inspector General, and others, maintained, or in the District of paper copies is the actual cost of as part of their duties and Columbia. reproduction. For fees above $250, responsibilities involving Federal advance payment is required. You employment, contracts, and security. Subpart 105–64.4—Amending a Record should pay by check or money order § 105–64.401 Can I amend my record? § 105–64.302 How will I be denied access? made payable to the General Services You may request to amend your Administration, and provide it to the If you request access to a record in an exempt system of records, the system record by writing to the system manager system manager. with the proposed amendment. Mark manager will consult with the Head of both the envelope and the letter § 105–64.208 What special conditions Service or Staff Office or Regional ‘‘Privacy Act Request to Amend apply to release of medical records? Administrator or their representatives, Record.’’ Medical records containing legal counsel, and other officials as information that may have an adverse appropriate, to determine if all or part § 105–64.402 What records are not subject effect upon a person will be released of the record may be disclosed. If the to amendment? only to a physician designated in decision is to deny access, the system You may not amend the following writing by you, or by your guardian or manager will provide a written notice to records under the law: conservator. Medical records in an you giving the reason for the denial and (a) Transcripts of testimony given Official Personnel Folder (OPF) fall your appeal rights. under oath or written statements made under the jurisdiction of the Office of under oath. Personnel Management (OPM) and will § 105–64.303 How do I appeal a denial to (b) Transcripts of grand jury access a record? be referred to OPM for a response. proceedings, judicial proceedings, or If you are denied access to a record in § 105–64.209 What special conditions quasi-judicial proceedings which whole or in part, you may file an constitute the official record of the apply to access of law enforcement and administrative appeal within 30 days of security records? proceedings. the denial. The appeal should be in Law enforcement and security records writing and addressed to: GSA Privacy (c) Pre-sentence reports that are are generally exempt from disclosure to Act Officer (CIB), General Services maintained within a system of records individuals except when the system Administration, 1800 F Street NW, but are the property of the courts. manager, in consultation with legal Washington DC 20405. Mark both the (d) Records exempted from counsel and the Head of the Service or envelope and the appeal letter ‘‘Privacy amendment by notice published in the Staff Office or Regional Administrator or Act Appeal.’’ Federal Register. their representatives, determines that information in a record has been used § 105–64.304 How are administrative § 105–64.403 What happens when I submit or is being used to deny you any right, appeal decisions made? a request to amend a record? privilege, or benefit for which you are The GSA Privacy Act Officer will The system manager will consult with eligible or entitled under Federal law. If conduct a review of your appeal by the Head of Service or Staff Office or
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Regional Administrator or their provided with the record. If the Deputy jurisdiction; to the Comptroller General representatives, and legal counsel. They Administrator denies the appeal, he or or an authorized representative in the will determine whether to amend an she will notify you in writing of the performance of the duties of the existing record by comparing its reason for denial, of your right to a Government Accountability Office accuracy, relevance, timeliness, and judicial review, and of your right to file (GAO); under a court order; or to a completeness with the amendment you a Statement of Disagreement. The consumer reporting agency under the propose. The system manager will amendment appeal review will be made Federal Claims Collection Act of 1966, notify you within 10 workdays whether within 30 workdays after the Privacy 31 U.S.C. 3711. your proposed amendment is approved Act Officer receives your appeal. The or denied. In case of an expected delay, Deputy Administrator may extend the § 105–64.502 How do I find out if my the system manager will acknowledge time limit by notifying you in writing of record has been disclosed? receipt of your request in writing and the reason for the extension before the You may request an accounting of the provide an estimate of when you may 30 days are up. expect a decision. If your request to persons or agencies to whom your amend is approved, the system manager § 105–64.407 How do I file a Statement of record has been disclosed, including the Disagreement? will amend the record and send an date and purpose of each disclosure, by amended copy to you and to anyone You may file a Statement of writing to the system manager. Mark who had previously received the record. Disagreement with the system manager both the envelope and the letter If your request to amend is denied, the within 30 days of the denial to amend ‘‘Privacy Act Accounting Request.’’ The system manager will advise you in a record. The statement should explain system manager will provide the writing, giving the reason for denial, a why you believe the record to be requested information in the same way proposed alternative amendment if inaccurate, irrelevant, untimely, or as that for granting access to records, see possible, and your appeal rights. The incomplete. The system manager will Subpart 105–64.2, providing no system manager also will notify the GSA file the statement with your record, restrictions to disclosure or accounting Privacy Act Officer of any request for provide a copy to anyone who had of disclosures applies. amendment and its disposition. previously received the record, and include a copy of it in any future § 105–64.503 What is an accounting of § 105–64.404 What must I do if I agree to disclosure. disclosures? an alternative amendment? If you agree to the alternative § 105–64.408 What is my recourse to a The system manager maintains an amendment proposed by the system denial decision? account of each record disclosure for manager, you must notify the manager You may file a civil action to have the five years or for the life of the record, in writing of your concurrence. The GSA decision overturned within two whichever is longer. The accounting of system manager will amend the record years after denial of an amendment disclosure information includes the and send an amended copy to you and appeal. You may file the civil action in name of the person or agency to whom to anyone else who had previously a Federal District Court where you live your record has been provided, the date, received the record. or have a principal place of business, the type of information disclosed, and where the records are maintained, or in the reason for disclosure. Other § 105–64.405 Can I appeal a denial to the District of Columbia. amend a record? pertinent information, such as You may file an appeal within 30 Subpart 105–64.5—Disclosure of justifications for disclosure and any workdays of a denial to amend your Records written consent that you may have record by writing to the: GSA Privacy provided, is also included. No § 105–64.501 Under what conditions may a accounting needs to be maintained for Act Officer (CIB), General Services record be disclosed without my consent? Administration, 1800 F Street NW, disclosures to GSA officials or A system manager may disclose your employees in the performance of their Washington DC 20405. Mark both the record without your consent under the duties, or disclosures under the envelope and the appeal letter ‘‘Privacy Privacy Act when the disclosure is: to Freedom of Information Act. Act Amendment Appeal.’’ Appeals to GSA officials or employees in the amend records in a GSA employee’s performance of their official duties; official personnel file will be sent to the § 105–64.504 Under what conditions will I required by the Freedom of Information be denied an accounting of disclosures? Office of Personnel Management, Act; for a routine use stated in a Federal Washington DC 20415. Register notice; to the Bureau of the The system manager will deny your § 105–64.406 How will my appeal be Census for use in fulfilling its duties; for request for an accounting of disclosures handled? statistical research or reporting, and when the disclosures are to GSA The GSA Privacy Act Officer will only when the record is not individually officials or employees in the consult with legal counsel and identifiable; to the National Archives performance of their duties or appropriate GSA officials concerning and Records Administration (NARA) disclosures under the Freedom of your appeal. If they decide to reject your when the record has been determined to Information Act, for which no appeal, the Privacy Act Officer will be of historical or other value that accounting is required; law enforcement provide the Deputy Administrator with warrants permanent retention; to a U.S. agencies for law enforcement activities; all pertinent information about the case law enforcement agency or and systems of records exempted by and request a final administrative instrumentality for a civil or criminal notice in the Federal Register. You may decision. The Deputy Administrator law enforcement purpose; under appeal a denial using the same may approve your amendment, in compelling circumstances affecting an procedures as those for denial of access which case the Privacy Act Officer will individual’s health and safety, and upon to records, see Subpart 105–64.3. notify you in writing, and the system disclosure a notification will be sent to manager will amend the record and the individual; to Congress or its send an amended copy to you and committees and subcommittees when anyone who had previously been the record material falls within their
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Subpart 105–64.6—Establishing or Rico, and Virgin Islands), 26 Federal ACTION: Final rule; delay of effective Revising Systems of Records in GSA Plaza, New York, NY 10278. date. Mid-Atlantic Region (includes § 105–64.601 Procedures for establishing Delaware, Maryland, Pennsylvania, SUMMARY: In a final rule of August 17, system of records. Virginia, and West Virginia, but 2005 (70 FR 48295), we updated our The following procedures apply to excludes the National Capital Region), standard regulating motor vehicle any proposed new or revised system of The Strawbridge Building, 20 North 8th controls, telltales and indicators. The records: Street, Philadelphia, PA 19107–3191. standard specifies requirements for the (a) Before establishing a new or Southeast-Sunbelt Region (includes location, identification, and revising an existing system of records, Alabama, Florida, Georgia, Kentucky, illumination of these items. The rule the system manager, with the Mississippi, North Carolina, South extended the standard’s telltale and concurrence of the appropriate Head of Carolina, and Tennessee), Office of the indicator requirements to vehicles with Service or Staff Office, will provide to Regional Administrator (4A), 77 Forsyth a Gross Vehicle Weight Rating (GVWR) the GSA Privacy Act Officer a proposal Street, Atlanta, GA 30303. of 4,536 kg (10,000 pounds) and greater, describing and justifying the new Great Lakes Region (includes Illinois, updated the standard’s requirements for system or revision. Indiana, Michigan, Ohio, Minnesota, multi-function controls and multi-task (b) The GSA Privacy Act Officer will and Wisconsin), 230 South Dearborn displays to make the requirements submit a proposal to establish or revise Street, Chicago, IL 60604–1696. appropriate for advanced systems, and the system to the President of the The Heartland Region (includes Iowa, reorganized the standard to make it Senate, the Speaker of the House of Kansas, Missouri, and Nebraska), 1500 easier to read. The final rule announced Representatives, and the Director of the East Bannister Road, Kansas City, MO an effective date of February 13, 2006, Office of Management and Budget 64131–3088. and a compliance date of February 13, (OMB) for evaluation at least 40 Greater Southwest Region (includes 2006 for requirements applicable to calendar days before the planned system Arkansas, Louisiana, Oklahoma, New vehicles under 4,536 kg (10,000 pounds) establishment or revision date. Mexico, and Texas), 819 Taylor Street, GVWR. (c) The GSA Privacy Act Officer will Fort Worth, TX 76102. In response to a petition for extension publish in the Federal Register a notice Rocky Mountain Region (includes of the effective date from the Alliance of of intent to establish or revise the Colorado, Montana, North Dakota, Automobile Manufacturers (Alliance), system of records at least 30 calendar South Dakota, Utah, and Wyoming), this final rule announces a delay in the days before the planned system U.S. General Services Administration, effective date to September 1, 2006. The establishment or revision date. DFC, Bldg. 41, Rm. 210, P.O. Box 25006, additional time allows us to consider (d) The new or revised system Denver, CO 80225–0006. issues raised by the Alliance and other becomes effective 30 calendar days after Pacific Rim Region (includes Arizona, petitioners in petitions to reconsider the notice is published in the Federal California, Hawaii, and Nevada), 450 certain items and identifications Register unless submitted comments Golden Gate Avenue, San Francisco, CA described in the August 17, 2005 final result in a revision to the notice, in 94102–3400. rule. which case, a new revised notice will be Northwest/Arctic Region (includes DATES: Effective date: The effective date issued. Alaska, Idaho, Oregon, and of the rule amending 49 CFR 571.101 Washington), 400 15th Street SW, published at 70 FR 48295, August 17, Subpart 105–64.7—Assistance and Auburn, WA 98001–6599. 2005 is delayed until September 1, Referrals National Capital Region (includes the 2006. § 105–64.701 Submittal of requests for District of Columbia; the counties of Compliance date: The compliance assistance and referrals. Montgomery and Prince George’s in date for the extension of the standard’s Address requests for assistance Maryland; the city of Alexandria, telltale and indicator requirements to involving GSA Privacy Act rules and Virginia; and the counties of Arlington, vehicles with a GVWR of 4,536 kg procedures, or for referrals to system Fairfax, Loudoun, and Prince William in (10,000 pounds) or greater is September managers or GSA officials responsible Virginia), 7th and D Streets, SW, 1, 2013. The compliance date for all for implementing these rules to: GSA Washington, DC 20407. other requirements is delayed until Privacy Act Officer (CIB), General [FR Doc. 06–669 Filed 1–23–06; 8:45 am] September 1, 2006. Voluntary Services Administration, 1800 F Street BILLING CODE 6820–34–S compliance is permitted as of August N.W., Washington DC 20405. 17, 2005. Petitions for reconsideration: Petitions Appendix A to Part 105–64—Addresses DEPARTMENT OF TRANSPORTATION for reconsideration of this final rule for Geographically Dispersed Records must be received not later than March Address requests for physically National Highway Traffic Safety 10, 2006. dispersed records, as noted in the Administration ADDRESSES: Petitions for reconsideration system of records notices, to the of the final rule must refer to the docket Regional Privacy Act Coordinator, 49 CFR Part 571 and notice number set forth above and General Services Administration, at the [Docket No. NHTSA–2006–23651] be submitted to the Administrator, appropriate regional GSA office, as National Highway Traffic Safety follows: RIN 2127–AJ81 Administration, 400 Seventh Street, SW., Washington, DC 20590, with a New England Region (includes Federal Motor Vehicle Safety Connecticut, Maine, Massachusetts, copy to Docket Management, Room PL– Standards; Controls, Telltales and 401, 400 Seventh Street, SW., New Hampshire, Rhode Island, and Indicators Vermont), 10 Causeway Street, Boston, Washington, DC 20590. MA 02222. AGENCY: National Highway Traffic FOR FURTHER INFORMATION CONTACT: For Northeast and Caribbean Region Safety Administration (NHTSA), non-legal issues you may call Ms. Gayle (includes New Jersey, New York, Puerto Department of Transportation (DOT). Dalrymple, Office of Crash Avoidance
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Standards at (202) 366–5559. Her fax Extension of Effective Date Rulemaking Analyses and Notices number is (202) 366–7002. For legal A. Executive Order 12866 and DOT issues, you may call Ms. Dorothy In a petition dated October 3, 2005, Regulatory Policies and Procedures Nakama, Office of the Chief Counsel at the Alliance of Automobile (202) 366–2992. Her fax number is (202) Manufacturers (Alliance) petitioned for Executive Order 12866, ‘‘Regulatory 366–3820. You may send mail to both a delay in the final rule’s effective date Planning and Review’’ (58 FR 51735, of these officials at National Highway to September 1, 2006. The Alliance October 4, 1993), provides for making Traffic Safety Administration, 400 stated its position that the final rule determinations whether a regulatory Seventh St., SW., Washington, DC ‘‘imposes a number of new requirements action is ‘‘significant’’ and therefore 20590. that will become applicable to passenger subject to Office of Management and Budget (OMB) review and to the SUPPLEMENTARY INFORMATION: cars and other light-duty vehicles effective February 13, 2006.’’ The requirements of the Executive Order. Background Alliance asked for the delay to give The Order defines a ‘‘significant regulatory action’’ as one that is likely NHTSA issued the original version of NHTSA enough time to respond to the to result in a rule that may: Federal Motor Vehicle Safety Standard Alliance’s petition for reconsideration, (FMVSS) No. 101, Controls and (1) Have an annual effect on the filed as a separate document, and also economy of $100 million or more or Displays, in 1967 (32 FR 2408) as one dated October 3, 2005. of the initial FMVSSs. The standard adversely affect in a material way the applies to passenger cars, multipurpose Although NHTSA stated that the final economy, a sector of the economy, passenger vehicles (MPVs), trucks, and rule would not require design changes, productivity, competition, jobs, the buses. The purpose of FMVSS No. 101 but would relieve restrictions on vehicle environment, public health or safety, or is to assure the accessibility and manufacturers, the Alliance asserted State, local, or tribal governments or visibility of motor vehicle controls and that certain final rule provisions will communities; displays under daylight and nighttime require vehicle redesign that cannot be (2) Create a serious inconsistency or conditions, in order to reduce the safety completed by the February 13, 2006 otherwise interfere with an action taken hazards caused by the diversion of the effective date. The Alliance stated: or planned by another agency; (3) Materially alter the budgetary driver’s attention from the driving task, ‘‘These new requirements are included impact of entitlements, grants, user fees, and by mistakes in selecting controls. in: S5.2.1; S5.3.2.2(b); S5.3.4(d); S5.4.3, or loan programs or the rights and At present, FMVSS No. 101 specifies and S5.5.2. In addition appropriate requirements for the location (S5.1), obligations or recipients thereof; or changes are needed to Table 1 and Table (4) Raise novel legal or policy issues identification (S5.2), and illumination 2 along with their respective footnotes.’’ (S5.3) of various controls and displays. arising out of legal mandates, the The Alliance asserted that the President’s priorities, or the principles It specifies that those controls and additional time will allow NHTSA to displays must be accessible and visible set forth in the Executive Order. review and take ‘‘final action’’ on the We have considered the impact of this to a driver properly seated wearing his issues raised in the Alliance’s petition rulemaking action under Executive or her safety belt. Table 1, ‘‘Identification and Illumination of for reconsideration. Order 12866 and the Department of Controls,’’ and Table 2, ‘‘Identification After considering the rationale Transportation’s regulatory policies and and Illumination of Displays,’’ indicate explaining the need to maintain the procedures. This rulemaking document which controls and displays are subject status quo while NHTSA considers the was not reviewed by the Office of to the identification requirements, and Alliance’s petition for reconsideration, Management and Budget under E.O. 12866, ‘‘Regulatory Planning and how they are to be identified, colored, NHTSA has decided that it is in the Review.’’ The rulemaking action is also and illuminated. public interest to grant the Alliance’s not considered to be significant under Final Rule petition. By delaying the effective date the Department’s Regulatory Policies to September 1, 2006, NHTSA will be In the final rule of August 17, 2005, and Procedures (44 FR 11034; February able to reconsider certain required items NHTSA amended FMVSS No. 101 by 26, 1979). and identifications described in the extending the standard’s telltale and For the following reasons, NHTSA indicator requirements to vehicles of August 17, 2005 final rule before they concludes that this final rule will not Gross Vehicle Weight Rating (GVWR) become mandatory. Manufacturers will have any quantifiable cost effect on 4,536 kilograms (10,000 pounds) and not have to make vehicle redesigns that motor vehicle manufacturers. This final over, updating the standard’s they have informed NHTSA they will rule delays from February 13, 2006 to requirements for multi-function controls not be able to complete by February 13, September 1, 2006, the effective date for and multi-task displays to make the 2006. Since voluntary compliance has the FMVSS No. 101 final rule published requirements appropriate for advanced been permitted as of August 17, 2005, on August 17, 2005. Since the delay in systems, and reorganizing the standard those manufacturers that are able to the effective date is intended to to make it easier to read. Table 1 and comply by February 13, 2006 may maintain the status quo while NHTSA Table 2 continue to include only those continue to do so. Moreover, because considers the issues in the Alliance’s symbols and words previously specified the safety benefits of the final rule are petition for reconsideration, in the controls and displays standard or very small, there will be no measurable manufacturers will incur no costs as a in another Federal motor vehicle safety effect on safety as a result of this delay result of the delay in the effective date. standard. However, both Tables 1 and 2 in effective date. Therefore, NHTSA The August 17, 2005 final rule removed were reorganized to make the symbols delays the effective date of the final rule a regulatory restriction (for multi- and words easier to find. of August 17, 2005 (70 FR 48295) to function controls) requiring The final rule announced an effective September 1, 2006. We will also identification ‘‘on or adjacent to’’ the date of February 13, 2006 for controls and provided for immediate consider other timely petitions for requirements applicable to passenger optional voluntary compliance. Thus, reconsideration of this final rule that we cars, multipurpose passenger vehicles, manufacturers benefiting from the trucks and buses under 4,536 kg GVWR. have already received. amendment to FMVSS No. 101’s ‘‘on or
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adjacent’’ to requirement will not be this action would not have any maintain a safety standard applicable to affected by the delay in the effective significant impact on the quality of the the same aspect of performance which date. Also, because the safety benefits of human environment. is not identical to the Federal standard, this final rule are very small, there will except to the extent that the state D. Executive Order 13132 (Federalism) be no measurable effect on safety as a requirement imposes a higher level of result of this delay in effective date. Executive Order 13132 requires performance and applies only to Because the economic effects of this NHTSA to develop an accountable vehicles procured for the State’s use. 49 final rule are so minimal, no further process to ensure ‘‘meaningful and U.S.C. 30161 sets forth a procedure for regulatory evaluation is necessary. timely input by State and local officials judicial review of final rules in the development of regulatory B. Regulatory Flexibility Act establishing, amending, or revoking policies that have federalism Federal motor vehicle safety standards. Pursuant to the Regulatory Flexibility implications.’’ The Executive Order That section does not require Act (5 U.S.C. 601 et seq., as amended by defines ‘‘policies that have federalism submission of a petition for the Small Business Regulatory implications’’ to include regulations reconsideration or other administrative Enforcement Fairness Act (SBREFA) of that have ‘‘substantial direct effects on proceedings before parties may file suit 1996), whenever an agency is required the States, on the relationship between in court. to publish a notice of rulemaking for the National Government and the States, any proposed or final rule, it must or on the distribution of power and F. Paperwork Reduction Act prepare and make available for public responsibilities among the various Under the Paperwork Reduction Act comment a regulatory flexibility levels of government.’’ Under Executive of 1995, a person is not required to analysis that describes the effect of the Order 13132, NHTSA may not issue a respond to a collection of information rule on small entities (i.e., small regulation with federalism implications, by a Federal agency unless the businesses, small organizations, and that imposes substantial direct collection displays a valid Office of small governmental jurisdictions). The compliance costs, and that is not Management and Budget (OMB) control Small Business Administration’s required by statute, unless the Federal number. This final rule does not require regulations at 13 CFR part 121 define a Government provides the funds any collections of information, or small business, in part, as a business necessary to pay the direct compliance recordkeeping or retention requirements entity ‘‘which operates primarily within costs incurred by State and local as defined by the OMB in 5 CFR part the United States.’’ (13 CFR 121.105(a)). governments, or the agency consults 1320. No regulatory flexibility analysis is with State and local officials early in the required if the head of an agency process of developing the regulation. G. National Technology Transfer and certifies that the rule will not have a NHTSA also may not issue a regulation Advancement Act significant economic impact on a with federalism implications and that Section 12(d) of the National substantial number of small entities. preempts State law unless the agency Technology Transfer and Advancement The SBREFA amended the Regulatory consults with State and local officials Act of 1995 (NTTAA), Public Law 104– Flexibility Act to require Federal early in the process of developing the 113, section 12(d) (15 U.S.C. 272) agencies to provide a statement of the regulation. directs NHTSA to use voluntary factual basis for certifying that a rule NHTSA has analyzed this rulemaking consensus standards in its regulatory will not have a significant economic action in accordance with the principles activities unless doing so would be impact on a substantial number of small and criteria set forth in Executive Order inconsistent with applicable law or entities. 13132. The agency has determined that otherwise impractical. Voluntary The Head of the Agency has this rule will not have sufficient consensus standards are technical considered the effects of this rulemaking federalism implications to warrant standards (e.g., materials specifications, action under the Regulatory Flexibility consultation with State and local test methods, sampling procedures, and Act (5 U.S.C. 601 et seq.) and certifies officials or the preparation of a business practices) that are developed or that this final rule will not have a federalism summary impact statement. adopted by voluntary consensus significant economic impact on a This rule will not have any substantial standards bodies, such as the Society of substantial number of small entities. effects on the States, or on the current Automotive Engineers (SAE). The The statement of the factual basis for the Federal-State relationship, or on the NTTAA directs the agency to provide certification is that this final rule delays current distribution of power and Congress, through the OMB, until September 1, 2006, the effective responsibilities among the various local explanations when we decide not to use date of the final rule published on officials. The reason is that this final available and applicable voluntary August 17, 2005. As earlier stated, no rule applies to motor vehicle consensus standards. small business manufacturer will incur manufacturers, and not to the States or After conducting a search of available costs as a result of this final rule. local governments. Thus, the sources, we have determined that there For these reasons, and for the reasons requirements of Section 6 of the is no applicable voluntary consensus described in our discussion on Executive Order do not apply. standard for this final rule, which Executive Order 12866 and DOT delays the effective date of the August E. Executive Order 12988 (Civil Justice Regulatory Policies and Procedures, 17, 2005 final rule amending FMVSS Reform) NHTSA concludes that this final rule No. 101. will not have a significant economic Pursuant to Executive Order 12988 H. Unfunded Mandates Reform Act impact on a substantial number of small ‘‘Civil Justice Reform,’’ we have entities. considered whether this final rule Section 202 of the Unfunded would have any retroactive effect. Mandates Reform Act of 1995 (UMRA) C. National Environmental Policy Act NHTSA concludes that this final rule requires Federal agencies to prepare a NHTSA has analyzed this rulemaking will not have any retroactive effect. written assessment of the costs, benefits, action for the purposes of the National Under 49 U.S.C. 30103, whenever a and other effects of proposed or final Environmental Policy Act. The agency Federal motor vehicle safety standard is rules that include a Federal mandate has determined that implementation of in effect, a State may not adopt or likely to result in the expenditure by
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State, local or tribal governments, in the subject to the requirements of sections document, please address them to the aggregate, or by the private sector, of 202 and 205 of the UMRA. DOT Docket Number cited in the more than $100 million in any one year I. Plain Language heading of this notice. (adjusted for inflation with base year of 1995). Before promulgating a rule for Executive Order 12866 requires each J. Regulation Identifier Number (RIN) agency to write all rules in plain which a written statement is needed, The Department of Transportation section 205 of the UMRA generally language. Application of the principles assigns a regulation identifier number requires NHTSA to identify and of plain language includes consideration (RIN) to each regulatory action listed in consider a reasonable number of of the following questions: the Unified Agenda of Federal regulatory alternatives and adopt the —Have we organized the material to suit Regulations. The Regulatory Information least costly, most cost-effective, or least the public’s needs? burdensome alternative that achieves —Are the requirements in the rule Service Center publishes the Unified the objectives of the rule. The clearly stated? Agenda in April and October of each provisions of section 205 do not apply —Does the rule contain technical year. You may use the RIN contained in when they are inconsistent with language or jargon that is not clear? the heading at the beginning of this applicable law. Moreover, section 205 —Would a different format (grouping document to find this action in the allows NHTSA to adopt an alternative and order of sections, use of headings, Unified Agenda. other than the least costly, most cost- paragraphing) make the rule easier to Authority: 49 U.S.C. 322, 30111, 30115, effective or least burdensome alternative understand? 30166, and 30177; delegation of authority at if the agency publishes with the final —Would more (but shorter) sections be 49 CFR 1.50. rule an explanation why that alternative better? was not adopted. —Could we improve clarity by adding Issued on: January 13, 2006. This rule will not result in the tables, lists, or diagrams? Jacqueline Glassman, expenditure by State, local, or tribal —What else could we do to make this Deputy Administrator. governments, in the aggregate, or by the rulemaking easier to understand? [FR Doc. 06–537 Filed 1–23–06; 8:45 am] private sector of more than $100 million If you have comments on the Plain BILLING CODE 4910–59–P annually. Accordingly, this rule is not Language implications of this final rule
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Proposed Rules Federal Register Vol. 71, No. 15
Tuesday, January 24, 2006
This section of the FEDERAL REGISTER stated above. Telephone: (202) 720– agricultural business sector in the contains notices to the public of the proposed 3241. importing country. Since inception, the issuance of rules and regulations. The SUPPLEMENTARY INFORMATION: instrument establishing the importer’s purpose of these notices is to give interested obligation to pay the export value has persons an opportunity to participate in the Background been a promissory note form, prescribed rule making prior to the adoption of the final rules. The regulations for the SCGP became by CCC and issued by the importer to effective on August 30, 1996. The the exporter. The U.S. exporter can hold program became operational with an the SCGP payment guarantee or assign DEPARTMENT OF AGRICULTURE announcement for Mexico on that same the guarantee to a U.S. financial day, providing coverage for high-value institution. In many cases, where the Commodity Credit Corporation agricultural products such as fruits, exporter has assigned SCGP payment vegetables, tree nuts, potatoes, wine, guarantees to a U.S. financial 7 CFR Part 1493 brandy, dairy products, and ice cream. institution, the exporter is paid the The products made eligible were those percentage guaranteed by CCC by that RIN 0551–ZA00 that typically traded in smaller financial institution and retains the risk of payment by the importer. In other Supplier Credit Guarantee Program transactions and not commonly financed under the existing CCC Export cases, the U.S. financial institution, in AGENCY: Commodity Credit Corporation Credit Guarantee Program (GSM–102). taking an assignment of the SCGP (CCC), USDA. CCC viewed the SCGP as a means of payment guarantee, may be willing to pay the exporter for the entire export ACTION: Advance Notice of Proposed supplementing the GSM–102 program value if that financial institution is able Rulemaking (ANPR). and providing more flexibility and options in leveraging private sector to make a credit assessment of the SUMMARY: This ANPR solicits comments credit. importer and is willing to accept the on options to reform the USDA, CCC, Since 1981, the GSM–102 program risk of default for the uncovered portion Supplier Credit Guarantee Program has served as a means of guaranteeing of the sale. (SCGP). The purpose of this ANPR is to the payment by foreign banks of credit Overall, since 1997, CCC issued invite suggestions on changes to reform extended by U.S. exporters or banks for approximately $2.78 billion in credit the program to reduce the risk of agricultural commodity sales. The SCGP guarantees under the SCGP supporting default, improve the ability to effect a provides a similar guarantee for more than $4.3 billion in U.S. export collection on defaulted obligations, and payment by importers when U.S. sales of agricultural commodities and consider alternative program exporters’ extend short-term credit, up products. Mexico has dominated the mechanisms and forms of payment to 180-days, in export sales. CCC SCGP as an import destination with obligations that are consistent with developed the SCGP as an export credit more than 60 percent of the volume of commercial export practices. The intent alternative that did not require a letter activity, but other regions such as of this request is to seek comments on of credit as a payment mechanism, Central America, South East Asia, and program reforms that would improve would better accommodate smaller the Caribbean have benefited and the SCGP’s effectiveness and efficiency transaction sizes associated with further growth in these regions is and lower costs. containerized shipping, and would react expected. The SCGP has supported the DATES: Comments must be submitted on to importers’ general desire to obtain U.S. export of a variety of agricultural or before February 23, 2006. open-account terms of payment from commodities and products ranging from U.S. exporters. bulk commodities such as feed grains, ADDRESSES: You may submit comments, At inception, the SCGP offered a 50 oilseeds, protein meals, rice, and cotton, by any of the following methods: E-mail: percent guarantee in the event that an but also including significant volumes [email protected]. importer of U.S. agricultural of red meat, poultry, fruits, grocery store Fax: (202) 690–1595 Attention: commodities or products defaulted on items, and other high value agricultural ‘‘SCGP/ANPR Comments.’’ an obligation to pay the exporter for the products. Mail: William S. Hawkins, Director, value of the goods sold. On December 3, From 1997 to 2004, the defaults Program Administration Division, 1997, CCC amended the commodity experienced in the SCGP were Export Credits, Foreign Agricultural eligibility for the SCGP to include bulk manageable given the limited size of the Service, U.S. Department of Agriculture, commodities such as cotton, feed grains, SCGP at that time and the sporadic 1400 Independence Ave., SW., Stop oilseeds, protein meals, and wheat. On nature of the defaults incurred. 1031, Washington, DC 20250–1031. October 1, 1999, guaranteed coverage However, in 2004 and 2005 CCC Hand Delivery/Courier: 1400 under the SCGP increased from 50 to 65 experienced significant defaults under Independence Ave., SW., Room 4083, percent. the SCGP. In reaction to these increased Washington, DC 20250–1031. The SCGP relies upon the principle of defaults, CCC made improvements to its All comments received will be risk-sharing between exporter and CCC claims recovery process, but CCC available for public inspection at the to work. Exporters are often in a unique continues to seek other means to reduce above address during regular business position to assess the ability of an defaults and better recoveries. hours. importer to pay for an export transaction CCC’s interest in SCGP improvements FOR FURTHER INFORMATION CONTACT: because of past contractual experience, also arises from the outcome of the William S. Hawkins, Director, access to importer’s credit references, or recent World Trade Organization (WTO) Administration Division, at the address specialized knowledge of the dispute brought by Brazil against the
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United States with respect to the CCC 5. Collection Experiences on Foreign interested parties via the rulemaking export credit guarantee programs, Bank Obligations: What are U.S. process. Other changes might be including SCGP. The WTO dispute exporters’ or U.S. financial institutions’ adopted by changing internal policies panel’s ruling requires CCC to charge collection experiences in using banker’s and procedures. Comments received premia that are adequate to cover the acceptances or avalized promissory will help the Department determine that long-term operating costs and losses of notes? extent and scope of any future the programs as a whole. In response, on 6. Risk Mitigation Techniques: rulemaking. • July 1, 2005, CCC revised the premia for Should CCC permit the U.S. Authority: 7 U.S.C. 5602, 5622, 5661, 5662, the export credit guarantee programs to exporter or financial institution to 5663, 5664, 5676; 15 U.S.C. 714b(d), 714c(f). reflect program default risk and mitigate their risk on the portion of the transaction value not covered by the Signed at Washington, DC, on December operating costs. CCC is interested in 16, 2005. exploring potential revisions to the SCGP payment guarantee? W. Kirk Miller, structure, design, or operation of SCGP • If CCC permits risk mitigation, what that can contribute to meeting this should CCC do to ensure that the risk- General Sales Manager and Vice President, Commodity Credit Corporation. ‘‘break-even’’ goal, particularly by sharing principal is maintained and that incurring fewer program losses. all monies are shared, on a pro-rata [FR Doc. 06–610 Filed 1–23–06; 8:45 am] We request interested parties to basis, between CCC and the exporter/ BILLING CODE 3410–05–M comment on the following specific assignee? questions under consideration for the 7. Standby Letters of Credit: SCGP. Interested parties may choose to • Should CCC require that the NUCLEAR REGULATORY address any or all of the questions listed importer open a standby letter of credit COMMISSION or provide other comment. CCC’s aim is to the exporter for a portion of the to improve upon the SCGP’s integrity, export value that could be drawn upon 10 CFR Part 73 effectiveness, flexibility, and continued by the exporter and shared with CCC on RIN 3150–AH60 viability. a pro-rate basis in the event of the 1. Transaction Size Considerations: default? Design Basis Threat; Reopening of What limit, if any, should be imposed • What costs might be expected if the Comment Period on the value of transactions or the importer were required to maintain a AGENCY: Nuclear Regulatory amount of exposure that CCC should standby letter of credit associated with Commission. take on the importer that would be the SCGP transaction? consistent with commercial practices? 8. Creditworthiness Assessment of ACTION: Proposed rule: Reopening of 2. Level of Guarantee Coverage: Importers: comment period. • Is the current level of guarantee • What are exporters’ and U.S. SUMMARY: On November 7, 2005 (70 FR coverage at 65 percent appropriate? financial institutions’ experiences in 67380), the Nuclear Regulatory • If a higher level of guarantee their attempts to assess the Commission (NRC) published for public coverage is desired, what measures creditworthiness of the importer using comment a proposed rule consolidating should CCC adopt to better ensure that commercial credit reference services? the supplemental requirements importers are capable of meeting their • Are there countries and regions established by the April 29, 2003, credit obligations? where credit assessments on agricultural • If CCC offered a lower level of importers cannot be performed readily design basis threat (DBT) orders with guarantee coverage, at what point would and reliably? the existing DBT requirements in 10 one the SCGP no longer be a viable 9. Collections and Recoveries: CFR 73.1(a). Specific details of the program for U.S. exporters? • How can CCC best partner with the attributes of the DBT to be protected 3. Assignments of Payment exporter and/or the financial institution against, which include both safeguards Guarantees: that has accepted assignment of a SCGP information (SGI) and classified • Should CCC require assignment of payment guarantee in order to effect a information, are consolidated in the SCGP payment guarantee and risk? collection? adversary characteristics documents • Should CCC permit, but not require • What other means should CCC (ACDs) and Regulatory Guides (RGs). the exporter to assign the SCGP employ in its recovery efforts on SCGP The proposed rule would revise the payment guarantee risk? defaults? DBT requirements both for radiological • Should CCC not permit the exporter 10. Other Concerns: What other sabotage and for theft or diversion of to assign the SCGP payment guarantee concerns, comments, or interests Strategic Special Nuclear Material and risk? relating to the program regulations, (SSNM). ACDs and RGs provide 4. Alternative Payment Obligations: mechanisms, and operations of the guidance to licensees concerning the • Should CCC permit alternative SCGP are important? DBT for radiological sabotage, theft and forms of payment obligations that would diversion. They contain the specific change the obligor risk from the Consideration of Comments details of the attributes of the threat importer to a foreign bank? (Examples of Additional comments on other which licensees need to know in order such alternative payment obligation are: program modifications to the SCGP that to evaluate what is necessary to comply A banker’s acceptance from an eligible are responsive to the principles outlined with the proposed rule. On December foreign bank, a guarantee of an eligible herein are encouraged. CCC will 21, 2005, the Nuclear Energy Institute foreign bank of the importer’s obligation carefully consider all comments (NEI) requested a 30 day extension to to pay, or a bank aval (obligation to pay) submitted by interested parties. After the public comment period. Their added to the importer’s promissory consideration of the comments received, request was based on the fact that note.) CCC will consider what changes, if any, though the proposed rule was published • What are the estimated costs of should be made to the SCGP. Some of on November 7, 2005, the RGs and the requiring a foreign bank guarantee the above-described changes would ACDs were not available at that time. mechanism on the importer’s obligation require additional notice and NEI requested copies of these as stated in the question above? consideration of comments from documents. The NRC staff agreed to
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provide these documents to the properly Regulatory Commission, Washington, and follow the instructions for sending cleared individuals with a need to DC 20555–0001; telephone (301) 415– your comments electronically. know, and NEI received the draft RGs 2905; e-mail [email protected] or Mr. • Mail: Docket Management Facility, and ACDs for power reactors on Richard Rasmussen, Office of Nuclear U.S. Department of Transportation, 400 December 19, 2005. In view of the delay Security and Incident Response, U.S. Seventh Street SW., Nassif Building, in providing the documents to the Nuclear Regulatory Commission, room PL–401, Washington, DC 20590. cleared personnel and in the interests of Washington, DC 20555–0001; telephone • Fax: (202) 493–2251. obtaining public comment from the (301) 415–8380; e-mail [email protected]. • Hand Delivery: Room PL–401 on broadest range of stakeholders, the Dated at Rockville, Maryland, this 18th day the plaza level of the Nassif Building, comment period on the proposed rule is of January, 2006. 400 Seventh Street, SW., Washington, being extended for an additional 30 For the Nuclear Regulatory Commission. DC, between 9 a.m. and 5 p.m., Monday days from the original January 23, 2006, Annette L. Vietti-Cook, through Friday, except Federal holidays. deadline to February 22, 2006. Contact Fokker Services B.V., P.O. Secretary of the Commission. DATES: The comment period has been Box 231, 2150 AE Nieuw-Vennep, the [FR Doc. 06–676 Filed 1–23–06; 8:45 am] extended and now expires on February Netherlands, for service information 22, 2006. Comments received after this BILLING CODE 7590–01–P identified in this proposed AD. date will be considered if it is practical FOR FURTHER INFORMATION CONTACT: Tom to do so, but the Commission is able to Rodriguez, Aerospace Engineer, ensure consideration only for comments DEPARTMENT OF TRANSPORTATION International Branch, ANM–116, FAA, received before this date. Federal Aviation Administration Transport Airplane Directorate, 1601 ADDRESSES: Mail written comments to: Lind Avenue, SW., Renton, Washington Secretary, U.S. Nuclear Regulatory 14 CFR Part 39 98055–4056; telephone (425) 227–1137; Commission, Washington, DC 20555– fax (425) 227–1149. 0001, Attn: Rulemakings and [Docket No. FAA–2006–23659; Directorate SUPPLEMENTARY INFORMATION: Adjudications Staff. Identifier 2005–NM–236–AD] Comments Invited Hand delivered comments should also RIN 2120–AA64 be addressed to the Secretary, U.S. We invite you to submit any relevant Nuclear Regulatory Commission, and Airworthiness Directives; Fokker written data, views, or arguments delivered to 11555 Rockville Pike, Model F27 Mark 100, 200, 300, 400, 500, regarding this proposed AD. Send your Rockville, MD, between 7:30 a.m. and 600, and 700 Airplanes comments to an address listed in the 4:15 p.m. Federal workdays. ADDRESSES section. Include the docket AGENCY: You may also provide comments via Federal Aviation number ‘‘FAA–2006–23659; Directorate the NRC’s interactive rulemaking Web Administration (FAA), Department of Identifier 2005–NM–236–AD’’ at the site: http://ruleforum.llnl.gov. This site Transportation (DOT). beginning of your comments. We also provides the availability to upload ACTION: Notice of proposed rulemaking specifically invite comments on the comments as files (any format), if your (NPRM). overall regulatory, economic, Web browser supports that function. For environmental, and energy aspects of SUMMARY: The FAA proposes to adopt a information about the interactive the proposed AD. We will consider all new airworthiness directive (AD) for all rulemaking site, contact Ms. Carol comments received by the closing date Fokker Model F27 Mark 100, 200, 300, Gallagher, (301) 415–5905; e-mail: and may amend the proposed AD in 400, 500, 600, and 700 airplanes. This [email protected]. light of those comments. proposed AD would require revising the Certain documents relating to this We will post all comments we Limitations section of the airplane flight rulemaking, including comments receive, without change, to http:// manual regarding the use of continuous received, may be examined at the NRC dms.dot.gov, including any personal ignition, fuel filter heating, and resetting Public Document Room, 11555 information you provide. We will also circuit breakers during flight in certain Rockville Pike, Room O1–F21, post a report summarizing each conditions such as icing. This proposed Rockville, MD. The same documents substantive verbal contact with FAA AD results from reports of power loss on may also be viewed and downloaded personnel concerning this proposed AD. one or both engines in icing conditions. electronically via the rulemaking Web Using the search function of that Web We are proposing this AD to advise the site: http://ruleforum.llnl.gov. site, anyone can find and read the flightcrew that continuous ignition will Documents created or received at the comments in any of our dockets, not reduce the probability of power loss, NRC after November 1, 1999 are also including the name of the individual and what action they must take to avoid available electronically at the NRC’s who sent the comment (or signed the this hazard. Loss of power in one or Public Electronic Reading room on the comment on behalf of an association, more engines during flight, if not Internet at http://www.nrc.gov/NRC/ business, labor union, etc.). You may prevented, could result in loss of control ADAMS/index.html. From this site, the review the DOT’s complete Privacy Act of the airplane. public can gain entry into the NRC’s Statement in the Federal Register Agencywide Document Access and DATES: We must receive comments on published on April 11, 2000 (65 FR Management System (ADAMS), which this proposed AD by February 23, 2006. 19477–78), or you may visit http:// provides text and image files of NRC’s ADDRESSES: Use one of the following dms.dot.gov. public documents. For more addresses to submit comments on this information, contact the NRC Public proposed AD. Examining the Docket Document Room (PDR) Reference staff • DOT Docket Web site: Go to You may examine the AD docket on at 1–800–397–4209, 202–634–3273 or http://dms.dot.gov and follow the the Internet at http://dms.dot.gov, or in by e-mail to [email protected]. instructions for sending your comments person at the Docket Management FOR FURTHER INFORMATION CONTACT: Mr. electronically. Facility office between 9 a.m. and 5 Manash K. Bagchi, Office of the Nuclear • Government-wide rulemaking Web p.m., Monday through Friday, except Reactor Regulation, U.S. Nuclear site: Go to http://www.regulations.gov Federal holidays. The Docket
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Management Facility office (telephone § 21.29 of the Federal Aviation 1. Is not a ‘‘significant regulatory (800) 647–5227) is located on the plaza Regulations (14 CFR 21.29) and the action’’ under Executive Order 12866; level of the Nassif Building at the DOT applicable bilateral airworthiness 2. Is not a ‘‘significant rule’’ under the street address stated in the ADDRESSES agreement. Pursuant to this bilateral DOT Regulatory Policies and Procedures section. Comments will be available in airworthiness agreement, the CAA–NL (44 FR 11034, February 26, 1979); and the AD docket shortly after the Docket has kept the FAA informed of the 3. Will not have a significant Management System receives them. situation described above. We have economic impact, positive or negative, examined the CAA–NL’s findings, Discussion on a substantial number of small entities evaluated all pertinent information, and The Civil Aviation Authority—The under the criteria of the Regulatory determined that we need to issue an AD Flexibility Act. Netherlands (CAA–NL), which is the for airplanes of this type design that are airworthiness authority for The certificated for operation in the United We prepared a regulatory evaluation Netherlands, notified us that an unsafe States. Therefore, we are proposing this of the estimated costs to comply with condition may exist on all Fokker Model AD, which would require revising the this proposed AD and placed it in the F27 Mark 100, 200, 300, 400, 500, 600, normal, abnormal, and emergency AD docket. See the ADDRESSES section and 700 airplanes. The CAA–NL advises procedures sections of the AFM for a location to examine the regulatory that since the start of operations with regarding the use of continuous ignition, evaluation. the Fokker F27 in 1958, there have been fuel filter heating, and resetting circuit List of Subjects in 14 CFR Part 39 13 reports of power loss on a single breakers during flight in certain engine in icing conditions, and 9 reports conditions such as icing conditions. Air transportation, Aircraft, Aviation of power loss on both engines in icing safety, Safety. conditions. Investigation revealed that Costs of Compliance The Proposed Amendment the use of continuous ignition in icing This proposed AD would affect about conditions while the auto-feather 27 airplanes of U.S. registry. The AFM Accordingly, under the authority system is armed could cause damage to revision would take about 1 work hour delegated to me by the Administrator, the engine turbine on both engines if per airplane, at an average labor rate of the FAA proposes to amend 14 CFR part there is an engine flame-out or loss of $65 per work hour. Based on these 39 as follows: power. Continuous ignition used in figures, the estimated cost of the these circumstances could cause an proposed AD for U.S. operators is PART 39—AIRWORTHINESS immediate relight with the propeller $1,755, or $65 per airplane. DIRECTIVES already in a course pitch and, as a consequence, damage the turbine and Authority for This Rulemaking 1. The authority citation for part 39 cause the engine to shut down. In this Title 49 of the United States Code continues to read as follows: case, the engine cannot be restarted. The specifies the FAA’s authority to issue Authority: 49 U.S.C. 106(g), 40113, 44701. investigation also revealed that the rules on aviation safety. Subtitle I, § 39.13 [Amended] requirements in the airplane flight section 106, describes the authority of manual (AFM) regarding the use of the FAA Administrator. subtitle VII, 2. The Federal Aviation continuous ignition in certain Aviation Programs, describes in more Administration (FAA) amends § 39.13 operational conditions will not reduce detail the scope of the Agency’s by adding the following new the probability of loss of engine power. authority. airworthiness directive (AD): Loss of power in one or more engines We are issuing this rulemaking under Fokker Services B.V.: Docket No. FAA– during flight, if not prevented, could the authority described in subtitle VII, 2006–23659; Directorate Identifier 2005– result in loss of control of the airplane. part A, subpart III, section 44701, NM–236–AD. ‘‘General requirements.’’ Under that Comments Due Date Relevant Service Information section, Congress charges the FAA with Fokker Service B.V. has issued Fokker promoting safe flight of civil aircraft in (a) The FAA must receive comments on Manual Change Notification— air commerce by prescribing regulations this AD action by February 23, 2006. Operational Documentation (MCNO) for practices, methods, and procedures Affected ADs MCNO–F27–020, dated June 1, 2004, to the Administrator finds necessary for (b) None. the Fokker F27 AFM. The MCNO safety in air commerce. This regulation revises the normal, abnormal, and is within the scope of that authority Applicability emergency procedures sections of the because it addresses an unsafe condition (c) This AD applies to all Fokker Model AFM regarding the use of continuous that is likely to exist or develop on F27 Mark 100, 200, 300, 400, 500, 600, and ignition, fuel filter heating, and resetting products identified in this rulemaking 700 airplanes, certificated in any category. circuit breakers during flight in certain action. Unsafe Condition operating conditions such as icing Regulatory Findings (d) This AD results from reports of power conditions. The CAA–NL mandated the loss on one or both engines in icing AFM revisions and issued Dutch We have determined that this conditions. We are issuing this AD to advise airworthiness directive 2004–122, dated proposed AD would not have federalism the flightcrew that continuous ignition will October 28, 2004, to ensure the implications under Executive Order not reduce the probability of power loss, and continued airworthiness of these 13132. This proposed AD would not what action they must take to avoid this airplanes in the Netherlands. have a substantial direct effect on the hazard. Loss of power in one or more engines States, on the relationship between the during flight, if not prevented, could result FAA’s Determination and Requirements national Government and the States, or in loss of control of the airplane. of the Proposed AD on the distribution of power and Compliance These airplane models are responsibilities among the various (e) You are responsible for having the manufactured in the Netherlands and levels of government. actions required by this AD performed within are type certificated for operation in the For the reasons discussed above, I the compliance times specified, unless the United States under the provisions of certify that the proposed regulation: actions have already been done.
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Airplane Flight Manual (AFM) Revision (ft.) above the surface at Minchumina, All communications received on or (f) Within 30 days after the effective date AK. before the specified closing date for of this AD, revise the Limitations section of DATES: Comments must be received on comments will be considered before the Fokker F27 AFM by incorporating the or before March 10, 2006. taking action on the proposed rule. The information specified in Fokker Manual proposal contained in this notice may ADDRESSES: Send comments on the Change Notification—Operational be changed in light of comments proposal to the Docket Management Documentation (MCNO) MCNO–F27–020, received. All comments submitted will System, U.S. Department of dated June 1, 2004, into the Limitations be available for examination in the section of the AFM. Transportation, Room Plaza 401, 400 public docket both before and after the Seventh Street, SW., Washington, DC Note 1: The actions required by paragraph closing date for comments. A report (f) of this AD may be done by inserting a 20590–0001. You must identify the summarizing each substantive public copy of MCNO MCNO–F27–020 into the docket number FAA–2005–23276/ contact with FAA personnel concerned Normal Procedures, Abnormal Procedures, Airspace Docket No. 05–AAL–41, at the with this rulemaking will be filed in the and Emergency Procedures sections of the beginning of your comments. You may docket. Fokker F27 AFM. When this MCNO, MCNO– also submit comments on the Internet at F27–020, has been included in general http://dms.dot.gov. You may review the Availability of Notice of Proposed revisions of the AFM, the general revisions may be inserted in the AFM, provided the public docket containing the proposal, Rulemaking’s (NPRM’s) relevant information in the general revision any comments received, and any final An electronic copy of this document is identical to that in MCNO MCNO–F27– disposition in person in the Dockets may be downloaded through the 020. Office between 9 a.m. and 5 p.m., Internet at http://dms.dot.gov. Recently Monday through Friday, except Federal published rulemaking documents can Alternative Methods of Compliance holidays. The Docket Office (telephone (AMOCs) also be accessed through the FAA’s Web 1–800–647–5527) is on the plaza level page at http://www.faa.gov or the (g)(1) The Manager, International Branch, of the Department of Transportation ANM–116, Transport Airplane Directorate, Superintendent of Document’s Web NASSIF Building at the above address. page at http://www.access.gpo.gov/nara. FAA, has the authority to approve AMOCs An informal docket may also be for this AD, if requested in accordance with Additionally, any person may obtain examined during normal business hours a copy of this notice by submitting a the procedures found in 14 CFR 39.19. at the office of the Manager, Safety, (2) Before using any AMOC approved in request to the Federal Aviation accordance with § 39.19 on any airplane to Alaska Flight Service Operations, Administration, Office of Air Traffic which the AMOC applies, notify the Federal Aviation Administration, 222 Airspace Management, ATA–400, 800 appropriate principal inspector in the FAA West 7th Avenue, Box 14, Anchorage, Independence Avenue, SW., Flight Standards Certificate Holding District AK 99513–7587. Washington, DC 20591 or by calling Office. FOR FURTHER INFORMATION CONTACT: Gary (202) 267–8783. Communications must Related Information Rolf, Federal Aviation Administration, identify both docket numbers for this (h) Dutch airworthiness directive 2004– 222 West 7th Avenue, Box 14, notice. Persons interested in being 122, dated October 28, 2004, also addresses Anchorage, AK 99513–7587; telephone placed on a mailing list for future the subject of this AD. number (907) 271–5898; fax: (907) 271– NPRM’s should contact the FAA’s 2850; e-mail: [email protected]. Issued in Renton, Washington, on January Office of Rulemaking, (202) 267–9677, 13, 2006. Internet address: http:// to request a copy of Advisory Circular www.alaska.faa.gov/at. Ali Bahrami, No. 11–2A, Notice of Proposed SUPPLEMENTARY INFORMATION: Manager, Transport Airplane Directorate, Rulemaking Distribution System, which Aircraft Certification Service. Comments Invited describes the application procedure. [FR Doc. E6–795 Filed 1–23–06; 8:45 am] Interested parties are invited to The Proposal BILLING CODE 4910–13–P participate in this proposed rulemaking The FAA is considering an by submitting such written data, views, amendment to the Code of Federal or arguments as they may desire. Regulations (14 CFR part 71), which DEPARTMENT OF TRANSPORTATION Comments that provide the factual basis would create Class E airspace at Federal Aviation Administration supporting the views and suggestions Minchumina, AK. The intended effect of presented are particularly helpful in this proposal is to create Class E 14 CFR Part 71 developing reasoned regulatory airspace upward from 700 ft. above the decisions on the proposal. Comments surface to contain Instrument Flight [Docket No. FAA–2005–23276; Airspace are specifically invited on the overall Rules (IFR) operations at Minchumina, Docket No. 05–AAL–41] regulatory, aeronautical, economic, AK. environmental, and energy-related The FAA Instrument Flight Proposed Establishment of Class E aspects of the proposal. Procedures Production and Airspace; Minchumina, AK Communications should identify both Maintenance Branch has developed two AGENCY: Federal Aviation docket numbers and be submitted in new SIAPs and revised one SIAP for the Administration (FAA), DOT. triplicate to the address listed above. Minchumina Airport. The new ACTION: Notice of proposed rulemaking. Commenters wishing the FAA to approaches are; (1) Area Navigation acknowledge receipt of their comments (Global Positioning System) (RNAV SUMMARY: This action proposes to create on this notice must submit with those (GPS)) Runway (RWY) 03, original; (2) Class E airspace at Minchumina, AK. comments a self-addressed, stamped RNAV (GPS) RWY 21, original. The One revised Standard Instrument postcard on which the following revised SIAP is the Non-directional Approach Procedure (SIAP) and two statement is made: ‘‘Comments to Beacon (NDB) RWY 03, amendment 3. new SIAPs are being published for the Docket No. FAA–2005–23276/Airspace New Class E controlled airspace Minchumina Airport. Adoption of this Docket No. 05–AAL–41.’’ The postcard extending upward from 700 ft. above the proposal would result in creation of will be date/time stamped and returned surface within the Minchumina Airport Class E airspace upward from 700 feet to the commenter. area would be established by this action.
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The proposed airspace is sufficient to The Proposed Amendment revisions to the State Implementation contain aircraft executing the new and In consideration of the foregoing, the Plan (SIP) as submitted by the Governor revised instrument procedures at the Federal Aviation Administration of North Dakota with a letter dated April Minchumina Airport. proposes to amend 14 CFR part 71 as 11, 2003. The revisions affect certain The area would be depicted on follows: portions of air pollution control rules aeronautical charts for pilot reference. regarding permitting and prevention of The coordinates for this airspace docket PART 71—DESIGNATION OF CLASS A, significant deterioration. EPA is also are based on North American Datum 83. CLASS B, CLASS C, CLASS D, AND providing notice that on July 27, 2005, The Class E airspace areas designated as CLASS E AIRSPACE AREAS; North Dakota was delegated authority to 700/1200 foot transition areas are AIRWAYS; ROUTES; AND REPORTING implement and enforce certain New published in paragraph 6005 in FAA POINTS Source Performance Standards, as of Order 7400.9N, Airspace Designations January 31, 2004. In the ‘‘Rules and and Reporting Points, dated September 1. The authority citation for 14 CFR Regulations’’ section of this Federal 1, 2005, and effective September 15, part 71 continues to read as follows: Register, EPA is approving the State’s 2005, which is incorporated by Authority: 49 U.S.C. 106(g), 40103, 40113, SIP revision as a direct final rule reference in 14 CFR 71.1. The Class E 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– without prior proposal because the airspace designations listed in this 1963 Comp., p. 389. Agency views this as a noncontroversial document would be published § 71.1 [Amended] SIP revision and anticipates no adverse subsequently in the Order. 2. The incorporation by reference in comments. A detailed rationale for the The FAA has determined that this 14 CFR 71.1 of Federal Aviation approval is set forth in the preamble to proposed regulation only involves an Administration Order 7400.9N, the direct final rule. If EPA receives no established body of technical Airspace Designations and Reporting adverse comments, EPA will not take regulations for which frequent and Points, dated September 1, 2005, and further action on this proposed rule. If routine amendments are necessary to effective September 15, 2005, is to be EPA receives adverse comments, EPA keep them operationally current. It, amended as follows: will withdraw the direct final rule and therefore: (1) Is not a ‘‘significant it will not take effect. EPA will address * * * * * regulatory action’’ under Executive all public comments in a subsequent Order 12866; (2) is not a ‘‘significant Paragraph 6005 Class E airspace extending final rule based on this proposed rule. rule’’ under DOT Regulatory Policies upward from 700 feet or more above the EPA will not institute a second and Procedures (44 FR 11034; February surface of the earth. comment period on this action. Any 26, 1979); and (3) does not warrant * * * * * parties interested in commenting must preparation of a regulatory evaluation as AAL AK E5 Minchumina, AK [New] do so at this time. Please note that if EPA receives adverse comment on an the anticipated impact is so minimal. Minchumina Airport, AK Since this is a routine matter that will (Lat. 63°53′10″ N., long. 152°18′07″ W.) amendment, paragraph, or section of this rule and if that provision may be only affect air traffic procedures and air That airspace extending upward from 700 navigation, it is certified that this rule, feet above the surface within a 7-mile radius severed from the remainder of the rule, when promulgated, will not have a of the Minchumina Airport. EPA may adopt as final those provisions of the rule that are not the subject of an significant economic impact on a * * * * * substantial number of small entities adverse comment. under the criteria of the Regulatory Issued in Anchorage, AK, on January 13, 2006. DATES: Written comments must be Flexibility Act. received on or before February 23, 2006. The FAA’s authority to issue rules Anthony M. Wylie, ADDRESSES: Submit your comments, regarding aviation safety is found in Manager, Safety, Area Flight Service identified by Regional Material in Title 49 of the United States Code. Operations. EDOCKET (RME) ID Number R08–OAR– Subtitle 1, section 106 describes the [FR Doc. 06–599 Filed 1–23–06; 8:45 am] 2005–ND–0002, by one of the following authority of the FAA Administrator. BILLING CODE 4910–13–P methods: Subtitle VII, Aviation Programs, • describes in more detail the scope of the Federal eRulemaking Portal: http:// agency’s authority. ENVIRONMENTAL PROTECTION www.regulations.gov. Follow the on-line This rulemaking is promulgated AGENCY instructions for submitting comments. • under the authority described in subtitle Agency Web site: http:// 40 CFR Part 52 VII, part A, subpart 1, section 40103, docket.epa.gov/rmepub/. On November Sovereignty and use of airspace. Under [EPA–R08–OAR–2005–ND–0002; FRL– 28, 2005, Regional Material in that section, the FAA is charged with 8011–2] EDOCKET (RME), EPA’s electronic prescribing regulations to ensure the public docket and comment system, was safe and efficient use of the navigable Clean Air Act Approval and replaced by an enhanced federal-wide airspace. This regulation is within the Promulgation of Air Quality electronic docket management and scope of that authority because it Implementation Plan Revision for comment system located at http:// proposes to create Class E airspace North Dakota; Revisions to the Air www.regulations.gov. Therefore, you sufficient in size to contain aircraft Pollution Control Rules; Delegation of will be redirected to that site to access executing instrument procedures at Authority for New Source Performance the docket EPA–R08–OAR–2005–ND– Minchumina Airport and represents the Standards 0002 and submit comments. Follow the on-line instructions for submitting FAA’s continuing effort to safely and AGENCY: Environmental Protection comments. efficiently use the navigable airspace. Agency (EPA). • E-mail: [email protected] and ACTION: Proposed rule. List of Subjects in 14 CFR Part 71 [email protected]. Airspace, Incorporation by reference, SUMMARY: EPA is proposing to take • Fax: (303) 312–6064 (please alert Navigation (air). direct final action approving certain the individual listed in the FOR FURTHER
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INFORMATION CONTACT if you are faxing Register, EPA is approving the State’s 200, Denver, Colorado 80202–2466, comments). SIP revision as a direct final rule (303) 312–6437, [email protected]. • Mail: Richard R. Long, Director, Air without prior proposal because the SUPPLEMENTARY INFORMATION: See the and Radiation Program, Environmental Agency views this as a noncontroversial information provided in the Direct Final Protection Agency (EPA), Region 8, SIP revision and anticipates no adverse action of the same title which is located Mailcode 8P–AR, 999 18th Street, Suite comments. A detailed rationale for the in the Rules and Regulations section of 200, Denver, Colorado 80202–2466. approval is set forth in the preamble to this Federal Register. • Hand Delivery: Richard R. Long, the direct final rule. If EPA receives no Authority: 42 U.S.C. 7401 et seq. Director, Air and Radiation Program, adverse comments, EPA will not take EPA Region 8, Mailcode 8P–AR, 999 further action on this proposed rule. If Dated: December 7, 2005. 18th Street, Suite 200, Denver, Colorado EPA receives adverse comments, EPA Kerrigan G. Clough, 80202–2466. Such deliveries are only will withdraw the direct final rule and Acting Regional Administrator, Region 8. accepted Monday through Friday, 8 a.m. it will not take effect. EPA will address [FR Doc. 06–632 Filed 1–23–06; 8:45 am] to 4:55 p.m., excluding Federal all public comments in a subsequent BILLING CODE 6560–50–P holidays. Special arrangements should final rule based on this proposed rule. be made for deliveries of boxed EPA will not institute a second information. comment period on this action. Any ENVIRONMENTAL PROTECTION Please see the direct final rule which parties interested in commenting must AGENCY is located in the Rules Section of this do so at this time. Please note that if Federal Register for detailed EPA receives adverse comment on an 40 CFR Part 52 instructions on how to submit amendment, paragraph, or section of [EPA–R08–OAR–2005–CO–0002; FRL– comments. this rule and if that provision may be 8010–1] FOR FURTHER INFORMATION CONTACT: severed from the remainder of the rule, Amy Platt, Environmental Protection EPA may adopt as final those provisions Clean Air Act Approval and Agency, Region 8, 999 18th Street, Suite of the rule that are not the subject of an Promulgation of Air Quality 200, Denver, CO 80202–2466, (303) adverse comment. Implementation Plan Revision for 312–6449, [email protected]. DATES: Written comments must be Colorado; Long-Term Strategy of State SUPPLEMENTARY INFORMATION: See the received on or before February 23, 2006. Implementation Plan for Class I Visibility Protection information provided in the Direct Final ADDRESSES: Submit your comments, action of the same title which is located identified by Docket ID No. EPA–R08– AGENCY: Environmental Protection in the Rules and Regulations Section of OAR–2005–MT–0001, by one of the Agency (EPA). this Federal Register. following methods: ACTION: Proposed rule. Authority: 42 U.S.C. 7401 et seq. • http://www.regulations.gov. Follow the on-line instructions for submitting SUMMARY: EPA is proposing to approve Dated: December 7, 2005. a State Implementation Plan (SIP) Kerrigan G. Clough, comments. • revision submitted by the Governor of Acting Regional Administrator, Region 8. E-mail: [email protected] and [email protected]. Colorado with a letter dated March 24, [FR Doc. 06–628 Filed 1–23–06; 8:45 am] • Fax: (303) 312–6064 (please alert the 2005. This revision updates the Long- BILLING CODE 6560–50–P Term Strategy of the Visibility SIP to individual listed in the FOR FURTHER establish strategies, activities, and INFORMATION CONTACT if you are faxing comments). monitoring plans that constitute ENVIRONMENTAL PROTECTION reasonable progress toward the National • Mail: Richard R. Long, Director, Air AGENCY visibility goal. In the ‘‘Rules and and Radiation Program, Environmental Regulations’’ section of this Federal 40 CFR Part 52 Protection Agency (EPA), Region 8, Register, EPA is approving the State’s Mailcode 8P–AR, 999 18th Street, Suite [EPA–R08–OAR–2005–MT–0001, FRL–8012– SIP revision as a direct final rule 200, Denver, Colorado 80202–2466. 6] without prior proposal because the • Hand Delivery: Richard R. Long, Agency views this as a noncontroversial Director, Air and Radiation Program, Approval and Promulgation of Air SIP revision and anticipates no adverse Environmental Protection Agency Quality Implementation Plans; comments. A detailed rationale for the (EPA), Region 8, Mailcode 8P–AR, 999 Montana; Revisions to the approval is set forth in the preamble to 18th Street, Suite 300, Denver, Colorado Administrative Rules of Montana; the direct final rule. If EPA receives no 80202–2466. Such deliveries are only Proposed Rule adverse comments, EPA will not take accepted Monday through Friday, 8 a.m. further action on this proposed rule. If AGENCY: Environmental Protection to 4:55 p.m., excluding Federal EPA receives adverse comments, EPA Agency (EPA). holidays. Special arrangements should will withdraw the direct final rule and ACTION: Proposed rule. be made for deliveries of boxed it will not take effect. EPA will address information. SUMMARY: EPA is proposing to approve all public comments in a subsequent a State Implementation Plan (SIP) Please see the direct final rule which final rule based on this proposed rule. revision submitted by the State of is located in the Rules Section of this EPA will not institute a second Montana on August 25, 2004. The Federal Register for detailed comment period on this action. Any revisions are to the Administrative instructions on how to submit parties interested in commenting must Rules of Montana and correct internal comments. do so at this time. Please note that if references to state documents; correct FOR FURTHER INFORMATION CONTACT: EPA receives adverse comment on an references to, or update citations of, Laurie Ostrand, Air and Radiation amendment, paragraph, or section of Federal documents; and make minor Program, Mailcode 8P–AR, this rule and if that provision may be editorial changes. In the ‘‘Rules and Environmental Protection Agency severed from the remainder of the rule, Regulations’’ section of this Federal (EPA), Region 8, 999 18th Street, Suite EPA may adopt as final those provisions
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of the rule that are not the subject of an Dated: December 7, 2005. Department of Environmental Protection adverse comment. Kerrigan G. Clough, (ME DEP), State House Station 17, Acting Regional Administrator, Region 8. Hospital Street, Augusta, Maine 04333. DATES: Written comments must be For review of Maine’s application at the received on or before February 23, 2006. [FR Doc. 06–631 Filed 1–23–06; 8:45 am] BILLING CODE 6560–50–P Maine Department of Environmental ADDRESSES: Submit your comments, Protection, (ME DEP), one day advance identified by Docket ID No. R08–OAR– notice is requested by ME DEP and may 2005–CO–0002, by one of the following ENVIRONMENTAL PROTECTION be made by calling (207) 287–2651; and methods: AGENCY (2) EPA New England—Region 1 • Federal eRulemaking Portal: http:// Library, One Congress Street—11th 40 CFR Parts 239, 257, and 258 www.regulations.gov. Follow the on-line Floor, Boston, MA 02114–2023, business hours: 10 a.m. to 3 p.m., instructions for submitting comments. [FRL–8024–1] Monday through Thursday, telephone • Agency Web site: http:// Maine: Proposed Determination of number: (617) 918–1990. docket.epa.gov/rmepub/. On November Adequacy for the State Municipal Solid FOR FURTHER INFORMATION CONTACT: 28, 2005, Regional Material in Waste Landfill (MSWLF) Permitting Chuck Franks, Hazardous Waste Unit, EDOCKET (RME), EPA’s electronic Program Office of Ecosystems Protection, EPA public docket and comment system, was New England—Region 1, One Congress replaced by an enhanced Federal-wide AGENCY: Environmental Protection Street, Suite 1100 (CHW), Boston, MA electronic docket management and Agency (EPA). 02114–2023; telephone: (617) 918–1554; comment system located at http:// ACTION: Proposed rule. e-mail: [email protected]. www.regulations.gov. Therefore, you SUPPLEMENTARY INFORMATION: For will be redirected to that site to access SUMMARY: The EPA is proposing to the docket EPA–R08–OAR–2005–CO– approve the State of Maine’s permit additional information, please see the direct final rule published in the ‘‘Rules 0002 and submit comments. Follow the program for municipal solid waste and Regulations’’ section of this Federal on-line instructions for submitting landfills (MSWLF’s) and to approve the Register. comments. State’s approach of not allowing Dated: December 27, 2005. • E-mail: [email protected] and conditionally exempt small quantity [email protected]. generator (CESQG) hazardous waste to Robert W. Varney, be sent to non-municipal, non- Regional Administrator, EPA New England. • Fax: (303) 312–6064 (please alert hazardous waste disposal units. [FR Doc. 06–626 Filed 1–23–06; 8:45 am] the individual listed in the FOR FURTHER Elsewhere in today’s Federal Register, BILLING CODE 6560–50–P INFORMATION CONTACT if you are faxing EPA is publishing a direct final rule that comments). determines the adequacy of the State of • Mail: Richard R. Long, Director, Air Maine’s municipal solid waste DEPARTMENT OF COMMERCE and Radiation Program, Environmental permitting program without a prior Protection Agency (EPA), Region 8, proposal because we believe this action National Oceanic and Atmospheric Mailcode 8P–AR, 999 18th Street, Suite is not controversial and do not expect Administration 200, Denver, Colorado 80202–2466. comments that oppose it. Unless we get • Hand Delivery: Richard R. Long, relevant written comments which 50 CFR Part 270 oppose this determination of adequacy Director, Air and Radiation Program, during the comment period, the [Docket No. 040720212–4212–01; I.D. Environmental Protection Agency decision will take effect. If we receive 040204A] (EPA), Region 8, Mailcode 8P–AR, 999 comments that oppose this action, we 18th Street, Suite 200, Denver, Colorado RIN 0648–AS09 will publish a document in the Federal 80202–2466. Such deliveries are only Register withdrawing this rule before it Fish and Seafood Promotion Act accepted Monday through Friday, 8 a.m. takes effect and this separate document Provisions; Seafood Marketing to 4:55 p.m., excluding Federal in this proposed rules section of the Councils holidays. Special arrangements should direct final Federal Register will serve be made for deliveries of boxed AGENCY: National Marine Fisheries as the proposal to determine the information. Service (NMFS), National Oceanic and adequacy of the State Municipal Solid Atmospheric Administration (NOAA), Please see the direct final rule which Waste Landfill permitting program. is located in the Rules Section of this Department of Commerce. DATES: Send your written comments by ACTION: Proposed rule; request for Federal Register for detailed February 23, 2006. instructions on how to submit comments. comments. ADDRESSES: Send any written comments to Chuck Franks, EPA Region 1, One SUMMARY: In 1989, NMFS issued a final FOR FURTHER INFORMATION CONTACT: Congress Street, Suite 1100 (CHW), rule enacting the Fish and Seafood Amy Platt, Environmental Protection Boston, MA 02114–2023; telephone: Promotion Act of 1986 (Act), as it Agency, Region 8, 999 18th St., Suite (617) 918–1554; e-mail: pertains to Seafood Marketing Councils 200, Denver, Colorado, 80202, 303–312– [email protected]. Documents (Councils), for one or more species of 6449, [email protected]. related to EPA’s decision regarding the fish or fish products. That rule, along Determination of Adequacy (the with a large number of other rules and SUPPLEMENTARY INFORMATION: See the ‘‘Administrative Record’’) are available regulations unused or little used, was information provided in the Direct Final for inspection and copying during stricken from the Code of Federal action of the same title which is located normal business hours at the following Regulations (CFR) as part of a in the Rules and Regulations section of locations: (1) Monday through government-wide Presidential this Federal Register. Thursday, 8:30 a.m. to 4:30 p.m. and regulatory reform effort. Although the Authority: 42 U.S.C. 7401 et seq. Friday, 8:30 a.m. to 12:30 p.m., Maine implementing regulations were
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withdrawn from the CFR, the Act strategies and implement measures to Mexico states. Additional interest has remains in effect. In response to better inform consumers; promote the been expressed by U.S. tuna processors renewed industry support for marketing utilization of one or more species of fish who are also facing declining market and promotion-related activities, NMFS or fish products; enter into agreements shares due to foreign competition. The proposes regulations implementing the with eligible members of the seafood accompanying IRFA and RIR indicate Act governing the establishment and industry; fund referenda to establish that at least twelve fish species could operation of marketing Councils. and terminate species-specific Councils; benefit from the development of Therefore, the intent of the proposed and establish quality standards, attend organized marketing programs. rule is to responsibly implement the Act Council meetings, and approve seafood Marketing and promotion plans to be consistent with NMFS’ goals and marketing plans. prepared by a Council would be mission statement. That is, to ensure In 1986, when Congress enacted the designed to increase the general demand that NMFS stewardship goal is not Act, it found that: (1) The commercial for fish and fish products by jeopardized while increasing benefits fishing industry of the United States encouraging, expanding, and improving from domestic fisheries. Several significantly contributed to the national the marketing and utilization of fish and revisions to the 1989 implementing economy, and could make a great fish products both in domestic or regulations are proposed in this contribution if fish resources within the foreign markets, through consumer document in order to comply with new United States Exclusive Economic Zone education, research, and other regulatory and/or legal requirements. were more fully utilized; (2) the marketing and promotion activities. DATES: Comments on this proposed rule commercial fisheries of the United Therefore, NMFS proposes to are requested, and must be received no States provided significant employment implement regulations that would later than 5 p.m., local time, February in coastal areas and in processing and provide the foundation for the 23, 2006. distribution centers; (3) fish contributed establishment, organization, and an important nutritional component to practices of the Councils. This proposed ADDRESSES: Written comments on this the American diet; (4) increased proposed rule should be sent by any of rule identifies the role of the Secretary consumption of seafood in the United of Commerce, who has delegated the following methods: States could significantly lower the risk • E-mail: [email protected]. authority to NMFS, in the establishment of many cardiovascular diseases; (5) and administration of the Council Include in the subject line the following: Federally supported development ‘‘Comments on the Proposed Rule for process. Also provided are guidelines programs for commercial fisheries were for preparation of the application Seafood Marketing Councils;’’ unable to meet present and future • Federal e-Rulemaking Portal: http:// package including specific requirements marketing needs; (6) many fish species for proposed charters, identification of www.regulations.gov; were underutilized by the United States • Mail: Paper, disk, or CD-ROM sector participants who are eligible to fishing industry because of comments should be sent to Gordon J. vote in the referendum, descriptions of underdeveloped markets; and (7) the Helm, Acting Director, Office of how a referendum would be conducted, United States fishing industry had the and determination of payment and/or Constituent Services, Room 9553, potential to expand greatly its SSMC3, 1315 East-West Highway, Silver refunding of assessment fees. Also contribution to interstate and foreign addressed are petitions of objection Spring, MD 20910; and commerce, favorably affecting the • Fax: (301) 713–2384. related to assessment fees and petitions balance of trade. for the dissolution of a Council. NMFS Copies of the Regulatory Impact A final rule implementing the Act was suggests that interested persons also Review are available from Gordon Helm. published in the Federal Register on read the Act along with this document The Initial Regulatory Flexibility December 7, 1989 (54 FR 50504). A Analysis (IRFA) is contained in the National Seafood Marketing Council for additional information. Classification section of this proposed (National Council) was established Content and Submission of Application rule. under the Act. The National Council Package to Establish A Council Written comments regarding the was authorized to enter into agreements burden-hour estimates or other aspects with applicants to fund referenda to An application package submitted to of the collection-of-information establish and terminate species-specific NMFS to establish a Council would requirements contained in this rule marketing councils. However, no consist of the following information: (1) should be submitted to Gordon Helm species-specific marketing councils An application requesting NMFS to (see ADDRESSES) and to David Rostker, were established and the National establish a Council; (2) a list of sector Office of Management and Budget Council was disbanded. In 1996, the participants who are eligible to vote in (OMB), by e-mail at regulations implementing the Act were the referendum; (3) a proposed charter _ David [email protected], or fax to removed from the CFR as part of the under which the proposed Council (202) 395–7285. government-wide Presidential would operate; and (4) an IRFA and/or FOR FURTHER INFORMATION CONTACT: regulatory reform effort. other analytical documentation Gordon J. Helm, Office of Constituent The 1986 Congressional findings and addressing the requirements of the Services, telephone: (301) 713–2379 or statement of purpose (16 U.S.C. 4001 & Regulatory Flexibility Act, E.O. 12866, E-mail: [email protected]. 4002) concerning the value of the the National Environmental Policy Act, SUPPLEMENTARY INFORMATION: commercial fisheries to the United and other information NMFS considers States may still apply today. necessary or appropriate for the review Background Furthermore, industry interest and and approval of the application. The Fish and Seafood Promotion Act support for seafood marketing and One signed original and two copies of of 1986 (16 U.S.C. 4001 et seq.), enacted promotion-related activities has been the completed application package November 14, 1986, authorizes the expressed. Niche marketing programs should be submitted to the Assistant creation of Seafood Marketing Councils. have been initiated by both the Pacific Administrator for Fisheries, 1315 East- The Act provides authority to the salmon harvesters in Alaska and by the West Highway, Silver Spring, MD Secretary of Commerce (Secretary) to: Wild American Shrimp organization in 20910. NMFS would acknowledge Establish Councils that would develop the southern Atlantic and Gulf of receipt of the application package and
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contact the applicant if further provide available information in its (13) The procedures for providing information is required. possession of a non-proprietary nature refunds to sector participants subject to 1. Application. to assist in developing this list. assessments who request refunds in The application should be comprised The Council, if approved, would be accordance with the time limits; of the signatures or corporate required to maintain a list of sector (14) A provision setting forth the certifications of no less than three sector participants. The Council would need a voting procedures by which votes participants in each sector who current list of sector participants in each would be cast by proxy; collectively accounted for, in the sector represented on the Council, (15) A provision that the Council previous 12-month period, not less than particularly for the purposes of would have voting members 10 percent of the value of the fish or fish collecting assessments and voting in representing the harvesting, receiving products that were handled by each referenda. and, if subject to assessment, importing such sector during that period. For 3. Charter. sectors; purposes of the Act and this proposed At a minimum the text of the (16) A provision setting forth the rule, ‘‘sector’’ means: (A) The sector proposed charter would contain the definition of a quorum for making consisting of harvesters; (B) the sector following information: decisions on Council business and the consisting of importers; (C) the sector (1) The name of the Council and a procedures for selecting a chairperson of consisting of marketers; (D) the sector provision proclaiming its establishment; the Council; consisting of processors; (E) the sector (2) A declaration of the purposes and (17) A provision that members of the consisting of receivers; or (F) the objectives of the Council; Council would serve without consumer sector consisting of persons (3) A description of the species of fish compensation, but would be reimbursed professionally engaged in the and fish products, including the for reasonable expenses incurred in dissemination of information pertaining scientific and common name(s), for performing their duties as members of to the nutritional benefits and which the Council would implement the Council; preparation of fish and fish products. marketing and promotion plans under (18) A provision containing a Persons who meet these minimum the Act; requirement for submission of requirements would be eligible to (4) A description of the geographic documentation as requested by NMFS submit an application to NMFS to area (state(s)) within the United States for purposes of evaluating the establish a Council. The application covered by the Council; performance of proposed marking plans should include a statement that, if (5) The identification of each sector and the Council’s related performance; established, the Council would have and the number and terms of (19) A provision containing the sufficient resources, e.g., cash, donated representatives for each sector that minimum number of participants that office space, services, supplies, etc., would be voting members on the would be needed for sustained available for initial administrative Council; operations that cannot receive expenditures pending collection of (6) The identification of those sectors assessment refunds; assessments. (which would be required to include a (20) A provision acknowledging that 2. List of Sector Participants Eligible to sector consisting of harvesters, a sector NMFS would have the right to Vote in the Referendum. consisting of receivers, and, if subject to participate in Council meetings; The applicant would provide a list of assessment, a sector consisting of (21) A provision that NMFS would sector participants, to the extent importers) eligible to vote in the have final approval authority over practicable, identifying the business referendum to establish the Council; proposed marketing plans and Council name and address of all sector (7) For each sector a threshold level actions; participants that the applicant believes specifying the minimum requirements, (22) A provision containing a meet the requirements for eligibility to as measured by income, volume of sales, requirement for the Council to arrange vote in the referendum on the adoption or other relevant factors, that a person for a complete audit report to be of the proposed charter. The list would engaging in business in the sector would conducted by an independent public include all sectors in which a sector be required to meet in order to accountant and submitted to NMFS at participant meets the eligibility participate in a referendum; the end of each fiscal year; requirements. If the sector participant (8) A description of the rationale and (23) A provision containing a has more than one place of business procedures for determining assessment requirement for the Council to conduct located within the geographic area of rates based on a fixed amount per unit a market assessment based on economic, the Council, all such places would be of weight or measure, or on a percentage market, social and demographic, and listed and the primary place of business of value of the product handled; biological information as deemed should be designated. At the time of (9) The proposed rate or rates that necessary by NMFS; and submission of the application the would be imposed by the Council on (24) A provision containing a referendum list of sector participants receivers and, if subject to assessment, requirement for the Council to update would also contain the list of required importers during its first year of the list of sector participants eligible to signatures or corporate certifications. operation; vote in a referendum on an annual basis. NMFS acknowledges that (10) The maximum amount by which 4. Analytical Documentation. development of the list of sector an assessment rate for any period may Analytical documentation would be participants meeting the minimum be raised above the rate applicable for required as part of the application requirements stated in the proposed the immediately preceding period; package in order to determine the charter may be difficult. The Act (11) The maximum rate or rates that impacts of the proposed Council under requires the applicant, to the extent would be imposed by a Council on applicable law. Individual Councils, practicable, to develop such a list. receivers or importers during the once established, may impact on small NMFS would, to the extent practicable, operation of the Council; entities, but the impacts could not be verify the validity of the applicant’s list, (12) The maximum limit on the determined until the charter is drafted which may require adding or deleting amount any one sector participant with ranges of assessments based on names provided by applicant. At the would be required to pay under an volume, income, etc., of sector request of an applicant, NMFS would assessment for any period; participants to be involved in the
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Council. Specifically, the imposition of formal comment period. That notice proposed charter. NMFS would notify assessments on certain members of the would serve as a proposed rule thus the applicants of the results of the industry would have an effect on a triggering the requirements of the referendum and publish the results of firm’s financial situation. Any other Regulatory Flexibility Act. As is the referendum in the Federal Register. costs or requirements which the Council standard practice, NMFS in the Federal 2. Costs of Conducting a Referendum would impose on industry would also Register document would announce NMFS would initially pay all costs have to be considered and analyzed. availability of the IRFA and/or other related to the conduct of the referendum Since these parameters would vary with analytical documents for review and to establish a Council. Once an each application, a determination of comment. application has been approved, NMFS impact would be made on a case-by-case would estimate the cost of conducting Referendum on Adoption of Proposed basis. Therefore, the applicant would the referendum, notify the applicants, Charter provide an IRFA and/or other analytical and request that they post a bond or documentation addressing the 1. Sector Participant Vote provide other applicable security, such requirements of the Regulatory NMFS would conduct a referendum as a cashier’s check, to cover costs of the Flexibility Act, E.O. 12866, the National on the adoption of the proposed charter referendum. Although the cost of each Environmental Policy Act, and other within 90 days of its initial affirmative referendum would vary according to the information NMFS considers necessary decision. The referendum would be size of the Council, there would be some or appropriate for the review and conducted among all sector participants cost categories that would be common approval of the application. This other that meet the requirements for eligibility to the conduct of all referenda, e.g., necessary and appropriate information to participate in the referendum, as verification of the list of sector required for the review of the identified in the proposed charter. The participants, publication of the application includes, but is not limited vote may be made by any responsible application, charter, and list of sector to, an analysis of the primary, officer, owner, or employee representing participants in the Federal Register, secondary, and tertiary affects of a sector participant. printing and postage costs for the increasing demand for seafood. This A vertically integrated seafood ballots, etc. In the event a public hearing information would have to be company may qualify to vote in more is requested, this would also add to the incorporated into the NEPA analysis to than one sector, depending on the cost. determine if a proposed council or its requirements established for each sector After the referendum has been marketing program is consistent with by the Council. However, only one vote conducted, NMFS would inform the NMFS conservation goals, national may be cast by each sector participant applicants of the exact cost. If the standards, other national guidelines, who is eligible to vote, regardless of the referendum is approved and the and would have to be demonstrated to number of individuals that make up the proposed charter is adopted, the be consistent with Federal standards ‘‘sector participant’’ and how many Council would be required to reimburse and guidelines on nutrition and health. sectors the participant is engaged in. NMFS for the total actual costs of the Therefore, it is requested that referendum within 2 years after Initial Decision petitioners specify in the list of sector establishment of the Council. This NMFS would make an initial decision participants all sectors for which a amount would be paid for from on the application, list of sector sector participant meets the eligibility assessments collected by the Council. If participants eligible to vote in the requirements to vote in a referendum. a referendum fails to result in referendum, charter, and other required The ballot for each referendum would establishment of a Council, NMFS analytical documentation such as the request that each person voting certify would immediately recover all expenses IRFA within 180 days of receipt. NMFS in which sector he/she is voting in that incurred from the bond or security would determine if the application particular referendum. This certification posted by applicants. In either case, package is complete and complies with by sector participants voting in a such expenses would not include all of the requirements set forth in the referendum will be important to NMFS salaries of government employees or implementing regulations, the Act, and and the Council in order to determine other administrative overhead, but other applicable law. the success or failure of a referendum, would be limited to those additional If a negative determination is made, since the percentage of sector direct costs incurred in connection with NMFS would advise the applicant in participants voting favorably and the conducting the referendum to establish writing of the reasons for the negative value of fish products they handled in a Council. determination, such as missing a sector will determine the outcome. documentation. The applicant may The referendum to establish a Council Appointments, Terms, Vacancies, and submit a revised application package for would pass if votes cast in favor of the Removal of Council Members reconsideration. NMFS would then have proposed charter constitute a majority of Within 30 days after a Council is 180 days from receipt of the revised the sector participants voting in each established, NMFS would solicit application package to make a and every sector. Further, the majority nominations for Council members from determination. must collectively account for, in the the sector participants represented on If an affirmative decision is made, the preceding 12-month period, at least 66 the Council in accordance with the Act requires NMFS to publish (by such percent of the value of the fish and fish approved charter. The members of each means as will result in wide publicity products described in the proposed Council would be individuals who, by in regions affected by the proposed charter that were handled during this reason of their occupational or other charter) the text of the proposed charter period, in that sector, and by those who experience, scientific expertise, or and a list of those sector participants met the eligibility requirements to vote training, are knowledgeable with regard eligible to vote in the referendum and in the referendum. If the referendum to the activities of the sector which the provide for public comment, including passes, NMFS could establish a Council individual would represent on the the opportunity for public meeting and and approve the proposed charter. If a Council. To the extent practicable, the to amend the list of sector participants. referendum fails to pass in any sector of nominations should result in equitable NMFS intends to publish notification in the proposed Council, NMFS would not representation for the constituent the Federal Register and provide a establish the Council or approve the regions.
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NMFS would appoint the members of entrants into a fishery, and other effort assessments will be imposed. With the the Council from among the nominees control measures, would be programs concurrence of the Secretary, a Council within 60 days. The term for members that comply with this standard. In would establish the applicable would be 3 years. Initially, to ensure addition, NMFS would retain the assessment for those seeking to rejoin or continuity, half of the members’ terms authority to determine if the continued participate in a Council at a future time. would be 2 years and half would be 3 operation of a Council would be in the 1. Sector Participant and Related years. Reappointments would be public interest. Councils would be Assessment. permissible. required to meet performance standards An assessment on sector participants Vacancies on a Council would be approved by NMFS that demonstrate in the receiving sector would be in the filled within 60 days after the vacancy that marketing and promotion programs form of a percentage of the value or a occurs, in the same manner in which are effective in increasing consumer fixed amount per unit of weight or the original appointment was made. A demand for species-specific seafood volume of the fish described in the member appointed to fill a vacancy products. Councils would also be charter when purchased by receivers occurring before the expiration of the required to conduct market assessments from fish harvesters. term for which the member’s based on economic, market, social and An assessment on sector participants predecessor was appointed would be demographic, and biological who own fish processing vessels and appointed only for the remainder of that information as deemed necessary by harvest the fish described in the charter term. NMFS. This information and data would be in the form of a percentage of Council members would serve would be provided to NMFS with the the value or on a fixed amount per unit without compensation but would be market assessment for review and of weight or volume of the fish in the reimbursed for their reasonable verification of results and analysis and charter that is no less than the value if expenses incurred in performing their may be used by NMFS subject to normal such fish had been purchased by a duties as members of the Council. rules and guidelines for industry receiver other than the owner of the NMFS would remove a member of a generated data and information. harvesting vessel. Council if the Council recommended, by An assessment on sector participants Reports and Marketing Plans not less than two-thirds of its members, in the importing sector would be in the removal for cause. Such a Councils would be required to submit form of a percentage of the value that an recommendation of a Council should be annual plans and budgets for species- importer pays to a foreign supplier, as in writing and accompanied by a specific marketing and promotion plans, determined for the purposes of the statement of the reasons upon which the including when applicable consumer customs laws, or a fixed amount per recommendation would be based. education, research, and other activities unit of weight or volume, of the fish or of the Councils. Councils would also be Continued Operation of the Council fish products described in the charter required to submit progress reports on when entered or withdrawn from Continued operation of a Council implementation of the marketing and warehouse for consumption, in the would be at the discretion of NMFS and promotion plans and a financial reports customs territory of the United States by subject to NMFS’ annual review of a with respect to the receipt and such sector participants. market assessment prepared by the disbursement of funds entrusted to it. 2. Notice of Assessment to Sector Council and evaluation of Council NMFS would require a complete audit Participant performance. Increases in product report to be conducted by an The Council would provide notice to prices would not be the sole criteria for independent public accountant and a sector participant subject to determining the effectiveness of a submitted to NMFS at the end of each assessment that the assessment is due. marketing program. The Council must fiscal year. The notice of assessment would contain: demonstrate that the marketing plan The Council must maintain reports, a. A specific reference to the would not adversely impact those books, and records for a minimum of 3 provisions of the Act, regulations, fisheries for which conservation and years, even if the Council is terminated charter, and referendum that authorize management measures are necessary to in less than 3 years. The purpose of this the assessment; prevent overfishing and rebuild requirements is to enable NMFS to b. The amount of the assessment; overfished stocks, i.e., the market plan ensure that all remaining business of the c. The period of time covered by the would be designed to increase profits terminated Council is concluded in an assessment; rather than increase harvest. The orderly manner. The 3-year time limit is d. The date the assessment would be marketing plan should also demonstrate in accordance with the Office of due and payable, which would not be that conservation and management Management and Budget guidelines for earlier than 30 days from the date of the efforts in other fisheries are not implementing the Paperwork Reduction notice; adversely affected, but the Secretary Act. e. The form(s) of payment; and may use the primary, secondary, or f. To whom and where the payment Assessments tertiary impacts in evaluating whether would be made. the Council should be allowed to Councils would be funded through g. Notification of the right to seek continue operating. Where measures voluntary assessment of the industry review of the assessment by filing a have been implemented to reduce the represented on the Councils. written petition of objection with NMFS overall harvest in a fishery, the Assessments would be imposed on at any time during the time period to marketing plan should clearly identify sector participants in the receiving which the assessment applies in how stock conservation harvest capacity sector or the importing sector or both as accordance with the procedures in reduction would not be adversely specified in the approved Council § 270.19. impacted. Council support of the charter. Assessment rates would be h. Notification of the right to request regional fishery management council’s based on value that may be expressed in a hearing on the petition of objection. adoption of dedicated or controlled monetary units or units of weight or i. Notification of the a right to request access programs, for example but not volume. Once a participant declines to a refund of the assessment; the request limited to programs such as Individual pay an assessment, or elects not to for a refund may be submitted for not Fishing Quota, moratorium on new participant in a Council, no future less than 90 days from the date of the
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assessment; and the Council would in a referendum or other business of the Administration’s minimum make the refund within 60 days from Council during the remainder of the requirements for fish and fish products the date of the receipt. assessment rate period. However, if for human consumption and must be Persons subject to an assessment assessments should be paid during a consistent with applicable standards of would be required to pay the assessment future assessment rate period and no the U.S. Department of Commerce on or before the date due, unless they refund is requested, that sector (National Oceanic and Atmospheric have demanded a refund or filed a participant would be able to again Administration) or other recognized petition of objection with NMFS under participate in a referendum or other Federal standards and/or specifications § 270.21. However, person who have business of the Council. for fish and fish products. demanded a refund under § 270.22 or The intent of quality standards must Quality Standards filed a petition of objection under not be to discriminate against importers § 270.21 may submit proof of these Each Council may develop and who are not members of the Council. actions in leu of payment. In the case of submit to NMFS for approval, or upon Quality standards must not be a petition of objection, NMFs will the request of a Council, NMFS would developed for the purpose of creating inform the Council and the petitioner of develop quality standards for the non-tariff barriers. Such standards must its finding at which time petitioner must species of fish or fish products be compatible with U.S. obligations pay the revised assessment if applicable. described in the approved charter. Any under the General Agreement on Tariffs 3. Petition of Objection quality standard developed should be and Trade, or under other international Requests for NMFS to modify or take consistent with the purposes of the Act. standards deemed acceptable by NMFS. other appropriate action regarding the A quality standard should be adopted No quality standard adopted by a assessment may be made by filing with by a Council by a majority of its Council can be used in false or NMFS a written petition of objection. members following a referendum misleading advertising or promotion of Any sector participant subject to an conducted by the Council among sector fish or fish products. A quality standard assessment may file a written petition participants of the concerned sector(s). may be adopted which requires sector with NMFS alleging that the assessment, In order for a quality standard to be the plan approved upon which the participants to be in the U.S. brought before Council members for Department of Commerce voluntary assessment is based, or any obligation adoption, the majority of the sector imposed under the plan, is not in seafood inspection program. participants of the concerned sector(s) With respect to a quality standard accordance with the law. A petition of must vote in favor of the standard. objection may request NMFS to modify adopted under this section, the Council Further, according to the best available would develop and file with NMFS an or take other appropriate action data, the majority must collectively regarding the assessment or plan. A official identifier in the form of a account for, in the preceding 12-month symbol, stamp, label or seal that would petition may be filed only during the period, not less than 66 percent of the time period to which the assessment be used to indicate that a fish or fish value of the fish or fish products product meets the quality standard at applies. The petitioner may also request described in the charter that were a formal hearing. Following the hearing, the time the official identifier is affixed handled during such period in that to the fish or fish product, or is affixed or if no hearing is held, as soon as sector by those who meet the eligibility practicable, NMFS would decide the to or printed on the packaging material requirements to vote in the referendum. of the fish or fish product. The use of matter and serve written notice of the Councils may develop quality standards decision to the petitioner and the such identifier would be governed by establishing the criteria for the fish or § 270.15. Council. NMFS’s decision would be fish products being promoted. The based on a consideration of all relevant Council would submit a plan to conduct Dissolution of a Council documentation and other evidence the referendum on the quality standards submitted, and would constitute the 1. Petition for Termination to NMFS for approval at least 60 days final administrative decision and order No less than three sector participants in advance of such referendum date. of the agency. in any one sector may file a petition to The plan would consist of the following: 4. Refund of Assessment terminate a Council. The petition would Pursuant to 16 U.S.C. 4014, any sector (1) Date(s) for conducting the be accompanied by a written document participant who pays an assessment referendum; explaining the reasons for the petition. (2) Method (by mail or in person); If NMFS initially determines that the under the Act may demand and must (3) Copy of the proposed notification petition is accompanied by the promptly receive from the Council a to sector participants informing them of signatures, or corporate certifications, of refund of the assessment. A demand for the referendum; refund must be made in accordance (4) List of sector participants eligible no less than three sector participants in with procedures in the approved charter to vote; the sector who collectively accounted and within the time limits prescribed by (5) Name of individuals responsible for, in the preceding 12-month period, the Council and approved by NMFS. for conducting the referendum; not less than 20 percent of the value of Procedures to provide such a refund (6) Copy of proposed ballot package to the fish or fish products that were would be established before any such be used in the referendum; and handled by that sector during the assessment would be collected. The (7) Date(s) and location of ballot period, NMFS within 90 days after the refund procedures would allow the counting. initial determination, would conduct a sector participant to request a refund for An official observer appointed by referendum for termination of the not less than 90 days from the date of NMFS would be allowed to be present Council among all sector participants in the assessment and the Council would at the ballot counting and any other that sector. make the refund within 60 days from phase of the referendum process, and NMFS would publish notification in the date of the receipt of the request for may take whatever steps NMFS deems the Federal Register of the referendum, the refund. Once a refund has been appropriate to verify the validity of the including an explanation of the reasons requested by a sector participant and process and results of the referendum. for the petition for termination and any paid by the Council, that sector Quality standards developed must other relevant information NMFS participant would no longer participate meet or exceed the U.S. Food and Drug considers appropriate. The notification
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would be published at least 30 days purposes of Executive Order 12866. The harvesters, 935 processing plants, and prior to the referendum. primary concern is that the market may 2,446 wholesale and marketing 2. Referendum Vote on Termination have failed to provide information on establishments that could be affected by If the referendum votes which are cast the quality, safety, and availability of this proposed rule. in favor of terminating the Council fishery products that is accurate and Economic Impact Analysis constitute a majority of the sector easily available to consumers. NMFS participants voting and the majority, in requests comments from the public on Overview the preceding 12-month period, what market failures justifiy creation of Despite a strong U.S. demand for fish collectively accounted for not less than seafood marketing councils, the degree and shellfish, the domestic seafood 66 percent of the value of such fish and to which industry structure affects these industry is faced with a number of fish products the that were handled market failures, and whether this challenges. The industry has been during that period by the sector who program is narrowly tailored to remedy experiencing declining prices, sales, and filed the petition, NMFS would by order those market failures. earnings; increased input costs, NMFS prepared an IRFA that terminate the Council effective as of a particularly fuel; increasingly restrictive describes the economic impacts of this date by which the affairs of the Council management; strong competition from proposed rule, if adopted, would have would be concluded. imports and aquaculture; loss of access 3. Cost of Referendum on small entities. A description of the to supporting infrastructure (e.g., dock NMFS would initially pay all costs of action, why it is being considered, and space); and numerous health advisories this referendum. However, prior to the legal basis for this action are regarding seafood consumption. The conducting the referendum, NMFS contained in the SUMMARY and nominal price of canned tuna, for would require petitioners to post a bond SUPPLEMENTARY INFORMATION section of or other security acceptable to NMFS in the preamble. This proposed rule does example, declined from $2.55 in 1980 to an amount which NMFS determines to not duplicate, overlap, or conflict with $1.78 in 2004. Between 1979 and 2003, be sufficient to pay any expenses other Federal rules. the real or deflated (2004 constant dollar incurred for the conduct of the value) ex-vessel price of all finfish and Recordkeeping and Reporting referendum. shellfish combined declined from $0.76 If a Council is terminated, NMFS, Requirements to $0.35 per pound. The domestic after recovering all expenses incurred In addition to recordkeeping and seafood industry is experiencing for the conduct of the referendum, reporting requirements required to problems in the form of competition would take action as is necessary and create a Council, small entities could from imports and increased fuel prices, practicable to ensure that moneys also be required to complete forms and established generic marketing remaining in the account established by required to administer assessment fees, programs have been shown to be the Council are paid on a prorated basis petition for a refund of assessment fees, effective in improving the demand for to the sector participants from whom or participate in any referendum under some food commodities. The RIR those moneys were collected. If a a specific Council’s charter. NMFS analysis summarized below indicates referendum fails to result in the believes the number of burden hours to that similar marketing programs, if termination of the Council, NMFS small entities to meet Council effective in raising prices, could would immediately recover the amount obligations could range between 5 and generate positive net benefits and of the bond posted by the petitioners. 20 hours annually. This proposed rule provide for increased national economic If the amount remaining in the does not implement a seafood marketing impacts. Council account is insufficient for program, therefore, the Paperwork The economic analysis performed in NMFS to recover all expenses incurred Reduction Act requirements are not support of this action examined 12 for the conduct of the referendum, triggered. However, there may be a need species complexes: (1) Grouper (all NMFS would recover the balance of the for additional burden hours once a species of group), (2) snapper (all expenses from the petitioners that Council’s charter is accepted. species of snapper), (3) roundfish (cod, posted a bond. haddock, and pollock), (4) tuna (all Description of Small Entities Affected by species of tuna), (5) halibut, (6) flatfish Proprietary Business Data or this Proposed Rule (all species of flatfish), (7) salmon (all Commercial Information The potential universe of entities wild caught species of salmon), (8) Commercial or financial information affected by this action includes all scallops (all species of scallops), (9) submitted to NMFS in compliance with harvesters, importers, marketers, and Dungeness and snow crab, (10) all other any requirement or regulation related to processors of seafood. With the species of crabs, (11) lobster (spiny and the Act, implementing regulations, or exception of a small number of catcher- North American), and (12) all species of other applicable law would be treated as processor vessels, most harvesters are shrimp. Per capita consumption was proprietary or confidential and identified as small entities under the defined as per-capita landings between protected from public disclosure to the Regulatory Flexibility Act meeting a size 1950 and 2003. A synthetic inverse extent possible under applicable law standard of less than $3.5 million in demand system (SIDS) model was (see 16 U.S.C. 4012(f)). However, NMFS gross receipts. Importers and marketers specified and estimated following Park may release or make public general or are characterized as small if the number et al. (2004). The SIDS model was used statistical statements based upon reports of employees working in a typical pay to estimate changes in ex-vessel of a number of persons (in aggregate or period number are 100 or fewer while revenues and compensating variation or summary form) which does not directly seafood processors employing 500 economic value, which might be or indirectly disclose the identify or people or less are considered small. A induced by a successful generic business of any individual or business Council could be made up of any marketing program. Economic impacts who submits the information. combination of small or large firms were estimated using a national input/ depending upon the sector or sectors of output model, which was developed for Classification a particular fishery the Council is NOAA Fisheries in 2004. The The proposed rule has been representing. NMFS statistics indicate estimation of impacts also did not determined to be significant for the that there are approximately 17,679 include the potential impacts of other
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meat producing and consuming sectors have substantially higher costs of given to whether or not a marketing (e.g., cattle producers and consumers of reaching agreement on a marketing program would shift out the demand or beef). strategy; preventing an effective strategy change the various quantity coefficients, Based on the potential changes in from being developed. The Federal which would be an expected effect of a sales of Alaska’s, Maryland’s, and the government can assist in reducing these marketing campaign. Alternatively, a Tilapia Marketing Association’s costs, but its involvement must be marketing program would be expected marketing campaigns for salmon, blue limited in these TAC-limited, marine, to increase the demand for a given price, wild-capture fisheries to the extent that crabs, and tilapia, the analysis of and thus, shift the demand curve out an increase in demand would not economic impact prepared by NMFS from the origin so that at every price, jeopardize conservation goals and assumed that a marketing campaign consumers would demand more objectives. could promote a 10 percent increase in seafood. Without detailed information NOAA stewardship of fisheries on the relationship between advertising demand. These relatively small, resources under the Magnuson-Stevens homogeneous groups with common and seafood demand, it is difficult to Act, Endangered Species Act, and other even state the magnitude of bias from goals were successful in reaching applicable laws in managing U.S. agreement on developing a marketing assuming that a marketing program fisheries ensures that conservation and increases the quantity demanded. strategy. During the Alaskan salmon management goals and objectives are campaign, sales (quantity demanded) not jeopardized. As part of this process, As illustrated in Tables 1, a 10 increased by 19.6 percent; sales of blue NMFS must submit annually a Status of percent increase in the demand for crabs in Maryland increased by 52.2 Fisheries Stocks report to Congress seafood generates considerable percent; and sales of Tilapia increased reporting on the status of overfished economic activity for the U.S. economy. by more than 54.5 percent between 2001 fisheries and fisheries where overfishing If the demand for all 12 species or and 2003. As much as 40% of Alaskan is continuing. Seafood Council actions species grouping were to increase by 10 salmon wild landings are based on established under this rule may not percent (or $108.1 million ex-vessel), hatchery production and tilapia is a interfere with the continued this would, in turn, generate total sales fresh water aquaculture product; both management and conservation of of $500.7 million in the U.S. economy products can be increased to respond to fisheries required under other statutes. and $172.3 million in income (which increases in demand. Maryland blue The analysis estimated potential includes profits). Those species with the crab while a substantial part is still only changes in revenues and welfare and potential greatest level of economic a single component of a much larger was limiting since: it considered only impacts are shrimp, salmon, and tuna. market allowing for the reallocation of the harvesting sector; the processing and Combined, they account for nearly 60 sales between different markets due to final retail sectors were not included; percent of the total potential output, 58 real or perceived quality differences. the analysis considered a marketing percent of the total potential income, Larger, heterogeneous groups with program, which increased the per capita and 59 percent of the total potential different goals and objectives could quantity demanded; no attention was employment.
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EAFOOD S EMAND FOR D NCREASE IN THE 10% I ENERATED BY A ) G OLLARS D ONSTANT 2004 C OF (1,000$ UTPUT O Direct Indirect Induced Total Induced Total Induced Total Direct Indirect Direct Indirect Direct Indirect HANGES IN 1. C 3,362.6 1,991 1,576 4,380 7,947 2,335 1,625 5,217 9,178 4,326 3,202 9,597 17,125 3,362.6 1,991 1,576 4,380 7,947 2,335 1,625 5,217 9,178 4,326 3,202 9,597 15,353 2,995.3 2,102 1,338 3,737 7,178 2,080 1,448 4,647 8,176 4,182 2,786 8,385 10,984.6 7,709 4,908 13,706 26,332 7,629 5,310 17,043 29,981 15,338 10,218 30,749 56,313 108,078.2 71,853 52,607 125,960 250,430 61,927 44,561 143,736 250,223 133,781 97,169 269,696 500,653 Ex-vessel Revenues ABLE Change In T Harvesting Sector Harvesting Sector Impacts Processor, Wholesaler, and Dealer Impacts Impacts for All Sectors Species Grouper 561.1 335 228 745 1,308 389 272 871 1,532 724 500 1,616 2,840 1,616 1,532 724 500 1,308 389 272 871 Grouper 561.1 335 228 745 40,019 23,646 21,887 9,657 6,716 Snapper 12,442 1,391.3 18,132 5,569 3,876 830 11,204 8,018.8 4,088 2,840 566 1,846 3,242 Roundfish 966 673 2,159 3,797 1,796 1,239 4,005 7,040 Tuna 15,920.5 10,135 Salmon 6,956 14,519 31,610 121,458 9,966 23,620.2 17,173 12,499 27,314 56,985 16,404 11,418 36,650 64,473 33,577 23,917 63,964 7,899 25,399 43,264 20,101 14,855 39,918 74,874 Halibut 17,972 33,040 10,294 18,728 3,555.7 2,045 1,445 4,777 8,267 2,469 1,719 5,517 9,705 4,514 3,164 17,778 8,338 5,974 10,165 Flatfish 15,262 4,447 3,166 6,518.5 3,891 2,808 8,563 Sea Scal- lop Dungeness and Snow Crab All Other Crabs Lobster 12,464 2,393.1 1,875 1,456 2,678 6,009 1,221 1,239 3,995 6,455 3,096 2,695 6,674 Shrimp 28,756.5 19,681 15,987 32,489 68,157 8,450 102,155 5,916 19,631 33,998 28,131 21,903 52,120 Total har- vesters
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A generic marketing campaign, if commodity program, which resulted in Maryland blue crab, on the other hand, successful, would be expected to increased supplies of imports, could is a wild-capture fishery that needs to be increase sales of seafood. Using the drive domestic ex-vessel and retail carefully monitored to ensure that estimated changes in revenues prices down. Producers would overfishing does not occur. Large associated with a generic marketing experience declining revenues and increases in sales were also found to campaign, which is assumed to generate profits, but consumers might experience characterize Maryland blue crabs at least a 10 percent increase in sales, increased welfare. Although the RIR following their implementation of a and the national I/O model, changes in indicates that the potential exists for the marketing program for blue crabs. While output or sales and income are generation of positive net benefits from a significant part, Maryland blue crab estimated. The analysis, however, a marketing program, the merits of a landings are only a portion of the total ignores potential changes in other specific proposed council would have to fishery and these increases in landings sectors of the economy, which might be judged on a case by case basis. could represent a reallocation of result from increased sales in seafood Unfortunately, data necessary for demand from one segment of the market (e.g., the impacts on beef, pork, and conducting an economic analysis of the to another in response to changes in poultry producers and processors). The potential benefits and impacts of generic perceived product quality. While impacts do, however, explicitly marketing campaigns or generic promotional programs involving consider changes in demand from commodity programs are not available. homogeneous and species-specific supporting or related seafood sectors There is insufficient information to products have been for the most part (e.g., fuel and gear for vessels, purchases statistically examine the relationship successful, an attempt to form a national of supplies by processors, etc.). between advertising expenditures for seafood Council to promote an increase It was estimated that a successful seafood and the demand for seafood. in consumption of all seafood failed generic commodity program for all 12 Data are not available on retail prices because of difficulty in getting species could generate up to $108.1 and consumption, by species, or mode agreement among fishermen, processors, million (2004 constant dollar value) in of sale (e.g., fish markets, grocery stores, and marketing firms over funding, addition ex-vessel revenues, and $115.5 and restaurants). Cost and earnings data program thrusts, and other elements million in consumer welfare or are highly inconsistent over time, and required to make a program successful. compensating variation; i.e., net thus it is not possible to consider In addition, increases in generic seafood benefits. The largest gains were returns to the various producing and demand in times prior to the large scale determined to be associated with marketing sectors--harvesters, availability of imported seafood shrimp, salmon, and tuna. In terms of processors, wholesalers, retail outlets, products created concerns among the potential changes in economic and restaurants. Moreover, no seafood managers that increased prices at the impacts, it was estimated that generic entity has yet proposed a generic dockside might create additional commodity programs for the 12 species commodity program. harvesting pressure for already A review of the scant empirical data or species groupings could increase overexploited fish stocks. sales and income by, respectively, available on generic commodity $500.7 million and $172.3 million. programs reveals mixed evidence about While data are not available to Shrimp, salmon, and tuna were the success of generic marketing measure the direct effects of advertising determined to be the largest campaigns, particularly relative to on seafood demand, over the last two beneficiaries of generic commodity seafood. One study suggests that generic decades agricultural economists have programs, which successfully increased advertising to promote the sales of estimated rates of return from consumption by 10 percent. In addition seafood either had no effect on sales or promotional programs under the to the limitations already discussed, the depressed sales. Another study Department of Agriculture’s checkoff analysis excludes the costs of generic concluded that advertising and health programs developed for beef, pork, and commodity programs. Existing programs awareness significantly affected the soybeans. In a checkoff program, in the U.S., regardless of whether or not demand for seafood; these studies, producers are required to pay a fee the program promotes seafood or beef, however, were restricted to one retail based on a fraction of their production pork, or poultry, typically impose firm in Houston, and used inches of to commodity marketing and charges on producing and/or marketing print in fliers and newspapers as a development boards. The fees are used companies. These costs, if known, measure of advertising. The Alaska to promote consumption and support would have to be deducted from the Seafood Marketing Institute (ASMI), the production and utilization research. A estimated benefits. Maryland Seafood Marketing Advisory 2000 study to measure effects of the The analysis also does not consider Commission, and the Tilapia Marketing pork checkoff program on demand the distribution of potential benefits or Institute have stated that they estimated returns to advertising economic welfare; that is, it remains implemented successful marketing investment as measured by a net benefit unknown whether or not a generic campaigns, respectively, for salmon, cost ratio (NBCR) to be 15 to 1, while commodity program would benefit blue crabs, and tilapia. Up to 40 percent in 2001, the NBCR for advertisement fishers, processors and dealers, retailers, of the wild-capture, Alaskan salmon and research investment for soybeans all, or one group more than the other. starts its life in hatcheries and tilapia is was estimated at 8 to 1. These large The analysis also does not consider the a product of fresh-water aquculture benefit to cost ratios need to be possibility that generic commodity product, both of which can be increased tempered when applied to fishery programs will potentially benefit in supply to match market pressures. products because agricultural product importers and foreign producers of Per capita consumption of tilapia supplies can be increased when prices seafood. Most U.S. fisheries are heavily increased by nearly 55.0 percent rise creating additional benefits in the regulated, and there has been an between 2001 and 2003; they initiated form of producer and consumer surplus. increasing reliance on imports, and the marketing campaign in 1999. Total Fish product supplies are generally thus, it is unlikely that in the near landings of Alaskan salmon increased fixed by regulation and increases in future, domestic producers would be 21.8 percent between 2001 and 2002; prices can cause the dissipation of rents able to satisfy an increased demand for the years the ASMI conducted a generic in a command and control managed seafood. Alternatively, a generic marketing program for salmon. fishery. In a rationalized fishery, such as
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halibut/sablefish or wreck fish, such in gross receipts attributable a Council’s relatively higher returns to individual rent dissipation would not occur and marketing efforts versus the amount of and aggregate firms than agricultural net benefits could increase substantially fees they are assessed. Increased firms. The ‘‘free rider’’ problem would as was demonstrated in recent studies of demand would increase revenues to the occur if a demand induced increase in proposed rationalization programs for aggregate of firms comprising any one price caused by a marketing program the Gulf of Mexico shrimp fishery. market, but this does not guarantee that triggers an appreciable amount of individual firms would have similar supply onto the market from non- Potential Economic Impact to Small increases in gross receipts measured in participants, i.e., entities who paid no Entities magnitude or as a percentage of the total fee for the promotion of the product but Agricultural commodity promotional increase. Therefore, there could be benefitted from the marketing campaign. programs have yielded aggregate marginal firms whose profit margins are The use of quality seals or ecolabels profitability of varying degrees as smaller than the representative sector such as ‘‘dolphin free’’ tuna create measured by several studies using that would not benefit greatly from an easily identifiable quality differences econometric techniques. Furthermore, increased demand yet be saddled with between essentially homogeneous as indicated through referenda for beef, an assessment fee. The number of these products and prevent the ‘‘free rider’’ poultry, and pork, agricultural firms, if they exist, is indeterminate. problem from occurring and the producers have in large part supported However, it is unlikely that business associated dissipation of benefits checkoff programs in their respective failures would occur as a result of generated by the initial marketing commodities. The few studies involving creating a Council. efforts. As a result, if the ‘‘free rider’’ seafood marketing programs indicate problem did exist for fishery products, Assessment Fees that they have been, for the most part, it would likely not be as severe as the successful when involving a specific Assessment fees exacted by situation facing other commodity product. Based on the results of these agriculture marketing programs have a markets since domestic supplies are studies NMFS has concluded that commonality in that the fees are based relatively fixed under the present marketing boards that are species and or on relative levels of production, e.g., the management regime and the creation of product specific are likely to be fees for the dairy, soybean, and beef seals or labels would, in most cases, successful in increasing demand and, marketing programs are 2 cents per create a differentiated product for hence, profitability for the sector or gallon, 0.5 percent of sales price, and 1 consumers in domestic markets. sectors of the fishery represented by the dollar per head of live weight, Council. Therefore, small entities, on respectively. This rule would Voluntary Versus Mandatory average, would likely profit, at least in implement a fee similar to those Participation the short term, from a well-run and specified for agriculture programs based Agricultural marketing programs managed Council. While the typical on a percentage or a fixed amount per conceived under various legislation fishery may profit from increased unit of weight or volume based on gross incorporate mandatory participation demand through advertising and other sales receipts for producers or product programs based on the economic promotions, there would be no costs for importers. Either way, these premise that -- if the majority of guarantee that all fisheries and all methods of imposing fees should potential participants accept, through sectors of fisheries and the firms minimize any disproportionate impacts referenda, the idea that additional comprising those sectors would profit on profitability for small firms versus profits could be earned through a equally. This would depend on large firms from the assessment of fees marketing program, then it would be individual firm’s profit margins, the within fisheries or sectors of fisheries. If profitable for all firms to participate. assessment fee, and price effects caused the fee were not based on a relative The economic reality faced by the by advertising (positive) and the ability assessment, small firms could be agricultural marketing programs is that of non-participants to profit from free negatively impacted by large blanket if only the firms voting in the advertising (negative) by increasing fees. This rule would allow individual affirmative in a given referendum were supply and driving down prices (also firms to request and collect a refund of subject to assessment there might not be known as the free rider problem). There fees ninety-days after an assessment. enough operating funds to carry out the is also the mandatory versus voluntary The methods and the timing of refunds mandates of the legislation imposed, participation or the ‘‘under-advertising’’ would need to be specified in a i.e., increase wealth by increasing argument. Council’s charter. demand and/or introducing better products. If NMFS, through its authority Profit Margins Price Effects and the Free Rider Problem to waive fees, did not impose mandatory NMFS recognizes that profit margins The magnitudes of price changes participation in a particular Council, will vary largely by fishery sector and relative to increased demand or supply i.e., voluntary participation, it is safe to individual firms within fishery sectors. depend on price elasticities of demand assume that those firms voting in the There are examples of small firms with or supply in a given product market. affirmative in a referendum had larger profit margins within a fishery or With the exception of a few species of determined a priori that it would be sector of a fishery than their larger seafood, most notably American lobster, economically advantageous to pay an counterparts, e.g., small-vessel seafood markets exhibit an elastic or flat assessment fee through a Council to groundfish harvesters in the Northeast. demand and an inelastic supply because promote their products. Therefore, it Producers of specialty products for many substitute commodities exist for would be difficult to make the case that niche markets such as fancy canned fishery products. As a result, prices implementation of a voluntary Council albacore, smoked mussels, shrimp would remain relatively stable with would have adverse impacts on those cocktail, etc. are assumed to have higher large increases in fishery products participants who voted in the profit margins than their large volume supplies. With relatively fixed supplies affirmative. However, a voluntary counterparts. Nevertheless, direct of fish, at least in the short run, changes program would face two obstacles. impacts to the profit margins of in seafood demand could result in large Firstly, there could be a level of funding individual firms from seafood marketing changes in price. Therefore, an increase through voluntary assessments that programs would depend on the increase in demand would most likely exhibit would not allow a Council to create a
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promotional program that would meet standards is estimated at 40 hours with § 270.9 Terms, vacancies, and removal of the objective of increasing demand for a no more than annual frequency. Council members. particular product(s). Secondly, the Additionally, assessed participants of a § 270.10 Responsibilities of a Council. level of funding may not be optimal to Council submission of a petition of § 270.11 Responsibilities of NMFS. achieve maximum benefits of a § 270.12 Notice of Council meetings. objection and/or request for refund is § 270.13 Books, records and reports. marketing program. In the case of estimated at 2 hours each no more than § 270.14 Update of sector participant data. voluntary participation, fisheries, in 6 times a year. These estimated § 270.15 Quality standards. general, would be less affected by the reporting times include the time for § 270.16 Deposit of funds. free rider problem when compared to reviewing instructions, searching § 270.17 Authority to impose assessments. other commodity markets due to the existing data sources, gathering and § 270.18 Method of imposing assessments. different price elasticities of demand maintaining the data needed, and § 270.19 Notice of assessment. and supply, use of labels and quality completing and reviewing the collection § 270.20 Payment of assessments. standards, and the regulatory control of of information. § 270.21 Petition of objection. supplies. § 270.22 Refunds. Public comment is sought regarding: § 270.23 Dissolution of Councils. Paper Work Reduction Act whether this proposed collection of information is necessary for the proper Authority: 16 U.S.C. 4001–4017. This proposed rule contains a performance of the functions of the collection-of-information requirement § 270.1 Scope. agency, including whether the subject to review and approval by OMB This part 270 describes matters information shall have practical utility; under the Paperwork Reduction Act pertaining to the establishment, the accuracy of the burden estimate; (PRA). This requirement has been representation, organization, practices, ways to enhance the quality, utility, and submitted to OMB for approval. The procedures, and termination of Seafood clarity of the information to be information collection requirements Marketing Councils. collected; and ways to minimize the contained in this rule can be broadly burden of the collection of information, § 270.2 Definitions. categorized into two categories: (1) including through the use of automated Information required of an individual or The following terms and definitions collection techniques or other forms of organization applying for consideration are in addition to or amplify those to form a Council, and (2) information information technology. Send comments contained in the Fish and Seafood required of a formed and operating on these or any other aspects of the Promotion Act of 1986: Council. Information required of an collection of information to NMFS and Act means the Fish and Seafood individual or organization applying for OMB (see ADDRESSES). Promotion Act of 1986 (Pub. L. 99–659) consideration to form a Council, Notwithstanding any other provision and any subsequent amendments. consists of an ‘‘application for charter’’ of the law, no person is required to Consumer education means actions that is composed of three sections: respond to, nor shall any person be undertaken to inform consumers of petition, proposed charter, and a list of subject to a penalty for failure to comply matters related to the consumption of eligible referendum participants. Based with, a collection of information subject fish and fish products. on discussions with the tuna industry, to the requirements of the Paperwork Council means a Seafood Marketing (the seafood industry group most likely Reduction Act, unless that collection-of- Council for one or more species of fish to first apply for formation of a Council), information displays a currently valid and fish products of that species the estimated reporting time for this OMB control number. established under section 210 of the Act (16 U.S.C. 4009). portion of the collection requirement in List of Subjects in 50 CFR Part 270 50 CFR 270 is 320 hours in total, with Expenditure means monetary or an average of 80 hours to develop a Administrative practice and material worth of fishery products. petition, 200 hours to develop a procedure, Fish, Marketing, Seafood. Expenditure is determined at the point proposed charter, and 40 hours to Dated: January 17, 2006. a receiver obtains product from a develop a list of eligible referendum William T. Hogarth, harvester or an importer obtains product from a foreign supplier. Value may be participants. All other information Assistant Administrator for Fisheries, requirements in the proposed rule are National Marine Fisheries Service. expressed in monetary units (the price imposed on the Councils, once they are a receiver pays to a harvester or an established. The estimated reporting For the reasons set out in the importer pays to a foreign supplier). time for these information requirements preamble, NMFS proposes to amend Fiscal year means any 12-month varies from 1 to 120 hours per response. title 50 chapter II as follows: period as NMFS may determine for each Council submission of an annual plan, 1. A new subchapter H consisting of Council. an annual budget, and an annual part 270 is added to read as follows: Fish means finfish, mollusks, financial report are estimated at 120 crustaceans, and all other forms of SUBCHAPTER H—FISH AND SEAFOOD aquatic animal life used for human hours each for a total of 360 hours. PROMOTION Council submissions of semi-annual consumption; the term does not include progress reports is estimated at 40 hours PART 270—SPECIES-SPECIFIC marine mammals and seabirds. twice a year, notice of assessments at 20 SEAFOOD MARKETING COUNCILS Harvester means any person in the hours once a year, list of Council business of catching or growing fish for nominations following a favorable Sec. purposes of sale in domestic or foreign referendum at 20 hours once a year, and § 270.1 Scope. markets. meeting notices at 1–2 hours once a § 270.2 Definitions. Importer means any person in the year. Other submissions are optional § 270.3 Submission of application. business of importing fish or fish § 270.4 Review of application. and are dependent upon the operation § 270.5 Conduct of referendum. products from another country into the of a particular Council and its § 270.6 Sector participants eligible to vote. United States and its territories, as participants. For instance, Council § 270.7 Results of referendum. defined by the Act, for commercial submission of a plan to conduct a § 270.8 Nomination and appointment of purposes, or who acts as an agent, referendum on development of quality Council members. broker, or consignee for any person or
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nation that produces, processes or entity of the U.S. fishing industry specified in the charter that were markets fish or fish products outside of organized or existing under the laws of handled during such period in each the United States for sale or for other the United States or any state, sector by those who meet the eligibility commercial purposes in the United commonwealth, territory or possession requirements to vote in the referendum States. of the United States who meets the as defined by the application. The Marketer means any person in the eligibility requirements as defined in a application must also include a business of selling fish or fish products proposed charter to vote in a statement that, if established, the in the wholesale, export, retail, or referendum. Council will have sufficient resources restaurant trade, but whose primary Species means a fundamental (e.g., cash, donated office space, business function is not the processing category of taxonomic classification, services, supplies, etc.) available for or packaging of fish or fish products in ranking after genus, and consisting of initial administrative expenditures preparation for sale. animals that possess common pending collection of assessments. Marketing and promotion means any characteristic(s) distinguishing them (2) Proposed charter. A proposed activity aimed at encouraging the from other similar groups. charter must contain, at a minimum, the consumption of fish or fish products or Value means monetary or material following information: expanding or maintaining commercial worth of fishery products. Value is the (i) The name of the Council and a markets for fish or fish products. difference between what a receiver is provision proclaiming its establishment; Member means any person serving on willing to pay for a product provided by (ii) A declaration of the purposes and any Council. a harvester and its market price or an objectives of the Council; Participant means a member of a importer is willing to pay for a product (iii) A description of the species of sector or business identified in an from a foreign supplier and its market fish and fish products, including the application for a Council charter as price. Value may be expressed in scientific and common name(s), for being subject to the referendum or monetary units representing consumer which the Council will implement assessment process. surplus or producer surplus. marketing and promotion plans under Person means any individual, group the Act. (The American Fisheries of individuals, association, § 270.3 Submission of application. Society’s ‘‘List of Common and proprietorship, partnership, (a) Persons who meet the minimum Scientific Names of Fishes from the corporation, cooperative, or any private requirements for sector participants as United States and Canada’’ (latest entity of the U.S. fishing industry described in the proposed charter may edition) or where available, an organized or existing under the laws of file an application with NMFS for a appropriate volume of its ‘‘List of the United States or any state, charter for a Seafood Marketing Council Common and Scientific Names of commonwealth, territory or possession for one or more species of fish and fish Aquatic Invertebrates of the United of the United States who meets the products of that species. One signed States and Canada’’ (latest edition) eligibility requirements as defined in a original and two copies of the should be used as the authority for all proposed charter to vote in a completed application package must be scientific and common names.); referendum. submitted to the Assistant (iv) A description of the geographic Processor means any person in the Administrator for Fisheries, National area (state(s)) within the United States business of preparing or packaging fish Marine Fisheries Service, NOAA, 1315 covered by the Council; or fish products (including fish of the East-West Highway, Silver Spring, (v) The identification of each sector processor’s own harvesting) for sale in Maryland 20910. Applications should and the number and terms of domestic or foreign markets. not be bound. representatives for each sector that will Receiver means any person who owns (b) The application consists of four be voting members on the Council. (The fish processing vessels and any person parts: number of Council members should be in the business of acquiring (taking title (1) A document requesting NMFS to manageable, while ensuring equitable to) fish directly from harvesters. establish a Council; geographic representation. The term for Research means any type of research (2) A proposed charter under which members will be 3 years. Initially, to designed to advance the image, the proposed Council will operate; ensure continuity, half of the members’ desirability, usage, marketability, (3) A list of eligible referendum terms will be 2 years and half will be production, quality and safety of fish participants; and 3 years. Reappointments are and fish products. (4) Analytical documentation permissible.); Secretary means the Secretary of addressing requirements of applicable (vi) The identification of those sectors Commerce, or the Secretary’s designee. law. (which must include a sector consisting Sector means (c) Content of application—(1) of harvesters, a sector consisting of (1) The sector consisting of harvesters; Application or requesting document. receivers, and, if subject to assessment, (2) The sector consisting of importers; The application or requesting document a sector consisting of importers), eligible (3) The sector consisting of marketers; submitted by the applicants to NMFS to vote in the referendum to establish (4) The sector consisting of requesting that the Council be the Council; processors; established, to the extent practicable, (vii) For each sector described under (5) The sector consisting of receivers; must include the signatures or corporate paragraph (c)(2)(v) of this section, a or certifications, of no less than three threshold level specifying the minimum (6) The consumer sector consisting of sector participants representing each requirements, as measured by income, persons professionally engaged in the sector identified in accordance with volume of sales, or other relevant dissemination of information pertaining paragraph (c)(2)(v) of this section and factors, that a person engaging in to the nutritional benefits and who, according to the available data, business in the sector must meet in preparation of fish and fish products; collectively accounted for, in the 12- order to participate in a referendum; Sector participant means any month period immediately preceding (viii) A description of the rationale individual, group of individuals, the month in which the application was and procedures for determining association, proprietorship, partnership, filed, not less than 10 percent of the assessment rates as provided in corporation, cooperative, or any private value of the fish or fish products § 270.18, based on a fixed amount per
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unit of weight or measure, or on a (xxiii) A provision containing a (c) If NMFS finds minor deficiencies percentage of value of the product requirement for the Council to arrange in an application that can be corrected handled; for a complete audit report to be within the 180-day review period, (ix) The proposed rate or rates that conducted by an independent public NMFS will advise the applicants in will be imposed by the Council on accountant and submitted to NMFS at writing of what must be submitted by a receivers and, if subject to assessment, the end of each fiscal year; specific date to correct the minor importers during its first year of (xxiv) A provision containing a deficiencies. operation; requirement for the Council to conduct (d) If NMFS makes a final negative (x) The maximum amount by which a market assessment based on economic, determination, on an application, NMFS an assessment rate for any period may market, social and demographic, and will advise the applicant in writing of be raised above the rate applicable for biological information as deemed the reason for the determination. The the immediately preceding period; necessary by NMFS; and applicant may submit another (xi) The maximum rate or rates that (xxv) A provision containing a application at any time thereafter. can be imposed by a Council on requirement for the Council to update NMFS then has 180 days from receipt of receivers or importers during the the list of referendum participants on an the new application to render a final operation of the Council; annual basis. determination on its acceptability. (xii) The maximum limit on the (3) List of referendum participants. amount any one sector participant may The list of referendum participants, to § 270.5 Conduct of referendum. be required to pay under an assessment the extent practicable, must identify the (a) Upon making affirmative for any period; business name and address of all sector determinations under § 270.4, NMFS, (xiii) The procedures for providing participants that the applicants believe within 90 days after the date of the last refunds to sector participants subject to meet the requirements for eligibility to affirmative determination, will conduct assessment who request the same in vote in the referendum on the adoption a referendum on the adoption of the accordance with the time limits of the proposed charter. proposed charter. specified § 270.22; (i) The list should include all sectors (b) NMFS will estimate the cost of (xiv) A provision setting forth the in which a sector participant meets the conducting the referendum, notify the voting procedures by which votes may eligibility requirements to vote in a applicants, and request that applicants be cast by proxy; referendum. If a sector participant has post a bond or provide other applicable (xv) A provision that the Council will more than one place of business located security, such as a cashier’s check, to have voting members representing the within the geographic area of the cover costs of the referendum. harvesting, receiving and, if subject to Council, all such places should be listed (c) NMFS will initially pay all costs assessment, importing sectors; and the primary place of business of a referendum to establish a Council. (xvi) A provision setting forth the should be designated. The agency will Within two years after establishment, definition of a quorum for making provide appropriate information in its the Council must reimburse NMFS for decisions on Council business and the possession of a non-proprietary nature the total actual costs of the referendum procedures for selecting a chairperson of to assist the applicants in developing from assessments collected by the the Council; the list of sector participants. Council. If a referendum fails to result (xvii) A provision that members of the (ii) [Reserved] in establishment of a Council, NMFS Council will serve without (4) Analytical documentation. The will immediately recover all expenses compensation, but will be reimbursed applicant must address the incurred for conducting the referendum for reasonable expenses incurred in requirements of the Act, implementing from the bond or security posted by performing their duties as members of regulations, and other applicable law, applicants. In either case, such expenses the Council; i.e., E.O. 12866, Regulatory Flexibility will not include salaries of government (xviii) A provision containing a Act, National Environmental Policy Act, employees or other administrative requirement for submission to NMFS and other law as NMFS determines overhead, but will be limited to those the criteria and supporting data for appropriate. additional direct costs incurred in evaluating the annual and/or multi-year connection with conducting the performance of proposed marketing § 270.4 Review of application. referendum. plans and the Council’s performance; Within 180 days of receipt of the (d) No less than 30 days prior to (xix) A provision containing a application to establish a Council, holding a referendum, NMFS will: requirement for submission of NMFS will: (1) Publish in the Federal Register the documentation as requested by NMFS (a) Determine if the application is text of the proposed charter and the for purposes of evaluating performance complete and complies with all of the most complete list available of sector of proposed marking plans and the requirements set out in § 270.3 and participants eligible to vote in the Council’s related performance; complies with all provisions of the Act referendum; and (xx) Where adequate funds are not and other applicable laws. (2) Provide for public comment, available, a provision containing the (b) Identify, to the extent practicable, including the opportunity for a public minimum number of participants those sector participants who meet the meeting. needed for sustained operations that requirements for eligibility to cannot receive assessment refunds; participate in the referendum to § 270.6 Sector participants eligible to vote. (xxi) A provision acknowledging that establish the Council. NMFS may (a) Any participant who meets the NMFS will have the right to participate require additional information from the minimum requirements as measured by in Council meetings; applicants or proposed participants in income, volume of sales or other (xxii) A provision that the Council order to verify eligibility. NMFS may relevant factors specified in the will conduct its activities in accordance add names to or delete names from the approved charter may vote in a with applicable NMFS requirements list of sector participants believed referendum. and that NMFS has final approval eligible by the applicants until the time (b) Only one vote may be cast by each authority over proposed marketing of the referendum based on additional participant who is eligible to vote, plans and Council actions; information received. regardless of the number of individuals
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that make up such ‘‘participant’’ and § 270.9 Terms, vacancies and removal of marketing and promotion plans or how many sectors the participant is Council members. projects; engaged in. The vote may be made by (a) A Council term is for 3 years, (iii) The costs of the collection of any responsible officer, owner, or except for initial appointments to a assessments; and employee representing a participant. newly established Council where: (iv) The expense of repayment of the (1) Half of the Council member terms costs of each referendum conducted in § 270.7 Results of referendum. will be 2 years; and regard to the Council. (a) Favorable vote to establish a (2) Half of the Council member terms (7) Comply with NMFS requirements, Council. NMFS will, by order, establish will be 3 years. and prepare and submit to NMFS for the Council and approve an acceptable (b) A vacancy on a Council will be review, evaluation, and verification of proposed charter, if the referendum filled, within 60 days after the vacancy results and analysis an annual market votes which are cast in favor of the occurs, in the same manner in which assessment and related analytical proposed charter constitute a majority of the original appointment was made. A documentation that is based on the sector participants voting in each member appointed to fill a vacancy economic, market, social, demographic, and every sector. Further, according to occurring before the expiration of the and biological information as deemed the best available data, the majority term for which the member’s necessary by NMFS; must collectively account for, in the 12- predecessor was appointed will be (8) Maintain books and records, month period immediately preceding appointed only for the remainder of prepare and submit to NMFS reports in the month in which the proposed such term. accordance with respect to the receipt charter was filed, at least 66 percent of (c) Any person appointed under the and disbursement of funds entrusted to the value of the fish and fish products Act who consistently fails or refuses to it, and submit to NMFS a completed described in the proposed charter perform his or her duties properly and/ audit report conducted by an handled during such period in each or participates in acts of dishonesty or independent auditor at the end of each sector by those who meet the eligibility willful misconduct with respect to fiscal year; (9) Reimburse NMFS for the expenses requirements to vote in the referendum responsibilities under the Act will be incurred for the conduct of the as defined by the applicants. removed from the Council by NMFS if two-thirds of the members of the referendum to establish the Council or (b) Unfavorable vote to establish a Council recommend action. All requests any subsequent referendum to terminate Council. If a referendum fails to pass in from a Council to NMFS for removal of the Council that fails; any sector of the proposed Council, a Council member must be in writing (10) Prepare and submit to NMFS NMFS will not establish the Council or and accompanied by a statement of the report or proposals as the Council approve the proposed charter. NMFS reasons upon which the determines appropriate to further the will immediately recover the cost of recommendation is based. purposes of the Act. conducting the referendum according to (b) Funds collected by a Council § 270.5(c). § 270.10 Responsibilities of a Council. under § 270.17 will be used by the (c) Notification of referendum results. (a) Each Council will: Council for-- NMFS will notify the applicants of the (1) Implement all terms of its (1) Research, consumer education, results of the referendum and publish approved charter; and other marketing and promotion the results of the referendum in the (2) Prepare and submit to NMFS, for activities regarding the quality and Federal Register. review and approval under marketing of fish and fish projects; § 270.11(a)(1), a marketing and (2) Other expenses, as described in § 270.8 Nomination and appointment of promotion plan and amendments to the § 270.10(a)(1); Council members. plan which contain descriptions of the (3) Such other expenses for the administration, maintenance, and (a) Within 30 days after a Council is projected consumer education, research, functioning of the Council as may be established, NMFS will solicit and other marketing and promotion authorized by NMFS; and nominations for Council members from activities of the Council; (3) Implement and administer an (4) Any reserve fund established the sectors represented on the Council approved marketing and promotion plan under § 270.10(e)(4) of this section and in accordance with the approved and amendments to the plan; any administrative expenses incurred by charter. If the harvesters and receivers (4) Determine the assessment to be NMFS specified as reimbursable under represented on the Council are engaged made under § 270.18 and administer the this Part. in business in two or more states, but collection of such assessments to (c) Marketing and promotion plans within the geographic area of the finance Council expenses described in and amendments to such plans prepared Council, the nominations made under paragraph (b) of this section; by a Council under § 270.10(a)(2) of this this section must, to the extent (5) Receive, investigate and report to section will be designed to increase the practicable, result in equitable NMFS accounts of violations of rules or general demand for fish and fish representation for those states. orders relating to assessments collected products described in accordance with Nominees must be knowledgeable and under § 270.20, or quality standard § 270.3(c)(2)(iii) by encouraging, experienced with regard to the activities requirements established under expanding, and improving the of, or have been actively engaged in the § 270.15; marketing, promotion and utilization of business of, the sector that such person (6) Prepare and submit to NMFS, for such fish and fish products, in domestic will represent on the Council. review and approval a budget (on a or foreign markets, or both, through Therefore, a resume will be required for fiscal year basis) of the anticipated consumer education, research, and other each nominee. expenses and disbursements of the marketing and promotion activities. (b) In accordance with 16 U.S.C. Council, including (d) Consumer education and other 4009(f), NMFS will, within 60 days after (i) All administrative and contractual marketing and promotion activities the end of the 30-day period, appoint expenses; carried out by a Council under a the members of the Council from among (ii) The probable costs of consumer marketing and promotion plan and the nominees. education, research, and other amendments to a plan may not contain
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references to any private brand or trade (b) NMFS may provide, on a account for, in the 12-month period name and will avoid the use of reimbursable or other basis, such immediately preceding the month in deceptive acts or practices in promoting administrative or technical assistance as which the referendum is held, not less fish or fish products or with respect to a Council may request for purposes of than 66 percent of the value of the fish the quality, value, or use of any the initial organization and subsequent or fish products described in the charter competing product or group of products. operation of the Council. However, a that were handled during such period in (e) Authority of a Council. A Council Council is responsible for the cost of that sector by those who meet the may: preparing and submitting information eligibility requirements to vote in the (1) Sue and be sued; (e.g., reports, evaluation data, etc.) referendum as defined by the (2) Enter into contracts; requested by NMFS. petitioners. (3) Employ and determine the salary (c) The Council must submit a plan to of an executive director who may, with § 270.12 Notice of Council meetings. conduct the referendum on the quality the approval of the Council employ and The Council will give NMFS the same standards to NMFS for approval at least determine the salary of such additional notice of its meetings as it gives to its 60 days in advance of such referendum staff as may be necessary; members. NMFS will have the right to date. The plan must consist of the (4) Establish a reserve fund from participate in all Council meetings. following: monies collected and received under (1) Date(s) for conducting the § 270.13 Books, records and reports. § 270.17 to permit an effective and referendum; sustained program of research, (a) The Council must submit to NMFS (2) Method (by mail or in person); consumer education, and other the following documents according to (3) Copy of the proposed notification marketing and promotion activities the schedule approved in the Council’s to sector participants informing them of regarding the quality and marketing of charter: the referendum; fish and fish products in years when (1) A marketing assessment and (4) List of sector participants eligible production and assessment income may promotion plan; to vote; be reduced, but the total reserve fund (2) A financial report with respect to (5) Name of individuals responsible may not exceed the amount budgeted the receipt and disbursement of funds; for conducting the referendum; for the current fiscal year of operation. (3) An audit report conducted by an (6) Copy of proposed ballot package to (f) Amendment of a charter. A independent public accountant; and be used in the referendum; and Council may submit to NMFS (4) Other reports or data NMFS (7) Date(s) and location of ballot amendments to the text of the Council’s determines necessary to evaluate the counting. charter. Any proposed amendments to a Council’s performance and verify the (d) An official observer appointed by charter will be approved or disapproved results of the market assessment and NMFS will be allowed to be present at in the same manner as the original promotion plan.. the ballot counting and any other phase charter was approved under § 270.4 and (b) All Council records, reports, and of the referendum process, and may take § 270.5 with the exception of § 270.4(b). data must be maintained by the Council whatever steps NMFS deems for a minimum of 3 years, even if the appropriate to verify the validity of the § 270.11 Responsibilities of NMFS. Council is terminated. process and results of the referendum. (a) In addition to the duties prescribed (e) Quality standards developed under under 16 U.S.C. 4009, NMFS will: § 270.14 Update of sector participant data. this section of the regulations must, at (1) Participate in Council meetings The Council will submit to NMFS at a minimum, meet Food and Drug and review, for consistency with the the end of each fiscal year an updated Administration (FDA) minimum provisions of 50 CFR 270 and other list of sector participants who meet the requirements for fish and fish products applicable law, and approve or minimum requirements for eligibility to for human consumption. disapprove, marketing and promotion participate in a referendum as stated in (f) Quality standards must be plans and budgets within 60 days after the approved charter. consistent with applicable standards of their submission by a Council; the U.S. Department of Commerce § 270.15 Quality standards. (2) Immediately notify a Council in (National Oceanic and Atmospheric writing of the disapproval of a (a) Each Council may develop and Administration) or other recognized marketing and promotion plan or submit to NMFS for approval or, upon Federal standards and/or specifications budget, together with reasons for such the request of a Council, NMFS will for fish and fish products. disapproval; develop quality standards for the (g) No quality standard adopted by a (3) Issue orders and amendments to species of fish or fish products Council may be used in the advertising such orders that are necessary to described in the approved charter. Any or promotion of fish or fish products as implement quality quality standard developed under this being inspected by the United States standards under § 270.15; paragraph must be consistent with the Government unless the standard (4) Promulgate regulations necessary purposes of the Act. requires sector participants to be in the to carry out the purposes of this chapter; (b) A quality standard developed U.S. Department of Commerce voluntary (5) Enforce the provisions of the Act; under paragraph (a) of this section may seafood inspection program. (6) Make all appointments to Councils be adopted by a Council by a majority (h) The intent of quality standards in accordance with § 270.8 and the of its members following a referendum must not be to discriminate against approved Council charter; conducted by the Council among sector importers who are not members of the (7) Approve the criteria and time participants of the concerned sector(s). Council. frames under which a Council’s In order for a quality standard to be (i) Quality standards must not be performance will be evaluated; and brought before Council members for developed for the purpose of creating (8) Implement the provisions of 16 adoption, the majority of the sector non-tariff barriers. Such standards must U.S.C. 4001 et seq. in accordance with participants of the concerned sector(s) be compatible with U.S. obligations the available financial and management must vote in favor of the standard. under the General Agreement on Tariffs resources NMFS determines can be Further, according to the best available and Trade, or under other international utilized. data, the majority must collectively standards deemed acceptable by NMFS.
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(j) The procedures applicable to the (iii) If an account has been that the assessment is due. The notice adoption and the operation of quality established, collateral may be held at of assessment must contain: standards developed under this the local Federal Reserve Bank. (1) A specific reference to the subchapter also apply to subsequent Otherwise, another depository must provisions of the Act, regulations, amendments or the termination of such hold the collateral. charter and referendum that authorize standards. the assessment; (k) With respect to a quality standard § 270.17 Authority to impose (2) The amount of the assessment; adopted under this section, the Council assessments. (3) The period of time covered by the must develop and file with NMFS an A Council will impose and administer assessment; official identifier in the form of a the collection of the assessments that (4) The date the assessment is due and symbol, stamp, label or seal that will be are necessary to pay for all expenses payable, which will not be earlier than used to indicate that a fish or fish incurred by the Council in carrying out 30 days from the date of the notice; product meets the quality standard at its functions under 50 CFR part 270. (5) The form(s) of payment; and (6) To whom and where the payment the time the official identifier is affixed § 270.18 Method of imposing to the fish or fish product, or is affixed assessments. must be made. to or printed on the packaging material (b) The notice must advise such Assessments will be imposed on of the fish or fish product. The use of person of his or her right to seek review sector participants in the receiving such identifier is governed by § 270.15. of the assessment by filing a written sector or the importing sector or both as petition of objection with NMFS at any § 270.16 Deposit of funds. specified in an approved Council time during the time period to which All funds collected or received by a charter. Assessment rates will be based the assessment applies, including the Council under this section must be on value that may be expressed in right to request a hearing on the deposited in an appropriate account in monetary units or units of weight or petition. The notice must state that the the name of the Council specified in its volume. petition of objection must be filed in charter. Funds eligible to be collected or (a) An assessment on sector accordance with the procedures in received by a Council must be limited participants in the receiving sector will § 270.21. to those authorized under the Act. be in the form of a percentage of the (c) The notice must also advise such (a) Pending disbursement, under an value or a fixed amount per unit of persons of his or her right to a refund approved marketing plan and budget, weight or volume of the fish described of the assessment as provided in funds collected through assessments in the charter when purchased by such § 270.22. The notice must state that a authorized by the Act must be deposited receivers from fish harvesters. refund may be requested for not less in any interest-bearing account or (b) An assessment on sector than 90 days from such collection, and certificate of deposit of a bank that is a participants who own fish processing provide that the Council will make the member of the Federal Reserve System, vessels and harvest the fish described in refund within 60 days after the request or in obligations fully guaranteed as to the charter will be in the form of a for the refund is requested. principal and interest by the United percentage of the value or on a fixed States Government. amount per unit of weight or volume of § 270.20 Payment of assessments. (b) The Council may, however, the fish described in the charter that is Persons subject to an assessment pending disbursement of these funds, no less than the value if such fish had would be required to pay the assessment invest in risk-free, short-term, interest- been purchased by a receiver other than on or before the date due, unless they bearing instruments. the owner of the harvesting vessel. have demanded a refund or filed a (1) Risk-free. All investments must be (c) An assessment on sector petition of objection with NMFS under insured or fully collateralized with participants in the importing sector will § 270.21. However, person who have Federal Government securities. In the be in the form of a percentage of the demanded a refund under § 270.22 or absence of collateral, accounts value that an importer pays to a foreign filed a petition of objection under established at financial institutions supplier, as determined for the purposes § 270.21 may submit proof of these should, in aggregate, total less than of the customs laws, or a fixed amount actions in leu of payment. In the case of $100,000 to assure both principal and per unit of weight or volume, of the fish a petition of objection, NMFs will interest are federally insured in full. or fish products described in the charter inform the Council and the petitioner of (2) Short-term. Generally, all when entered or withdrawn from its finding at which time petitioner must investments should be for a relatively warehouse for consumption, in the pay the revised assessment if applicable. short time period (one year or less) to customs territory of the United States by assure that the principal is maintained such sector participants. § 270.21 Petition of objection. and readily convertible to cash. (d) A Council may not impose an (a) Filing a petition. Any person (3) Collateralization. Investments assessment on any person that was not issued a notice of assessment under exceeding the $100,000 insurance eligible to vote in the referendum § 270.19 may request that NMFS modify coverage level must be fully establishing the Council by reason of or take other appropriate action collateralized by the financial failure to meet the requirements regarding the assessment or promotion institution. specified under unless that person, after plan by filing a written petition of (i) Collateral must be pledged at face the date on which the referendum is objection with NMFS. Petitions of value and must be pledged prior to held, meets the requirements of section. objection may be filed: sending funds to the institution. (e) Any person may make voluntary (1) Only if the petitioner determines (ii) Government securities are payments or in-kind contributions to a one or more of the following criteria is acceptable collateral. Declining balance, Council for purposes of assisting the not in accordance with the law: mortgage backed securities such as Council in carrying out its functions. (i) The assessment; Government National Mortgage (ii) The plan upon which the Association (GNMA) and Federal § 270.19 Notice of assessment. assessment is based; or National Mortgage Association (FNMA) (a) The Council must serve each (iii) Any obligation imposed on the are not acceptable collateral. person subject to assessment with notice petitioner under the plan.
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(2) Only during the time period to agency. NMFS will have the discretion (3) Not less than 30 days prior to which the assessment applies. to waive collection of a contested holding a referendum, NMFS will (b) Contents of the petition of assessment or revise, modify, or alter publish an announcement in the objection. A petition must be addressed the assessment amount based on a Federal Register of the referendum, to Assistant Administrator for Fisheries, Council method of assessment. including an explanation of the reasons National Marine Fisheries Service, 1315 for the petition for termination filed § 270.22 Refunds. East-West Highway, Silver Spring, MD under (a)(1) of this section and any 20910, and must contain the following: (a) Notwithstanding any other other relevant information NMFS (1) The petitioner’s correct name, provision of the Act, any person who considers appropriate. address, and principal place of business. pays an assessment under the Act may demand and must promptly receive (4) If the referendum votes which are If the petitioner is a corporation, this cast in favor of terminating the Council must be stated, together with the date from the Council a refund of such assessment. A demand for refund must constitute a majority of the sector and state of incorporation, and the participants voting and the majority, in names, addresses, and respective be made in accordance with procedures in the approved charter and within such the period in (a)(2) of this section, positions of its officers; if a partnership, collectively accounted for not less than the date and place of formation and the time as will be prescribed by the Council and approved by NMFS. 66 percent of the value of such fish and name and address of each partner; fish products the that were handled (2) The grounds upon which the Procedures to provide such a refund must be established before any such during such period by the sector in petition of objection is based, including paragraph (a)(1) of this section, NMFS the specific terms or provisions of the assessment may be collected. Such procedures must allow any person to will by order terminate the Council assessment, the marketing and effective as of a date by which the affairs promotion plan, or obligation imposed request a refund 90 days or more from such collection, and provide that such of the Council may be concluded on an by the plan, to which the petitioner orderly basis. objects; refund must be made within 60 days (3) A full statement of the facts upon after demand for such refund is made. (5) NMFS initially will pay all costs (b) Once a refund has been requested which the petition is based, set forth of a referendum conducted in section by a sector participant and paid by the clearly and concisely, accompanied by § 270.23. Prior to conducting such a Council, that sector participant may no any supporting documentation; referendum, NMFS will require longer participate in a referendum or (4) The specific relief requested; and petitioners to post a bond or other (5) A statement as to whether or not other business of the Council during the security acceptable to NMFS in an remainder of the assessment rate period. the petitioner requests a hearing. amount which NMFS determines to be (c) Notice to Council. NMFS will Future assessments will only be sent to sufficient to pay any expenses incurred promptly furnish the appropriate such a sector participant at the request for the conduct of the referendum. of the sector participant. If assessments Council with a copy of the petition of are paid during a future assessment rate (6) If a referendum conducted under objection. § 270.23 fails to result in the termination (d) Opportunity for informal hearing. period and no refund is requested, that sector participant may again participate of the Council, NMFS will immediately (1) Any person filing a petition of in a referendum or other business of the recover the amount of the bond posted objection may request an informal Council. by the petitioners under § 270.23(a)(5). hearing on the petition. The hearing (7) If a referendum conducted under request must be submitted with the § 270.23 Dissolution of Councils. this subsection results in the petition of objection. (a) Petition for termination. (1) A termination of the Council, NMFS will (2) If a request for hearing is timely petition to terminate a Council may be recover the expenses incurred for the filed, or if NMFS determines that a filed with NMFS by no less than three conduct of the referendum from the hearing is advisable, NMFS will so sector participants in any one sector. account established by the Council. If notify the petitioner and the Council. Any petition filed under this subsection the amount remaining in such account NMFS will establish the applicable must be accompanied by a written is insufficient for NMFS to recover all procedures, and designate who will be document explaining the reasons for expenses incurred for the conduct of the responsible for conducting a hearing. such petition. referendum, NMFS will recover the The petitioner, the Council, and any (2) If NMFS determines that a petition balance of the expenses from the other interested party, may appear at the filed under paragraph (a)(1) of this petitioners that posted a bond under hearing in person or through a section is accompanied by the paragraph (a)(5) of this section. representative, and may submit any signatures, or corporate certifications, of relevant materials, data, comments, no less than three sector participants in (b) Payment of remaining funds. If a arguments, or exhibits. NMFS may the sector referred to in paragraph (a)(1) Council is terminated under section consolidate two or more hearing of this section who collectively § 270.23(a)(4), NMFS, after recovering requests into a single proceeding. accounted for, in the 12-month period all expenses incurred for the conduct of (3) Final decision. Following the immediately preceding the month in the referendum under paragraph (a) of hearing, or if no hearing is held, as soon which the petition was filed, not less this section, will take such action as is as practicable, NMFS will decide the than 20 percent of the value of the fish necessary and practicable to ensure that matter and serve written notice of the or fish products described in moneys remaining in the account decision on the petitioner and the § 270.3(c)(2)(iii) that were handled by established by the Council under Council. NMFS’s decision will be based that sector during the period, NMFS § 270.17 are paid on a prorated basis to on a consideration of all relevant within 90 days after the determination, the sector participants from whom those documentation and other evidence will conduct a referendum for moneys were collected under § 270.20. submitted, and will constitute the final termination of the Council among all [FR Doc. 06–666 Filed 1–23–06; 8:45 am] administrative decision and order of the sector participants in that sector. BILLING CODE 3510–22–S
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Notices Federal Register Vol. 71, No. 15
Tuesday, January 24, 2006
This section of the FEDERAL REGISTER The ACHP’s membership will use the Secretary of Agriculture ‘‘To develop contains documents other than rules or public input it receives to draft its and improve standards of quality, proposed rules that are applicable to the formal comments to the Forest Service condition, quantity, grade and public. Notices of hearings and investigations, on the undertaking. The ACHP plans to packaging and recommend and committee meetings, agency decisions and finalize and transmit those comments to demonstrate such standards in order to rulings, delegations of authority, filing of petitions and applications and agency the Forest Service on or before February encourage uniformity and consistency statements of organization and functions are 21, 2006. in commercial practices.’’ AMS is examples of documents appearing in this Dated: January 18, 2006. committed to carrying out this authority in a manner that facilitates the section. John M. Fowler, marketing of agricultural commodities Executive Director. and makes copies of official standards ADVISORY COUNCIL ON HISTORIC [FR Doc. 06–602 Filed 1–23–06; 8:45 am] available upon request. The United PRESERVATION BILLING CODE 4310–K6–M States Standards for Grades of Fruits and Vegetables not connected with Extension of Public Comment Period Federal Marketing Orders or U.S. Import on ACHP Formal Comments Regarding DEPARTMENT OF AGRICULTURE Requirements, no longer appear in the the Replacement of a Microwave Code of Federal Regulations, but are Communications System in Mount Agricultural Marketing Service maintained by USDA/AMS/Fruit and Graham, AZ [Docket Number FV–05–304] Vegetable Programs. AMS is revising the voluntary United AGENCY: Advisory Council on Historic United States Standards for Grades of States Standards for Grades of Fresh Preservation. Fresh Asparagus Asparagus using the procedures that ACTION: Extension of Public Comment appear in Part 36, Title 7 of the Code of Period. AGENCY: Agricultural Marketing Service, Federal Regulations (7 CFR part 36). USDA. SUMMARY: The Advisory Council on ACTION: Notice. Background Historic Preservation has extended the Prior to undertaking detailed work to public comment period regarding its SUMMARY: The Agricultural Marketing develop a proposed revision to the upcoming issuance formal comments, Service (AMS) of the Department of standards, AMS published a notice on under the National Historic Presevation Agriculture (USDA) is revising the March 29, 2005 in the Federal Register Act, to the United States Forest Service voluntary United States Standards for (70 FR 15817) soliciting comments on a regarding its intent to issue a special use Grades of Fresh Asparagus. Specifically, possible revision of the United States permit for the replacement of a AMS is revising the standards to allow Standards for Grades of Fresh microwave communications system in purple and white asparagus to be graded Asparagus. Based on comments received Mount Graham, Arizona. using the standards. This change will and information gathered, a second DATES: Comments must be received on bring the standards for asparagus in line notice was published on October 6, or before February 6, 2006. with current marketing practices, 2005 in the Federal Register (70 FR thereby, improving the usefulness of the ADDRESSES: Address all comments to 58370) proposing to revise the standards standards in serving the industry. John L. Nau, III, Chairman, c/o Stephen to allow purple and white asparagus to Del Sordo, Advisory Council on Historic DATES: Effective Date: February 23, be graded using the standards. In Preservation, 1100 Pennsylvania 2006. response to this notice AMS received Avenue, NW., Suite 809, Washington, FOR FURTHER INFORMATION CONTACT: two comments from Peruvian asparagus DC 20004. Fax (202) 606–8672. Cheri L. Emery, Standardization organizations supporting the proposed Comments may also be submitted by Section, Fresh Products Branch, Fruit revision. The comments are available by electronic mail to: [email protected]. and Vegetable Programs, Agricultural accessing the AMS, Fresh Products Branch Web site at: http:// FOR FURTHER INFORMATION CONTACT: Marketing Service, U.S. Department of www.ams.usda.gov/standards/ Stephen Del Sordo, (202) 606–8580. E- Agriculture, 1400 Independence Ave., SW., Room 1661, South Building, Stop stanfrfv.htm mail: [email protected]. Further The two comments from Peruvian 0240, Washington, DC 20250–0240, information may be found in the ACHP asparagus organizations supporting the (202) 720–2185, fax (202) 720–8871, or Web site: http://www.achp.gov. proposed revision stated that the e-mail [email protected]. The SUPPLEMENTARY INFORMATION: The revision would facilitate the marketing revised United States Standards for Advisory Council on Historic of fresh asparagus. Based on comments Grades of Fresh Asparagus is available Preservation (ACHP) has extended until received and information gathered, either from the above address or by February 6, 2006, the public comment AMS is revising the fresh asparagus accessing the AMS, Fresh Products period on the replacement of a standards to allow purple and white Branch Web site at: http:// microwave communications system in asparagus to be graded using the U.S. www.ams.usda.gov/standards/ Mount Graham (undertaking). standards. Information on the undertaking was stanfrfv.htm. The official grade of a lot of fresh published in the Federal Register on SUPPLEMENTARY INFORMATION: Section asparagus covered by these standards January 9, 2006 (71 FR 1406–1407). That 203(c) of the Agricultural Marketing Act will be determined by the procedures notice is available on the ACHP Web of 1946 (7 U.S.C. 1621–1627), as set forth in the Regulations Governing site at http://www.achp.gov. amended, directs and authorizes the Inspection, Certification, and Standards
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of Fresh Fruits, Vegetables and Other Products Branch Web site at: http:// The United States Standards for Products (Sec. 51.1 to 51.61). www.ams.usda.gov/standards/ Grades of Globe Artichokes will become The United States Standards for stanfrfv.htm. effective 30 days after the publication of Grades of Fresh Asparagus will be SUPPLEMENTARY INFORMATION: Section this notice in the Federal Register. effective 30 days after publication of 203(c) of the Agricultural Marketing Act Authority: 7 U.S.C. 1621–1627. this notice in the Federal Register. of 1946 (7 U.S.C. 1621–1627), as Dated: January 18, 2006. Authority: 7 U.S.C. 1621–1627. amended, directs and authorizes the Lloyd C. Day, Dated: January 18, 2006. Secretary of Agriculture ‘‘To develop Administrator, Agricultural Marketing Lloyd C. Day, and improve standards of quality, Service. Administrator, Agricultural Marketing condition, quantity, grade and [FR Doc. E6–785 Filed 1–23–06; 8:45 am] Service. packaging and recommend and BILLING CODE 3410–02–P [FR Doc. E6–782 Filed 1–23–06; 8:45 am] demonstrate such standards in order to BILLING CODE 3410–02–P encourage uniformity and consistency in commercial practices.’’ AMS is DEPARTMENT OF AGRICULTURE committed to carrying out this authority DEPARTMENT OF AGRICULTURE in a manner that facilitates the Agricultural Marketing Service marketing of agricultural commodities Agricultural Marketing Service and makes copies of official standards [Docket Number FV–06–301] [Docket Number FV–05–305] available upon request. The United United States Standards for Grades of States Standards for Grades of Fruits Mixed Commodities United States Standards for Grades of and Vegetables not connected with Globe Artichokes Federal Marketing Orders or U.S. Import AGENCY: Agricultural Marketing Service, Requirements, no longer appear in the USDA. AGENCY: Agricultural Marketing Service, Code of Federal Regulations, but are ACTION: Notice. USDA. maintained by USDA/AMS/Fruit and ACTION: Notice. Vegetable Programs. SUMMARY: The Agricultural Marketing AMS is revising the voluntary United Service (AMS) of the Department of SUMMARY: The Agricultural Marketing Agriculture (USDA) is soliciting Service (AMS) of the Department of States Standards for Grades of Globe Artichokes using procedures that appear comments on the proposed voluntary Agriculture (USDA) is revising the United States Standards for Grades of United States Standards for Grades of in Part 36, Title 7 of the Code of Federal Regulations (7 CFR part 36). Mixed Commodities. This action is Globe Artichokes. Specifically, AMS is being taken at the request of the Fruit revising the standards to add a U.S. No. Background and Vegetable Industry Advisory 1 Long Stem grade along with an Prior to undertaking work to develop Committee, which asked AMS to undersize tolerance of 5 percent in the a proposed revision to the standard, identify products that may be better standards. The new grade will have the AMS published a notice on April 26, served if grade standards are developed. same requirements as the U.S. No. 1 2005, in the Federal Register (70 FR The proposed standards would provide except that the stems must be smoothly 21391) soliciting comments on a industry with a common language and cut to a minimum length of at least 8 possible revision to the United States uniform basis for trading, thus inches, unless specified to a longer Standards for Grades of Globe promoting orderly and efficient length in connection with the grade. Artichokes. After receiving comments, a marketing of fresh produce shipments AMS is further defining ‘‘fairly second notice was published in the containing different commodities compact’’ by including a definition for September 12, 2005, Federal Register packaged in the same container. ‘‘slightly spread’’ to mean, ‘‘the outer (70 FR 53774) proposing to revise the DATES: Comments must be received by scales may be slightly open, but the standards by adding a new grade ‘‘U.S. March 27, 2006. inner scales at the tip of the artichoke No. 1 Long Stem’’ and further defining ADDRESSES: Interested persons are must be closely folded into the bud.’’ ‘‘fairly compact’’ by including a invited to submit written comments to The revisions would bring the standards definition for ‘‘slightly spread.’’ In the Standardization Section, Fresh for globe artichokes in line with current response to this notice AMS received Products Branch, Fruit and Vegetable marketing practices, thereby improving one comment from an industry group Programs, Agricultural Marketing their usefulness in serving the industry. supporting the proposed revision. The Service, U.S. Department of Agriculture, DATES: Effective Date: February 23, comment is available by accessing the 1400 Independence Ave., SW., Room 2006. AMS, Fresh Products Branch Web site 1661, South Building, Stop 0240, FOR FURTHER INFORMATION CONTACT: at: http://www.ams.usda.gov/fv/ Washington, DC 20250–0240, fax (202) Cheri L. Emery, Standardization fpbdocketlist.htm. 720–8871, e-mail Section, Fresh Products Branch, Fruit Based on comments received and [email protected]. Comments and Vegetable Programs, Agricultural information gathered, AMS believes the should make reference to the dates and Marketing Service, U.S. Department of revision to the standards will bring the page number of this issue of the Federal Agriculture, 1400 Independence standards for globe artichokes in line Register and will be made available for Avenue, SW., Room 1661 South with current marketing practices and public inspection in the above office Building, STOP 0240, Washington, DC thereby improve their usefulness. during regular business hours and on 20250–0240, Fax (202) 720–8871 or call The official grade of a lot of globe the Internet. (202) 720–2185; E-mail artichokes covered by these standards is The draft of the proposed United [email protected]. The revised determined by the procedures set forth States Standards for Grades of Mixed United States Standards for Grades of in the Regulations Governing Commodities is available by accessing Globe Artichokes will be available Inspection, Certification, and Standards AMS, Fresh Products Branch Web site either through the address cited above of Fresh Fruits, Vegetables and Other at: http://www.ams.usda.gov/fv/ or by accessing the AMS, Fresh Products (Sec. 51.1 to 51.61). fpbdocketlist.htm.
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FOR FURTHER INFORMATION CONTACT: Inspection, Certification, and Standards www.ams.usda.gov/fv/ Cheri L. Emery, at the above address or of Fresh Fruits, Vegetables and Other fpbdocketlist.htm. call (202) 720–2185, e-mail Products (Sec. 51.1 to 51.61). FOR FURTHER INFORMATION CONTACT: [email protected]. This notice provides for a 60 day Cheri L. Emery, at the above address or SUPPLEMENTARY INFORMATION: Section comment period for interested parties to call (202) 720–2185; E-mail 203(c) of the Agricultural Marketing Act comment on the proposed United States [email protected]. of 1946 (7 U.S.C. 1621–1627), as Standards for Grades of Mixed Commodities. SUPPLEMENTARY INFORMATION: Section amended, directs and authorizes the 203(c) of the Agricultural Marketing Act Secretary of Agriculture to develop and Authority: 7 U.S.C. 1621–1627. of 1946 (7 U.S.C. 1621–1627), as improve standards of quality, condition, Dated: January 18, 2006. amended, directs and authorizes the quantity, grade and packaging and Lloyd C. Day, Secretary of Agriculture ‘‘To develop recommend and demonstrate such Administrator, Agricultural Marketing and improve standards of quality, standards in order to encourage Service. condition, quantity, grade, and uniformity and consistency in [FR Doc. E6–780 Filed 1–23–06; 8:45 am] packaging, and recommend and commercial practices. AMS is BILLING CODE 3410–02–P demonstrate such standards in order to committed to carrying out this authority encourage uniformity and consistency in a manner that facilitates the in commercial practices.’’ AMS is marketing of agricultural commodities DEPARTMENT OF AGRICULTURE committed to carrying out this authority and makes copies of official standards in a manner that facilitates the available upon request. The United Agricultural Marketing Service marketing of agricultural commodities States Standards for Grades of Fruits and makes copies of official standards and Vegetables not connected with [Docket Number FV–05–308] available upon request. The United Federal Marketing Orders or U.S. Import States Standards for Grades of Fruits Requirements, no longer appear in the United States Standards for Grades of and Vegetables that are not Code of Federal Regulations, but are Pea Pods requirements of Federal Marketing maintained by the USDA/AMS/Fruit AGENCY: Agricultural Marketing Service, Orders or U.S. Import Requirements, no and Vegetable Programs. USDA. longer appear in the Code of Federal AMS is proposing to establish Regulations, but are maintained by ACTION: Notice. voluntary United States Standards for USDA, AMS, Fruit and Vegetable Grades of Mixed Commodities using the SUMMARY: The Agricultural Marketing Programs. procedures that appear in Part 36, Title Service (AMS) of the Department of AMS is proposing to establish 7 of the Code of Federal Regulations (7 Agriculture (USDA) is soliciting voluntary United States Standards for CFR part 36). comments on the proposed voluntary Grades of Pea Pods using the procedures Background United States Standards for Grades of that appear in Part 36, Title 7 of the Pea Pods. This action is being taken at Code of Federal Regulations (7 CFR part At a meeting of the Fruit and 36). Vegetable Industry Advisory Committee, the request of the Fruit and Vegetable AMS was asked to identify fresh fruit Industry Advisory Committee, which Background asked AMS to identify commodities that and vegetables that may be better served At a meeting of the Fruit and if grade standards are developed. AMS may be better served if grade standards are developed. The proposed standards Vegetable Industry Advisory Committee, identified fresh produce that are AMS was asked to identify fresh fruit uniformly packaged with different types would provide industry with a common language and uniform basis for trading, and vegetables that may be better served of commodities in the same container, if grade standards are developed. As a as possibly in need of official grade thus promoting the orderly and efficient marketing of pea pods. result, AMS identified pea pods, or as standards. Such standards are used by they are sometimes called snow peas, as the fresh produce industry to describe DATES: Comments must be received by a commodity possibly in need of official the products they are trading, thus March 27, 2006. grade standards. Such standards are facilitating the marketing of those ADDRESSES: Interested persons are used by the fresh produce industry to products. invited to submit written comments to describe the product they are trading, AMS has developed proposed the Standardization Section, Fresh thus facilitating the marketing of the voluntary grade standards for shipments Products Branch, Fruit and Vegetable product. of mixed commodities. These standards Programs, Agricultural Marketing Prior to undertaking research and would establish a grade U.S. Mixed as Service, U.S. Department of Agriculture, other work associated to develop the well as sections pertaining to sampling, 1400 Independence Ave., SW., Room standards, AMS published a notice on tolerances, application of tolerances, 1661 South Building, Stop 0240, May 2, 2005 in the Federal Register (70 and definitions for Injury, Damage and Washington, DC 20250–0240; Fax (202) FR 83) soliciting comments on the Serious Damage. 720–8871, E-mail possible development of the United The adoption of these proposed [email protected]. Comments States Standards for Grades of Pea Pods. standards would provide the ever should make reference to the dates and In response to the request for expanding mixed commodity industry page number of this issue of the Federal comments, AMS received one comment with U.S. grade standards similar to Register and will be made available for on the development of U.S. standards those extensively in use by the fresh public inspection in the above office for pea pods. The comment was from an produce industry to assist in orderly during regular business hours and on industry group that expressed support marketing of other commodities. the Internet. for the development of standards for pea The official grade of a lot of mixed The draft of the proposed United pods. The comment is available by commodities covered by these standards States Standards for Grades of Pea Pods accessing AMS, Fresh Products Branch will be determined by the procedures is available by accessing AMS, Fresh Web site at: http://www.ams.usda.gov/ set forth in the Regulations Governing Products Branch Web site at: http:// fvfpbdocketlist.htm. Based on the
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comment received and information [email protected]. The revised providing more objectivity to an gathered, AMS has developed proposed United States Standards for Grades of inspection. grade standards for pea pods. This Strawberries will be available either Additionally, AMS is eliminating the proposal would establish the following through the address cited above or by unclassified category. This section is grades, as well as a tolerance for each accessing the AMS, Fresh Products being removed in all standards, when grade: U.S. Fancy and U.S. No. 1. In Branch Web site at: http:// they are revised. This category is not a addition, there are proposed www.ams.usda.gov/standards/ grade and only serves to show that no ‘‘Tolerances,’’ and ‘‘Application of stanfrfv.htm. grade has been applied to the lot. It is Tolerances’’ sections. AMS is proposing no longer considered necessary. to define ‘‘Injury,’’ ‘‘Damage’’ and SUPPLEMENTARY INFORMATION: Section The official grade of a lot of ‘‘Serious Damage,’’ along with specific 203(c) of the Agricultural Marketing Act strawberries covered by these standards basic requirements and definitions for of 1946 (7 U.S.C. 1621–1627), as is determined by the procedures set defects. amended, directs and authorizes the forth in the Regulations Governing The official grade of a lot or shipment Secretary of Agriculture ‘‘To develop Inspection, Certification, and Standards of fresh vegetables covered by U.S. and improve standards of quality, of Fresh Fruits, Vegetables and Other standards is determined by the condition, quantity, grade and Products (Sec. 51.1 to 51.61). procedures set forth in the Regulations packaging and recommend and The United States Standards for Governing Inspection, Certification, and demonstrate such standards in order to Grades of Strawberries will become Standards of Fresh Fruits, Vegetables encourage uniformity and consistency effective 30 days after the publication of and Other Products (Sec. 51.1 to 51.61). in commercial practices.’’ AMS is this notice in the Federal Register. committed to carrying out this authority This notice provides for a 60-day Authority: 7 U.S.C. 1621–1627. comment period for interested parties to in a manner that facilitates the comment on the proposed United States marketing of agricultural commodities Dated: January 18, 2006. Standards for Grades of Pea Pods. and makes copies of official standards Lloyd C. Day, available upon request. The United Administrator, Agricultural Marketing Authority: 7 U.S.C. 1621–1627. States Standards for Grades of Fruits Service. Dated: January 18, 2006. and Vegetables not connected with [FR Doc. E6–781 Filed 1–23–06; 8:45 am] Lloyd C. Day, Federal Marketing Orders or U.S. Import BILLING CODE 3410–02–P Administrator, Agricultural Marketing Requirements, no longer appear in the Service. Code of Federal Regulations, but are [FR Doc. E6–784 Filed 1–23–06; 8:45 am] maintained by USDA/AMS/Fruit and DEPARTMENT OF AGRICULTURE BILLING CODE 3410–02–P Vegetable Programs. Agricultural Marketing Service AMS is revising the voluntary United States Standards for Grades of [Docket Number FV–06–304] DEPARTMENT OF AGRICULTURE Strawberries using procedures that United States Standards for Grades of Agricultural Marketing Service appear in Part 36, Title 7 of the Code of Federal Regulations (7 CFR part 36). Table Grapes (European or Vinifera [Docket Number FV–05–301] Type) Background United States Standards for Grades of AGENCY: Agricultural Marketing Service, Prior to undertaking detailed work to Strawberries USDA. develop a proposed revision to the ACTION: Notice. AGENCY: Agricultural Marketing Service, standard, AMS published a notice on USDA. March 11, 2005, in the Federal Register SUMMARY: The Agricultural Marketing ACTION: Notice. (70 FR 12175) soliciting comments on a Service (AMS) of the Department of possible revision to the United States Agriculture (USDA), is soliciting SUMMARY: The Agricultural Marketing Standards for Grades of Strawberries. comments on a proposal to revise the Service (AMS) of the Department of After receiving comments, a second United States Standards for Grades of Agriculture (USDA) is revising the notice was published in the September Table Grapes (European or Vinifera United States Standards for Grades of 7, 2005, Federal Register (70 FR 53148– Type). AMS has received petitions from Strawberries. AMS received a request 9) concerning the proposed percentage the California Grape and Tree Fruit from an industry group to modify the determination. In response to this League and Western Growers standards to allow that percentages be notice, AMS received one comment Association, requesting that the current determined by count and not volume. from a state agricultural representative standards be modified by adding a 10 The change will make tolerance opposing the proposed revision. The percent allowance for shattered berries determination more objective and more comment is available by accessing the in consumer containers for en route or uniform. AMS, Fresh Products Branch Web site at destination. DATES: Effective Date: February 23, at: http://www.ams.usda.gov/fv/ DATES: Comments must be received by 2006. fpbdocketlist.htm. March 27, 2006. FOR FURTHER INFORMATION CONTACT: The comment stated that the size ADDRESSES: Interested persons are Cheri L. Emery, Standardization variance is too great to make a count- invited to submit written comments to Section, Fresh Products Branch, Fruit based inspection an accurate the Standardization Section, Fresh and Vegetable Programs, Agricultural representation of the lot and that maybe Products Branch, Fruit and Vegetable Marketing Service, U.S. Department of the commodity should be inspected by Programs, Agricultural Marketing Agriculture, 1400 Independence weight. However, AMS believes that Service, U.S. Department of Agriculture, Avenue, SW., Room 1661 South allowing percentages to be determined 1400 Independence Ave., SW., Room Building, STOP 0240, Washington, DC by count and not volume would 1661 South Building, Stop 0240, 20250–0240, Fax (202) 720–8871 or call establish a uniform procedure for Washington, DC 20250–0240; Fax (202) (202) 720–2185; E-mail determining the percentages, thereby 720–8871, E-mail
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[email protected]. Comments present; (2) a lot of berries which has 23 FOR FURTHER INFORMATION CONTACT: should make reference to the dates and percent shattered berries 13 percent Robert M. Eadie, Branch Chief, Policy page number of this issue of the Federal would be reported as a defect which and Program Development Branch, Register and will be made available for would cause the lot to fail meet the Child Nutrition Division, Food and public inspection in the above office requirements of the U.S. No. Table 1 Nutrition Service, U.S. Department of during regular business hours. The grade by 1 percent. The petitioners Agriculture, 3101 Park Center Drive, United States Standards for Grades of stated that they feel change, specific to Room 640, Alexandria, Virginia 22302, Table Grapes (European or Vinifera consumer containers, is warranted as (703) 305–2590. Type) are available either through the the majority of table grapes are now SUPPLEMENTARY INFORMATION: This address cited above or by accessing the being sold in consumer containers program is listed in the Catalog of AMS, Fresh Products Branch Web site which allows shattered berries to be Federal Domestic Assistance under No. at: http://www.ams.usda.gov/standards/ fully utilized/sold. This does not hold 10.559 and is subject to the provisions stanfrfv.htm. true for shattered berries in bulk of Executive Order 12372 which FOR FURTHER INFORMATION CONTACT: containers, as these berries remain loose requires intergovernmental consultation Cheri L. Emery, at the above address or in the container, therefore, limiting the with State and local officials (7 CFR part call (202) 720–2185, E-mail ability to fully utilize/sell the shattered 3015, subpart V, and final rule related [email protected]. berries. notice published at 48 FR 29114, June 24, 1983). SUPPLEMENTARY INFORMATION: Prior to undertaking detailed work to Section In accordance with the Paperwork 203(c) of the Agricultural Marketing Act develop a proposed revision to the standards, AMS is soliciting comments Reduction Act of 1995 (44 U.S.C. 3501– of 1946 (7 U.S.C. 1621–1627), as 3518), no new recordkeeping or amended, directs and authorizes the on the petition submitted to revise the United States Standards for Grades of reporting requirements have been Secretary of Agriculture ‘‘To develop included that are subject to approval and improve standards of quality, Table Grapes (European or Vinifera Type). from the Office of Management and condition, quantity, grade and Budget. packaging and recommend and This notice provides for a 60-day comment period for interested parties to This notice is not a rule as defined by demonstrate such standards in order to the Regulatory Flexibility Act (5 U.S.C. encourage uniformity and consistency comment on changes to the standards. Should AMS conclude that revisions are 601–612) and thus is exempt from the in commercial practices.’’ AMS is provisions of that Act. Additionally, this committed to carrying out this authority needed, the Agency will develop a proposed revised standard that will be notice has been determined to be in a manner that facilitates the exempt from review by the Office of marketing of agricultural commodities published in the Federal Register with a request for comments. Management and Budget under and makes copies of official standards Executive Order 12866. available upon request. Authority: 7 U.S.C. 1621–1627. Definitions Background Dated: January 18, 2006. Lloyd C. Day, The terms used in this Notice shall AMS received petitions from the have the meaning ascribed to them in California Grape and Tree Fruit League Administrator, Agricultural Marketing Service. the regulations governing the Summer and Western Growers Association, [FR Doc. E6–783 Filed 1–23–06; 8:45 am] Food Service Program for Children (7 requesting a revision to the United CFR part 225). States Standards for Grades of Table BILLING CODE 3410–02–P Grapes (European or Vinifera Type). Background These standards were last revised in In accordance with Section 13 of the DEPARTMENT OF AGRICULTURE 1999. The petitioners represent more National School Lunch Act (NSLA) (42 than 85 percent of the European or Food and Nutrition Service U.S.C. 1761) and the regulations Vinifera type table grape production in governing the SFSP (7 CFR part 225), the United States. Summer Food Service Program for notice is hereby given of adjustments in The petitioners are requesting that Children Program Reimbursement for Program payments for meals served to AMS revise the standards to provide a 2006 children participating in the SFSP in 10 percent allowance for shattered 2006. Adjustments are based on changes berries in consumer containers for en AGENCY: Food and Nutrition Service, in the food away from home series of route or at destination. Shattered means USDA. the Consumer Price Index (CPI) for All that the berry is detached from the ACTION: Notice. Urban Consumers for the period bunch. The standards currently provide November 2004 through November a 12 percent total tolerance for bunches SUMMARY: This notice informs the public 2005. and berries failing to meet the of the annual adjustments to the Section 104(a) of the William F. requirements of grade for en route or at reimbursement rates for meals served in Goodling Child Nutrition destination. Revising the standards to the Summer Food Service Program for Reauthorization Act of 1998 (Public Law include a separate 10 percent allowance Children (SFSP). These adjustments 105–336) amended Section 12(f) of the would mean that shattered berries reflect changes in the Consumer Price NSLA (42 U.S.C. 1760(f)) to allow would not be scored as a defect against Index and are required by the statute adjustments to SFSP reimbursement the 12 percent total tolerance until the governing the Program. In addition, rates to reflect the higher cost of amount of shattered berries exceeds the further adjustments are made to these providing meals in the SFSP in Alaska 10 percent allowance. For example: (1) rates to reflect the higher costs of and Hawaii. Therefore, this notice A lot of berries which has 22 percent providing meals in the States of Alaska contains adjusted rates for Alaska and shattered berries 12 percent would be and Hawaii, as authorized by the Hawaii. This change was made in an reported as a defect, this lot would meet William F. Goodling Child Nutrition effort to be consistent with other Child the requirements of the U.S. No. 1 Table Reauthorization Act of 1998. Nutrition Programs, such as the grade provided no other defects were DATES: Effective Date: January 1, 2006. National School Lunch Program and the
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School Breakfast Program, which higher reimbursement rates for The 2006 reimbursement rates, in already had the authority to provide programs in Alaska and Hawaii. dollars, for all States excluding Alaska and Hawaii:
MAXIMUM PER MEAL REIMBURSEMENT RATES FOR ALL STATES (NOT AK OR HI)
Administrative costs Operating Rural or Other costs self-prepa- types of ration sites sites
Breakfast ...... $1.47 $.1450 $.1150 Lunch or Supper ...... 2.56 .2675 .2225 Supplement ...... 59 .0725 .0575
The 2006 reimbursement rates, in dollars, for Alaska:
MAXIMUM PER MEAL REIMBURSEMENT RATES FOR ALASKA ONLY
Administrative costs Operating Rural or Other costs self-prepa- types of ration sites sites
Breakfast ...... $2.38 $.2350 $.1875 Lunch or Supper ...... 4.15 .4350 .3600 Supplement ...... 97 .1175 .0925
The 2006 reimbursement rates, in dollars, for Hawaii:
MAXIMUM PER MEAL REIMBURSEMENT RATES FOR HAWAII ONLY
Administrative costs Operating Rural or Other costs self-prepa- types of ration sites sites
Breakfast ...... $1.72 $.1700 $.1350 Lunch or Supper ...... 3.00 .3125 .2600 Supplement ...... 70 .0850 .0675
The total amount of payments to State required by Section 11(a)(3)(B) of the of the Secure Rural Schools and agencies for disbursement to Program NSLA (42 U.S.C. 1759 (a)(3)(B)). Community Self Determination Act of sponsors will be based upon these Authority: Secs. 9, 13 and 14, National 2000 (Public Law 106–393 Program reimbursement rates and the School Lunch Act, as amended (42 U.S.C. number of meals of each type served. 1758, 1761, and 1762a). SUMMARY: This notice is published in The above reimbursement rates, for both Dated: January 17, 2006. accordance with section 10(a)(2) of the operating and administrative Federal Advisory Committee Act. Roberto Salazar, reimbursement rates, represent a 3.2 Meeting notice is hereby given for the percent increase during 2005 (from Administrator. southwest Mississippi Resource 189.6 in November 2004 to 195.6 in [FR Doc. E6–793 Filed 1–23–06; 8:45 am] Advisory Committee pursuant to November 2005) in the food away from BILLING CODE 3410–30–P Section 205 of the Secure Rural Schools home series of the Consumer Price and Community Self Determination Act Index for All Urban Consumers, of 2000, Public Law 106–393. Topics to DEPARTMENT OF AGRICULTURE published by the Bureau of Labor be discussed include: General Statistics of the Department of Labor. Forest Service information, possible Title II projects, The Department would like to point out and next meeting dates and agendas. that the SFSP administrative Southwest Mississippi Resource DATES: The meeting will be held on reimbursement rates continue to be Advisory Committee February 28, 2006, from 6 p.m. and end adjusted up or down to the nearest at approximately 9 p.m. quarter-cent, as has previously been the AGENCY: Forest Service, USDA. case. Additionally, operating ACTION: Meeting notice for the ADDRESSES: The meeting will be held at reimbursement rates have been rounded Southwest Mississippi Resource the Franklin County Public Library, 381 down to the nearest whole cent, as Advisory Committee under Section 205 First Street, Meadville, Mississippi.
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FOR FURTHER INFORMATION CONTACT: newspapers, including the daily The Panel is to consist of 15 voting Mary Bell Lunsford, Public Affairs Interlake based in Kalispell, Montana. members composed as follows: Not less Officer, USDA, Homochitto National Dated: January 17, 2006. than eight of the voting members of the Forest, 1200 Hwy. 184 East, Meadville, Bob Castaneda, panel should be individuals who, by MS 39653 (601–384–5876). reason of knowledge, experience, or Forest Supervisor. SUPPLEMENTARY INFORMATION: training, are especially qualified in one The [FR Doc. 06–615 Filed 1–23–06; 8:45 am] meeting is open to the public. or more of the disciplines and fields BILLING CODE 3410–11–M Committee discussion is limited to included in marine science. The other Forest Service staff, Committee voting members shall be individuals members and elected officials. However, who by reason of knowledge, DEPARTMENT OF COMMERCE persons who wish to bring matters to experience, or training, are especially the attention of the Committee may file Notice of Solicitation for Sea Grant qualified in, or representative of, written statements with the Committee Review Panelists education, extension service, state staff before or after the meeting. A government, industry, economics, public input session will be provided AGENCY: National Oceanic and planning, or any other activity which is and individuals who made written Atmospheric Administration Office of appropriate to, and important for, any requests by February 21, 2006, will have Oceanic and Atmospheric Research effort to enhance the understanding, the opportunity to address the (OAR) National Sea Grant Review Panel. assessment, development, utilization, or committee at that session. Individuals SUMMARY: This notice responds to the conservation of ocean and coastal wishing to speak or propose agenda National Sea Grant College Program Act, resources. No individual is eligible to be items must send their names and at 33 U.S.C. 1128, which requires the a voting member of the panel if the proposals to Tim Reed, District Ranger, Secretary of Commerce to solicit individual is (a) the director of a sea DFO, 1200 Hwy. 184 East, Meadville, nominations at least once a year for grant college, sea grant regional MS 39653. membership on the Sea Grant Review consortium, or sea grant program, (b) an Panel. This advisory committee Dated: January 13, 2006. applicant for or beneficiary (as provides advice on the implementation determined by the Secretary) of any Tim Reed, of the National Sea Grant College grant or contract under 33 U.S.C. 1124 Designated Federal Officer. Program. or (c) a full-time officer or employee of [FR Doc. 06–606 Filed 1–23–06; 8:45 am] DATES: Resumes should be sent to the the United States. The Director of the BILLING CODE 3410–11–M address specified and must be received National Sea Grant College Program and by 30 days from publication. one Director of a Sea Grant Program also serve as non-voting members. Panel DEPARTMENT OF AGRICULTURE ADDRESSES: Dr. Leon M. Cammen, Interim Executive Director; National Sea members are appointed for a 4-year Forest Service Grant College Program; 1315 East-West term. Highway, Room 11841; Silver Spring, Dated: January 18, 2006. Notice of Lincoln County Resource Maryland 20910 Mark E. Brown, Advisory Committee Meeting FOR FURTHER INFORMATION CONTACT: Dr. Chief Financial Officer, Office of Oceanic and AGENCY: Forest Service, USDA. Leon M. Cammen of the National Sea Atmospheric Research. [FR Doc. E6–830 Filed 1–23–06; 8:45 am] ACTION: Notice of meeting. Grant College Program at the address given above; telephone (301) 713–2435 BILLING CODE 3510–KA–P SUMMARY: Pursuant to the authorities in extension 136 or fax number (301) 713– the Federal Advisory Committee Act 0799. (Public Law 92–463) and under the SUPPLEMENTARY INFORMATION: Section DEPARTMENT OF COMMERCE Secure Rural Schools and Community 209 of the Act establishes a Sea Grant Bureau of Industry and Security Self-Determination Act of 2000 (Public Review Panel to advise the Secretary of Law 106–393) the Kootenai National Commerce, the Under Secretary for Transportation and Related Equipment Forest’s Lincoln County Resource Oceans and Atmosphere, and the Technical Advisory Committee; Notice Advisory Committee will meet on Director of the National Sea Grant of Open Meeting Wednesday February 1, 2006 at 6 p.m. College Program on the implementation at the Forest Supervisor’s Office in of the Sea Grant Program. The panel The Transportation and Related Libby, Montana for a business meeting. provides advice on such matters as: Equipment Technical Advisory The meeting is open to the public. (a) The Sea Grant Fellowship Committee will meet on February 9, DATES: February 1, 2006. Program; 2006, 9:30 a.m., in the Herbert C. ADDRESSES: Forest Supervisor’s Office, (b) Applications or proposals for, and Hoover Building, Room 3884, 14th 1101 U.S. Hwy. 2 West, Libby, Montana. performance under, grants and contracts Street between Pennsylvania and awarded under the Sea Grant Program FOR FURTHER INFORMATION CONTACT: Constitution Avenues, NW., Barbara Edgmon, Committee Improvement Act of 1976, as amended Washington, DC. The Committee Coordinator, Kootenai National Forest at at 33 U.S.C. 1124; advises the Office of the Assistant (c) The designation and operation of (406) 283–7764, or e-mail Secretary for Export Administration sea grant colleges and sea grant [email protected]. with respect to technical questions that institutes; and the operation of the sea affect the level of export controls SUPPLEMENTARY INFORMATION: Agenda grant program; applicable to transportation and related topics include status of approved (d) The formulation and application equipment or technology. projects, plan for receiving and of the planning guidelines and priorities approving proposals for 2007, and under 33 U.S.C. 1123 (a) and (c)(1); and Agenda receiving public comment. If the (e) Such other matters as the Secretary 1. Welcome and Introductions. meeting date or location is changed, refers to the panel for review and 2. Review of Bureau issues of notice will be posted in the local advice. significance to TRANSTAC members.
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3. Regulatory overview. preliminary results. The final results are defined as: (i) grade 1080 tire cord 4. Policy overview. listed below in the Final Results of quality wire rod measuring 5.0 mm or 5. Missile Technology Control Review section. more but not more than 6.0 mm in Regime. EFFECTIVE DATE: January 24, 2006. cross-sectional diameter; (ii) with an 6. Wassenaar proposal status. FOR FURTHER INFORMATION CONTACT: average partial decarburization of no 7. Jurisdiction technical working Salim Bhabhrawala or David Neubacher, more than 70 microns in depth group report. at (202) 482–1784 or (202) 482–5823, (maximum individual 200 microns); (iii) 8. Presentation of papers and respectively; AD/CVD Operations, having no non–deformable inclusions comments by the public. Office 1, Import Administration, greater than 20 microns and no 9. Follow-up on open action items. International Trade Administration, deformable inclusions greater than 35 The meeting will be open to the U.S. Department of Commerce, 14th microns; (iv) having a carbon segregation per heat average of 3.0 or public and a limited number of seats Street & Constitution Avenue, NW., better using European Method NFA 04– will be available. Reservations are not Washington, DC 20230. accepted. To the extent time permits, 114; (v) having a surface quality with no SUPPLEMENTARY INFORMATION: members of the public may present oral surface defects of a length greater than statements to the Committee. Written Background 0.15 mm; (vi) capable of being drawn to a diameter of 0.30 mm or less with 3 or statements may be submitted at any On July 20, 2005, the Department time before or after the meeting. fewer breaks per ton, and (vii) published in the Federal Register the containing by weight the following However, to facilitate distribution of preliminary results of the second public presentation materials to elements in the proportions shown: (1) administrative review of the 0.78 percent or more of carbon, (2) less Committee members, the Committee antidumping duty order on carbon and suggests that presenters forward the than 0.01 percent of aluminum, (3) certain alloy steel wire rod from Canada. 0.040 percent or less, in the aggregate, public presentation materials to Yvette See Notice of Preliminary Results of Springer at [email protected]. For of phosphorus and sulfur, (4) 0.006 Antidumping Duty Administrative percent or less of nitrogen, and (5) not more information contact Ms. Springer Review: Carbon and Certain Steel Alloy on (202) 482–4814. more than 0.15 percent, in the aggregate, Steel Wire Rod from Canada, 70 FR of copper, nickel and chromium. Dated: January 17, 2006. 41681 (July 20, 2005) (Preliminary Grade 1080 tire bead quality rod is Yvette Springer, Results). defined as: (i) grade 1080 tire bead Committee Liaison Officer. We invited parties to comment on the quality wire rod measuring 5.5 mm or [FR Doc. 06–589 Filed 1–23–06; 8:45 am] Preliminary Results. On August 29, more but not more than 7.0 mm in BILLING CODE 3510–JT–M 2005, we received case briefs from the cross-sectional diameter; (ii) with an respondents, Ivaco and Ispat, and the average partial decarburization of no petitioners, Gerdau Ameristeel US Inc., more than 70 microns in depth DEPARTMENT OF COMMERCE ISG Georgetown Inc., Keystone (maximum individual 200 microns); (iii) Consolidated Industries, Inc., and North having no non–deformable inclusions International Trade Administration Star Steel Texas, Inc. All parties greater than 20 microns and no submitted rebuttal briefs on September (A–122–840) deformable inclusions greater than 35 9, 2005. No public hearing was microns; (iv) having a carbon Notice of Final Results of Antidumping requested. segregation per heat average of 3.0 or Duty Administrative Review: Carbon Scope of the Order better using European Method NFA 04– and Certain Alloy Steel Wire Rod from 114; (v) having a surface quality with no Canada The merchandise subject to this order surface defects of a length greater than is certain hot–rolled products of carbon 0.2 mm; (vi) capable of being drawn to AGENCY: Import Administration, steel and alloy steel, in coils, of a diameter of 0.78 mm or larger with 0.5 International Trade Administration, approximately round cross section, 5.00 or fewer breaks per ton; and (vii) Department of Commerce. mm or more, but less than 19.00 mm, in containing by weight the following SUMMARY: On July 20, 2005, the solid cross-sectional diameter. elements in the proportions shown: (1) Department of Commerce (the Specifically excluded are steel 0.78 percent or more of carbon, (2) less Department) published the preliminary products possessing the above–noted than 0.01 percent of soluble aluminum, results of its second administrative physical characteristics and meeting the (3) 0.040 percent or less, in the review of the antidumping duty order Harmonized Tariff Schedule of the aggregate, of phosphorus and sulfur, (4) on carbon and certain alloy steel wire United States (HTSUS) definitions for 0.008 percent or less of nitrogen, and (5) rod from Canada. The review covers two (a) stainless steel; (b) tool steel; c) high either not more than 0.15 percent, in the producers of the subject merchandise, nickel steel; (d) ball bearing steel; and aggregate, of copper, nickel and Ivaco Inc. and Ivaco Rolling Mills (IRM) (e) concrete reinforcing bars and rods. chromium (if chromium is not (collectively, ‘‘Ivaco’’) and Ispat Sidbec, Also excluded are (f) free machining specified), or not more than 0.10 percent Inc. (Ispat) (now known as Mittal steel products (i.e., products that in the aggregate of copper and nickel Canada Inc. (Mittal)1). The period of contain by weight one or more of the and a chromium content of 0.24 to 0.30 review (POR) is October 1, 2003, following elements: 0.03 percent or percent (if chromium is specified). through September 30, 2004. Based on more of lead, 0.05 percent or more of For purposes of grade 1080 tire cord our analysis of comments received, bismuth, 0.08 percent or more of sulfur, quality wire rod and grade 1080 tire these final results differ from the more than 0.04 percent of phosphorus, bead quality wire rod, an inclusion will more than 0.05 percent of selenium, or be considered to be deformable if its 1 On June 24, 2005, we determined that Mittal more than 0.01 percent of tellurium). ratio of length (measured along the axis was the successor-in-interest to Ispat Sidbec, Inc. Also excluded from the scope are – that is, the direction of rolling – of the See Final Results of Changed Circumstances Antidumping Duty Administrative Review: Carbon 1080 grade tire cord quality wire rod rod) over thickness (measured on the and Certain Steel Alloy Wire Rod from Canada, 70 and 1080 grade tire bead quality wire same inclusion in a direction FR 39484 (July 8, 2005). rod. Grade 1080 tire cord quality rod is perpendicular to the axis of the rod) is
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equal to or greater than three. The size Memorandum), which is hereby Assessment of an inclusion for purposes of the 20 adopted by this notice. A list of the The Department will determine, and microns and 35 microns limitations is issues addressed in the Decision U.S. Customs and Border Protection the measurement of the largest Memorandum is appended to this (CBP) shall assess, antidumping duties dimension observed on a longitudinal notice. The Decision Memorandum is on on all appropriate entries, pursuant to section measured in a direction file in the Central Records Unit in Room 19 CFR 351.212(b). The Department perpendicular to the axis of the rod. B–099 of the main Commerce building, calculated importer–specific duty This measurement methodology applies and can also be accessed directly on the assessment rates on the basis of the ratio only to inclusions on certain grade 1080 Web at http://ia.ita.doc.gov/frn/ of the total amount of antidumping tire cord quality wire rod and certain index.html. The paper copy and duties calculated for the examined sales grade 1080 tire bead quality wire rod electronic version of the Decision to the total entered value of the that are entered, or withdrawn from Memorandum are identical in content. examined sales for that importer. Where warehouse, for consumption on or after the assessment rate is above de minimis, July 24, 2003. Changes Since the Preliminary Results The designation of the products as we will instruct CBP to assess duties on ‘‘tire cord quality’’ or ‘‘tire bead quality’’ Based on our analysis of comments all entries of subject merchandise by indicates the acceptability of the received, we have made adjustments to that importer. In accordance with 19 product for use in the production of tire the preliminary results calculation CFR 356.8(a), the Department will issue cord, tire bead, or wire for use in other methodologies in calculating the final appropriate assessment instructions rubber reinforcement applications such dumping margins. Brief descriptions of directly to CBP on or after 41 days as hose wire. These quality designations the company–specific changes are following the date of publication of are presumed to indicate that these provided below and the changes are these final results of review. products are being used in tire cord, tire discussed in detail in the Decision Cash Deposits bead, and other rubber reinforcement Memorandum. Furthermore, the following deposit applications, and such merchandise requirements will be effective upon intended for the tire cord, tire bead, or Ivaco publication of the final results of this other rubber reinforcement applications We have corrected ministerial errors is not included in the scope. However, administrative review for all shipments identified by parties in Ivaco’s of carbon and certain alloy steel wire should petitioners or other interested preliminary margin calculations as parties provide a reasonable basis to rod from Canada entered, or withdrawn follows: (1) we included indirect selling from warehouse, for consumption on or believe or suspect that there exists a expenses in the calculation of CEP pattern of importation of such products after the publication date of these final profit; (2) we used Ivaco’s reported for other than those applications, end– results, as provided by section 751(a) of credit expenses for its U.S. currency use certification for the importation of the Tariff Act of 1930, as amended (the denominated sales in the home market such products may be required. Under Act): (1) for companies covered by this such circumstances, only the importers and assigned it correctly throughout the review, the cash deposit rate will be the of record would normally be required to calculation program; (3) we readjusted rate listed above; (2) for previously certify the end use of the imported Ivaco’s date of sale on certain U.S. sales; reviewed or investigated companies not merchandise. and (4) we ensured that the freight listed above, the cash deposit rate will All products meeting the physical expenses from the border to the further continue to be the company–specific description of subject merchandise that processors were counted as a further rate published for the most recent are not specifically excluded are manufacturing expense for only those period; (3) if the exporter is not a firm included in this scope. sales which underwent further covered in this review, a prior review, The products under review are manufacturing in the United States. or the investigation, but the producer is, currently classifiable under subheadings the cash deposit rate will be that Ispat 7213.91.3010, 7213.91.3015, established for the producer of the 7213.91.3090, 7213.91.3092, We have corrected ministerial errors merchandise in these final results of 7213.91.4510, 7213.91.4590, identified by parties in Ispat’s review, a prior review, or in the final 7213.91.6010, 7213.91.6090, preliminary margin calculations as determination; and (4) if neither the 7213.99.0031, 7213.99.0038, follows: (1) we included the correct exporter nor the producer is a firm 7213.99.0090, 7227.20.0010, database and allowed for an offset in the covered in this review, a prior review, 7227.20.0020, 7227.20.0090, calculation of CEP profit within the or the investigation, the cash deposit 7227.20.0095, 7227.90.6010, margin program; and (2) we have rate will be 8.11 percent, the ‘‘All Others’’ rate established in the less– 7227.90.6051, 7227.90.6053, corrected the calculation of the CEP than-fair–value investigation. These 7227.90.6058, 7227.90.6059, and offset in the margin program. 7227.90.6080 of the HTSUS. Although deposit requirements shall remain in the HTSUS subheadings are provided Final Results of Review effect until publication of the final for convenience and customs purposes, results of the next administrative the written description of the scope of As a result of our review, we review. this proceeding is dispositive. determine that the following weighted– This notice also serves as a final average margins exist for the period of reminder to importers of their Analysis of Comments Received October 1, 2003, through September 30, responsibility under 19 CFR 351.402 (f) The issues raised in the case briefs by 2004: to file a certificate regarding the parties to this administrative review are reimbursement of antidumping duties addressed in the Issues and Decision Producer Weighted–Average prior to liquidation of the relevant Memorandum to David M. Spooner, Margin (Percentage) entries during this review period. Assistant Secretary for Import Ivaco ...... 3.08 Failure to comply with this requirement Administration, from Stephen J. Claeys, Ispat/Mittal ...... 6.13 could result in the Secretary’s Deputy Assistant Secretary (Decision presumption that reimbursement of
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antidumping duties occurred, and in the DEPARTMENT OF COMMERCE by additional 30 days and, as a result, subsequent assessment of double intends to issue the preliminary results antidumping duties. International Trade Administration of the full sunset review no later than February 17, 2006. The Department will This notice also is the only reminder (A–821–802) issue its final results of the full sunset to parties subject to administrative review on May 30, 2006, as specified in protective order (APO) of their Extension of Time Limit for Sunset Review of the Agreement Suspending the Notice of Extension. responsibility concerning the return or This notice is issued in accordance destruction of proprietary information the Antidumping Investigation on Uranium from the Russian Federation with sections 751(c)(5)(B) and (C)(v) of disclosed under APO in accordance the Act. with 19 CFR 351.305. Timely written AGENCY: Import Administration, Dated: January 17, 2006. notification of the return/destruction of International Trade Administration, Ronald K. Lorentzen, APO materials or conversion to judicial U.S. Department of Commerce. DirectorOffice of Policy. protective order is hereby requested. EFFECTIVE DATE: January 24, 2006. Failure to comply with the regulations [FR Doc. E6–825 Filed 1–23–06; 8:45 am] FOR FURTHER INFORMATION CONTACT: and the terms of an APO is a BILLING CODE 3510–DS–S Sally C. Gannon or Aishe Allen, Import sanctionable violation. Administration, International Trade We are issuing and publishing these Administration, U.S. Department of DEPARTMENT OF COMMERCE results and notice in accordance with Commerce. 14th Street and Constitution sections 751(a)(1) and 777(i)(1) of the Avenue, NW., Washington, DC 20230; International Trade Administration Act. (202) 482–0162 or (202) 482–0172, [A–489–501] Dated: January 17, 2006. respectively. Notice of Amended Final Results of David M. Spooner, Extension of Time Limit for Sunset Antidumping Duty Administrative Assistant Secretaryfor Import Administration. Review: Review: Certain Welded Carbon Steel APPENDIX On November 10, 2005, the Pipe and Tube from Turkey Department of Commerce (‘‘the AGENCY: Import Administration, I. General Issues Department’’) extended the time limit for the sunset review of the agreement International Trade Administration, Comment 1: Freight to Unaffiliated suspending the antidumping Department of Commerce. SUMMARY: On December 5, 2005, the Processors as Further investigation on uranium from the Department of Commerce (‘‘the Manufacturing Russian Federation in accordance with Department’’) issued the final results of section 751(c)(5)(B) of the Tariff Act of II. Company Specific Issues its administrative review of the 1930, as amended (‘‘the Act’’). See antidumping duty order on certain Issues Specific to Ivaco Extension of Time Limit for Sunset welded carbon steel pipe and tube Review of the Agreement Suspending (‘‘welded pipe and tube’’) from Turkey.1 Comment 2: Use of Level of Trade the Antidumping Investigation on The period of review is May 1, 2003, Adjustment for IRM’s and Sivaco’s Uranium from the Russian Federation, through April 30, 2004. Based on the U.S. Sales 70 FR 68397 (November 10, 2005) correction of certain ministerial errors, (‘‘Notice of Extension’’). The Comment 3: Level of Trade we have changed the margins for the Department has now determined to Methodology Used for IRM’s and Borusan Group (‘‘Borusan’’) and for the conduct a full sunset review of this Sivaco’s U.S. Sales Yucel Group, which includes Cayirova suspended investigation. See Comment 4: Ministerial Error Boru Sanayi ve Ticaret A.S. and its Memorandum from Sally C. Gannon to Allegations Specific to Ivaco affiliate, Yucel Boru Ithalat–Ihracat ve Ronald K. Lorentzen; ‘‘Sunset Review of Pazarlama A.S. (collectively referred to Uranium from the Russian Federation: Issues Specific to Ispat as ‘‘Cayirova’’). Adequacy of Domestic and Respondent Comment 5: Cost Averaging Periods Interested Party Responses to the Notice EFFECTIVE DATE: January 24, 2006. FOR FURTHER INFORMATION CONTACT: Comment 6: CEP Profit of Initiation and Decision to Conduct Full Sunset Review,’’ dated January 17, Christopher Hargett, George McMahon, Comment 7: Negative Net–Prices for 2006. or Jim Terpstra, AD/CVD Operations, U.S. Sales Pursuant to section 351.218(f) of the Office 3, Import Administration, Comment 8: Treatment of Certain Department’s regulations, the International Trade Administration, Sales as CEP Sales Department normally will issue its U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Comment 9: Offsetting for Export preliminary results in a full sunset Washington, DC 20230; telephone: (202) Sales that Exceed Normal Value review not later that 110 days after the date of publication in the Federal 482–4161, (202) 482–1167 or (202) 482– Comment 10: Ministerial Error Register of the notice of initiation. 3965, respectively. Allegations Specific to Ispat However, as determined in Notice of SUPPLEMENTARY INFORMATION: [FR Doc. E6–823 Filed 1–23–06; 8:45 am] Extension, the sunset review of the Background BILLING CODE 3510–DS–S agreement suspending the antidumping investigation on uranium from the On December 12, 2005, the Russian Federation is extraordinarily Department published in the Federal complicated and requires additional Register the final results of the time for the Department to complete its 1 See Notice of Final Results of Antidumping Duty analysis. Therefore, the Department is Administrative Review: Certain Welded Carbon extending the deadline for the Steel Pipe and Tube from Turkey, 70 FR 73447 preliminary results in this proceeding (December 12, 2005).
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administrative review of the shipments of the subject merchandise SUMMARY: The United States Air Force is antidumping duty order on welded pipe entered, or withdrawn from warehouse, issuing this Notice of Intent (NOI) to and tube from Turkey. We received for consumption on or after the announce that it is conducting an timely allegations of ministerial errors publication date of these amended final environmental assessment for the from Borusan and Cayirova. In its results of administrative review, as proposed action for increasing the comments dated December 9, 2005, provided by section 751(a) of the Tariff annual number of depleted uranium Borusan alleged that the Department Act of 1930, as amended (‘‘the Act’’): (1) (DU) rounds fired by A–10 aircraft using erred in that it did not include certain For the companies named above, the the 30-millimeter GAU–8 Gatling gun at U.S. sales in the margin program. In its cash deposit rate will be the rate listed the Nevada Test and Training Range comments dated December 12, 2005, above; (2) for merchandise exported by (NTTR), Range 63, Target 63–10. This Cayirova alleged that the Department manufacturers or exporters not covered NOI describes the Air Force’s proposed erred in the revised credit calculation in in this review but covered in a previous scoping process and identifies the Air the home market (CREDITH). Petitioner segment of this proceeding, the cash Force’s point of contact. Target 63–10 is did not comment on the ministerial deposit rate will continue to be the the Air Force’s only air-to-ground target errors alleged by respondents.2 We agree company–specific rate published in the for testing and training with DU rounds. with respondents that these errors are most recent final results in which that The proposed assessment will be ministerial errors and have amended the manufacturer or exporter participated; prepared in compliance with the final results to correct the errors (3) if the exporter is not a firm covered National Environmental Policy Act referenced herein. For a full explanation in this review or in any previous (NEPA) of 1969 (42 U.S.C. 4321–4347), of changes made by the Department, segment of this proceeding, but the the Council on Environmental Quality please see the Memorandum from manufacturer is, the cash deposit rate NEPA regulations (40 CFR parts 1500– Melissa G. Skinner to Stephen J. Claeys, will be that established for the 1508), and Air Force’s Environmental Deputy Assistant Secretary for Import manufacturer of the merchandise in Impact Analysis Process (EIAP) (Air Administration, Ministerial Error these final results of review or in the Force Instruction 32–7061 as Allegations Concerning the Notice of most recent segment of the proceeding promulgated at 32 CFR part 989) to Final Results of Antidumping Duty in which that manufacturer determine the potential environmental Administrative Review on Certain participated; and (4) if neither the effects of increasing DU rounds at the Welded Carbon Steel Pipe and Tube exporter nor the manufacturer is a firm NTTR. from Turkey, available in the Central covered in this review or in any As part of the proposal, the Air Force Records Unit, room B099 of the main previous segment of this proceeding, the will analyze three alternatives: A, B, and Department building. cash deposit rate will be 14.74 percent, C. Alternative A (proposed action) the ‘‘All–others’’ rate established in the Amended Final Results of Review would increase the annual use of 30-mm less–than-fair–value investigation. DU rounds in a combat mix (CM) from As a result of the correction of These deposit requirements shall an existing 9,500 to 22,800 annually. ministerial errors, the following remain in effect until publication of the CM contains armor-piercing incendiary weighted–average percentage margins final results of the next administrative (API) DU rounds mixed with high exist for the period May 1, 2003, review. explosive incendiary (HEI) rounds in a through April 30, 2004: We are issuing and publishing this 5 to 1 ratio. Alternative A would determination and notice in accordance increase the annual use of DU rounds Amended with sections 751(a)(1) and 777(i)(1) of Manufacturer/Ex- Margin from 7,900 to 19,000 (and HEI rounds Margin the Act. porter (percent) (percent) from 1,600 to 3,800) to provide the 422 Dated: January 18, 2006. Test and Evaluation Squadron (TES) Borusan ...... 0.86 0.74 David M. Spooner, and the 66 Weapons Squadron (WPS) Cayirova ...... 3.52 3.28 Assistant Secretaryfor Import Administration. graduates with sufficient DU rounds to accomplish essential testing and The Department shall determine, and [FR Doc. E6–824 Filed 1–23–06; 8:45 am] training requirements. Alternative B the U.S. Customs and Border Protection BILLING CODE 3510–DS–S would enhance testing by increasing the (‘‘CBP’’) shall assess, antidumping use of CM to a total of 31,680 rounds duties on all appropriate entries. In (26,400 DU and 5,280 HEI) at Target 63– accordance with section 351.212(b)(1) of DEPARTMENT OF DEFENSE 10. This alternative would meet test and the Department’s regulations, we have Department of the Air Force training requirements and also allow calculated importer–specific assessment additional testing by Tactics rates by dividing the dumping margin Notice of Intent To Perform an Development & Evaluation (TD&E) and found on the subject merchandise Environmental Assessment for Tactics Improvement Proposals (TIP). examined by the entered value of such Increased Depleted Uranium Use at Alternative C (no-action) would reflect merchandise. Where the importer– Nevada Test and Training Range, no change in current operations specific assessment rate is above de Nevada associated with Target 63–10 whereby minimis, we will instruct CBP to assess 9,500 CM rounds (7,900 DU and 1,600 antidumping duties on that importer’s AGENCY: Department of the Air Force HEI) are deployed for test and training. entries of subject merchandise. The (AF), Air Combat Command (ACC). This number (9,500) does not provide Department will issue appropriate ACTION: Notice of intent to prepare an enough rounds for effective TES testing assessment instructions directly to CBP Environmental Assessment (EA) for the and WPS training. within 15 days of publication of these Increased Depleted Uranium (DU) Use amended final results of review. at Nevada Test and Training Range DATES: The Air Force will conduct two Furthermore, the following deposit (NTTR). scoping meetings to receive public input requirements will be effective for all on alternatives, concerns, and issues to Authority: 42 United States Code §§ 4321– be addressed in the EA and to solicit 2 Petitioners are Allied Tube and Conduit 4347 40 Code of Federal Regulations (CFR) public input concerning the scope of the Corporation, and Wheatland Tube Company. parts 1500–1508. proposed action and alternatives. The
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schedule and locations of the scoping Public comments are particularly Control No. 9000–0130, Buy American meetings are as follows: January 31, invited on: Whether this collection of Act—Free Trade Agreements—Israeli 2006: 6:30 p.m.–8:30 p.m., Sunrise information is necessary for the proper Trade Act Certificate, in all Library, 5400 Harris Avenue, Las Vegas, performance of functions of the FAR, correspondence. Nevada and February 1, 2006: 6:30 and whether it will have practical Dated: January 13, 2006. p.m.–8:30 p.m., Indian Springs utility; whether our estimate of the Gerald Zaffos, Community Center, 719 West Gretta public burden of this collection of Director, Contract Policy Division. Lane, Indian Springs, Nevada. information is accurate, and based on The Air Force will accept comments valid assumptions and methodology; [FR Doc. 06–670 Filed 1–23–06; 8:45 am] at any time during the scoping period. ways to enhance the quality, utility, and BILLING CODE 6820–EP–S?≤ However, to ensure the Air Force clarity of the information to be considers relevant scoping issues in a collected; and ways in which we can timely fashion, all comments should be minimize the burden of the collection of DEPARTMENT OF EDUCATION forwarded to the address below no later information on those who are to than March 1, 2006. If during the respond, through the use of appropriate Submission for OMB Review; preparation of the EA, the Air Force technological collection techniques or Comment Request concludes an Environmental Impact other forms of information technology. AGENCY: Department of Education Statement (EIS) is warranted, comments DATES: Submit comments on or before SUMMARY: The IC Clearance Official, received during this scoping period will March 27, 2006. Regulatory Information Management be considered in the preparation of the ADDRESSES: Submit comments regarding Services, Office of the Chief Information EIS. this burden estimate or any other aspect Officer invites comments on the FOR FURTHER INFORMATION CONTACT: of the collection of information, submission for OMB review as required Mike Estrada, Nellis Air Force Base including suggestions for reducing this by the Paperwork Reduction Act of Office of Public Affairs, 4430 Grissom burden to the General Services 1995. Avenue, Ste 107, Nellis AFB, NV 89191, Administration, Regulatory Secretariat DATES: Interested persons are invited to (702) 652–2750. (VIR), 1800 F Street, NW, Room 4035, submit comments on or before February Washington, DC 20405. Lawrence Shade, 23, 2006. FOR FURTHER INFORMATION CONTACT Ms. Acting Air Force Federal Register Liaison ADDRESSES: Written comments should Kimberly Marshall, Contract Policy Officer. be addressed to the Office of Division, GSA, (202) 219–0986. [FR Doc. E6–794 Filed 1–23–06; 8:45 am] Information and Regulatory Affairs, BILLING CODE 5001–06–P SUPPLEMENTARY INFORMATION: Attention: Rachel Potter, Desk Officer, A. Purpose Department of Education, Office of Management and Budget, 725 17th Under the Free Trade Agreements DEPARTMENT OF DEFENSE Street, NW., Room 10222, New Acts of 1979, unless specifically Executive Office Building, Washington, GENERAL SERVICES exempted by statute or regulation, DC 20503 or faxed to (202) 395–6974. ADMINISTRATION agencies are required to evaluate offers over a certain dollar limitation to supply SUPPLEMENTARY INFORMATION: Section NATIONAL AERONAUTICS AND an eligible product without regard to the 3506 of the Paperwork Reduction Act of SPACE ADMINISTRATION restrictions of the Buy American Act or 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and [OMB Control No. 9000–0130] the Balance of Payments program. Offerors identify excluded end products Budget (OMB) provide interested Federal agencies and the public an early Federal Acquisition Regulation; and FTA end products on this opportunity to comment on information Information Collection; Buy American certificate. collection requests. OMB may amend or Act—Free Trade Agreements—Israeli The contracting officer uses the waive the requirement for public Trade Act Certificate information to identify the offered items which are domestic and FTA country consultation to the extent that public AGENCIES: Department of Defense (DOD), end products so as to give these participation in the approval process General Services Administration (GSA), products a preference during the would defeat the purpose of the and National Aeronautics and Space evaluation of offers. Items having information collection, violate State or Administration (NASA). components of unknown origin are Federal law, or substantially interfere ACTION: Notice of request for an considered to have been mined, with any agency’s ability to perform its extension to an existing OMB clearance produced, or manufactured outside the statutory obligations. The IC Clearance (9000–0130). United States. Official, Regulatory Information Management Services, Office of the SUMMARY: Under the provisions of the B. Annual Reporting Burden Chief Information Officer, publishes that Paperwork Reduction Act of 1995 (44 Respondents: 1,140. notice containing proposed information U.S.C. Chapter 35), the Federal Responses Per Respondent: 5. collection requests prior to submission Acquisition Regulation (FAR) Annual Responses: 5,700. of these requests to OMB. Each Secretariat will be submitting to the Hours Per Response: .167. proposed information collection, Office of Management and Budget Total Burden Hours: 666. grouped by office, contains the (OMB) a request to review and approve Obtaining Copies of Proposals: following: (1) Type of review requested, an extension of a currently approved Requesters may obtain a copy of the e.g. new, revision, extension, existing or information collection requirement information collection documents from reinstatement; (2) Title; (3) Summary of concerning Buy American Act—Free the General Services Administration, the collection; (4) Description of the Trade Agreements—Israeli Trade Act Regulatory Secretariat (VIR), Room need for, and proposed use of, the Certificate. The clearance currently 4035, Washington, DC 20405, telephone information; (5) Respondents and expires on April 30, 2006. (202) 501–4755. Please cite OMB frequency of collection; and (6)
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Reporting and/or Recordkeeping SUMMARY: The IC Clearance Official, Responses: 5,115. burden. OMB invites public comment. Regulatory Information Management Burden Hours: 1,023. Dated: January 17, 2006. Services, Office of the Chief Information Abstract: Borrowers who receive Officer invites comments on the Angela C. Arrington, loans through the William D. Ford submission for OMB review as required Federal Direct Loan Program will use IC Clearance Official,Regulatory Information by the Paperwork Reduction Act of Management Services,Office of the Chief this form to agree to statutory Information Officer. 1995. forbearances on their loans. DATES: Interested persons are invited to Requests for copies of the information Federal Student Aid submit comments on or before February collection submission for OMB review Type of Review: Extension. 23, 2006. may be accessed from http:// Title: Direct Loan Income Contingent ADDRESSES: Written comments should edicsweb.ed.gov, by selecting the Repayment Plan—Consent to Disclosure be addressed to the Office of ‘‘Browse Pending Collections’’ link and of Tax Information. Information and Regulatory Affairs, by clicking on link number 2936. When Frequency: On Occasion. Attention: Rachel Potter, Desk Officer, you access the information collection, Affected Public: Individuals or Department of Education, Office of click on ‘‘Download Attachments’’ to household. Management and Budget, 725 17th view. Written requests for information Reporting and Recordkeeping Hour Street, NW., Room 10222, New should be addressed to U.S. Department Burden: of Education, 400 Maryland Avenue, Responses: 393,577. Executive Office Building, Washington, DC 20503 or faxed to (202) 395–6974. SW., Potomac Center, 9th Floor, Burden Hours: 78,716. Washington, DC 20202–4700. Requests SUPPLEMENTARY INFORMATION: Section Abstract: This form is the means by may also be electronically mailed to IC 3506 of the Paperwork Reduction Act of which a William D. Ford Federal Direct [email protected] or faxed to 202–245– 1995 (44 U.S.C. Chapter 35) requires Loan Program borrower (and, if married, 6623. Please specify the complete title that the Office of Management and the borrower’s spouse) who chooses to of the information collection when Budget (OMB) provide interested repay under the Income Contingent making your request. Federal agencies and the public an early Repayment Plan provides written Comments regarding burden and/or opportunity to comment on information consent for the Internal Revenue Service the collection activity requirements collection requests. OMB may amend or to disclose certain tax return should be electronically mailed to the e- waive the requirement for public information to the Department of mail address IC [email protected]. consultation to the extent that public Education and its agents for the purpose Individuals who use a participation in the approval process of calculating the borrower’s monthly telecommunications device for the deaf would defeat the purpose of the repayment amount. (TDD) may call the Federal Information information collection, violate State or Requests for copies of the information Relay Service (FIRS) at 1–800–877– Federal law, or substantially interfere collection submission for OMB review 8339. may be accessed from http:// with any agency’s ability to perform its [FR Doc. E6–769 Filed 1–23–06; 8:45 am] edicsweb.ed.gov, by selecting the statutory obligations. The IC Clearance ‘‘Browse Pending Collections’’ link and Official, Regulatory Information BILLING CODE 4000–01–P by clicking on link number 2939. When Management Services, Office of the Chief Information Officer, publishes that you access the information collection, DEPARTMENT OF EDUCATION click on ‘‘Download Attachments’’ to notice containing proposed information view. Written requests for information collection requests prior to submission Submission for OMB Review; should be addressed to U.S. Department of these requests to OMB. Each Comment Request of Education, 400 Maryland Avenue, proposed information collection, SW., Potomac Center, 9th Floor, grouped by office, contains the AGENCY: Department of Education. Washington, DC 20202–4700. Requests following: (1) Type of review requested, SUMMARY: The IC Clearance Official, may also be electronically mailed to IC e.g. new, revision, extension, existing or Regulatory Information Management [email protected] or faxed to 202–245– reinstatement; (2) Title; (3) Summary of Services, Office of the Chief Information 6623. Please specify the complete title the collection; (4) Description of the Officer invites comments on the of the information collection when need for, and proposed use of, the submission for OMB review as required making your request. information; (5) Respondents and by the Paperwork Reduction Act of Comments regarding burden and/or frequency of collection; and (6) 1995. the collection activity requirements Reporting and/or Recordkeeping DATES: Interested persons are invited to should be electronically mailed to the e- burden. OMB invites public comment. submit comments on or before February mail address IC [email protected]. Dated: January 17, 2006. 23, 2006. Individuals who use a Angela C. Arrington, ADDRESSES: Written comments should telecommunications device for the deaf IC Clearance Official,Regulatory Information be addressed to the Office of (TDD) may call the Federal Information Management Services,Office of the Chief Information and Regulatory Affairs, Relay Service (FIRS) at 1–800–877– Information Officer. Attention: Rachel Potter, Desk Officer, 8339. Federal Student Aid Department of Education, Office of [FR Doc. E6–767 Filed 1–23–06; 8:45 am] Management and Budget, 725 17th Type of Review: Extension. BILLING CODE 4000–01–P Title: William D. Ford Federal Direct Street, NW., Room 10222, New Loan Program Statutory Forbearance Executive Office Building, Washington, DC 20503 or faxed to (202) 395–6974. DEPARTMENT OF EDUCATION Forms. Frequency: On Occasion. SUPPLEMENTARY INFORMATION: Section Submission for OMB Review; Affected Public: Individuals or 3506 of the Paperwork Reduction Act of Comment Request household. 1995 (44 U.S.C. Chapter 35) requires Reporting and Recordkeeping Hour that the Office of Management and AGENCY: Department of Education. Burden: Budget (OMB) provide interested
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Federal agencies and the public an early Washington, DC 20202–4700. Requests following: (1) Type of review requested, opportunity to comment on information may also be electronically mailed to IC e.g. new, revision, extension, existing or collection requests. OMB may amend or [email protected] or faxed to 202–245– reinstatement; (2) Title; (3) Summary of waive the requirement for public 6623. Please specify the complete title the collection; (4) Description of the consultation to the extent that public of the information collection when need for, and proposed use of, the participation in the approval process making your request. information; (5) Respondents and would defeat the purpose of the Comments regarding burden and/or frequency of collection; and (6) information collection, violate State or the collection activity requirements Reporting and/or Recordkeeping Federal law, or substantially interfere should be electronically mailed to the e- burden. OMB invites public comment. with any agency’s ability to perform its mail address IC [email protected]. Dated: January 18, 2006, Individuals who use a statutory obligations. The IC Clearance Angela C. Arrington, Official, Regulatory Information telecommunications device for the deaf (TDD) may call the Federal Information IC Clearance Official, Regulatory Information Management Services, Office of the Management Services, Office of the Chief Chief Information Officer, publishes that Relay Service (FIRS) at 1–800–877– Information Officer. notice containing proposed information 8339. Office of Elementary and Secondary collection requests prior to submission [FR Doc. E6–770 Filed 1–23–06; 8:45 am] of these requests to OMB. Each Education BILLING CODE 4000–01–P proposed information collection, Type of Review: Revision. grouped by office, contains the Title: Consolidated State Application/ following: (1) Type of review requested, DEPARTMENT OF EDUCATION Consolidated State Annual Report. e.g. new, revision, extension, existing or Frequency: Annually. reinstatement; (2) Title; (3) Summary of Submission for OMB Review; Affected Public: State, Local, or Tribal the collection; (4) Description of the Comment Request Gov’t, SEAs or LEAs. need for, and proposed use of, the Reporting and Recordkeeping Hour information; (5) Respondents and AGENCY: Department of Education. SUMMARY: Burden: frequency of collection; and (6) The IC Clearance Official, Regulatory Information Management Responses: 52. Reporting and/or Recordkeeping Burden Hours: 7,800. burden. OMB invites public comment. Services, Office of the Chief Information Officer invites comments on the Abstract: This information collection Dated: January 17, 2006. submission for OMB review as required package describes the proposed criteria Angela C. Arrington, by the Paperwork Reduction Act of and procedures that govern the IC Clearance Official,Regulatory Information 1995. consolidated State application under Management Services,Office of the Chief which State educational agencies will DATES: Information Officer. Interested persons are invited to apply to obtain funds for implementing submit comments on or before February ESEA programs. The option of Federal Student Aid 23, 2006. submitting a consolidated application Type of Review: Revision. ADDRESSES: Written comments should for obtaining federal formula program Title: Direct Loan Income Contingent be addressed to the Office of grant funds is provided for in the Repayment Plan Alternative Information and Regulatory Affairs, reauthorized ESEA (No Child Left Documentation of Income. Attention: Rachel Potter, Desk Officer, Behind—NCLB) sections 9301–9306. Frequency: On Occasion. Department of Education, Office of This information collection package will Affected Public: Individuals or Management and Budget, 725 17th guide the States in identifying the household. Street, NW., Room 10222, New information and data required in the Reporting and Recordkeeping Hour Executive Office Building, Washington, application. Burden: DC 20503 or faxed to (202) 395–6974. Requests for copies of the information Responses: 863,357. SUPPLEMENTARY INFORMATION: Section collection submission for OMB review Burden Hours: 285,007. 3506 of the Paperwork Reduction Act of may be accessed from http:// Abstract: A William D. Ford Federal 1995 (44 U.S.C. Chapter 35) requires edicsweb.ed.gov, by selecting the Direct Loan Program borrower (and, if that the Office of Management and ‘‘Browse Pending Collections’’ link and married, the borrower’s spouse) who Budget (OMB) provide interested by clicking on link number 2886. When chooses to repay under the Income Federal agencies and the public an early you access the information collection, Contingent Repayment Plan uses this opportunity to comment on information click on ‘‘Download Attachments’’ to form to submit alternative collection requests. OMB may amend or view. Written requests for information documentation of income if the waive the requirement for public should be addressed to U.S. Department borrower’s adjusted gross income is not consultation to the extent that public of Education, 400 Maryland Avenue, available or does not accurately reflect participation in the approval process SW., Potomac Center, 9th Floor, the borrower’s current income. would defeat the purpose of the Washington, DC 20202–4700. Requests Requests for copies of the information information collection, violate State or may also be electronically mailed to IC collection submission for OMB review Federal law, or substantially interfere [email protected] or faxed to 202–245– may be accessed from http:// with any agency’s ability to perform its 6623. Please specify the complete title edicsweb.ed.gov, by selecting the statutory obligations. The IC Clearance of the information collection when ‘‘Browse Pending Collections’’ link and Official, Regulatory Information making your request. by clicking on link number 2937. When Management Services, Office of the Comments regarding burden and/or you access the information collection, Chief Information Officer, publishes that the collection activity requirements click on ‘‘Download Attachments’’ to notice containing proposed information should be electronically mailed to the e- view. Written requests for information collection requests prior to submission mail address IC [email protected]. should be addressed to U.S. Department of these requests to OMB. Each Individuals who use a of Education, 400 Maryland Avenue, proposed information collection, telecommunications device for the deaf SW., Potomac Center, 9th Floor, grouped by office, contains the (TDD) may call the Federal Information
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Relay Service (FIRS) at 1–800–877– Dated: January 18, 2006. notice published on January 18, 2006 8339. Angela C. Arrington, (71 FR 2916). [FR Doc. E6–811 Filed 1–23–06; 8:45 am] IC Clearance Official, Regulatory Information SUPPLEMENTARY INFORMATION: On Management Services, Office of the Chief January 18, 2006, we published a notice BILLING CODE 4000–01–P Information Office. in the Federal Register inviting Federal Student Aid applications for new awards for fiscal DEPARTMENT OF EDUCATION year 2006 for the Early Reading First Type of Review: Extension. program. The date listed under Deadline Title: Federal Stafford Loan Master for Transmittal of Pre-Applications was Submission for OMB Review; Promissory Note. Comment Request incorrect, in that it falls on a Federal Frequency: On Occasion. holiday. The correct Deadline for Affected Public: Individuals or AGENCY: Department of Education. Transmittal of Pre-Applications date is household. February 21, 2006. SUMMARY: The IC Clearance Official, Reporting and Recordkeeping Hour FOR FURTHER INFORMATION CONTACT: Jill Regulatory Information Management Burden: Stewart, U.S. Department of Education, Services, Office of the Chief Information Responses: 2,959,380. 400 Maryland Avenue, SW., room Officer invites comments on the Burden Hours: 2,219,535. 3C136, Washington, DC 20202–6132. submission for OMB review as required Abstract: The Federal Stafford Loan Telephone: (202) 260–2533 or by e-mail: by the Paperwork Reduction Act of Master Promissory Note is the means by [email protected] or Rebecca Haynes, 1995. which an eligible student borrower U.S. Department of Education, 400 promises to repay a Federal Stafford Maryland Avenue, SW., room 3C138, DATES: Interested persons are invited to Loan. Washington, DC 20202–6132. submit comments on or before February Requests for copies of the information Telephone: (202) 260–0968 or by e-mail: 23, 2006. collection submission for OMB review [email protected]. may be accessed from http:// ADDRESSES: Written comments should If you use a telecommunications edicsweb.ed.gov, by selecting the be addressed to the Office of device for the deaf (TDD), you may call ‘‘Browse Pending Collections’’ link and Information and Regulatory Affairs, the Federal Relay Service (FIRS) at 1– by clicking on link number 2898. When Attention: Rachel Potter, Desk Officer, 800–877–8339. you access the information collection, Individuals with disabilities may Department of Education, Office of click on ‘‘Download Attachments’’ to Management and Budget, 725 17th obtain this document in an alternative view. Written requests for information format (e.g., Braille, large print, Street, NW., Room 10222, New should be addressed to U.S. Department Executive Office Building, Washington, audiotape, or computer diskette) on of Education, 400 Maryland Avenue, request to the program contact persons DC 20503 or faxed to (202) 395–6974. SW., Potomac Center, 9th Floor, listed in this section. SUPPLEMENTARY INFORMATION: Section Washington, DC 20202–4700. Requests Electronic Access to This Document 3506 of the Paperwork Reduction Act of may also be electronically mailed to IC 1995 (44 U.S.C. Chapter 35) requires [email protected] or faxed to 202–245– You may view this document, as well that the Office of Management and 6623. Please specify the complete title as all other documents of this of the information collection when Budget (OMB) provide interested Department published in the Federal making your request. Federal agencies and the public an early Register, in text or Adobe Portable Comments regarding burden and/or Document Format (PDF) on the Internet opportunity to comment on information the collection activity requirements at the following site: www.ed.gov/news/ collection requests. OMB may amend or should be electronically mailed to the e- fedregister. waive the requirement for public mail address IC [email protected]. To use PDF you must have Adobe consultation to the extent that public Individuals who use a Acrobat Reader, which is available free participation in the approval process telecommunications device for the deaf at this site. If you have questions about would defeat the purpose of the (TDD) may call the Federal Information using PDF, call the U.S. Government information collection, violate State or Relay Service (FIRS) at 1–800–877– Printing Office (GPO), toll free, at 1– Federal law, or substantially interfere 8339. 888–293–6498; or in the Washington, with any agency’s ability to perform its [FR Doc. E6–812 Filed 1–23–06; 8:45 am] DC, area at (202) 512–1530. statutory obligations. The IC Clearance For additional program information Official, Regulatory Information BILLING CODE 4000–01–P call one of the program contact persons Management Services, Office of the listed in this section between the hours Chief Information Officer, publishes that DEPARTMENT OF EDUCATION of 8 a.m. and 5 p.m., Eastern Time, notice containing proposed information Monday through Friday. collection requests prior to submission [CFDA No. 84.359A/B] Note: The official version of this document of these requests to OMB. Each is the document published in the Federal proposed information collection, Office of Elementary and Secondary Register. Free Internet access to the official grouped by office, contains the Education; Early Reading First edition of the Federal Register and the Code following: (1) Type of review requested, Program; Correction; Notice of Federal Regulations is available on GPO Correcting the Deadline for Transmittal Access at: www.gpoaccess.gov/nara/ e.g. new, revision, extension, existing or index.html. reinstatement; (2) Title; (3) Summary of of Pre-Applications Date the collection; (4) Description of the Dated: January 19, 2006. ACTION: Correction; Notice correcting the need for, and proposed use of, the deadline for Transmittal of Pre- Henry L. Johnson, information; (5) Respondents and Applications Date. Assistant Secretary for Elementary and frequency of collection; and (6) Secondary Education. Reporting and/or Recordkeeping SUMMARY: We correct the Deadline for [FR Doc. E6–827 Filed 1–23–06; 8:45 am] burden. OMB invites public comment. Transmittal of Pre-Applications in the BILLING CODE 4000–01–P
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DEPARTMENT OF EDUCATION Relationship Between HSI and Title III, Cooperative Arrangement Development Part A Programs Awards: 14. Office of Postsecondary Education; Note: The Department is not bound by any Note 1: A grantee under the HSI Program, Overview Information; Developing estimates in this notice. Applicants should which is authorized by Title V of the Higher Hispanic-Serving Institutions (HSI) periodically check the HSI Program Web site Education Act of 1965, as amended (HEA), Program; Notice Inviting Applications for further information. The address is: may not receive a grant under any HEA, Title for New Awards for Fiscal Year (FY) http://www.ed.gov/programs/idueshsi/ III, Part A Program. The Title III, Part A index.html. 2006 Programs include: the Strengthening Institutions Program, the American Indian Project Period: Up to 60 months. Catalog of Federal Domestic Assistance Tribally Controlled Colleges and Universities (CFDA) Number: 84.031S. Program; and the Alaska Native and Native Full Text of Announcement DATES: Applications Available: January Hawaiian-Serving Institutions Programs. I. Funding Opportunity Description 24, 2006. Further, a current HSI Program grantee may not give up its HSI grant in order to receive Purpose of Program: The HSI Program Deadline for Transmittal of a grant under any Title III, Part A Program. provides grants to assist HSIs to expand Applications: March 10, 2006. educational opportunities for, and Deadline for Intergovernmental Note 2: An eligible HSI that does not fall improve the academic attainment of, within the limitation described in Note 1, Review: March 27, 2006. Hispanic students. The HSI Program i.e., is not a current grantee under the HSI grants also enable HSIs to expand and Eligible Applicants: Institutions of Program, may apply for a FY 2006 grant enhance their academic offerings, higher education (IHEs) that qualify as under all Title III, Part A Programs for which it is eligible, as well as under the HSI program quality, and institutional eligible HSIs are eligible to apply for stability. new Individual Development Grants Program. However, a successful applicant may receive only one grant. and Cooperative Arrangement Program Authority: 20 U.S.C. 1101–1101d, 1103–1103g. Development Grants under the HSI Note 3: An eligible HSI that previously Program. To be an eligible HSI, an IHE received a five-year Individual Development Applicable Regulations: (a) The must— Grant under the HSI Program must wait for Education Department General (1) Be accredited or preaccredited by two years after the date the five-year grant Administrative Regulations (EDGAR) in ended, including any time extensions the 34 CFR parts 74, 75, 77, 79, 81, 82, 84, a nationally recognized accrediting grant may have received, to apply for another agency or association that the Secretary 85, 86, 97, 98, and 99. (b) The Individual Development Grant under the HSI regulations for this program in 34 CFR has determined to be a reliable authority Program. as to the quality of education or training part 606. offered; Note 4: An eligible HSI that submits more II. Award Information than one application may only be awarded (2) Be legally authorized by the State one Individual Development Grant or one Type of Award: Discretionary grant. in which it is located to be a junior Cooperative Arrangement Development Grant Five-year Individual Development college or to provide an educational in a fiscal year. Furthermore, we will not Grants and Five-year Cooperative program for which it awards a award a second Cooperative Arrangement Arrangement Development Grants will bachelor’s degree; Development Grant to an otherwise eligible be awarded in FY 2006. Planning grants (3) Be designated as an ‘‘eligible HSI for the same award year as the will not be awarded in FY 2006. institution’s existing Cooperative Estimated Available Funds: institution’’ by demonstrating that it: (A) Arrangement Development Grant award. Has an enrollment of needy students as $20,433,000. described in 34 CFR 606.3; and (B) has Estimated Available Funds: Estimated Range of Awards: low average educational and general $20,433,000. Individual Development Grant: expenditures per full-time equivalent Estimated Range of Awards: $300,000–$575,000. Cooperative (FTE) undergraduate student as Individual Development Grant: Arrangement Development Grant: described in 34 CFR 606.4; $300,000–$575,000. Cooperative $400,000–$700,000. Arrangement Development Grant: Estimated Average Size of Awards: (4) At the time of application, have an $400,000–$700,000. Individual Development Grant: enrollment of undergraduate FTE Estimated Average Size of Awards: $500,000. Cooperative Arrangement students that is at least 25 percent Individual Development Grant: Development Grant: $600,000. Hispanic students; and $500,000. Cooperative Arrangement Maximum Awards: Individual (5) Provide assurances that not less Development Grant: $600,000. Development Grant: $575,000. than 50 percent of its Hispanic students Maximum Awards: Individual Cooperative Arrangement Development are low-income individuals. Development Grant: $575,000 per year; Grant: $700,000. Cooperative Arrangement Development We will not fund any application at For purposes of making the Grant: $700,000 per year. an amount exceeding the maximum determinations described in paragraphs We will not fund any application at amounts specified above for a single (4) and (5) above, IHEs shall use student an amount exceeding the maximum budget period of 12 months. We may enrollments for the fall 2005 academic amounts specified above for a single choose not to further consider or review year. budget period of 12 months. We may applications with budgets that exceed The Notice Inviting Applications for choose not to further consider or review the maximum amounts specified above, Designation as Eligible Institutions for applications with budgets that exceed if we conclude, during our initial review FY 2006 was published in the Federal the maximum amounts specified above, of the application, that the proposed Register on December 16, 2005 (70 FR if we conclude, during our initial review goals and objectives cannot be obtained 74781). The HSI eligibility requirements of the application, that the proposed with the specified maximum amount. are in 34 CFR 606.2 through 606.5 and goals and objectives cannot be obtained Estimated Number of Awards: can be accessed from the following Web with the specified maximum amount. Individual Development Awards: 22. site: http://www.access.gpo.gov/nara/ Estimated Number of Awards: Cooperative Arrangement Development cfr/waisidx_01/34cfr606_01.html. Individual Development Awards: 22. Awards: 14.
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Note: The Department is not bound by any Note 2: An eligible HSI that does not fall the institution’s total enrollment of Hispanic estimates in this notice. Applicants should within the limitation described in Note 1, students and is calculated based upon head periodically check the HSI Program Web site i.e., is not a current grantee under the HSI count. Instructions for formatting and for further information. The address is: Program, may apply for a FY 2006 grant submitting the verification documentation to http://www.ed.gov/programs/idueshsi/ under all Title III, Part A Programs for which Grants.gov are in the application package. index.html. it is eligible, as well as under the HSI b. Additional requirements Project Period: Up to 60 months. Program. However, a successful applicant may receive only one grant. concerning the content of an III. Eligibility Information application, together with the forms you Note 3: An eligible HSI that previously must submit, are in the application Eligible Applicants: IHEs that qualify received a five-year Individual Development package for this program. as eligible HSIs are eligible to apply for Grant under the HSI Program must wait for Page Limits: The program narrative new Individual Development Grants two years after the date the five-year grant (Part III of the application) is where you, and Cooperative Arrangement ended, including any time extensions the the applicant, address the selection Development Grants under the HSI grant may have received, to apply for another criteria that reviewers use to evaluate Program. To be an eligible HSI, an IHE Individual Development Grant under the HSI your application. We have established Program. must— mandatory page limits for both the (1) Be accredited or preaccredited by Note 4: An eligible HSI that submits more Individual Development Grant and the a nationally recognized accrediting than one application may only be awarded Cooperative Arrangement Development agency or association that the Secretary one Individual Development Grant or one Grant applications. You must limit the has determined to be a reliable authority Cooperative Arrangement Development Grant section of the narrative that addresses as to the quality of education or training in a fiscal year. Furthermore, we will not the selection criteria to no more than 50 offered; award a second Cooperative Arrangement pages for the Individual Development (2) Be legally authorized by the State Development Grant to an otherwise eligible Grant application and 70 pages for the HSI for the same award year as the in which it is located to be a junior Cooperative Arrangement Development college or to provide an educational institution’s existing Cooperative Arrangement Development Grant award. Grant application, using the following program for which it awards a standards: bachelor’s degree; 2. Cost Sharing or Matching: There are • A ‘‘page’’ is 8.5″ x 11″, on one side (3) Be designated as an ‘‘eligible no cost sharing or matching only, with 1 inch margins at the top, institution’’ by demonstrating that it: (A) requirements, unless the grantee uses a bottom, and both sides. Has an enrollment of needy students as portion of its grant for establishing or • Double space (no more than three described in 34 CFR 606.3; and (B) has improving an endowment fund. If a lines per vertical inch) all text in the low average educational and general grantee uses a portion of its grant for application narrative, except titles, expenditures per FTE undergraduate endowment fund purposes, it must headings, footnotes, quotations, student as described in 34 CFR 606.4; match those grant funds with non- references, captions and all text in (4) At the time of application, have an Federal funds. (20 U.S.C. 1101c). charts, tables, and graphs. enrollment of undergraduate FTE • Use one of the following fonts: students that is at least 25 percent IV. Application and Submission Information Times New Roman, Courier, Courier Hispanic students; and New, or Arial. Applications submitted (5) Provide assurances that not less 1. Address to Request Application in any other font (including Times than 50 percent of its Hispanic students Package: J. Alexander Hamilton, U.S. Roman and Arial Narrow) will not be are low-income individuals. Department of Education, 1990 K Street, accepted. For purposes of making the NW., 6th Floor, Washington, DC 20006– • Use font size 12. determinations described in paragraphs 8513. Telephone: (202) 502–7583 or by The page limit does not apply to Part (4) and (5) above, IHEs shall use student e-mail: [email protected] I, the application for federal assistance enrollments for the fall 2005 academic If you use a telecommunications face sheet (SF 424); the supplemental year. device for the deaf (TDD), you may call information form required by the The Notice Inviting Applications for the Federal Relay Service (FRS) at 1– Department of Education; Part II, the Designation as Eligible Institutions for 800–877–8339. budget information summary form (ED FY 2006 was published in the Federal Individuals with disabilities may Form 524); and Part IV, the assurances Register on December 16, 2005 (70 FR obtain a copy of the application package and certifications. The page limit also 74781). The HSI eligibility requirements in an alternative format (e.g., Braille, does not apply to a table of contents or are in 34 CFR 606.2 through 606.5 and large print, audiotape, or computer the program abstract. If you include any can be accessed from the following Web diskette) by contacting the program attachments or appendices other than site: http://www.access.gpo.gov/nara/ contact person listed in this section. _ _ those specifically requested, these items cfr/waisidx 01/34cfr606 01.html. 2. Content and Form of Application will be counted as part of the program Relationship Between HSI and Title III, Submission: narrative (Part III) for purposes of the Part A Programs a. Applicants must provide, as an page limit requirement. You must attachment to the application, the include your complete response to the Note 1: A grantee under the HSI Program, documentation the institution relied selection criteria in the program which is authorized by Title V of the HEA, upon in determining that, for the fall narrative. may not receive a grant under any HEA, Title 2005 academic year, at least 25 percent We will reject your application if— III, Part A Program. The Title III, Part A of the institution’s undergraduate FTE • You apply these standards and Programs include: the Strengthening students are Hispanic, and at least 50 exceed the page limit; or Institutions Program; the American Indian percent of the enrolled Hispanic • You apply other standards and Tribally Controlled Colleges and Universities Program; and the Alaska Native and Native students are low-income individuals. exceed the equivalent of the page limit. Hawaiian-Serving Institutions Programs. Note: The 25 percent requirement applies 3. Submission Dates and Times: Further, a current HSI Program grantee may only to undergraduate Hispanic students and Applications Available: January 24, not give up its HSI grant in order to receive is calculated based upon FTE students. The 2006. Deadline for Transmittal of a grant under any Title III, Part A Program. 50 percent low-income requirement includes Applications: March 10, 2006.
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Applications for grants under this Applications for grants under the HSI • You should review and follow the program competition must be submitted Program (CFDA Number 84.031S) must Education Submission Procedures for electronically using the Grants.gov be submitted electronically using the submitting an application through Apply site (Grants.gov). For information Grants.gov Apply site at: http:// Grants.gov that are included in the (including dates and times) about how www.grants.gov. Through this site, you application package for this program to submit your application will be able to download a copy of the competition to ensure that you submit electronically or by mail or hand application package, complete it offline, your application in a timely manner to delivery if you qualify for an exception and then upload and submit your the Grants.gov system. You can also find to the electronic submission application. You may not e-mail an the Education Submission Procedures requirement, please refer to section IV. electronic copy of a grant application to pertaining to Grants.gov at http://e- 6. Other Submission Requirements in us. Grants.ed.gov/help/ this notice. We will reject your application if you GrantsgovSubmissionProcedures.pdf. • We do not consider an application submit it in paper format unless, as To submit your application via that does not comply with the deadline described elsewhere in this section, you Grants.gov, you must complete all of the requirements. qualify for one of the exceptions to the steps in the Grants.gov registration Deadline for Intergovernmental electronic submission requirement and process (see http://www.Grants.gov/ Review: March 27, 2006. submit, no later than two weeks before GetStarted). These steps include (1) 4. Intergovernmental Review: This the application deadline date, a written registering your organization, (2) program is subject to Executive Order statement to the Department that you registering yourself as an Authorized 12372 and the regulations in 34 CFR qualify for one of these exceptions. Organization Representative (AOR), and part 79. Information about Further information regarding (3) getting authorized as an AOR by Intergovernmental Review of Federal calculation of the date that is two weeks your organization. Details on these steps Programs under Executive Order 12372 before the application deadline date is are outlined in the Grants.gov 3-Step is in the application package for this provided later in this section under Registration Guide (see http:// program. Exception to Electronic Submission www.grants.gov/assets/ 5. Funding Restrictions: We reference Requirement. GrantsgovCoBrandBrochure8X11.pdf). You also must provide on your the regulations outlining funding You may access the electronic grant application the same D–U–N–S Number restrictions in the Applicable application for the HSI Program at: used with this registration. Please note Regulations section of this notice. http://www.grants.gov. You must search that the registration process may take • Applicability of Executive Order for the downloadable application five or more business days to complete, 13202. Applicants that apply for package for this program by the CFDA and you must have completed all construction funds under the HSI number. Do not include the CFDA registration steps to allow you to number’s alpha suffix in your search. Program must comply with Executive successfully submit an application via Order 13202, signed by President Bush Please note the following: • Grants.gov. on February 17, 2001 and amended on When you enter the Grants.gov site, • You will not receive additional April 6, 2001. This Executive order you will find information about point value because you submit your provides that recipients of Federal submitting an application electronically application in electronic format, nor construction funds may not ‘‘require or through the site, as well as the hours of will we penalize you if you qualify for prohibit bidders, offerors, contractors, or operation. an exception to the electronic • subcontractors to enter into or adhere to Applications received by Grants.gov submission requirement, as described agreements with one or more labor are time and date stamped. Your elsewhere in this section, and submit organizations, on the same or other application must be fully uploaded and your application in paper format. construction project(s)’’ or ‘‘otherwise submitted, and must be date/time • You must submit all documents discriminate against bidders, offerors, stamped by the Grants.gov system no electronically, including all information contractors, or subcontractors for later than 4:30 p.m., Washington, DC typically included on the Application becoming or refusing to become or time, on the application deadline date. for Federal Education Assistance (SF remain signatories or otherwise adhere Except as otherwise noted in this 424), Budget Information—Non- to agreements with one or more labor section, we will not consider your Construction Programs (ED 524), and all organizations, on the same or other application if it is date/time stamped by necessary assurances and certifications. construction project(s).’’ However, the the Grants.gov system later than 4:30 You must attach any narrative sections Executive order does not prohibit p.m., Washington, DC time, on the of your application as files in a .DOC contractors or subcontractors from application deadline date. When we (document), .RTF (rich text), or .PDF voluntarily entering into these retrieve your application from (Portable Document) format. If you agreements. Projects funded under this Grants.gov, we will notify you if we are upload a file type other than the three program that include construction rejecting your application because it file types specified above or submit a activity will be provided a copy of this was date/time stamped by the password protected file, we will not Executive order and grantees will be Grants.gov system after 4:30 p.m., review that material. asked to certify that they will adhere to Washington, DC time, on the • Your electronic application must it. application deadline date. comply with any page limit 6. Other Submission Requirements: • The amount of time it can take to requirements described in this notice. Applications for grants under this upload an application will vary • After you electronically submit program competition must be submitted depending on a variety of factors your application, you will receive an electronically unless you qualify for an including the size of the application and automatic acknowledgment from exception to this requirement in the speed of your Internet connection. Grants.gov that contains a Grants.gov accordance with the instructions in this Therefore, we strongly recommend that tracking number. The Department will section. you do not wait until the application retrieve your application from a. Electronic Submission of deadline date to begin the submission Grants.gov and send you a second Applications. process through Grants.gov. confirmation by e-mail that will include
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a PR/Award number (an ED-specified which of the two grounds for an Note: The U.S. Postal Service does not identifying number unique to your exception prevent you from using the uniformly provide a dated postmark. Before application). Internet to submit your application. If relying on this method, you should check • We may request that you provide us you mail your written statement to the with your local post office. original signatures on forms at a later Department, it must be postmarked no c. Submission of Paper Applications date. later than two weeks before the by Hand Delivery. Application Deadline Date Extension application deadline date. If you fax If you qualify for an exception to the in Case of Technical Issues with the your written statement to the electronic submission requirement, you Grants.gov System: If you are prevented Department, we must receive the faxed (or a courier service) may deliver your from electronically submitting your statement no later than two weeks paper application to the Department by application on the application deadline before the application deadline date. hand. You must deliver the original and date because of technical problems with Address and mail or fax your two copies of your application by hand, the Grants.gov system, we will grant you statement to: J. Alexander Hamilton, on or before the application deadline an extension until 4:30 p.m., U.S. Department of Education, 1990 K date, to the Department at the following Washington, DC time, the following Street, NW., room 6052, Washington, address: business day to enable you to transmit DC 20006–8513 FAX: (202) 502–7861. U.S. Department of Education, your application electronically, or by Your paper application must be Application Control Center, hand delivery. You also may mail your submitted in accordance with the mail Attention: (CFDA Number 84.031S), application by following the mailing or hand delivery instructions described 550 12th Street, SW., Room 7041, instructions as described elsewhere in in this notice. Potomac Center Plaza, Washington, this notice. If you submit an application b. Submission of Paper Applications DC 20202–4260. after 4:30 p.m., Washington, DC time, on by Mail. The Application Control Center the deadline date, please contact the If you qualify for an exception to the accepts hand deliveries daily between 8 person listed elsewhere in this notice electronic submission requirement, you a.m. and 4:30 p.m., Washington, DC under FOR FURTHER INFORMATION may mail (through the U.S. Postal time, except Saturdays, Sundays and CONTACT, and provide an explanation of Service or a commercial carrier) your Federal holidays. the technical problem you experienced application to the Department. You Note for Mail or Hand Delivery of with Grants.gov, along with the must mail the original and two copies Paper Applications: If you mail or hand Grants.gov Support Desk Case Number of your application, on or before the deliver your application to the (if available). We will accept your application deadline date, to the Department: application if we can confirm that a Department at the applicable following (1) You must indicate on the envelope technical problem occurred with the address: and—if not provided by the Grants.gov system and that that problem By mail through the U.S. Postal Department—in Item 4 of the affected your ability to submit your Service: Application for Federal Education application by 4:30 p.m., Washington, U.S. Department of Education, Assistance (SF 424) the CFDA number— DC time, on the application deadline Application Control Center, and suffix letter, if any—of the date. The Department will contact you Attention: (CFDA Number 84.031S), competition under which you are after a determination is made on 400 Maryland Avenue, SW., submitting your application. whether your application will be Washington, DC 20202–4260 or, (2) The Application Control Center accepted. By mail through a commercial carrier: will mail a grant application receipt Note: Extensions referred to in this section U.S. Department of Education, acknowledgment to you. If you do not apply only to the unavailability of or Application Control Center—Stop receive the grant application receipt technical problems with the Grants.gov 4260, Attention: (CFDA Number system. We will not grant you an extension acknowledgment within 15 business if you failed to fully register to submit your 84.031S), 7100 Old Landover Road, days from the application deadline date, application to Grants.gov before the deadline Landover, MD 20785–1506. you should call the U.S. Department of date and time or if the technical problem you Regardless of which address you use, Education Application Control Center at experienced is unrelated to the Grants.gov you must show proof of mailing (202) 245–6288. system. consisting of one of the following: V. Application Review Information Exception to Electronic Submission (1) A legibly dated U.S. Postal Service Requirement: You qualify for an postmark, 1. Selection Criteria: The selection exception to the electronic submission (2) A legible mail receipt with the criteria for this program are in 34 CFR requirement, and may submit your date of mailing stamped by the U.S. 606.22(a)–(g). Applicants must address application in paper format, if you are Postal Service, each of the following selection criteria unable to submit an application through (3) A dated shipping label, invoice, or (separately for each proposed activity). the Grants.gov system because— receipt from a commercial carrier, or The total weight of the selection criteria • You do not have access to the (4) Any other proof of mailing is 100 points; the weight of each Internet; or acceptable to the Secretary of the U.S. criterion is noted in parentheses. • You do not have the capacity to Department of Education. (a) Quality of The Applicant’s upload large documents to the If you mail your application through Comprehensive Development Plan Grants.gov system; and the U.S. Postal Service, we do not (Total 25 Points). • No later than two weeks before the accept either of the following as proof (b) Quality of Activity Objectives application deadline date (14 calendar of mailing: (Total 15 Points). days or, if the fourteenth calendar day (1) A private metered postmark, or (c) Quality of Implementation Strategy before the application deadline date (2) A mail receipt that is not dated by (Total 20 Points). falls on a Federal holiday, the next the U.S. Postal Service. (d) Quality of Key Personnel (Total 7 business day following the Federal If your application is postmarked after Points). holiday), you mail or fax a written the application deadline date, we will (e) Quality of Project Management statement to the Department, explaining not consider your application. Plan (Total 10 Points).
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(f) Quality of Evaluation Plan (Total information, as directed by the Dated: January 19, 2006. 15 Points). Secretary. If you receive a multi-year Sally L. Stroup, (g) Budget (Total 8 Points). award, you must submit an annual Assistant Secretary for Postsecondary 2. Review and Selection Process: performance report that provides the Education. Tiebreaker for Development Grants. In most current performance and financial [FR Doc. E6–829 Filed 1–23–06; 8:45 am] tie-breaking situations for development expenditure information as specified by BILLING CODE 4000–01–P grants described in 34 CFR 606.23(b), the Secretary in 34 CFR 75.118, 34 CFR the HSI Program regulations require that 75.720, and in 34 CFR 606.31. we award one additional point to an 4. Performance Measures: The DEPARTMENT OF ENERGY application from an IHE that has an Secretary has established the following endowment fund for which the market key performance measures for assessing Amended Record of Decision: value per FTE student is less than the the effectiveness of the HSI Program: (1) Savannah River Site Salt Processing comparable average per FTE student at The percentage of full-time Alternatives a similar type of IHE. We also award one undergraduate students who were in additional point to an application from AGENCY: Department of Energy (DOE). their first year of postsecondary ACTION: Amended record of decision. an IHE that had expenditures for library enrollment in the previous year and are materials per FTE student that are less enrolled in the current year at the same SUMMARY: The Department of Energy than the comparable average per FTE institution; (2) The percentage of (DOE), pursuant to 10 CFR 1021.315, is student at a similar type IHE. students enrolled at 4-year HSIs amending its Record of Decision: For the purpose of these funding graduating within 6 years of enrollment; Savannah River Site Salt Processing considerations, we use 2003–2004 data. If a tie remains after applying the and (3) The percentage of students Alternatives issued on October 17, 2001 tiebreaker mechanism above, priority enrolled at 2-year HSIs graduating (66 FR 52752). At that time the will be given in the case of applicants within 3 years of enrollment. Department decided to implement the Caustic Side Solvent Extraction (CSSX) for: (a) Individual Development Grants VII. Agency Contacts to applicants that addressed the technology, one of the alternative statutory priority found in section For Further Information Contact: J. technologies evaluated in DOE/EIS– 511(d) of the HEA; and (b) Cooperative Alexander Hamilton, U.S. Department 0082–S2 (Savannah River Site Salt Arrangement Development Grants to of Education, 1990 K Street, NW., 6th Processing Alternatives Final applicants in accordance with section Floor, Washington, DC 20006–8513. Supplemental Environmental Impact 514(b) of the HEA, if the Secretary Telephone: (202) 502–7583 or by e-mail: Statement (SPA SEIS), June 2001) for determines that the cooperative [email protected] or Carnisia separation of the high-activity fraction arrangement is geographically and Proctor, Telephone: (202) 502–7606 or from the low-activity fraction of economically sound or will benefit the by e-mail: [email protected]. Savannah River Site (SRS) salt wastes. DOE has initiated design of the Salt applicant HSI. If you use a telecommunications Waste Processing Facility (SWPF), If a tie still remains after applying the device for the deaf (TDD), you may call which will house the CSSX technology. additional point(s), and the relevant the Federal Relay Service (FRS) at 1– Now, using technologies described in statutory priority, we will determine the 800–877–8339. ranking of applicants based on the the SPA SEIS, DOE has decided to Individuals with disabilities may change the processing and disposition lowest endowment values per FTE obtain this document in an alternative student. pathway for a fraction of the low format (e.g., Braille, large print, activity salt waste currently stored in VI. Award Administration Information audiotape, or computer diskette) on the F- and H-Area tank farms. This 1. Award Notices: If your application request to the program contact person action is called Interim Salt Processing. is successful, we notify your U.S. listed in this section. When the SWPF becomes operational, Representative and U.S. Senators and VIII. Other Information the remaining (and by far the majority) send you a Grant Award Notification salt waste will be processed through the (GAN). We may also notify you Electronic Access to This Document: SWPF using the CSSX technology as informally. You may view this document, as well as described in the SPA SEIS; this action If your application is not evaluated or all other documents of this Department is called High Capacity Salt Processing. not selected for funding, we notify you. published in the Federal Register, in DOE will proceed with this interim 2. Administrative and National Policy text or Adobe Portable Document approach because doing so will enable Requirements: We identify Format (PDF) on the Internet at the DOE to continue uninterrupted use of administrative and national policy following site: http://www.ed.gov/news/ the Defense Waste Processing Facility requirements in the application package fedregister. (DWPF) to vitrify higher activity sludge and reference these and other To use PDF you must have Adobe waste for disposal at a geologic requirements in the Applicable Acrobat Reader, which is available free repository for spent nuclear fuel and Regulations section of this notice. at this site. If you have questions about high-level waste. It will also allow DOE We reference the regulations outlining using PDF, call the U.S. Government to use SWPF at higher capacity as soon the terms and conditions of an award in Printing Office (GPO), toll free, at 1– as it comes on line. This will allow DOE the Applicable Regulations section of 888–293–6498; or in the Washington, to complete cleanup and closure of the this notice and include these and other DC, area at (202) 512–1530. tanks years earlier than would otherwise specific conditions in the GAN. The be the case. That, in turn, will reduce GAN also incorporates your approved Note: The official version of this document the time during which the tanks— is the document published in the Federal application as part of your binding Register. Free Internet access to the official including some that do not have full commitments under the grant. edition of the Federal Register and the Code secondary containment and have a 3. Reporting: At the end of your of Federal Regulations is available on GPO known history of leak sites—continue to project period, you must submit a final Access at: http://www.gpoaccess.gov/nara/ store liquid radioactive waste. Finally, performance report, including financial index.html. Interim Salt Processing will make more
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tank space available for routine solid saltcake (including the interstitial level waste and that disposal in a operations, thereby reducing the liquid) would be combined. The four geologic repository is not required, if it number of transfers among tanks and salt processing technology alternatives meets certain criteria. DOE prepared a increasing the safety of operations. considered in the SPA EIS all include Draft section 3116 Determination for Therefore, Interim Salt Processing will initial separation of actinides (including Salt Waste Disposal at the Savannah accelerate the reduction of potential risk plutonium and uranium) present in the River Site in February 2005, and to the environment, the public, and salt solution by sorption on consulted with the NRC pursuant to workers. monosodium titanate (MST), followed section 3116 of the NDAA. Although not DOE has prepared a Supplement by removal by filtration. The separated required by section 3116, DOE made the Analysis (SA), Salt Processing actinides would be sent to the DWPF for draft 3116 Determination available for Alternatives at the Savannah River Site vitrification along with the sludge public review concurrent with DOE’s (DOE/EIS–0082–S2–SA–01), in portion of the tank waste, which would consultation with the NRC. accordance with DOE National not be processed through the salt The NRC consultation process has Environmental Policy Act (NEPA) processing facility. The remaining salt been completed. On December 28, 2005, regulations (10 CFR 1021.314) to solution, which would have high the NRC issued its Technical Evaluation determine whether implementation of concentrations of cesium (Cs) but very Report of the U.S. Department of Energy Interim Salt Processing is a substantial low concentrations of actinides after the Draft section 3116 Waste Determination change to the selected CSSX processing MST step, would be further processed to for Salt Waste Disposal (TER). The TER of salt waste or whether there are remove most of the Cs. presents information on DOE’s salt significant new circumstances or The alternatives described in the SPA waste processing strategy, the applicable information relevant to environmental SEIS differ in the approach for removal review criteria, and the NRC’s review concerns such that a supplement to the of radioactive Cs from the salt solution. approach, as well as the NRC’s analysis SPA SEIS or a new EIS would be For each action alternative except Direct and conclusions with respect to whether needed. Based on the SA, DOE has Disposal in Grout, most of the Cs would there is reasonable assurance that DOE’s determined that a supplement to the be extracted from the salt solution and proposed approach can meet the SPA SEIS or a new EIS is not needed. incorporated into a vitrified waste form applicable requirements of the NDAA at the DWPF, along with the sludge for determining that waste is not high- FOR FURTHER INFORMATION CONTACT: portion of the tank waste and the level waste. As noted in its executive Copies of the SPA SEIS and the 2001 actinides extracted in the MST step. The summary, ‘‘Based on the information Record of Decision are available on remaining low-activity salt waste stream provided by DOE to the NRC * * *, the DOE’s NEPA Web site at: http:// would be sent to the Saltstone NRC staff has concluded that there is www.eh.doe.gov/nepa. Copies of this Production Facility, where it would be reasonable assurance that the applicable amended Record of Decision, and the combined with grout in a homogeneous criteria of the NDAA can be met SA, will be available on DOE’s NEPA mixture and sent to the Saltstone provided certain assumptions made in Web site at: http://www.eh.doe.gov/nepa Disposal Facility (also referred to as the DOE’s analyses are verified via under DOE NEPA Documents. To Saltstone Vaults) for onsite disposal. monitoring.’’ 1 request copies of these documents, Under the SEIS, all action alternatives DOE considered the NRC’s TER, as please contact: The Center for but Direct Disposal in Grout would meet well as the public comments on the Environmental Management current permit conditions equivalent to Draft section 3116 Waste Determination, Information, P.O. Box 23769, Class A low-level waste. The Direct before issuing the section 3116 Waste Washington, DC 20026–3769. Disposal in Grout alternative would not Determination in January 2006. DOE Telephone: 800–736–3282 (in meet the permit conditions due to high also considered whether the comments Washington, DC: 202–863–5084). Cs concentrations. Under all action on the Draft section 3116 Waste For further information regarding the alternatives, the actinide concentration Determination raise issues or provide processing and disposal of salt waste at of the salt waste disposed in the information that would affect the the Savannah River Site, or to obtain Saltstone Disposal Facility would not environmental discussion in the Salt copies of the SA discussed herein, or exceed the Nuclear Regulatory Processing Alternatives SA and has this amended Record of Decision, Commission (NRC) concentration limits determined that they do not. contact: Mr. Andrew R. Grainger, for Class A low-level waste, and would In the section 3116 Determination for Savannah River Operations Office, U.S. be about 10 nanocuries per gram. Salt Waste Disposal at the Savannah Department of Energy, P.O. Box B, DOE issued the Final SPA SEIS in River Site DOE concluded that, as Aiken, SC 29802. Telephone: 803–952– June 2001 and in October 2001 DOE demonstrated in the section 3116 8001. E-mail: [email protected]. issued a Record of Decision selecting Determination for Salt Waste Disposal at For information on DOE’s NEPA the preferred alternative described in the Savannah River Site and in process, contact: Ms. Carol Borgstrom, the Final SPA SEIS—CSSX, with MST consideration of DOE’s consultation Director, Office of NEPA Policy and for removal of actinides—as the with the NRC, the solidified low-activity Compliance, EH–42, U.S. Department of treatment technology for salt waste. salt waste is not high-level waste and Energy, 1000 Independence Avenue, DOE is currently designing the SWPF may be disposed of in the Saltstone SW., Washington, DC 20585–0119. which will house the CSSX and MST Disposal Facility at SRS. DOE also Telephone 202–586–4600, or leave a treatment technologies. stated that DOE will continue to take message at 800–472–2756. The disposal of saltstone waste in the actions (such as sampling, monitoring, SUPPLEMENTARY INFORMATION: Saltstone Disposal Facility is subject to and ensuring vault inventory limits) to the requirements of section 3116 of the confirm the ongoing validity of the I. Background Ronald W. Reagan National Defense Determination and to explore additional DOE evaluated the environmental Authorization Act for Fiscal Year 2005 impacts of construction and operation of (NDAA). NDAA section 3116 authorizes 1 NRC also made a number of observations four alternative technologies for salt the Secretary of Energy, in consultation regarding DOE’s analysis. DOE addressed several key NRC observations in the Section 3116 waste processing in the SPA SEIS. First, with the NRC, to determine that certain Determination for Salt Waste Disposal at the the concentrated supernate solution and waste from reprocessing is not high- Savannah River Site.
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actions to further enhance the About 33.8 million gallons (Mgal) of MCi, or 1.3 percent of the total will be protection of workers, the public, and salt waste are currently stored in disposed of in the Saltstone Disposal the environment. underground waste storage tanks at SRS. Facility, and 3.0 MCi is used in this This waste, along with future salt waste document. The higher number of 5 MCi Interim Salt Processing and SWPF forecasted to be sent to the tank farms, represents uncertainties in the Operation 2 will be processed through DDA, ARP/ radiological characterization of the salt Since issuing the SPA SEIS and ROD, MCU, and the SWPF. DOE estimated in waste. DOE has further considered options to preparing the Section 3116 Deliquification, Dissolution, and maintain sufficient tank space to Determination that an additional 41.3 Adjustment, Actinide Removal Process, continue to vitrify sludge waste in the Mgal of unconcentrated salt waste and Modular CSSX Unit DWPF in the interim before the SWPF would have been received by the Tank is operational. Continuing to operate Farms between December 1, 2004, and These facilities and processes are DWPF will allow DOE to remove and the completion of salt waste processing. described in the Salt Processing vitrify sludge waste; prepare salt waste After both liquid removal by processing Alternatives SA, and in greater detail in for treatment and disposal, and empty through the Tank Farm evaporator DOE’s section 3116 Determination for waste tanks so they may be closed. All systems and later additions of liquid for Salt Waste Disposal at the Savannah of these actions will contribute to DOE’s saltcake dissolution and chemistry River Site. The DDA process will be the ability to continue to reduce the human adjustments required for processing, first interim process used and will be health and environmental risk inherent approximately 84 Mgal (5.9 Mgal used to process some of the lowest in storage of high volumes of liquid existing salt waste through the DDA activity salt waste from 2006 until 2011 radioactive waste. process, 1.0 Mgal future salt waste when the SWPF begins operation. The DOE will now process the salt waste through the DDA process, 2.1 Mgal DDA process will also be used to using a two-phase, three-part process. existing and future salt waste through prepare waste feed streams for the ARP The first phase (herein referred to as ARP/MCU, 69.1 Mgal existing salt waste and MCU and will operate in parallel Interim Salt Processing) will involve through SWPF, and 5.9 Mgal future salt with those facilities. two parts to treat some of the lower waste through SWPF) of salt solution In 2007, ARP and MCU operations activity salt waste: (1) Beginning in will be processed by Interim Salt will be initiated to process slightly 2006, processing of a minimal amount Processing and High Capacity Salt higher activity salt waste. ARP and MCU will use processes described in the of the lowest activity salt waste through Processing resulting in approximately a process involving deliquification, SPA SEIS (MST treatment and CSSX), 168 Mgal of grout output from the dissolution, and adjustment (DDA) of the same technologies that will be Saltstone Production Facility to be the waste; and (2) beginning in 2007, incorporated in the SWPF, which will disposed of in the Saltstone Disposal processing a minimal amount of process about 98.7 percent of the 223 Facility. additional salt waste with slightly In terms of curies, implementation of million curies in salt waste. The ARP will be comprised of the higher activity levels using an Actinide Interim Salt Processing followed by actinide removal process that was Removal Process (ARP) and a Modular High Capacity Salt Processing will described as part of the pilot plant, CSSX Unit (MCU), following result in onsite disposal of 3.0 to 5.0 which also included a low-capacity deliquification, dissolution, and million curies (MCi), with the majority CSSX capability, in the SPA SEIS. In adjustment of saltcake. The second and (about 2.8 MCi of 3.0 MCi) resulting order to take advantage of existing longer term phase, herein referred to as from Interim Salt Processing, in the infrastructure and minimize High Capacity Salt Processing, is Saltstone Disposal Facility. This construction costs, DOE will modify identical to the CSSX technology as represents 1.3 to 2.2 percent of the existing SRS facilities 512–S (formerly presented in the SPA SEIS and will, approximately 223 MCi in the salt the Late Wash Facility) and 241–96H beginning in 2011, separate and process waste. DOE’s current estimate is that 3.0 the remaining (and by far the majority) (formerly the filter building portion of of the salt waste using the SWPF resulting in an approximate two year delay in the the In-Tank Precipitation facility). The (augmented as necessary by ARP). The planned startup of SWPF. DOE anticipates that it MCU will house a low-capacity CSSX second phase will begin as soon as will continue to explore possible ways to improve technology, similar to the pilot plant SWPF is constructed, permitted by the the schedule for design and construction of the described in the SPA SEIS. The MCU is SWPF. It remains DOE’s goal to complete State of South Carolina, and becomes processing of salt waste through the SWPF by 2019 being constructed in the former cold operational. The first, interim although this date may need to be modified in the feeds area of the In-Tank Precipitation processing phase will cease at that time future. Despite this projected delay, DOE will not facility. The SA provides further details (except that ARP could be used as increase the quantity of waste (total curies) to be of the new and existing facilities and 3 disposed of in the Saltstone Disposal Facility, nor necessary to augment SWPF). increase the quantities (curies) processed with processes that will be used for Interim interim processes or SWPF from those described Salt Processing. 2 The numbers and percentages in this Amended here and in the Draft Section 3116 Determination Record of Decision are either rounded numbers and for Salt Waste Disposal at the Savannah River Site Regulatory Requirements percentages or are DOE’s best estimates at this time. and the Section 3116 Determination for Salt Waste A modification to the Saltstone The numbers, percentages, and dates in this Disposal at the Savannah River Site. Therefore, the Amended Record of Decision should be viewed as date change does not affect the analyses in the Disposal Facility Industrial Solid Waste approximate numbers, percentages, and dates. Section 3116 Determination for Salt Waste Disposal Landfill (ISWL) permit, issued by the 3 The start date for SWPF operations has been at the Savannah River Site, its supporting South Carolina Department of Health delayed (from 2009 to 2011) to allow for documents, or the NRC consultation. The modified and Environmental Control (SCDHEC), modification of the SWPF preliminary design to schedule is reflected in the Section 3116 incorporate a higher degree of performance category Determination for Salt Waste Disposal at the will be required prior to implementation (PC) in the confinement barriers necessary for Savannah River. However, the technical and of Interim Salt Processing. The current worker protection during natural phenomena programmatic documents that are referenced by the Saltstone Disposal Facility ISWL permit hazard events. The Defense Nuclear Facilities Section 3116 Determination for Salt Waste Disposal authorizes disposal of waste with Safety Board initially identified concerns related to at the Savannah River Site have not been updated the PC designations of the SWPF in August, 2004. to reflect this new date because the schedule change radionuclide concentrations comparable DOE agreed in November, 2005, to modify the did not occur until after those documents were to Class A low-level waste limits (10 SWPF design after extensive analysis and review, completed. nCi/g) as defined in NRC regulations at
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10 CFR 61.55. SCDHEC under its State about 0.1 Ci/gal and actinide 0.1 Ci/gal and an actinide concentration wastewater permitting authority issued concentration of less than 10 nCi/g. comparable to SWPF waste (i.e., less the permit. The permit requires DOE to than 10 nCi/g) after processing, and will III. Basis for the Decision notify SCDHEC if the characteristics of result in about 0.3 MCi processed wastes to be disposed in the Saltstone DOE has initiated design of the Salt through the Saltstone Production Disposal Facility would change, as will Waste Processing Facility (SWPF), Facility for disposal at the Saltstone be the case with the higher which will house the CSSX technology Disposal Facility. These concentrations concentrations of radionuclides (about selected in the Record of Decision. Now, are the same as those described in the 0.2 Ci/gal rather than about 0.1 Ci/gal, using technologies described in the SPA SPA SEIS for salt waste processed using and about 41 nCi/g actinides rather than SEIS, DOE has decided to change the the CSSX technology. less than 10 nCi/g) in saltstone that will processing and disposition pathway for After the SWPF becomes operational be disposed when DOE implements a fraction of the salt waste currently in 2011, waste sent to the Saltstone stored in the F- and H-Area tank farms. Interim Salt Processing. DOE has Disposal Facility will have This action is called Interim Salt submitted a request for a modification to concentrations the same as those Processing. When the SWPF becomes the Saltstone Disposal Facility ISWL evaluated in the SPA SEIS, until waste operational, the remaining salt waste permit. The requested modification processing is completed. In all, will be processed using High Capacity would cover waste with concentrations implementing Interim Salt Processing Salt Processing through the SWPF using less than the NRC Class C limits (100 followed High Capacity Salt Processing the CSSX technology as described in the nCi/gm). using the CSSX technology at the SWPF SPA SEIS. II. Decision If DOE is to be in a position to will result in disposal of about 3.0 MCi, continue removal and vitrification of the or 1.3 percent of the total curies DOE has decided to implement high-activity sludge between now and contained in the salt waste, at the 4 Interim Salt Processing, followed by the startup of the SWPF, including Saltstone Disposal Facility. High Capacity Salt Processing using the removing sludge waste from the tanks The SA addressed the impacts of the CSSX technology when the SWPF that lack full secondary containment, processing and disposal of higher becomes operational. DOE will change and to operate the SWPF efficiently after concentrations of actinides during the processing and disposition pathway its construction is complete, DOE must Interim Salt Processing than evaluated for a fraction (about 1.3 percent, or proceed with Interim Salt Processing. in the Salt Processing Alternatives SEIS. about 3.0 MCi) of the salt waste The only practical way DOE will be able These higher concentrations will be currently stored in the F- and H-Area to move forward with sludge found in that fraction of the salt waste tank farms. DOE will use the DDA vitrification without significant segregated using the DDA process and process to segregate supernate and disruption and delay, and assure sent directly for disposal without interstitial liquid from saltcake in order efficient operation of the SWPF, is to treatment in the ARP and MCU. to send salt waste with low curie use interim salt processing technologies For the analysis presented in the SA, content (about 2.5 MCi, or about 6.9 to remove and dispose of a limited DOE conservatively assumed the entire Mgal) to the Saltstone Production amount of the salt waste currently in the salt waste inventory, processed through Facility, where it will be combined with tanks during this interim period. the SWPF using the CSSX for the chemicals to form a grout matrix and Otherwise, DOE would be forced to operating life of the facility, would be sent to the Saltstone Disposal Facility. decrease, postpone, and eventually halt sent to the Saltstone Production Facility The waste processed with DDA will, the on-going activities to remove and with an actinide concentration of 100 after solidification, have an average Cs stabilize tank waste that currently are nCi/g, the concentration limit for Class concentration of about 0.2 Ci/gal and reducing risk to the occupational C waste. However, when Interim Salt actinide concentration of about 41 nCi/ workers, the public, and the Processing is implemented, g. DOE will also use the DDA process to environment. concentrations will be less. That is, dispose of 0.24 Mgal of relatively low about 41 nCi/g resulting from the DDA IV. Supplement Analysis activity salt solution currently stored in process will be sent to the Saltstone Tank 48. DOE will process this waste To determine whether the proposed Production Facility without treatment in without removal of radionuclides by action warrants a supplement to the ARP and MCU from 2006 until about combining the stream with another salt SPA SEIS or a new EIS, DOE prepared 2011 when the SWPF becomes waste stream, currently planned to be the SA, Salt Processing Alternatives at operational. DOE estimates that only the low-activity liquid recycle waste the Savannah River Site (DOE/EIS– about 6.8 Mgal or about 6 percent of the stream from the DWPF. About 2.1 Mgal 0082–S2–SA–01). In the SA DOE total salt waste inventory will have an of salt waste with slightly higher curie compared the impacts of implementing average concentration of about 41 nCi/ content will be prepared for processing Interim Salt Processing followed by g. For the SA analysis DOE used the through the ARP and MCU; about 0.3 High Capacity Salt Processing to the same Cs concentration DOE used for the MCi, or about 2.1 Mgal, will be disposed impacts of the salt processing SPA SEIS. The differences in impacts of in the Saltstone Disposal Facility. alternatives evaluated in the SPA SEIS. When SWPF becomes operational in Using the DDA process from 2006 4 Due to uncertainties in the characterization of about 2011 the CSSX technology will be until about 2011, salt waste with a Cs the salt waste, the total curies disposed could range used to process the inventory of salt concentration of about 0.2 Ci/gal and an up to 5.0 MCi. The uncertainty concerning disposal waste that was not processed during actinide concentration of about 41 nCi/ of 3.0 MCi or up to about 5.0 MCi is inconsequential in light of the Direct Disposal in interim salt processing. DOE expects to g, totaling about 2.5 MCi, will be sent Grout impacts analysis found in the SPA SEIS. As process about 98.7 percent (about 220 to the Saltstone Production Facility and explained in the SPA SEIS, the impacts of the MCi) of the salt waste inventory using then to the Saltstone Disposal Facility. Direct Disposal in Grout alternative are greater than the CSSX technology as described in the Salt waste processed through the ARP those of the other alternatives. DOE concluded, however, that any of the alternatives evaluated, SPA SEIS. After processing in the SWPF and MCU, which will operate from 2007 including Direct Disposal in Grout, could be waste sent to the Saltstone Disposal until the SWPF becomes operational implemented with only small and acceptable Facility will have a Cs concentration of will have a Cs concentration of about environmental impacts.
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are therefore attributed solely to the constructs and lives in a permanent SWPF using the CSSX technology to increased actinide concentration. residence on the vaults. At 100 years relieve tank space limitations and assure post-closure a sufficient layer of soil that vitrification of the high-activity Short-Term Impacts would be present over the still-intact fraction of liquid radioactive waste As evaluated in the SPA SEIS, short- disposal vaults so that the resident (sludge waste) at the Savannah River term impacts are incurred during would be unaware that the residence Site will continue uninterrupted while operation of the salt waste processing was constructed over the vaults. At construction of the SWPF is completed. facilities, and long-term impacts are 1,000 years post-closure the saltstone is Issued in Washington, DC, this 17th day of those resulting from release of disposed assumed to have weathered sufficiently January 2006. radionuclides from the Saltstone so that the resident could construct a James A. Rispoli, Disposal Facility. As described in the residence without being aware of the SA, differences in short-term impacts Assistant Secretary for Environmental presence of the saltstone. Management. resulting from implementing Interim Under the Agricultural Scenario the [FR Doc. E6–818 Filed 1–23–06; 8:45 am] Salt Processing followed by SWPF doses and latent cancer fatalities operation using the CSSX technology resulting from Interim Salt Processing BILLING CODE 6450–01–P will be small compared to operation of followed by SWPF operation using the the CSSX technology as described in the CSSX technology increase slightly. DEPARTMENT OF ENERGY SPA SEIS. Modifications to the Under the Residential Scenario at 100 Saltstone Production Facility were Years, impacts from Interim Salt Section 3116 Determination for Salt completed within the existing structure Processing would be comparable to Waste Disposal at the Savannah River and result in no new land disturbance. Caustic Side Solvent Extraction Site Impacts from construction of the MCU analyzed in the SPA SEIS. For the will not differ from those described for Residential Scenario at 100 Years doses AGENCY: Office of Environmental the pilot plant in the SPA SEIS. The are dominated by Cs, which has largely Management, Department of Energy. existing 512–S and 241–96H facilities decayed by 1,000 years post-closure. ACTION: Notice of Availability. will be modified for the ARP and will When Interim Salt Processing SUMMARY: be operated remotely. No adverse followed by SWPF operation using the The Department of Energy impacts are anticipated from CSSX technology is implemented, waste (DOE) announces the availability of a construction. Implementation of Interim with a concentration of about 41 nCi/g section 3116 determination for the Salt Processing will not necessitate resulting from the DDA process without disposal of separated, solidified, low- changes in the design or operation of the ARP and MCU treatment will be sent to activity salt waste at the Savannah River SWPF. the Saltstone Disposal Facility until Site (SRS) near Aiken, South Carolina. There is the potential for short-term SWPF becomes operational. Using ARP Section 3116 of the Ronald W. Reagan impacts to the health of workers and the and throughout the operating life of the National Defense Authorization Act for public due to radiation doses from SWPF, salt waste sent to the Saltstone Fiscal Year 2005 authorizes the airborne releases of Cs and actinides Disposal Facility will have actinide Secretary of Energy, in consultation from processing activities. For example, concentrations of 10 nCi/g or less. Long- with the Nuclear Regulatory the dose to the maximum exposed term impacts will be less than shown in Commission, to determine that certain individual would increase from the 0.31 the SA when DOE implements Interim waste from reprocessing is not high- millirem analyzed under the Caustic Salt Processing followed by SWPF level waste (HLW) if it meets the Side Solvent Extraction alternative in because the actual inventory of statutory criteria set forth in Section the SPA SEIS to 0.58 millirem (due to actinides disposed of in the Saltstone 3116. The Section 3116 determination increased actinide concentrations in Disposal Facility will be less than sets forth the basis on which the that portion of the salt waste segregated assumed in the calculation. Secretary has determined that the salt using DDA but not treated using ARP waste is not high-level waste because it V. Conclusions and MCU before disposal). Similar small (1) does not require permanent isolation increases would occur in involved DOE will process about 98.7 percent in a deep geologic repository, (2) has worker doses and non-involved worker of the salt waste inventory (about 220 of had highly radioactive radionuclides doses. The 0.31 millirem dose to the about 223 MCi) using the CSSX removed to the maximum extent maximum exposed individual would technology as described in the SPA practical, and (3) meets the NRC result in a probability of a latent cancer SEIS. When SWPF becomes operational performance objectives for the disposal fatality of about 2 chances in 1,000,000 the CSSX technology will be used to of low level waste. In a separate notice (2.0 × 10¥6). The 0.58 millirem dose to process the inventory of salt waste that published in today’s Federal Register, the maximum exposed individual was not processed during interim salt DOE is also making available the would result in a probability of a latent processing. Interim Salt Processing amended Record of Decision for cancer fatality of about 3.7 chances in followed by High Capacity Salt Savannah River Site Salt Processing 1,000,000 (3.7 × 10¥6). Processing through SWPF using the Alternatives Final Supplemental CSSX technology does not constitute a Environmental Impact Statement, Long-Term Impacts substantial change in actions previously originally issued on October 17, 2001 In the SA, DOE compares calculated analyzed and does not present (66 FR 52752). doses and impacts from the SPA SEIS significant new circumstances or ADDRESSES: The final determination, as (the SWPF using the CSSX technology) information relevant to environmental well as DOE’s responses to the public and the increased actinide concerns and bearing on the impacts of comments received on the draft concentrations in the Saltstone Disposal DOE’s salt processing and waste determination, are available on the Facility from implementing Interim Salt disposal program. Therefore, DOE does Internet at http://apps.em.doe.gov/swd, Processing followed by SWPF operation. not need to undertake additional NEPA and are publicly available for review at Three scenarios are used. In the analysis, and DOE will implement the following locations: U.S. Agricultural Scenario an individual is Interim Salt Processing followed by Department of Energy, Public Reading assumed to unknowingly farm and High Capacity Salt Processing through Room, 1000 Independence Avenue,
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SW., Room 1E–190, Washington, DC phase will begin as soon as the Salt Any person desiring to intervene or to 20585, Phone: (202) 586–5955, or Fax: Waste Processing Facility is protest this filing must file in (202) 586–0575; and U.S. Department of constructed, permitted by the State of accordance with Rules 211 and 214 of Energy, Savannah River Operations South Carolina, and operational. the Commission’s Rules of Practice and Office, Public Reading Room, 171 DOE believes that this two-phase, Procedure (18 CFR 385.211 and University Parkway, Aiken, SC 29801, three-part approach to processing and 385.214). Protests will be considered by Phone: (803) 641–3320, or Fax: (803) disposing of the salt waste at SRS will the Commission in determining the 641–3302. enable it to complete cleanup and appropriate action to be taken, but will SUPPLEMENTARY INFORMATION: As of closure of the tanks years earlier and not serve to make protestants parties to November 2005 there are 36.4 million maximize reduction of the potential the proceeding. Any person wishing to gallons (Mgal) of liquid radioactive risks that the tank wastes pose to the become a party must file a notice of waste stored in underground waste environment, the public, and SRS intervention or motion to intervene, as storage tanks at SRS. The waste consists workers. Taken together, the various appropriate. The Respondent’s answer of two distinct kinds of material: technologies that will be used are and all interventions, or protests must approximately 2.6 Mgal of sludge, expected to result in the removal and be filed on or before the comment date. comprised primarily of metals that vitrification through the DWPF of 98 to The Respondent’s answer, motions to settled at the bottom of the tanks; and 99 percent of the total radioactivity intervene, and protests must be served approximately 33.8 Mgal of salt waste, currently contained in the salt waste, on the Complainants. which is comprised of concentrated salt while minimizing the time that waste The Commission encourages solution (supernate) and crystallized will be stored in the underground tanks, electronic submission of protests and saltcake. some of which have a known history of interventions in lieu of paper using the DOE’s plans call for stabilizing and leaks. ‘‘eFiling’’ link at http://www.ferc.gov. disposing of retrieved sludge in a deep Issued in Washington, DC, on January 17, Persons unable to file electronically geologic repository for spent nuclear 2006. should submit an original and 14 copies fuel and high-level radioactive waste. James A. Rispoli, of the protest or intervention to the This will be done by stabilizing the Assistant Secretary for Environmental Federal Energy Regulatory Commission, HLW in a borosilicate glass matrix Management. 888 First Street, NE., Washington, DC through vitrification in a facility known [FR Doc. E6–814 Filed 1–23–06; 8:45 am] 20426. as the Defense Waste Processing Facility BILLING CODE 6450–01–P This filing is accessible on-line at (DWPF). This process has been ongoing http://www.ferc.gov, using the since 1996. ‘‘eLibrary’’ link and is available for Regarding the salt waste, DOE plans DEPARTMENT OF ENERGY review in the Commission’s Public to remove cesium, strontium, and Reference Room in Washington, DC. actinides from these materials using a Federal Energy Regulatory There is an ‘‘eSubscription’’ link on the variety of technologies, combining the Commission Web site that enables subscribers to removed cesium, strontium, and receive e-mail notification when a [Docket No. EL06–46–000] actinides with the sludge being vitrified document is added to a subscribed in DWPF, and solidifying the remaining Tucson Electric Power Company, docket(s). For assistance with any FERC low-activity salt stream into a grout Complainant, v. El Paso Electric Online service, please e-mail matrix, known as saltstone grout, Company, Respondent; Notice of [email protected], or call suitable for disposal in vaults at the Complaint (866) 208–3676 (toll free). For TTY, call Saltstone Disposal Facility at SRS. The (202) 502–8659. disposal of this low-activity salt stream January 17, 2006. Comment Date: 5 p.m. Eastern Time on site is the subject of this section 3116 Take notice that on January 11, 2006, on January 31, 2006. determination. Tucson Electric Power Company (TEP) Magalie R. Salas, DOE is separating the salt waste to filed a complaint against El Paso segregate the low-activity fraction using Electric Company (EPE) pursuant to Secretary. a two-phase, three-part process. The Rule 206 of the Commission’s Rules. [FR Doc. E6–792 Filed 1–23–06; 8:45 am] first phase will involve two parts to treat TEP states that EPE has refused to BILLING CODE 6717–01–P the lower activity salt waste: (1) permit TEP to use transmission rights Beginning in 2006, DOE will process a on certain EPE transmission facilities DEPARTMENT OF ENERGY minimal amount of the lowest-activity that were assigned to it in a Tucson-El salt waste through a process involving Paso Power Exchange and Transmission Federal Energy Regulatory deliquification, dissolution, and Agreement on file with the Commission Commission adjustment of the waste; and (2) (Power Exchange Agreement) for beginning in 2007, DOE will process a transmission of electricity from the Combined Notice of Filings #1 minimal amount of additional salt waste newly-constructed Luna Generating with slightly higher activity levels using Station near Deming, NM, to the TEP January 17, 2006. an Actinide Removal Process and a electric system. TEP has asked for Fast Take notice that the Commission Modular Caustic Side Solvent Track Processing of the Complaint and received the following electric rate Extraction Unit. The second, and longer- for prompt issuance of an order filings. term phase, which is scheduled to begin requiring EPE to refrain from Docket Numbers: ER01–205–010; in 2011, involves the separation and disconnecting the Luna Generating ER98–2640–008; ER98–4590–006; processing of the remaining (and by far Station to the TEP grid and to transmit ER99–1610–013; EL05–115–000. the majority) of the salt waste using a electricity from TEP’s share of the Luna Applicants: Xcel Energy Services, high capacity Salt Waste Processing Generating Station to the TEP service Inc.; Northern States Power Company; Facility, augmented as necessary by the territory in accordance with the terms of Public Service Company of Colorado; Actinide Removal Process. This second the Power Exchange Agreement. Southwestern Public Service Company,
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New Century Services, Inc.; Xcel Energy Docket Numbers: ER06–318–001. Interconnection Agreement, and Small Services, Inc. Applicants: North American Energy Generator Interconnection Agreement Description: Xcel Energy Services, Credit and Clearing. sections of its Tapoco Division OATT. Inc., on behalf of Southwestern Public Description: North American Energy Filed Date: January 10, 2006. Service Co. et al. submit an amendment Credit and Clearing submits Accession Number: 20060112–0329. to its updated market power analysis in supplemental information and a revised Comment Date: 5 p.m. Eastern Time response to FERC’s December 8, 2005 rate schedule to amend the Petition for on Tuesday, January 31, 2006. letter and January 12, 2006 revision Acceptance of Initial Rate Schedule, Docket Numbers: ER96–1551–015; filing for Attachment B to this filing. Wavier and Blanket Authority. ER01–615–011. Filed Date: January 10, 2006. Filed Date: January 10, 2006. Applicants: Public Service Company Accession Number: 20060112–0038. Accession Number: 20060113–0147. of New Mexico. Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Description: Public Service Co. of on Tuesday, January 31, 2006. on Tuesday, January 31, 2006. New Mexico, submits filing of a possible Docket Numbers: ER01–642–004; Docket Numbers: ER06–326–001. change in status with regard to the ER01–1335–006; ER01–1011–008. Applicants: North American Energy characteristics that the Commission Applicants: CottonWood Energy Credit and Clearing. previously relied upon in granting PNM Company LP; Magnolia Energy LP; Description: North American Energy Market-Based Rate Authority. Redbud Energy LP. Credit & Clearing submits supplemental Filed Date: January 10, 2006. Description: Cottonwood Energy, LP, information and a revised rate schedule Accession Number: 20060113–0177. Magnolia Energy LP and Redbud Energy to amend the Petition for Acceptance of Comment Date: 5 p.m. Eastern Time LP submit an amended notification of Initial Rate Schedule, Waivers & on Tuesday, January 31, 2006. change in status under market-based BlanketAuthority. Docket Numbers: ER98–1150–007. rate authority. Filed Date: January 10, 2006. Applicants: Tucson Electric Power Filed Date: January 10, 2006. Accession Number: 20060113–0148. Company. Accession Number: 20060112–0035. Comment Date: 5 p.m. Eastern Time Description: Tucson Electric Power Comment Date: 5 p.m. Eastern Time on Tuesday, January 31, 2006. Co., submits filing of a change in status on Tuesday, January 31, 2006. Docket Numbers: ER06–463–000. with regard to the characteristics that Docket Numbers: ER01–642–005; Applicants: Alcoa Power Generating, the Commission relied upon in granting ER01–1335–007; ER01–1011–009. Inc. market-based rate authority. Applicants: CottonWood Energy Description: Alcoa Power Generating, Filed Date: January 10, 2006. Company LP; Magnolia Energy LP; Inc., submits the required ministerial Accession Number: 20060113–0125. Comment Date: 5 p.m. Eastern Time Redbud Energy LP. changes to the Large Generator on Tuesday, January 31, 2006. Description: Cottonwood Energy Co., Interconnection Agreement, Small LP et al. submit revisions to their Generator Interconnection Procedures Docket Numbers: ER99–1757–009; respective market-based tariff to include and Small Gen. Interconnection EL05–67–000. a Conduct of Conduct. Agreement sections of its Yadkin OATT. Applicants: The Empire District Filed Date: January 10, 2006. Filed Date: January 10, 2006. Electric Company. Accession Number: 20060113–0145. Accession Number: 20060112–0323. Description: The Empire District Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Electric Co., submits additional on Tuesday, January 31, 2006. on Tuesday, January 31, 2006. information in response to the Docket Numbers: ER03–394–004; Commission’s deficiency letter order Docket Numbers: ER06–464–000. ER03–427–004; ER03–175–006. dated December 9, 2005. Applicants: Highlands Energy Group Applicants: Elk Hills Power, LLC; Filed Date: January 9, 2006. LLC. Mesquite Power, LLC, Termoelectrica Accession Number: 20060112–0306. Description: Highlands Energy Group, U.S., LLC. Comment Date: 5 p.m. Eastern Time Description: Elk Hills Power, LLC, LLC’s petition for acceptance of initial on Monday, January 30, 2006. rate schedule, waivers, and blanket Mesquite Power, LLC, et al. submit an Docket Numbers: ER99–3077–002. authority. updated market power analysis Applicants: Colorado Power Partners. pursuant to FERC’s March 21, 2003 Filed Date: January 10, 2006. Description: Colorado Power Partners Accession Number: 20060112–0324. Order. submits an amendment to its triennial Comment Date: 5 p.m. Eastern Time Filed Date: January 10, 2006. updated market power analysis and on Tuesday, January 31, 2006. Accession Number: 20060113–0124. substitute tariff sheets to FERC Electric Comment Date: 5 p.m. Eastern Time Docket Numbers: ER06–466–000. Tariff, Original Volume No. 1. on Tuesday, January 31, 2006. Applicants: EL Paso Electric Filed Date: January 10, 2006. Docket Numbers: ER05–1312–001; Company. Accession Number: 20060112–0036. EC05–123–000. Description: El Paso Electric Co., Comment Date: 5 p.m. Eastern Time Applicants: Monongahela Power submits an unexecuted Service on Tuesday, January 31, 2006. Company and Columbus Southern Agreement with Tucson Electric Power Docket Numbers: ER99–3197–002. Power Company. Co. Applicants: BIV Generation Company Description: Monongahela Power Co., Filed Date: January 10, 2006. LLC. on behalf of Columbus Southern Power Accession Number: 20060112–0326. Description: BIV Generation Co., LLC Co., notifies FERC that the dispositions Comment Date: 5 p.m. Eastern Time submits an amendment to its triennial and acquisition of the jurisdiction on Tuesday, January 31, 2006. updated market power analysis and facilities authorized by such order was Docket Numbers: ER06–470–000. Substitute tariff sheets to FERC Electric consummated on December 31, 2005. Applicants: Alcoa Power Generating Tariff, Original Volume No. 1. Filed Date: January 10, 2006. Inc. Filed Date: January 10, 2006. Accession Number: 20060113–0146. Description: Alcoa Power Generating Accession Number: 20060112–0037. Comment Date: 5 p.m. Eastern Time Inc., submits required ministerial Comment Date: 5 p.m. Eastern Time on Tuesday, January 31, 2006. changes to the Large Generator on Tuesday, January 31, 2006.
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Any person desiring to intervene or to DEPARTMENT OF ENERGY DEPARTMENT OF ENERGY protest in any of the above proceedings must file in accordance with Rules 211 Federal Energy Regulatory Federal Energy Regulatory and 214 of the Commission’s Rules of Commission Commission Practice and Procedure (18 CFR 385.211 Notice of Application for Non-Project and 385.214) on or before 5 p.m. Eastern [Project No. 11588–011, Alaska] Use of Project Lands and Waters and Time on the specified comment date. It Alaska Power and Telephone Soliciting Comments, Motions To is not necessary to separately intervene Intervene, and Protests again in a subdocket related to a Company; Notice of Availability of compliance filing if you have previously Environment Assessment January 17, 2006. intervened in the same docket. Protests Take notice that the following January 17, 2006. will be considered by the Commission application has been filed with the in determining the appropriate action to An environmental assessment (EA) is Commission and is available for public be taken, but will not serve to make available for public review. The EA was inspection: protestants parties to the proceeding. prepared for an application filed by the a. Application Type: Non-Project Use Anyone filing a motion to intervene or Alaska Power and Telephone Company of Project Lands and Waters. protest must serve a copy of that (licensee) on October 17, 2005, b. Project No.: 2503–092. document on the Applicant. In reference requesting Commission approval to c. Date Filed: December 21, 2005. to filings initiating a new proceeding, make certain design and site location d. Applicant: Duke Power, a division of Duke Energy Corporation. interventions or protests submitted on changes to project facilities as licensed. e. Name of Project: Keowee-Toxaway or before the comment deadline need The changes include: (1) Constructing a 675-foot-long, 9 foot horseshoe tunnel to Project. not be served on persons other than the f. Location: Lake Keowee is located in Applicant. provide a route for the upper section of the penstock and access to the diversion Pickens and Oconee County, South The Commission encourages structure, (2) altering the penstock Carolina. This project does not occupy electronic submission of protests and composition and alignment and the any tribal or federal lands. g. Filed Pursuant to: Federal Power interventions in lieu of paper, using the alignment and width of the access road Act, 16 U.S.C. 791(a)–825(r) and 799 FERC Online links at http:// for a length of 2,860 feet, (3) moving the and 801. www.ferc.gov. To facilitate electronic powerhouse 80 feet south of the original service, persons with Internet access h. Applicant Contact: Mr. Joe Hall, location and increase the tailrace length Lake Management Representative; Duke who will eFile a document and/or be from 75 feet to 163 fee, (4) moving the listed as a contact for an intervenor Energy Corporation; P.O. Box 1006; marine access about 600 feet north of Charlotte, NC 28201–1006; 704–382– must create and validate an the original location and construct a eRegistration account using the 8576. 250-foot-long jetty with a quay and boat i. FERC Contact: Any questions on eRegistration link. Select the eFiling ramp; and (5) constructing a 33,000 link to log on and submit the this notice should be addressed to Brian square-foot rockfill staging area onshore. Romanek at (202) 502–6175 or by e- intervention or protests. The EA evaluates the environmental mail: [email protected]. Persons unable to file electronically impacts that would result from j. Deadline for filing comments and or should submit an original and 14 copies approving the licensee’s proposed motions: February 17, 2006. of the intervention or protest to the changes to certain project facilities and All documents (original and eight Federal Energy Regulatory Commission, locations. Some additional ground copies) should be filed with: Ms. 888 First St., NE., Washington, DC disturbance would occur but impacts to Magalie R. Salas, Secretary, Federal 20426. the terrestrial and marine environments Energy Regulatory Commission, 888 The filings in the above proceedings are expected to be minor and short term. First Street, NE., Washington DC 20426. are accessible in the Commission’s The EA finds that approval of the Please include the project number (P– eLibrary system by clicking on the amendment application would not 2503–092) on any comments or motions appropriate link in the above list. They constitute a major Federal action filed. Comments, protests, and interventions may be filed electronically are also available for review in the significantly affecting the quality of the via the internet in lieu of paper. See, 18 Commission’s Public Reference Room in human environment. CFR 385.2001(a)(1)(iii) and the Washington, DC. There is an A copy of the EA is attached to a instructions on the Commission’s Web eSubscription link on the Web site that Commission order titled ‘‘Order site under the ‘‘e-Filing’’ link. The enables subscribers to receive e-mail Amending License’’, issued January 12, Commission strongly encourages e- notification when a document is added 2006, and is available in the filings. to a subscribed dockets(s). For Commission’s Public Reference Room. k. Description of Request: Duke assistance with any FERC Online A copy of the EA may also be viewed Power, licensee for the Keowee- service, please e-mail on the Commission’s Web site at http:// Toxaway Hydroelectric Project, has [email protected]. or call www.ferc.gov using the ‘‘eLibrary’’ link. requested Commission authorization to (866) 208–3676 (toll free). For TTY, call Enter the docket number (P–11588) in lease project lands to Outerbanks, Inc. (202) 502–8659. the docket field to access the document. for the purpose of reconfiguring a For assistance, call (202) 502–8222 or marina previously approved by the Magalie R. Salas, (202) 502–8659 (for TTY). Commission. The reconfiguration would Secretary. reduce the existing marina footprint [FR Doc. E6–789 Filed 1–23–06; 8:45 am] Magalie R. Salas, from 1.62 acres to 1.56 acres and the BILLING CODE 6717–01–P Secretary. number of boat slips from 56 to 54. The [FR Doc. E6–791 Filed 1–23–06; 8:45 am] marina would accommodate residents of BILLING CODE 6717–01–P the Outerbanks Subdivision on Lake
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Keowee off of Hatteras Ridge Road in ENVIRONMENTAL PROTECTION mission includes supporting leading- Six Mile, South Carolina. (Pickens AGENCY edge research to stimulate the sound use County). of science and technology to fulfill [FRL–8024–4] l. Location of the Application: This EPA’s mission to protect human health filing is available for review at the Office of the Science Advisor; Office of and safeguard the natural environment. Commission or may be viewed on the Research and Development; Broad One way to accomplish this is to Commission’s Web site at http:// Agency Announcement for provide broad informational technical www.ferc.gov, using the ‘‘eLibrary’’ link. Conferences, Workshops, or Meetings support through conferences, which Enter the docket number excluding the further environmental research by AGENCY: last three digits in the docket number Environmental Protection communicating ideas, knowledge, field to access the document. For Agency. expertise, innovation and creativity in assistance, contact FERC Online ACTION: Notice. solving complex environmental issues. The Agency intends to assist in this Support at SUMMARY: The U.S. Environmental [email protected] or toll- sharing of information with the broad Protection Agency (EPA) is issuing this scientific community by awarding free at (866) 208–3676, or for TTY, Broad Agency Announcement (BAA) contact (202) 502–8659. grant/cooperative agreement support for soliciting applications from eligible such efforts. The Agency also m. Individuals desiring to be included applicants for the planning, arranging, encourages the coordination and use of on the Commission’s mailing list should administering, and conducting of EPA funding with other Federal and/or so indicate by writing to the Secretary conferences, workshops, and/or non Federal sources of funds to leverage of the Commission. meetings in the areas of EPA mission additional resources to carry out the n. Comments, Protests, or Motions to related issues connected to protecting, proposed effort. Applicants may use Intervene—Anyone may submit human health and safeguarding the their own funds or other resources (e.g. comments, a protest, or a motion to natural environment; advancing the support from a collaborating institution intervene in accordance with the scientific and technical research that or organization) for a voluntary match or requirements of Rules of Practice and promotes environmental protection; cost share if the standards at 40 CFR Procedure, 18 CFR 385.210, .211, .214. exploring current and emerging issues 30.23 or 40 CFR 31.24, as applicable, are In determining the appropriate action to of importance to environmental met. take, the Commission will consider all protection; and/or encouraging protests or other comments filed, but collaboration among the nation’s best II. Eligibility Information only those who file a motion to scientists and engineers in academia, States, territories and possessions, intervene in accordance with the business and nonprofit research and Tribal nations of the U.S., including Commission’s Rules may become a institutes. the District of Columbia, public and party to the proceeding. Any comments, DATES: The opening date for this BAA is private universities and colleges, protests, or motions to intervene must January 19, 2006 and it will close on hospitals, laboratories, local be received on or before the specified January 18, 2007. The Agency will make governments, other public or private comment date for the particular funding decisions on a quarterly basis nonprofit institutions, are eligible to application. beginning approximately April 18, 2006, apply. Universities and educational o. Filing and Service of Responsive and thereafter approximately every institutions must be subject to OMB Documents—Any filings must bear in three months. The next funding Circular A–21. Profit-making firms are all capital letters the title decisions will be approximately on July not eligible to receive grants from the ‘‘COMMENTS’’, 17, 2006, October 16, 2006, and January EPA under this program. ‘‘RECOMMENDATIONS FOR TERMS 16, 2007. However, in order for a Eligible nonprofit organizations AND CONDITIONS’’, ‘‘PROTEST’’, OR proposal to be considered for funding, it include any organizations that meet the ‘‘MOTION TO INTERVENE’’, as must be received by EPA no later than definition of nonprofit in OMB Circular applicable, and the Project Number of three months prior to the start of the A–122. However, nonprofit the particular application to which the conference for which the applicant is organizations described in Section filing refers. A copy of any motion to requesting EPA funding under this BAA 501(c)(4) of the Internal Revenue Code intervene must also be served upon each and no later than January 18, 2007. that lobby are not eligible to apply. FOR FURTHER INFORMATION CONTACT: representative of the Applicant III. Award Information specified in the particular application. Eligibility Contact: Michael Bender, p. Agency Comments—Federal, state, 202–564–6829; email: Anticipated Type of Award: Grant or and local agencies are invited to file [email protected] Electronic Cooperative Agreement. comments on the described Submissions: ORD Call Center (Phone: Estimated Number of Awards Under applications. A copy of the applications 202–343–5500) Technical Contact: this BAA: Approximately 25 awards may be obtained by agencies directly [Michael Bender, Project Officer]; depending upon the amount of any from the Applicant. If an agency does Phone: 202–564–6829; e-mail: individual award. not file comments within the time [email protected] Anticipated Funding Amount: Office specified for filing comments, it will be SUPPLEMENTARY INFORMATION: of the Science Advisor (OSA), Office of presumed to have no comments. One Research and Development may have up I. Introduction copy of an agency’s comments must also to an estimated $150,000 for awards be sent to the Applicant’s Advancing sound science on cross- under this BAA; other ORD offices may representatives. cutting issues at EPA is a goal of the have additional funding of up to an Office of the Science Advisor (OSA), estimated $600,000 available for awards Magalie R. Salas, Office of Research and Development under this BAA—therefore the total Secretary. (ORD) which is based at EPA estimated amount available for all [FR Doc. E6–790 Filed 1–23–06; 8:45 am] headquarters in Washington, DC. OSA, awards under this BAA may be BILLING CODE 6717–01–P Office of Research and Development’s approximately $750,000.
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IV. Potential Funding per Grant notification of an award will be made by SUMMARY: This notice announces the EPA may award funding under this the Agency’s Grants Administration final agency action on 44 TMDLs BAA in the following two categories: Division. prepared by EPA Region 6 for waters 1. Meeting and workshop support up Nonprofit applicants recommended listed in the state of Arkansas, under to $25,000 per agreement including for funding under this BAA will be section 303(d) of the Clean Water Act direct and indirect costs. This category subject to a preaward administrative (CWA). These TMDLs were completed is for major support of small scale, capability review consistent with in response to the lawsuit styled Sierra focused meetings and workshops on a sections 8.b, 8.c, and 9.d of EPA Order Club, et al. v. Clifford, et al., No. LR– specific subject or subjects, or for partial 5700.8, EPA Policy on Assessing C–99–114. Documents from the support of a larger conference. Capabilities of Non-Profit Applicants for administrative record files for the final 2. Large conference support up to Managing Assistance Awards (http:// 44 TMDLs, including TMDL $75,000 per agreement including direct www.epa.gov/ogd/grants/ calculations and responses to and indirect costs. This category is for regulations.htm). comments, may be viewed at http:// major support of broader conferences Before or after an award, applicants www.epa.gov/earth1r6/6wq/artmdl.htm. that include a wide range of subjects may be required to provide additional quality assurance documentation. ADDRESSES: The administrative record relating to environmental research. files for these 44 TMDLs may be EPA will not consider applications for Further information, if needed, may be obtained from the EPA officials obtained by writing or calling Ms. Diane less than $5,000. Smith, Environmental Protection All grants and cooperative agreements indicated under the section titled: ‘‘For Specialist, Water Quality Protection will have a duration of up to 1 year to Further Information Contact.’’ Division, U.S. Environmental Protection provide for follow-up activities such as Information regarding this BAA Agency Region 6, 1445 Ross Ave., publication of reports and proceedings. obtained from sources other than these Dallas, TX 75202–2733. Please contact Cost-sharing is not required for awards Agency Contacts may not be accurate. E- Ms. Smith to schedule an inspection. under this BAA. mail inquiries are preferred. To view the full Broad Agency Announcement go to: FOR FURTHER INFORMATION CONTACT: V. Award Notices http://www.epa.gov/ord/htm/ Diane Smith at (214) 665–2145. EPA will notify successful and grantopportunity.htm. unsuccessful applicants by e-mail. SUPPLEMENTARY INFORMATION: In 1999, Dated: January 18, 2006. five Arkansas environmental groups, the Applicants selected for funding will be William H. Farland, required to provide additional Sierra Club, Federation of Fly Fishers, Chief Scientist, Office of the Science Advisor. information listed under ‘‘Award Crooked Creek Coalition, Arkansas Fly Notices.’’ EPA may require selected [FR Doc. E6–810 Filed 1–23–06; 8:45 am] Fishers, and Save our Streams applicants to submit additional forms BILLING CODE 6560–50–P (plaintiffs), filed a lawsuit in Federal and certifications. The application will Court against the EPA, styled Sierra then be forwarded to EPA’s Grants Club, et al. v. Clifford, et al., No. LR– ENVIRONMENTAL PROTECTION C–99–114. Among other claims, Administration Division for award in AGENCY accordance with the EPA’s procedures. plaintiffs alleged that EPA failed to The Agency is not obligated to fund [FRL–8023–9] establish Arkansas TMDLs in a timely selected applicants until a grant is manner. Clean Water Act Section 303(d): Final awarded by EPA’s Grants EPA Takes Final Agency Action on 44 Agency Action on 44 Total Maximum Administration Division. TMDLs Applicants are cautioned that only a Daily Loads (TMDLs) grants officer can bind the Government AGENCY: Environmental Protection By this notice EPA is taking final to the expenditure of funds; preliminary Agency (EPA). agency action on the following 44 selection by EPA does not guarantee an TMDLs for waters located within the ACTION: Notice of availability. award will be made. The official state of Arkansas:
Segment-Reach Waterbody name Pollutant
08020401–003 ...... Wabbaseka Bayou ...... Siltation/turbidity. 11110205–011 ...... Cadron Creek ...... Siltation/turbidity.. 11110205–012 ...... Cadron Creek ...... Siltation/turbidity. 11110203–927 ...... White Oak Creek ...... Siltation/turbidity. 08020302–004 ...... Bayou Deview ...... Siltation/turbidity. 08020302–005 ...... Bayou Deview ...... Siltation/turbidity. 08020302–006 ...... Bayou Deview ...... Siltation/turbidity. 08020302–007 ...... Bayou Deview ...... Siltation/turbidity. 08020302–009 ...... Bayou Deview ...... Siltation/turbidity. 08020302–016 ...... Cache River ...... Siltation/turbidity. 08020302–017 ...... Cache River ...... Siltation/turbidity. 08020302–018 ...... Cache River ...... Siltation/turbidity. 08020302–019 ...... Cache River ...... Siltation/turbidity. 08020302–020 ...... Cache River ...... Siltation/turbidity. 08020302–021 ...... Cache River ...... Siltation/turbidity. 08020302–027 ...... Cache River ...... Siltation/turbidity. 08020302–028 ...... Cache River ...... Siltation/turbidity. 08020302–029 ...... Cache River ...... Siltation/turbidity. 08020302–031 ...... Cache River ...... Siltation/turbidity. 08020302–032 ...... Cache River ...... Siltation/turbidity. 11010013–006 ...... Village Creek ...... Siltation/turbidity. 11010013–007 ...... Village Creek ...... Siltation/turbidity.
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Segment-Reach Waterbody name Pollutant
11010013–008 ...... Village Creek ...... Siltation/turbidity. 11010013–012 ...... Village Creek ...... Siltation/turbidity. 11010013–014 ...... Village Creek ...... Siltation/turbidity. 11010014–009 ...... Ten Mile Creek ...... Siltation/turbidity. 11010012–004 ...... Strawberry River ...... Siltation/turbidity. 11010012–005 ...... Strawberry River ...... Siltation/turbidity. 11010012–006 ...... Strawberry River ...... Siltation/turbidity. 110100 12–008 ...... Strawberry River ...... Siltation/turbidity. 11010012–009 ...... Strawberry River ...... Siltation/turbidity. 11010012–010 ...... Little Strawberry River ...... Siltation/turbidity. 11010012–011 ...... Strawberry River ...... Siltation/turbidity. 11010001–023 ...... West Fork White River ...... Siltation/turbidity. 11010001–024 ...... White River ...... Siltation/turbidity. 08020203–012 ...... Tyronza River ...... Siltation/turbidity. 11110105–001 ...... Poteau River near Fort Smith ...... Siltation/turbidity. 11110105–031L ...... Poteau River near Waldron ...... Total phosphorus, Copper, and Zinc. 11140302–003 ...... Days Creek ...... Nitrate. 11140109–919 ...... Rolling Fork ...... Total phosphorus, and Nitrate. 11010001–045L ...... Osage Creek near Berryville ...... Total phosphorus.
EPA requested the public to provide operating unlawfully. Named in the Act of 1984 and the Commission’s EPA with any significant data or order are: Moving Services, L.L.C.; regulations at 46 CFR Parts 515 and 520 information that might impact the 44 Worldwide Relocations, Inc.; by operating as non-vessel-operating TMDLs at Federal Register Notices: International Shipping Solutions, Inc.; common carriers in the U.S. trades Volume 70, Number 217, pages 68448– Dolphin International Shipping, Inc.; without obtaining licenses from the 68449 (November 10, 2005) and Volume All-in-One Shipping, Inc.; Boston Commission, without providing proof of 70, Number 46, page 11971 (March 10, Logistics Corp.; Around the World financial responsibility, without 2005). The comments received and Shipping, Inc.; Tradewind Consulting, publishing an electronic tariff, and by EPA’s response to comments may be Inc.; Global Direct Shipping; Sharon failing to establish, observe, and enforce found at http://www.epa.gov/earth1r6/ Fachler; Oren Fachler; Lucy Norry; just and reasonable regulations and 6wq/artmdl.htm. Patrick J. Costadoni; Steve Kuller; practices relating to or connected with Dated: January 10, 2006. Megan K. Karpick (a.k.a. Catherine receiving, handling, storing, or Kaiser, Kathryn Kaiser, Catherine delivering property; (2) Whether, in the Miguel I. Flores, Kerpick, Megan Kaiser and Alexandria event one or more violations of sections Director, Water Quality Protection Division, Hudson); Barbara Deane (a.k.a. Barbara 8, 10 and 19 of the Shipping Act of 1984 Region 6. Fajardo); Baruch Karpick; Martin J. and 46 CFR Parts 515 and 520 are [FR Doc. E6–813 Filed 1–23–06; 8:45 am] McKenzie; Joshua S. Morales; Elizabeth found, civil penalties should be BILLING CODE 6560–50–P F. Hudson; Daniel E. Cuadrado (a.k.a. assessed and, if so, the identity of the Daniel Edward); Ronald Eaden; and persons and/or corporations to whom Robert Bachs (collectively ‘‘the the penalties should be assessed and the FEDERAL MARITIME COMMISSION Respondents’’). amount of the penalties to be assessed; The Commission has received over (3) Whether, in the event violations are [Docket No. 06–01] 250 consumer complaints from shippers found, appropriate cease and desist Worldwide Relocations, Inc., All-in-One regarding the above individuals and orders should be issued. Shipping, Inc., Boston Logistics Corp., companies alleging, among other things, The full text of this order may be Around the World Shipping, Inc., that the companies: failed to deliver the viewed on the Commission’s home page Tradewind Consulting, Inc., Global cargo and refused to return pre-paid at http://www.fmc.gov or at the Office of Direct Shipping, Megan K. Karpick ocean freight; lost the cargo; charged the the Secretary, Room 1046, 800 North (a.k.a. Catherine Kaiser, Kathryn shipper for marine insurance which Capitol Street, NW., Washington DC. Kaiser, Catherine Kerpick, Megan they never obtained; misled the shipper Any person may file a petition for leave Kaiser and Alexandria Hudson), Martin as to the whereabouts of cargo; charged to intervene in accordance with 46 CFR J. McKenzie, Patrick John Costadoni, the shipper an inflated rate and 502.72. Elizabeth F. Hudson, Sharon Fachler, withheld cargo until that rate was paid; Bryant L. VanBrakle, and failed to pay the common carrier. In and Oren Fachler, et al.—Possible Secretary. Violations of Sections 8, 10 and 19 of many cases, the shipper was forced to pay another carrier or warehouse a [FR Doc. E6–786 Filed 1–23–06; 8:45 am] the Shipping Act of 1984 and the BILLING CODE 6730–01–P Commission’s Regulations at 46 CFR second time in order to have the cargo 515.3, 515.21 and 520.3; Notice of released. In addition, none of the Order of Investigation and Hearing companies or individuals listed is licensed as OTIs by the Federal FEDERAL RESERVE SYSTEM Notice is given that on January 11, Maritime Commission, nor have they Proposed Agency Information 2006 the Federal Maritime Commission provided proof of financial Collection Activities; Comment issued an Order of Investigation and responsibility, or published a tariff Request Hearing to determine whether nine showing their rates. apparently related household goods This proceeding seeks to determine: AGENCY: Board of Governors of the moving companies and their owners (1) Whether Respondents violated Federal Reserve System and/or primary corporate officers were sections 8, 10, and 19 of the Shipping SUMMARY: Background.
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On June 15, 1984, the Office of instructions for submitting comments at 602, and 625) and is given confidential Management and Budget (OMB) http://www.federalreserve.gov/ treatment (5 U.S.C. § 552(b) (4)). delegated to the Board of Governors of generalinfo/foia/ProposedRegs.cfm. Abstract: This reporting form collects the Federal Reserve System (Board) its Federal eRulemaking Portal: http:// data quarterly on the geographic approval authority under the Paperwork www.regulations.gov. Follow the distribution of the assets and liabilities Reduction Act, as per 5 CFR 1320.16, to instructions for submitting comments. of major foreign branches and approve of and assign OMB control E–mail: subsidiaries of U.S. commercial banks numbers to collection of information [email protected]. and of Edge and agreement requests and requirements conducted or Include docket number in the subject corporations. Data from this reporting sponsored by the Board under line of the message. form comprise a piece of the flow of conditions set forth in 5 CFR 1320 FAX: 202/452–3819 or 202/452–3102. funds data that are compiled by the Appendix A.1. Board–approved Mail: Jennifer J. Johnson, Secretary, Federal Reserve. collections of information are Board of Governors of the Federal Current action: The Federal Reserve incorporated into the official OMB Reserve System, 20th Street and proposes the following revisions: (1) inventory of currently approved Constitution Avenue, NW., Washington, Discontinuing Schedule A as a result of collections of information. Copies of the DC 20551. the elimination of M3; (2) discontinuing OMB 83-Is and supporting statements All public comments are available Memorandum item 3a; (3) revising the and approved collection of information from the Board’s Web site at http:// instructions for data to be submitted for instruments are placed into OMB’s www.federalreserve.gov/generalinfo/ the unallocated data items; (4) reducing public docket files. The Federal Reserve foia/ProposedRegs.cfm as submitted, the reporting panel to require offices may not conduct or sponsor, and the unless modified for technical reasons. located only in the Caribbean and the respondent is not required to respond Accordingly, your comments will not be United Kingdom to file the FR 2502q; to, an information collection that has edited to remove any identifying or and (5) conforming the names of several been extended, revised, or implemented contact information. Public comments countries and one region to the country on or after October 1, 1995, unless it may also be viewed electronically or in list compiled by the U.S. Treasury. displays a currently valid OMB control paper in Room MP–500 of the Board’s 2. Report title: Consolidated Report of number. Martin Building (20th and C Streets, Condition and Income for Edge and Request for comment on information NW.) between 9 a.m. and 5 p.m. on Agreement Corporations weekdays. Agency form number: FR 2886b collection proposals OMB control number: 7100–0086 The following information FOR FURTHER INFORMATION CONTACT: A Frequency: Quarterly collections, which are being handled copy of the proposed form and Reporters: Edge and agreement under this delegated authority, have instructions, the Paperwork Reduction corporations received initial Board approval and are Act Submission (OMB 83–I), supporting Annual reporting hours: 3,055 hereby published for comment. At the statement, and other documents that Estimated average hours per response: end of the comment period, the will be placed into OMB’s public docket 14.7 banking corporations, 8.5 proposed information collections, along files once approved may be requested investment corporations with an analysis of comments and from the agency clearance officer, whose Number of respondents: 19 banking recommendations received, will be name appears below. corporations, 57 investment submitted to the Board for final Michelle Long, Federal Reserve Board corporations approval under OMB delegated Clearance Officer (202/452–3829), General description of report: This authority. Comments are invited on the Division of Research and Statistics, information collection is mandatory (12 following: Board of Governors of the Federal U.S.C. §§ 602 and 625). For Edge a. Whether the proposed collection of Reserve System, Washington, DC 20551. corporations engaged in banking, information is necessary for the proper Telecommunications Device for the Deaf information collection on schedules performance of the Federal Reserve’s (TDD) users may contact (202/263– RC–M and RC–V are held confidential functions; including whether the 4869), Board of Governors of the Federal pursuant to section (b)(4) of the information has practical utility; Reserve System, Washington, DC 20551. Freedom of Information Act (5 U.S.C. b. The accuracy of the Federal 552(b)(4)). For investment Edge Reserve’s estimate of the burden of the Proposal to approve under OMB corporations, only information collected proposed information collection, delegated authority the extension for on schedule RC–M are given including the validity of the three years, with revision, of the confidential treatement pursuant to methodology and assumptions used; following reports: section (b)(4) of the Freedom of c. Ways to enhance the quality, 1. Report title: Quarterly Report of Information Act (5 U.S.C. 552(b)(4)). utility, and clarity of the information to Assets and Liabilities of Large Foreign Abstract: This reporting form be collected; and Offices of U.S. Banks comprises a balance sheet, income d. Ways to minimize the burden of Agency form number: FR 2502q statement, two schedules reconciling information collection on respondents, OMB control number: 7100–0079 changes in capital and reserve accounts, including through the use of automated Frequency: Quarterly and ten supporting schedules, and it collection techniques or other forms of Reporters: Large foreign branches and parallels the commercial bank information technology. banking subsidiaries of U.S. depository Consolidated Reports of Condition and DATES: Comments must be submitted on institutions Income (Call Report)(FFIEC 031; OMB or before March 27, 2006. Annual reporting hours: 826 hours No. 7100–0036). The Federal Reserve ADDRESSES: You may submit comments, Estimated average hours per response: uses the data collected on the FR 2886b identified by FR 2502q, FR Y–8, FR 3.5 hours to supervise Edge corporations, identify 2886b, FR 2050, or FR 2415 by any of Number of respondents: 59 present and potential problems, and the following methods: General description of report: This monitor and develop a better Agency Web Site: http:// information collection is required (12 understanding of activities within the www.federalreserve.gov. Follow the U.S.C. §§ 248(a) (2), 353 et seq., 461, industry.
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Current action: The Federal Reserve Estimated average hours per response: Abstract: This voluntary report proposes to delete three items related to 1.0 hour collects one data item, repurchase bankers acceptances, consistent with Number of respondents: 36 agreements (RPs), in denominations of proposed changes to the Call Report and General description of report: This $100,000 or more, in immediately– to make minor clarifications to the information collection is voluntary (12 available funds, on U.S. government and reporting form and instructions. U.S.C. §§ 248(a)(2), 353 et seq., 461, federal agency securities, transacted 602, and 625). Individual respondent’s with specified holders. Depository Proposal to approve under OMB data are confidential under section institutions file the FR 2415 report delegated authority the extension for (b)(4) of the Freedom of Information Act weekly, quarterly or annually three years, without revision, of the (5 U.S.C. 552(b)(4)). depending on the volume of their RPs. following report: Abstract: The report collects data on In general, the larger the respondent’s 1. Report title: Bank Holding Eurodollar deposits payable to nonbank level of RPs, the more frequent is its Company Report of Insured Depository U.S. addressees from foreign branches reporting. The weekly panel reports Institutions’ Section 23A Transactions and subsidiaries of U.S. commercial daily data once each week; the quarterly with Affiliates banks and Edge and agreement panel files daily data for the four one– Agency form number: FR Y–8 corporations. The data are used for the week reporting periods that contain OMB control number: 7100–0126 construction of the Eurodollar quarter–end dates; the annual panel Frequency: Quarterly component of the monetary aggregates reports daily data only for the week Reporters: All top–tier bank holding and for analysis of banks’ liability encompassing June 30 each year. The companies (BHCs), including financial management practices. primary purpose of the data is for holding companies (FHCs), and foreign Current Actions: The Board of construction of the RP component of the banking organizations (FBOs) that Governors of the Federal Reserve M3 monetary aggregate and for analysis directly own U.S. subsidiary banks. System announced on November 10, of depository institutions’ funding Annual reporting hours: 53,419 hours 2005, that it would cease publication of practices. Estimated average hours per response: the M3 monetary aggregate on March 23, Current Actions: The Board of Institutions with covered transactions, 2006. M3 does not appear to contain any Governors of the Federal Reserve 7.8 hours; institutions without covered additional information about economic System announced on November 10, transactions, 1 hour activity that is not already embodied in 2005, that it would cease publication of Number of respondents: 6,310 M2. Moreover, the role of M3 in the the M3 monetary aggregate on March 23, General description of report: This monetary policy process has greatly 2006. M3 does not appear to contain any information collection is mandatory diminished over time. The costs to the additional information about economic (section 5(c)) of the Bank Holding Federal Reserve and the private sector of activity that is not already embodied in Company Act (12 U.S.C. 1844(c)) and collecting data and publishing M3 now M2. Moreover, the role of M3 in the section 225.5(b) of Regulation Y (12 CFR outweigh the benefits. The monetary policy process has greatly 225.5(b)) and is given confidential discontinuation of this report will diminished over time. The costs to the treatment (5 U.S.C 552(b)(4) and (8)). reduce private sector burden by 1,872 Federal Reserve and the private sector of Abstract: This reporting form collects hours per year. collecting data and publishing M3 now information on transactions between an 2. Report title: Report of Repurchase outweigh the benefits. The insured depository institution and its Agreements (RPs) on U.S. Government discontinuation of this report will affiliates that are subject to section 23A and Federal Agency Securities with reduce private sector burden by 2,615 of the Federal Reserve Act. The primary Specified Holders hours per year. purpose of the data is to enhance the Agency form number: FR 2415 Board of Governors of the Federal Reserve Federal Reserve’s ability to monitor OMB Control number: 7100–0074 System, January 19, 2006. bank exposures to affiliates and to Effective Date: Weekly reporters will Jennifer J. Johnson, ensure banks’ compliance with section submit their final FR 2415 for the report Secretary of the Board. 23A of the Federal Reserve Act. Section week ending March 6, 2006. Quarterly 23A of the Federal Reserve Act is one reporters will submit their final data for [FR Doc. E6–804 Filed 1–23–06; 8:45 am] of the most important statutes on the week containing the last calendar BILLING CODE 6210–01–S limiting exposures to individual day of December 2005. Since annual institutions and protecting against the reporters submit data for the week FEDERAL RESERVE SYSTEM expansion of the federal safety net. containing June 30, they will no longer file the FR 2415. Change in Bank Control Notices; Proposal to approve under OMB Frequency: Weekly, quarterly, or delegated authority the discontinuance Acquisition of Shares of Bank or Bank annually Holding Companies of the following reports: Reporters: U.S chartered commercial 1. Report title: Weekly Report of banks, U.S branches and agencies of The notificants listed below have Eurodollar Liabilities Held by Selected foreign banks, thrift institutions, and applied under the Change in Bank U.S. Addressees at Foreign Offices of credit unions Control Act (12 U.S.C. 1817(j)) and U.S. Banks Annual reporting hours: 2,615 hours § 225.41 of the Board’s Regulation Y (12 Agency form number: FR 2050 Estimated average hours per response: CFR 225.41) to acquire a bank or bank OMB Control number: 7100–0068 30 minutes holding company. The factors that are Effective Date: Respondents will Number of respondents: 84 weekly, considered in acting on the notices are submit their final data for the reporting 128 quarterly, and 350 annually Small set forth in paragraph 7 of the Act (12 week ending March 6, 2006. businesses are not affected. U.S.C. 1817(j)(7)). Frequency: Weekly General description of report: This The notices are available for Reporters: Foreign branches and information collection is voluntary (12 immediate inspection at the Federal banking subsidiaries of U.S. depository U.S.C. 248(a)(2) and 3105(b)) and is Reserve Bank indicated. The notices institutions. given confidential treatment (5 U.S.C. also will be available for inspection at Annual reporting hours: 1,872 hours 552(b)(4)). the office of the Board of Governors.
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Interested persons may express their must be received at the Reserve Bank procedural and other information about views in writing to the Reserve Bank indicated or the offices of the Board of the meeting. indicated for that notice or to the offices Governors not later than February 17, Dated: January 20, 2006. of the Board of Governors. Comments 2006. Robert deV. Frierson, must be received not later than February A. Federal Reserve Bank of Atlanta Deputy Secretary of the Board. 8, 2006. (Andre Anderson, Vice President) 1000 A. Federal Reserve Bank of Atlanta Peachtree Street, NE., Atlanta, Georgia [FR Doc. 06–715 Filed 1–20–06; 3:13 pm] (Andre Anderson, Vice President) 1000 30303: BILLING CODE 6210–01–P Peachtree Street, NE., Atlanta, Georgia 1. Floridian Financial Group, Inc., 30303: Ormond Beach, Florida; to become a GENERAL SERVICES 1. David F. Barker, Kyle D. Barker, bank holding company by acquiring 100 ADMINISTRATION Julia K. Barker, all of Dunlap, percent of the voting shares of Floridian Tennessee, and Dorris B. Birchett, Bank, Ormond Beach, Florida (in [OMB Control No. 3090–0044] Cohutta, Georgia; to acquire voting organization). shares of Sequatchie County Bancorp, B. Federal Reserve Bank of Chicago Public Buildings Service; Information Inc., and thereby indirectly acquire (Patrick M. Wilder, Assistant Vice Collection; GSA Form 3453, voting shares of Mountain Valley Bank, President) 230 South LaSalle Street, Application/Permit for Use of Space in both of Dunlap, Tennessee. Chicago, Illinois 60690-1414: Public Buildings and Grounds Board of Governors of the Federal Reserve 1. First National Bancorp, Inc., AGENCY: Public Buildings Service, GSA. System, January 19, 2006. Kalamazoo, Michigan; to become a bank ACTION: Notice of request for comments Robert deV. Frierson, holding company by acquiring 100 regarding a renewal to an existing OMB Deputy Secretary of the Board. percent of the voting shares of First clearance. [FR Doc. E6–807 Filed 1–23–06; 8:45 am] National Bank of Michigan, Kalamazoo, BILLING CODE 6210–01–S Michigan. SUMMARY: Under the provisions of the Board of Governors of the Federal Reserve Paperwork Reduction Act of 1995 (44 System, January 19, 2006. U.S.C. Chapter 35), the General Services FEDERAL RESERVE SYSTEM Robert deV. Frierson, Administration will be submitting to the Deputy Secretary of the Board. Office of Management and Budget Formations of, Acquisitions by, and (OMB) a request to review and approve [FR Doc. E6–806 Filed 1–23–06; 8:45 am] Mergers of Bank Holding Companies a renewal of a currently approved BILLING CODE 6210–01–S The companies listed in this notice information collection requirement have applied to the Board for approval, regarding GSA Form 3453, Application/ pursuant to the Bank Holding Company FEDERAL RESERVE SYSTEM Permit for Use of Space in Public Act of 1956 (12 U.S.C. 1841 et seq.) Buildings and Grounds. The clearance (BHC Act), Regulation Y (12 CFR part Sunshine Act Meeting currently expires on May 31, 2006. Public comments are particularly 225), and all other applicable statutes invited on: Whether this collection of and regulations to become a bank AGENCY HOLDING THE MEETING: Board of information is necessary and whether it holding company and/or to acquire the Governors of the Federal Reserve will have practical utility; whether our assets or the ownership of, control of, or System. estimate of the public burden of this the power to vote shares of a bank or TIME AND DATE: 12 p.m., Monday, collection of information is accurate, bank holding company and all of the January 30, 2006. and based on valid assumptions and banks and nonbanking companies PLACE: Marriner S. Eccles Federal methodology; ways to enhance the owned by the bank holding company, Reserve Board Building, 20th and C quality, utility, and clarity of the including the companies listed below. Streets, NW., Washington, DC 20551. information to be collected. The applications listed below, as well STATUS: Closed. as other related filings required by the DATES: Submit comments on or before: MATTERS TO BE CONSIDERED: Board, are available for immediate March 27, 2006. 1. Personnel actions (appointments, inspection at the Federal Reserve Bank FOR FURTHER INFORMATION CONTACT: promotions, assignments, indicated. The application also will be Frank Giblin, Public Buildings Service, reassignments, and salary actions) available for inspection at the offices of at telephone (202) 501–1856, or via e- involving individual Federal Reserve the Board of Governors. Interested mail to [email protected]. System employees. persons may express their views in ADDRESSES: Submit comments regarding 2. Any items carried forward from a writing on the standards enumerated in this burden estimate or any other aspect previously announced meeting. the BHC Act (12 U.S.C. 1842(c)). If the of this collection of information, proposal also involves the acquisition of FOR FURTHER INFORMATION CONTACT: including suggestions for reducing this a nonbanking company, the review also Michelle A. Smith, Director, Office of burden, to the Regulatory Secretariat includes whether the acquisition of the Board Members; 202–452–2955. (VIR), General Services Administration, nonbanking company complies with the SUPPLEMENTARY INFORMATION: You may Room 4035, 1800 F Street, NW., standards in section 4 of the BHC Act call 202–452–3206 beginning at Washington, DC 20405. Please cite OMB (12 U.S.C. 1843). Unless otherwise approximately 5 p.m. two business days Control No. 3090–0044, GSA Form noted, nonbanking activities will be before the meeting for a recorded 3453, Application/Permit for Use of conducted throughout the United States. announcement of bank and bank Space in Public Buildings and Grounds, Additional information on all bank holding company applications in all correspondence. holding companies may be obtained scheduled for the meeting; or you may SUPPLEMENTARY INFORMATION: from the National Information Center contact the Board’s Web site at http:// Web site at http://www.ffiec.gov/nic/. www.federalreserve.gov for an electronic A. Purpose Unless otherwise noted, comments announcement that not only lists The general public uses GSA Form regarding each of these applications applications, but also indicates 3453, Application/Permit for Use of
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Space in Public Buildings and Grounds, or reduced-fee health care services at to prepare its estimates of the number of to request the use of public space in certain hospitals and other facilities for individuals and families in poverty. Federal buildings and on Federal persons meeting eligibility criteria As required by law, this update is grounds for cultural, educational, or involving the poverty guidelines), accomplished by increasing the latest recreational activities. A copy, sample, contact the Office of the Director, published Census Bureau poverty or description of any material or item Division of Facilities Compliance and thresholds by the relevant percentage proposed for distribution or display Recovery, Health Resources and change in the Consumer Price Index for must also accompany this request. Services Administration, HHS, Room All Urban Consumers (CPI–U). The B. Annual Reporting Burden 10–105, Parklawn Building, 5600 guidelines in this 2006 notice reflect the Fishers Lane, Rockville, Maryland 3.4 percent price increase between Respondents: 8,000. 20857. To speak to a person, call (301) Responses Per Respondent: 1. calendar years 2004 and 2005. After this 443–5656. To receive a Hill-Burton inflation adjustment, the guidelines are Hours Per Response: 0.05. information package, call 1–800–638– Total Burden Hours: 400. rounded and adjusted to standardize the Obtaining Copies of Proposals: 0742 (for callers outside Maryland) or differences between family sizes. The Requesters may obtain a copy of the 1–800–492–0359 (for callers in same calculation procedure was used information collection documents from Maryland). You may also visit http:// this year as in previous years. (Note that the General Services Administration, www.hrsa.gov/osp/dfcr/. The Division of these 2006 guidelines are roughly equal Regulatory Secretariat (VIR), 1800 F Facilities Compliance and Recovery to the poverty thresholds for calendar Street, NW., Room 4035, Washington, notes that as set by 42 CFR 124.505(b), year 2005 which the Census Bureau DC 20405, telephone (202) 208–7312. the effective date of this update of the expects to publish in final form in Please cite OMB Control No. 3090–0044, poverty guidelines for facilities August 2006.) GSA Form 3453, Application/Permit for obligated under the Hill-Burton Use of Space in Public Buildings and Uncompensated Services Program is 2006 POVERTY GUIDELINES FOR THE Grounds, in all correspondence. sixty days from the date of this 48 CONTIGUOUS STATES AND THE publication. DISTRICT OF COLUMBIA Dated: January 13, 2006. For information about the percentage Michael W. Carleton, multiple of the poverty guidelines to be Poverty Chief Information Officer. used on immigration forms such as Persons in family unit guideline [FR Doc. 06–671 Filed 1–23–06; 8:45 am] USCIS Form I–864, Affidavit of Support, BILLING CODE 6820–23–S contact U.S. Citizenship and 1 ...... $9,800 Immigration Services at 1–800–375– 2 ...... 13,200 5283 or visit http://uscis.gov/graphics/ 3 ...... 16,600 DEPARTMENT OF HEALTH AND howdoi/affsupp.htm. 4 ...... 20,000 HUMAN SERVICES For information about the number of 5 ...... 23,400 6 ...... 26,800 people in poverty or about the Census Office of the Secretary 7 ...... 30,200 Bureau poverty thresholds, visit the 8 ...... 33,600 Poverty section of the Census Bureau’s Annual Update of the HHS Poverty Web site at http://www.census.gov/ For family units with more than 8 persons, Guidelines hhes/www/poverty/poverty.html or add $3,400 for each additional person. AGENCY: Department of Health and contact the Housing and Household Human Services. Economic Statistics Information Staff at 2006 POVERTY GUIDELINES FOR ALASKA ACTION: Notice. (301) 763–3242. For general questions about the SUMMARY: This notice provides an poverty guidelines themselves, contact Poverty Persons in family unit guideline update of the HHS poverty guidelines to Gordon Fisher, Office of the Assistant account for last calendar year’s increase Secretary for Planning and Evaluation, 1 ...... $12,250 in prices as measured by the Consumer Room 404E, Humphrey Building, 2 ...... 16,500 Price Index. Department of Health and Human 3 ...... 20,750 DATES: Effective Date: Date of Services, Washington, DC 20201— 4 ...... 25,000 publication, unless an office telephone: (202) 690–7507—or visit 5 ...... 29,250 administering a program using the http://aspe.hhs.gov/poverty/. 6 ...... 33,500 7 ...... 37,750 guidelines specifies a different effective SUPPLEMENTARY INFORMATION: date for that particular program. 8 ...... 42,000 Background ADDRESSES: Office of the Assistant For family units with more than 8 persons, Secretary for Planning and Evaluation, Section 673(2) of the Omnibus Budget add $4,250 for each additional person. Room 404E, Humphrey Building, Reconciliation Act (OBRA) of 1981 (42 Department of Health and Human U.S.C. 9902(2)) requires the Secretary of 2006 POVERTY GUIDELINES FOR Services (HHS), Washington, DC 20201. the Department of Health and Human HAWAII FOR FURTHER INFORMATION CONTACT: For Services to update, at least annually, the information about how the guidelines poverty guidelines, which shall be used Persons in family unit Poverty are used or how income is defined in a as an eligibility criterion for the guideline particular program, contact the Federal, Community Services Block Grant 1 ...... $11,270 state, or local office that is responsible program. The poverty guidelines also 2 ...... 15,180 for that program. Contact information are used as an eligibility criterion by a 3 ...... 19,090 for two frequently requested programs is number of other Federal programs. The 4 ...... 23,000 given below: poverty guidelines issued here are a 5 ...... 26,910 For information about the Hill-Burton simplified version of the poverty 6 ...... 30,820 Uncompensated Services Program (free thresholds that the Census Bureau uses 7 ...... 34,730
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2006 POVERTY GUIDELINES FOR these terms, traceable to the different potential to change prior HAWAII—Continued laws and regulations that govern the recommendations including inactive various programs. Therefore, questions ones; and, potential for greatest Task about how a particular program applies Force impact (e.g., clinical controversy, Persons in family unit Poverty guideline the poverty guidelines (e.g., Is income practice does not reflect evidence, before or after taxes? Should a particular inappropriate timing in delivery of 8 ...... 38,640 type of income be counted? Should a services). The USPSTF will prioritize For family units with more than 8 persons, particular person be counted in the topics for which there is a performance add $3,910 for each additional person. family or household unit?) should be gap and the potential to significantly Separate poverty guideline figures for directed to the organization that improve clinical practice. Individuals Alaska and Hawaii reflect Office of administers the program. and organizations may nominate new Economic Opportunity administrative Dated: January 18, 2006. topics or topics previously reviewed by practice beginning in the 1966–1970 Michael O. Leavitt, the USPSTF. Basic Topic Nomination period. (Note that the Census Bureau Secretary of Health and Human Services. poverty thresholds—the version of the Requirements: Nominations must be no [FR Doc. 06–624 Filed 1–20–06; 8:45 am] more than 500 words in length and must poverty measure used for statistical BILLING CODE 4151–05–P purposes—have never had separate include the following information. figures for Alaska and Hawaii). The Nominations may include an appendix that contains references and supporting poverty guidelines are not defined for DEPARTMENT OF HEALTH AND documents (not included in word Puerto Rico or other outlying HUMAN SERVICES jurisdictions. In cases in which a count). Federal program using the poverty Agency for Healthcare Research and 1. Name of topic. guidelines serves any of those Quality 2. Rationale for consideration by the jurisdictions, the Federal office that USPSTF, to include: administers the program is responsible Solicitation for Nominations for New a. Primary or secondary prevention for deciding whether to use the Primary and Secondary Health Topics topic (screening, counseling or contiguous-states-and-DC guidelines for To Be Considered for Review by the preventive medication). b. Primary care relevance (aplicable those jurisdictions or to follow some United States Preventive Services Task clinical preventive service must be other procedure. Force Due to confusing legislative language initiated in the primary care setting AGENCY: Agency for Healthcare Research which can be defined as family practice, dating back to 1972, the poverty and Quality (AHRQ), DHHS. guidelines have sometimes been internal medicine, pediatrics or ACTION: Solicit for new topic mistakenly referred to as the ‘‘OMB’’ obstetrics/gynecology and provided by a nominations. (Office of Management and Budget) primary care provider). c. Description of public health poverty guidelines or poverty line. In SUMMARY: The Agency for Healthcare importance (burden of disease/suffering, fact, OMB has never issued the Research and Quality (AHRQ) invites potential of preventive service to reduce guidelines; the guidelines are issued individuals and organizations to burden, including effective each year by the Department of Health nominate primary and secondary interventions). Citations and supporting and Human Services. The poverty prevention topics pertaining to clinical documents are recommended. guidelines may be formally referenced preventive services that they would like d. Summary of new evidence, if any, as ‘‘the poverty guidelines updated the United States Preventive Services that has potential to affect the Task periodically in the Federal Register by Task Force (USPSTF) to consider for Force’s recommendation on a the U.S. Department of Health and review. A list of topics that have been previously reviewed topic. Please refer Human Services under the authority of recently reviewed or are currently under to http://preventiveservices.ahrg.gov for 42 U.S.C. 9902(2).’’ review by the USPSTF is listed below in USPSTF recommendations. Citations Some programs use a percentage the supplementary information section. and supporting documents are multiple of the guidelines (for example, The USPSTF is an independent panel recommended. 125 percent or 185 percent of the of experts that makes evidence-based e. Description of potential impact of guidelines), as noted in relevant recommendations regarding the USPSTF’s review of the topic, i.e., authorizing legislation or program provision of clinical preventive services. change in clinical practice, research regulations. Non-Federal organizations Clinical preventive services include focus, etc. that use the poverty guidelines under screening, counseling and preventive DATES: their own authority in non-Federally- medications. The USPSTF makes Topic nominations should be funded activities can choose to use a recommendations about preventive submitted by February 23, 2006, in percentage multiple of the guidelines services for asymptomatic people— order to be considered for 2006–2008. such as 125 percent or 185 percent. people without recognized signs or AHRQ will not reply to submissions in The poverty guidelines do not make a symptoms of the specific conditions response to the request for nominations, distinction between farm and non-farm targeted by the preventive service. but will consider all topic nominations families or between aged and non-aged Topics can be nominated by during the selection process. If a topic units. (Only the Census Bureau poverty individuals, organizations, evidence- is selected for review by the USPSTF, thresholds have separate figures for aged based practice centers (EPC) and the nominator will be notified by and non-aged one-person and two- USPSTF members. The USPSTF will AHRQ. person units). consider nominations and prioritize ADDRESSES: Please submit nominations Note that this notice does not provide topics for review based on the following to: Therese Miller, DrPH, ATTN: definitions of such terms as ‘‘income’’ or set of criteria: Public health importance USPSTF Topic Nominations, Center for ‘‘family.’’ This is because there is (burden of suffering, potential of Primary Care, Prevention & Clinical considerable variation in how different preventive service to reduce the Partnerships, Agency for Healthcare programs that use the guidelines define burden); new evidence that has the Research and Quality, 540 Gaither Road,
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Rockville, MD 20850, Fax: vision and hearing disorders). Selection Type of 301.427.1597, E-mail: [email protected]. of suggested topics will be made on the preventive service FOR FURTHER INFORMATION CONTACT: basis of qualifications of nominations as outlined above (see basic topic Therese Miller at [email protected] or Low Back Pain ...... C Gloria Washington at nomination requirements) and the Lung Cancer ...... S [email protected]. current expertise of the USPSTF. Obesity in Children ...... S Arrangement For Public Inspection: U.S. Preventive Services Task Force Oral Cancer ...... S All nominations will be available for Ovarian Cancer ...... S public inspections by appointment at Type of Pancreatic Cancer ...... S the Center for Primary Care, Prevention preventive Peripheral Arterial/Vascular S & Clinical Partnerships, 301.427.1500, service Disease. Physical Activity ...... C weekdays between 10 a.m. and 5 p.m. Topics Currently Under Review: Postmenopausal Hormone PM (eastern time). Additional Risk Factors for In- S Prophylaxis (HRT). SUPPLEMENTARY INFORMATION: termediate CHD Risk. Prostate Cancer ...... S Aspirin Primary Prevention of PM Rh Incompatibility ...... S Background CHD. Suicide Risk ...... S Under Title IX of the Public Health Aspirin Prophylaxis in Preg- PM Syphilis ...... S Service Act, AHRQ is charged with nancy. Testicular Cancer ...... S enhancing the quality, appropriateness Aspirin/NSAIDs to prevent PM Thyroid Disease ...... S Colorectal Cancer. Visual Impairment in Children S and effectiveness of health care services Bacterial Vaginosis in Preg- S and access to such services. AHRQ nancy. Type of Preventive Service: S = Screening; accomplishes these goals through Breast Cancer ...... S/PM C = Counseling; PM = Preventive Medications. scientific research and promotion of Carotid Artery Stenosis ...... S Dated: January 17, 2006. improvements in clinical practice, Chlamydial Infection ...... S including prevention of diseases and Colorectal Cancer ...... S Carolyn M. Clancy, other health conditions and Depression in Adults ...... S Director. improvements in the organization, Drug Misuse ...... S [FR Doc. 06–612 Filed 1–23–06; 8:45 am] Dyslipidemia in Adults and S BILLING CODE 4160–90–M financing and delivery of health care Children. services (42 U.S.C. 299–299c–7 as Gestational Diabetes Mellitus S amended by Pub. L. 106–129 (1999)). Hearing Impairment in Elderly S The United States Preventive Services Hearing Impairment Newborn S DEPARTMENT OF HEALTH AND Task Force (USPSTF) is an independent Hemochromatosis ...... S HUMAN SERVICES expert panel, first established in 1984 Hip Dysplasia ...... S Agency for Healthcare Research and under the auspices of the U.S. Public HIV & Other Sexually Trans- C Quality Health Service. Currently, under mitted Diseases. Iron Deficiency Anemia, in- S AHRQ’s authorizing legislation noted cluding iron prophylaxis. Notice of Meetings above, the Director of AHRQ is Lead Levels in Childhood & S responsible for convening the USPSTF Pregnancy. In accordance with section 10(d) of to be composed of individuals with Motor Vehicle Occupant Inju- C the Federal Advisory Committee Act as appropriate expertise. The mission of ries. amended (5 U.S.C., Appendix 2), the the Task Force is to rigorously evaluate Obesity in Adults ...... S/C Agency for Healthcare Research and the effectiveness of critical preventive Osteoporosis to prevent Frac- S Quality (AHRQ) announces meetings of services and to formulate tures. scientific peer review groups. The recommendations for primary care Skin Cancer ...... S/C Speech & Language Delay ..... S subcommittees listed below are part of clinicians regarding the appropriate Thyroid Cancer ...... S the Agency’s Health Services Research provision of preventive services. The Topics Recently Reviewed: Initial Review Group Committee. USPSTF transitioned to a standing Task Abdominal Aortic Aneurysm ... S The subcommittee meetings will be Force in 2001. Current Task Force Adolescent Idiopathic Scoliosis S closed to the public in accordance with recommendations and associated Alcohol Misuse ...... C the Federal Advisory Committee Act, evidence reviews are available at Bladder Cancer ...... S section 10(d) of 5 U.S.C., Appendix 2 http://www.preventiveservices.ahrq.gov. BRCA 1 & 2 ...... S and 5 U.S.C. 552b(c)(6). Grant Breastfeeding ...... C Topic Nomination Solicitation Cervical Cancer ...... S applications are to be reviewed and Coronary Heart Disease S discussed at these meetings. These The purpose of this solicitation for discussions are likely to involve new topics by AHRQ and the USPSTF screening by EKG, ETT, EBCT. information concerning individuals is to create a balanced portfolio of Dementia ...... S associated with the applications, relevant topics for the current Task Dental Caries in Preschool S including assessments of their personal Force library. The library is based on Children. qualifications to conduct their proposed populations, types of services Diabetes Mellitus Type 2 ...... S projects. This information is exempt (screening, counseling, preventive Family Violence ...... S Genital Herpes Simplex ...... S from mandatory disclosure under the medications), and disease types (cancer; above-cited statutes. heart and vascular disease; injury and Glaucoma ...... S violence-related disorders; infectious Gonorrhea ...... S 1. Name of Subcommittee: Health Care Hepatitis B Virus Infection ...... S Technology and Decision Sciences. diseases; mental disorders and Hepatitis C Virus Infection in S substance abuse; metabolic, nutritional Adults. Date: February 2, 2006 (Open from 8 and endocrine diseases; musculoskeletal Healthy Diet ...... C a.m. to 8:15 a.m. on February 2 and conditions; obstetric and gynecological HIV Infection ...... S closed for remainder of the conditions; pediatric disorders; and, Hypertension ...... S meeting).
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2. Name of Subcommittee: Health Budget (OMB) in compliance with the burden for the Application for Research Dissemination and Paperwork Reduction Act (44 U.S.C. Registration is 2,191 hours. Implementation. Chapter 35). To request a copy of these Entities may amend their registration Date: February 16, 2006 (Open from 8 requests, call the CDC Reports Clearance (42 CFR, 73.7(h)(1)) if any changes occur a.m. to 8:15 a.m. on February 16 Officer at (404) 639–4766 or send an e- in the information submitted to CDC. To and closed for remainder of the mail to [email protected]. Send written apply for an amendment to a certificate meeting). comments to CDC Desk Officer, Office of of registration, an entity must obtain the 3. Name of Subcommittee: Health Care Management and Budget, Washington, relevant portion of the application Quality and Effectiveness Research. DC or by fax to (202) 395–6974. Written package and submit the information Date: February 23, 2006 (Open from 8 comments should be received within 30 requested in the package to CDC. a.m. to 8:15 a.m. on February 23 days of this notice. Estimated time to amend a registration package is 1 hour. and closed for remainder of the Proposed Project meeting). The Request to Transfer Select Agent 4. Name of Subcommittee: Health Possession, Use, and Transfer of or Toxin form (42 CFR 73.16) is used by Research Training. Select Agents and Toxins (OMB Control entities requesting transfer of a select Date: February 27–28, 2006 (Open No. 0920–0576)—Revision—Office of agent or toxin to their facility and by the from 9 a.m. to 9:15 a.m. on February the Director (OD), Centers for Disease entity transferring the agent. CDC 27 and closed for remainder of the Control and Prevention (CDC). revised the Request to Transfer Select Agent or Toxin form by removing the meeting). Background and Brief Description requirement that entities provide 5. Name of Subcommittee: Health The Public Health Security and written notice within five business days Systems Research. Bioterrorism Preparedness and when select agents or toxins are Date: February 28, 2006 (Open from 9 Response Act of 2002 (Pub. L. 107–188) consumed or destroyed after a transfer. a.m. to 9:15 a.m. on February 28 specifies that the Secretary of Health Estimated average time to complete this and closed for remainder of the and Human Services (HHS) shall form is 1 hour, 30 minutes. meeting). provide for the establishment and The Report of Theft, Loss, or Release All the meetings above will take place enforcement of standards and of Select Agent and Toxin form (42 CFR at: Agency for Healthcare Research and procedures governing the possession, 73.19(a)(b)) must be completed by Quality, John Eisenberg Conference use, and transfer of select agents and entities whenever there is theft, loss, or Center, 540 Gaither Road, Rockville, toxins that have the potential to pose a release of a select agent or toxin. Maryland 20850. severe threat to public health and safety. Estimated average time to complete this Contact Person: Anyone wishing to The Act specifies that entities that form is 1 hour. obtain a roster of members, agenda or possess, use, and transfer these select The Report of Identification of Select minutes of the nonconfidential portions agents register with the HHS Secretary. Agent or Toxin form 42 CFR 73.5(a)(b) of the meetings should contact Mrs. The HHS Secretary has designated CDC and 73.6(a)(b)) is used by clinical and Bonnie Campbell, Committee as the agency responsible for collecting diagnostic laboratories to notify CDC Management Officer, Office of this information. that select agents or toxins identified as Extramural Research, Education and CDC is requesting continued OMB the result of diagnostic or proficiency Priority Populations, AHRQ, 540 approval to collect this information testing have been disposed of in a Gaither Road, Suite 2000, Rockville, through the use of five separate forms. proper manner. In addition, the form is Maryland 20850, Telephone (301) 427– These forms are: (1) Application for used by Federal law enforcement 1554. Registration, (2) Request to Transfer agencies to report the seizure and final Agenda items for these meetings are Select Agent or Toxin, (3) Report of disposition of select agents and toxins. subject to change as priorities dictate. Theft, Loss, or Release of Select Agent Estimated average time to complete this This notice is being published less and Toxin, (4) Report of Identification of form is 1 hour. than 15 days prior to the February 2 Select Agent or Toxin, and (5) Request The Request for Exemption form (42 meeting, due to the time constraints of for Exemption. CFR 73.5 (d)(e) and 73.6 (d)(e)) is used reviews and funding cycles. The Application for Registration (42 by entities that are using an Dated: January 13, 2006. CFR, 73.7(d)) is used by entities to investigational product that are, bear, or Carolyn M. Clancy, register with CDC. The Application for contain select agents or toxins or in Director. Registration requests facility cases of public health emergency. information; a list of select agents or [FR Doc. 06–611 Filed 1–23–06; 8:45 am] Estimated average time to complete this toxins in use, possession, or for transfer form is 1 hour. BILLING CODE 4160–90–M by the entity; characterization of the In addition to the standardized forms, select agent or toxin; and laboratory this regulation also outlines situations DEPARTMENT OF HEALTH AND information. Estimated average time to in which an entity must notify or may HUMAN SERVICES complete this form is 3 hours, 45 make a request of the HHS Secretary in minutes for an entity with one principal writing. An entity may apply to the HHS Centers for Disease Control and investigator working with one select Secretary for an expedited review of an Prevention agent or toxin. CDC estimates that individual by the Attorney General (42 entities will need an additional 45 CFR 73.10(e)). To apply for this [30Day–06–0576] minutes for each additional investigator expedited review, an entity must submit Agency Forms Undergoing Paperwork or agent. In our regulatory analysis, we a request in writing to the HHS Reduction Act Review have estimated that 70% of the 350 Secretary establishing the need for such entities have 1–3 principal investigators, action. The estimated time to gather the The Centers for Disease Control and 15% have 5 principal investigators, and information and submit this request is Prevention (CDC) publishes a list of 15% have 10 principal investigators. We 30 minutes. CDC has not developed information collection requests under have used these figures to calculate the standardized forms to use in the above review by the Office of Management and burden for this section. Estimated situations. Rather, the entity should
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provide the information as requested in average, such documentation will take 1 should include a statement of the the appropriate section of the hour. factual basis for the review. CDC regulation. As part of the training requirements of estimates the time to prepare and An entity may also apply to the HHS this regulation, the entity is required to submit such a request is 4 hours. Secretary for an exclusion of an record the identity of the individual Finally, an entity must implement a attenuated strain of a select agent or trained, the date of training, and the system to ensure that certain records toxin that does not pose a severe threat means used to verify that the employee and databases are accurate and that the to public health and safety (42 CFR understood the training (42 CFR authenticity of records may be verified 73.3(e)(1) and 73.4(e)(1)). The estimated 73.15(c)). Estimated time for this (42 CFR 73.17(b)). The time to time to gather the information and documentation is 2 hours per principal implement such a system is estimated to submit this request is 1 hour. investigator. average 4 hours. As part of the requirements of the An individual or entity may request The cost to respondents is their time Responsible Official, the Responsible administrative review of a decision to complete the forms and comply with Official is required to conduct regular denying or revoking certification of the reporting and recordkeeping inspections (at least annually) of the registration or an individual may appeal components of the Act plus a one-time laboratory where select agents or toxins a denial of access approval (42 CFR purchase of a file cabinet (estimated cost are stored. Results of these self- 73.20). This request must be made in $400) to maintain records. The total inspections must be documented (42 writing and within 30 calendar days estimated annualized burden hours are CFR 73.9(a)(5)). CDC estimates, that, on after the adverse decision. This request 7,785.
ESTIMATED ANNUALIZED BURDEN HOURS
Average CFR reference Data collection instrument Number of Responses per burden per respondents respondent response
73.7(d) ...... Registration application form ...... 350 1 3.75 73.7(d) ...... Additional investigators ...... 245 2 45/60 73.7(d) ...... Additional investigators ...... 53 4 45/60 73.7(d) ...... Additional investigators ...... 52 9 45/60 73.7(h)(1) ...... Amendment to registration application ...... 350 2 1 73.19(a)(b) ...... Report of theft, loss, or release ...... 12 1 1 73.5 & 73.6 (d–e)/ Request for exemption form/exclusion ...... 17 1 1 73.3 & 73.4 (e)(1). 73.16 ...... Request to transfer ...... 350 2 1.5 73.5 & 73.6 (a)(b) ...... Report of identification ...... 325 4 1 73.10(e) ...... Request expedited review ...... 10 1 30/60 73.9(a)(5) ...... Documentation of self-inspection ...... 350 1 1 73.15(c) ...... Documentation of training ...... 350 1 2 73.20 ...... Administrative review ...... 15 1 4 73.17 ...... Ensure secure recordkeeping system ...... 350 1 4
Dated: January 18, 2006. in Tonawanda, New York, as an FOR FURTHER INFORMATION CONTACT: Betsey Dunaway, addition to the Special Exposure Cohort Larry Elliott, Director, Office of Acting Reports Clearance Officer, Centers for (SEC) under the Energy Employees Compensation Analysis and Support, Disease Control and Prevention. Occupational Illness Compensation National Institute for Occupational [FR Doc. E6–808 Filed 1–23–06; 8:45 am] Program Act of 2000. On December 8, Safety and Health, 4676 Columbia BILLING CODE 4163–18–P 2005, as provided for under 42 U.S.C. Parkway, MS C–46, Cincinnati, OH 7384q(b), the Secretary of HHS 45226, Telephone 513–533–6800 (this is designated the following class of not a toll-free number). Information DEPARTMENT OF HEALTH AND employees as an addition to the SEC: requests can also be submitted by e-mail HUMAN SERVICES Atomic weapons employees who worked at to [email protected]. Centers for Disease Control and the Linde Ceramics Plant from October 1, Dated: January 17, 2006. Prevention 1942, through October 31, 1947, and who John Howard, were employed for a number of work days Director, National Institute for Occupational Final Effect of Designation of a Class aggregating at least 250 work days either Safety and Health, Centers for Disease Control solely under this employment or in of Employees for Addition to the and Prevention. Special Exposure Cohort combination with work days occurring [FR Doc. 06–593 Filed 1–23–06; 8:45 am] within the parameters (excluding aggregate AGENCY: Centers for Disease Control and work day requirements) established for other BILLING CODE 4163–19–M Prevention (CDC), Department of Health classes of employees included in the SEC. and Human Services (HHS). ACTION: Notice. This designation became effective on January 7, 2006, as provided for under SUMMARY: The Department of Health and 42 U.S.C. 7384l(14)(C). Hence, Human Services (HHS) gives notice beginning on January 7, 2006, members concerning the final effect of the HHS of this class of employees, defined as decision to designate a class of reported in this notice, became members employees at the Linde Ceramics Plant, of the Special Exposure Cohort.
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DEPARTMENT OF HEALTH AND services (known as the ‘‘Community approved plan. The State did not HUMAN SERVICES Alternative Funding System,’’ or CAFS respond fully to CMS’ requests for program) in SPA 05–008 and, thus, is no information concerning State payment Centers for Medicare & Medicaid longer ‘‘grandfathered’’ based on its and funding issues. Absent such Services previously approved State plan information, CMS could not determine provision. Because there is no provision whether the proposed SPA would Notice of Hearing: Reconsideration of of the State’s Medicaid plan as approved operate in compliance with all Disapproval of Ohio State Plan on or before June 30, 1989, that provides applicable requirements of section Amendments 05–07 and 05–020 coverage of habilitation services in the 1902(a) of the Act. AGENCY: Centers for Medicare & State’s current approved plan, the Finally, for Ohio SPA 05–020 alone, Medicaid Services (CMS), HHS. provisions of section 6411(g)(1)(A) of the State did not show compliance with OBRA–89, that prohibit the Secretary ACTION: Notice of hearing. section 1902(a)(4) of the Act, which from withholding, suspending, specifies that the State plan must SUMMARY: This notice announces an disallowing, or denying Federal provide for such methods of administrative hearing to be held on financial participation for habilitation administration as are found by the February 28, 2006, in Suite #500, 233 N. services, no longer apply. Secretary to be necessary for the proper Michigan Avenue, Minnesota In addition, the SPAs do not comply and efficient administration of the plan. Conference Room, Chicago, IL 60202, to with the requirements of section Pursuant to this provision, States must reconsider CMS’ decision to disapprove 1902(a)(1) of the Act that services under include in their State plans all Ohio State plan amendments 05–07 and the plan be available statewide. Under information necessary for CMS to 05–020. the SPAs, services would be covered determine whether the plan can be Closing Date: Requests to participate only for select groups of students in approved to serve as a basis for Federal in the hearing as a party must be participating schools but services would financial participation. Absent received by the presiding officer by not be available to other eligible information on the methodology used to February 8, 2006. individuals. Because not all parts of the develop the fee schedules, this State may have participating schools, FOR FURTHER INFORMATION CONTACT: requirement is not met. the SPAs violate statewideness Kathleen Scully-Hayes, Presiding For the reasons cited above, and after requirements. The restricted availability Officer, CMS, Lord Baltimore Drive, consultation with the Secretary, as of services also violates the Mail Stop LB–23–20, Baltimore, required by 42 CFR 430.15(c)(2), Ohio requirements of section 1902(a)(10)(B) Maryland 21244. Telephone: (410) 786– SPAs 05–07 and 05–020 were of the Act that services available to each 2055. disapproved. individual within a Medicaid eligibility Section 1116 of the Act and Federal SUPPLEMENTARY INFORMATION: This group must be comparable in amount, regulations at 42 CFR Part 430, establish notice announces an administrative duration, and scope (and that services Department procedures that provide an hearing to reconsider CMS’ decision to available to categorically needy groups administrative hearing for disapprove Ohio State plan cannot be less in amount, duration, and reconsideration of a disapproval of a amendments (SPAs) 05–07 and 05–020, scope than those available to the State plan or plan amendment. CMS is which were submitted on August 1, medically needy). The SPAs are not required to publish a copy of the notice 2005, and September 1, 2005, consistent with comparability to a State Medicaid agency that informs respectively. Both SPAs were requirements because the services are disapproved on October 28, 2005. Under available only to select groups of the agency of the time and place of the SPAs 05–07 and 05–020, Ohio sought to students. hearing, and the issues to be considered. implement the Medicaid School Additionally, these SPAs explicitly If we subsequently notify the agency of Program. deny the provision of Medicaid fair additional issues that will be considered The amendments were disapproved hearing requests for individuals who are at the hearing, we will also publish that because they do not comport with the denied services. This provision is at notice. requirements of section 1902(a) of the variance with section 1902(a)(3) of the Any individual or group that wants to Social Security Act (the Act) and Act and Federal regulations at 42 CFR participate in the hearing as a party implementing regulations. The specific 431.200(a) which require that a State must petition the presiding officer reasons for disapproval are identified plan ‘‘provide an opportunity for a fair within 15 days after publication of this below. hearing to any person whose claim for notice, in accordance with the Under section 1902(a)(10) of the Act, assistance is denied or not acted upon requirements contained at 42 CFR a State plan must provide for making promptly.’’ 430.76(b)(2). Any interested person or medical assistance available to eligible In addition, the State did not organization that wants to participate as individuals. ‘‘Medical assistance,’’ as demonstrate that the proposed payment amicus curiae must petition the defined in section 1905(a) of the Act, methodology would comply with the presiding officer before the hearing does not include habilitation services. statutory requirements of sections begins in accordance with the After CMS determined that habilitation 1902(a)(2), 1902(a)(30)(A), and requirements contained at 42 CFR services were not properly included 1903(a)(1) of the Act, which require that 430.76(c). If the hearing is later within the scope of the statutory the State plan assure adequate funding rescheduled, the presiding officer will category of rehabilitation services, the for the non-Federal share of notify all participants. Omnibus Budget Reconciliation Act of expenditures from State or local The notice to Ohio announcing an 1989 (OBRA–89) ‘‘grandfathered’’ sources; that State or local sources have administrative hearing to reconsider the certain States, including Ohio, to methods and procedures to assure that disapproval of its SPA reads as follows: provide habilitation services under payments are consistent with efficiency, Mr. Jim Petro, Office of the Attorney previously approved State plan economy, and quality of care; and that General, Health & Human Services provisions as part of the Medicaid Federal matching funds are only Section, 30 E. Broad Street, 26th Floor, rehabilitation benefit. However, Ohio available for actual expenditures made Columbus, OH 43215–3400. formally terminated its habilitation by States for services under the Dear Mr. Petro:
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I am responding to your request for group must be comparable in amount, I am scheduling a hearing on your reconsideration of the decision to duration, and scope (and that services request for reconsideration to be held on disapprove Ohio State plan available to categorically needy groups February 28, 2006, at Suite #500, 233 N. amendments (SPAs) 05–07 and 05–020, cannot be less in amount, duration, and Michigan Avenue, Minnesota which were submitted on August 1, scope than those available to the Conference Room, Chicago, IL 60202, to 2005, and September 1, 2005, medically needy). The SPAs are not reconsider the decision to disapprove respectively, and disapproved on consistent with comparability SPA 05–07 and 05–020. If this date is October 28, 2005. requirements because the services are not acceptable, we would be glad to set Under SPAs 05–07 and 05–020, Ohio available only to select groups of another date that is mutually agreeable was seeking to implement the Medicaid students. to the parties. The hearing will be School Program. Additionally, these SPAs explicitly governed by the procedures prescribed The amendments were disapproved deny the provision of Medicaid fair at 42 CFR Part 430. because they did not comport with the hearing requests for individuals who are I am designating Ms. Kathleen Scully- requirements of section 1902(a) of the denied services. This provision is at Hayes as the presiding officer. If these Social Security Act (the Act) and variance with section 1902(a)(3) of the arrangements present any problems, implementing regulations. The specific Act and Federal regulations at 42 CFR please contact the presiding officer at reasons for disapproval are identified 431.200(a) which require that a State (410) 786–2055. In order to facilitate any below. plan ‘‘provide an opportunity for a fair communication which may be necessary Under section 1902(a)(10) of the Act, hearing to any person whose claim for between the parties to the hearing, a State plan must provide for making assistance is denied or not acted upon please notify the presiding officer to medical assistance available to eligible promptly.’’ indicate acceptability of the hearing individuals. ‘‘Medical assistance,’’ as In addition, the State did not date that has been scheduled and defined in section 1905(a) of the Act, demonstrate that the proposed payment provide names of the individuals who does not include habilitation services. methodology would comply with the will represent the State at the hearing. After the Centers for Medicare & Sincerely, Medicaid Services (CMS) determined statutory requirements of sections Mark B. McClellan, MD., PhD. that habilitation services were not 1902(a)(2), 1902(a)(30)(A), and Section 1116 of the Social Security properly included within the scope of 1903(a)(1) of the Act, which require that Act (42 U.S.C. 1316); 42 CFR 430.18. the statutory category of rehabilitation the State plan assure adequate funding for the non-Federal share of (Catalog of Federal Domestic Assistance services, the Omnibus Budget Program No. 13.714, Medicaid Assistance Reconciliation Act of 1989 (OBRA–89) expenditures from State or local Program) ‘‘grandfathered’’ certain States, sources; that State or local sources have methods and procedures to assure that Dated: January 13, 2006. including Ohio, to provide habilitation Mark B. McClellan, services under previously approved payments are consistent with efficiency, economy, and quality of care; and that Administrator, Centers for Medicare & State plan provisions as part of the Medicaid Services. Medicaid rehabilitation benefit. Federal matching funds are only [FR Doc. E6–788 Filed 1–23–06; 8:45 am] However, Ohio formally terminated its available for actual expenditures made habilitation services (known as the by States for services under the BILLING CODE 4120–01–P ‘‘Community Alternative Funding approved plan. The State did not System,’’ or CAFS program) in SPA 05– respond fully to CMS’ requests for information concerning State payment DEPARTMENT OF HEALTH AND 008 and, thus, is no longer HUMAN SERVICES ‘‘grandfathered’’ based on its previously and funding issues. Absent such approved State plan provision. Because information, CMS could not determine Food and Drug Administration there is no provision of the State’s whether the proposed SPA would Medicaid plan as approved on or before operate in compliance with all [Docket No. 2005N–0396] applicable requirements of section June 30, 1989, that provides coverage of Agency Information Collection habilitation services in the State’s 1902(a) of the Act. Finally, for Ohio SPA 05–020 alone, Activities; Submission for Office of current approved plan, the provisions of Management and Budget Review; section 6411(g)(1)(A) of OBRA–89, that the State did not show compliance with section 1902(a)(4) of the Act, which Comment Request; Guidance for prohibit the Secretary from withholding, Industry on Formal Dispute suspending, disallowing, or denying specifies that the State plan must provide for such methods of Resolution; Appeals Above the Federal financial participation for Division Level habilitation services, no longer apply. administration as are found by the In addition, the SPAs do not comply Secretary to be necessary for the proper AGENCY: Food and Drug Administration, with the requirements of section and efficient administration of the plan. HHS. 1902(a)(1) of the Act that services under Pursuant to this provision, States must ACTION: Notice. the plan be available statewide. Under include in their State plans all the SPAs, services would be covered information necessary for CMS to SUMMARY: The Food and Drug only for select groups of students in determine whether the plan can be Administration (FDA) is announcing participating schools but services would approved to serve as a basis for Federal that a proposed collection of not be available to other eligible financial participation. Absent information has been submitted to the individuals. Because not all parts of the information on the methodology used to Office of Management and Budget State may have participating schools, develop the fee schedules, this (OMB) for review and clearance under the SPAs violate statewideness requirement is not met. the Paperwork Reduction Act of 1995. requirements. The restricted availability For the reasons cited above, and after DATES: Fax written comments on the of services also violates the consultation with the Secretary, as collection of information by February requirements of section 1902(a)(10)(B) required by 42 CFR 430.15(c)(2), Ohio 23, 2006. of the Act that services available to each SPAs 05–07 and 05–020 were ADDRESSES: OMB is still experiencing individual within a Medicaid eligibility disapproved. significant delays in the regular mail,
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including first class and express mail, (OMB Control No. 0910–0001), and part following information should be and messenger deliveries are not being 601 (21 CFR part 601) (OMB Control No. submitted to the appropriate center with accepted. To ensure that comments on 0910–0338), which specify the each request for dispute resolution so the information collection are received, information that manufacturers must that the center may quickly and OMB recommends that written submit so that FDA may properly efficiently respond to the request: (1) A comments be faxed to the Office of evaluate the safety and effectiveness of brief but comprehensive statement of Information and Regulatory Affairs, drugs and biological products. This each issue to be resolved, including a OMB, Attn: Fumie Yokota, Desk Officer information is usually submitted as part description of the issue, the nature of for FDA, FAX: 202–395–6974. of an IND, NDA, or biologics license the issue (i.e., scientific, procedural, or FOR FURTHER INFORMATION CONTACT: application (BLA), or as a supplement to both), possible solutions based on Karen Nelson, Office of Management an approved application. While FDA information in the administrative file, Programs (HFA–250), Food and Drug already possesses in the administrative whether informal dispute resolution Administration, 5600 Fishers Lane, file the information that would form the was sought prior to the formal appeal, Rockville, MD 20857, 301–827–1482. basis of a decision on a matter in whether advisory committee review is dispute resolution, the submission of sought, and the expected outcome; (2) a SUPPLEMENTARY INFORMATION: In particular information regarding the statement identifying the review compliance with 44 U.S.C. 3507, FDA request itself and the data and division/office that issued the original has submitted the following proposed information relied on by the requestor decision on the matter and, if collection of information to OMB for in the appeal would facilitate timely applicable, the last agency official that review and clearance. resolution of the dispute. The guidance attempted to formally resolve the Guidance for Industry on Formal describes the following collection of matter; (3) a list of documents in the Dispute Resolution; Appeals Above the information not expressly specified administrative file, or additional copies Division Level—(OMB Control Number under existing regulations: The of such documents, that are deemed 0910–0430)—Extension submission of the request for dispute necessary for resolution of the issue(s); resolution as an amendment to the and (4) a statement that the previous This information collection approval application for the underlying product, supervisory level has already had the request is for an FDA guidance on the including the submission of supporting opportunity to review all of the material process for formally resolving scientific information with the request for dispute relied on for dispute resolution. The and procedural disputes in the Center resolution. information that the agency suggests for Drug Evaluation and Research Agency regulations (§§ 312.23(d), submitting with a formal request for (CDER) and the Center for Biologics 314.50, 314.94, and 601.2) state that dispute resolution consists of: (1) Evaluation and Research (CBER) that information provided to the agency as Statements describing the issue from the cannot be resolved at the division level. part of an IND, NDA, ANDA, or BLA is perspective of the person with a The guidance describes procedures for to be submitted in triplicate and with an dispute, (2) brief statements describing formally appealing such disputes to the appropriate cover form. Form FDA 1571 the history of the matter, and (3) the office or center level and for submitting must accompany submissions under documents previously submitted to FDA information to assist center officials in INDs and Form FDA 356h must under an OMB approved collection of resolving the issue(s) presented. The accompany submissions under NDAs, information. guidance provides information on how ANDAs, and BLAs. Both forms have Based on FDA’s experience with the agency will interpret and apply valid OMB control numbers as follows: dispute resolution, the agency expects provisions of the existing regulations FDA Form 1571, OMB Control No. that most persons seeking formal regarding internal agency review of 0910–0014, expires January 31, 2006; dispute resolution will have gathered decisions (§ 10.75 (21 CFR 10.75)) and and FDA Form 356h, OMB Control No. the materials listed previously when dispute resolution during the 0910–0338, expires August 31, 2005. identifying the existence of a dispute investigational new drug (IND) process In the guidance document, CDER and with the agency. Consequently, FDA (21 CFR 312.48) and the new drug CBER ask that a request for formal anticipates that the collection of application/abbreviated new drug dispute resolution be submitted as an information attributed solely to the application (NDA/ANDA) process (21 amendment to the application for the guidance will be minimal. CFR 314.103). In addition, the guidance underlying product and that it be Description of Respondents: A provides information on how the agency submitted to the agency in triplicate sponsor, applicant, or manufacturer of a will interpret and apply the specific with the appropriate form attached, drug or biological product regulated by Prescription Drug User Fee Act either Form FDA 1571 or Form FDA the agency under the Federal Food, (PDUFA) goals for major dispute 356h. The agency recommends that a Drug, and Cosmetic Act (21 U.S.C. 355) resolution associated with the request be submitted as an amendment or section 351 of the Public Health development and review of PDUFA in this manner for two reasons: To Service Act who requests formal products. ensure that each request is kept in the resolution of a scientific or procedural Existing regulations, which appear administrative file with the entire dispute. primarily in parts 10, 312, and 314 (21 underlying application and to ensure Burden Estimate: Provided in table 1 CFR parts 10, 312, and 314), establish that pertinent information about the of this document is an estimate of the procedures for the resolution of request is entered into the appropriate annual reporting burden for requests for scientific and procedural disputes tracking databases. Use of the dispute resolution. Based on data between interested persons and the information in the agency’s tracking collected from review divisions and agency, CDER, and CBER. All agency databases enables the appropriate offices within CDER and CBER, FDA decisions on such matters are based on agency official to monitor progress on estimates that approximately 8 sponsors information in the administrative file the resolution of the dispute and to and applicants (respondents) submit (§ 10.75(d)). In general, the information ensure that appropriate steps will be requests for formal dispute resolution to in an administrative file is collected taken in a timely manner. CDER annually and approximately 1 under existing regulations in parts 312 CDER and CBER have determined and respondent submits requests for formal (OMB Control No. 0910–0014), 314 the guidance recommends that the dispute resolution to CBER annually.
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The total annual responses are the total request for formal dispute resolution in Therefore, FDA estimates that 88 hours number of requests submitted to CDER accordance with this guidance, will be spent per year by respondents and CBER in 1 year, including requests including the time it takes to gather and requesting formal dispute resolution for dispute resolution that a single copy brief statements describing the under the guidance. respondent submits more than one time. issue from the perspective of the person In the Federal Register of October 24, FDA estimates that CDER receives with the dispute, brief statements 2005, (70 FR 61453), FDA announced approximately 10 requests annually and describing the history of the matter, and CBER receives approximately 1 request supporting information that has already the availability of the draft guidance and annually. The hours per response is the been submitted to the agency. Based on requested comments for 60 days on the estimated number of hours that a experience, FDA estimates that information collection. No comments respondent would spend preparing the approximately 8 hours on average were received on this information information to be submitted with a would be needed per response. collection.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Requests for Formal Dispute Reso- No. of Respond- No. of Responses Total Annual Re- Hours per Re- lution ents per Respondent sponses sponse Total Hours
CDER 8 1.25 10 8 80
CBER 1 1 1 8 8
Total 88 1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 13, 2006. DATES: Submit written or electronic of the proposed collection of Jeffrey Shuren, comments on the collection of information set forth in this document. Assistant Commssioner for Policy. information by March 27, 2006. With respect to the following collection of information, FDA invites [FR Doc. E6–763 Filed 1–23–06; 8:45 am] ADDRESSES: Submit electronic comments on these topics: (1) Whether BILLING CODE 4160–01–S comments on the collection of the proposed collection of information information to: http://www.fda.gov/ is necessary for the proper performance dockets/ecomments. Submit written of FDA’s functions, including whether DEPARTMENT OF HEALTH AND comments on the collection of the information will have practical HUMAN SERVICES information to the Division of Dockets utility; (2) the accuracy of FDA’s Management (HFA–305), Food and Drug estimate of the burden of the proposed Food and Drug Administration Administration, 5630 Fishers Lane, rm. collection of information, including the 1061, Rockville, MD 20852. All validity of the methodology and [Docket No. 2006N–0021] comments should be identified with the assumptions used; (3) ways to enhance docket number found in brackets in the the quality, utility, and clarity of the Agency Information Collection heading of this document. information to be collected; and (4) Activities; Proposed Collection; FOR FURTHER INFORMATION CONTACT: ways to minimize the burden of the Comment Request; Request for Jonna Capezzuto, Office of Management collection of information on Samples and Protocols Programs (HFA–250), Food and Drug respondents, including through the use Administration, 5600 Fishers Lane, of automated collection techniques, AGENCY: Food and Drug Administration, Rockville, MD 20857, 301–827–4659. when appropriate, and other forms of HHS. information technology. SUPPLEMENTARY INFORMATION: Under the ACTION: Notice. PRA (44 U.S.C. 3501–3520), Federal Request for Samples and Protocols agencies must obtain approval from the (OMB Control Number 0910–0206)— SUMMARY: The Food and Drug Office of Management and Budget Extension) Administration (FDA) is announcing an (OMB) for each collection of Under section 351 of the Public opportunity for public comment on the information they conduct or sponsor. Health Service Act (42 U.S.C. 262), FDA proposed collection of certain ‘‘Collection of information’’ is defined has the responsibility to issue information by the agency. Under the in 44 U.S.C. 3502(3) and 5 CFR regulations that prescribe standards Paperwork Reduction Act of 1995 (the 1320.3(c) and includes agency requests designed to ensure the safety, purity, PRA), Federal agencies are required to or requirements that members of the and potency of biological products and publish notice in the Federal Register public submit reports, keep records, or to ensure that the biologics licenses for concerning each proposed collection of provide information to a third party. such products are only issued when a information, including each proposed Section 3506(c)(2)(A) of the PRA (44 product meets the prescribed standards. extension of an existing collection of U.S.C. 3506(c)(2)(A)) requires Federal Under § 610.2 (21 CFR 610.2), FDA may information, and to allow 60 days for agencies to provide a 60-day notice in at any time require manufacturers of public comment in response to the the Federal Register concerning each licensed biological products to submit notice. This notice solicits comments on proposed collection of information, to FDA samples of any lot along with the information collection requirements including each proposed extension of an the protocols showing the results of relating to the regulations which state existing collection of information, applicable tests prior to marketing the that protocols for samples of biological before submitting the collection to OMB lot of the product. In addition to § 610.2, products must be submitted to the for approval. To comply with this there are other regulations that require agency. requirement, FDA is publishing notice the submission of samples and protocols
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for specific licensed biological products: Hepatitis B Surface Antigen product, of information under §§ 660.6(b), §§ 660.6 (21 CFR 660.6) (Antibody to and § 660.46(b) provides the 660.36(a)(2) and (b), and 660.46(b) are Hepatitis B Surface Antigen), 660.36 (21 requirements for the submission of a manufacturers of the specific products CFR 660.36) (Reagent Red Blood Cells), protocol containing specific information referenced previously in this document. and 660.46 (21 CFR 660.46) (Hepatitis B along with each required sample. For The estimated number of respondents Surface Antigen). § 660.46 products subject to official for each regulation is based on the Section 660.6(a) provides release by FDA, one sample from each annual number of manufacturers that requirements for the frequency of filling of each lot is required to be submitted samples and protocols for submission of samples from each lot of submitted along with a protocol biological products including Antibody to Hepatitis B Surface Antigen consisting of a summary of the history submissions for lot release, surveillance, product, and § 660.6(b) provides the or manufacture of the product, licensing, or export. Based on requirements for the submission of a including all results of each test for information obtained from FDA’s protocol containing specific information which test results are requested by database system, approximately 70 along with each required sample. For CBER. After notification of official manufacturers submitted samples and § 660.6 products subject to official release is received, one sample along protocols in fiscal year (FY) 2005, under release by FDA, one sample from each with a protocol is required to be the regulations cited previously in this filling of each lot is required to be submitted at an interval of 90 days. In document. FDA estimates that 65 submitted along with a protocol addition, samples, which must be manufacturers submitted protocols consisting of a summary of the history accompanied by a protocol, may at any under § 610.2, and 4 manufacturers or manufacture of the product, time be required to be submitted to FDA submitted protocols under the including all results of each test for if continued evaluation is deemed regulations (§§ 660.6 and 660.46) for the which test results are requested by the necessary. other specific products. FDA received Center for Biologics Evaluation and Samples and protocols are required by no submissions under § 660.36, however Research (CBER). After official release is FDA to help ensure the safety, purity, or FDA is using the estimate of one no longer required, one sample along potency of the product because of the protocol submission in the event one is with a protocol is required to be potential lot-to-lot variability of a submitted in the future. submitted at an interval of 90 days. In product produced from living The estimated total annual responses addition, samples, which must be organisms. In cases of certain biological are based on FDA’s final actions accompanied by a protocol, may at any products (e.g., Albumin, Plasma Protein completed in FY 2005, which totaled time be required to be submitted to FDA Fraction, and specified biotechnology 4,930, for the various submission if continued evaluation is deemed and specified synthetic biological requirements of samples and protocols necessary. products) that are known to have lot-to- Section 660.36(a) requires, after each lot consistency, official lot release is not for the licensed biological products. The routine establishment inspection by normally required. However, rate of final actions is not expected to FDA, the submission of samples from a submissions of samples and protocols of change significantly in the next few lot of final Reagent Red Blood Cell these products may still be required for years. The hours per response are based product along with a protocol surveillance, licensing, and export on information provided by industry. containing specific information. Section purposes, or in the event that FDA The burden estimates provided by 660.36(a)(2) requires that a protocol obtains information that the industry ranged from 1 to 5.5 hours. contain information including, but not manufacturing process may not result in Under § 610.2, the hours per response limited to, manufacturing records, test consistent quality of the product. are based on the average of these records, and test results. Section 660.36 The following burden estimate is for estimates and rounded to 3 hours. (b) requires a copy of the antigenic the protocols that are required to be Under the remaining regulations, the constitution matrix specifying the submitted with each sample. The hours per response are based on the antigens present or absent to be collection of samples is not a collection higher end of the estimate (rounded to submitted to FDA at the time of initial of information under 5 CFR 5 or 6 hours) since more information is distribution of each lot. 1320.3(h)(2). Respondents to the generally required to be submitted in Section 660.46(a) provides collection of information under § 610.2 the protocol than under § 610.2. requirements for the frequency of are manufacturers of licensed biological FDA estimates the burden of this submission of samples from each lot of products. Respondents to the collection collection of information as follows:
Annual Frequency 21 CFR Section No. of Respondents per Response Total Annual Responses Hours per Response Total Hours
610.2 65 74 .1 4,816 3 14,448
660.6(b) 3 26 78 5 390
660.36(a)(2) and (b) 1 1 1 6 6
660.46(b) 1 35 35 5 175
Total 70 4,930 15,019 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: January 13, 2006. of Prescription Drug User Fee Act §§ 312.23, 314.50, and 601.2; therefore, Jeffrey Shuren, (PDUFA) products. The guidance requests should be submitted to the Assistant Commissioner for Policy. describes procedures for requesting, agency with the appropriate form [FR Doc. E6–764 Filed 1–23–06; 8:45 am] scheduling, conducting, and attached, either Form FDA 1571 or Form BILLING CODE 4160–01–S documenting such formal meetings. The FDA 356h. The agency recommends that guidance provides information on how a request be submitted in this manner the agency will interpret and apply for the following two reasons: (1) To DEPARTMENT OF HEALTH AND section 119(a) of the Food and Drug ensure that each request is kept in the HUMAN SERVICES Administration Modernization Act (the administrative file with the entire Modernization Act), specific PDUFA underlying application, and (2) to Food and Drug Administration goals for the management of meetings ensure that pertinent information about associated with the review of human [Docket No. 2005N–0395] the request is entered into the drug applications for PDUFA products, appropriate tracking databases. Use of Agency Information Collection and provisions of existing regulations the information in the agency’s tracking Activities; Submission for Office of describing certain meetings (§§ 312.47 databases enables the agency to monitor Management and Budget Review; and 312.82 (21 CFR 312.47 and 312.82)). progress on the activities attendant to Comment Request; Guidance for The guidance describes two scheduling and holding a formal Industry on Formal Meetings With collections of information: The meeting and to ensure that appropriate Sponsors and Applicants for submission of a meeting request steps will be taken in a timely manner. Prescription Drug User Fee Act containing certain information and the Under the guidance, the agency Products submission of an information package in requests that sponsors and applicants advance of the formal meeting. Agency include in meeting requests certain AGENCY: Food and Drug Administration, regulations at § 312.47(b)(1)(ii), information about the proposed HHS. (b)(1)(iv), and (b)(2) describe meeting. Such information includes the ACTION: Notice. information that should be submitted in following: support of a request for an End of Phase • Information identifying and SUMMARY: The Food and Drug 2 meeting and a Pre New Drug describing the product, Administration (FDA) is announcing Application (NDA) meeting. The • The type of meeting being that a proposed collection of information collection provisions of requested, information has been submitted to the § 312.47 have been approved by OMB • A brief statement of the purpose of Office of Management and Budget (OMB control number 0910–0014). the meeting, (OMB) for review and clearance under However, the guidance provides • A list of objectives and expected the Paperwork Reduction Act of 1995. additional recommendations for outcomes from the meeting, DATES: Fax written comments on the submitting information to FDA in • A preliminary proposed agenda, collection of information by February support of a meeting request. As a • A draft list of questions to be raised 23, 2006. result, FDA is submitting additional at the meeting, • ADDRESSES: OMB is still experiencing estimates for OMB approval. A list of individuals who will significant delays in the regular mail, I. Request for a Meeting represent the sponsor or applicant at the meeting, including first class and express mail, Under the guidance, a sponsor or • and messenger deliveries are not being A list of agency staff requested to be applicant interested in meeting with the in attendance, accepted. To ensure that comments on Center for Drug Evaluation and Research • the information collection are received, The approximate date that the (CDER) or the Center for Biologics information package will be sent to the OMB recommends that written Evaluation and Research (CBER) should comments be faxed to the Office of agency, and submit a meeting request to the • Suggested dates and times for the Information and Regulatory Affairs, appropriate FDA component as an meeting. OMB, Attn: Fumie Yokota, Desk Officer amendment to the underlying This information will be used by the for FDA, FAX: 202–395–6974. application. FDA regulations (§§ 312.23, agency to determine the utility of the FOR FURTHER INFORMATION CONTACT: 314.50, and 601.2 (21 CFR 312.23, meeting, to identify agency staff Karen Nelson, Office of Management 314.50, and 601.2)) state that necessary to discuss proposed agenda Programs (HFA–250), Food and Drug information provided to the agency as items, and to schedule the meeting. Administration, 5600 Fishers Lane, part of an Investigational New Drug Rockville, MD 20857, 301–827–1482. Application (IND), NDA, or Biological II. Information Package SUPPLEMENTARY INFORMATION: In License Application (BLA) must be A sponsor or applicant submitting an compliance with 44 U.S.C. 3507, FDA submitted with an appropriate cover information package to the agency in has submitted the following proposed form. Form FDA 1571 must accompany advance of a formal meeting should collection of information to OMB for submissions under INDs and Form FDA provide summary information relevant review and clearance. 356h must accompany submissions to the product and supplementary under NDAs and BLAs. Both forms have information pertaining to any issue Guidance for Industry on Formal valid OMB control numbers as follows: raised by the sponsor, applicant, or Meetings with Sponsors and Applicants FDA Form 1571, OMB control number agency. The agency recommends that for Prescription Drug User Fee Act 0910–0014; and FDA Form 356h, OMB information packages generally include Products (OMB Control Number 0910– control number 0910–0338, expires the following: 0429)—Extension September 30, 2008. • Identifying information about the This information collection approval In the guidance document, CDER and underlying product; request is for an FDA guidance on the CBER ask that a request for a formal • A brief statement of the purpose of procedures for formal meetings between meeting be submitted as an amendment the meeting; FDA and sponsors or applicants to the application for the underlying • A list of objectives and expected regarding the development and review product under the requirements of outcomes of the meeting;
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• A proposed agenda for the meeting; development and review of a PDUFA information packages to CBER annually • A list of specific questions to be product. prior to a formal meeting regarding the addressed at the meeting; Burden Estimate: Provided in the development and review of a PDUFA • A summary of clinical data that will following paragraphs is an estimate of product. The hours per response, which be discussed (as appropriate); the annual reporting burden for the is the estimated number of hours that a • A summary of preclinical data that submission of meeting requests and respondent would spend preparing the will be discussed (as appropriate); and information packages under the information package in accordance with • Chemistry, manufacturing, and guidance. the guidance, is estimated to be controls information that may be III. Request For a Formal Meeting approximately 18 hours. Based on discussed (as appropriate). FDA’s experience, the agency expects it Based on data collected from the will take respondents this amount of The purpose of the information review divisions and offices within package is to provide agency staff the time to gather and copy brief statements CDER and CBER, FDA estimates that about the product, a description of the opportunity to adequately prepare for approximately 713 sponsors and the meeting, including the review of details for the anticipated meeting, and applicants (respondents) request data and information that generally relevant data concerning the product. approximately 1,783 formal meetings Although FDA reviews similar would already have been compiled for with CDER annually and approximately submission to the agency. information in the meeting request, the 164 respondents request approximately information package should provide 286 formal meetings with CBER As stated earlier, the guidance updated data that reflect the most annually regarding the development and provides information on how the agency current and accurate information review of a PDUFA product. The hours will interpret and apply section 119(a) available to the sponsor or applicant. per response, which is the estimated of the Modernization Act, specific The agency finds that reviewing such number of hours that a respondent PDUFA goals for the management of information is critical to achieving a would spend preparing the information meetings associated with the review of productive meeting. to be submitted with a meeting request human drug applications for PDUFA The collection of information in accordance with the guidance, is products, and provisions of existing described in the guidance reflects the estimated to be approximately 10 hours. regulations describing certain meetings current and past practice of sponsors Based on FDA’s experience, the agency (§§ 312.47 and 312.82). The information and applicants to submit meeting expects it will take respondents this collection provisions in § 312.47 requests as amendments to INDs, NDAs, amount of time to gather and copy brief concerning End of Phase 2 meetings and and BLAs and to submit background statements about the product and a Pre NDA meetings have been approved information prior to a scheduled description of the purpose and details of by OMB (OMB control number 0910– meeting. Agency regulations currently the meeting. 0014). However, the guidance provides permit such requests and recommend additional recommendations for the submission of an information IV. Information Package submitting information to FDA in package before an End of Phase 2 Based on data collected from the support of a meeting request. As a meeting (§§ 312.47(b)(1)(ii) and review divisions and offices within result, FDA is submitting for OMB (b)(1)(iv)) and a Pre NDA meeting CDER and CBER, FDA estimates that approval these additional estimates. (§ 312.47(b)(2)). approximately 615 respondents In the Federal Register of October 24, Description of respondents: A sponsor submitted approximately 1,365 2005 (70 FR 61445), FDA published a or applicant for a drug or biological information packages to CDER annually 60-day notice requesting public product who requests a formal meeting and approximately 132 respondents comment on the information collection with the agency regarding the submitted approximately 208 provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Meeting Requests and No. of No. of Responses Total Annual Hours per Information Packages Respondents per Respondent Responses Response Total Hours
Meeting Requests
CDER 713 2.50 1,783 10 17,830
CBER 164 1.74 286 10 2,860
Total 20,690
Information Packages
CDER 615 2.22 1,365 18 24,570
CBER 132 1.58 208 18 3,744
Total 28,314
Grand Total 49,004 1There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: January 13, 2006. DEPARTMENT OF HEALTH AND applicable, the business or professional Jeffrey Shuren, HUMAN SERVICES affiliation of the interested person. In the interest of security, NIH has Assistant Commissioner for Policy. National Institutes of Health instituted stringent procedures for entrance [FR Doc. E6–765 Filed 1–23–06; 8:45 am] into the building by non-government BILLING CODE 4160–01–S Fogarty International Center; Notice of employees. Persons without a government Meeting I.D. will need to show a photo I.D. and sign- in at the security desk upon entering the DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the building. HUMAN SERVICES Federal Advisory Committee Act, as Information is also available on the amended (5 U.S.C. Appendix 2), notice Institute’s/Center’s home page: http:// is hereby given of a meeting of the www.nih.gov/fic/about/advisory.html, where Food and Drug Administration an agenda and any additional information for Fogarty International Center Advisory the meeting will be posted when available. [Docket No. 2004N–0296] Board. The meeting will be open to the (Catalogue of Federal Domestic Assistance Program Nos. 93.106, Minority International Agency Information Collection public as indicated below, with Research Training Grant in the Biomedical Activities; Announcement of Office of attendance limited to space available. and Behavioral Sciences; 93.154, Special Management and Budget Approval; Individuals who plan to attend and International Postdoctoral Research Program Good Laboratory Practice Regulations need special assistance, such as sign in Acquired Immunodeficiency Syndrome; language interpretation or other 93.168, International Cooperative for Nonclinical Studies reasonable accommodations, should Biodiversity Groups Program; 93.934, Fogarty notify the Contact Person listed below International Research Collaboration Award; AGENCY: Food and Drug Administration, in advance of the meeting. 93.989, Senior International Fellowship HHS. The meeting will be closed to the Awards Program, National Institutes of Health, HHS) ACTION: Notice. public in accordance with the provisions set forth in sections Dated: January 11, 2006. SUMMARY: The Food and Drug 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Anna Snouffer, Administration (FDA) is announcing as amended. The grant applications Acting Director, Office of Federal Advisory that a collection of information entitled and/or contract proposals and the Committee Policy. ‘‘Good Laboratory Practice Regulations discussions could disclose confidential [FR Doc. 06–652 Filed 1–23–06; 8:45 am] for Nonclinical Studies’’ has been trade secrets or commercial property BILLING CODE 4140–01–M approved by the Office of Management such as patentable material, and personal information concerning and Budget (OMB) under the Paperwork individuals associated with the grant DEPARTMENT OF HEALTH AND Reduction Act of 1995. applications and/or contract proposals, HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: the disclosure of which would Karen Nelson, Office of Management constitute a clearly unwarranted National Institutes of Health invasion of personal privacy. Programs (HFA–250), Food and Drug National Cancer Institute; Notice of Administration, 5600 Fishers Lane, Name of Committee: Fogarty International Closed Meeting Rockville, MD 20857, 301–827–1482. Center Advisory Board. Date: February 6–7, 2006. Pursuant to section 10(d) of the SUPPLEMENTARY INFORMATION: In the Closed: February 6, 2006, 1 p.m. to Federal Advisory Committee Act, as Federal Register of January 4, 2005 (70 Adjournment. amended (U.S.C. Appendix 2), notice is FR 364) the agency announced that the Agenda: To review and evaluate grant hereby given of the following meetings. proposed information collection had applications and proposals. The meetings will be closed to the Place: National Institutes of Health, been submitted to OMB for review and public in accordance with the clearance under 44 U.S.C. 3507. An Lawton Chiles International House, Bethesda, MD 20892. provisions set forth in sections agency may not conduct or sponsor, and Open: February 7, 2006, 8:30 a.m. to 5 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., a person is not required to respond to, Agenda: A report of the FIC Director on as amended. The grant applications and a collection of information unless it updates and overviews of new FIC initiatives. the discussions could disclose displays a currently valid OMB control Topics to be discussed: The Disease Control confidential trade secrets or commerical number. OMB has now approved the Priorities Project: An Update. property such as patentable material, information collection and has assigned Place: National Institutes of Health, and personal information concerning Lawton Chiles International House, Bethesda, individuals associated with the grant OMB control number 0910–0119. The MD 20892. approval expires on April 30, 2008. A Contact Person: Jean L. Flagg-Newton, applications, the disclosure of which copy of the supporting statement for this PhD, Special assistant to the Director, FIC, would constitute a clearly unwarranted information collection is available on Fogarty International Center, National invasion of personal privacy. the Internet at http://www.fda.gov/ Institutes of Health, 9000 Rockville Pike, Name of Committee: National Cancer ohrms/dockets. Building 31, Room B2C29, Bethesda, MD Institute Initial Review Group Subcommittee 20892. (301) 496–2968. A—Cancer Centers. Dated: January 13, 2006. [email protected]. Date: April 5, 2006. Jeffrey Shuren, This notice is being published less than 15 Time: 1 p.m. to 5 p.m. Assistant Commissioner for Policy. days prior to the meeting due to the timing Agenda: To review and evaluate grant limitations imposed by the review and applications [FR Doc. E6–768 Filed 1–23–06; 8:45 am] funding cycle. Place: Wyndham City Center Hotel, 1143 BILLING CODE 4160–01–S Any interested person may file written New Hampshire Ave., NW., Washington, DC comments with the committee by forwarding 20037. the statement to the Contact Person listed on Contact Person: David E. Maslow, PhD, this notice. The statement should include the Scientific Review Administrator, Resources name, address, telephone number and when and Training Review Branch, Division of
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Extramural Activities, National Cancer 93.398, Cancer Research Manpower; 93.399, DEPARTMENT OF HEALTH AND Institute, 6116 Executive Blvd., Room 8117, Cancer Control, National Institutes of Health, HUMAN SERVICES Bethesda, MD 20892–7405, (301) 496–2330, HHS) [email protected]. Dated: January 10, 2006. National Institutes of Health (Catalogue of Federal Domestic Assistance Anna Snouffer, Program Nos. 93.392, Cancer Construction; National Cancer Institute; Amended 93.393, Cancer Cause and Prevention Acting Director, Office of Federal Advisory Notice of Meeting Research; 93.394, Cancer Detection and Committee Policy. Diagnosis Research; 93.395, Cancer [FR Doc. 06–644 Filed 1–23–06; 8:45 am] Notice is hereby given of a change in Treatment Research; 93.396, Cancer Biology BILLING CODE 4140–01–M the meeting of the National Cancer Research; 93.397, Cancer Centers Support; Institute Special Emphasis Panel, 93.398, Cancer Research Manpower; 93.399, February 27, 2006, 8 a.m. to February Cancer Control, National Institutes of Health, DEPARTMENT OF HEALTH AND HHS) 27, 2006, 5 p.m., Ramada Inn Rockville, HUMAN SERVICES 1775 Rockville Pike, Rockville, MD, Dated: January 10, 2006 20852 which was published in the Anna Snouffer, National Institutes of Health Federal Register on December 21, 2005, Acting Director, Office of Federal Advisory 70FR75824. National Cancer Institute; Notice of Committee Policy. The meeting is amended to change the Closed Meeting [FR Doc. 06–643 Filed 1–23–06; 8:45 am] meeting format to a teleconference, the BILLING CODE 4140–01–M meeting time to 11 a.m.–4 p.m. and the Pursuant to section 10(d) of the meeting location to 6130 Executive Federal Advisory Committee Act, as Blvd., Conference Room F in Rockville, amended (5 U.S.C. Appendix 2), notice DEPARTMENT OF HEALTH AND MD and to remove SBIR Topic 206. The is hereby given of the following HUMAN SERVICES meeting is closed to the public. meeting. Dated: January 11, 2006. National Institutes of Health The meeting will be closed to the public in accordance with the Anna Snouffer, National Cancer Institute; Notice of Acting Director, Office of Federal Advisory Closed Meeting provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee Policy. Pursuant to section 10(d) of the as amended. The grant applications and [FR Doc. 06–648 Filed 1–23–06; 8:45 am] Federal Advisory Committee Act, as the discussions could disclose BILLING CODE 4140–01–M amended (5 U.S.C. Appendix 2), notice confidential trade secrets or commerical is hereby given of the following property such as patentable material, meeting. and personal information concerning DEPARTMENT OF HEALTH AND The meeting will be closed to the individuals associated with the grant HUMAN SERVICES public in accordance with the applications, the disclosure of which National Institutes of Health provisions set forth in sections would constitute a clearly unwarranted 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy. National Cancer Institute; Notice of as amended. The grant applications and Name of Committee: National Cancer Meeting the discussions could disclose Institute Special Emphasis Panel, Cancer confidential trade secrets or commercial Therapeutics. Pursuant to section 10(d) of the property such as patentable material, Date: February 15, 2006. Federal Advisory Committee Act, as and personal information concerning Time: 8 a.m. to 1 p.m. amended (5 U.S.C. Appendix 2), notice individuals associated with the grant Agenda: To review and evaluate grant is hereby given of the meeting of the applications, the disclosure of which applications. National Cancer Advisory Board. would constitute a clearly unwarranted Place: Gaithersburg Marriott The meeting will be open to the invasion of personal privacy. Washingtonian Center, 9751 Washingtonian public as indicated below, with Boulevard, Gaithersburg, MD 20878. attendance limited to space available. Name of Committee: National Cancer Contact Person: Shakeel Ahmad, PhD, Institute Special Emphasis Panel CA06–001 Individuals who plan to attend and Scientific Review Administrator, Research need special assistance, such as sign (Cancer Detection) and CA06–004/CA06–007 Programs Review Branch, National Cancer (Cancer Sample Preparation). language interpretation or other Institute, Division of Extramural Activities, Date: March 9–10, 2006. 6116 Executive Blvd., Bethesda, MD 20892, reasonable accommodations, should Time: 8 a.m. to 5 p.m. (301) 594–0114, [email protected]. notify the Contact Person listed below Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance in advance of the meeting. applications. A portion of the meeting will be Place: Bethesda Marriott, 5151 Pooks Hill Program Nos. 93.392, Cancer Construction; Road, Bethesda, MD 20814. 93.393, Cancer Cause and Prevention closed to the public in accordance with Contact Person: Timothy C. Meeker, MD, Research; 93.394, Cancer Detection and the provisions set forth in sections Scientific Review Administrator, Special Diagnosis Research; 93.395, Cancer 552b(c)(4), and 552b(c)(6), as amended. Review and Logistics Branch, Division of Treatment Research; 93.396, Cancer Biology The grant applications and the Extramural Activities, National Cancer Research; 93.397, Cancer Centers Support; discussions could disclose confidential Institute, 6116 Executive Boulevard, Room 93.398, Cancer Research Manpower; 93.399, trade secrets or commercial property 8103, Bethesda, MD 20892, (301) 594–1279, Cancer Control, National Institutes of Health, such as patentable material, and [email protected]. HHS) personal information concerning (Catalogue of Federal Domestic Assistance Dated: January 10, 2006. individuals associated with the grant Program Nos. 93.392, Cancer Construction; Anna Snouffer, applications, the disclosure of which 93.393, Cancer Cause and Prevention Acting Director, Office of Federal Advisory would constitute a clearly unwarranted Research; 93.394, Cancer Detection and Committee Policy. Diagnosis Research; 93.395, Cancer invasion of personal privacy. Treatment Research; 93.396, Cancer Biology [FR Doc. 06–645 Filed 1–23–06; 8:45 am] Name of Committee: National Cancer Research; 93.397, Cancer Centers Support; BILLING CODE 4140–01–M Advisory Board.
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Open: February 7, 2006, 8:30 a.m. to 4:30 confidential trade secrets or commercial Contact Person: Mohan Viswanathan, PhD, p.m. property such as patentable material, Deputy Director, National Center for Agenda: Program reports and and personal information concerning Research Resources, or National Institutes of presentations; Business of the Board. individuals associated with the grant Health, 6701 Democracy Blvd., Room 1084, Place: National Cancer Institute, 9000 MSC 4874, 1 Democracy Plaza, Bethesda, MD Rockville Pike, Building 31, C Wing, 6th applications, the disclosure of which 20892–4874. 301–435–0829. [email protected]. Floor, Conference Room 10, Bethesda, MD would constitute a clearly unwarranted 20892. invasion of personal privacy. (Catalogue of Federal Domestic Assistance Contact Person: Dr. Paulette S. Gray, Name of Committee: National Center for Program Nos. 93.306, Comparative Medicine; Executive Secretary, National Cancer Research Resources Initial Review Group; 93.333, Clinical Research; 93.371, Biomedical Institute, National Institutes of Health, 6116 Comparative Medicine Review Committee. Technology; 93.389, Research Infrastructure, Executive Boulevard, 8th Floor, Room 8001, Date: February 7–8, 2006. 93.306, 93.333, National Institutes of Health, Bethesda, MD 20892–8327. (301) 496–5147. Time: 8 a.m. to 5 p.m. HHS) Name of Committee: National Cancer Agenda: To review and evaluate grant Advisory Board. applications. Dated: January 11, 2006. Closed: February 7, 2006, 4:30 p.m. to 6 Place: Double Tree Rockville, 1750 Anna Snouffer, p.m. Rockville Pike, Rockville, MD 20852. Acting Director, Office of Federal Advisory Agenda: Review of grant applications. Contact Person: John R. Glowa, PhD, Committee Policy. Contact Person: Dr. Paulette S. Gray, Scientific Review Administrator, Office of [FR Doc. 06–659 Filed 1–23–06; 8:45 am] Executive Secretary, National Cancer Review, National Center for Research Institute, National Institutes of Health, 6116 Resources, 6701 Democracy Boulevard, Room BILLING CODE 4140–01–M Executive Boulevard, 8th Floor, Room 8001, 1078–MSC 4874, Bethesda, MD 20892–4874. Bethesda, MD 20892–8327. (301) 496–5147. 301–435–0807. [email protected]. Any interested person may file written (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND comments with the committee by forwarding Program Nos. 93.306, Comparative Medicine; HUMAN SERVICES the statement to the Contact Person listed on 93.333, Clinical Research; 93.371, Biomedical this notice. The statement should include the Technology; 93.389, Research Infrastructure, National Institutes of Health name, address, telephone number and when 93.306, 93.333, National Institutes of Health, applicable, the business or professional HHS) National Center for Research affiliation of the interested person. Dated: January 11, 2006. Resources; Notice of Closed Meeting Information is also available on the Institute’s/Center’s home page: Anna Snouffer, deainfo.nci.nih.gov/advisory/ncab.htm, Acting Director, Office of Federal Advisory Pursuant to section 10(d) of the where an agenda and any additional Committee Policy. Federal Advisory Committee Act, as information for the meeting will be posted [FR Doc. 06–658 Filed 1–23–06; 8:45 am] amended (5 U.S.C. Appendix 2), notice when available. BILLING CODE 4140–01–M is hereby given of the following (Catalogue of Federal Domestic Assistance meeting. Program Nos. 93.392, Cancer Construction; The meeting will be closed to the 93.393, Cancer Cause and Prevention DEPARTMENT OF HEALTH AND public in accordance with the Research; 93.394, Cancer Detection and HUMAN SERVICES Diagnosis Research; 93.395, Cancer provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Treatment Research; 93.396, Cancer Biology National Institutes of Health Research; 93.397, Cancer Centers Support; as amended. The grant applications and 93.398, Cancer Research Manpower; 93.399, National Center for Research the discussions could disclose Cancer Control, National Institutes of Health, Resources; Notice of Closed Meeting confidential trade secrets or commercial HHS) property such as patentable material, Dated: January 12, 2006. Pursuant to section 10(d) of the and personal information concerning Anna Snouffer, Federal Advisory Committee Act, as individuals associated with the grant amended (5 U.S.C. Appendix 2), notice Acting Director, Office of Federal Advisory applications, the disclosure of which Committee Policy. is hereby given of the following would constitute a clearly unwarranted meeting. invasion of personal privacy. [FR Doc. 06–663 Filed 1–23–06; 8:45 am] The meeting will be closed to the BILLING CODE 4140–01–M public in accordance with the Name of Committee: National Center for provisions set forth in sections Research Resources Special Emphasis Panel. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: February 22–23, 2006. DEPARTMENT OF HEALTH AND Time: 8 a.m. to 5 p.m. HUMAN SERVICES as amended. The grant applications and the discussions could disclose Agenda: To review and evaluate grant applications. National Institutes of Health confidential trade secrets or commercial property such as patentable material, Place: Double Tree Rockville, 1750 National Center for Research and personal information concerning Rockville Pike, Rockville, MD 20852. Contact Person: Carol Lambert, PhD, Resources; Notice of Closed Meeting individuals associated with the grant Scientific Review Administrator, Office of applications, the disclosure of which Review, National Center for Research Pursuant to section 10(d) of the would constitute a clearly unwarranted Resources, National Institutes of Health, 6701 Federal Advisory Committee Act, as invasion of personal privacy. amended (5 U.S.C. Appendix 2), notice Democracy Boulevard, 1 Democracy Plaza, is hereby given of the following Name of Committee: National Center for Room 1076, Bethesda, MD 20892–4874 (301) meeting. Research Resources Initial Review Group; 435–0814. [email protected]. The meeting will be closed to the Clinical Research Review Committee. Date: February 8–9, 2006. (Catalogue of Federal Domestic Assistance public in accordance with the Time: 8 a.m. to 5 p.m. Program Nos. 93.306, Comparative Medicine; provisions set forth in sections Agenda: To review and evaluate grant 93.333, Clinical Research; 93.371, Biomedical 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. Technology; 93.389, Research Infrastructure, as amended. The grant applications and Place: Residence Inn Bethesda, 7335 93.306, 93.333, National Institutes of Health, the discussions could disclose Wisconsin Avenue, Bethesda, MD 20814. HHS)
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Dated: January 11, 2006. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Anna Snouffer, HUMAN SERVICES HUMAN SERVICES Acting Director, Office of Federal Advisory Committee Policy. National Institutes of Health National Institutes of Health [FR Doc. 06–660 Filed 1–23–06; 8:45 am] National Heart, Lung, and Blood National Institute of Environmental BILLING CODE 4140–01–M Institute; Notice of Closed Meeting Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as Pursuant to section 10(d) of the HUMAN SERVICES amended (5 U.S.C. Appendix 2), notice Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice National Institutes of Health is hereby given of the following meeting. is hereby given of the following meeting. National Heart, Lung, and Blood The meeting will be closed to the Institute; Notice of Closed Meeting public in accordance with the The meeting will be closed to the provisions set forth in sections public in accordance with the Pursuant to section 10(d) of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Federal Advisory Committee Act, as as amended. The grant applications and as amended. The grant applications and amended (5 U.S.C. Appendix 2), notice the discussions could disclose the discussions could disclose is hereby given of the following confidential trade secrets or commercial meeting. confidential trade secrets or commercial property such as patentable material, property such as patentable material, The meeting will be closed to the and personal information concerning and personal information concerning public in accordance with the provision individuals associated with the grant individuals associated with the grant set forth in sections 552b(c)(4) and applications, the disclosure of which applications, the disclosure of which 552b(c)(6), Title 5 U.S.C., as amended. would constitute a clearly unwarranted would constitute a clearly unwarranted The grant applications and the invasion of person privacy. invasion of personal privacy. discussions could disclose confidential Name of Committee: National Heart, Lung, Name of Committee: National Institute of trade secrets or commercial property and Blood Institute Special Emphasis Panel. Environmental Health Sciences Special such as patentable material, and Exploratory/Developmental Grants (R21). Emphasis Panel Effects of Inhaled Florida personal information concerning Date: January 26, 2006. Red Tide Brevetoxins. individuals associated with the grant Time: 12 p.m. to 1 p.m. Date: February 10, 2006. applications, the disclosure of which Agenda: To review and evaluate grant Time: 9 a.m. to 4:30 p.m. would constitute a clearly unwarranted applications. Agenda: To review and evaluate grant invasion of personal privacy. Place: National Institutes of Health, 6701 applications. Rockledge Drive, Bethesda, MD 20892. Place: Nat. Inst. of Environmental Health Name of Committee: National Heart, Lung, (Telephone Conference Call). Sciences, Building 101, Rodbell Auditorium, and Blood Institute Special Emphasis Panel. Contact Person: Valerie L. Prenger, PhD, 111 T.W. Alexander Drive, Research Triangle Resource-Related Research Projects (R24). Health Scientist Administrator, Review Park, NC 27709. Date: February 9, 2006. Branch, Room 7214, Division of Extramural Contact Person: Linda K. Bass, PhD, Time: 2 p.m. to 4 p.m. Affairs, National Heart, Lung, and Blood Scientific Review Administrator, Scientific Agenda: To review and evaluate grant Institute, 6701 Rockledge Drive, MSC 7924, Review Branch, Division of Extramural applications. Bethesda, MD 20892–7924. (301) 435–0270. Research and Training, Nat. Institute of Place: National Institutes of Health, 6701 [email protected]. Environmental Health Sciences, P.O. Box Rockledge Drive, Bethesda, MD 20892. This notice is being published less than 15 12233, MD EC–30, Research Triangle Park, (Telephone Conference Call). days prior to the meeting due to the timing NC 27709, 919/541–1307. This notice is being published less than 15 Contact Person: Shelley S. Sehnert, PhD, limitations imposed by the review and days prior to the meeting due to the timing Scientific Review Administrator, Review funding cycle. Branch, NIH/NHLBI, 6701 Rockledge Drive, limitations imposed by the review and (Catalogue of Federal Domestic Assistance Room 7206, Bethesda, MD 20892–7924. 301/ funding cycle. Program Nos. 93.233, National Center for 435–0303. [email protected]. (Catalogue of Federal Domestic Assistance Sleep Disorders Research; 93.837, Heart and Program Nos. 93.115, Biometry and Risk (Catalogue of Federal Domestic Assistance Vascular Diseases Research; 93.838, Lung Program Nos. 93.233, National Center for Estimation—Health Risks from Diseases Research; 93.839, Blood Diseases Environmental Exposures; 93.142, NIEHS Sleep Disorders Research; 93.837, Heart and and Resources Research, National Institutes Vascular Diseases Research; 93.838, Lung Hazardous Waste Worker Health and Safety of Health, HHS) Training; 93.143, NIEHS Superfund Diseases Research; 93.839, Blood Diseases Hazardous Substances—Basic Research and and Resources Research, National Institutes Dated: January 11, 2006. Education; 93.894, Resources and Manpower of Health, HHS) Anna Snouffer, Development in the Environmental Health Dated: January 13, 2006. Acting Director, Office of Federal Advisory Sciences; 93.113, Biological Response to Committee Policy. Anna Snouffer, Environmental Health Hazards; 93.114, [FR Doc. 06–650 Filed 1–23–06; 8:45 am] Applied Toxicological Research and Testing, Acting Director, Office of Federal Advisory National Institutes of Health, HHS) Committee Policy. BILLING CODE 4140–01–M [FR Doc. 06–640 Filed 1–23–06; 8:45 am] Dated: January 12, 2006. BILLING CODE 4140–01–M Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–637 Filed 1–23–06; 8:45 am] BILLING CODE 4140–01–M
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DEPARTMENT OF HEALTH AND Dated: January 13, 2006. DEPARTMENT OF HEALTH AND HUMAN SERVICES Anna Snouffer, HUMAN SERVICES Acting Director, Office of Federal Advisory National Institutes of Health Committee Policy. National Institutes of Health [FR Doc. 06–638 Filed 1–23–06; 8:45 am] National Institute on Alcohol Abuse National Institute of of Neurological and Alcoholism; Notice of Closed BILLING CODE 4140–01–M Disorders and Stroke; Notice of Closed Meetings Meetings Pursuant to section 10(d) of the DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the Federal Advisory Committee Act, as HUMAN SERVICES Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice amended (5 U.S.C. Appendix 2), notice is hereby given of the following National Institutes of Health is hereby given of the following meetings. meetings. National Institute of Mental Health; The meetings will be closed to the The meetings will be closed to the Notice of Closed Meeting public in accordance with the public in accordance with the provisions set forth in sections provisions set forth in sections Pursuant to section 10(d) of the 552b9c)(4) and 552b(c)(6), Title 5 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Federal Advisory Committee Act, as U.S.C., as amended. The grant as amended. The grant applications and amended (5 U.S.C. Appendix 2), notice applications and the discussions could the discussions could disclose is hereby given of the following disclose confidential trade secrets or confidential trade secrets or commercial meeting. commercial property such as patentable property such as patentable material, material, and personal information The meeting will be closed to the and personal information concerning concerning individuals associated with public in accordance with the individuals associated with the grant the grant applications, the disclosure of provisions set forth in sections applications, the disclosure of which which would constitute a clearly 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., would constitute a clearly unwarranted unwarranted invasion of personal as amended. The grant applications and invasion of personal privacy. privacy. the discussion could disclose Name of Committee: Training Grant and confidential trade secrets or commercial Name of Committee: National Institute on Career Development Review Committee NST. Alcohol Abuse and Alcoholism Initial property such as patentable material, Date: January 19–20, 2006. Review Group Health Services Research and personal information concerning Time: 8 a.m. to 5 p.m. Review Subcommittee. individuals associated with the grant Agenda: To review and evaluate grant Date: March 8–9 2006. applications, the disclosure of which applications. Time: 8 a.m. to 5 p.m. would constitute a clearly unwarranted Place: Jurys Doyle, 1500 New Hampshire Agenda: To review and evaluate grant invasion of personal privacy. Avenue, NW., Washington, DC 20036. applications. Contact Person: Raul A. Saavedra, PhD, Place: Hyatt Regency Bethesda, One Name of Committee: National Institute of Scientific Review Administrator, Scientific Bethesda Metro Center, 7400 Wisconsin Mental Health Special Emphasis Panel; Review Branch, Division of Extramural Avenue, Bethesda, MD 20814. Depression Treatment Follow-up Study. Research, NINDS/NIH/DHHS, NSC; 6001 Contact Person: Lorraine Gunzerath, PhD, Date: February 3, 2006. Executive Blvd., Ste. 3208, Bethesda, MD MBA, Scientific Review Administrator, Time: 12 p.m. to 1:30 p.m. 20892–9529, 301–496–9223, National Institute on Alcohol Abuse and Agenda: to review and evaluate grant saavedrrAninds.nih.gov. Alcoholism, Office of Extramural Activities, applications. This notice is being published less than 15 Extramural Project Review Branch, 5635 Place: National Institutes of Health, days prior to the meeting due to the timing Fishers Lane, Room 3043, Bethesda, MD Neuroscience Center, 6001 Executive limitations imposed by the review and 20892–9304, Bethesda, MD 20892–9304, Boulevard, Rockville, MD 20852. (Telephone funding cycle. 301–443–2369, [email protected]. Conference Call). Name of Committee: National Institute of Name of Committee: National Institute on Contact Person: David I. Sommers, PhD, Neurological Disorders and Stroke Initial Review Group Neurological Sciences and Alcohol Abuse and Alcoholism Special Scientific Review Administrator, Division of Disorders B. Emphasis Panel. Extramural Activities, National Institute of Date: February 21–22, 2006. Date: March 8, 2006. Mental Health, NIH, Neuroscience Center, Time: 8:30 a.m. to 5 p.m. Time; 8 a.m. to 9 a.m. 6001 Executive Blvd., Room 6144, MSC 9606, Agenda: To review and evaluate grant Agenda: To review and evaluate grant Bethesda, MD 20892–9606. 301–443–7861. [email protected]. applications. applications. Place: Renaissance, Washington, DC Hotel, Place: Hyatt Regency Bethesda, One This notice is being published less than 15 days prior to the meeting due to the timing 999 Ninth Street, NW., Washington, DC Bethesda Metro Center, 7400 Wisconsin 20001. Avenue, Bethesda, MD 20814. limitations imposed by the review and funding cycle. Contact Person: W. Ernest Lyons, PhD, Contact Person: Lorraine Gunzerath, PhD, Scientific Review Administrator, Scientific MBA, Scientific Review Administrator, (Catalogue of Federal Domestic Assistance Review Branch, NINDS/NIH/DHHS, National Institute on Alcohol Abuse and Program Nos. 93.242, Mental Health Research Neuroscience Center, 6001 Executive Blvd., Alcoholism, Office of Extramural Activities, Grants; 93.281, Scientist Development Suite 3208, MSC 9529, Bethesda, MD 20892– Extramural Project Review Branch, 5635 Award, Scientist Development Award for 9529, 301–496–4056. Fishers Lane, Room 3043, Bethesda, MD Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Name of Committee: National Institute of 20892–9304, 301–443–2369, Neurological Disorders and Stroke Initial Service Awards for Research Training, [email protected]. Review Group Neurological Sciences and National Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance Disorders C. Program Nos. 93.271, Alcohol Research Dated: January 13, 2006. Date: February 22, 2006. Career Development Awards for Scientists Anna Snouffer, Time: 8 a.m. to 5 p.m. and Clinicians; 93.272, Alcohol National Agenda: To review and evaluate grant Acting Director, Office of Federal Advisory Research Service Awards for Research applications. Committee Policy. Training; 93.273, Alcohol Research Programs; Place: Renaissance, Washington, DC Hotel, 93.891, Alcohol Research Center Grants, [FR Doc. 06–639 Filed 1–23–06; 8:45 am] 999 Ninth Street, NW., Washington, DC National Institutes of Health, HHS) BILLING CODE 4140–01–M 20001–4427.
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Contact Person: Andrea Sawczuk, DDS, the discussions could disclose Time: 9 a.m. to 4 p.m. PhD, Scientific Review Administrator, confidential trade secrets or commercial Agenda: To review and evaluate grant Scientific Review Branch, Division of property such as patentable material, applications. Extramural Research, NINDS/NIH/DHHS, and personal information concerning Place: Hyatt Regency Bethesda, One 6001 Executive Boulevard, Room #3208, Bethesda Metro Center, 7400 Wisconsin Bethesda, MD 20892, 301–496–0660, individuals associated with the contract Avenue, Bethesda, MD 20814. [email protected]. proposals, the disclosure of which Contact Person: Mark Swieter, PhD, Chief, Name of Committee: National Institute of would constitute a clearly unwarranted Training and Special Projects Review Branch, Neurological Disorders and Stroke Initial invasion of personal privacy. Office of Extramural Affairs, National Review Group Neurological Sciences and Name of Committee: National Institute of Institute on Drug Abuse, NIH, DHHS, 6101 Disorders A. Child Health and Human Development Executive Boulevard, Suite 220, Bethesda, Date: March 2–3, 2006. Special Emphasis Panel. Maintenance and MD 20892–8401. (301) 435–1389. Time: 8 a.m. to 5:30 p.m. Operation of a Chemical Synthesis Facility. [email protected]. Agenda: To review and evaluate grant Date: February 9, 2006. (Catalogue of Federal Domestic Assistance applications. Time: 12 p.m. to 1:30 p.m. Program Nos. 93.277, Drug Abuse Scientist Place: Villa Florence Hotel, 450 Powell St., Agenda: To review and evaluate contract Development Award for Clinicians, Scientist San Francisco, CA 94102. proposals. Development Awards, and Research Scientist Contact Person: Richard D. Crosland, PhD, Place: National Institutes of Health, 6100 Awards; 93.278, Drug Abuse National Scientific Review Administrator, Scientific Executive Boulevard, Room 5B01, Rockville, Research Service Awards for Research Review Branch, Division of Extramural MD 20852. (Telephone Conference Call). Training; 93.279, Drug Abuse Research Research, NINDS/NIH/DHHS Neuroscience Contact Person: Hameed Khan, PhD, Programs, National Institutes of Health, HHS) Center, 6001 Executive Blvd, Suite 3208, Scientific Review Administrator, Division of Dated: January 11, 2006. MSC 9529, Bethesda, MD 20892–9529, 301– Scientific Review, National Institute of Child 496–9223. Health and Human Development, NIH, 6100 Anna Snouffer, Name of Committee: National Institute of Executive Blvd., Room 5B01, Bethesda, MD Acting Director, Office of Federal Advisory Neurological Disorders and Stroke Initial 20892. 301–435–6902. [email protected]. Committee Policy. Review Group Neurological Sciences and (Catalogue of Federal Domestic Assistance [FR Doc. 06–651 Filed 1–23–06; 8:45 am] Disorders. Program Nos. 93.864, Population Research; BILLING CODE 4140–01–M Date: March 13–14, 2006. 93.865, Research for Mothers and Children; Time: 8 a.m. to 5 p.m. 93.929, Center for Medical Rehabilitation Agenda: To review and evaluate grant Research; 93.209, Contraception and DEPARTMENT OF HEALTH AND applications. Infertility Loan Repayment Program, National HUMAN SERVICES Place: Radisson Poco Diablo Resort, 1752 Institutes of Health, HHS) S. Hwy 179, Sedona, AZ 86336. Contact Person: Katherine M. Woodbury, Dated: January 11, 2006. National Institutes of Health PhD, Scientific Review Administrator, Anna Snouffer, Scientific Review Branch, NINDS/NIH/ Acting Director, Office of Federal Advisory National Institute on Drug Abuse; DHHS, Neuroscience Center, 6001 Executive Committee Policy. Notice of Closed Meetings Blvd, Suite 3208, MSC 9529, Bethesda, MD [FR Doc. 06–649 Filed 1–23–05; 8:45am] Pursuant to section 10(d) of the 20892–9529, 301–496–9223. BILLING CODE 4140–01–M Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance amended (5 U.S.C. Appendix 2), notice Program Nos. 93.853, Clinical Research is hereby given of the following Related to Neurological Disorders; 93.854, DEPARTMENT OF HEALTH AND meetings. Biological Basis Research in the HUMAN SERVICES Neuroscience, National Institutes of Health, The meetings will be closed to the HHS) public in accordance with the National Institutes of Health provisions set forth in sections Dated: January 13, 2006. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Anna Snouffer, National Institute on Drug Abuse; Notice of Closed Meeting as amended. The contract proposals and Acting Director, Office of Federal Advisory the discussions could disclose Committee Policy. Pursuant to section 10(d) of the confidential trade secrets or commercial [FR Doc. 06–642 Filed 1–23–06; 8:45 am] Federal Advisory Committee Act, as property such as patentable material, BILLING CODE 4140–01–M amended (5 U.S.C. Appendix 2), notice and personal information concerning is hereby given of the following individuals associated with the contract meeting. proposals, the disclosure of which DEPARTMENT OF HEALTH AND The meeting will be closed to the would constitute a clearly unwarranted HUMAN SERVICES public in accordance with the invasion of personal privacy. provisions set forth in sections National Institutes of Health Name of Committee: National Institute on 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Drug Abuse Special Emphasis Panel. National Institute of Child Health and as amended. The grant applications and Development of State-of-the-Art Mechanisms Human Development; Notice of Closed the discussions could disclose for Epidemiologial Research (Phase I SBIR). Meeting confidential trade secrets or commercial Date: January 26, 2006. property such as patentable material, Time: 10 a.m. to 12 p.m. Pursuant to section 10(d) of the and personal information concerning Agenda: To review and evaluate contract Federal Advisory Committee Act, as individuals associated with the grant proposals. amended (5 U.S.C. Appendix 2), notice applications, the disclosure of which Place: National Institutes of Health, 6101 is hereby given of the following would constitute a clearly unwarranted Executive Boulevard, Rockville, MD 20852. (Telephone Conference Call). meeting. invasion of personal privacy. Contact Person: Eric Zatman, Contract The meeting will be closed to the Name of Committee: National Institute on Review Specialist, Office of Extramural public in accordance with the Drug Abuse Special Emphasis Panel. affairs, National Institute on Drug Abuse, provisions set forth in sections Minority Institutions’ Drug Abuse Research NIH, DHHS, Room 220, MSC 8401, 6101 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Development Program (MIDARP) Meeting. Executive Boulevard, Bethesda, MD 20892– as amended. The contract proposal and Date: February 8, 2006. 8401. (301) 435–1438.
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This notice is being published less than 15 Agenda: to review and evaluate grant Contact Person: Gary J. Nabel, MD, PhD, days prior to the meeting due to the timing applications. Director, Vaccine Research Center, NIAID/ limitations imposed by the review and Place: Bethesda Marriott, 5151 Pooks Hill NIH, 40 Convent Drive, Bldg 40, Room 4502, funding cycle. Road, Bethesda, MD 20814. Bethesda, MD 20892. 401–496–1852. Name of Committee: National Institute on Contact Person: Annie Walker-Abbey, PhD, [email protected]. Drug Abuse Special Emphasis Panel. E- Scientific Review Administrator, Scientific (Catalogue of Federal Domestic Assistance Review Program, Division of Extramural Health Applications of Empirically Program Nos. 93.855, Allergy, Immunology, Activities, National Institute of Health/ Supported Therapies in English and/or and Transplantation Research; 93.856, Spanish. NIAID, 6700B Rockledge Drive, RM. 3266, Bethesda, MD 20892–7616, (301)–451–2671, Microbiology and Infectious Diseases Date: February 15, 2006. Research, National Institutes of Health, HHS) Time: 9 a.m. to 4 p.m. [email protected]. Agenda: To review and evaluate contract (Catalogue of Federal Domestic Assistance Dated: January 11, 2006. proposals. Program Nos. 93.855, Allergy, Immunology, Anna Snouffer, Place: Courtyard by Marriott Rockville, and Transplantation Research; 93.856, Acting Director, Office of Federal Advisory 2500 Research Boulevard, Rockville, MD Microbiology and Infectious Diseases Committee Policy. 20850. Research, National Institutes of Health, HHS) [FR Doc. 06–656 Filed 1–23–06; 8:45 am] Contact Person: Lyle Furr, Contract Review Dated: January 11, 2006. Specialist, Office of Extramural Affairs, BILLING CODE 4140–01–M National Institute on Drug Abuse, NIH, Anna Snouffer, DHHS, Room 220, MSC 8401, 6101 Executive Acting Director, Office of Federal Advisory Boulevard, Bethesda, MD 20892–8401. (301) Committee Policy. DEPARTMENT OF HEALTH AND 435–1439. lf33c.nih.gov. [FR Doc. 06–655 Filed 1–23–06; 8:45 am] HUMAN SERVICES (Catalogue of Federal Domestic Assistance BILLING CODE 4140–01–M Program Nos. 93.277, Drug Abuse Scientist National Institutes of Health Development Award for Clinicians, Scientist Development Awards, and Research Scientist DEPARTMENT OF HEALTH AND National Institute of Allergy and Awards; 93.278, Drug Abuse National HUMAN SERVICES Infectious Diseases; Notice of Closed Research Service Awards for Research Meeting Training; 93.279, Drug Abuse Research National Institutes of Health Programs, National Institutes of Health, HHS) Pursuant to section 10(d) of the Dated: January 11, 2006. National Institute of Allergy and Federal Advisory Committee Act, as Anna Snouffer, Infectious Diseases; Notice of Closed amended (5 U.S.C. Appendix 2), notice Acting Director, Office of Federal Advisory Meeting is hereby given of the following Committee Policy. meeting. Pursuant to section 10(d) of the [FR Doc. 06–653 Filed 1–23–06; 8:45 am] Federal Advisory Committee Act, as The meeting will be closed to the BILLING CODE 4140–01–M amended (5 U.S.C. Appendix 2), notice public in accordance with the is hereby given of a meeting of the provisions set forth in sections Board of Scientific Counselors, NIAID. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DEPARTMENT OF HEALTH AND as amended. The grant applications and HUMAN SERVICES The meeting will be closed to the public as indicated below in accordance the discussions could disclose confidential trade secrets or commercial National Institutes of Health with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended property such as patentable material, National Institute of Allergy and for the review, discussion, and and personal information concerning Infectious Diseases; Notice of Closed evaluation of individual intramural individuals associated with the grant Meeting programs and projects conducted by the applications, the disclosure of which National Institute of Allergy and would constitute a clearly unwarranted Pursuant to section 10(d) of the Infectious Diseases, including invasion of personal privacy. Federal Advisory Committee Act, as consideration of personnel Name of Committee: National Institute of amended (5 U.S.C. Appendix 2), notice qualifications and performance, and the Allergy and Infectious Diseases Special is hereby given of the following competence of individual investigators, Emphasis Panel; Units for HIV/AIDS Clinical meeting. the disclosure of which would Trials Network (1)—FRA–05–002. The meeting will be closed to the constitute a clearly unwarranted Date: February 14, 2006. public in accordance with the invasion of personal privacy. Time: 10 a.m. to 4 p.m. Agenda: To review and evaluate grant provisions set forth in sections Name of Committee: Board of Scientific 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. Counselors, NIAID; Vaccine Research Center, Place: National Institutes of Health, as amended. The grant applications and Board of Scientific Counselors. Rockledge 6700, 6700B Rockledge Drive, the discussion could disclose Date: January 30–31, 2006. Bethesda, MD 20817 (Telephone Conference Time: January 30, 2006, 1 p.m. to 7 p.m. confidential trade secrets or commercial Call). property such as patentable material, Agenda: To review and evaluate personal qualifications and performance, and Contact Person: Mary J. Homer, PhD, and personal information concerning Scientific Review Administrator, Scientific individuals associated with the grant competence of individual investigators. Place: National Institutes of Health, Review Program, National Institute of Allergy applications, the disclosure of which Vaccine Research Center, 40 Convent Drive, and Infectious Diseases, DEA/NIH/DHHS, would constitute a clearly unwarranted Bethesda, MD 20892. 6700–B Rockledge Drive MSC 7616 Room invasion of personal privacy. Time: January 31, 2006, 9 a.m. to 4:30 p.m. 3147, Bethesda, MD 20892. (301) 496–2550. Name of Committee: Microbiology, Agenda: To review and evaluate personal [email protected]. Infectious Diseases and AIDS Initial Review qualifications and performance, and (Catalogue of Federal Domestic Assistance Group Microbiology and Infectious Diseases competence of individual investigators. Program Nos. 93.855, Allergy, Immunology, Research Committee. Place: National Institutes of Health, and Transplantation Research; 93.856, Date: February 21–23, 2006. Vaccine Research Center, 40 Convent Drive, Microbiology and Infectious Diseases Time: 8 a.m. to 6 p.m. Bethesda, MD 20892. Research, National Institutes of Health, HHS)
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Dated: January 11, 2006. Agenda: To review and evaluate grant Agenda: To review and evaluate grant Anna Snouffer, applications. applications. Place: National Institutes of Health, Place: National Institutes of Health, 6120 Acting Director, Office of Federal Advisory Natcher Building, 45 Center Drive, Bethesda, Executive Blvd., Rockville, MD 20852. Committee Policy. MD 20892. (Telephone Conference Call). (Telephone Conference Call). [FR Doc. 06–657 Filed 1–23–06; 8:45 am] Contact Person: Raj K Krishnaraju, PhD, Contact Person: Stanley C. Oaks, PhD, BILLING CODE 4140–01–M MS, Scientific Review Administrator, Scientific Review Administrator, Division of Scientific Review Branch, National Inst of Extramural Activities, NIDCD, NIH, Dental & Craniofacial Research, National Executive Plaza South, Room 400C, 6120 DEPARTMENT OF HEALTH AND Institutes of Health, 45 Center Dr. Rm 4AN Executive Blvd-MSC 7180, Bethesda, MD HUMAN SERVICES 32J, Bethesda, MD 20892. 301–594–4864. 20892–7180. 301–496–8683. [email protected]. Name of Committee: National Institute of Name of Committee: National Institute on National Institutes of Health Dental and Craniofacial Research Special Deafness and Other Communications Emphasis Panel; 06–52, Review R21s. Disorders Special Emphasis Panel; National Institute of Dental & Date: Feburary 28, 2006. Translational Research (Laryngeal/Voice). Craniofacial Research; Notice of Time: 10:30 a.m. to 12:30 p.m. Date: February 14, 2006. Closed Meetings Agenda: To review and evaluate grant Time: 12:30 p.m. to 2 p.m. applications. Agenda: To review and evaluate grant Pursuant to section 10(d) of the Place: National Institutes of Health, applications. Federal Advisory Committee Act, as Natcher Building, 45 Center Drive, Bethesda, Place: National Institutes of Health, 6120 amended (5 U.S.C. Appendix 2), notice MD 20892. (Telephone Conference Call). Executive Blvd., Rockville, MD 20852. Contact Person: Raj K Krishnaraju, PhD, (Telephone Conference Call). is hereby given of the following MS, Scientific Review Administrator, Contact Person: Stanley C. Oaks, PhD, meetings. Scientific Review Branch, National Inst of Scientific Review Administrator, Division of The meetings will be closed to the Dental & Craniofacial Research, National Extramural Activities, NIDCD, NIH, public in accordance with the Institutes of Health, 45 Center Dr. Rm 4AN Executive Plaza South, Room 400C, 6120 provisions set forth in section 552b(c)(4) 32J, Bethesda, MD 20892. 301–594–4864. Executive Blvd-MSC 7180, Bethesda, MD 20892–7180. 301–496–8683. [email protected]. and 552b(c)(6), Title 5 U.S.C., as (Catalogue of Federal Domestic Assistance amended. The grant applications and Program Nos. 93.121, Oral Diseases and Name of Committee: Communication the discussions could disclose Disorders Research, National Institutes of Disorders Review Committee. confidential trade secrets or commercial Health, HHS) Date: February 15–16, 2006. Time: 8 a.m. to 5 p.m. property such as patentable material, Dated: January 11, 2006. Agenda: To review and evaluate grant and personal information concerning Anna Snouffer, applications. individuals associated with the grant Acting Director, Office of Federal Advisory Place: Wyndham Washington, DC, 1400 M applications, the disclosure of which Committee Policy. Street, NW., Washington, DC 20005. would constitute a clearly unwarranted Contact Person: Melissa J. Stick, PhD, [FR Doc. 06–661 Filed 1–23–06; 8:45 am] invasion of personal privacy. MPH, Chief, Scientific Review Branch, BILLING CODE 4140–01–M Scientific Review Branch, Division of Name of Committee: National Institute of Extramural Research, NIDCD/NIH, 6120 Dental and Craniofacial Research Special Executive Blvd., Bethesda, MD 20892. 301– Emphasis Panel; 06–51, Review R01. DEPARTMENT OF HEALTH AND 496–8683. Date: February 15, 2006. HUMAN SERVICES Name of Committee: National Institute on Time: 11 a.m. to 12 p.m. Deafness and Other Communications Agenda: To review and evaluate grant National Institutes of Health Disorders Special Emphasis Panel, Auditory applications. Neural Prostheses. Place: National Institutes of Health, National Institute on Deafness and Date: February 21, 2006. Natcher Building, 45 Center Drive, Bethesda, Other Communication Disorders; Time: 1 p.m. to 4 p.m. MD 20892. (Telephone Conference Call). Notice of Closed Meetings Agenda: To review and evaluate contract Contact Person: H. George Hausch, PhD, proposals. Acting Director, 45 Center Drive, Natcher Pursuant to section 10(d) of the Place: National Institutes of Health, 6120 Building, Rm. 4AN44F, National Inst. of Federal Advisory Committee Act, as Executive Blvd., Rockville, MD 20852. Dental & Craniofacial Research, National amended (5 U.S.C. Appendix 2), notice (Telephone Conference Call). Institutes of Health, Bethesda, MD 20892. Contact Person: Sheo Singh, PhD, (301) 594–2904. [email protected]. is hereby given of the following meetings. Scientific Review Administrator, Scientific Name of Committee: National Institute of The meetings will be closed to the Review Branch, Division of Extramural Dental and Craniofacial Research Special Activities, Executive Plaza South, Room Emphasis Panel; 06–46, Review R21s, R03s. public in accordance with the 400C, 6120 Executive Blvd., Bethesda, MD Date: February 22, 2006. provisions set forth in sections 20892. 301–496–8683. [email protected]. Time: 10:30 a.m. to 12:30 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Institute on Agenda: To review and evaluate grant as amended. The contract proposals and Deafness and Other Communications applications. the discussions could disclose Disorders Special Emphasis Panel; NIDCD Place: National Institutes of Health, confidential trade secrets or commercial R03 Review Meeting. Natcher Building, 45 Center Drive, Bethesda, property such as patentable material, Date: February 22–23, 2006. MD 20892, (Telephone Conference Call). and personal information concerning Time: 8 a.m. to 5 p.m. Contact Person: Raj K Krishnaraju, PhD, individuals associated with the contact Agenda: To review and evaluate grant MS, Scientific Review Administrator, applications. Scientific Review Branch, National Inst of proposals, the disclosure of which Place: The Watergate, 2650 Virginia Dental & Craniofacial Research, National would constitute a clearly unwarranted Avenue, NW., Washington, DC 20037. Institutes of Health, 45 Center Dr. Room 4AN invasion of personal privacy. Contact Person: Shiguang Yang, PhD, 32J, Bethesda, MD 20892. 301–594–4864. Name of Committee: National Institute on DVM, Scientific Review Administrator, Name of Committee: National Institute of Deafness and Other Communications Division of Extramural Activities, NIDCD, Dental and Craniofacial Research Special Disorders Special Emphasis Panel; NIH, 6120 Executive Blvd., Bethesda, MD Emphasis Panel; 06–47, Review R21s. Translational Research (BCI). 20892. 301–496–8683. Date: Feburary 24, 2006. Date: February 14, 2006. Name of Committee: National Institute on Time: 10:30 a.m. to 12:30 p.m. Time: 3 p.m. to 4 p.m. Deafness and Other Communications
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Disorders Special Emphasis Panel; Vestibular Dated: January 11, 2006. DEPARTMENT OF HEALTH AND Nerve Stimulation. Anna Snouffer, HUMAN SERVICES Date: February 22, 2006. Acting Director, Office of Federal Advisory Time: 1 p.m. to 3 p.m. Committee Policy. National Institutes of Health Agenda: To review and evaluate grant [FR Doc. 06–662 Filed 1–23–06; 8:45 am] applications. Center for Scientific Review; Notice of Place: National Institutes of Health, 6120 BILLING CODE 4140–01–M Closed Meetings Executive Blvd., Rockville, MD 20852. Pursuant to section 10(d) of the (Telephone Conference Call). Contact Person: Sheo Singh, PhD, DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as Scientific Review Administrator, Scientific HUMAN SERVICES amended (5 U.S.C. Appendix 2), notice Review Branch, Division of Extramural is hereby given of the following Activities, Executive Plaza South, Room National Institutes of Health meetings. 400C, 6120 Executive Blvd., Bethesda, MD The meetings will be closed to the 20892. 301–496–8683. [email protected]. National Library of Medicine; Notice of public in accordance with the provisions set forth in sections Name of Committee: National Institute on Closed Meeting Deafness and Other Communications 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Disorders Special Emphasis Panel; Pursuant to section 10(d) of the as amended. The grant applications and Translational Research (Aud/Oto/Balance). Federal Advisory Committee Act, as the discussions could disclose Date: February 23, 2006. amended (5 U.S.C. Appendix 2), notice confidential trade secrets or commercial Time: 1 p.m. to 4:30 p.m. is hereby given of the following property such as patentable material, Agenda: To review and evaluate grant meeting. and personal information concerning individuals associated with the grant applications. The meeting will be closed to the applications, the disclosure of which Place: National Institutes of Health, 6120 public in accordance with the Executive Blvd., Rockville, MD 20852. would constitute a clearly unwarranted provisions set forth in sections (Telephone Conference Call). invasion of personal privacy. Contact Person: Stanley C. Oaks, PhD, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and Name of Committee: Center for Scientific Scientific Review Administrator, Division of Review Special Emphasis Panel. High-End Extramural Activities, NIDCD, NIH, the discussions could disclose NMR Shared Instrumentation Grant Executive Plaza South, Room 400C, 6120 confidential trade secrets or commercial Applications. Executive Blvd-MSC 7180, Bethesda, MD property such as patentable material, Date: February 3, 2006. 20892–7180. 301–496–8683 [email protected]. and personal information concerning Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant Name of Committee: National Institute on individuals associated with the grant applications. Deafness and Other Communications applications, the disclosure of which Place: Clarion Hotel Bethesda Park, 8400 Disorders Special Emphasis Panel; Cochlear would constitute a clearly unwarranted Wisconsin Avenue, Bethesda, MD 20814. Implants. invasion of personal privacy. Contact Person: Sergei Ruvinov, PhD, Date: February 24, 2006. Scientific Review Administrator, Center for Name of Committee: Biomedical Library Time: 1 p.m. to 4 p.m. Scientific Review, National Institutes of Agenda: To review and evaluate grant and Informatics Review Committee. Health, 6701 Rockledge Drive, Room 4158, applications. Date: March 9–10, 2006. MSC 7806, Bethesda, MD 20892. 301–435– Place: National Institutes of Health, 6120 Time: March 9, 2006, 8 a.m. to 6 p.m. 1180. [email protected]. Executive Blvd., Rockville, MD 20852. Agenda: To review and evaluate grant Name of Committee: Surgical Sciences, (Telephone Conference Call). applications. Biomedical Imaging and Bioengineering Contact Person: Sheo Singh, PhD, Place: National Library of Medicine, Integrated Review Group. Medical Imaging Scientific Review Administrator, Scientific Building 38, Second Floor, Board Room, Study Section. Review Branch, Division of Extramural 8600 Rockville Pike, Bethesda, MD 20892. Date: February 9–10, 2006. Time: 8 a.m. to 5 p.m. Activities, Executive Plaza South, Room Time: March 10, 2006, 8 a.m. to 12 p.m. Agenda: To review and evaluate grant 400C, 6120 Executive Blvd., Bethesda, MD Agenda: To review and evaluate grant applications. 20892. 301–496–8683. [email protected]. applications. Place: Bahia Resort Hotel, 998 West Name of Committee: National Institute on Place: National Library of Medicine, Mission Bay Drive, San Diego, CA 92109. Deafness and Other Communications Building 38, Second Floor, Board Room, Contact Person: Eileen W. Bradley, DSC, Disorders Special Emphasis Panel; CDRC 8600 Rockville Pike, Bethesda, MD 20892. Scientific Review Administrator and Chief, Conflicts. Contact Person: Arthur A. Petrosian, PhD, Center for Scientific Review, National Date: February 28, 2006. Scientific Review Administrator, Division of Institutes of Health, 6701 Rockledge Drive, Room 5100, MSC 7854, Bethesda, MD 20892. Time: 1 p.m. to 5 p.m. Extramural Programs, National Library of (301) 435–1179. [email protected]. Agenda: To review and evaluate grant Medicine, 6705 Rockledge Drive, Suite 301, applications. Bethesda, MD 20892–7968. 301–496–4253. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Place: National Institutes of Health, 6120 [email protected]. Group. Biobehavioral Regulation, Learning Executive Blvd., Rockville, MD 20852. (Catalogue of Federal Domestic Assistance and Ethology Study Section. (Telephone Conference Call). Program Nos. 93.879, Medical Library Date: February 9–10, 2006. Contact Person: Sheo Singh, PhD, Assistance, National Institutes of Health, Time: 9 a.m. to 6 p.m. Scientific Review Administrator, Scientific HHS) Agenda: To review and evaluate grant Review Branch, Division of Extramural applications. Activities, Executive Plaza South, Room Dated: January 11, 2006. Place: The Fairmont Washington, DC, 2401 400C, 6120 Executive Blvd., Bethesda, MD Anna Snouffer, M Street, NW., Washington, DC 20037. 20892. 301–496–8683. [email protected]. Acting Director, Office of Federal Advisory Contact Person: Luci Roberts, PhD, Scientific Review Administrator, Center for Committee Policy. (Catalogue of Federal Domestic Assistance Scientific Review, National Institutes of Program Nos. 93.173, Biological Research [FR Doc. 06–654 Filed 1–23–06; 8:45 am] Health, 6701 Rockledge Drive, Room 3188, Related to Deafness and Communicative BILLING CODE 4140–01–M MSC 7848, Bethesda, MD 20892. 301–435– Disorders, National Institutes of Health, HHS) 0692. [email protected].
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Name of Committee: Center for Scientific Contact Person: Zhenya Li, PhD, Scientific Place: Wyndham Washington, DC, 1400 M Review Special Emphasis Panel. Surgery, Review Administrator, Center for Scientific Street, NW., Washington, DC 20005. Anesthesia, and Trauma Member Conflict. Review, National Institutes of Health, 6701 Contact Person: Morris I. Kelsey, PhD, Date: February 10, 2006. Rockledge Drive, Room 1113, MSC 7849, Scientific Review Administrator, Center for Time: 2:30 p.m. to 5 p.m. Bethesda, MD 20892. (301) 435–2417. Scientific Review, National Institutes of Agenda: To review and evaluate grant [email protected]. Health, 6701 Rockledge Drive, Room 6158, applications. Name of Committee: Center for Scientific MSC 7804, Bethesda, MD 20892. 301–435– Place: National Institutes of Health, 6701 Review Special Emphasis Panel. 1718. [email protected]. Rockledge Drive, Bethesda, MD 20892. Neurodegeneration, Neuroinflammation, Name of Committee: Oncological Sciences (Telephone Conference Call). Oxidative Stress and Mitochondria. Integrated Review Group. Cancer Genetics Contact Person: Roberto J. Matus, MD, Date: February 13–14, 2006. Study Section. Scientific Review Administrator, Center for Time: 8 a.m. to 4 p.m. Data: February 13–14, 2006. Scientific Review, National Institutes of Agenda: To review and evaluate grant Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 5108, applications. Agenda: To review and evaluate grant MSC 7854, Bethesda, MD 20892. 301–435– Place: One Washington Circle Hotel, One applications. 22204. [email protected]. Washington Circle, Washington, DC 20037. Place: Embassy Suites at the Chevy Chase Name of Committee: Musculoskeletal, Oral Contact Person: Carole L. Jelsema, PhD, Pavilion, 4300 Military Road, NW., and Skin Sciences Integrated Review Group. Chief and Scientific Review Administrator, Washington, DC 20015. Skeletal Biology Development and Disease MDCN Scientific Review Group, Center for Contact Person: Zhiqiang Zou, PhD, MD, Study Section. Scientific Review, National Institutes of Scientific Review Administrator, Center for Date: February 12–14, 2006. Health, 6701 Rockledge Drive, Room 4146, Scientific Review, National Institutes of Time: 8 a.m. to 5 p.m. MSC 7850, Bethesda, MD 20892. 301–435– Health, 6701 Rockledge Drive, Room 6190, Agenda: To review and evaluate grant 1248. [email protected]. MSC 7804, Bethesda, MD 20892. 301–451– applications. Name of Committee: Center for Scientific 0132. [email protected]. Place: Wyndham City Center Hotel, 1143 Review Special Emphasis Panel, Bridges to Name of Committee: Center for Scientific New Hampshire Ave., NW., Washington, DC the Future. Review Special Emphasis Panel. Member Date: February 13, 2006. 20037. Conflicts in Depression, Bipolar Disorder and Time: 8 a.m. to 6 p.m. Contact Person: Priscilla B. Chen, PhD, Social Phobia. Agenda: To review and evaluate grant Scientific Review Administrator, Center for Date: February 13, 2006. applications. Scientific Review, National Institutes of Time: 10 a.m. to 12 p.m. Health, 6701 Rockledge Drive, Room 4104, Place: The River Inn, 924 25th Street, NW., Washington, DC 20037. Agenda: To review and evaluate grant MSC 7814, Bethesda, MD 20892. 301–435– applications. 1787. [email protected]. Contact Person: Cathleen L. Cooper, PhD, Scientific Review Administrator, Center for Place: National Institutes of Health, 6701 Name of Committee: Cell Biology Scientific Review, National Institutes of Rockledge Drive, Bethesda, MD 20892. Integrated Review Group. Biology and Health, 6701 Rockledge Drive, Room 4208, (Telephone Conference Call). Diseases of the Posterior Eye. MSC 7812, Bethesda, MD 20892. 301–435– Contact Person: Dana Jeffrey Plude, PhD, Date: February 13–14, 2006. 3566. [email protected]. Scientific Review Administrator, Center for Time: 8 a.m. to 5:30 p.m. Scientific Review, National Institutes of Name of Committee: Digestive Sciences Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 3192, Integrated Review Group. Hepatobiliary applications. MSC 7848, Bethesda, MD 20892. 301–435– Pathophysiology Study Section. Place: Hyatt Regency Bethesda, One Date: February 13–14, 2006. 2309. [email protected]. Bethesda Metro Center, 7400 Wisconsin Time: 8 a.m. to 6:30 p.m. Name of Committee: Center for Scientific Avenue, Bethesda, MD 20814. Agenda: To review and evaluate grant Review Special Emphasis Panel. Skeletal Contact Person: Michael H. Chaitin, PhD, applications. Muscle Biology and Exercise Physiology: A Scientific Review Administrator, Center for Place: Hyatt Regency Bethesda, One Member Conflict Panel. Scientific Review, National Institutes of Bethesda Metro Center, 7400 Wisconsin Date: February 14, 2006. Health, 6701 Rockledge Drive, Room 5202, Avenue, Bethesda, MD 20814. Time: 11:30 a.m. to 3 p.m. MSC 7850, Bethesda, MD 20892. (301) 435– Contact Person: Rass M. Shayiq, PhD, Agenda: To review and evaluate grant 0910. [email protected]. Scientific Review Administrator, Center for applications. Name of Committee: Biobehavioral and Scientific Review, National Institutes of Place: National Institutes of Health, 6701 Behavioral Processes Integrated Review Health, 6701 Rockledge Drive, Room 2182, Rockledge Drive, Bethesda, MD 20892. Group. Moter Function, Speech and MSC 7818, Bethesda, MD 20892. 301–435– (Telephone Conference Call). Rehabilitation Study Section. 2359. [email protected]. Contact Person: Tamizchelvi Thyagarajan, Date: February 13–14, 2006. Name of Committee: Center for Scientific PhD, Scientific Review Administrator, Center Time: 8 a.m. to 6 p.m. Review Special Emphasis Panel. for Scientific Review, National Institutes of Agenda: To review and evaluate grant Computational Biophysics. Health, 6701 Rockledge Drive, Room 4016K, applications. Date: February 13, 2006. MSC 7814, Bethesda, MD 20892. 301–451– Place: Georgetown Suite, 1000 29th Street, Time: 8 a.m. to 6 p.m. 1327. [email protected]. NW., Washington, DC 20007. Agenda: To review and evaluate grant Name of Committee: Surgical Sciences, Contact Person: Biao Tian, PhD, Scientific applications. Biomedical Imaging and Bioengineering Review Administrator, Center for Scientific Place: The Watergate, 2650 Virginia Integrated Review Group. Surgery, Review, National Institutes of Health, 6701 Avenue, NW., Washington, DC 20037. Anesthesiology and Trauma Study Section. Rockledge Drive, Room 3089B, MSC 7848, Contact Person: George W. Chacko, PhD, Date: February 15–16, 2006. Bethesda, MD 20892. 301–402–4411. Scientific Review Administrator, Center for Time: 1 p.m. to 2 p.m. [email protected]. Scientific Review, National Institutes of Agenda: To review and evaluate grant Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room 4186, applications. Review Special Emphasis Panel. Targeting MSC 7849, Bethesda, MD 20892. 301–435– Place: Holiday Inn Georgetown, 2101 Disease Caused by Protein Misfolding or 1220. [email protected]. Wisconsin Avenue, NW., Washington, DC Misprocessing. Name of Committee: Oncological Sciences 20007. Date: February 13–14, 2006. Integrated Review Group. Drug Discovery Contact Person: Weihua Luo, PhD, MD, Time: 8 a.m. to 5 p.m. and Molecular Pharmacology Study Section. Scientific Review Administrator, Center for Agenda: To review and evaluate grant Date: February 13–14, 2006. Scientific Review, National Institutes of applications. Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 5114, Place: The Watergate, 2650 Virginia Agenda: To review and evaluate grant MSC 7854, Bethesda, MD 20892. 301–435– Avenue, NW., Washington, DC 20037. applications. 1170. [email protected].
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Name of Committee: Center for Scientific is hereby given of the following limitations imposed by the review and Review Special Emphasis Panel. Member meetings. funding cycle. SEP in Cell Biology. The meetings will be closed to the Name of Committee: Center for Scientific Date: February 15, 2006. public in accordance with the Review Special Emphasis Panel Biomedical Time: 1 p.m. to 2 p.m. provisions set forth in sections Computing and Health Informatics. Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: February 1–2, 2006. applications. Time: 8 a.m. to 5 p.m. Place: National Institutes of Health, 6701 as amended. The grant applications and Agenda: To review and evaluate grant Rockledge Drive, Bethesda, MD 20892. the discussions could disclose applications. (Telephone Conference Call). confidential trade secrets or commercial Place: National Institutes of Health, 6701 Contact Person: Alexandra M. Ainsztein, property such as patentable material, Rockledge Drive, Bethesda, MD 20891, PhD, Scientific Review Administrator, Center and personal information concerning (Virtual Meeting). for Scientific Review, National Institutes of individuals associated with the grant Contact Person: Bill Bunnag, PhD, Health, 6701 Rockledge Drive, Room 5114, applications, the disclosure of which Scientific Review Administration, Center for MSC 7840, Bethesda, MD 20892. 301–451– Scientific Review, National Institutes of 3848. [email protected]. would constitute a clearly unwarranted invasion of personal privacy. Health, 6701 Rockledge Drive, Room 5124, Name of Committee: Center for Scientific MSC 7854, Bethesda, MD 20892, (301) 435– Review Special Emphasis Panel. Gene Name of Committee: Center for Scientific 1177, [email protected]. Therapy and Inborn Errors. Review Special Emphasis Panel Software This notice is being published less than 15 Date: February 15–16, 2006. Development and Maintenance. days prior to the meeting due to the timing Time: 5 p.m. to 3:30 p.m. Date: January 17–18, 2006. limitations imposed by the review and Agenda: To review and evaluate grant Time: 7 p.m. to 5 p.m. funding cycle. applications. Agenda: To review and evaluate grant Name of Committee: Endocrinology, Place: The Fairmont Washington, DC, 2401 applications. Metabolism, Nutrition and Reproductive M Street, NW., Washington, DC, 20037. Place: Renaissance Mayflower Hotel, 1127 Sciences Integrated Review Group Integrative Contact Person: Richard Panniers, PhD, Connecticut Avenue, NW., Washington, DC and Clinical Endocrinology and 20036. Scientific Review Administrator, Center for Reproduction Study Section. Contact Person: Zhenya Li, PhD, Scientific Scientific Review, National Institutes of Date: February 2–3, 2006. Review Administrator, Center for Scientific Health, 6701 Rockledge Drive, Room 2212, Time: 8 a.m. to 5 p.m. Review, National Institutes of Health, 6701 MSC 7890, Bethesda, MD 20892. 301–435– Agenda: To review and evaluate grant Rockledge Drive, Room 1113, MSC 7849, 1741. [email protected]. applications. Bethesda, MD 20892, (301) 435–2417, Name of Committee: Endocrinology, Place: Holiday Inn Select Bethesda, 8120 [email protected]. Metabolism, Nutrition and Reproductive Wisconsin Avenue, Bethesda, MD 20814. This notice is being published less than 15 Sciences Integrated Review Group. Cellular Contact Person: Abubakar A. Shaikh, DVM, days prior to the meeting due to the timing Aspects of Diabetes and Obesity Study PhD, Scientific Review Administrator, Center Section. limitations imposed by the review and funding cycle. for Scientific Review, National Institutes of Date: February 15–17, 2006. Health, 6701 Rockledge Drive, Room 6168, Time: 7 p.m. to 5 p.m. Name of Committee: Center for Scientific MSC 7892, Bethesda, MD 20892, (301) 435– Agenda: To review and evaluate grant Review Special Emphasis Panel 1042, [email protected]. applications. Neuroimmune Mechanisms and Chronic This notice is being published less than 15 Place: Hyatt Regency Bethesda, One Fatigue Syndrome. days prior to the meeting due to the timing Bethesda Metro Center, 740 Wisconsin Date: January 26, 2006. limitations imposed by the review and Avenue, Bethesda, MD 20814. Time: 8:30 a.m. to 5 p.m. funding cycle. Contact Person: Ann A. Jerkins, PhD, Agenda: To review and evaluate grant Scientific Review Administrator, Center for applications. Name of Committee: Oncological Sciences Scientific Review, National Institutes of Place: National Institutes of Health, Integrated Review Group Tumor Progression Health, 6701 Rockledge Drive, Room 6154, Executive Plaza North, 6130 Executive Blvd., and Metastasis Study Section. MSC 7892, Bethesda, MD 20892. 301–435– Conference Rooms C & D, Rockville, MD Date: February 2–3, 2006. 4514. [email protected]. 20852. Time: 8 a.m. to 5 p.m. Contact Person: J. Terrell Hoffeld, PhD, Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance applications. Program Nos. 93.306, Comparative Medicine; DDS, Dental Officer, USPHS, Center for Scientific Review, National Institutes of Place: Holiday Inn Georgetown, 2101 93.333, Clinical Research, 93.306, 93.333, Wisconsin Avenue, NW., Washington, DC 93.337, 93.393–93.396, 93.837–93.844, Health, 6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 20892, 301–435– 20007. 93.846–93.878, 93.893, National Institutes of Contact Person: Martin L. Padarathsingh, Health, HHS) 1781, [email protected]. This notice is being published less than 15 PhD, Scientific Review Administrator, Center Dated: January 13, 2006. days prior to the meeting due to the timing for Scientific Review, National Institutes of Anna Snouffer, limitations imposed by the review and Health, 6701 Rockledge Drive, Room 6212, MSC 7804, Bethesda, MD 20892, (301) 435– Acting Director, Office of Federal Advisory funding cycle. 1717, [email protected]. Committee Policy. Name of Committee: Oncological Sciences This notice is being published less than 15 [FR Doc. 06–641 Filed 1–23–06; 8:45 am] Integrated Review Group Cancer Molecular Pathobiology Study Section. days prior to the meeting due to the timing BILLING CODE 4140–01–M Date: January 29–31, 2006. limitations imposed by the review and Time: 6 p.m. to 5 p.m. funding cycle. Agenda: To review and evaluate grant Name of Committee: Center for Scientific DEPARTMENT OF HEALTH AND applications. Review Special Emphasis Panel, Member HUMAN SERVICES Place: Latham Hotel, 3000 M Street, NW., Conflicts: Visual Processes ZRG1 IFCNA (03). Washington, DC 20007. Date: February 3, 2006. National Institutes of Health Contact Person: Elaine Sierra-Rivera, PhD, Time: 1 p.m. to 3 p.m. Scientific Review Administrator, Center for Agenda: To review and evaluate grant Center for Scientific Review; Notice of Scientific Review, National Institutes of applications. Closed Meetings Health, 6701 Rockledge Drive, Room 6184, Place: National Institutes of Health, 6701 MSC 7804, Bethesda, MD 20892, 301–435– Rockledge Drive, Bethesda, MD 20892, Pursuant to section 10(d) of the 1779, [email protected]. (Telephone Conference Call). Federal Advisory Committee Act, as This notice is being published less than 15 Contact Person: Christine L. Melchior, amended (5 U.S.C. Appendix 2), notice days prior to the meeting due to the timing PhD, Scientific Review Administrator, Center
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for Scientific Review, National Institutes of Contact Person: Marcia Steinberg, PhD, Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 5176, Scientific Review Administrator, Center for applications. MSC 7844, Bethesda, MD 20892, 301–435– Scientific Review, National Institutes of Place: Hyatt Regency Bethesda, One 1713, [email protected]. Health, 6701 Rockledge Drive, Room 5130, Bethesda Metro Center, 7400 Wisconsin This notice is being published less than 15 MSC 7840, Bethesda, MD 20892. (301) 435– Avenue, Bethesda, MD 20814. days prior to the meeting due to the timing 1023. [email protected]. Contact Person: Ghenima Dirami, PhD, limitations imposed by the review and Name of Committee: Digestive Sciences Scientific Review Administrator, Center for funding cycle. Integrated Review Group. Clinical and Scientific Review, National Institutes of (Catalogue of Federal Domestic Assistance Integrative Gastrointestinal Pathobiology Health, 6701 Rockledge Drive, Room 2159, Program Nos. 93.306, Comparative Medicine; Study Section. MSC 7818, Bethesda, MD 20892. 301–435– 93.333, Clinical Research, 93.306, 93.333, Date: February 6–7, 2006. 1321. [email protected].. 93.878, 93.337, 93.393–93.396, 93.837– Time: 8 a.m. to 5 p.m. Name of Committee: Center for Scientific 93.844, 93.846–93.892, 93.893, National Agenda: To review and evaluate grant Review Special Emphasis Panel. Chemistry/ Institutes of Health, HHS) applications. Biophysics Program Project. Place: Hyatt Regency Bethesda, One Date: February 6, 2006. Dated: January 11, 2006. Bethesda Metro Center, 7400 Wisconsin Time: 8:30 a.m. to 5 p.m. Anna Snouffer, Avenue, Bethesda, MD 20814. Agenda: To review and evaluate grant Acting Director, Office of Federal Advisory Contact Person: Mushtaq A. Khan, DVM, applications. Committee Policy. PhD, Scientific Review Administrator, Center Place: The Watergate, 2650 Virginia [FR Doc. 06–646 Filed 1–23–06; 8:45 am] for Scientific Review, National Institutes of Avenue, NW., Washington, DC 20037. Contact Person: Vonda K. Smith, PhD, BILLING CODE 4140–01–M Health, 6701 Rockledge Drive, Room 2176, MSC 7818, Bethesda, MD 20892. 301–435– Scientific Review Administrator, Center for 1778. [email protected]. Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4172, Name of Committee: Surgical Sciences, DEPARTMENT OF HEALTH AND MSC 7806, Bethesda, MD 20892. 301–435– Biomedical Imaging and Bioengineering HUMAN SERVICES 1789. [email protected].. Integrated Review Group. Bioengineering, Name of Committee: Integrative, National Institutes of Health Technology and Surgical Sciences Study Section. Functional and Cognitive Neuroscience Integrated Review Group. Center for Scientific Review; Notice of Date: February 6–7, 2006. Time: 8 a.m. to 5 p.m. Date: February 7–8, 2006. Closed Meetings Agenda: To review and evaluate grant Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant Pursuant to section 10(d) of the applications. Place: Holiday Inn Select Bethesda, 8120 applications. Federal Advisory Committee Act, as Place: Hyatt Regency Bethesda, 7400 amended (5 U.S.C. Appendix 2), notice Wisconsin Ave, Bethesda, MD 20814. Contact Person: Dharam S. Dhindsa, DVM, Wisconsin Avenue, Bethesda, MD 20814. is hereby given of the following PhD, Scientific Review Administrator, Center Contact Person: Michael A. Steinmetz, PhD, Scientific Review Administrator, Center meetings. for Scientific Review, National Institutes of for Scientific Review, National Institutes of The meetings will be closed to the Health, 6701 Rockledge Drive, Room 5110, Health, 6701 Rockledge Drive, Room 5172, public in accordance with the MSC 7854, Bethesda, MD 20892. (301) 435– MSC 7844. Bethesda, MD 20892. 301–435– provisions set forth in sections 1174. [email protected].. 1247. [email protected]. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: Digestive Sciences Name of Committee: Biological Chemistry as amended. The grant applications and Integrated Review Group. Gastrointestinal and Macromolecular Biophysics Integrated the discussion could disclose Cell and Molecular Biology Study Section. Review Group. Biochemistry and Biophysics confidential trade secrets or commercial Date: February 6–7, 2006. of Membranes Study Section. property such as patentable material, Time: 8 a.m. to 5 p.m. Date: February 7–8, 2006. and personal information concerning Agenda: To review and evaluate grant Time: 8:30 a.m. to 5 p.m. individuals associated with the grant applications. Agenda: To review and evaluate grant Place: Hyatt Regency Bethesda, One applications. applications, the disclosure of which Bethesda Metro Center, 7400 Wisconsin would constitute a clearly unwarranted Place: Churchill Hotel, 1914 Connecticut Avenue, Bethesda, MD 20814. Avenue, NW., Washington, DC 20009. invasion of personal privacy. Contact Person: Najma Begum, PhD, Contact Person: Nuria E. Assa-Munt, PhD, Name of Committee: Center for Scientific Scientific Review Administrator, Center for Scientific Review Administrator, Center for Review Special Emphasis Panel. Intercellular Scientific Review, National Institutes of Scientific Review, National Institutes of Interactions. Health, 6701 Rockledge Drive, Room 2175, Health, 6701 Rockledge Drive, Room 3120, Date: February 2–3, 2006. MSC 7818, Bethesda, MD 20892. 301–435– MSC 7806, Bethesda, MD 20892. (301) 451– Time: 8 a.m. to 6 p.m. 1243. [email protected].. 1323. [email protected]. Agenda: To review and evaluate grant Name of Committee: Oncological Sciences Name of Committee: Center for Scientific applications. Integrated Review Group. Review Special Emphasis Panel. Place: The Watergate, 2650 Virginia Date: February 6–7, 2006. Antimicrobial Agents Drug Discovery. Avenue, NW., Washington, DC 20037. Time: 8 a.m. to 5 p.m. Date: February 7, 2006. Contact Person: Raya Mandler, PhD, Agenda: To review and evaluate grant Time: 1 p.m. to 3 p.m. Scientific Review Administrator, Center for applications. Agenda: To review and evaluate grant Scientific Review, National Institutes of Place: The Watergate, 2650 Virginia applications. Health, 6701 Rockledge Drive, Room 5217, Avenue, NW., Washington, DC 20037. Place: National Institutes of Health, 6701 MSC 7840, Bethesda, MD 20892. (301) 402– Contact Person: Bo Hong, PhD, Scientific Rockledge Drive, Bethesda, MD 20892. 8228. [email protected]. Review Administrator, Center for Scientific (Telephone Conference Call). Name of Committee: Cell Biology Review, National Institutes of Health, 6701 Contact Person: Fouad A. El-Zaatari, PhD, Integrated Review Group. Membrane Biology Rockledge Drive, Room 6194, MSC 7804, Scientific Review Administrator, Center for and Protein Processing. Bethesda, MD 20892. 301–435–5879. Scientific Review, National Institutes of Date: February 2–3, 2006. [email protected].. Health, 6701 Rockledge Drive, Room 3206, Time: 8:30 a.m. to 4 p.m. Name of Committee: Regulatory Sciences MSC 7808, Bethesda, MD 20814–9692. (301) Agenda: To review and evaluate grant Integrated Review Group. Lung Injury, 435–1149. [email protected]. applications. Repair, and Remodeling Study Section. Name of Committee: Center for Scientific Place: Melrose Hotel, 2430 Pennsylvania Date: February 6–7, 2006. Review Special Emphasis Panel. Fetal Ave., NW., Washington, DC 20037. Time: 8 a.m. to 5 p.m. Alcohol Exposure.
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Date: February 7, 2006. Review, National Institutes of Health, 6701 Time: 8 a.m. to 3:30 p.m. Time: 1 p.m. to 2:30 p.m. Rockledge Drive, Room 5116, MSC 7854, Agenda: To review and evaluate grant Agenda: To review and evaluate grant Bethesda, MD 20892. 301–435–1171. applications. applications. [email protected]. Place: Churchill Hotel, 1914 Connecticut Place: National Institutes of Health, 6701 Name of Committee: Infectious Diseases Avenue, NW., Washington, DC 20009. Rockledge Drive, Bethesda, MD 20892. and Microbiology Integrated Review Group. Contact Person: Janet Nelson, PhD, (Telephone Conference Call). Pathogenic Eukaryotes Study Section. Scientific Review Administrator, Center for Contact Person: Christine L. Melchior, Date: February 9–10, 2006. Scientific Review, National Institutes of PhD, Scientific Review Administrator, Center Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 4168, for Scientific Review, National Institutes of Agenda: To review and evaluate grant MSC 7806, Bethesda, MD 20892. (301) 435– Health, 6701 Rockledge Drive, Room 5176, applications. 1723. [email protected]. MSC 7844, Bethesda, MD 20892. 301–435– Place: Holiday Inn Georgetown, 2101 Name of Committee: Integrative, 1713. [email protected]. Wisconsin Avenue, NW., Washington, DC Functional and Cognitive Neuroscience Name of Committee: Digestive Sciences 20007. Integrated Review Group. Integrated Review Group. Xenobiotic and Contact Person: Jean Hickman, PhD, Neuroendocrinology, Neuroimmunology, and Nutrient Disposition and Action Study Scientific Review Administrator, Center for Behavior Study Section. Section. Scientific Review, National Institutes of Date: February 9–10, 2006. Date: February 8–9, 2006. Health, 6701 Rockledge Drive, Room 3194, Time: 8 a.m. to 4:30 p.m. Time: 8 a.m. to 1 p.m. MSC 7808, Bethesda, MD 20892. 301–435– Agenda: To review and evaluate grant Agenda: To review and evaluate grant 1146. [email protected]. applications. applications. Name of Committee: Cell Biology Place: Hyatt Regency Bethesda, One Place: Wyndham City Center Hotel, 1143 Integrated Review Group. Cell Structure and Bethesda Metro Center, 7400 Wisconsin New Hampshire Ave., NW., Washington, DC Function. Avenue, Bethesda, MD 20814. 20037. Date: February 9–10, 2006. Contact Person: Michael Selmanoff, PhD, Contact Person: Patricia Greenwel, PhD, Time: 8 a.m. to 5:30 p.m. Scientific Review Administrator, Center for Scientific Review Administrator, Center for Agenda: To review and evaluate grant Scientific Review, National Institutes of Scientific Review, National Institutes of applications. Health, 6701 Rockledge Drive, Room 3134, Health, 6701 Rockledge Drive, Room 2174, Place: Hyatt Regency Baltimore on the MSC 7844, Bethesda, MD 20892. (301) 435– MSC 7818, Bethesda, MD 20892. 301–435– Inner Harbor, 300 Light Street, Baltimore, MD 1119. [email protected]. 1169. [email protected]. 21202. Name of Committee: Molecular, Cellular Name of Committee: Biological Chemistry Contact Person: Alexandra M. Ainsztein, and Developmental Neuroscience Integrated and Macromolecular Biophysics Integrated PhD, Scientific Review Administrator, Center Review Group. Neurotransporters, Receptors, Review Group. Synthetic and Biological for Scientific Review, National Institutes of and Calcium Signaling Study Section. Chemistry A Study Section. Health, 6701 Rockledge Drive, Room 5144, Date: February 9–10, 2006. Date: February 8–9, 2006. MSC 7840, Bethesda, MD 20892. 301–451– Time: 8 a.m. to 5:30 p.m. Time: 8 a.m. to 5 p.m. 3848. [email protected]. Agenda: To review and evaluate grant Agenda: To review and evaluate grant applications. Name of Committee: Integrative, applications. Place: Beacon Hotel and Corporate Functional and Cognitive Neuroscience Place: Renaissance Mayflower Hotel, 1127 Quarters, 1615 Rhode Island Avenue, NW., Integrated Review Group. Neurobiology of Connecticut Avenue, NW., Washington, DC Washington, DC 20036. Motivated Behavior Study Section. 20036. Contact Person: Robert Lees, PhD, Date: February 9–10, 2006. Contact Person: Peter B. Guthrie, PhD, Scientific Review Administrator, Center for Time: 8 p.m. to 5 p.m. Scientific Review Administrator, Center for Scientific Review, National Institutes of Agenda: To review and evaluate grant Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4182, applications. Health, 6701 Rockledge Drive, Room 4142, MSC 7806, Bethesda, MD 20892. (301) 435– Place: Hyatt Regency Bethesda, One MSC 7850, Bethesda, MD 20892. (301) 435– 2684. [email protected]. Bethesda Metro Center, 7400 Wisconsin 1239. [email protected]. Avenue, Bethesda, MD 20814. Name of Committee: Center for Scientific Name of Committee: Health of the Contact Person: Gamil C. Debbas, PhD, Review Special Emphasis Panel. Oral Population Integrated Review Group. Scientific Review Administrator, Center for Microbiology and Signal Transduction: A Community Influences on Health Behavior. Scientific Review, National Institutes of Member Conflict Panel. Date: February 9–10, 2006. Health, 6701 Rockledge Drive, Room 5170, Date: February 8, 2006. Time: 8:30 a.m. to 3 p.m. MSC 7844, Bethesda, MD 20892. (301) 435– Time: 12:30 p.m. to 3 p.m. Agenda: To review and evaluate grant 1018. [email protected]. Agenda: To review and evaluate grant applications. applications. Name of Committee: Molecular, Cellular Place: Washington Plaza Hotel, 10 Thomas Place: National Institutes of Health, 6701 and Developmental Neuroscience Integrated Circle, NW., Washington, DC 20005. Rockledge Drive, Bethesda, MD 20892. Review Group. Synapses, Cytoskeleton and Contact Person: Ellen K. Schwartz, EDD, (Telephone Conference Call). Trafficking Study Section. Scientific Review Administrator, Center for Contact Person: Tamizchelvi Thyagarajan, Date: February 9–10, 2006. Scientific Review, National Institutes of PhD, Scientific Review Administrator, Center Time: 8 a.m. to 4 p.m. Health, 6701 Rockledge Drive, Room 3168, for Scientific Review, National Institutes of Agenda: To review and evaluate grant MSC 7770, Bethesda, MD 20892, (301) 435– Health, 6701 Rockledge Drive, Room 4016K, applications. 0681, [email protected]. MSC 7814, Bethesda, MD 20892. 301–451– Place: Beacon Hotel and Corporate Name of Committee: Center for Scientific 1327. [email protected].. Quarters, 1615 Rhode Island Avenue, NW., Review Special Emphasis Panel, Infectious Name of Committee: Surgical Sciences, Washington, DC 20036. Disease, Reproductive Health, Asthma, and Biomedical Imaging and Bioengineering Contact Person: Jonathan K. Ivins, PhD, Pulmonary Epidemiology. Integrated Review Group. Biomedical Scientific Review Administrator, Center for Date: February 9–10, 2006. Imaging Technology Study Section. Scientific Review, National Institutes of Time: 8 a.m. to 5 p.m. Date: February 9–10, 2006. Health, 6701 Rockledge Drive, Room 4040A, Agenda: To review and evaluate grant Time: 8 a.m. to 5 p.m. MSC 7806, Bethesda, MD 20892. (301) 594– applications. Agenda: To review and evaluate grant 1245. [email protected]. Place: Sheraton Crystal City Hotel, 1800 applications. Name of Committee: Biological Chemistry Jefferson Davis Highway, Arlington, VA Place: Bahia Resort Hotel, 998 West and Macromolecular Biophysics Integrated 22202. Mission Bay Drive, San Diego, CA 02109. Review Group. Macromolecular Structure Contact Person: Sandra L. Melnick, DRPH, Contact Person: Lee Rosen, PhD, Scientific and Function A Study Section. Scientific Review Administrator, Center for Review Administrator, Center for Scientific Date: February 9–10, 2006. Scientific Review, National Institutes of
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Health, 6701 Rockledge Drive, Room 3028D, Dated: January 11, 2006. FOR FURTHER INFORMATION CONTACT: MSC 7770, Bethesda, MD 20892, (301) 435– Anna Snouffer, Steve Yonkers, Privacy Officer, US– 1251, [email protected]. Acting Director, Office of Federal Advisory VISIT, Department of Homeland Name of Committee: Biology of Committee Policy. Security, Washington, DC 20528, by Development and Aging Integrated Review [FR Doc. 06–647 Filed 1–23–06; 8:45 am] telephone (202) 298–5200 or facsimile Group, International and Cooperative BILLING CODE 4140–01–M (202) 298–5201; Maureen Cooney, Projects—1 Study Section. Acting Chief Privacy Officer, Date: February 9, 2006. Department of Homeland Security, Time: 9 a.m. to 3 p.m. DEPARTMENT OF HOMELAND Arlington, VA 22202 by telephone (571) Agenda: To review and evaluate grant 227–3813 or facsimile (571) 227–4171. applications. SECURITY Place: Holiday Inn Chevy Chase, 5520 SUPPLEMENTARY INFORMATION: On June Wisconsin Avenue, Chevy Chase, MD 20815. Office of the Secretary 16, 2005, the United States Visitor and Immigrant Status Indicator Technology Contact Person: Zakir Bengali, PhD, [DHS–2005–0056] Scientific Review Administrator, Center for (US–VISIT) Program announced its Scientific Review, National Institutes of Privacy Impact Assessment intention to conduct a live test of the Health, 6701 Rockledge Drive, Room 5150, technology required to read MSC 7842, Bethesda, MD 20892, (301) 435– AGENCY: Department of Homeland biometrically enabled travel documents 1116, [email protected]. Security, United States Visitor and that comply with international Name of Committee: Health of the Immigrant Status Indicator Technology standards. In connection with Phase I of Population Integrated Review Group, Program. that test, US–VISIT published a revised Community-Level Health Promotion Study ACTION: Notice of availability of Privacy version of its Privacy Impact Section. Impact Assessment. Assessment (PIA) addressing the Date: February 9–10, 2006. privacy concerns associated with the Time: 9 a.m. to 5 p.m. SUMMARY: The Department of Homeland live test. (70 FR 35110). Agenda: To review and evaluate grant Security intends to modify the United US–VISIT is now set to begin Phase applications States Visitor and Immigrant Status II of the live test, which will operate Place: Hotel Helix, 1430 Rhode Island Indicator Technology Program to from January 15, 2006, until April 15, Avenue, NW., Washington, DC 20005. conduct the second phase of a live test 2006. During Phase II, basic access Contact Person: William N. Elwood, PhD, of the technology required to read Scientific Review Administrator, Center for controls of e-Passports will be tested biometrically enabled travel documents against the selected U.S. document Scientific Review, National Institutes of that comply with international Health, 6701 Rockledge Drive, Room 3162, reader solution at one U.S. port of entry MSC 7770, Bethesda, MD 20892, (301) 435– standards. As a result, US–VISIT is and on international airport. Because 1503, [email protected]. revising its Privacy Impact Assessment the implementation of Phase II modifies to discuss the impact of Phase II of the Name of Committee: Center for Scientific the privacy risk associated with the US– live test on privacy. This revised Review Special Emphasis Panel, GRIP VISIT Program, the Department of Review. Privacy Impact Assessment is available publishing another update to its PIA. Date: February 9–10, 2006. on the Web site of the Privacy Office of The revised Privacy Impact Time: 3 p.m. to 5 p.m. the Department of Homeland Security, Assessment is available on the Web site Agenda: To review and evaluate grant http://www.dhs.gov/privacy, and on the of the Privacy Office of the Department applications US–VISIT Web site, http:// of Homeland Security, http:// Place: Holiday Inn Chevy Chase, 5520 www.dhs.gov/usvisit. It is also available www.dhs.gov/privacy, and on the US– Wisconsin Avenue, Chevy Chase, MD 20815. by written request to US–VISIT. VISIT Web site, http://www.dhs.gov/ Contact Person: Zakir Bengali, PhD, ADDRESSES: You may submit comments usvisit. It is also available by written Scientific Review Administrator, Center for on the revised Privacy Impact request to US–VISIT at the address Scientific Review, National Institutes of Assessment, identified by Docket provided above. Health, 6701 Rockledge Drive, Room 5150, Number DHS–2005–0056, by one of the MSC 7842, Bethesda, MD 20892, (301) 435– Dated: January 6, 2005. following methods: 1116, [email protected]. Maureen Cooney, • Federal eRulemaking Portal: http:// Name of Committee: Center for Scientific Acting Chief Privacy Officer, Department of www.regulations.gov. Follow the Homeland Security. Review Special Emphasis Panel, instructions for submitting comments. Bioengineering Research Partnerships. [FR Doc. E6–766 Filed 1–23–06; 8:45 am] • Fax: (202) 298–5201 (not a toll-free Date: February 10, 2006. BILLING CODE 4410–10–P Time: 8 a.m. to 5 p.m. number). • E-mail: [email protected]. Agenda: To review and evaluate grant • applications Mail: Steve Yonkers, Privacy DEPARTMENT OF HOMELAND Place: Bahia Resort Hotel, 998 West Officer, US–VISIT, Department of SECURITY Mission Bay Drive, San Diego, CA 92109. Homeland Security, Washington, DC Contact Person: Xiang-Ning Li, PhD, 20528. Coast Guard Scientific Review Administrator, Center for Instructions: All submissions received Scientific Review, National Institutes of must include the agency name and [USCG–2005–21093] Health, 6701 Rockledge Drive, Room 5112, docket number for this notice. All Notification of the Imposition of MSC 7854, Bethesda, MD 20892, (301) 435– comments received will be posted 1744, [email protected]. Conditions of Entry for Certain Vessels without change to http:// Arriving to the United States (Catalogue of Federal Domestic Assistance www.regulations.gov, including any Program Nos. 93.306, Comparative Medicine; personal information provided. AGENCY: Coast Guard, DHS. 93.333, Clinical Research, 93.306, 93.333, Docket: For access to the docket to ACTION: Notice of policy. 93.337, 93.393–93.396, 93.837–93.844, read background documents or 93.846–93.878, 93.892, 93.893, National comments received, go to http:// SUMMARY: The Coast Guard announces Institutes of Health, HHS) www.regulations.gov. that effective anti-terrorism measures
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are not in place in certain ports of exceeded and/or minimum hours of rest ADDRESSES: Vessel owners or operators Equatorial Guinea and that it will are met, or provided by outside security must send written requests for impose conditions of entry on vessels forces approved by the ship’s master extensions to the local Officer in Charge, arriving from that country. The Coast and Company Security Officer; Marine Inspection (OCMI) for Guard also announces that conditions of • Attempt to execute a Declaration of consideration. entry are being removed from vessels Security; arriving from ports in the Democratic • Log all security actions in the ship’s FOR FURTHER INFORMATION CONTACT: If Republic of Congo. log; you have questions regarding this notice, contact Lieutenant Commander DATES: The policy announced in this • Report actions taken to the Brian J. Downey, Office of Vessel notice is effective on February 7, 2006. cognizant U.S. Coast Guard Captain of the Port prior to arrival into U.S. waters; Activities (G–PCV–1), by telephone ADDRESSES: The Docket Management 202–267–0495, fax 202–267–4394, or e- Facility maintains the public docket for and • mail [email protected]. If you this notice. This notice will be available Ensure that each access point to the ship is guarded by armed, private have questions on viewing to the for inspection or copying at room PL– docket, call Ms. Renee V. Wright, 401 on the Plaza level of the Nassif security guards and that they have total visibility of the exterior (both landside Program Manager, Docket Operations, Building, 400 Seventh Street, SW., telephone 202–493–0402. Washington, DC, between 9 a.m. and 5 and waterside) of the vessel while in p.m., Monday through Friday, except U.S. ports. The number and position of SUPPLEMENTARY INFORMATION: the guards has to be acceptable to the Federal holidays. You may also find this Background docket, including this notice, on the Coast Guard Captain of the Port. Internet at http://dms.dot.gov.. Based on recent information, the Following the devastation of FOR FURTHER INFORMATION CONTACT: If Coast Guard is removing the conditions Hurricane Katrina that struck the U.S. you have questions on this notice, call of entry announced in its previously Gulf Coast on August 29, 2005, the Mr. Mike Brown, Coast Guard, published Notice of Policy (70 FR Coast Guard mounted an unprecedented telephone 202–267–4330. 22668) for the Democratic Republic of emergency response. Urgent Congo. reprioritization of Coast Guard missions SUPPLEMENTARY INFORMATION: With this notice, the current list of and reallocation of resources was Background and Purpose countries not maintaining effective anti- required to effectively manage the Section 70110 of the Maritime terrorism measures is as follows: regional response. In an effort to reduce Transportation Security Act provides Equatorial Guinea, Guinea-Bissau, the impact to the marine industry that the Secretary of Homeland Security Liberia, and Mauritania. because of the Coast Guard’s hurricane may impose conditions of entry into the January 10, 2006. response measures, Congress authorized United States from ports that are not Craig E. Bone, temporary vessel inspection regulatory maintaining effective anti-terrorism Rear Admiral, U.S. Coast Guard, Assistant relief through H.R. 4508. measures. The Coast Guard has been Commandant for Prevention, Acting. Policy delegated the authority by the Secretary [FR Doc. E6–756 Filed 1–23–06; 8:45 am] to carry out the provisions of this BILLING CODE 4910–15–P Vessel owners or operators must send section. The Docket contains previous written requests for extensions to the notices imposing or removing local Officer in Charge, Marine conditions of entry on vessels arriving DEPARTMENT OF HOMELAND Inspection (OCMI) for consideration. from certain countries and those SECURITY OCMIs, at their discretion, may extend conditions of entry and the countries expiration dates for Certificates of they pertain to remain in effect unless Coast Guard Inspection (COIs) and Certificates of Compliance (COCs) that will expire modified by this notice. [USCG–2006–23652] The Coast Guard has determined that before February 28, 2006. Extensions are ports, with certain exceptions, in Temporary Authorization To Extend only authorized in cases where the Equatorial Guinea are not maintaining Certificates of Inspection and OCMI lacks resources to provide timely effective anti-terrorism measures. Certificates of Compliance service or in cases where vessel Accordingly, effective February 7, 2006, operators clearly document that an the Coast Guard will impose the AGENCY: Coast Guard, DHS. extension is required to provide direct/ following conditions of entry on vessels ACTION: Notice of policy. emergent hurricane relief efforts. that visited ports in Equatorial Guinea Vessels, not normally inspected in with the exception of Punta Europa, K– SUMMARY: The Coast Guard announces Alabama, Mississippi or Louisiana are 5, Luba, Zafiro, and Ceiba during their that Congress authorized (through H.R. not eligible for extension. Vessels with last five port calls. Vessels must: 4508), the Secretary of Homeland certificates expiring after February 28, • Implement measures per the ship’s Security to extend temporarily the 2006 are not eligible for extension. security plan equivalent to Security duration or the validity of Certificates of Vessel owner/operator requests should Level 2; Inspection and Certificates of define the length of extension required • Ensure that each access point to the Compliance that are issued under (not to exceed 90 days), outline the ship is guarded and that the guards have chapter 33 or 37, respectively, of title cause for the extension, and should total visibility of the exterior (both 46, U.S. Code. These certificates may be attest to the vessel’s substantial landside and waterside) of the vessel extended for up to three (3) months for compliance with applicable inspection while the vessel is in ports in the above any vessel inspected by the Coast Guard regulations. OCMIs must authorize all countries. Guards may be provided by in Alabama, Mississippi, or Louisiana. extensions with official correspondence the ship’s crew, however additional DATES: This temporary extension to the requester detailing the extended crewmembers should be placed on the authorization for the Secretary of expiration date. Vessels operating with ship if necessary to ensure that limits on Homeland Security expires on February expired COIs and COCs without a maximum hours of work are not 28, 2006. written extension are in violation of
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applicable vessel inspection laws and would occur at Champlain, New York; In a General Notice published in the can be subject to enforcement action. Detroit, Michigan; Laredo, Texas; Otay Federal Register (70 FR 60096) on Dated: January 13, 2006. Mesa, California; and Port Huron, October 14, 2005, CBP announced that Craig E. Bone, Michigan, on dates to be announced. the test was to be further deployed in a The notice stated that the Bureau of cluster of ports, in the State of Rear Admiral, U.S. Coast Guard, Acting Assistant Commandant for Prevention. Customs and Border Protection (CBP) Michigan, no earlier than the dates would announce the implementation indicated as follows (all in the year [FR Doc. E6–754 Filed 1–23–06; 8:45 am] and sequencing of truck manifest 2005): Windsor Tunnel, October 4; BILLING CODE 4910–15–P functionality at these ports as they occur Barge Transport, October 5; Ambassador and further stated that additional Bridge, October 7; Port Huron, October DEPARTMENT OF HOMELAND participants and ports would be selected 14; Marine City, October 18; Algonac, SECURITY throughout the duration of the test. The October 18; and Sault St. Marie, October test is to be expanded eventually to 28. No port in this cluster was Bureau of Customs and Border include ACE Truck Carrier Account designated as a ‘‘model port.’’ Protection participants at all land border ports, and subsequent releases of ACE will include New Clusters Automated Commercial Environment all modes of transportation. Through this notice, CBP announces (ACE): National Customs Automation the next two clusters of ports to be Implementation of the Test Program Test of Automated Truck brought up for purposes of Manifest for Truck Carrier Accounts; The test commenced in Blaine, implementation of the test. The test will Deployment Schedule Washington in December 2004, but not be deployed at the following cluster of at Buffalo, New York. In light of ports no earlier than January 2006: Eagle AGENCY: Customs and Border Protection; experience with the implementation of Pass, Texas and Del Rio, Texas. The test Department of Homeland Security. the test in Blaine, Washington, CBP will also be deployed no earlier than ACTION: General notice. decided to change the implementation January 2006 at the following cluster of schedule and published a General SUMMARY: The Bureau of Customs and ports: Brownsville, Texas; Pharr, Texas; Notice in the Federal Register on May Border Protection, in conjunction with Progresso, Texas; Rio Grande City, 31, 2005 (70 FR 30964) announcing the the Department of Transportation, Texas; and Roma, Texas. No ports in changes. Federal Motor Carrier Safety these clusters are designated as ‘‘model As noted in the May 31, 2005, General ports.’’ Administration, is currently conducting Notice, the next deployment sites will a National Customs Automation be brought up as clusters. In some Previous NCAP Notices Not Concerning Program (NCAP) test concerning the instances, one site in the cluster will be Deployment Schedules transmission of automated truck identified as the ‘‘model site’’ or ‘‘model On Monday, March 21, 2005, a manifest data. This document port’’ for the cluster. This deployment announces the next two groups, or General Notice was published in the strategy will allow for more efficient Federal Register (70 FR 13514) clusters, of ports to be deployed for this equipment set-up, site checkouts, port test. announcing a modification to the NCAP briefings and central training. test to clarify that all relevant data DATES: Effective Dates: The ports The ports identified belonging to the elements are required to be submitted in identified in this notice, in the state of first cluster announced in the May 31, the automated truck manifest Texas, are expected to deploy in two 2005, notice included the original port submission. That notice did not clusters no earlier than January 2006, as of implementation: Blaine, Washington. announce any change to the deployment provided in this notice. Comments Sumas, Washington, was designated as schedule and is not affected by concerning this notice and all aspects of the model port. The other ports of publication of this notice. All the announced test may be submitted at deployment in the cluster included the requirements and aspects of the test, as any time during the test period. following: Point Roberts, WA; Oroville, set forth in the September 13, 2004 FOR FURTHER INFORMATION CONTACT: Mr. WA (including sub ports); Boundary, notice, as modified by the March 21, James Swanson via e-mail at WA; Danville, WA; Ferry, WA; Frontier, 2005 notice, continue to be applicable. [email protected]. WA; Laurier, WA; Metaline Falls, WA; Dated: January 12, 2006. SUPPLEMENTARY INFORMATION: Nighthawk, WA; and Lynden, WA. In a notice published in the Federal William S. Heffelfinger III, Background Register (70 FR 43892) on July 29, 2005, Acting Assistant Commissioner, Office of The National Customs Automation CBP announced that the test was being Field Operations. Program (NCAP) test concerning the further deployed, in two clusters, at [FR Doc. 06–620 Filed 1–23–06; 8:45 am] transmission of automated truck ports in the States of Arizona and North BILLING CODE 9111–14–P manifest data for truck carrier accounts Dakota. CBP stated that the test would was announced in a General Notice be deployed at the following ports in published in the Federal Register (69 Arizona as of July 25, 2005: Douglas, DEPARTMENT OF HOMELAND FR 55167) on September 13, 2004. That AZ; Naco, AZ; Lukeville, AZ; Sasabe, SECURITY AZ; and Nogales, AZ. Douglas, AZ was notice stated that the test of the U.S. Citizenship and Immigration designated as the model port. The test Automated Truck Manifest would be Services conducted in a phased approach, with was also to be deployed, according to primary deployment scheduled for no information provided in the notice, at Agency Information Collection earlier than November 29, 2004. The the following ports in North Dakota as Activities: Extension of a Currently document identified the ports of Blaine, of August 15, 2005: Pembina, ND; Approved Information Collection; Washington, and Buffalo, New York, as Neche, ND; Noyes, ND; Walhalla, ND; Comment Request the original deployment sites. Maida, ND; Hannah, ND; Sarles, ND; The September 13, 2004, notice stated and Hansboro, ND. Pembina, ND, was ACTION: 30-Day Notice of Information that subsequent deployment of the test designated as the model port. Collection Under Review; Monthly
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Report Naturalization Papers; Form N– (1) Type of Information Collection: DEPARTMENT OF HOMELAND 4. OMB Control No. 1615–0051. Extension of an existing information SECURITY collection. The Department of Homeland U.S. Citizenship and Immigration (2) Title of the Form/Collection: Security, U.S. Citizenship and Services Monthly Report Naturalization Papers. Immigration Services (USCIS) has submitted the following information (3) Agency form number, if any, and Agency Information Collection collection request to the Office of the applicable component of the Activities: Extension of a Currently Management and Budget (OMB) for Department of Homeland Security Approved Information Collection; review and clearance in accordance sponsoring the collection: Form N–4; Comment Request with the Paperwork Reduction Act of U.S. Citizenship and Immigration ACTION: 30-Day Notice of Information 1995. The information collection was Services. Collection Under Review; USCIS Case previously published in the Federal (4) Affected public who will be asked Register on November 22, 2005, at 70 Status Service Online; OMB Control or required to respond, as well as a brief Number 1615–0080. FR 70631. The notice allowed for a 60- abstract: Primary: Federal, State or local day public comment period. No Governments. Section 339 of the The Department of Homeland comments were received on this Immigration and Nationality Act (Act) Security, U.S. Citizenship and information collection. requires that the clerk of each court that Immigration Services (USCIS) has The purpose of this notice is to allow administers the oath of allegiance notify submitted the following information an additional 30 days for public the U.S. Citizenship and Immigration collection request to the Office of comments. Comments are encouraged Services (USCIS) of all persons to whom Management and Budget (OMB) for and will be accepted until February 23, the oath of allegiance for naturalization review and clearance in accordance 2006. This process is conducted in with the Paperwork Reduction Act of is administered, within 30 days after the accordance with 5 CFR 1320.10. 1995. The information collection was close of the month in which the oath Written comments and/or suggestions previously published in the Federal was administered. This form provides a regarding the item(s) contained in this Register on November 22, 2005, at 70 format for submitting a list of those notice, especially regarding the FR 70631. The notice allowed for a 60- persons to USCIS and provides estimated public burden and associated day public comment period. No response time, should be directed to the accountability for the delivery of the comments were received on this Department of Homeland Security certificates of naturalization as required information collection. (DHS), USCIS, Director, Regulatory under that section of law. The purpose of this notice is to allow Management Division, Clearance Office, (5) An estimate of the total number of an additional 30 days for public 111 Massachusetts Avenue, 3rd floor, respondents and the amount of time comments. Comments are encouraged Washington, DC 20529. Comments may estimated for an average respondent to and will be accepted until February 23, also be submitted to DHS via facsimile respond: 160 respondents at 12 2006. This process is conducted in to 202–272–8352 or via e-mail at responses annually at 30 minutes (.50) accordance with 5 CFR 1320.10. [email protected]. When submitting per response. Written comments and/or suggestions comments by e-mail please make sure to regarding the item(s) contained in this (6) An estimate of the total public add OMB Control Number 1615–0051 in notice, especially regarding the burden (in hours) associated with the the subject box. Written comments and estimated public burden and associated suggestions from the public and affected collection: 960 annual burden hours. response time, should be directed to the agencies should address one or more of If you have additional comments, Department of Homeland Security the following four points: suggestions, or need a copy of the (DHS), USCIS, Director, Regulatory (1) Evaluate whether the collection of proposed information collection Management Division, Clearance Office, information is necessary for the proper instrument with instructions, or 111 Massachusetts Avenue, 3rd floor, performance of the functions of the additional information, please visit the Washington, DC 20529. Comments may agency, including whether the USCIS Web site at: http://uscis.gov/ also be submitted to DHS via facsimile information will have practical utility; graphics/formsfee/forms/pra/index.htm. to 202–272–8352 or via e-mail at [email protected]. When submitting (2) Evaluate the accuracy of the If additional information is required comments by e-mail please make sure to agencies estimate of the burden of the contact: USCIS, Regulatory Management add OMB Control Number 1615–0080 in collection of information, including the Division, 111 Massachusetts Avenue, the subject box. Written comments and validity of the methodology and 3rd Floor, Washington, DC 20529, (202) suggestions from the public and affected assumptions used; 272–8377. agencies should address one or more of (3) Enhance the quality, utility, and Dated: January 17, 2006. the following four points: clarity of the information to be Richard A. Sloan, (1) Evaluate whether the collection of collected; and information is necessary for the proper (4) Minimize the burden of the Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. performance of the functions of the collection of information on those who agency, including whether the [FR Doc. 06–560 Filed 1–23–06; 8:45 am] are to respond, including through the information will have practical utility; use of appropriate automated, BILLING CODE 4410–10–P (2) Evaluate the accuracy of the electronic, mechanical, or other agencies estimate of the burden of the technological collection techniques or collection of information, including the other forms of information technology, validity of the methodology and e.g., permitting electronic submission of assumptions used; responses. (3) Enhance the quality, utility, and Overview of this information clarity of the information to be collection: collected; and
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(4) Minimize the burden of the ACTION: Notice. manage public housing and is used for collection of information on those who operating purposes. are to respond, including through the SUMMARY: The proposed information Agency form numbers, if applicable: use of appropriate automated, collection requirement described below None. electronic, mechanical, or other will be submitted to the Office of Members of affected public: State or technological collection techniques or Management and Budget (OMB) for Local Government; individuals or other forms of information technology, review, as required by the Paperwork households. e.g., permitting electronic submission of Reduction Act. The Department is Estimation of the total number of responses. soliciting public comments on the hours needed to prepare the information Overview of this information subject proposal. collection including number of collection: DATES: Comments Due Date: March 27, respondents, frequency of response, and (1) Type of Information Collection: 2006. hours of response: 3,330 responses, one Extension of an existing information ADDRESSES: Interested persons are time for new and modified leases, 48 collection. invited to submit comments regarding average hours per response, 158,400 (2) Title of the Form/Collection: this proposal. Comments should refer to hours total recordkeeping burden. USCIS Case Status Service Online. the proposal by name and/or OMB Status of the proposed information (3) Agency form number, if any, and Control number and should be sent to: collection: Reinstatement, without the applicable component of the Aneita Waites, Reports Liaison Officer, change. Department of Homeland Security Public and Indian Housing, Department sponsoring the collection: No Agency Authority: Section 3506 of the Paperwork of Housing and Urban Development, Form No. (File No. OMB–33). U.S. Reduction Act of 1995, 44 U.S.C. Chapter 35, 451 7th Street, SW., Room 4116, Citizenship and Immigration Services. as amended. (4) Affected public who will be asked Washington, DC 20410–5000. Dated: January 18, 2006. or required to respond, as well as a brief FOR FURTHER INFORMATION CONTACT: Bessy Kong, abstract: Primary: Individuals or Aneita Waites, (202) 708–0713, Deputy Assistant Secretary, Office of Policy, households. This system allows extension 4114. (This is not a toll-free Program and Legislative Initiative. individuals or their representatives to number). [FR Doc. E6–817 Filed 1–23–06; 8:45 am] SUPPLEMENTARY INFORMATION request case status of their pending : The BILLING CODE 4210–33–P application through USCIS’ Web site. Department will submit the proposed (5) An estimate of the total number of information collection to OMB for respondents and the amount of time review, as required by the Paperwork DEPARTMENT OF HOUSING AND estimated for an average respondent to Reduction Act of 1995 (44 U.S.C. URBAN DEVELOPMENT respond: 24,000,000 respondents at 23⁄4 Chapter 35, as amended). minutes (.046) per response. This Notice is soliciting comments [Docket No. FR 5044–N–02] (6) An estimate of the total public from members of the public and affected burden (in hours) associated with the agencies concerning the proposed Notice of Proposed Information collection: 1,104,000 annual burden collection of information to: (1) Evaluate Collection for Public Comment hours. whether the proposed collection of Screening and Eviction for Drug Abuse If you have additional comments, information is necessary for the proper and Other Criminal Activity suggestions, or need a copy of the performance of the functions of the AGENCY: Office of the Assistant proposed information collection agency, including whether the instrument with instructions, or Secretary for Public and Indian information will have practical utility; Housing, HUD. additional information, please visit the (2) evaluate the accuracy of the agency’s ACTION: USCIS Web site at: http://uscis.gov/ estimate of the burden of the proposed Notice. graphics/formsfee/forms/pra/index.htm. collection of information; (3) enhance If additional information is required SUMMARY: The proposed information the quality, utility, and clarity of the collection requirement described below contact: USCIS, Regulatory Management information to be collected; and (4) Division, 111 Massachusetts Avenue, will be submitted to the Office of minimize the burden of the collection of Management and Budget (OMB) for 3rd Floor, Washington, DC 20529, (202) information on those who are to 272–8377. review, as required by the Paperwork respond, including through the use of Reduction Act. The Department is Dated: January 17, 2006. appropriate automated collection soliciting public comments on the Richard A. Sloan, techniques or other forms of information subject proposal. Director, Regulatory Management Division, technology; e.g., permitting electronic DATES: Comments Due Date: March 27, U.S. Citizenship and Immigration Services. submission of responses. 2006. [FR Doc. 06–561 Filed 1–23–06; 8:45 am] This Notice also lists the following ADDRESSES: BILLING CODE 4410–10–P information: Interested persons are Title of Proposal: Lease invited to submit comments regarding Requirements—24 CFR 966.4, this proposal. Comments should refer to DEPARTMENT OF HOUSING AND Recordkeeping. the proposal by name/or OMB Control URBAN DEVELOPMENT OMB Control Number: 2577–0006. number and should be sent to: Aneita Description of the need for the Waites, Reports Liaison Officer, Public [Docket No. FR–5044–N–01] information and proposed use: The and Indian Housing, Department of Housing and Urban Development, 451 Notice of Proposed Information collection of information is contained in HUD regulations at 24 CFR 966.4. Public 7th Street, SW., Room 4116, Collection for Public Comment—Lease Washington, DC 20410–5000. Requirements, Recordkeeping Housing Agencies (PHAs) are required to keep records for implementation of FOR FURTHER INFORMATION CONTACT: AGENCY: Office of the Assistant Federal regulations governing dwelling Aneita L. Waites, (202) 708–0713, Secretary for Public and Indian leases in public housing. The extension 4114, for copies of the Housing, HUD. information is retained by the PHAs that proposed forms and other available
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documents (This is not a toll-free Status of the proposed information the avenues to inform the public of the number). collection: Extension. date and time for the meeting. SUPPLEMENTARY INFORMATION: The Authority: Section 3506 of the Paperwork Individuals wishing to comment on the Department will submit the proposed Reduction Act of 1995, 44 U.S.C. Chapter 35, Draft Comprehensive Conservation Plan information collection to OMB for as amended. and Environmental Assessment for review, as required by the Paperwork Dated: January 18, 2006. Choctaw National Wildlife Refuge should do so no later than March 10, Reduction Act of 1995 (44 U.S.C. Bessy Kong, 2006. Chapter 35, as amended). Deputy Assistant Secretary, Office of Policy, This Notice is soliciting comments Program and Legislative Initiatives. ADDRESSES: Requests for copies of the from members of the public and affected [FR Doc. E6–819 Filed 1–23–06; 8:45 am] Draft Comprehensive Conservation Plan agencies concerning the proposed BILLING CODE 4210–33–P and Environmental Assessment should collection of information to: (1) Evaluate be addressed to Choctaw National whether the proposed collection of Wildlife Refuge, P.O. Box 808, Jackson, information is necessary for the proper Alabama 36545; Telephone 251/246– DEPARTMENT OF THE INTERIOR performance of the functions of the 3583. The plan and environmental agency, including whether the Fish and Wildlife Service assessment may also be accessed and information will have practical utility; downloaded from the Service’s Internet (2) evaluate the accuracy of the agency’s Choctaw National Wildlife Refuge Web site http://southeast.fws.gov/ estimate of the burden of the proposed planning/. Comments on the draft plan collection of information; (3) enhance AGENCY: Fish and Wildlife Service, may be submitted to the above address the quality, utility, and clarity of the Department of the Interior. or via electronic mail to information to be collected; and (4) ACTION: Notice of Availability of the [email protected]. Please include minimize the burden of the collection of Draft Comprehensive Conservation Plan your name and return address in your information on those who are to and Environmental Assessment for Internet message. Our practice is to respond, including through the use of Choctaw National Wildlife Refuge in make comments, including names and appropriate automated collection Choctaw County, Alabama. home addresses of respondents, techniques or other forms of information available for public review during technology; e.g., permitting electronic SUMMARY: The Fish and Wildlife Service regular business hours. Individual submission of responses. announces that a Draft Comprehensive respondents may request that we This Notice also lists the following Conservation Plan and Environmental withhold their home addresses from the information: Assessment for Choctaw National record, which we will honor to the Title of Proposal: Screening and Wildlife Refuge are available for review extent allowed by law. Eviction for Drug Abuse and Other and comment. The National Wildlife SUPPLEMENTARY INFORMATION: The Criminal Activity—Final Rule. Refuge System Administration Act of Service developed four alternatives for OMB Control Number: 2577–0232. 1966, as amended by the National managing the refuge and chose Description of the need for the Wildlife Refuge System Improvement Alternative D as the preferred information and proposed use: The Act of 1997, requires the Service to alternative. collection of information implements develop a comprehensive conservation statute and gives Public Housing plan for each national wildlife refuge. Alternatives Agencies (PHAs) and assisted housing The purpose in developing a owners the tools for adopting and The draft comprehensive conservation comprehensive conservation plan is to plan and environmental assessment implementing fair, effective and provide refuge manages with a 15-year comprehensive policies for screening evaluates the four alternatives for strategy for achieving refuge purposes managing the refuge over the next 15 out program applicants who engage in and contributing toward the mission of illegal drug use or other criminal years. These alternatives are briefly the National Wildlife Refuge System, activity and for evicting or terminating described as follows: consistent with sound principles of fish assistance of persons who engage in and wildlife management, conservation, Alternative A: No Action (Current such activity. PHAs that administer a legal mandates, and Service policies, In Management Direction) Section 8 or public housing program addition to outlining broad management under an Annual Contributions Contract Choctaw National Wildlife Refuge’s direction on conserving wildlife and (ACC) with HUD may request criminal most important terrestrial vegetation their habitats, plans identify wildlife- history records from any law community is its bottomland hardwood dependent recreational opportunities enforcement agency concerning an adult forests, which provide habitat for available to the public, including member of a household applying for migratory birds, including both admission to a public housing or opportunities for hunting, fishing, waterfowl and neotropical migratory Section 8 program. wildlife observation, wildlife forest-dependent birds, and other Agency form numbers, if applicable: photography, and environmental species. The refuge has a current Forest None. education and interpretation. Management Plan, but it has not been Members of affected public: State or Significant issues addressed in the fully implemented; some stand Local Government; Public Housing draft plan include: threatened and treatments have been applied, but Agencies (PHAs). endangered species, waterfowl secondary treatments, such as thinnings, Estimation of the total number of management, neotropical migratory have not. Regeneration is occurring on hours needed to prepare the information birds, bottomland hardwood restoration, the forest floor, but not stand collection including number of fisheries management, visitor services, recruitment; saplings are not maturing respondents, frequency of response, and funding and staffing, cultural resources, due to being eaten by deer and feral hours of response: 3,300 PHAs and land protection. hogs, frequent flooding, and shady (respondents); estimated average DATES: A meeting will be held to present conditions. There is a dense canopy at number of respondents 15,200; total the plan to the public. Mailings, present that inhibits regeneration of all annual burden hours 73,550. newspaper articles, and posters will be but the most shade-tolerant trees. While
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mast production is a good at present, it documented as occurring on the refuge. is remote, and frequent flooding makes will probably decrease over the long Two active bald eagle nests are located much of it inaccessible for much of year. term as oaks become over-mature and on the refuge; these are protected by This isolation and seasonal are not replaced by younger, more sanctuaries that involve some restriction inaccessibility will continue under the vigorous and productive oaks. of public access by boaters, anglers, Current Management Direction Backwaters, sloughs, and wetlands on hunters, and other refuge users. Wood Alternative. the refuge are gradually filling in with storks are observed occasionally during The current number of staff at the sediments, a natural process of the summer. This is a population that refuge is four: The refuge manager and ecological succession that has been nests in Florida and migrates north after an office assistant are located at the accelerated by human activity, namely the nesting season. headquarters in Jackson, Alabama, and the Coffeeville Dam and Reservoir With regard to resource protection, two maintenance workers are located on standing water, in which sediments the Corps of Engineers has limited funds the refuge itself. As a result of staffing drop out and accumulate. This long- for dredging areas of the refuge that and budgetary limitations, there are term process will continue under the have been filling in with sediments. The limited data on wildlife and habitat Current Management Direction Service’s Daphne, Alabama, Ecological distributions and trends, which inhibits Alternative. Services Office has contaminants the quantification of management The main aquatic invasive species on specialists who, in the past, have objectives. the refuge at present are hydrilla, conducted contaminants surveys but alligator weed, and water hyacinth; the these are now dated and no complete Alternative B. Enhanced Wildlife/ potential exists for additional species to surveys have ever been conducted. Oil Fisheries and Habitat Management become problematic, as is giant salvinia. and gas rights on the refuge are Under Alternative B, the refuge would Major infestation by aquatic invasives of outstanding, and production update and fully implement its Forest virtually all water bodies at present are necessitates communication and Management Plan. Some tree harvest displacing native aquatic/wetland cooperation with oil/gas companies to removal would be necessary to achieve plants and can exacerbate siltation. reduce above-ground impacts and understory and midstory conditions, This, in turn, degrades fish habitat, disturbance, as well as to avoid, with an emphasis on regeneration of including raising water temperature and minimize, and mitigate spills and bottomland hardwood oaks and other reducing dissolved oxygen. There are contamination. mast-bearing trees. As feasible, the also significant effects on water-based The principal public use on the refuge Service would work with the Corps of recreation and waterfowl habitat. At is fishing, which is regulated by the Engineers to help adjust hydrological present, 75 acres of backwater slough State of Alabama. Both bank fishing and periods so that summer flooding occurs emergents per year are treated with boat fishing are available. Concerns at fewer intervals and for shorter herbicides and this will continue under have been expressed by the public about periods. The reason is to not kill oak this alternative. To a lesser extent, declining quality of the fishing trees and stymie oak regeneration. biological controls will also continue to experience, mainly because of degraded be used. aquatic habitat from invasives and With regard to backwaters, sloughs, Invasive terrestrial plants and animals reduced access to potential fishing areas and wetlands filling in with sediments, on the refuge include cogongrass and that have been rendered impenetrable this alternative would use aerial and feral hogs. Cogongrass is sprayed due to emergent weedy vegetation. The GPS/GIS techniques to document annually. Feral hogs are in incidental Alabama Division of Wildlife and current colonization by plants and species, which can be taken during Freshwater Fisheries conducts periodic sedimentation trends over time. Aquatic other refuge hunts. The staff conducts creel and angler surveys. invasive species would be kept under limited trapping of these animals on the Secondary public uses on the refuge control via cooperative agreements with refuge. A recent reduction in the are hunting and wildlife observation. the Corps of Engineers and the State of refuge’s population of feral hogs appears There is one wildlife observation Alabama. The refuge would initiate to be due to off-refuge trapping by one platform, next to the moist-soil units. discussions with the Corps to reduce or more neighboring landowners. Under There is a 0.5-mile loop interpretive impacts of too-frequent inundation by the Current Management Direction trail near the platform. Other forest the Coffeeville Dam and Reservoir and Alternative, there will continue to be roads permit foot travel, but access is with the State to utilize approved limited trapping and incidental hunting difficult (only by boat). Current refuge methods of controlling invasive aquatic of feral hogs on the refuge. hunts include an archery hunt for deer, plants, which help trap sediments and As mentioned above, the refuge’s and a small game season for squirrels, worsen the problem. The result would bottomland hardwood forests provide rabbits, and raccoons. There is no be more effective control and reduced important habitat for waterfowl and waterfowl hunting. The same public severity of infestations and slower neotropical migratory birds, as well as access and use under this alternative sedimentation of refuge waters. resident wildlife. In addition, the refuge would continue; to gain access to many Cogongrass would be sprayed actively manages habitat for migratory areas is by boat only from the reservoir. annually with the objective being to birds by means of force-account farming The staff works with private land eradicate this exotic invasive species. (35 acres) and moist-soil management owners of approximately eight Farm The refuge would investigate replacing (15 acres at present). Under the Current Service Agency tracts to restore cogongrass on one bank it now infests, Management Direction Alternative, bottomland hardwood forests (i.e., which provides ground cover to avoid these acreages will not change. The planting oak trees) on easement areas. erosion, with a native plant species. refuge also assists in the reproduction of Isolation of the refuge itself from the Programs like the State Landowner the wood duck by providing 400 nest refuge headquarters—45 minutes to 1 Incentive Program may offer funding or boxes; these are cleaned once annually. hour away by road—inhibits hands-on technical support that could be used in Staff members monitor them and collect refuge management; for example, there private lands habitat and wildlife nesting data. is no law enforcement, biological, management, including control of Two federally listed species—the bald forestry, or management presence on the problem species, such as feral hogs. eagle and the wood stork—are refuge half of the time. The refuge itself Partners for Fish and Wildlife is another
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program that might offer support to the Secondary public uses would of all but the most shade-tolerant trees. refuge. continue to be hunting and wildlife At first, mast production would remain Alternative B would provide habitat observation. There would be one high, but would probably decrease over for migratory birds, including waterfowl wildlife observation platform, next to the long term (i.e., beyond the 15-year and neotropical, by using force-account the moist-soil units, as at present, and life of the comprehensive conservation farming (e.g., millet and grain sorghum) a 0.5-mile loop interpretive trail near plan) as oaks become over-mature and and intensified moist-soil management. the platform. Other forest roads would are not replaced by younger, more Staff would level and regrade moist-soil permit foot travel, but overall access vigorous and productive oaks. units to facilitate water management; in would remain difficult (only by boat). Backwaters, sloughs, and wetlands on addition, the area of moist soil would be Under Alternative B, the Service would the refuge would continue gradually increased to 25–35 acres by converting look to build a bridge across the mouth filling in with sediments, a natural existing crop fields. Over the 15-year of Okatuppa Creek to facilitate process of ecological succession that has life of the plan, all crop fields would be management access; this bridge would been accelerated by human activity, phased out and transitioned to moist- also be accessible to public foot travel. namely the Coffeeville Dam and soil units. Refuge hunts would include those held Reservoir’s standing water, in which Under this alternative, staff would currently: an archery hunt for deer, and sediments drop out and accumulate. maintain the existing stock of 400 wood a small game season for squirrels, This long-term process would continue duck nest boxes, but more intensively rabbits, and raccoons. No waterfowl under the Enhanced Wildlife-Dependent monitor and collect nesting data from hunting would be permitted. Feral hogs Recreation Alternative. them. Each nest box would be cleaned would be considered incidental species Although the main aquatic invasive at least twice annually, from once and could be taken during all refuge species on the refuge are hydrilla, annually at present. hunts. The same public access and use alligator weed, and water hyacinth at present, the potential exists for Two active bald eagle nests are on the under this alternative would continue; additional species to become refuge and would remain active under to gain access to many areas would problematic, such as giant salvinia. Alternative B. They would continue to remain only by boat from the reservoir. Major infestation by aquatic invasives of be protected by sanctuaries that involve The staff would continue to monitor habitat restoration of approximately virtually all waterbodies at present are some restriction of public access by eight Farm Service Agency tracts displacing native aquatic/wetland boaters, anglers, hunters, and other planted in bottomland hardwood plants like giant bulrush and can refuge visitors. It is assumed that wood forests. exacerbate siltation. This, in turn, storks would continue to be observed Under the Enhanced Wildlife/ degrades fish habitat, including raiding occasionally during the summer, as in Fisheries and Habitat Management water temperature and reducing the Current Management Direction Alternative, isolation of the refuge itself dissolved oxygen. There are also Alternative. Under the Enhanced from refuge headquarters would significant effects on water-based Wildlife/Fisheries and Habitat continue to inhibit hands-on recreation and waterfowl habitat. At Management Alternative, the Service management. The remoteness of the present, 75 acres of backwater slough would investigate the movements of refuge would not change, and frequent emergents per year are treated with these wood storks via a radio telemetry flooding would continue to render herbicides and this would continue study. much of it inaccessible for much of the under this alternative. To a lesser The refuge would obtain the year. extent, biological controls would also assistance of contaminants specialists at One assistant refuge manager with continue to be used. the Service’s Daphne, Alabama, law enforcement collateral duty would There would be no change in the Ecological Services Office to conduct be added, as well as one wildlife management of invasive terrestrial contaminants surveys on the refuge to biologist. The refuge would investigate plants and animals on the refuge under update information on key toxic sharing a forester with other refuges. this alternative from the Current contaminants, such as mercury and Recommended staffing would consist of Management Direction Alternative. other heavy metals, pesticides, and salt a refuge manager, assistant refuge The refuge would continue to actively water. Oil and gas production on the manager, and office assistant at the manage habitat for migratory birds by refuge would continue under refuge headquarters, and a biologist and means of force-account farming and Alternative B, necessitating two maintenance workers on the refuge moist-soil management. Under this communication and cooperation with itself. alternative, the acreages would not oil companies to reduce above-ground change from the acreages being farmed impacts and disturbance, as well as to Alternative C. Enhanced Wildlife- Dependent Recreation under the Current Management avoid, minimize, and mitigate spills and Direction Alternative. contamination. Under Alternative C, the refuge’s The refuge would continue to assist in The principal wildlife-dependent existing Forest Management Plan, which the reproduction of the wood duck by recreation under the Enhanced Wildlife/ has not been fully implemented, would providing 400 nest boxes and managing Fisheries and Habitat Management continue in effect, but again would not as is currently being done. Alternative would continue to be be fully implemented. Some stand Management of two federally listed fishing, regulated by the State of treatments would be applied, but species—bald eagle and wood stork— Alabama. Both bank and boat fishing secondary treatments (thinnings) would would remain the same as under the would be available. The State would not. Regeneration would occur on the Current Management Direction conduct periodic creel and angler forest floor, but stand recruitment Alternative. surveys, as it does at present. Improved would continue to lag. Most saplings With regard to resource protection, aquatic habitat management would aim would not mature because of heavy the Corps of Engineers has limited funds to increase fish populations and angler foraging pressure by white-tailed deer for dredging areas of the refuge that access. This alternative would explore and feral hogs, frequent flooding, and have been filling in with sediments. The stump removal to improve both fisheries shady conditions. A dense canopy Service’s Daphne, Alabama, Ecological habitat and boat access. would continue to inhibit regeneration Services Office has contaminants
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specialists who, in the past, have Alternative D. Enhanced Wildlife/ Under this alternative, staff would conducted contaminants surveys but Fisheries, Habitat, and Public Use maintain the existing stock of 400 wood these are now dated and no complete (Preferred Alternative) duck nest boxes, but more intensively surveys have ever been conducted. Oil monitor and collect nesting data from and gas rights on the refuge are Under Alternative D, the refuge would them. Each nest box would be cleaned outstanding, and production update and fully implement its Forest at least twice annually (from once necessitates communication and Management Plan. Some tree harvest annually at present). cooperation with oil/gas companies to removal would be necessary to achieve Two active bald eagle nests are on the reduce above-ground impacts and understory and midstory conditions, refuge and would remain active under disturbance, as well as to avoid, with an emphasis on regeneration of Alternative D. They would continue to minimize, and mitigate spills and bottomland hardwood oaks and other be protected by sanctuaries that involve contamination. mast-bearing trees. As feasible, the some restriction of public access by Service would work with the Corps of Refuge staff would continue to work boaters, anglers, hunters and other Engineers to adjust hydrological periods with private landowners on refuge visitors. It is assumed that wood so that summer flooding occurs at fewer approximately eight Farm Service tracts storks would continue to be observed intervals and for shorter periods. This to restore bottomland hardwood forests occasionally during the summer, as in would avoid oak seedling mortality that on easement areas. the Current Management Direction now thwarts oak regeneration. Under Alternative C, the principal Alternative. Under Alternative D, the wildlife-dependent recreation would With regard to the refuge backwaters, Service would investigate the remain fishing, regulated by the State. sloughs, and wetlands now filling in movements of these wood storks via a Both bank and boat fishing would be with sediments, Alternative D would radio telemetry study. Under the preferred alternative only, available. The State would continue to utilize aerial and GPS/GIS techniques to the refuge would request the assistance conduct periodic creel and angler document current colonization by of contaminants specialists form the surveys. Within five years of the plants and sedimentation trends over Service’s Daphane, Alabama, Ecological comprehensive conservation plan’s time. Aquatic invasive species would be Services Office to conduct complete approval, the refuge would build new kept under control via cooperative contaminants surveys on the refuge to fishing facilities, such as a handicapped agreements with the Corps of Engineers update information on the status of key accessible fishing pier. It would also and the State of Alabama. The refuge toxic contaminants, such as mercury provide additional woody structure would initiate discussions with the and other heavy metals, pesticides, and within the reservoir, and open boating Corps to reduce impacts of too-frequent salt water. Oil and gas production on access via stump removal and increased inundation by the Coffeeville Dam and Reservoir, and with the State to utilize the refuge would continue, necessitating aquatic vegetation control. communication and cooperation with Secondary public uses would approved methods of controlling invasive aquatic plants, which help trap oil companies to reduce above-ground continue to be hunting and wildlife impacts and disturbance, as well as to observation in the Enhanced Wildlife- sediments and worsen the problem. The result would be more effective control avoid, minimize, and mitigate spills and Dependent Recreation Alternative. This contamination. alternative would also offer an and reduced severity of infestations and slower sedimentation of refuge waters. Under Alternative D, the principal improved wildlife observation platform, wildlife-dependent recreation would next to the moist-soil units. The Service Cogongrass would be sprayed remain fishing, regulated by the State of would seek to build a pedestrian bridge annually with the objective being to Alabama. Both bank and boat fishing over the mouth of Okatuppa Creek to eradicate this exotic invasive species. would be available. The State would facilitate and improve access to Middle The refuge would investigate replacing continue to conduct periodic creel and Swamp. Refuge hunts would include an cogongrass on one bank it now infests, angler surveys. Within 5 years of archery hunt for deer, and small game which provides ground cover to avoid approval of the comprehensive season for squirrels, rabbits, and erosion, with a native plant species. conservation plan, the refuge would raccoons. A waterfowl hunt for youths Programs like the State Landowner build new fishing facilities, such as a would be added, contingent upon Incentive Program may offer funding or handicapped accessible fishing pier. It having staffing resources to manage the technical support that could be used in would also provide additional woody hunt. Feral hogs would be considered private lands habitat and wildlife structure within the reservoir, and open an incidental species and could be taken management, including control of boating access via stump removal and during all refuge hunts. The same public problem species like feral hogs. Another increased aquatic vegetation control. access and use would continue under possibility that the refuge would explore Secondary public uses would this alternative; to gain access to many using is the Partners for Fish and continue to be hunting and wildlife areas would remain by boat only from Wildlife program. observation as in the Enhanced the reservoir. More environmental Alternative D would provide habitat Wildlife-Dependent Recreation education opportunities both on and off for migratory birds, including waterfowl Alternative. This alternative would also the refuge would be pursued. and neotropical migratory birds, by offer an improved wildlife observation Isolation of the refuge from its using force-account farming (e.g., millet platform, next to the moist-soil units. headquarters would continue to inhibit and grain sorghum) and intensified The Service would seek to build a hands-on management. Alternative C moist-soil management. Staff would pedestrian bridge over the mouth of would add one assistant refuge manager level and regrade moist-soil units to Okatuppa Creek to facilitate and with law enforcement collateral duty, as facilitate water management; in improve access to Middle Swamp. well as one park ranger. Recommended addition, the area of moist soil would be Refuge hunts would include an archery staffing would then be six: Refuge increased to 25–35 acres by converting hunt for deer, and a small game season manager, assistant refuge manager, and existing crop fields. Over the 15-year for squirrels, rabbits and raccoons. A office assistant at refuge headquarters, life of the comprehensive conservation waterfowl hunt for youths would be and a park ranger and two maintenance plan, all crop fields would be phased added, contingent on having staffing workers on the refuge. out and transitioned to moist-soil units. resources to manage the hunt. The same
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public access and use under this supporting Environmental Action increased property use restrictions if alternative would continue; to gain Statement (EAS) Screening Form. All their efforts attract listed species to their access to many areas would remain by comments received, including names property or increase the numbers or boat only from the reservoir. Many more and addresses, will become part of the distribution of listed species already on environmental education opportunities official administrative record and may their property. Application both on and off the refuge would be be made available to the public, subject requirements and issuance criteria for pursued. to the requirements of the Privacy Act ESPs through Safe Harbor Agreements Even under Alternative D, isolation of and Freedom of Information Act. For are found in 50 CFR 17.22 and 17.32. the refuge from its headquarters would further information and instructions on The FFWCs proposed state-wide continue to hamper hands-on refuge reviewing and commenting on this Agreement is designed to encourage management. The alternative would add application, see the ADDRESSES section, voluntary RCW habitat restoration or one assistant refuge manager with law below. enhancement activities by relieving a enforcement collateral duty, and one DATES: Written comments should be landowner who enters into a wildlife biologist with visitor services received on or before February 23, 2006. landowner-specific agreement (the collateral duty; and would also ADDRESSES: You may obtain a copy of SHMA) from any additional investigate sharing a forester with other the information available by contacting responsibility under the Act beyond that refuges. Recommended staffing would the Service’s Regional Safe Harbor which exists at the time he or she enters be six: Refuge manager, assistant refuge Coordinator, U.S. Fish and Wildlife into the program. The SHMA will manager, and office assistant at refuge Service, 1875 Century Boulevard, Suite identify any existing RCWs and any headquarters, and a biologist and two 200, Atlanta, Georgia 30345, or Field associated habitat (the baseline) and maintenance workers on the refuge. Supervisor, U.S. Fish and Wildlife will describe the actions that the landowner commits to take (e.g., Authority: This notice is published under Service, Ecological Services Field the authority of the National Wildlife Refuge Office, 1601 Balboa Avenue, Panama hardwood midstory removal, cavity System Improvement Act of 1997, Public City, Florida 32405. Alternatively, you provisioning, prescribed burning, etc.) Law 105–57. may set up an appointment to view or will allow to be taken to improve RCW habitat on the property, and the Dated: July 25, 2005. these documents at either location time period within which those actions Linda H. Kelsey, during normal business hours. Written data or comments should be submitted are to be taken and maintained. A Acting Regional Director. participating landowner must maintain [FR Doc. 06–616 Filed 1–23–06; 8:45 am] to the Atlanta, Georgia, Regional Office. Requests for the documentation must be the baseline on his/her property (i.e., BILLING CODE 4310–55–M in writing to be processed, and any existing RCW groups and/or comments must be in writing to be associated habitat), but may be allowed the opportunity to incidentally take DEPARTMENT OF THE INTERIOR considered. When you are requesting or reviewing the information provided in RCWs at some point in the future if above baseline RCWs are attracted to this notice, please reference ‘‘Proposed Fish and Wildlife Service that site by the proactive management Programmatic Statewide Red-cockaded measures undertaken by the landowner. Proposed Programmatic Statewide Woodpecker Safe Harbor Agreement, It is important to note that the Red-cockaded Woodpecker Safe Florida’’ in any correspondence. Harbor Agreement, Florida Agreement does not envision, nor will FOR FURTHER INFORMATION CONTACT: Mr. it authorize, incidental take of any pre- AGENCY: Fish and Wildlife Service, Richard Gooch, Regional Safe Harbor SHMA existing RCW group with one Interior. Program Coordinator at the Service’s exception. This exception is incidental Southeast Regional Office (see ACTION: Notice of permit application. take related to a baseline shift; in this ADDRESSES above), telephone (404) 679– circumstance the baseline will be SUMMARY: The Florida Fish and Wildlife 7124; or Mr. Stan Simpkins, Ecologist, maintained but redrawn or shifted on Conservation Commission (FFWC or Panama City Ecological Services Field that landowner’s property. Among the Applicant) has applied to the Fish and Office (see ADDRESSES above), telephone minimization measures proposed by the Wildlife Service (Service) for an (850) 769–0552. Applicant are no incidental take of enhancement of survival permit (ESP) SUPPLEMENTARY INFORMATION: Primary RCWs during the breeding season, pursuant to section 10(a)(1)(A) of the threats to the RCW throughout its range consolidation of small, isolated RCW Endangered Species Act of 1973, as all have the same basic cause: lack of populations at sites capable of amended (Act) (16 U.S.C. 1531 et seq.). suitable habitat. To help address this supporting a viable RCW population, The ESP application includes a threat, the Service has previously and measures to improve current and proposed Safe Harbor Agreement entered into programmatic Safe Harbor potential habitat for the species. Further (Agreement) for the endangered red- Agreements in Georgia, Louisiana, and details on the topics described above are cockaded woodpecker, (Picoides South Carolina. These previous found in the aforementioned documents borealis) (RCW), for a period of 99 years. agreements are similar to the Agreement available for review under this notice. If approved, the Agreement would allow that is being proposed by FFWC. The geographic scope of the the Applicant to issue Certificates of Under a Safe Harbor Agreement, Applicant’s Agreement is the entire Inclusion (CI) throughout the State of participating property owners State of Florida, but the Agreement Florida to eligible non-Federal voluntarily undertake management would only authorize the future landowners that complete an approved activities on their property to enhance, incidental take of above-baseline RCW Safe Harbor Management Agreement restore, or maintain habitat benefiting groups on lands for which a CI has been (SHMA). species listed under the Act. Safe issued. Lands potentially eligible for We announce the opening of a 30-day Harbor Agreements encourage private inclusion include all privately owned comment period and request comments and other non-Federal property owners lands and public lands owned by cities, from the public on the Applicant’s ESP to implement conservation efforts for counties, and municipalities, with application; the accompanying listed species by assuring property potentially suitable RCW habitat in proposed Agreement, and the owners they will not be subjected to Florida.
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The agreement is expected to attract DEPARTMENT OF THE INTERIOR procedures for review and approval by sufficient interest among Florida the Secretary of the Interior. Sections landowners to generate substantial Bureau of Indian Affairs 291.4, 291.10, 291.12 and 291.15 of 25 conservation benefits to the RCW on a CFR Part 291, Class III Gaming landscape scale. FFWCs agreement was Proposed Information Collection Under Procedures, specifies the information developed in an adaptive management the Paperwork Reduction Act; collection requirement. An Indian tribe framework to allow changes in the Comment Request must ask the Secretary to issue Class III program based on new scientific AGENCY: Bureau of Indian Affairs, gaming procedures. The information to information including, but not limited Interior. be collected includes: The name of to, biological needs and management ACTION: Notice. Tribe and the State, tribal documents, actions proven to benefit the species or State documents, regulatory schemes, its habitat. SUMMARY: In compliance with the the proposed procedures and other We have made a preliminary Paperwork Reduction Act of 1995, the documents deemed necessary. determination that issuance of the ESP Bureau of Indian Affairs (BIA) invites Collection of this information is will not result in significant comments on two information currently authorized under an approval environmental, economic, social, collection requests which will be by OMB (OMB Control Number 1076– historical, cultural impacts and is renewed. The two collections are: Class 0149). All information is collected when therefore, categorically excluded from III Gaming Procedures, 1076–0149, and the tribe makes a request for Class III review under the National Tribal Revenue Allocation Plans, 1076– gaming procedures. Annual reporting Environmental Policy Act (NEPA) of 0150. and recordkeeping burden for this 1969, as amended pursuant to 516 DATES: Submit your comments and collection of information is estimated to Department Manual 2, Appendix 1 and suggestions on or before March 27, occur one time on an annual basis. The 516 Department Manual 6 Appendix 1. 2006, to be assured of consideration. estimated number of annual requests is In addition, we have evaluated the ADDRESSES: Comments should be sent 12 tribes seeking Class III gaming proposed ESP under section 106 of the to: George Skibine, Bureau of Indian procedures. The estimated time to National Historic Preservation Act and Affairs, Office of Indian Gaming review instructions and complete each have concluded that this Agreement Management, Mail Stop 4600–MIB, application is 320 hours. Thus, the total will not affect cultural resources on or 1849 C Street, NW., Washington, DC annual reporting and recordkeeping eligible for, the National Historic 20240. burden for this collection is estimated to be 3,840 hours. Register of Historic Places. We base our FOR FURTHER INFORMATION CONTACT: conclusions on our review of the Frequency of Collection: Annually. Interested persons may get copies of the Description of Respondents: Federally process for protection and consideration information collection requests without recognized tribes. of cultural resources included in the charge by contacting George Skibine at Total Respondents: 12. associated Agreement as well as the (202) 219–4066 or facsimile number Burden Hours per Application: 320. scope of the voluntary management (202) 273–3153. Total Annual Burden Hours: 3,840 actions identified in the Agreement. We SUPPLEMENTARY INFORMATION: The hours. have consulted with the Florida State Paperwork Reduction Act of 1995 Tribal Revenue Allocation Plans Historic Preservation Officer and have provides an opportunity for interested received concurrence with our parties to comment on proposed Type of review: Extension of a conclusion. We have also consulted information collection requests. The currently-approved collection. with the appropriate Tribal Preservation Bureau of Indian Affairs, Office of Title: Tribal Revenue Allocation Officers. Indian Gaming Management is Plans, 25 CFR 290. We provide this notice pursuant to proceeding with this public comment Summary: In order for Indian tribes to section 10(c) of the Act and pursuant to period as the first step in getting a distribute net gaming revenues in the implementing regulations for NEPA (40 normal information collection clearance form of per capita payments, CFR 1506.6). We will evaluate the from the Office of Management and information is needed by the BIA to proposed Agreement, associated Budget (OMB). Each request contains (1) ensure that Tribal Revenue Allocation documents, and comments submitted type of review, (2) title, (3) summary of Plans include assurances that certain thereon to determine whether the the collection, (4) respondents, (5) statutory requirements are met, a requirements of section 10(a) of the Act frequency of collection, (6) reporting breakdown of the specific uses to which and NEPA have been met. If we and recordkeeping requirements. net gaming revenues will be allocated, determine that the requirements are Please note that we will not sponsor eligibility requirements for met, we will issue an ESP under section nor conduct, and you need not respond participation, tax liability notification 10(a)(1)(A) of the Act to the Applicant to, a request for information unless we and the assurance of the protection and in accordance with the terms of the display the OMB control number and preservation of the per capita share of Agreement and specific terms and the expiration date. minors and legal incompetents. Sections conditions of the authorizing ESP. We 290.12, 290.17, 290.24 and 290.26 of 25 Class III Gaming Procedures will not make our final decision until CFR Part 290, Tribal Revenue Allocation after the end of the 30-day comment Type of review: Renewal. Plans, specifies the information period and will fully consider all Title: Class III Gaming Procedures, 25 collection requirement. An Indian tribe comments received during the comment CFR 291. must ask the Secretary to approve a period. Summary: The collection of Tribal Revenue Allocation Plan. The information will ensure that the information to be collected includes: Dated: December 28, 2005. provisions of IGRA, the relevant name of Tribe, tribal documents, the Cynthia K. Dohner, provisions of State laws, Federal law allocation plan and other documents Acting Regional Director. and the trust obligations of the United deemed necessary. Collection of this [FR Doc. E6–797 Filed 1–23–06; 8:45 am] States are met when federally information is currently authorized BILLING CODE 4310–55–P recognized tribes submit Class III under an approval by OMB (OMB
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Control Number 1076–0152). All Dated: January 12, 2006. period in order to further review the information is collected when the Tribe Michael D. Olsen, recommendation. BLM has decided to submits a Tribal Revenue Allocation Acting Principal Deputy Assistant Secretary— act in accordance with this request, Plan. Annual reporting and record Indian Affairs. therefore, comments on the Ring of Fire keeping burden for this collection of [FR Doc. E6–816 Filed 1–23–06; 8:45 am] Draft RMP/EIS will now be accepted information is estimated to average BILLING CODE 4310–4N–P through January 30, 2006. between 75–100 hours for Dated: January 6, 2006. approximately 50 respondents, Henri R. Bisson, DEPARTMENT OF THE INTERIOR including the time for reviewing State Director. instructions, researching existing data [FR Doc. E6–774 Filed 1–23–06; 8:45 am] sources, gathering and maintaining the Bureau of Land Management BILLING CODE 4310–JA–P data needed, and completing and [AK–040–06–1610–DP] reviewing the collection of information. Thus, the total annual reporting and Notice of Extension of the Public DEPARTMENT OF THE INTERIOR recordkeeping burden for this collection Comment Period for the Ring of Fire is estimated to be 3,750—5,000 hours. Draft Resource Management Plan/ National Park Service We are using the higher estimate for Environmental Impact Statement Route 66 Corridor Preservation purposes of estimating the public AGENCY: Bureau of Land Management, burden. Program, Advisory Council; Notice of Interior. Meeting Frequency of Collection: Annually. ACTION: Notice of Extension of the Description of Respondents: Federally Public Comment Period for the Ring of Notice is hereby given in accordance recognized tribes. Fire Draft Resource Management Plan/ with the Federal Advisory Committee Environmental Impact Statement. Act, Public Law 92–463, that a meeting Total Respondents: 50. of the Route 66 Corridor Preservation Burden Hours per Response: 100. SUMMARY: The Bureau of Land Program Advisory Council will be held Management (BLM) announces an Total Annual Burden Hours: 5,000 February 9 and 10, 2006, at the Hotel extension of the public comment period hours. Albuquerque at Old Town, 800 Rio on the Ring of Fire Draft Resource Grande, NW., Albuquerque, New Request for Comments Management Plan/Environmental Mexico. The meeting will begin at 8:30 Impact Statement (RMP/EIS). The a.m. on February 9 and will end by 1 The Bureau of Indian Affairs solicits original notice issued September 30, p.m. on February 10. comments in order to: 2005, provided for a comment period to The Route 66 Corridor Preservation (1) Evaluate whether the proposed end on December 29, 2005. BLM is Program Advisory Council was collection of information is necessary extending the comment period until established to consult with the Secretary for the proper performance of the January 30, 2006. of the Interior on matters relating to the functions of the bureau, including DATES: Written comments on issues Route 66 Corridor Preservation Program, whether the information will have relating to the future land use, planning, including recommendations for ways to practical utility; and management of the Ring of Fire best preserve important properties along Route 66, recommendations for grant (2) Evaluate the bureau’s estimate of Planning Area must be submitted or and cost-share awards to eligible the burden of the proposed collection of postmarked no later than January 30, applicants owning or administering information, including the validity of 2006. historic properties along the Route 66 the methodology and assumptions used; ADDRESSES: Comments on the document Corridor, and recommendations for should be addressed to Robert Lloyd, (3) Enhance the quality, utility and technical assistance provided by the Project Manager, Ring of Fire RMP/EIS, clarity of the information to be National Park Service to partners along Bureau of Land Management, collected; and the route. Anchorage Field Office (040), 6881 The matters to be discussed include: (4) Minimize the burden of the Abbott Loop Road, Anchorage, Alaska collection of the information on those 99507. Comments can also be submitted —Assessment/general recommendations who are to respond. by accessing the e-mail box developed of program to date — assessment/recommendations for for this project at [email protected]. Any public comments received will cost-share grants be addressed in the Bureau of Indian FOR FURTHER INFORMATION CONTACT: — assessment/recommendations for Affairs’ submission of the information Robert Lloyd, (907) 267–1214, or by technical assistance (site visits, collect request to the Office of mail at the Anchorage Field Office, 6881 workshops, community meetings, Management and Budget. Abbott Loop Road, Anchorage, Alaska etc.) All comments will be available for 99507. The meeting will be open to the public review during regular business SUPPLEMENTARY INFORMATION: The public. However, facilities and space for hours. There may be an instance when original Notice of Availability was accommodating members of the public we decide to withhold information, but published September 30, 2006, and are limited, and persons will be if you wish us to withhold your name provided for comments on the Ring of accommodated on a first-come, first- and address, you must state this Fire Draft RMP/EIS to be received served basis. Any member of the public prominently at the beginning of your through December 29, 2005. During the may file a written statement concerning comment. We will honor your request to public comment period it was the matters to be discussed with the extent allowed by law. We will not discovered that the maps depicting the Michael Taylor, Route 66 Corridor consider anonymous comments, and we proposed Neacola Mountains Area of Preservation Program Manager. will make public all comments from Critical Environmental Concern Persons wishing further information businesses and from individuals who contained errors. Trustees for Alaska concerning this meeting, or who wish to represent businesses. requested an extension of the comment submit written statements may contact
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Michael Taylor, Route 66 Corridor before the end of the comment period The purpose of this notice is to allow Preservation Program Manager, National on the DEIS. The public and agencies for an additional 30 days for public Trails System—Santa Fe, National Park will be able to review this information comment until February 23, 2006. This Service, P.O. Box 728, Santa Fe, New concurrently with the DEIS released process is conducted in accordance with Mexico 87504–0728, telephone 505/ October 7, 2005, and may provide 5 CFR 1320.10. 988–6742. Minutes of the meeting will comments on the DEIS and the Written comments and/or suggestions be available for public inspection at the supplemental information in a single regarding the items contained in this Route 66 Corridor Preservation Program response. The final environmental notice, especially the estimated public Office, located in Room 122, Old Santa impact statement will consider and burden and associated response time, Fe Trail Building, 1100 Old Santa Fe contain responses to all substantive should be directed to the Office of Trail, Santa Fe, New Mexico. comments received on the DEIS. Management and Budget, Office of Information and Regulatory Affairs, Dated: January 17, 2006. Our practice is to make comments, Attention Department of Justice Desk Bernard C. Fagan, including names and home addresses of respondents, available for public Officer, Washington, DC 20503. Deputy Chief, Office of Policy. review. Individual respondents may Additionally, comments may be [FR Doc. E6–760 Filed 1–23–06; 8:45 am] request that we withhold their home submitted to OMB via facsimile to (202) BILLING CODE 4312–52–P address from public disclosure, which 395–5806. we will honor to the extent allowable by Written comments and suggestions law. There also may be circumstances in from the public and affected agencies DEPARTMENT OF THE INTERIOR which we would withhold a concerning the proposed collection of information are encouraged. Your Bureau of Reclamation respondent’s identity from public disclosure, as allowable by law. If you comments should address one or more San Luis Unit Long-Term Contract wish us to withhold your name and/or of the following four points: Renewal address, you must state this —Evaluate whether the proposed prominently at the beginning of your collection of information is necessary AGENCY: Bureau of Reclamation, comment. We will make all submissions for the proper performance of the Interior. from organizations or businesses, and functions of the agency, including ACTION: Second extension of comment from individuals identifying themselves whether the information will have period for review of Draft as representatives or officials of practical utility; Environmental Impact Statement (DEIS). organizations or businesses, available —Evaluate the accuracy of the agency’s for public disclosure in their entirety. estimate of the burden of the SUMMARY: The Bureau of Reclamation proposed collection of information, Dated: January 3, 2006. (Reclamation) is extending the comment including the validity of the period for the DEIS to April 3, 2006. The Frank Michny, methodology and assumptions used; notice of availability of the DEIS was Regional Environmental Officer, Mid-Pacific —Enhance the quality, utility, and published in the Federal Register on Region. clarity of the information to be September 30, 2005 (70 FR 57324). The [FR Doc. E6–796 Filed 1–23–06; 8:45 am] collected; and public comment period was originally BILLING CODE 4310–MN–P —Minimize the burden of the collection to end on November 21, 2005. A notice of information on those who are to to extend the comment period to respond, including through the use of January 17, 2006 was published in the DEPARTMENT OF JUSTICE appropriate automated, electronic, Federal Register on December 6, 2005 mechanical, or other technological (70 FR 72652). Office of Community Oriented Policing collection techniques or other forms DATES: Submit comments on the DEIS Services (COPS); Agency Information of information technology, e.g., on or before April 3, 2006. Collection Activities: Extension of permitting electronic submission of ADDRESSES: Send comments on the DEIS Currently Approved Collection; responses. Comments Requested to Mr. Shane Hunt, Bureau of Overview of This Information Reclamation, South-Central California Collection Area Office, 1243 N Street, Fresno, CA ACTION: 30-Day Notice of Information 93721. Comments may also be e-mailed Collection Under Review: (1) Type of Information Collection: to [email protected]. Copies of the Methamphetamine Project Status Extension of a currently approved DEIS may be requested by calling Mr. Update Report (SUR). collection. Hunt at 559–487–5138, TDD 559–487– (2) Title of the Form/Collection: The Department of Justice (DOJ) 5933. Methamphetamine Project Status Office of Community Oriented Policing Update Report (SUR). FOR FURTHER INFORMATION CONTACT: Mr. Services (COPS) has submitted the (3) Agency form number, if any, and Shane Hunt at 559–487–5138, TDD 559– following information collection request the applicable component of the 487–5933. to the Office of Management and Budget Department of Justice sponsoring the SUPPLEMENTARY INFORMATION: This (OMB) for review and approval in collection: Form Number: None. U.S. extension will allow Reclamation to accordance with the Paperwork Department of Justice Office of prepare and release supplemental Reduction Act of 1995. The proposed Community Oriented Policing Services information as part of the review information collection is published to (COPS). process for this action. Reclamation obtain comments from the public and (4) Affected public who will be asked decided to prepare this supplemental affected agencies. This proposed or required to respond, as well as a brief information to address issues and information collection was previously abstract: Primary: Law Enforcement concerns that have been identified published in the Federal Register Agencies and government entities that following preparation of the DEIS. The Volume 70, Number 209, on page 62330 are Methamphetamine grant recipients. supplemental information will be on October 31, 2005, allowing for a 60- Other: Universities and Private Non- available February 2006, at least 45 days day comment period. Profit Agencies. Abstract: The
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information collected will be used by respect to the five other defendants DEPARTMENT OF LABOR the COPS Office to determine grantee’s named in the complaint. Employment and Training progress toward grant implementation The Consent Decree provides, inter Administration and for compliance monitoring efforts. alia, that the Rossomondo Defendants (5) An estimate of the total number of and EPA will enter into a settlement respondents and the amount of time Notice of Determinations Regarding estimated for an average respondent to pursuant to EPA’s ability-to-pay policies Eligibility To Apply for Worker respond: There will be an estimated 100 and procedures. As part of settlement Adjustment Assistance negotiations, EPA requested that the responses from methamphetamine In accordance with Section 223 of the grantees. The estimated amount of time Rossomondo Defendants provide Trade Act of 1974, as amended, (19 required for the average respondent to information regarding each defendant’s U.S.C. 2273), the Department of Labor respond is 3 hours and 15 minutes. financial status, and the Rossomondo (6) An estimate of the total public Defendants cooperatively provided all herein presents summaries of burden (in hours) associated with the of the requested information, which was determinations regarding eligibility to collection: The estimated total burden necessary under EPA’s policies and apply for trade adjustment assistance for associated with the collection is 325 procedures to perform an ability-to-pay workers (TA–W) number and alternative hours. settlement analysis. Based upon the trade adjustment assistance (ATAA) by (TA–W) number issued during the If additional information is required analysis, EPA determined that the periods of January 2006. contact: Brenda Dyer, Department Rossomondo Defendants had the In order for an affirmative Clearance Officer, United States financial ability to pay a nominal determination to be made and a Department of Justice, Justice amount, or $325.00, of EPA’s response Management Division, Patrick Henry certification of eligibility to apply for costs that were incurred in connection directly-impacted (primary) worker Building, Suite 1600, 601 D Street, NW., with the clean-up of the Site. Washington, DC 20530. adjustment assistance to be issued, each The Department of Justice will of the group eligibility requirements of Dated: January 18, 2006. receive, for a period of 30 days from the Section 222(a) of the Act must be met. Brenda Dyer, date of this publication, comments I. Section (a)(2)(A) all of the following Department Clearance Officer, United States relating to the proposed Consent Decree. must be satisfied: Department of Justice. Comments should be addressed to the A. A significant number or proportion [FR Doc. E6–787 Filed 1–23–06; 8:45 am] Assistant Attorney General for the of the workers in such workers’ firm, or BILLING CODE 4410–AT–P Environment and Natural Resources an appropriate subdivision of the firm, Division, P.O. Box 7611, U.S. have become totally or partially Department of Justice, Washington, DC separated, or are threatened to become DEPARTMENT OF JUSTICE 20044–7611, and should refer to United totally or partially separated; B. The sales or production, or both, of Notice of Lodging of Consent Decree States v. Beehive Barrel and Drum, Inc. such firm or subdivision have decreased Under Comprehensive Environmental d/b/a Cascade Cooperage, Inc., DOJ Ref. absolutely; and Response, Compensation and Liability No. 90–11–3–08170. C. Increased imports of articles like or Act The proposed Consent Decree may be directly competitive with articles In accordance with Departmental examined at the Office of the United produced by such firm or subdivision policy, 28 CFR 50.7, notice is hereby States Attorney, 185 South State, Ste. have contributed importantly to such given that on January 10, 2006, a 400, Salt Lake City, Utah 84111; and workers’ separation or threat of proposed Consent Decree in United U.S. EPA Region 8, 999 18th Street, separation and to the decline in sales or States v. Beehive Barrel and Drum, Inc. Denver, Colorado 80202. During the production of such firm or subdivision; d/b/a Cascade Cooperage, Inc. (D. public comment period, the proposed or Utah), C.A. No. 2:04–CV–00570 (TC), Consent Decree may also be examined II. Section (a)(2)(B) both of the was lodged with the United States on the following Department of Justice following must be satisfied: District Court for the District of Utah, Web site, http://www.usdoj.gov/enrd/ A. A significant number or proportion Central Division. open.html. A copy of the proposed of the workers in such workers’ firm, or In this action, the United States seeks Consent Decree may be obtained by mail an appropriate subdivision of the firm, response costs incurred and to be from the Consent Decree Library, P.O. have become totally or partially incurred by the Environmental Box 7611, U.S. Department of Justice, separated, or are threatened to become Protection Agency (‘‘EPA’’), pursuant to Washington, DC 20044–7611 or by totally or partially separated; Section 107 of the Comprehensive faxing or e-mailing a request to Tonia B. There has been a shift in Environmental Response, Compensation Fleetwood ([email protected]), production by such workers’ firm or and Liability Act, as amended fax number (202) 514–0097, phone subdivision to a foreign country of (‘‘CERCLA’’), 42 U.S.C. 9607, in confirmation number (202) 514–1547. In articles like or directly competitive with connection with the Service First Barrel requesting a copy of the Consent Decree articles which are produced by such and Drum Site, located in Salt Lake from the Consent Decree Library, please firm or subdivision; and City, Utah. Three defendants, Adria enclose a check in the amount of $6.00 C. One of the following must be Rossomondo, Arthur Rossomondo, and (.25 cents per page reproduction costs), satisfied: Beehive Barrel and Drum, Inc. d/b/a payable to the U.S. Treasury. 1. The country to which the workers’ Cascade Cooperage, Inc. (‘‘Rossomondo firm has shifted production of the Defendants’’), have resolved the United Robert D. Brook, articles is a party to a free trade States’ response cost claims through this Assistant Section Chief, Environmental agreement with the United States; Consent Decree. The settlement Enforcement Section, Environment and 2. The country to which the workers’ incorporated in the Consent Decree does Natural Resources Division. firm has shifted production of the not resolve the United States’ response [FR Doc. 06–603 Filed 1–23–06; 8:45 am] articles to a beneficiary country under cost claims or any other claim with BILLING CODE 4410–15–M the Andean Trade Preference Act,
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African Growth and Opportunity Act, or TA–W–58,326; Reliable Garment, Los imports) and (a)(2)(B)(II.B) (No shift in the Caribbean Basin Economic Recovery Angeles, CA, November 10, 2004. production to a foreign country) have Act; or TA–W–58,401; Accutech Mold and not been met. 3. There has been or is likely to be an Engineering, Little Falls, MN, TA–W–58,421; Sony Electronics, Direct increase in imports of articles that are November 22, 2004. View CRT, Mt. Pleasant, PA. like or directly competitive with articles TA–W–58,456; WestPoint Home, Inc., TA–W–58,481; Collins and Aikman, which are or were produced by such Bath Products Div., Ambassador Southwest Laminates, Inc. Division, firm or subdivision. Personnel, Valley, AL, December 2, El Paso, TX. Also, in order for an affirmative 2004. TA–W–58,274; Saint-Gobain Container, determination to be made and a TA–W–57,987; Sun Chemical, Carteret, NJ. Performance Pigments Division, certification of eligibility to apply for The investigation revealed that Cincinnati, OH, September 12, worker adjustment assistance as an criteria (a)(2)(A)(I.C.) (Increased imports adversely affected secondary group to be 2004. TA–W–58,388; Chuan Hing Sewing, Inc., and (a)(2)(B)(II.C) (has shifted issued, each of the group eligibility production to a foreign country) have requirements of Section 222(b) of the San Francisco, CA, November 21, 2004. not been met. Act must be met. None. (1) Significant number or proportion The following certifications have been The workers firm does not produce an of the workers in the workers’ firm or issued. The requirements of (a)(2)(B) article as required for certification under an appropriate subdivision of the firm (shift in production) of Section 222 have Section 222 of the Trade Act of 1974. been met. have become totally or partially TA–W–58,487; U.S. Airways, Greentree separated, or are threatened to become TA–W–58,396; Leesburg Knit Mill, Reservations, Pittsburgh, PA. totally or partially separated; Knitting Div., Union Underwear Co., Inc., Leesburg, AL, November 21, The investigation revealed that (2) The workers’ firm (or subdivision) criteria (2) has not been met. The is a supplier or downstream producer to 2004. TA–W–58,480; LeSportsac, Inc., Stearns, workers firm (or subdivision) is not a a firm (or subdivision) that employed a supplier or downstream producer to group of workers who received a KY, November 30, 2004. TA–W–58,499; Metaldyne Corporation, trade-affected companies. certification of eligibility to apply for None. trade adjustment assistance benefits and LLC, Heartland Industrial Partners, such supply or production is related to Edon, OH, December 6, 2005. Affirmative Determinations for the article that was the basis for such TA–W–58,502; Wella Manufacturing of Alternative Trade Adjustment certification; and Virginia, USA Staffing, Spherion, Assistance STAT, Aerotek, Will Rogers, (3) Either— In order for the Division of Trade (A) The workers’ firm is a supplier Richmond, VA, November 28, 2004. TA–W–58,295; Pixelworks, Inc., Adjustment Assistance to issue a and the component parts it supplied for Tualatin, OR, November 4, 2004. certification of eligibility to apply for the firm (or subdivision) described in TA–W–58,295A; Pixelworks, Inc., Alternative Trade Adjustment paragraph (2) accounted for at least 20 Campbell, CA, November 4, 2004. Assistance (ATAA) for older workers, percent of the production or sales of the the group eligibility requirements of workers’ firm; or The following certification has been issued. The requirement of supplier to Section 246(a)(3)(A)(ii) of the Trade Act (B) A loss or business by the workers’ must be met. firm with the firm (or subdivision) a trade certified firm has been met. None. The following certifications have been described in paragraph (2) contributed The following certification has been issued; the date following the company importantly to the workers’ separation issued. The requirement of downstream name and location of each or threat of separation. producer to a trade certified firm has determination references the impact Affirmative Determinations for Worker been met. date for all workers of such Adjustment Assistance None. determinations. In the following cases, it has been The following certifications have been Negative Determinations for Worker determined that the requirements of issued; the date following the company Adjustment Assistance Section 246(a)(3)(ii) have been met. name and location of each In the following cases, the I. Whether a significant number of determination references the impact investigation revealed that the criteria workers in the workers’ firm are 50 date for all workers of such for eligibility have not been met for the years of age or older. determination. reasons specified. II. Whether the workers in the The following certifications have been The investigation revealed that workers’ firm possess skills that are not issued. The requirements of (a) (2) (A) criterion (a)(2)(A)(I.A) and (a)(2)(B)(II.A) easily transferable. (increased imports) of Section 222 have (no employment decline) has not been III. The competitive conditions within been met. met. the workers’ industry (i.e., conditions TA–W–58,327; Hewlett Packard, TA–W–58,413; Badger Paper Mills, within the industry are adverse). Ontario, CA, November 10, 2004. BPM, Inc., Flexible Packaging Div., TA–W–58,396; Leesburg Knit Mill, TA–W–58,412; F. Schumacher and Oconton Falls, WI. Knitting Div., Union Underwear Co., Company, Newark Customer The investigation revealed that Inc., Leesburg, AL, November 21, Service Facility, Newark, DE, criteria (a)(2)(A)(I.B.) (Sales or 2004. November 28, 2004. production, or both, did not decline) TA–W–58,480; LeSportsac, Inc., Stearns, TA–W–58,526; IPF Management and (a)(2)(B)(II.B) (No shift in KY, November 30, 2004. Company, Inc., d/b/a Invincible IPF, production to a foreign country) have TA–W–58,499; Metaldyne Corporation, Paterson, NJ, December 20, 2004. not been met. LLC, Heartland Industrial Partners, TA–W–58,070; Carrier Access None. Edon, OH, December 6, 2005. Corporation, Boulder, CO, October The investigation revealed that TA–W–58,502; Wella Manufacturing of 4, 2004. criteria (a)(2)(A)(I.C.) (increased Virginia, USA Staffing, Spherion,
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STAT, Aerotek, Will Rogers, issued during the month of January eligibility for workers and former Richmond, VA, November 28, 2004. 2006. Copies of these determinations are workers of the subject firm to apply for TA–W–58,388; Chuan Hing Sewing, Inc., available for inspection in Room C– Trade Adjustment Assistance (TAA) and San Francisco, CA, November 21, 5311, U.S. Department of Labor, 200 Alternative Trade Adjustment 2004. Constitution Avenue, NW., Washington, Assistance (ATAA). The denial notice TA–W–58,456; WestPoint Home, Inc., DC 20210, during normal business was signed on November 10, 2005 and Bath Products Div., Ambassador hours or will be mailed to persons who published in the Federal Register on Personnel, Valley, AL, December 2, write to the above address. December 6, 2005 (70 FR 72653). Pursuant to 29 CFR 90.18(c) 2004. Dated: January 12, 2006. TA–W–58,327; Hewlett Packard, reconsideration may be granted under Erica R. Cantor, Ontario, CA, November 10, 2004. the following circumstances: TA–W–58,526; IPF Management Director, Division of Trade Adjustment (1) If it appears on the basis of facts Company, Inc., d/b/a Invincible IPF, Assistance. not previously considered that the Paterson, NJ, December 20, 2004. [FR Doc. E6–803 Filed 1–23–06; 8:45 am] determination complained of was BILLING CODE 4510–30–P erroneous; Negative Determinations for Alternative (2) If it appears that the determination Trade Adjustment Assistance complained of was based on a mistake DEPARTMENT OF LABOR In order for the Division of Trade in the determination of facts not Adjustment Assistance to issue a previously considered; or Employment and Training (3) If in the opinion of the Certifying certification of eligibility to apply for Administration Alternative Trade Adjustment Officer, a misinterpretation of facts or of Assistance (ATAA) for older workers, [TA–W–58,309] the law justified reconsideration of the the group eligibility requirements of decision. OBG Manufacturing Company; Liberty, The TAA petition, filed on behalf of Section 246(a)(3)(A)(ii) of the Trade Act KY; Dismissal of Application for workers at Plasti-Coil, Inc., Lake must be met. Reconsideration Geneva, Wisconsin engaged in In the following cases, it has been production of custom injection molding determined that the requirements of Pursuant to 29 CFR 90.18(C) an was denied because the ‘‘contributed Section 246(a)(3)(ii) have not been met application for administrative importantly’’ group eligibility for the reasons specified. reconsideration was filed with the requirement of Section 222 of the Trade Since the workers are denied Director of the Division of Trade Act of 1974 was not met, nor was there eligibility to apply for TAA, the workers Adjustment Assistance for workers at a shift in production from that firm to cannot be certified eligible for ATAA. OBG Manufacturing Company, Liberty, a foreign country. The ‘‘contributed TA–W–58,487; U.S. Airways, Greentree Kentucky. The application did not importantly’’ test is generally Reservations, Pittsburgh, PA. contain new information supporting a demonstrated through a survey of the TA–W–58,274; Saint-Gobain Container, conclusion that the determination was workers’ firm’s declining customers. Carteret, NJ. erroneous, and also did not provide a The survey revealed no increase in TA–W–58,421; Sony Electronics, Direct justification for reconsideration of the imports of custom injection molding. View CRT, Mt. Pleasant, PA. determination that was based on either The subject firm did not import custom TA–W–58,481; Collins and Aikman, mistaken facts or a misinterpretation of injection molding in the relevant period, Southwest Laminates, Inc. Division, facts or of the law. Therefore, dismissal nor did it shift production to a foreign El Paso, TX. of the application was issued. country. The Department as determined that TA–W–58,309; OBG Manufacturing In the request for reconsideration, the criterion (1) of Section 246 has not been Company, Liberty, Kentucky petitioner alleges that the layoffs at the met. Workers at the firm are 50 years of (January 11, 2006). subject firm are attributable to a shift in age or older. production to China. To support the None. Signed at Washington, DC this 11th day of January 2006. allegations, the petitioner attached a The Department as determined that Erica R. Cantor, copy of the letter from the subject firm’s criterion (2) of Section 246 has not been company official stating that ‘‘a met. Workers at the firm possess skills Director, Division of Trade Adjustment Assistance. significant portion of the business has that are easily transferable. been transferred to China’’. [FR Doc. E6–802 Filed 1–23–06; 8:45 am] TA–W–58,295; Pixelworks, Inc., A company official was contacted Tualatin, OR. BILLING CODE 4510–30–P regarding the above allegations. The TA–W–58,295A; Pixelworks, Inc., company official confirmed what was Campbell, CA. DEPARTMENT OF LABOR revealed during the initial investigation. TA–W–58,070; Carrier Access In particular, the official stated that Corporation, Boulder, CO. Employment and Training Plasti-Coil, Inc., Lake Geneva, TA–W–58,401; Accutech Mold and Administration Wisconsin was contemplating to move Engineering, Little Falls, MN. portion of its production to China, TA–W–57,987; Sun Chemical, [TA–W–58,047] however, the shift did not occur and Performance Pigments Division, Plasti-Coil, Inc.; Lake Geneva, WI; there are no current plans to move Cincinnati, OH. Notice of Negative Determination production from the subject firm to a The Department as determined that Regarding Application for foreign country. The official further criterion (3) of Section 246 has not been Reconsideration clarified that the letter mentioned by the met. Competition conditions within the petitioner meant that the subject firm’s workers’ industry are not adverse. By application of December 8, 2005 a customers transferred significant None. petitioner requested administrative volumes of their business to China and I hereby certify that the reconsideration of the Department’s other Asian countries, which had a aforementioned determinations were negative determination regarding negative impact on production of the
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subject firm. The subject firm did not importantly to the declines in sales and DEPARTMENT OF LABOR shift production of custom injection employment at the subject firm. The molding abroad. investigation further revealed that sales, Employment and Training Administration Conclusion production and employment at the subject firm declined during the [TA–W–57,838] After review of the application and relevant time period. investigative findings, I conclude that Texstyle, Inc., Manchester, KY; Notice there has been no error or In accordance with Section 246 the Trade Act of 1974 (26 U.S.C. 2813), as of Affirmative Determination Regarding misinterpretation of the law or of the Application for Reconsideration facts which would justify amended, the Department of Labor reconsideration of the Department of herein presents the results of its By application of October 17, 2005, Labor’s prior decision. Accordingly, the investigation regarding certification of petitioners requested administrative application is denied. eligibility to apply for alternative trade reconsideration of the Department of Signed at Washington, DC this 13th day of adjustment assistance (ATAA) for older Labor’s Notice of Negative January, 2006. workers. Determination Regarding Eligibility to Elliott S. Kushner, In order for the Department to issue Apply for Worker Adjustment Certifying Officer, Division of Trade a certification of eligibility to apply for Assistance, applicable to workers of Adjustment Assistance. ATAA, the group eligibility TexStyle, Inc., Manchester, Kentucky (the subject firm). The negative [FR Doc. E6–801 Filed 1–23–06; 8:45 am] requirements of Section 246 of the determination for the subject firm was BILLING CODE 4510–30–P Trade Act must be met. The Department issued on September 15, 2005, and has determined in this case that the published in the Federal Register on requirements of Section 246 have been DEPARTMENT OF LABOR October 31, 2005 (70 FR 62345). met. Under a prior certification (TA–W– Employment and Training A significant number of workers at the 51,404), workers were eligible to apply Administration firm are age 50 or over and possess for worker adjustment assistance (issued [TA–W–57,945; TA–W–57,945A] skills that are not easily transferable. on April 21, 2003; expired on April 21, Competitive conditions within the 2005). The investigation instituted on Polyvision Corporation; 13646 Route industry are adverse. August 25, 2005, revealed that the 402 Highway North Facility; Clymer, workers did not produce an article or PA; 2170 Barr Slope Road Facility; Conclusion support an affiliated domestic Dixonville, PA; Notice of Revised After careful review of the additional production facility during the relevant period. Determination on Reconsideration facts obtained on reconsideration, I New information provided on conclude that increased imports of By letter dated December 5, 2005, December 1, 2005 by the subject firm articles like or directly competitive with Greater Pennsylvania Regional Council revealed that some production did occur of Carpenters requested administrative those produced at Polyvision at TexStyle, Inc., Manchester, Kentucky reconsideration regarding the Corporation, Clymer, Pennsylvania during the relevant period. Department’s Negative Determination (TA–W–57,945) and Polyvision The Department carefully reviewed Regarding Eligibility to Apply for Corporation, Dixonville, Pennsylvania the petitioners’ request for Worker Adjustment Assistance, (TA–W–57,945A), contributed reconsideration and has determined that applicable to the workers of the subject importantly to the declines in sales or the Department will conduct further firm. production and to the total or partial investigation based on new information The initial investigation resulted in a separation of workers at the subject provided by the subject firm. negative determination signed on firm. In accordance with the provisions October 21, 2005 and was based on the of the Act, I make the following Conclusion finding that imports of casework certification: After careful review of the cabinets, marker and tack boards did not application, I conclude that the claim is ‘‘All workers of Polyvision Corporation, contribute importantly to worker of sufficient weight to justify Clymer, Pennsylvania (TA–W–57,945) and separations at the subject plant and no reconsideration of the Department of shift of production to a foreign source Polyvision Corporation, Dixonville, Pennsylvania (TA–W–57,945A) who became Labor’s prior decision. The application occurred. The denial notice was is, therefore, granted. published in the Federal Register on totally or partially separated from November 9, 2005 (70 FR 68099). employment on or after September 8, 2004 Signed at Washington, DC, this 22nd day To support the request for through two years from the date of this of December 2005. reconsideration, the petitioner supplied certification, are eligible to apply for Elliott S. Kushner, additional information. The Department adjustment assistance under Section 223 of Certifying Officer, Division of Trade of Labor reviewed surveys of the firms the Trade Act of 1974, and are eligible to Adjustment Assistance. to which the subject facility submitted apply for alternative trade adjustment [FR Doc. E6–799 Filed 1–23–06; 8:45 am] bids and was not subsequently awarded assistance under Section 246 of the Trade Act BILLING CODE 4510–30–P the contracts. A further contact with the of 1974.’’ surveyed companies revealed the fact Signed in Washington, DC this 13th day of that all the bids were awarded to January 2006. DEPARTMENT OF LABOR domestic bidders who manufacture case Elliott S. Kushner, Mine Safety and Health Administration work cabinets, market boards and tack Certifying Officer, Division of Trade boards abroad. The loss of these Adjustment Assistance. Petitions for Modification contracts as a result of increased [FR Doc. E6–800 Filed 1–23–06; 8:45 am] imports of case work cabinets, market The petition for modification notice boards and tack boards contributed BILLING CODE 4510–30–P published in the Federal Register on
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December 28, 2005 (70 FR 76892) for the Pennsylvania; R & R Coal Company, R petitioner proposes to modify existing R S & W Coal Company, Drift Mine, & R Coal Company Mine (MSHA I.D. scoops for use as mobile work platforms docket number M–2005–079–C, had the No. 36–08498) located in Schuylkill and implement operational restrictions wrong MSHA I.D. Number. The correct County, Pennsylvania; Six M Coal to safeguard miners working from the MSHA I.D. Number is 36–01818. Company, No. 1 Slope Mine (MSHA I.D. raised platform. The petitioner states The following parties have filed No. 36–09138) located in Dauphin that this petition will apply only to petitions to modify the application of County, Pennsylvania; Bear Gap Coal Wagner ST3.5 Scoops, Serial Nos. existing safety standards under section Company, Bear Gap Coal Company #6 SA04C0228, Company ID No. 24–25 and 101(c) of the Federal Mine Safety and Slope Mine (MSHA I.D. No. 36–09296) SA 04P0292, Company ID No. 24–26. Health Act of 1977. located in Dauphin County, The petitioner has listed in this petition Pennsylvania. The petitioner requests a specific terms and conditions that will 1. Anthracite Underground Rescue, Inc. modification of the existing standard to be used when the proposed alternative [Docket No. M–2005–085–C] permit the reduction of twelve self- is implemented. The petitioner asserts Anthracite Underground Rescue, Inc., contained oxygen breathing apparatus to that the proposed alternative method 44 Crescent Street, Tremont, eight self-contained breathing would provide at least the same Pennsylvania 17981 has filed a petition apparatus, and the reduction of twelve measure of protection as the existing to modify the application of 30 CFR permissible cap lamps and charging standard. rack to eight permissible cap lamps and 49.6(a)(1) & (5) (Equipment and 4. Twentymile Coal Company maintenance requirements) for the charging rack. The petitioner states that following Anthracite Underground reduction of two rescue teams with five [Docket No. M–2006–002–C] Mines in District 1: Alfred Brown Coal members and one alternate to two Twentymile Coal Company, 29515 Company, 7 FT Slope Mine (MSHA I.D. rescue teams of three members with one Routt County Road #27, Oak Creek, No. 36–08893) located in Schuylkill alternative has been granted to all Colorado 80467 has filed a petition to County, Pennsylvania; B & B Rockridge operating anthracite coal mines. The modify the application of 30 CFR Slope, Rockridge No. 1 Slope Mine petitioner asserts that eight self- 75.500(d) (Permissible electric (MSHA I.D. No. 36–07741) located in contained breathing apparatus and eight equipment) to its Foidel Creek Mine Schuylkill County, Pennsylvania; permissible cap lamps are sufficient to (MSHA I.D. No. 05–03836) located in Chestnut Coal Company, No. 10 Slope supply the seven members of the rescue Routt County, Colorado. The petitioner Mine (MSHA I.D. No. 36–07059) located team, and that the proposed alternate requests a modification of the existing in Northumberland County, method of compliance will not alter, standard to permit an alternative Pennsylvania; D & D Coal Company, change, or reduce the ability, method of compliance to use battery- Primrose Slope Mine (MSHA I.D. No. effectiveness, or safety of the powered non-permissible hand-held 36–08341) located in Schuylkill County, underground mine personnel. computers in or inby the last open Pennsylvania; F.K.Z Coal Company, No. 2. Bear Gap Coal Company crosscut, including in the return 1 Slope Mine (MSHA I.D. No. 36–08637) airways, to allow supervisors and located in Northumberland County, [Docket No. M–2005–086–C] selected miners to collect and record Pennsylvania; Joliett Coal Company, #3 Bear Gap Coal Company, Box 64 data pertinent to safety observations Vein Slope Mine (MSHA I.D. No. 36– Kushwa Road, Spring Glen, during work processes. The petitioner 08702) located in Schuylkill County, Pennsylvania 17978 has filed a petition states that the recorded data in the Pennsylvania; Little Buck Coal to modify the application of 30 CFR hand-held computers will be Company, No. 2 Slope Mine (MSHA I.D. 49.2(b) (Availability of mine rescue downloaded at the end of the shift and No. 36–08299) located in Schuylkill teams) to its Bear Gap Coal Company #6 collated with other data to allow the County, Pennsylvania; R & D Coal Slope Mine (MSHA I.D. No. 36–09296) petitioner to proactively correct unsafe Company, R & D Coal Co., Inc. Mine located in Dauphin County, practices and to prevent accidents (MSHA I.D. No. 36–02053) located in Pennsylvania. The petitioner requests a before they occur. The petitioner has Schuylkill County, Pennsylvania; R S & modification of the existing standard to listed in this petition specific terms and W Coal Co., Inc., R S & W Drift Mine permit the reduction of two mine rescue conditions that will be used when the (MSHA I.D. No. 36–01818) located in teams with five members and one proposed alternative method is Schuylkill County, Pennsylvania; alternate each to two mine rescue teams implemented. The petitioner asserts that Orchard Coal Company, Orchard Slope of three members with one alternate for the proposed alternative method would Mine (MSHA I.D. No. 36–08346) located either team. The petitioner asserts that provide at least the same measure of in Schuylkill County, Pennsylvania; application of the existing standard will protection as the existing standard. result in a diminution of safety to the Snyder Coal Company, N & L Slope 5. Twentymile Coal Company Mine (MSHA I.D. No. 36–02203) located miners, and that the proposed in Northumberland County, alternative method would provide at [Docket No. M–2006–003–C] Pennsylvania; Snyder Coal Company, least the same measure of protection as Twentymile Coal Company, 29515 Rock Slope #1 Mine (MSHA I.D. No. 36– the existing standard. Routt County Road #27, Oak Creek, 09256) located in Northumberland 3. Oxbow Mining, LLC Colorado 80467 has filed a petition to County, Pennsylvania; Tito Coal modify the application of 30 CFR Company, Whites Vein Slope Mine [Docket No. M–2006–001–C] 75.1002(a) (Installation of electric (MSHA I.D. No. 36–06815) located in Oxbow Mining, LLC, P.O. Box 535, equipment and conductors; Schuylkill County, Pennsylvania; UAE 3737 Highway 133, Somerset, Colorado permissibility) to its Foidel Creek Mine Coalcorp Association, Harmony Mine 81434 has filed a petition to modify the (MSHA I.D. No. 05–03836) located in (MSHA I.D. No. 36–07838) located in application of 30 CFR 75.1726(a) Routt County, Colorado. The petitioner Northumberland County, Pennsylvania; (Performing work from a raised position; requests a modification of the existing S & M Coal Company, Buck Mountain safeguards) to its Elk Creek Mine standard to permit an alternative Slope Mine (MSHA I.D. No. 36–02022) (MSHA I.D. No. 05–04674) located in method of compliance to use battery- located in Dauphin County, Gunnison County, Colorado. The powered non-permissible hand-held
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computers in or inby the last open Appendix B, to reflect organizational entirety and the revised Appendix B as crosscut, including in the return changes and to update addresses. follows: airways, to allow supervisors and DATES: Effective Date: The revision to NARA 1 selected miners to collect and record NARA 1, Researcher Application Files, data pertinent to safety observations will become effective without further SYSTEM NAME: during work processes. The petitioner notice on February 23, 2006, unless Researcher Application Files. states that the recorded data in the comments received on or before that SECURITY CLASSIFICATION: hand-held computers will be date cause a contrary decision. If downloaded at the end of the shift and changes are made based on NARA’s None. collated with other data to allow the review comments received, a new final SYSTEM LOCATION: petitioner to proactively correct unsafe notice will be published. practices and to prevent accidents Researcher application files are before they occur. The petitioner has ADDRESSES: Send comments to the maintained in the following locations in listed in this petition specific terms and Privacy Act Officer, Office of General the Washington, DC area and other conditions that will be used when the Counsel (NGC), Room 3110, National geographical regions. The addresses for proposed alternative method is Archives and Records Administration, these locations are listed in Appendix B implemented. The petitioner asserts that 8601 Adelphi Road, College Park, MD following the NARA Notices: the proposed alternative method would 20740–6001. They may be faxed to 301– (1) Customer Services Division; provide at least the same measure of 837–0293. You may also comment via (2) Presidential libraries and projects; protection as the existing standard. the Internet to [email protected]. and (3) Regional records services facilities. Request for Comments FOR FURTHER INFORMATION CONTACT: Ramona Branch Oliver, Privacy Act CATEGORIES OF INDIVIDUALS COVERED BY THE Persons interested in these petitions Officer, National General Counsel, SYSTEM: are encouraged to submit comments via Room 3110, AII, at telephone number Individuals covered by this system E-mail: [email protected]; 301–837–2024 or fax number 301–837– include persons who apply to use Fax: (202) 693–9441; or Regular Mail/ 0293. original records for research in NARA Hand Delivery/Courier: Mine Safety and SUPPLEMENTARY INFORMATION: facilities in the Washington, DC area, Health Administration, Office of The last notice for this system was published in the Presidential libraries, and the Standards, Regulations, and Variances, regional records services facilities. 1100 Wilson Boulevard, Room 2350, the Federal Register on April 2, 2002. Arlington, Virginia 22209. All The notice for this system of records CATEGORIES OF RECORDS IN THE SYSTEM: comments must be postmarked or states the name and the location of the Researcher application files may received in that office on or before record system, the authority for and include: Researcher applications; February 23, 2006. Copies of these manner of its operation, the categories related correspondence; and electronic petitions are available for inspection at of individuals that it covers, the types records. These files may contain the that address. of records that it contains, the sources following information about an of information in the records, and the individual: Name, address, telephone Dated at Arlington, Virginia this 18th day proposed ‘‘routine uses’’ of the system of January 2006. number, proposed research topic(s), of records. The notice also includes the Robert F. Stone, occupation, name and address of business address of the NARA official employer/institutional affiliation, Acting Director, Office of Standards, who will inform interested persons of Regulations, and Variances. educational level and major field, the procedures whereby they may gain expected result(s) of research, photo, [FR Doc. E6–828 Filed 1–23–06; 8:45 am] access to and correct records pertaining BILLING CODE 4510–43–P researcher card number, type of records to themselves. used, and other information furnished One of the purposes of the Privacy by the individual. Electronic systems Act, as stated in section 2(b)(4) of the NATIONAL ARCHIVES AND RECORDS may also contain additional information Act, is to provide certain safeguards for related to the application process. ADMINISTRATION an individual against an invasion of AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Privacy Act of 1974, as Amended; personal privacy by requiring Federal System of Records Notices agencies to disseminate any record of 44 U.S.C. 2108, 2111 note, and identifiable personal information in a 2203(f)(1). AGENCY: National Archives and Records manner that assures that such action is PURPOSE(S): Administration (NARA). for a necessary and lawful purpose, that ACTION: Notice of a proposed new information is current and accurate for The information in this system is used routine use for an existing privacy its intended use, and that adequate to register researchers who wish to gain system of records and the revision of the safeguards are provided to prevent access to original records; to assist existing inventory of Privacy Act system misuse of such information. NARA NARA in maintaining intellectual managers. intends to follow these principles in control over archival holdings and to transferring information to another refer related information to the Office of SUMMARY: The National Archives and agency or individual as a ‘‘routine use’’, Inspector General if original records are Records Administration (NARA) is including assurance that the determined to be missing or mutilated; proposing to revise an existing system of information is relevant for the purposes to disseminate information related to records, NARA 1—Researcher for which it is transferred. events and programs of interest to Application Files. The system is being NARA’s researchers as appropriate; and revised to add as a routine use the Dated: January 14, 2006. measure customer satisfaction with invitation for researchers to participate Allen Weinstein, NARA services. Aggregate information in voluntary customer satisfaction Archivist of the United States. from this system may be used for the surveys. NARA is also revising its Accordingly, we are publishing the purposes of review, analysis, planning, inventory of system managers, revised system of records notice in its and policy formulation related to
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customer service staffing and facility accordance with the disposition system of records, may be referred, as a needs. instructions in the NARA records routine use, to the appropriate agency, schedule contained in FILES 203, the whether Federal, State, local, or foreign, ROUTINE USES OF RECORDS MAINTAINED IN THE NARA Files Maintenance and Records charged with the responsibility of SYSTEM, INCLUDING CATEGORIES OF USERS AND Disposition Manual. Individuals may investigating or prosecuting such violation or THE PURPOSES OF SUCH USES: charged with enforcing or implementing the request a copy of the disposition NARA maintains researcher statute, or rule, regulation or order issued instructions from the NARA Privacy Act application files on individuals to: pursuant thereto. Officer. Register persons who apply to use B. Routine Use—Disclosure When Requesting original records for research at a NARA SYSTEM MANAGER(S) AND ADDRESS: Information facility; record initial research interests For researchers who apply to use A record from this system of records may of researchers; determine which records records and Nixon presidential be disclosed as a routine use to a Federal, researchers may want to use; contact materials in the Washington, DC area, State, or local agency maintaining civil, researchers if additional information of the system manager for researcher criminal or other relevant enforcement research interest is found or if problems application files is: Assistant Archivist information or other pertinent information, with the requested records are for Records Services—Washington, DC such as current licenses, if necessary, to discovered; and prepare mailing lists for obtain information relevant to an agency (NW). For researchers who apply to use decision concerning the hiring or retention of sending notices of events and programs accessioned records, presidential of interest to researchers, including the an employee, the issuance of a security records, and donated historical clearance, the letting of a contract, or the fundraising and related activities of materials in the Presidential libraries issuance of a license, grant, or other benefit. NARA-associated foundations, and and the regional records services invitations to participate in voluntary C. Routine Use—Disclosure of Requested facilities, the system managers of Information customer satisfaction surveys, unless researcher application files are the individuals elect that their application directors of the individual libraries and A record from this system of records may information not be used for this be disclosed to a Federal agency, in response regional records services facilities. The to its request, in connection with the hiring purpose. The electronic databases serve addresses for these locations are listed as finding aids to the applications. or retention of an employee, the issuance of in Appendix B following the NARA a security clearance, conducting a security or Information in the system is also used Notices. suitability investigation, classifying a job, the by NARA staff to compile statistical and reporting of an investigation of an employee, other aggregate reports regarding NOTIFICATION PROCEDURE: the letting of a contract, or the issuance of a researcher use of records. Individuals interested in inquiring license, grant, or other benefit by the The routine use statements A, C, E, F, about their records should notify the requesting agency, to the extent that the and G, described in Appendix A NARA Privacy Act Officer, whose information is relevant and necessary to the following the NARA Notice, also apply address is listed in Appendix B after the requesting agency’s decision on the matter. to this system of records. NARA Notices. D. Routine Use—Grievance, Complaint, Appeal DISCLOSURE TO CONSUMER REPORTING RECORD ACCESS PROCEDURES: AGENCIES: A record from this system of records may Individuals who wish to gain access In addition to the routine use be disclosed to an authorized appeal or to their records should submit their grievance examiner, formal complaints statements referenced above, the request in writing to the NARA Privacy examiner, equal employment opportunity researcher application files are handled Act Officer at the address given in investigator, arbitrator, or other duly consistent with disclosure provisions in Appendix B. authorized official engaged in investigation 5 U.S.C. 552a(b)(1) through (b)(12). or settlement of a grievance, complaint, or CONTESTING RECORD PROCEDURES: appeal filed by an employee. A record from POLICIES AND PRACTICES FOR STORING, NARA rules for contesting the this system of records may be disclosed to RETRIEVING, ACCESSING, RETAINING, AND the United States Office of Personnel DISPOSING OF RECORDS IN THE SYSTEM: contents and appealing initial determinations are found in 36 CFR part Management, the Merit Systems Protection Board, Federal Labor Relations Authority, or STORAGE: 1202. Paper and electronic records. the Equal Employment Opportunity RECORD SOURCE CATEGORIES: Commission when requested in the RETRIEVABILITY: performance of their authorized duties. To Information in researcher application Information in the records may be the extent that official personnel records in files is obtained from researchers and the custody of NARA are covered within the retrieved by the name of the individual from NARA employees who maintain system of records published by the Office of or by researcher card number. the files. Personnel Management as Governmentwide records, those records will be considered as SAFEGUARDS: EXEMPTIONS CLAIMED FOR THE SYSTEM: NONE a part of that Governmentwide system. Other During normal hours of operation, Appendix A—Routine Uses records covered by notices published by paper records are maintained in areas NARA and considered to be separate systems accessible only to authorized personnel The following routine use statements will of records may be transferred to the Office of of NARA. Electronic records are apply to National Archives and Records Personnel Management in accordance with accessible via passwords from terminals Administration notices where indicated: official personnel programs and activities as a routine use. located in attended offices. After hours, A. Routine Use—Law Enforcement buildings have security guards and/or In the event that a system of records E. Routine Use—Congressional Inquiries doors are secured and all entrances are maintained by this agency to carry out its A record from this system of records may monitored by electronic surveillance functions indicates a violation or potential be disclosed as a routine use to a Member of equipment. violation of law, whether civil, criminal or Congress or to a Congressional staff member regulatory in nature, and whether arising by in response to an inquiry of the RETENTION AND DISPOSAL: general statute or particular program statute, Congressional office made at the request of Researcher application files are or by regulation, rule or order issued the individual about whom the record is temporary records and are destroyed in pursuant thereto, the relevant records in the maintained.
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F. Routine Use—NARA Agents Road, Room 1320, College Park, MD Washington National Records Center A record from this system of records may 20740–6001. (WNRC), 4205 Suitland Road, Suitland, be disclosed as a routine use to an expert, Ronald Reagan Library, 40 Presidential Drive, MD 20746–8001. consultant, agent, or a contractor of NARA to Simi Valley, CA 93065–0600. If the system manager is the Director of the the extent necessary for them to assist NARA Franklin D. Roosevelt Library, 4079 Albany National Historical Publications and Records Post Road, Hyde Park, NY 12538–1999. in the performance of its duties. Agents Commission (NHPRC), the records are Harry S. Truman Library, 500 West US include, but are not limited to, GSA or other located at the following address: Highway 24, Independence, MO 64050– entities supporting NARA’s payroll, finance, National Historical Publications and Records 1798. and personnel responsibilities. Commission (NHPRC), National Archives Office of Presidential Libraries, National and Records Administration, 700 G. Routine Use—Department of Justice/ Archives at College Park, 8601 Adelphi Pennsylvania Avenue, NW., Room 111, Courts Road, Room 2200, College Park, MD Washington, DC 20408–0001. 20740–6001. A record from this system of records may If the system manager is the Director of the If the system manager is the director of a be disclosed to the Department of Justice or Policy and Planning Staff, the records are Federal Records Center or Regional Archives in a proceeding before a court or adjudicative located at the following address: Policy and facility, the records are located at the body before which NARA is authorized to Planning Staff (NPOL), National Archives appropriate Federal Records Center or appear, when: (a) NARA, or any component and Records Administration, 8601 Adelphi Regional Archives Facility: thereof; or, (b) any employee of NARA in his Road, Room 4100, College Park, MD 20740– or her official capacity; or, (c) any employee NARA’s Pacific Alaska Region (Anchorage), 6001. of NARA in his or her individual capacity 654 West Third Avenue, Anchorage, If the system manager is the Director of the where the Department of Justice or NARA Alaska 99501–2145. Congressional Affairs and Communications has agreed to represent the employee; or (d) NARA’s Southeast Region (Atlanta), 5780 Staff, the records are located at the following the United States, where NARA determines Jonesboro Road, Morrow, Georgia 30260. address: Congressional Affairs and that litigation is likely to affect the agency or NARA‘s Northeast Region (Boston), Frederick Communications Staff (NCON), National any of its components, is a party to litigation C. Murphy Federal Center, 380 Trapelo Archives and Records Administration, 700 or has an interest in such litigation, and the Road, Waltham, Massachusetts 02452– Pennsylvania Avenue, NW., Room 102, use of such records by the Department of 6399. Washington, DC 20408–0001. Justice or by NARA before a court or NARA’s Great Lakes Region (Chicago), 7358 If the system manager is the Assistant adjudicative body is deemed by NARA to be South Pulaski Road, Chicago, Illinois Archivist for Information Services, the relevant and necessary to the litigation, 60629–5898. records are located at the following address: NARA’s Great Lakes Region (Dayton), 3150 provided, however, that in each case, NARA Office of Information Services (NH), National Springboro Road, Dayton, Ohio 45439– determines that disclosure of the records is Archives and Records Administration, 8601 1883. a use of the information contained in the Adelphi Road, Room 4400, College Park, MD NARA’s Rocky Mountain Region (Denver), records that is compatible with the purpose 20740. Bldg. 48, Denver Federal Center, West 6th for which the records were collected. If the system manager is the Assistant Avenue and Kipling Street, Denver, Archivist for Administration, the records are Appendix B Colorado 80225–0307. located at the following address: Office of NARA’s Southwest Region (Fort Worth), 501 Administration (NA), National Archives and To inquire about your records or to gain West Felix Street, Building 1, Fort Worth, Records Administration, 8601 Adelphi Road, access to your records, you should submit Texas 76115–3405. Room 4200, College Park, MD 20740. your request in writing to: NARA Privacy Act NARA’s Central Plains Region (Kansas City), If the system manager is the Director of the Officer, Office of General Counsel (NGC), 2312 East Bannister Road, Kansas City, Federal Register, the records are located at National Archives at College Park, 8601 Missouri 64131–3. the following address: Office of the Federal Adelphi Road, Room 3110, College Park, MD NARA’s Pacific Region (Laguna Niguel, CA), Register (NF), National Archives and Records 20740–6001. 24000 Avila Road, 1st Floor, East Entrance, Administration, 700 Pennsylvania Avenue, If the system manager is the Assistant Laguna Niguel, California 92677–3497. NW, Washington, DC 20408–0001. Archivist for Record Services—Washington, NARA’s Central Plains Region (Lee’s If the system manager is the Inspector DC (NW), the records are located at the Summit, MO), 200 Space Center Drive, General, the records are located at the following address: Office of Record Lee’s Summit, Missouri 64064–1182. following address: Office of the Inspector Services—Washington, DC (NW), National NARA’s Northeast Region (New York City), General (OIG), National Archives and Archives at College Park, 8601 Adelphi Road, 201 Varick Street, New York, New York Records Administration, 8601 Adelphi Road, Room 3400, College Park, MD 20740–6001. 10014–4811. Room 1300, College Park, MD 20740. If the system manager is the director of a NARA’s Mid Atlantic Region (Center City If the system manager is the General Presidential Library, the records are located Philadelphia), 900 Market Street, Counsel, the records are located at the at the appropriate Presidential Library, Staff Philadelphia, Pennsylvania 19107–4292. following address: Office of the General or Project: NARA’s Mid Atlantic Region (Northeast Counsel (NGC), National Archives and George Bush Library, 1000 George Bush Drive Philadelphia), 14700 Townsend Road, Records Administration, 8601 Adelphi Road, West, College Station, TX 77845. Philadelphia, Pennsylvania 19154–1096. Room 3110, College Park, MD 20740. Jimmy Carter Library, 441 Freedom Parkway, NARA’s Mid Atlantic Region (Center City [FR Doc. E6–798 Filed 1–23–06; 8:45 am] Atlanta, GA 30307–1498. Philadelphia), 900 Market Street, William J. Clinton Presidential Library, 1200 Philadelphia, Pennsylvania 19107–4292. BILLING CODE 7515–01–P President Clinton Avenue, Little Rock, AR NARA’s Northeast Region (Pittsfield, MA), 10 72201. Conte Drive, Pittsfield, Massachusetts Dwight D. Eisenhower Library, 200 SE 4th 01201–8230. NUCLEAR REGULATORY Street, Abilene, KS 67410–2900. NARA’s Pacific Region (San Francisco), 1000 COMMISSION Gerald R. Ford Library, 1000 Beal Avenue, Commodore Drive, San Bruno, California Ann Arbor, MI 48109–2114. 94066–2350. Sunshine Act Meeting Herbert Hoover Library, 210 Parkside Drive, NARA’s Pacific Alaska Region (Seattle), 6125 P.O. Box 488, West Branch, IA 52358– Sand Point Way NE., Seattle, Washington AGENCY HOLDING THE MEETINGS: Nuclear 0488. 98115–7999. Regulatory Commission. Lyndon B. Johnson Library, 2313 Red River National Personnel Records Center, Civilian DATE: Weeks of January 23, 30, February Street, Austin, TX 78705–5702. Personnel Records, 111 Winnebago Street, John F. Kennedy Library, Columbia Point, St. Louis, Missouri 63118–4126. 6, 13, 20, 27, 2006. Boston, MA 02125–3398. National Personnel Records Center, Military PLACE: Commissioners’ Conference Nixon Presidential Materials Staff, National Personnel Records, 9700 Page Avenue, St. Room, 11555 Rockville Pike, Rockville, Archives at College Park, 8601 Adelphi Louis, MO 63132–5100. Maryland.
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STATUS: Public and closed. Week of February 13, 2006—Tentative Dated: January 19, 2006. R. Michelle Schroll, MATTERS TO BE CONSIDERED: Tuesday, February 14, 2006 Office of the Secretary. Week of January 23, 2006 2 p.m.—Briefing on Office of Nuclear [FR Doc. 06–698 Filed 1–20–06; 11:05 am] There are no meetings scheduled for Materials Safety and Safeguards BILLING CODE 7590–01–M the Week of January 23, 2006. (NMSS). Programs, Performance, Week of January 30, 2006—Tentative and Plans—Waste Safety (Public Meeting). (Contact: Teresa Mixon, Tuesday, January 31, 2006 301–415–7474; Derek Widmayer, POSTAL RATE COMMISSION 9:25 a.m.—Affirmation Session (Public 301–415–6677.) Meeting). This meeting will be Webcast live at [Docket No. MC2006–2; Order No. 1452] a. FIRSTENERGY Nuclear Operating the Web address—http://www.nrc.gov. Co. (Beaver Valley Power Station, Repositionable Notes Minor Unit Nos. 1&2; Davis Besse Power Wednesday, February 15, 2006 Classification Changes Station, Unit 1; Perry Nuclear 9:30 a.m.—Briefing on Office of Chief AGENCY: Postal Rate Commission. Power Plant, Unit No. 1), Docket Financial Officer (CFO) Programs, ACTION: Notice and order. Nos. 50–334–LT, 50–346–LT, 50– Performance, and Plans (Public 412–LT, & 50–440–LT. Meeting). (Contact: Edward New, b. Private Fuel Storage (Independent SUMMARY: This document establishes a 301–415–5646.) Spent Fuel Storage Installation) formal docket to consider extending the Docket No. 72–22–ISFSI This meeting will be Webcast live at one-year Repositionable Notes market (Tentative). the Web address—http://www.nrc.gov. test beyond its scheduled expiration in early April 2006. The Service seeks the c. Motion to Reopen the Millstone Week of February 20, 2006—Tentative License Renewal Proceedings Filed extension because it had planned to file by Connecticut Coalition Against There are no meetings scheduled for a new request involving a modified Millstone (Tentative). the Week of February 20, 2006. Repositionable Notes service prior to the expiration of the current test, but would 9:30 a.m.—Briefing on Strategic Week of February 27, 2006—Tentative like to complete a review of a recently- Workforce Planning and Human filed academic research paper before Capital Initiatives (Public Meeting). There are no meetings scheduled for doing so. Extending the current test (Contact: Kristen Davis, 301–415– the Week of February 27, 2006. would allow this review to take place 7108.) * The schedule for Commission and for the anticipated new request to This meeting will be Webcast live at meetings is subject to change on short be adjusted, if warranted, without the the Web address—http://www.nrc.gov. notice. To verify the status of meetings disruption associated with expiration of Wednesday, February 1, 2006 call (recording)—(301) 415–1292. the current test. Contact person for more information: DATES: See SUPPLEMENTARY INFORMATION 9:30 a.m.—Discussion of Security Issues Michelle Schroll, (301) 415–1662. (Closed—Ex. 1 & 3). for dates. The NRC Commission Meeting ADDRESSES: Submit comments Week of February 6, 2006—Tentative Schedule can be found on the Internet electronically via the Commission’s at: http://www.nrc.gov/what-we-do/ Monday, February 6, 2006 Filing Online system at http:// policy-making/schedule.html. www.prc.gov. 9:30 a.m.—Briefing on Materials The NRC provides reasonable Degradation Issues and Fuel accommodation to individuals with FOR FURTHER INFORMATION CONTACT: Reliability (Public Meeting). disabilities where appropriate. If you Stephen L. Sharfman, general counsel, (Contact: Jennifer Uhle, 301–415– need a reasonable accommodation to at 202–789–6818. 6200.) participate in these public meetings, or SUPPLEMENTARY INFORMATION: This meeting will be Webcast live at need this meeting notice or the Regulatory History the Web address—http://www.nrc.gov. transcript or other information from the 2 p.m.—Discussion of Security Issues public meetings in another format (e.g. Docket No. MC2004–5, 68 FR 45353 (Closed—Ex. 1 & 3). braille, large print), please notify the (July 29, 2004). Wednesday, February 8, 2006 NRC’s Disability Program Coordinator, I. Background August Spector, at 301–415–7080, TDD: 9:30 a.m.—Briefing on Office of Nuclear 301–415–2100, or by e-mail at Notice is hereby given that on January Materials Safety and Safeguards [email protected]. Determinations on 12, 2006, the Postal Service filed a (NMSS). Programs, Performance, requests for reasonable accommodation request with the Postal Rate and Plans—Materials Safety (Public will be made on a case-by-case basis. Commission pursuant to section 3623 of the Postal Reorganization Act, 39 U.S.C. Meeting). (Contact: Teresa Mixon, This notice is distributed by mail to 101 et seq., for a recommended decision 301–415–7474; Derek Widmayer, several hundred subscribers; if you no on its request for an extension of the 301–415–6677.) longer wish to receive it, or would like current provisional Repositionable This meeting will be Webcast live at to be added to the distribution, please Notes (RPN) service.1 The Postal Service the Web address—http://www.nrc.gov. contact the Office of the Secretary, denominates this request a minor 1:30 p.m.—Briefing on Office of Washington, DC 20555 (301–415–1969). classification change and seeks to have Research (RES) Programs, In addition, distribution of this meeting it considered under the Commission’s Performance and Plans (Public notice over the Internet system is Meeting). (Contact: Gene Carpenter, available. If you are interested in 301–415–7333.) 1 Request of the United States Postal Service for receiving this Commission meeting a Recommended Decision on Change of Expiration This meeting will be Webcast live at schedule electronically, please send an Date for Provisional Repositionable Notes the Web address—http://www.nrc.gov. electronic message to [email protected]. Classifications and Rates, filed January 12, 2006.
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rules for expedited minor classification foster to be considered in designing the 3. Notices of intervention shall be cases (39 CFR 3001.69). modified service. filed no later than February 7, 2006. The Postal Service’s extension request The Commission will appoint Postal 4. Shelley S. Dreifuss, director of the indicates that it had been finalizing a Service counsel to serve as settlement Commission’s Office of the Consumer request for further testing of a modified coordinator in this proceeding. In this Advocate, is designated to represent the RPN service that would address the capacity, counsel for the Postal Service interests of the general public. suggestions made by the Commission in shall report on the status of settlement 5. Answers to the Postal Service’s its Opinion in Docket No. MC2004–5. discussions at the prehearing Conditional Motion for Waiver of the The request observes that on January 6, conference. The Commission will make portions of rule 64 are due on February 2006, the Postal Service received a copy its hearing room available for settlement 7, 2006. of the Commission-sponsored white conferences at such times deemed 6. Postal Service counsel is appointed paper addressing various issues raised necessary by the settlement coordinator. to serve as settlement coordinator in this by the RPN service from an academic If someone intervenes after a settlement proceeding. The Commission will make perspective. The request states that the conference is held, the settlement its hearing room available for settlement Postal Service decided to delay coordinator could brief such person on conferences at such times deemed finalizing its request for a modified RPN the substance of the conference. necessary by the settlement coordinator. 7. A prehearing conference is service in order to incorporate III. Expedition consideration of the white paper. The provisionally scheduled for February Postal Service explains its decision to Further procedures. Rule 69b affords 23, 2006, at 11 a.m. in the Commission’s incorporate consideration of the white all interested parties 26 days after filing hearing room. paper in its request makes it impossible of the Postal Service’s request (February 8. Participants who wish to request a to process a request for testing of a 7, 2006) to intervene and respond to the hearing on the Postal Service’s request modified RPN service prior to the Postal Service’s proposal to have this in this docket to extend its market test scheduled expiration of the provisional request considered under the expedited shall submit such a request, together RPN service on April 3, 2006. The procedures of rule 69. On February 8, with statements in conformance with 39 Postal Service asks the Commission to 2006, the Commission will determine if CFR 3001.69b(h) on or before February approve an extension of that service in expedited rule 69 procedures are 23, 2006. order to avoid disruption to customers appropriate. If the Commission 9. The Secretary shall cause this that would be caused by termination of determines that they are, intervenors notice and order to be published in the the provisional RPN service on April 3, will have until February 23, 2006, to Federal Register. 2006, pending consideration of the next state with specificity those issues of By the Commission. phase of the service. material fact, if any, that they contend Steven W. Williams, require a hearing, the period that rule The Postal Services proposes that the Secretary. 69b(h) allows. They may make their status quo continue until a replacement statement in writing, or orally at the [FR Doc. 06–609 Filed 1–23–06; 8:45 am] provisional or permanent service is prehearing conference, provisionally BILLING CODE 7710–FW–P implemented, or, if no such service is scheduled for February 23. If the implemented, three months after the Commission determines that hearings Commission takes action on a Postal are warranted, they will commence on SECURITIES AND EXCHANGE Service request to implement such a March 1, 2006, the period that rule COMMISSION service. If the Postal Service does not 69b(i) allows. If no hearing is necessary, file such a request, the proposal is that Proposed Collection; Comment a recommended decision will be issued the provisional service expire on April Request promptly. 3, 2007. See page 2 and Attachment A of the Request. The request includes IV. Public Participation Upon written request, copies available attachments and is supported by the from: Securities and Exchange Public participation. In conformance Commission, Office of Filings and testimony of witness Kirk Kaneer. It also with section 3624(a) of title 39, the includes a conditional motion for Information Services, Washington, DC Commission designates Shelley S. 20549. waiver of rule 64 of our rules of Dreifuss, director of the Commission’s practice, if material incorporated from Office of the Consumer Advocate (OCA), Extension: Docket No. R2005–1 is not considered Rule 15c2–1; SEC File No. 270–418; OMB to represent the interests of the general Control No. 3235–0485. adequate to satisfy that rule. The request public in this proceeding. Pursuant to is on file in the Commission’s docket this designation, Ms. Dreifuss will direct Notice is hereby given that pursuant room for inspection during regular the activities of Commission personnel to the Paperwork Reduction Act of 1995 business hours and is available on the assigned to assist her and, upon request, (44 U.S.C. 3501 et seq.,) the Securities Commission’s Web site at http:// will supply their names for the record. and Exchange Commission www.prc.gov. Neither Ms. Dreifuss nor any of the (‘‘Commission’’) is publishing the II. Settlement assigned personnel will participate in or following summaries of collections for provide advice on any Commission public comment. Proposed settlement procedures. The decision in this proceeding. Rule 15c2–1 prohibits the Postal Service requests that the commingling under the same lien of Commission establish settlement V. Ordering Paragraphs securities of margin customers (a) with procedures in this proceeding. It argues It is ordered: other customers without their written that settlement of issues surrounding its 1. The Commission establishes Docket consent and (b) with the broker or request is appropriate, since the purpose No. MC2006–2 to consider the Postal dealer. The rule also prohibits the of the extension of the status quo is to Service Request referred to in the body rehypothecation of customers’ margin allow a modified RPN service to reflect of this order. securities for a sum in excess of the the white paper and the public dialogue 2. The Commission will act en banc customer’s aggregate indebtedness. See that the white paper is intended to in this proceeding. Securities Exchange Act Release No.
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2690 (November 15, 1940); Securities SECURITIES AND EXCHANGE December 23, 2005, the Committee filed Exchange Act Release No. 9428 COMMISSION with the Commission another (December 29, 1971). Pursuant to Rule amendment to the Plan, Amendment 16. [Release No. 34–53131; File No. S7–24–89] 15c2–1, respondents must collect Amendment 16 to the Plan reflects the information necessary to prevent the Joint Industry Plan; Notice of Filing addition of the International Securities rehypothecation of customer securities and Immediate Effectiveness of Exchange as a Plan Participant. in contravention of the rule, issue and Amendment Nos. 15 and 16 to the Amendment 16 was unanimously retain copies of notices of hypothecation Joint Self-Regulatory Organization approved by the Committee on of customer securities in accordance Plan Governing the Collection, November 17, 2005.4 The Commission with the rule, and collect written Consolidation and Dissemination of is publishing this notice of filing and consents from customers in accordance Quotation and Transaction Information immediate effectiveness to solicit with the rule. The information is for Nasdaq-Listed Securities Traded on comments from interested persons on necessary to ensure compliance with the Exchanges on an Unlisted Trading Amendment Nos. 15 and 16. rule, and to advise customers of the Privileges Basis, Submitted by the II. Background rule’s protections. Pacific Exchange, Inc., the National Association of Securities Dealers, Inc., The Plan governs the collection, There are approximately 145 the American Stock Exchange LLC, the consolidation, and dissemination of respondents (i.e., broker-dealers that Boston Stock Exchange, Inc., the carry or clear customer accounts that Chicago Stock Exchange, Inc., the quotation and transaction information also have bank loans) that require an National Stock Exchange, Inc., and the for the Nasdaq Stock Market, Inc. aggregate total of 3263 hours to comply Philadelphia Stock Exchange, Inc. (‘‘Nasdaq’’) National Market (‘‘NNM’’) with the rule. Each of these and Nasdaq SmallCap securities listed approximately 145 registered broker- January 17, 2006. on Nasdaq or traded on an exchange dealers makes an estimated 45 annual I. Introduction and Description pursuant to unlisted trading privileges responses. Each response takes (‘‘UTP’’).5 The Plan provides for the approximately 0.5 hours to complete. Pursuant to Rule 608 of the Securities collection from Plan Participants and 1 Thus, the total compliance burden per Exchange Act of 1934 (the ‘‘Act’’) the consolidation and dissemination to notice is hereby given that on December year is 3263 burden hours. vendors, subscribers, and others of 15, 2005, the operating committee quotation and transaction information Written comments are invited on: (a) (‘‘Operating Committee’’ or in Eligible Securities.6 Whether the proposed collection of ‘‘Committee’’) 2 of the Joint Self- information is necessary for the proper Regulatory Organization Plan Governing The Commission originally approved performance of the functions of the the Collection, Consolidation, and the Plan on a pilot basis on June 26, agency, including whether the Dissemination of Quotation and 1990.7 The parties did not begin trading information shall have practical utility; Transaction Information for Nasdaq- until July 12, 1993; accordingly, the (b) the accuracy of the agency’s estimate Listed Securities Traded on Exchanges pilot period commenced on July 12, of the burden of the proposed collection on an Unlisted Trading Privilege Basis 1993. The Plan was most recently of information; (c) ways to enhance the (‘‘Nasdaq/UTP Plan’’ or ‘‘Plan’’) filed extended on December 14, 2005.8 quality, utility, and clarity of the with the Securities and Exchange information to be collected; and (d) Commission (‘‘Commission’’) ways to minimize the burden of the amendments to the Plan. These collection of information on amendments are incorporated in respondents, including through the use Amendment 15 to the Plan and reflect 4 See letter from Bridget M. Farrell, Chairman, of automated collection techniques or elimination of the New York Stock OTC/UTP Operating Committee, to Jonathan G. other forms of information technology. Exchange as a Plan Participant, removal Katz, Secretary, Commission, dated December 20, Consideration will be given to of an outdated section of the Plan 2005. regarding Eligible Securities, and 5 Section 12 of the Act generally requires an comments and suggestions submitted in modification of Exhibit 1 to the Plan to exchange to trade only those securities that the writing within 60 days of this reflect quarterly year-to-date payments exchange lists, except that section 12(f) of the Act publication. and adjustments of distributable net permits UTP under certain circumstances. For Direct your written comments to R. example, section 12(f) of the Act, among other operating income. Amendment 15 was things, permits exchanges to trade certain securities Corey Booth, Director/Chief Information unanimously approved by the that are traded over-the-counter (‘‘OTC/UTP’’), but Officer, Office of Information Committee on September 22, 2005.3 In only pursuant to a Commission order or rule. For Technology, Securities and Exchange addition, pursuant to Rule 608 of the a more complete discussion of the section 12(f) Commission, 100 F Street, NW., Act, notice is hereby given that on requirement, see Securities Exchange Act Release Washington, DC 20549. No. 36481 (November 13, 1995), 60 FR 58119 1 17 CFR 242.608. (November 24, 1995). Dated: January 17, 2006. 6 2 The Plan Participants (collectively, The Plan defines ‘‘Eligible Securities’’ as any Jill M. Peterson, ‘‘Participants’’) are: The American Stock Exchange, Nasdaq National Market or Nasdaq SmallCap security, as defined in NASD Rule 4200, (i) as to Assistant Secretary. LLC (‘‘AMEX’’), the Boston Stock Exchange, Inc. (‘‘BSE’’), the Chicago Board Options Exchange, Inc. which unlisted trading privileges have been granted [FR Doc. 06–622 Filed 1–23–06; 8:45 am] (‘‘CBOE’’), the Chicago Stock Exchange, Inc. to a national securities exchange pursuant to BILLING CODE 8010–01–P (‘‘CHX’’), the National Stock Exchange, Inc. section 12(f) of the Act or which become eligible for (‘‘NSX’’), the National Association of Securities such trading pursuant to order of the Commission, Dealers, Inc. (‘‘NASD’’), the Pacific Exchange or (ii) which is also listed on a national securities (‘‘PCX’’), and the Philadelphia Stock Exchange, Inc. exchange. (‘‘PHLX’’). 7 3 See letter from Bridget M. Farrell, Chairman, See Securities Exchange Act Release No. 28146, OTC/UTP Operating Committee, to Jonathan G. 55 FR 27917 (July 6, 1990). Katz, Secretary, Commission, dated December 14, 8 See Securities Exchange Act Release No. 52886, 2005. 70 FR 74059 (December 14, 2005).
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III. Description and Purpose of the involve solely technical or ministerial Commission and any person, other than Amendments 9 matters, and thus are being put into those that may be withheld from the effect upon filing with the Commission public in accordance with the A. Amendment No. 15 pursuant to Rules 608(b)(3)(ii) and provisions of 5 U.S.C. 552, will be The following is a summary of the 608(b)(3)(iii).10 At any time within 60 available for inspection and copying in changes to the Plan prepared by the days of the filing of any such the Commission’s Public Reference Participants: amendment, the Commission may Room. Copies of the filing also will be (i) Section I.A. of the Plan provides summarily abrogate the amendment and available for inspection and copying at for the list of Plan Participants. require that such amendment be refiled the Office of the Secretary of the Amendment 15 eliminates the New in accordance with paragraph (a)(1) of Committee, currently located at the York Stock Exchange (‘‘NYSE’’) as a Rule 608 under the Act 11 and reviewed Pacific Exchange, Inc. and Archipelago Plan Participant. in accordance with paragraph (b)(2) of Exchange L.L.C., 100 South Wacker (ii) Section VI.C.2 of the Plan provides Rule 608 under the Act,12 if it appears Drive, Suite 2000, Chicago, IL 60606. for a phase-in of Eligible Securities and to the Commission that such action is All comments received will be posted certain Auto-Quoting restrictions that necessary or appropriate in the public without change; the Commission does are no longer relevant. Accordingly, interest, for the protection of investors, not edit personal identifying Amendment 15 proposes to delete this or the maintenance of fair and orderly information from submissions. You section of the Plan. markets, to remove impediments to, and should submit only information that (iii) Section VI.C.3 and Section VI.C.4 perfect mechanisms of, a national you wish to make available publicly. All shall be renumbered due to the market system or otherwise in submissions should refer to File elimination of section VI.C.2. furtherance of the purposes of the Act.13 Number S7–24–89 and should be (iv) Section VIII.C sets forth the V. Solicitation of Comments submitted on or before February 14, symbols for market identification for 2006. quotation information and transaction The Commission seeks general comments on Amendment Nos. 15 and For the Commission, by the Division of reports. Amendment 15 eliminates ‘‘N’’ Market Regulation, pursuant to delegated as a symbol, since NYSE is being 16. Interested persons are invited to authority.14 submit written data, views, and eliminated as a plan participant. Jill M. Peterson, arguments concerning the foregoing, (v) Amendment 15 also modifies Assistant Secretary. Exhibit 1 to the Plan to reflect that including whether the proposal is Participants will be provided with consistent with the Act. Comments may Exhibit A written estimates of estimated quarterly be submitted by any of the following Amendment Nos. 15 and 16; Joint net distributable operating income methods: Self-Regulatory Organization Plan within 45 calendar days of the end of Electronic Comments Governing the Collection, Consolidation the quarter and estimated quarterly • and Dissemination of Quotation and payments shall be made on the basis of Use the Commission’s Internet comment form (http://www.sec.gov/ Transaction Information for Nasdaq- such estimates. Listed Securities Traded on Exchanges (vi) Further, Exhibit 1 has been rules/sro.shtml); or • Send an e-mail to rule- on an Unlisted Trading Privilege Basis. modified to reflect that each quarterly [email protected]. Please include File The undersigned registered national payment shall be reconciled against a Number S7–24–89 on the subject line. securities association and national Participant’s cumulative year-to-date securities exchanges (collectively payment received to date and adjusted Paper Comments referred to as the ‘‘Participants’’), have accordingly. Lastly, Amendment 15 • Send paper comments in triplicate jointly developed and hereby enter into clarifies language regarding interest to Nancy M. Morris, Secretary, this Nasdaq Unlisted Trading Privileges payments and audit adjustment Securities and Exchange Commission, Plan (‘‘Nasdaq UTP Plan’’ or ‘‘Plan’’). procedures. Station Place, 100 F Street, NE., I. Participants B. Amendment No. 16 Washington, DC 20549–9303. The Participants include the Section I.A. of the Plan provides for All submissions should refer to File following: the list of Plan Participants. Number S7–24–89. This file number A. Participants Amendment 16 adds the International should be included on the subject line Securities Exchange (‘‘ISE’’) as a Plan if e-mail is used. To help the 1. American Stock Exchange LLC, 86 Participant. ISE will commence quoting Commission process and review your Trinity Place, New York, New York and trading in Nasdaq-listed securities comments more efficiently, please use 10006. upon completing the necessary only one method. The Commission will 2. Boston Stock Exchange, 100 development and implementation work post all comments on the Commission’s Franklin Street, Boston, Massachusetts required to become a new Participant in Internet Web site (http://www.sec.gov/ 02110. Nasdaq-listed securities. ISE has paid rules/sro.shtml). Copies of the 3. Chicago Stock Exchange, 440 South the Plan entrance fee pursuant to submission, all subsequent LaSalle Street, Chicago, Illinois 60605. section XIII.A. amendments, all written statements 4. Chicago Board Options Exchange, with respect to the proposed rule Inc., 400 South LaSalle Street, 26th IV. Date of Effectiveness of the change that are filed with the Floor, Chicago, Illinois 60605. Amendment Commission, and all written 5. International Securities Exchange, The changes set forth in Amendment communications relating to the Inc., 60 Broad Street, New York, New Nos. 15 and 16 are concerned solely proposed rule change between the York 60605. with the administration of the plan or 6. National Association of Securities, 10 17 CFR 242.608(b)(3)(ii) and (b)(3)(iii). Dealers, Inc., 1735 K Street, NW., 9 The complete text of the Plan, as amended by 11 17 CFR 242.608(a)(1). Washington, DC 20006. Amendments No. 15 and 16, is attached as Exhibit 12 17 CFR 242.608(b)(2). A. 13 17 CFR 242.608(b)(3)(iii). 14 17 CFR 200.30–3(a)(27).
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7. National Stock Exchange, 440 market participants’’) acting in such the information first has been published South LaSalle Street, 26th Floor, capacity, or the Participant on whose by the Processor. Chicago, Illinois 60605. floor or through whose facilities the P. ‘‘OTC Montage Data Feed ‘‘ means 8. Pacific Exchange, Inc., 115 quotation was disseminated; and (ii) the data stream of information that Sansome Street, San Francisco, CA when used with respect to Transaction provides Vendors and Subscribers with 94104. Reports, the Participant through whose quotations and sizes from all 9. Philadelphia Stock Exchange, 1900 facilities the transaction took place or Participants and Nasdaq market Market Street, Philadelphia, was reported, or the Participant to participants. Pennsylvania 19103. whose facilities the order was sent for Q. ‘‘Participant’’ means a registered national securities exchange or national B. Additional Participants execution. F. ‘‘NASD’’ means the National securities association that is a signatory Any other national securities Association of Securities Dealers Inc. to this Plan. association or national securities G. ‘‘NASD Participant’’ means an R. ‘‘Plan’’ means this Nasdaq UTP exchange, in whose market Eligible NASD member that is registered as a Plan, as from time to time amended Securities become traded, may become market maker or an electronic according to its provisions, governing a Participant, provided that said communications network or otherwise the collection, consolidation and organization executes a copy of this utilizes the facilities of the NASD dissemination of Quotation Information Plan and pays its share of development pursuant to applicable NASD rules. and Transaction Reports in Eligible costs as specified in section XIII. H. ‘‘NASD Transaction Reporting Securities. S. ‘‘Processor’’ means the entity System’’ means the System provided for II. Purpose of Plan selected by the Participants to perform in the NASD’s Transaction Reporting The purpose of this Plan is to provide the processing functions set forth in the Plan filed with and approved by the for the collection, consolidation and Plan. Commission pursuant to SEC dissemination of Quotation Information T. ‘‘Quotation Information’’ means all Rule11Aa3–1, governing the reporting of and Transaction Reports in Eligible bids, offers, displayed quotation sizes, transactions in Nasdaq securities. Securities from the Participants in a the market center identifiers and, in the I. ‘‘UTP Quote Data Feed’’ means the manner consistent with the Exchange case of NASD and Nasdaq, the NASD service that provides Subscribers with Act. and Nasdaq market participant that the National Best Bid and Offer It is expressly understood that each entered the quotation, withdrawals and quotations, size and market center Participant shall be responsible for the other information pertaining to identifier, as well as the Best Bid and collection of Quotation Information and quotations in Eligible Securities Offer quotations, size and market center Transaction Reports within its market required to be collected and made identifier from each individual and that nothing in this Plan shall be available to the Processor pursuant to Participant in Eligible Securities. deemed to govern or apply to the this Plan. J. ‘‘Nasdaq Level 2 Service’’ means the manner in which each Participant does U. ‘‘Regulatory Halt’’ means a trade Nasdaq service that provides so. suspension or halt called for the Subscribers with query capability with purpose of dissemination of material III. Definitions respect to quotations and sizes in news, as described at Section X hereof A. ‘‘Current’’ means, with respect to securities included in the Nasdaq or that is called for where there are Transaction Reports or Quotation System, best bid and asked quotations, regulatory problems relating to an Information, such Transaction Reports and Transaction Reports. Eligible Security that should be clarified or Quotation Information during the K. ‘‘Nasdaq Level 3 Service’’ means before trading therein is permitted to fifteen (15) minute period immediately the Nasdaq service that provides Nasdaq continue, including a trading halt for following the initial transmission market participants with input and extraordinary market activity due to thereof by the Processor. query capability with respect to system misuse or malfunction under B. ‘‘Eligible Security’’ means any quotations and sizes in securities Section X.E.1. of the Plan Nasdaq National Market or Nasdaq included in the Nasdaq System, best bid (‘‘Extraordinary Market Regulatory SmallCap security, as defined in NASD and asked quotations, and Transaction Halt’’). Rule 4200: (i) As to which unlisted Reports. V. ‘‘Subscriber’’ means a person that trading privileges have been granted to L. ‘‘Nasdaq System’’ means the receives Current Quotation Information a national securities exchange pursuant automated quotation system operated by or Transaction Reports provided by the to Section 12(f) of the Exchange Act or Nasdaq. Processor or provided by a Vendor, for which become eligible for such trading M. ‘‘UTP Trade Data Feed’’ means the its own use or for distribution on a non- pursuant to order of the Securities and service that provides Vendors and Current basis, other than in connection Exchange Commission; or (ii) which Subscribers with Transaction Reports. with its activities as a Vendor. also is listed on a national securities N. ‘‘Nasdaq Security’’ or ‘‘Nasdaq- W. ‘‘Transaction Reports’’ means exchange. listed Security’’ means any security reports required to be collected and C. ‘‘Commission’’ and ‘‘SEC’’ shall listed on the Nasdaq National Market or made available pursuant to this Plan mean the U.S. Securities and Exchange Nasdaq SmallCap Market. containing the stock symbol, price, and Commission. O. ‘‘News Service’’ means a person size of the transaction executed, the D. ‘‘Exchange Act’’ means the that receives Transaction Reports or Market in which the transaction was Securities Exchange Act of 1934. Quotation Information provided by the executed, and related information, E. ‘‘Market’’ shall mean (i) when used Systems or provided by a Vendor, on a including a buy/sell/cross indicator and with respect to Quotation Information, Current basis, in connection with such trade modifiers, reflecting completed the NASD in the case of a Nasdaq person’s business of furnishing such transactions in Eligible Securities. market maker or a Nasdaq-registered information to newspapers, radio and X. ‘‘Upon Effectiveness of the Plan’’ electronic communications network/ television stations and other news means July 12, 1993, the date on which alternative trading system (hereafter media, for publication at least fifteen the Participants commenced publication collectively referred to as ‘‘Nasdaq (15) minutes following the time when of Quotation Information and
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Transaction Reports on Eligible meetings. The Operating Committee e. Except as provided under Section Securities as contemplated by this Plan. shall have the discretion, in limited IV(C)(3) hereof, requests for system Y. ‘‘Vendor’’ means a person that instances, to deviate from this policy if, changes; and receives Current Quotation Information as indicated by majority vote, the f. All other matters not specifically or Transaction Reports provided by the Operating Committee agrees that addressed by the Plan. Processor or provided by a Vendor, in circumstances so warrant. 2. With respect to the establishment of connection with such person’s business Nothing in this section or elsewhere new fees or increases in existing fees of distributing, publishing, or otherwise within the Plan shall authorize any relating to Quotation Information and furnishing such information on a person or organization other than Transaction Reports in Eligible Current basis to Subscribers, News Participants and their representatives to Securities, the affirmative vote of two- Services or other Vendors. participate on the Operating Committee thirds of the Participants entitled to vote Z. ‘‘NQDS’’ means the data stream of in any manner other than as an advisor shall be necessary to constitute the information that provides Vendors and or observer, or in any Executive Session action of the Operating Committee. Subscribers with the best quotations and of the Operating Committee. 3. The affirmative vote of a majority sizes from each Nasdaq Participant. of the Participants entitled to vote shall AA. ‘‘Nasdaq Participant’’ means an B. Operating Committee: Authority be necessary to constitute the action of entity that is registered as a market The Operating Committee shall be the Operating Committee with respect maker or an electronic communications responsible for: to: network in Nasdaq or otherwise utilizes 1. Overseeing the consolidation of a. Requests for system changes the facilities of The Nasdaq Stock Quotation Information and Transaction reasonably related to the function of the Market pursuant to applicable NASD Reports in Eligible Securities from the Processor as defined under the Plan. All rules but does not include an NASD Participants for dissemination to other requests for system changes shall Participant as defined in Section III.G. Vendors, Subscribers, News Services be governed by Section IV(C)(1)(e) of this Plan. and others in accordance with the hereof. b. Interpretive matters and decisions IV. Administration of Plan provisions of the Plan; 2. Periodically evaluating the of the Operating Committee arising A. Operating Committee: Composition Processor; under, or specifically required to be taken by, the provisions of the Plan as The Plan shall be administered by the 3. Setting the level of fees to be paid by Vendors, Subscribers, News Services written; Participants through an operating c. Interpretive matters arising under or others for services relating to committee (‘‘Operating Committee’’), Exchange Act Rules 11Aa3–1 and Quotation Information or Transaction which shall be composed of one 11Ac1–1; and Reports in Eligible Securities, and representative designated by each d. Denials of access (other than for taking action in respect thereto in Participant. Each Participant may breach of contract, which shall be accordance with the provisions of the designate an alternate representative or handled by the Processor), representatives who shall be authorized Plan; 4. It is expressly agreed and to act on behalf of the Participant in the 4. Determining matters involving the understood that neither this Plan nor absence of the designated interpretation of the provisions of the the Operating Committee shall have representative. Within the areas of its Plan; authority in any respect over any responsibilities and authority, decisions 5. Determining matters relating to the Participant’s proprietary systems. Nor made or actions taken by the Operating Plan’s provisions for cost allocation and shall the Plan or the Operating Committee, directly or by duly revenue-sharing; and Committee have any authority over the delegated individuals, committees as 6. Carrying out such other specific collection and dissemination of may be established from time to time, or responsibilities as provided under the quotation or transaction information in others, shall be binding upon each Plan. Eligible Securities in any Participant’s Participant, without prejudice to the C. Operating Committee: Voting marketplace, or, in the case of the rights of any Participant to seek redress NASD, from NASD Participants. from the SEC pursuant to Rule 11Aa3– Each Participant shall have one vote 2 under the Exchange Act or in any on all matters considered by the D. Operating Committee: Meetings other appropriate forum. Operating Committee. Regular meetings of the Operating An Electronic Communications 1. The affirmative and unanimous Committee may be attended by each Network, Alternative Trading System, vote of all Participants entitled to vote Participant’s designated representative Broker-Dealer or other securities shall be necessary to constitute the and/or its alternate representative(s), organization (‘‘Organization’’) which is action of the Operating Committee with and may be attended by one or more not a Participant, but has an actively respect to: other representatives of the parties. pending Form 1 Application on file a. Amendments to the Plan; Meetings shall be held at such times and with the Commission to become a b. Amendments to contracts between locations as shall from time to time be national securities exchange, will be the Processor and Vendors, Subscribers, determined by the Operating permitted to appoint one representative News Services and others receiving Committee. and one alternate representative to Quotation Information and Transaction Quorum: Any action requiring a vote attend regularly scheduled Operating Reports in Eligible Securities; only can be taken at a meeting in which Committee meetings in the capacity of c. Replacement of the Processor, a quorum of all Participants is present. an observer/advisor. If the except for termination for cause, which For actions requiring a simple majority Organization’s Form 1 petition is shall be governed by section V(B) vote of all Participants, a quorum of withdrawn, returned, or is otherwise not hereof; greater than 50% of all Participants actively pending with the Commission d. Reductions in existing fees relating entitled to vote must be present at the for any reason, then the Organization to Quotation Information and meeting before such a vote may be will no longer be eligible to be Transaction Reports in Eligible taken. For actions requiring a 2⁄3 represented in the Operating Committee Securities; and majority vote of all Participants, a
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quorum of at least 2⁄3 of all Participants academic involved in the scholarly the provisions of the Plan shall be the entitled to vote must be present at the study of the securities industry, or an reasonableness of its response to meeting before such a vote may be expert in one or more areas of the requests from Participants for taken. For actions requiring a securities industry. technological changes or enhancements unanimous vote of all Participants, a b. Each representative shall serve a pursuant to section IV(C)(3) hereof. The quorum of all Participants entitled to one-year term on the Advisory reasonableness of the Processor’s vote must be present at the meeting Committee. response to such requests shall be before such a vote may be taken. 2. Authority evaluated by the Operating Committee A Participant is considered present at in terms of the cost to the Processor of a meeting only if a Participant’s The Advisory Committee shall have purchasing the same service from a designated representative or alternate the opportunity to: third party and integrating such service representative(s) is either in physical a. Meet twice yearly, each meeting to into the Processor’s existing systems attendance at the meeting or is occur one day prior to a meeting of the and operations as well as the extent to participating by conference telephone, Operating Committee. which the requested change would b. Discuss any matter related to the or other acceptable electronic means. adversely impact the then current Any action sought to be resolved at a operation of the Plan. c. Present written comments or technical (as opposed to business or meeting must be sent to each Participant inquiries to the Operating Committee competitive) operations of the entitled to vote on such matter at least regarding matters related to the Processor. one week prior to the meeting via operation of the Plan. electronic mail, regular U.S. or private D. Processor’s Right To Appeal d. Respond to written inquiries from Termination for Cause mail, or facsimile transmission, the Operating Committee seeking provided however that this requirement comment from the Advisory Committee The Processor shall have the right to may be waived by the vote of the on matters related to the operation of appeal to the SEC a determination of the percentage of the Committee required to the Plan. Operating Committee terminating the vote on any particular matter, under Processor for cause and no action shall section C above. V. Selection and Evaluation of the become final until the SEC has ruled on Any action may be taken without a Processor the matter and all legal appeals of right meeting if a consent in writing, setting A. Generally therefrom have been exhausted. forth the action so taken, is sent to and signed by all Participant representatives The Processor’s performance of its E. Process for Selecting New Processor entitled to vote with respect to the functions under the Plan shall be At any time following effectiveness of subject matter thereof. All the approvals subject to review by the Operating the Plan, but no later than upon the evidencing the consent shall be Committee at least every two years, or termination of the Processor, whether delivered to the Chairman of the from time to time upon the request of for cause pursuant to section IV(C)(1)(c) Operating Committee to be filed in the any two Participants but not more or V(B) of the Plan or upon the Operating Committee records. The frequently than once each year. Based Processor’s resignation, the Operating action taken shall be effective when the on this review, the Operating Committee Committee shall establish procedures minimum number of Participants may choose to make a recommendation for selecting a new Processor (the entitled to vote have approved the to the Participants with respect to the ‘‘Selection Procedures’’). The Operating action, unless the consent specifies a continuing operation of the Processor. Committee, as part of the process of different effective date. The Operating Committee shall notify establishing Selection Procedures, may The Chairman of the Operating the SEC of any recommendations the solicit and consider the timely comment Committee shall be elected annually by Operating Committee shall make of any entity affected by the operation and from among the Participants by a pursuant to the Operating Committee’s of this Plan. The Selection Procedures majority vote of all Participants entitled review of the Processor and shall supply shall be established by a two-thirds to vote. The Chairman shall designate a the Commission with a copy of any majority vote of the Plan Participants, person to act as Secretary to record the reports that may be prepared in and shall set forth, at a minimum: minutes of each meeting. The location connection therewith. 1. The entity that will: of meetings shall be rotated among the B. Termination of the Processor for (a) Draft the Operating Committee’s locations of the principal offices of the Cause request for proposal for bids on a new Participants, or such other locations as If the Operating Committee processor; may from time to time be determined by (b) Assist the Operating Committee in the Operating Committee. Meetings may determines that the Processor has failed to perform its functions in a reasonably evaluating bids for the new processor; be held by conference telephone and and action may be taken without a meeting acceptable manner in accordance with the provisions of the Plan or that its (c) Otherwise provide assistance and if the representatives of all Participants guidance to the Operating Committee in entitled to vote consent thereto in reimbursable expenses have become excessive and are not justified on a cost the selection process. writing or other means the Operating 2. The minimum technical and Committee deems acceptable. basis, the Processor may be terminated at such time as may be determined by operational requirements to be fulfilled E. Advisory Committee a majority vote of the Operating by the Processor; Committee. 3. The criteria to be considered in 1. Composition selecting the Processor; and a. Each Plan Participant may C. Factors To Be Considered in 4. The entities (other than Plan designate three representatives to Termination for Cause Participants) that are eligible to participate in the Advisory Committee. Among the factors to be considered in comment on the selection of the The representatives shall each be an evaluating whether the Processor has Processor. employee of a member of that performed its functions in a reasonably Nothing in this provision shall be Participant, a professor or other acceptable manner in accordance with interpreted as limiting Participants’
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rights under section IV or section V of transaction information on Eligible 2. Quotation Data Streams the Plan or other Commission order. Securities from all Participants. The Processor shall disseminate on VI. Functions of the Processor Nothing herein shall be construed so the UTP Quote Data Feed a data stream as to prohibit or restrict in any way the of all Quotation Information regarding A. Generally right of any Participant to distribute Eligible Securities received from The Processor shall collect from the quotation, transaction or other Participants. Each quotation shall be Participants, and consolidate and information with respect to Eligible designated with a symbol identifying disseminate to Vendors, Subscribers and Securities quoted on or traded in its the Participant from which the News Services, Quotation Information marketplace to a marketplace outside quotation emanates. Quotation and Transaction Reports in Eligible the United States solely for the purpose Information from individual NASD Securities in a manner designed to of supporting an intermarket linkage, or Participants will not be disseminated on assure the prompt, accurate and reliable to distribute information within its own the UTP Quote Data Feed. The Processor collection, processing and marketplace concerning Eligible shall separately distribute on the OTC Montage Data Feed the Quotation dissemination of information with Securities in accordance with its own Information regarding Eligible Securities respect to all Eligible Securities in a fair format. If a Participant requests, the from all NASD Participants from which and non-discriminatory manner. The Processor shall make information about quotations emanate. The Processor shall Processor shall commence operations Eligible Securities in the Participant’s separately distribute NQDS for so long upon the Processor’s notification to the marketplace available to a foreign as Nasdaq is not registered as a national Participants that it is ready and able to marketplace on behalf of the requesting securities exchange and for so long as commence such operations. Participant, in which event the cost Nasdaq is the Processor. For so long as shall be borne by that Participant. B. Collection and Consolidation of Nasdaq is not registered as a national Information 1. Best Bid and Offer securities exchange and after Nasdaq is no longer the Processor for other SIP For as long as Nasdaq is the Processor, The Processor shall disseminate on datafeeds, either Nasdaq or a third party the Processor shall be capable of the UTP Quote Data Feed the best bid will act as the Processor to collect, receiving Quotation Information and and offer information supplied by each consolidate, and disseminate the Transaction Reports in Eligible Participant, including the Nasdaq quotation information contained in Securities from Participants by the Plan- market participants, and shall also NQDS. approved, Processor sponsored calculate and disseminate on the UTP 3. Transaction Reports interface, and shall consolidate and Quote Data Feed a national best bid and disseminate such information via the asked quotation with size based upon The Processor shall disseminate on UTP Quote Data Feed, the UTP Trade Quotation Information for Eligible the UTP Trade Data Feed a data stream Data Feed, and the OTC Montage Data Securities received from Participants. of all Transaction Reports in Eligible Feed to Vendors, Subscribers and News The Processor shall not calculate the Securities received from Participants. Services. For so long as Nasdaq is not best bid and offer for any individual Each transaction report shall be registered as a national securities Participant, including the NASD. designated with a symbol identifying exchange and for so long as Nasdaq is the Participant in whose Market the the Processor, the Processor shall also The Participant responsible for each transaction took place. collect, consolidate, and disseminate the side of the best bid and asked quotation D. Closing Reports quotation information contained in making up the national best bid and NQDS. For so long as Nasdaq is not offer shall be identified by an At the conclusion of each trading day, registered as a national securities appropriate symbol. If the quotations of the Processor shall disseminate a exchange and after Nasdaq is no longer more than one Participant shall be the ‘‘closing price’’ for each Eligible the Processor for other SIP datafeeds, same best price, the largest displayed Security. Such ‘‘closing price’’ shall be either Nasdaq or a third party will act size among those shall be deemed to be the price of the last Transaction Report as the Processor to collect, consolidate, the best. If the quotations of more than in such security received prior to and disseminate the quotation one Participant are the same best price dissemination. The Processor shall also information contained in NQDS. and best displayed size, the earliest tabulate and disseminate at the among those measured by the time conclusion of each trading day the C. Dissemination of Information reported shall be deemed to be the best. aggregate volume reflected by all The Processor shall disseminate A reduction of only bid size and/or ask Transaction Reports in Eligible consolidated Quotation Information and size will not change the time priority of Securities reported by the Participants. Transaction Reports in Eligible a Participant’s quote for the purposes of E. Statistics determining time reported, whereas an Securities via the UTP Quote Data Feed, The Processor shall maintain the UTP Trade Data Feed, and the OTC increase of the bid size and/or ask size will result in a new time reported. The quarterly, semi-annual and annual Montage Data Feed to authorized transaction and volume statistical Vendors, Subscribers and News Services consolidated size shall be the size of the Participant that is at the best. counts. The Processor shall, at cost to in a fair and non-discriminatory the user Participant(s), make such manner. The Processor shall specifically If the best bid/best offer results in a statistics available in a form agreed be permitted to enter into agreements locked or crossed quotation, the upon by the Operating Committee, such with Vendors, Subscribers and News Processor shall forward that locked or as a secure website. Services for the dissemination of crossed quote on the appropriate output quotation or transaction information on lines (i.e., a crossed quote of bid 12, ask VII. Administrative Functions of the Eligible Securities to foreign (non-U.S.) 11.87 shall be disseminated). The Processor marketplaces or in foreign countries. Processor shall normally cease the Subject to the general direction of the The Processor shall, in such instance, calculation of the best bid/best offer Operating Committee, the Processor disseminate consolidated quotation or after 6:30 p.m., Eastern Time. shall be responsible for carrying out all
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administrative functions necessary to The following types of transactions promptly notify the Processor of such the operation and maintenance of the are not required to be reported to the event or condition. Upon receiving such consolidated information collection and Processor pursuant to the Plan: notification, the Processor shall take dissemination system provided for in 1. Transactions that are part of a appropriate action, including either this Plan, including, but not limited to, primary distribution by an issuer or of closing the quotation or purging the record keeping, billing, contract a registered secondary distribution or of system of the affected quotations. an unregistered secondary distribution; administration, and the preparation of IX. Market Access financial reports. 2. Transactions made in reliance on section 4(2) of the Securities Act of A. Each Participant shall permit each VIII. Transmission of Information to 1933; Nasdaq market participant, acting in its Processor by Participants 3. Transactions in which the buyer capacity as such, direct telephone A. Quotation Information and the seller have agreed to trade at a access to the specialist, trading post, price unrelated to the Current Market and supervisory center in each Eligible Each Participant shall, during the for the security, e.g., to enable the seller Security in which such Nasdaq market time it is open for trading be responsible to make a gift; participant is registered as a market promptly to collect and transmit to the 4. Odd-lot transactions; maker or electronic communications Processor accurate Quotation 5. The acquisition of securities by a network/alternative trading system with information in Eligible Securities broker-dealer as principal in Nasdaq. Such access shall include through any means prescribed herein. anticipation of making an immediate appropriate procedures or requirements Quotation Information shall include: by each Participant or employee to 1. Identification of the Eligible exchange distribution or exchange offering on an exchange; assure the timely response to Security, using the Nasdaq Symbol; communications received through 2. The price bid and offered, together 6. Purchases of securities pursuant to telephonic access. No Participant shall with size; a tender offer; and permit the imposition of any access or 3. The Nasdaq market participant or 7. Purchases or sales of securities execution fee, or any other fee or charge, Participant from which the quotation effected upon the exercise of an option with respect to transactions in Eligible emanates; pursuant to the terms thereof or the 4. Identification of quotations that are exercise of any other right to acquire Securities effected with Nasdaq market not firm; and securities at a pre-established participants which are communicated to 5. Through appropriate codes and consideration unrelated to the Current the floor by telephone pursuant to the messages, withdrawals and similar Market. provisions of this Plan. A Participant matters. shall be free to charge for other types of C. Symbols for Market Identification for access to its floor or facilities. B. Transaction Reports Quotation Information and Transaction B. The NASD shall assure that each Reports Each Participant shall, during the Participant, and its members shall have time it is open for trading, be The following symbols shall be used direct telephone access to the trading responsible promptly to collect and to denote the marketplaces: desk of each Nasdaq market participant transmit to the Processor Transaction in each Eligible Security in which the Reports in Eligible Securities executed Code Participant Participant displays quotations, and to in its Market by means prescribed the Nasdaq Supervisory Center. Such A ...... American Stock Exchange, LLC. access shall include appropriate herein. With respect to orders sent by B ...... Boston Stock Exchange, Inc. one Participant Market to another procedures or requirements to assure W ...... Chicago Board Options Ex- the timely response of each Nasdaq Participant Market for execution, each change, Inc. Participant shall adopt procedures M ...... Chicago Stock Exchange, Inc. market participant to communications governing the reporting of transactions D ...... National Association of Securities received through telephone access. in Eligible Securities specifying that the Dealers, Inc. Neither the NASD nor any Nasdaq transaction will be reported by the Q ...... Nasdaq Stock Market. market participant shall impose any Participant whose member sold the C ...... National Stock Exchange. access or execution fee, or any other fee security. This provision shall apply only P ...... Pacific Exchange, Inc. or charge, with respect to transactions in X ...... Philadelphia Stock Exchange, Inc. to transactions between Plan Eligible Securities effected with a member of a Participant which are Participants. D. Whenever a Participant determines Transaction Reports shall include: communicated by telephone pursuant to 1. Identification of the Eligible that a level of trading activity or other the provisions of this Plan. unusual market conditions prevent it Security, using the Nasdaq Symbol; X. Regulatory Halts 2. The number of shares in the from collecting and transmitting transaction; Quotation Information or Transaction A. For purposes of this section X, 3. The price at which the shares were Reports to the Processor, or where a ‘‘Participant’’ shall include the Nasdaq purchased or sold; trading halt or suspension in an Eligible Stock Market. Whenever, in the exercise 4. The buy/sell/cross indicator; Security is in effect in its Market, the of its regulatory functions, the Listing 5. The Market of execution; and, Participant shall promptly notify the Market for an Eligible Security 6. Through appropriate codes and Processor of such condition or event determines that a Regulatory Halt is messages, late or out-of-sequence trades, and shall resume collecting and appropriate pursuant to section III.T, the corrections and similar matters. transmitting Quotation Information and Listing Market will notify all other All such Transaction Reports shall be Transaction Reports to it as soon as the Participants pursuant to section X.E and transmitted to the Processor within 90 condition or event is terminated. In the all other Participants shall also halt or seconds after the time of execution of event of a system malfunction resulting suspend trading in that security until the transaction. Transaction Reports in the inability of a Participant or its notification that the halt or suspension transmitted beyond the 90-second members to transmit Quotation is no longer in effect. The Listing Market period shall be designated as ‘‘late’’ by Information or Transaction Reports to shall immediately notify the Processor the appropriate code or message. the Processor, the Participant shall of such Regulatory Halt as well as notice
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of the lifting of a Regulatory Halt. The national market system communication approval among those Participants Processor, in turn, shall disseminate to media (‘‘Hoot-n-Holler’’) to verbally actively trading impacted Eligible Participants notice of the Regulatory provide real-time information to all Securities, the Listing Market may Halt (as well as notice of the lifting of Participants. Each Participant shall be determine based on the facts and a regulatory halt) through the UTP required to continuously monitor the circumstances, including available Quote Data Feed. This notice shall serve Hoot-n-Holler system during market input from Participants, to declare an as official notice of a regulatory halt for hours, and the failure of a Participant to Extraordinary Market Regulatory Halt in purposes of the Plan only, and shall not do so at any time shall not prevent the the affected Eligible Securities. substitute or otherwise supplant notice Listing Market from initiating a Simultaneously with the notification of that a Participant may recognize or Regulatory Halt in accordance with the the Processor to suspend the require under its own rules. Nothing in procedures specified herein. dissemination of quotations across all this provision shall be read so as to 1. The following procedures shall be Participants, the Listing Market must supplant or be inconsistent with a followed when one or more Participants verbally notify all Participants of the Participant’s own rules on trade halts, experiences extraordinary market trading halt utilizing the Hoot-n-Holler which rules apply to the Participant’s activity in an Eligible Security that is system. own members. The Processor will reject believed to be caused by the misuse or g. Absent any evidence of system any quotation information or transaction malfunction of systems operated by or misuse or malfunction, best efforts will reports received from any Participant on linked to one or more Participants. be used to ensure that trading is not an Eligible Security that has a a. The Participant(s) experiencing the halted across all Participants. Regulatory Halt in effect. extraordinary market activity or any 2. If the Listing Market declares a B. Whenever the Listing Market Participant that becomes aware of Regulatory Halt in circumstances other determines that an adequate publication extraordinary market activity will than pursuant to section X.E.1.f., the or dissemination of information has immediately use best efforts to notify all Listing Market must, simultaneously occurred so as to permit the termination Participants of the extraordinary market with the notification of the Processor to activity utilizing the Hoot-n-Holler of the Regulatory Halt then in effect, the suspend the dissemination of quotations system. Listing Market shall promptly notify the across all Participants, verbally notify Processor and each of the other b. The Listing Market will use best efforts to determine whether there is all Participants of the trading halt Participants that conducts trading in utilizing the Hoot-n-Holler system. such security pursuant to section X.F. material news regarding the Eligible F. If the Listing Market declares a Except in extraordinary circumstances, Security. If the Listing Market Regulatory Halt, trading will resume adequate publication or dissemination determines that there is non-disclosed according to the following procedures: shall be presumed by the Listing Market material news, it will immediately call 1. Within 15 minutes of the to have occurred upon the expiration of a Regulatory Halt pursuant to section one hour after initial publication in a X.E.2. declaration of the halt, all Participants national news dissemination service of c. Each Participant(s) will use best will make best efforts to indicate via the the information that gave rise to the efforts to determine whether one of its Hoot-n-Holler their intentions with Regulatory Halt. systems, or the system of a direct or respect to canceling or modifying C. Except in the case of a Regulatory indirect participant in its market, is transactions. Halt, the Processor shall not cease the responsible for the extraordinary market 2. All Participants will disseminate to dissemination of quotation or activity. their members information regarding the transaction information regarding any d. If a Participant determines the canceled or modified transactions as Eligible Security. In particular, it shall potential source of extraordinary market promptly as possible, and in any event not cease dissemination of such activity pursuant to section X.1.c., the prior to the resumption of trading. information because of a delayed Participant will use best efforts to 3. After all Participants have met the opening, imbalance of orders or other determine whether removing the requirements of section X.F.1–2, the market-related problems involving such quotations of one or more direct or Listing Market will notify the security. During a regulatory halt, the indirect market participants or barring Participants utilizing the Hoot-n-Holler Processor shall collect and disseminate one or more direct or indirect market and the Processor when trading may Transaction Information but shall cease participants from entering orders will resume. Upon receiving this collection and dissemination of all resolve the extraordinary market information, Participants may Quotation Information. activity. Accordingly, the Participant commence trading pursuant to section D. For purposes of this section X, will prevent the quotations from one or X.A. ‘‘Listing Market’’ for an Eligible Security more direct or indirect market XI. Hours of Operation means the Participant’s Market on participants in the affected Eligible which the Eligible Security is listed. If Securities from being transmitted to the A. Quotation Information may be an Eligible Security is dually listed, Processor. entered by Participants as to all Eligible Listing Market shall mean the e. If the procedures described in Securities in which they make a market Participant’s Market on which the section X.E.1.a.–d. do not rectify the between 9:30 a.m. and 4 p.m. Eastern Eligible Security is listed that also has situation, the Participant(s) Time (‘‘ET’’) on all days the Processor the highest number of the average of the experiencing extraordinary market is in operation. Transaction Reports reported transactions and reported share activity will cease transmitting all shall be entered between 9:30 a.m. and volume for the preceding 12-month quotations in the affected Eligible 4:01:30 p.m. ET by Participants as to all period. The Listing Market for dually- Securities to the Processor. Eligible Securities in which they listed Eligible Securities shall be f. If the procedures described in execute transactions between 9:30 a.m. determined at the beginning of each section X.E.1.a–e do not rectify the and 4 p.m. ET on all days the Processor calendar quarter. situation within five minutes of the first is in operation. E. For purposes of coordinating notification through the Hoot-n-Holler B. Participants that execute trading halts in Eligible Securities, all system, or if Participants agree to call a transactions in Eligible Securities Participants are required to utilize the halt sooner through unanimous outside the hours of 9:30 a.m. ET and
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4 p.m., ET, shall be required to report quotations to ensure that such occurs in indemnifying Participant in writing of such transactions as follows: a manner consistent with just and the commencement thereof; but the (i) Transactions in Eligible Securities equitable principles of trade. omission to so notify the indemnifying executed between 4 a.m. and 9:29:59 Participant will not relieve the XIII. Financial Matters a.m. ET and between 4:00:01 and 6:30 indemnifying Participant from any p.m. ET, shall be designated as ‘‘.T’’ A. Development Costs liability which it may have to any trades to denote their execution outside Any Participant becoming a signatory indemnified Participant. In case any normal market hours; to this Plan after June 26, 1990, shall, as such action is brought against any (ii) Transactions in Eligible Securities a condition to becoming a Participant, indemnified Participant and it promptly executed after 6:30 p.m. and before 12 pay to the other Plan Participants a notifies an indemnifying Participant of a.m. (midnight) shall be reported to the proportionate share of the aggregate the commencement thereof, the Processor between the hours of 4 a.m. development costs previously paid by indemnifying Participant will be and 6:30 p.m. ET on the next business Plan Participants to the Processor, entitled to participate in, and, to the day (T+1), and shall be designated ‘‘as/ which aggregate development costs extent that it may wish, jointly with any of’’ trades to denote their execution on totaled $439,530, with the result that other indemnifying Participant similarly a prior day, and be accompanied by the each Participant’s share of all notified, to assume and control the time of execution; development costs is the same. defense thereof with counsel chosen by (iii) Transactions in Eligible Securities Each Participant shall bear the cost of it. After notice from the indemnifying executed between 12 a.m. (midnight) implementation of any technical Participant of its election to assume the and 4 a.m. ET shall be transmitted to the enhancements to the Nasdaq system defense thereof, the indemnifying Processor between 4 a.m. and 9:30 a.m. made at its request and solely for its use, Participant will not be liable to such ET, on trade date, shall be designated as subject to reapportionment should any indemnified Participant for any legal or ‘‘.T’’ trades to denote their execution other Participant subsequently make use other expenses subsequently incurred outside normal market hours, and shall of the enhancement, or the development by such indemnified Participant in be accompanied by the time of thereof. connection with the defense thereof but execution; the indemnified Participant may, at its (iv) Transactions reported pursuant to B. Cost Allocation and Revenue Sharing own expense, participate in such this provision of the Plan shall be The provisions governing cost defense by counsel chosen by it included in the calculation of total trade allocation and revenue sharing among without, however, impairing the volume for purposes of determining net the Participants are set forth in Exhibit indemnifying Participant’s control of distributable operating revenue, but 1 to the Plan. the defense. The indemnifying shall not be included in the calculation Participant may negotiate a compromise of the daily high, low, or last sale. C. Maintenance of Financial Records or settlement of any such action, C. Late trades shall be reported in The Processor shall maintain records provided that such compromise or accordance with the rules of the of revenues generated and development settlement does not require a Participant in whose Market the and operating expenditures incurred in contribution by the indemnified transaction occurred and can be connection with the Plan. In addition, Participant. reported between the hours of 4 a.m. the Processor shall provide the and 6:30 p.m. Participants with: (a) A statement of XV. Withdrawal D. The Processor shall collect, process financial and operational condition on a Any Participant may withdraw from and disseminate Quotation Information quarterly basis; and (b) an audited the Plan at any time on not less than 30 in Eligible Securities at other times statement of financial and operational days prior written notice to each of the between 4 a.m. and 9:30 a.m. ET, and condition on an annual basis. other Participants. Any Participant after 4 p.m. ET, when any Participant or withdrawing from the Plan shall remain XIV. Indemnification Nasdaq market participant is open for liable for, and shall pay upon demand, trading, until 6:30 p.m. ET (the Each Participant agrees, severally and any fees for equipment or services being ‘‘Additional Period’’); provided, not jointly, to indemnify and hold provided to such Participant pursuant to however, that the best bid and offer harmless each other Participant, the contract executed by it or an quotation will not be disseminated Nasdaq, and each of its directors, agreement or schedule of fees covering before 4 a.m. or after 6:30 p.m. ET. officers, employees and agents such then in effect. Participants that enter Quotation (including the Operating Committee and A withdrawing Participant shall also Information or submit Transaction its employees and agents) from and remain liable for its proportionate share, Reports to the Processor during the against any and all loss, liability, claim, without any right of recovery, of Additional Period shall do so for all damage and expense whatsoever administrative and operating expenses, Eligible Securities in which they enter incurred or threatened against such including start-up costs and other sums quotations. persons as a result of any Transaction for which it may be responsible Reports, Quotation Information or other pursuant to section XIV hereof. Except XII. Undertaking by All Participants information reported to the Processor by as aforesaid, a withdrawing Participant The filing with and approval by the such Participant and disseminated by shall have no further obligation under Commission of this Plan shall obligate the Processor to Vendors. This the Plan or to any of the other each Participant to enforce compliance indemnity agreement shall be in Participants with respect to the period by its members with the provisions addition to any liability that the following the effectiveness of its thereof. In all other respects not indemnifying Participant may otherwise withdrawal. inconsistent herewith, the rules of each have. Promptly after receipt by an Participant shall apply to the actions of indemnified Participant of notice of the XVI. Modifications to Plan its members in effecting, reporting, commencement of any action, such The Plan may be modified from time honoring and settling transactions indemnified Participant will, if a claim to time when authorized by the executed through its facilities, and the in respect thereof is to be made against agreement of all of the Participants, entry, maintenance and firmness of an indemnifying Participant, notify the subject to the approval of the SEC.
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XVII. Applicability of Securities shall constitute one and the same By: Exchange Act of 1934 instrument. Chicago Board Options Exchange, Inc. By: The rights and obligations of the XXI. Depth of Book Display International Securities Exchange, Inc. Participants and of Vendors, News The Operating Committee has By: Services, Subscribers and other persons determined that the entity that succeeds National Association of Securities contracting with Participant in respect Nasdaq as the Processor should have the Dealers, Inc. of the matters covered by the Plan shall ability to collect, consolidate, and By: at all times be subject to any applicable disseminate quotations at multiple price National Stock Exchange provisions of the Act, as amended, and By: levels beyond the best bid and best offer any rules and regulations promulgated New York Stock Exchange, Inc. from any Participant that voluntarily thereunder. By: chooses to submit such quotations while Pacific Exchange, Inc. XVIII. Operational Issues determining that no Participant shall be By: A. Each Exchange Participant shall be required to submit such information. Philadelphia Stock Exchange, Inc. responsible for collecting and validating The Operating Committee has further By: determined that the costs of developing, quotes and last sale reports within their Exhibit 1 own system prior to transmitting this collecting, processing, and 1. Each Participant eligible to receive data to the Processor. disseminating such depth of book data B. Each Exchange Participant may shall be borne exclusively by those revenue under the Plan will receive an utilize a dedicated Participant line into Participants that choose to submit this annual payment for each calendar year the Processor to transmit trade and information to the Processor, by to be determined by multiplying (i) that quote information in Eligible Securities whatever allocation those Participants Participant’s percentage of total volume to the Processor. The Processor shall may choose among themselves. The in Nasdaq securities reported to the accept from Exchange Participants input Operating Committee has determined Processor for that calendar year by (ii) the total distributable net operating for only those issues that are deemed further that the primary purpose of the income (as defined below) for that Eligible Securities. Processor is the collection, processing C. The Processor shall consolidate and dissemination of best bid, best offer calendar year. In the event that total trade and quote information from each and last sale information (‘‘core data’’), distributable net operating income is Participant and disseminate this and as such, the Participants will adopt negative, each Participant eligible to information on the Nasdaq existing procedures to ensure that such receive revenue under the Plan will vendor lines. functionality in no way hinders the receive an annual bill for each calendar D. The Processor shall perform gross collecting, processing and year to be determined according to the validation processing for quotes and last dissemination of this core data. same formula (described in this sale messages in addition to the Therefore, implementing the depth of paragraph) for determining annual collection and dissemination functions, book display functionality will require a payments to eligible Participants. 2. A Participant’s percentage of total as follows: plan amendment that addresses all 1. Basic Message Validation. pertinent issues, including: volume in Nasdaq securities will be (a) The Processor may validate format (1) Procedures for ensuring that the calculated by taking the average of (i) for each type of message, and reject non- fully-loaded cost of the collection, the Participant’s percentage of total conforming messages. processing, and dissemination of depth- trades in Nasdaq securities reported to (b) Input must be for an Eligible of-book information will be tracked and the Processor for the year and (ii) the Security. invoiced directly to those Plan Participant’s percentage of total share 2. Logging Function—The Processor Participants that voluntarily choose to volume in Nasdaq securities reported to shall return all Participant input send that data, voluntarily, to the the Processor for the year (trade/volume messages that do not pass the validation Processor, allocating in whatever average). For any given year, a checks (described above) to the manner those Participants might agree; Participant’s percentage of total trades inputting Participant, on the entering and shall be calculated by dividing the total Participant line, with an appropriate (2) Necessary safeguards the Processor number of trades that that Participant reject notation. For all accepted will take to ensure that its processing of reports to the Processor for that year by Participant input messages (i.e., those depth-of-book data will not impede or the total number of trades in Nasdaq that pass the validation check), the hamper, in any way, its core Processor securities reported to the Processor for information shall be retained in the functionality of collecting, the year. A Participant’s total share Processor system. consolidating, and disseminating volume shall be calculated by National Best Bid and Offer data, multiplying the total number of trades XIX. Headings exchange best bid and offer data, and in Nasdaq securities in that year that The section and other headings consolidated last sale data. that Participant reports to the Processor contained in this Plan are for reference Upon approval of a Plan amendment multiplied by the number of shares for purposes only and shall not be deemed implementing depth of book display, each such trade. Unless otherwise stated to be a part of this Plan or to affect the this article of the Plan shall be in this agreement, a year shall run from meaning or interpretation of any automatically deleted. January 1 to December 31 and quarters provisions of this Plan. In Witness Whereof, this Plan has shall end on March 31, June 30, been executed as of thelll day September 30, and December 31. XX. Counterparts oflll, 200__, by each of the Processor shall endeavor to provide This Plan may be executed by the Signatories hereto. Participants with written estimates of Participants in any number of American Stock Exchange LLC each Participant’s percentage of total counterparts, no one of which need By: volume within five business days of contain the signature of all Participants. Boston Stock Exchange, Inc. month end. As many such counterparts as shall By: 3. For purposes of this Exhibit 1, net together contain all such signatures Chicago Stock Exchange, Inc. distributable operating income for any
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particular calendar year shall be Human Resources, Finance, Legal, and statement setting forth the basis upon calculated by adding all revenues from Administrative Services. which net operating income was the UTP Quote Data Feed, the UTP e. Processor costs excluded from the calculated, including a quarterly Trade Data Feed, the OTC Montage Data calculation of net distributable itemized statement of the Processor Feed, and NQDS, including revenues operating income include trade costs set forth in Paragraph 3 of this from the dissemination of information execution costs for transactions Exhibit. Such Processor costs and Plan among Eligible Securities to foreign executed using a Nasdaq service and revenues shall be adjusted annually marketplaces (collectively, ‘‘the Data trade report collection costs reported based solely on the Processor’s quarterly Feeds’’), and subtracting from such through a Nasdaq service, as such itemized statement audited pursuant to revenues the costs incurred by the services are market functions for which Processor’s annual audit. Processor shall Processor, set forth below, in collecting, Participants electing to use such pay or bill Participants for the audit consolidating, validating, generating, services pay market rate. adjustments within thirty days of and disseminating the Data Feeds. f. For the purposes of this provision, completion of the annual audit. By These costs include, but are not limited the following definitions shall apply: majority vote of the Operating to, the following: 1. ‘‘Quote engine’’ shall mean the Committee, the Processor shall engage a. The Processor costs directly Nasdaq’s NT or Tandem system that is an independent auditor to audit the attributable to creating OTC Montage operated by Nasdaq to collect quotation Processor’s costs or other calculation(s), Data Feed and NQDS, including: information for Eligible Securities; the cost of which audit shall be shared 2. ‘‘Trade engine’’ shall mean the 1. Cost of collecting Participant quotes equally by all Participants. The Nasdaq Tandem system that is operated into the Processor’s quote engine; Processor agrees to cooperate fully in by Nasdaq for the purpose of collecting 2. Cost of processing quotes and providing the information necessary to last sale information in Eligible creating OTC Montage Data Feed and complete such audit. NQDS messages within the Processor’s Securities. quote engine; 4. At the time a Participant [FR Doc. E6–773 Filed 1–23–06; 8:45 am] 3. Cost of the Processor’s implements a computer-to-computer- BILLING CODE 8010–01–P communication management subsystem interface or other Processor-approved that distributes OTC Montage Data Feed electronic interface with the Processor, SECURITIES AND EXCHANGE and NQDS to the market data vendor the Participant will become eligible to COMMISSION network for further distribution. receive revenue. 5. Processor shall endeavor to provide b. The costs directly attributable to Participants with written estimates of Sunshine Act Meetings creating the UTP Quote Data Feed, each Participant’s quarterly net including: distributable operating income within Notice is hereby given, pursuant to 1. Cost of calculating the national best the provisions of the Government in the bid and offer price within the 45 calendar days of the end of the quarter, and estimated quarterly Sunshine Act, Pub. L. 94–409, that the Processor’s quote engine; Securities and Exchange Commission 2. Cost of creating the UTP Quote Data payments or billings shall be made on the basis of such estimates. All quarterly will hold the following meetings during Feed message within the Processor’s the week of January 23, 2006: Closed quote engine; payments or billings shall be made to each eligible Participant within 45 days Meetings will be held on Thursday, 3. Cost of the Processor’s January 26, 2006 at 9 a.m. and on communication management subsystem following the end of each calendar quarter in which the Participant is January 26, 2006 at 2 p.m. that distributes the UTP Quote Data Commissioners and certain staff Feed to the market data vendors’ eligible to receive revenue, provided that each quarterly payment or billing members who have an interest in the networks for further distribution. matter will attend the Closed Meeting c. The costs directly attributable to shall be reconciled against a Participant’s cumulative year-to-date on January 26, 2006 at 9 a.m. creating the UTP Trade Data Feed, Commissioners, Counsel to the including: payment or billing received to date and adjusted accordingly, and further Commissioners, the Secretary to the 1. Cost of determining the appropriate Commission, and recording secretaries last sale price and volume amount provided that the total of such estimated payments or billings shall be reconciled will attend the Closed Meeting on within the Processor’s trade engine; January 26, 2006 at 2 p.m. Certain staff 2. Cost of utilizing the Processor’s at the end of each calendar year and, if members who have an interest in the trade engine to distribute the UTP Trade necessary, adjusted by March 31st of the matters may also be present. Data Feed for distribution to the market following year. Interest shall be data vendors. included in quarterly payments and in The General Counsel of the d. The additional costs that are shared adjusted payments made on March 31st Commission, or his designee, has across all Data Feeds, including: of the following year. Such interest shall certified that, in his opinion, one or 1. Telecommunication Operations accrue monthly during the period in more of the exemptions set forth in 5 costs of supporting the Participant lines which revenue was earned and not yet U.S.C. 552b(c), (3), (5), (7), (8), (9)(B), into the Processor’s facilities; paid and will be based on the 90-day and (10) and 17 CFR 200.402(a), (3), (5), 2. Telecommunications Operations Treasury bill rate in effect at the end of (7), (8), 9(ii) and (10) permit costs of supporting the external market the quarter in which the payment is consideration of the scheduled matters data vendor network; made. Monthly interest shall start at the Closed Meetings. 3. Data Products account management accruing 45 days following the month in Commissioner Glassman, as duty and auditing function with the market which it is earned and accrue until the officer, voted to consider the items data vendors; date on which the payment is made. listed for the closed meetings in closed 4. Market Operations costs to support In conjunction with calculating sessions and that no earlier notice symbol maintenance, and other data estimated quarterly and reconciled thereof was possible. integrity issues; annual payments under this Exhibit 1, The subject matter of the Closed 5. Overhead costs, including the Processor shall submit to the Meeting scheduled for 9 a.m. on management support of the Processor, Participants a quarterly itemized Thursday, January 26, 2006 will be:
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Institution and settlement of an Electronic Comments SEC–52 injunctive action. The subject matter of the Closed • Use the Commission’s Internet SYSTEM NAME: Meeting scheduled for 2 p.m. on comment form (http://www.sec.gov/ Visitor Badge and Employee Day Pass Thursday, January 26, 2006 will be: rules/other.shtml); or System. Formal orders of investigations; • Send an e-mail to rule- Institution and settlement of injunctive [email protected]. Please include File SYSTEM LOCATION: actions; Number S7–02–06 on the subject line. U.S. Securities and Exchange Institution and settlement of Paper Comments Commission, 100 F Street, NE., administrative proceedings of an Washington, DC 20549. enforcement nature; • Send paper comments in triplicate Opinion; and to Nancy M. Morris, Secretary, U.S. CATEGORIES OF INDIVIDUALS COVERED BY THE Amici consideration. SYSTEM: Securities and Exchange Commission, At times, changes in Commission 100 F Street, NE., Washington, DC Visitors from the public, other Federal priorities require alterations in the 20549–9303. agencies, Commission employees who scheduling of meeting items. require a Day Pass and Commission All submissions should refer to File For further information and to employees who pre-register or authorize Number S7–02–06. This file number ascertain what, if any, matters have been visitors. The system also covers should be included on the subject line added, deleted or postponed, please individuals or organizations that send if e-mail is used. To help us process and contact: and/or deliver trackable mail to the The Office of the Secretary at (202) review your comments more efficiently, Commission (e.g., express mail, courier 551–5400. please use only one method. The mail, or other forms of mail that is Commission will post all comments on Dated: January 20, 2006. tracked from the sender to the the Commission’s Internet Web site J. Lynn Taylor, recipient). (http://www.sec.gov/rules/other.shtml). Assistant Secretary. Comments are also available for public CATEGORIES OF RECORDS IN THE SYSTEM: [FR Doc. 06–707 Filed 1–20–06; 12:52 pm] inspection and copying in the BILLING CODE 8010–01–P Commission’s Public Reference Room, Records may include name, 100 F Street, NE., Washington, DC photograph, signature, company name, 20549. All comments received will be the number of the printed badge issued SECURITIES AND EXCHANGE posted without change; we do not edit for each visit, visitor category, business COMMISSION personal identifying information from phone number, fax number, address, e- [Release No. PA–34; File No. S7–02–06] submissions. You should submit only mail address, Web site if available, other information that you wish to make information from scanned business Privacy Act of 1974: Establishment of available publicly. cards, and the location, date, and time a New System of Records: Visitor of entry to the secure Commission Badge and Employee Day Pass System FOR FURTHER INFORMATION CONTACT: facility. Records will also include the (SEC–52) Barbara A. Stance, Chief Privacy Officer, following information from scanned U.S. Securities and Exchange driver’s licenses: Date of birth, weight, AGENCY: Securities and Exchange Commission, Operations Center, 6432 height, color of hair and eyes, date of Commission. General Green Way, Alexandria, VA expiration, and issuing jurisdiction ACTION: Notice of the establishment of a 22312–2413, (202) 551–7209. (license numbers will not be saved in new system of records. SUPPLEMENTARY INFORMATION: The the system). Further information contained within the system will be the SUMMARY: In accordance with the Commission gives notice of the name and title of the person being requirements of the Privacy Act of 1974, proposed establishment of a new system visited, the reason for the visit to the as amended, 5 U.S.C. 552a, the of records, entitled ‘‘Visitor Badge and facility, notation of approved parking, Securities and Exchange Commission Employee Day Pass System (SEC–52).’’ and the name, phone number and e-mail gives notice of a proposed Privacy Act The new system will contain records of address of Commission personnel system of records: ‘‘Visitor Badge and Commission visitors, employee day pass requesting authorization for the visitor Employee Day Pass System (SEC–52).’’ information and records related to the access. The system will maintain check This system of records will contain, status of trackable (special handling) in and check out times, current status of among other things, records of mail. visitor, and a custom ID number Commission visitors, employee day pass The Commission has submitted a assigned sequentially by the system information and records related to the report of the new system of records to software for each visitor record. The status of trackable (special handling) the Senate Committee on Homeland software system and data base has a mail. Security and Governmental Affairs, the module for tracking packages as well. DATES: The new system will become House Committee on Government Records include package check in time, effective March 6, 2006 unless further Reform, and the Office of Management quantity of packages, name of employee notice is given. The Commission will and Budget, pursuant to 5 U.S.C. 552a(r) to whom the package is addressed, publish a new notice if the effective date of the Privacy Act of 1974, as amended, location of package, sender’s name, type is delayed to review comments or if and Appendix I to OMB Circular A–130, of package, added description (if changes are made based on comment ‘‘Federal Agency Responsibilities for appropriate), carrier/agent delivering received. To be assured of Maintaining Records About the package, time and name of person to consideration, comments should be Individuals,’’ as amended on February whom package is delivered (final received on or before February 23, 2006. 20, 1996 (61 FR 6435). destination within the Commission), ADDRESSES: Comments may be Accordingly, the Commission is and a custom ID number assigned submitted by any of the following adding a new system of records to read sequentially by the system software for methods: as follows: each visitor record.
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AUTHORITY FOR MAINTENANCE OF THE SYSTEM: POLICIES AND PRACTICES FOR STORING, and yet seek access to their workplace RETRIEVING, ACCESSING, RETAINING, AND 5 U.S.C. 301 and Executive Order for official business. Additionally, DISPOSING OF RECORDS IN THE SYSTEM: information is provided by individuals 13231 of October 16, 2001 on Critical sending trackable (special handling) Infrastructure Protection. STORAGE: Records are maintained in a mail. Information is further provided by carriers and/or agents that deliver such PURPOSE(S): computerized database and on paper. Paper documents are kept in filing mail. Persons who decline to provide This system was primarily designed cabinets in secured facilities. the requested information will be to permit access to Commission denied access. facilities by public visitors and RETRIEVABILITY: EXEMPTIONS CLAIMED FOR THE SYSTEM: representatives from other Federal By use of a database, records may be agencies. It is also used to issue day retrieved by the individual’s name, date None. passes for Commission staff members or of visit and/or badge number (as printed Date: January 18, 2006. contract employees who are not in the form of a bar code on the badge). By the Commission. presently in possession of their ID and Jill M. Peterson, SAFEGUARDS: need to enter the workplace to perform Assistant Secretary. Records are safeguarded by restricted their duties. The system is further used [FR Doc. E6–805 Filed 1–23–06; 8:45 am] computer passwords, locked file to record and monitor the status of BILLING CODE 8010–01–P trackable (special handling) mail. cabinets, and safes. RETENTION AND DISPOSAL: ROUTINE USES OF RECORDS MAINTAINED IN THE Records are maintained in a SECURITIES AND EXCHANGE SYSTEM, INCLUDING CATEGORIES OF USERS AND computerized database and on paper. COMMISSION THE PURPOSE OF SUCH USES: Printed badges, and returned passes [Release No. 34–53135; File No. SR–CBOE– These records and information (and corresponding electronic records) 2005–83] contained in these records may be are destroyed three months after disclosed as follows: expiration, revocation, or return to Self-Regulatory Organizations; issuing office, as provided in the Chicago Board Options Exchange, (1) To the appropriate Federal, State Incorporated; Order Approving or local agency responsible for National Archives and Records Administration’s General Records Proposed Rule Change Relating to the investigating, prosecuting, enforcing, or SizeQuote Mechanism implementing a statute, rule, regulation, Schedule No. 11, Item 4. or order, where the Commission or other SYSTEM MANAGER(S) AND ADDRESS: January 17, 2006. On October 11, 2005, the Chicago appropriate Federal, State or local Chief of Security Branch, Office of Board Options Exchange, Incorporated agency may be aware of an indication of Administrative Services, Security (‘‘CBOE’’ or ‘‘Exchange’’) filed with the an actual or potential health, safety or Branch, U.S. Securities and Exchange Securities and Exchange Commission national security concern or a violation Commission, 100 F Street, NE., (‘‘Commission’’), pursuant to Section or potential violation of civil or criminal Washington, DC 20549–1627. law or regulation; 19(b)(1) of the Securities Exchange Act of 1934 (‘‘Act’’),1 and Rule 19b–4 (2) To another Federal agency, in NOTIFICATION PROCEDURE: thereunder,2 a proposed rule change to connection with a court proceeding All requests to determine whether this modify its pilot SizeQuote Mechanism when the Government is party to a system of records contains a record pertaining to the requesting individual for the execution of large-sized orders in proceeding before the court or to an 3 may be directed to the Privacy Act open outcry. The proposed rule change adjudicative tribunal when the was published for comment in the Government is appearing in a Officer, U.S. Securities and Exchange Commission, Operations Center, 6432 proceeding before that tribunal; 1 General Green Way, Mail Stop 0–7, 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b–4. (3) To a Federal, State, or local Alexandria, VA 22312–2413. agency, in response to its requests, in 3 CBOE Rule 6.74(f), which sets forth the rules and procedures for use of the SizeQuote RECORD ACCESS PROCEDURES: connection with the hiring or retention Mechanism, was approved by the Commission in of an employee, the issuance of a Persons wishing to obtain information February 2005 for adoption on a pilot basis. See security clearance, or the conducting of on the procedures for gaining access to Securities Exchange Act Release No. 51205 a security or background investigation or contesting the contents of this record (February 15, 2005), 70 FR 8647 (February 22, of an individual, to the extent that the 2005). may contact the Privacy Act Officer, In brief, a floor broker seeking to use the information is relevant and necessary to U.S. Securities and Exchange SizeQuote Mechanism to facilitate a customer’s the requesting agency; Commission, Operations Center, 6432 large-sized order (‘‘SizeQuote Order) must request General Green Way, Mail Stop 0–7, a ‘‘SizeQuote’’ from in-crowd market participants (4) To the Office of the Inspector (‘‘ICMPs’’), who may respond with indications of General for investigating allegations of Alexandria, VA 22312–2413. the price and size at which they would be willing to trade with the order. ICMPs who respond at the abuse or misconduct, or to perform CONTESTING RECORDS PROCEDURES: other functions within the jurisdiction best price have priority to trade with the order at See record access procedures above. that best price and at one trading increment better of the Office of the Inspector General; (the ‘‘improved best price’’). If the ICMPs do not and RECORD SOURCE CATEGORIES: execute the entire SizeQuote Order, the floor broker must be prepared to execute the remaining (5) To the Commission Security Information is provided by the visitor contracts against a facilitation order at the best price Branch and/or the Office of the seeking access to Commission facilities or the improved best price, as applicable. However, Inspector General in routine and ad hoc to meet with Commission employees or the floor broker has priority to facilitate the entire reports to review visitor and day pass contractors, by Commission employees SizeQuote Order at a price two trading increments better than the best price provided by the ICMPs. activity and to assess compliance with who pre-register visitors, and by For a more complete description, see Securities established security procedures and Commission employees or badged Exchange Act Release No. 50967 (January 5, 2005), policies. contractors who do not have their ID 70 FR 2197 (January 12, 2005).
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Federal Register on December 12, SECURITIES AND EXCHANGE 4901. Definitions 4 2005. The Commission received no COMMISSION (a) through (h) No Change. comments regarding the proposal. This [Release No. 34–53111; File No. SR–NASD– (i) The term ‘‘Participant’’ shall mean order approves the proposed rule 2006–002] an NASD member that fulfills the change. obligations contained in Rule 4902 The proposed rule change would Self-Regulatory Organizations; regarding participation in the System. establish that, in addition to a floor National Association of Securities Until [December 31, 2005,] February 8, broker crossing a SizeQuote Order with Dealers, Inc.; Notice of Filing and 2006, the term ‘‘Participant’’ shall also a facilitation order in accordance with Immediate Effectiveness of Proposed include non-NASD [members] broker/ the SizeQuote Mechanism’s procedures, Rule Change and Amendment No. 1 dealers that desire to use the System Thereto Related to Non-NASD Member a floor broker also may cross the and otherwise meet all other Broker-Dealer Access to Nasdaq’s Brut SizeQuote order with one or more requirements for System participation. Facility (j) through (w) No Change. solicited orders or a combination of solicited and facilitation orders. January 12, 2006. * * * * * The Commission finds that the Pursuant to section 19(b)(1) of the II. Self-Regulatory Organization’s proposed rule change is consistent with Securities Exchange Act of 1934 Statement of the Purpose of, and the requirements of the Act and the (‘‘Act’’),1 and Rule 19b–4 thereunder,2 Statutory Basis for, the Proposed Rule rules and regulations thereunder notice is hereby given that on January 3, Change 2006, the National Association of applicable to a national securities In its filing with the Commission, Securities Dealers, Inc. (‘‘NASD’’), exchange, and, in particular, with the Nasdaq included statements concerning through its subsidiary, The Nasdaq requirements of Section 6(b)(5) of the the purpose of and basis for the Stock Market, Inc. (‘‘Nasdaq’’), filed Act.5 The Commission believes that, by proposed rule change, as amended, and with the Securities and Exchange giving floor brokers the alternative of discussed any comments it received on Commission (‘‘Commission’’) the the proposed rule change, as amended. crossing customers’ SizeQuote Orders proposed rule change as described in The text of these statements may be with solicited orders, the proposed rule Items I and II below, which Items have examined at the places specified in Item change is intended to expand the been prepared by Nasdaq. On January IV below. Nasdaq has prepared potential benefits of the SizeQuote 12, 2006, Nasdaq submitted summaries, set forth in sections A, B, Mechanism. The Commission notes that Amendment No. 1 to the proposed rule and C below, of the most significant the proposal does not alter the change.3 Nasdaq has filed the proposal aspects of such statements. procedures a floor broker must follow in pursuant to section 19(b)(3)(A) of the executing SizeQuote Orders. Act 4 and Rule 19b–4(f)(6) thereunder,5 A. Self-Regulatory Organization’s It is therefore ordered, pursuant to which renders the proposal effective Statement of the Purpose of, and Section 19(b)(2) of the Act,6 that the upon filing with the Commission. The Statutory Basis for, the Proposed Rule proposed rule change (SR–CBOE–2005– Commission is publishing this notice to Change solicit comments on the proposed rule 83) is approved until the expiration of 1. Purpose the current SizeQuote pilot program on change, as amended, from interested Under current NASD Rule 4901(i), February 15, 2006.7 persons. entities that are not members of the For the Commission, by the Division of I. Self-Regulatory Organization’s NASD may use the Brut system until Market Regulation, pursuant to delegated Statement of the Terms of Substance of December 31, 2005. Nasdaq proposes to authority.8 the Proposed Rule Change amend this provision so as to allow non- Jill M. Peterson, Nasdaq proposes to continue to NASD member broker-dealers to use the 7 Assistant Secretary. provide, through February 8, 2006, Brut system through February 8, 2006. [FR Doc. E6–778 Filed 1–23–06; 8:45 am] broker-dealers that are not members of Nasdaq notes that the continued the NASD access to Nasdaq’s Brut provision of such access impacts seven BILLING CODE 8010–01–P facility. Nasdaq states that it would current Brut broker-dealer users (four implement the proposed rule change, as active and three inactive), which amended, immediately. Nasdaq has Nasdaq believes is similar to access designated this proposal as non- already being provided by the Arca controversial and has requested that the Trading subsidiary of the Archipelago 4 See Securities Exchange Act Release No. 52888 Commission waive the five-day pre- Exchange.8 Nasdaq commits that Brut (December 5, 2005), 70 FR 73492. filing requirement and the 30-day pre- will not accept any new broker-dealer 5 15 U.S.C. 78f(b)(5). In approving this proposed operative waiting period contained in subscribers to its system that are non- rule change, the Commission has considered the Rule 19b–4(f)(6)(iii) under the Act.6 NASD members during the extended proposed rule’s impact on efficiency, competition, The text of the proposed rule change, and capital formation. 15 U.S.C. 78c(f). as amended, is below. Proposed new 7 Nasdaq states that non-NASD member entities 6 15 U.S.C. 78s(b)(2). language is italicized; proposed that are not broker-dealers will not be able to use 7 The Commission notes that the current deletions are in [brackets]. the Brut system beyond December 31, 2005. Nasdaq SizeQuote pilot program expires on February 15, states that the February 8, 2006 date was selected 2006. The Exchange has indicated to Commission * * * * * to coincide with the current deadline for non-NASD staff its intent to propose an extension of the pilot member broker-dealers to leave Nasdaq’s INET Facility. See Securities Exchange Act Release No. program, as amended by the instant proposal, for 1 15 U.S.C. 78s(b)(1). 52902 (December 7, 2005); 70 FR 73810 (December an additional year. Telephone Conversation 2 17 CFR 240.19b–4. 13, 2005) (SR–NASD–2005–128). Nasdaq states that between Jennifer Lamie, Managing Senior Attorney, 3 Amendment No. 1 made technical changes to the INET Facility is expected to be merged into the CBOE and Ira Brandriss, Special Counsel, Division the proposed rule change. Brut broker-dealer in the near future. of Market Regulation, Commission on January 13, 4 15 U.S.C. 78s(b)(3)(A). 8 See Securities Exchange Act Release No. 52497 2006. 5 17 CFR 240.19b–4(f)(6). (September 22, 2005); 70 FR 56949 (September 29, 8 17 CFR 200.30–3(a)(12). 6 17 CFR 240.19b–4(f)(6)(iii). 2005) (SR–PCX–2005–90).
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access period for current non-NASD current non-NASD member broker- amendments, all written statements member broker-dealer system users dealers continued access to the Brut with respect to the proposed rule proposed in this filing. system without disruption. In addition, change, as amended, that are filed with the Commission notes that the proposed the Commission, and all written 2. Statutory Basis rule’s February 8, 2006 date matches the communications relating to the Nasdaq believes that the proposed date for which non-NASD members are proposed rule change between the rule change, as amended, is consistent required to leave Nasdaq’s INET facility. Commission and any person, other than with the provisions of section 15A of For these reasons, the Commission those that may be withheld from the the Act,9 in general, and with section designates the proposed rule change, as public in accordance with the 15A(b)(6) of the Act,10 in particular, in amended, to be effective and operative provisions of 5 U.S.C. 552, will be that it is designed to promote just and upon filing with the Commission.13 available for inspection and copying in equitable principles of trade, and to At any time within 60 days of the the Commission’s Public Reference remove impediments to a free and open filing of such proposed rule change, as Room. Copies of the filing also will be market and a national market system. amended, the Commission may available for inspection and copying at summarily abrogate such rule change if the principal office of the NASD. All B. Self-Regulatory Organization’s it appears to the Commission that such Statement on Burden on Competition comments received will be posted action is necessary or appropriate in the without change; the Commission does Nasdaq does not believe that the public interest, for the protection of not edit personal identifying proposed rule change, as amended, will investors or otherwise in furtherance of information from submissions. You result in any burden on competition that the purposes of the Act.14 should submit only information that is not necessary or appropriate in IV. Solicitation of Comments you wish to make available publicly. All furtherance of the purposes of the Act. submissions should refer to File Interested persons are invited to Number SR–NASD–2006–002 and C. Self-Regulatory Organization’s submit written data, views, and should be submitted on or before Statement on Comments on the arguments concerning the foregoing, February 14, 2006. Proposed Rule Change Received From including whether the proposed rule Members, Participants or Others change, as amended, is consistent with For the Commission, by the Division of the Act. Comments may be submitted by Market Regulation, pursuant to delegated Written comments were neither authority.15 solicited nor received. any of the following methods: Jill M. Peterson, III. Date of Effectiveness of the Electronic Comments Assistant Secretary. Proposed Rule Change and Timing for • Use the Commission’s Internet [FR Doc. E6–777 Filed 1–23–06; 8:45 am] Commission Action comment form (http://www.sec.gov/ BILLING CODE 8010–01–P rules/sro.shtml); or The foregoing proposed rule change, • as amended, is subject to section Send an e-mail to rule- 19(b)(3)(A)(iii) of the Act 11 and Rule [email protected]. Please include File SECURITIES AND EXCHANGE 19b–4(f)(6) thereunder 12 because the Number SR–NASD–2006–002 on the COMMISSION proposal: (i) Does not significantly affect subject line. the protection of investors or the public [Release No. 34–53117; File No. SR–PCX– Paper Comments 2005–87] interest; (ii) does not impose any • Send paper comments in triplicate significant burden on competition; and to Nancy M. Morris, Secretary, Self-Regulatory Organizations; Pacific (iii) does not become operative prior to Securities and Exchange Commission, Exchange, Inc.; Order Approving 30 days after the date of filing or such 100 F Street, NE., Washington, DC Proposed Rule Change, and shorter time as the Commission may 20549–9303. Amendment No. 1 Thereto, Relating to designate if consistent with the All submissions should refer to File the Tracking Order Process protection of investors and the public Number SR–NASD–2006–002. This file interest; provided that Nasdaq has given number should be included on the January 13, 2006. the Commission notice of its intent to subject line if e-mail is used. To help the I. Introduction file the proposed rule change, along Commission process and review your On July 26, 2005, the Pacific with a brief description and text of the comments more efficiently, please use Exchange, Inc. (‘‘PCX’’ or ‘‘Exchange’’), proposed rule change, at least five only one method. The Commission will through its wholly-owned subsidiary business days prior to the date of filing post all comments on the Commission’s PCX Equities, Inc. (‘‘PCXE’’), filed with of the proposed rule change, or such Internet Web site (http://www.sec.gov/ the Securities and Exchange shorter time as designated by the rules/sro.shtml). Copies of the Commission (‘‘Commission’’), pursuant Commission. submission, all subsequent Nasdaq has requested that the to Section 19(b)(1) of the Securities 1 Commission waive the five-day pre- 13 Exchange Act of 1934 (‘‘Act’’) and Rule For purposes only of accelerating the operative 2 filing requirement and the 30-day date of this proposal, the Commission has 19b–4 thereunder, a proposed rule operative delay. The Commission considered the proposed rule’s impact on change to replace the existing PCXE believes that waiving the five-day pre- efficiency, competition, and capital formation. 15 rules describing its current tracking U.S.C. 78c(f). order process (‘‘Tracking Order filing requirement and the 30-day 14 The effective date of the original proposed rule 3 operative delay is consistent with the change is January 3, 2006 and the effective date of Process’’) with new provisions for the protection of investors and the public Amendment No. 1 is January 12, 2006. For purposes Tracking Order Process. The PCX filed interest because such waiver will permit of calculating the 60-day period within which the Amendment No. 1 to the proposed rule Commission may summarily abrogate the proposed rule change, as amended, under section 19(b)(3)(C) 9 15 15 U.S.C. 78o–3. of the Act, the Commission considers the period to 17 CFR 200.30–3(a)(12). 10 15 U.S.C. 78o–3(b)(6). commence on January 12, 2006, the date on which 1 15 U.S.C. 78s(b)(1). 11 15 U.S.C. 78s(b)(3)(A)(iii). the Exchange submitted Amendment No. 1. See 15 2 17 CFR 240.19b–4. 12 17 CFR 240.19b–4(f)(6). U.S.C. 78s(b)(3)(C). 3 See PCXE Rule 7.37(c).
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change on November 22, 2005.4 The tradeable size, and the price (which is 87), as amended by Amendment No.1, proposed rule change, as amended, was set at the NBBO).13 be, and hereby is, approved. published for comment in the Federal III. Discussion For the Commission, by the Division of Register on December 13, 2005.5 The Market Regulation, pursuant to delegated Commission received no comments on After careful review, the Commission authority.19 the proposed rule change, as amended. finds that the proposed rule change, as Nancy M. Morris, II. Description amended, is consistent with the Secretary. requirements of the Act and the rules [FR Doc. E6–772 Filed 1–23–06; 8:45 am] The PCX proposes to amend its rules and regulations thereunder applicable to BILLING CODE 8010–01–P governing the Archipelago Exchange a national securities exchange.14 In (‘‘ArcaEx’’), the equities trading facility particular, the Commission finds that of PCXE. Specifically, the Exchange the proposal, as amended, is consistent SMALL BUSINESS ADMINISTRATION proposes to restructure its Tracking with Section 6(b)(5) of the Act,15 which Order Process by modifying the current requires, among other things, that a [Disaster Declaration # 10316 and # 10317] rule text governing the Tracking Order national securities exchange’s rules be Process 6 to implement a process based designed to prevent fraudulent and Oklahoma Disaster # OK–00002 on the submission of orders, rather than manipulative acts and practices, to AGENCY: U.S. Small Business instructions, to be executed in price/ promote just and equitable principles of Administration. time priority.7 trade, to foster cooperation and ACTION: Notice. PCX represents that the purpose of the coordination with persons engaged in Tracking Order Process is to provide a facilitating transactions in securities, SUMMARY: This is a Notice of the final opportunity for execution against and to remove impediments to and Presidential declaration of a major any remaining liquidity on the ArcaEx perfect the mechanism of a free and disaster for the State of Oklahoma system before routing to an away market open market and a national market (FEMA–1623–DR), dated 01/10/2006 . center.8 Under the proposed rule system, and, in general, to protect Incident: Severe Wildfire Threat. change, as is currently the case, if an investors and the public interest. Incident Period: 12/01/2005 and order submitted to the ArcaEx has not The Commission believes that under continuing. been executed in its entirety after the proposal, incoming orders executed Effective Date: 01/10/2006. progressing through ArcaEx’s directed in the Tracking Order Process should be Physical Loan Application Deadline order, display order and working order executed in a manner equivalent to that Date: 03/13/2006. processes,9 the order (or the remaining under PCX’s existing rules, but that the Economic Injury (EIDL) Loan portion of the order) would enter the proposed rule change should simplify Application Deadline Date: 10/10/2006. Tracking Order Process. An incoming the process for entering Tracking ADDRESSES: Submit completed loan order would be matched to Tracking Orders. Thus, the Commission believes applications to: U.S. Small Business Orders held in the Tracking Order that the proposed changes to the Administration, National Processing Process based on the price and time the Tracking Order Process do not raise any and Disbursement Center, 14925 Tracking Order was received. Under the new issues or regulatory concerns. The Kingsport Road, Fort Worth, TX 76155. proposal, a ‘‘Tracking Order’’ is an Commission notes that an order may not FOR FURTHER INFORMATION CONTACT: undisplayed, priced round lot order that be executed pursuant to the new A. is eligible for execution in the Tracking Tracking Order Process at a price that is Escobar, Office of Disaster Assistance, U.S. Small Business Administration, Order Process against an order equal to inferior to the NBBO.16 Furthermore, 409 3rd Street, SW., Suite 6050, or less than the aggregate size of the Commission notes that any order Washington, DC 20416. Tracking Order interest available at that that is not executed in its entirety price.10 Tracking Orders would execute pursuant to one of ArcaEx’s other order SUPPLEMENTARY INFORMATION: Notice is only if the price of the Tracking Order execution processes is eligible for hereby given that as a result of the is equal to or better than the national matching and execution pursuant to the President’s major disaster declaration on best bid or offer (‘‘NBBO’’).11 Pursuant Tracking Order Process, and that any 01/10/2006, applications for disaster to the proposed rule change, odd lot User of the ArcaEx system may submit loans may be filed at the address listed orders would continue to be matched to a Tracking Order.17 above or other locally announced odd lot tracking orders held in the locations. IV. Conclusion Tracking Order Process in accordance The following areas have been with a user’s 12 set parameters, such as It is therefore ordered, pursuant to determined to be adversely affected by maximum aggregate size, maximum Section 19(b)(2) of the Act,18 that the the disaster: proposed rule change (SR–PCX–2005– Primary Counties (physical damage and 4 Amendment No. 1, which replaced the original economic injury loans): filing in its entirety, made technical and clarifying 13 See current and proposed PCXE Rule 7.31(g) for Canadian, Cotton, Garvin, Hughes, changes to the proposed rule change. a definition of the odd lot tracking order and Lincoln, Logan, Mayes, Okfuskee, 5 See Exchange Act Release No. 52898 (Dec. 6, proposed PCXE Rule 7.37(c) for a description of the Oklahoma, Pottawatomie, 2005), 70 FR 73811 (Dec. 13, 2005) (‘‘Notice’’). odd lot tracking order process. Seminole, Stephens. 6 See PCXE Rule 7.37(c). 14 In approving this proposal, the Commission has 7 See proposed PCXE Rule 7.31(f). considered the proposed rule’s impact on Contiguous Counties (Economic Injury 8 See Notice. efficiency, competition, and capital formation. 15 Loans Only): 9 See PCXE Rule 7.37 for a description of the U.S.C. 78c(f). Oklahoma: Blaine, Caddo, Carter, ArcaEx execution processes that precede the 15 15 U.S.C. 78f(b)(5). Cherokee, Cleveland, Coal, Tracking Order Process, including the directed 16 See PCXE Rule 7.37. Comanche, Craig, Creek, Delaware, process, display process, and working order 17 As is currently the case, only an ‘‘Odd Lot Garfield, Grady, Jefferson, process. See also proposed PCX Rule 7.37(c). Dealer,’’ as defined in PCXE Rule 1.1(gg), may 10 See Proposed PCXE Rule 7.31(f). submit an odd lot tracking order. See current and Kingfisher, Mcclain, Mcintosh, 11 See PCXE Rule 7.37. proposed PCXE Rule 7.31(g). 12 ‘‘User’’ is defined in PCXE Rule 1.1(yy). 18 15 U.S.C. 78s(b)(2). 18 15 U.S.C. 78s(b)(2).
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Murray, Noble, Okmulgee, Payne, SUPPLEMENTARY INFORMATION: Notice is Economic Injury (EIDL) Loan Pittsburg, Pontotoc, Rogers, hereby given that as a result of the Application Deadline Date: 10/11/2006. Tillman, Wagoner. Administrator’s disaster declaration ADDRESSES: Submit completed loan Texas: Clay, Wichita. applications for disaster loans may be applications to: U.S. Small Business The Interest Rates are: filed at the address listed above or other Administration, National Processing locally announced locations. Percent and Disbursement Center, 14925 The following areas have been Kingsport Road, Fort Worth, TX 76155. For Physical Damage: determined to be adversely affected by the disaster: FOR FURTHER INFORMATION CONTACT: A. Homeowners with credit avail- Escobar, Office of Disaster Assistance, able elsewhere ...... 5.375 Primary Municipalities: U.S. Small Business Administration, Homeowners without credit Lares, Penuelas, Ponce, Toa Baja. 409 3rd Street, SW., Suite 6050, available elsewhere ...... 2.687 Contiguous Municipalities: Puerto Rico: Washington, DC 20416. Businesses with credit available Adjuntas, Bayamon, Camuy, Catano, elsewhere ...... 6.557 SUPPLEMENTARY INFORMATION: Notice is Businesses and pon-profit orga- Dorado, Guayanilla, Hatillo, Jayuya, nizations without credit avail- Juana Diaz, Las Marias, Maricao, hereby given that as a result of the able elsewhere ...... 4.000 San Sebastian, Toa Alta, Utuado, President’s major disaster declaration on Other (including non-profit orga- Yauco. 01/11/2006, applications for disaster nizations) with credit avail- The Interest Rates are: loans may be filed at the address listed able elsewhere ...... 5.000 above or other locally announced For Economic Injury: Percent locations. Businesses & Small Agricultural The following areas have been Cooperatives Without Credit Homeowners With Credit Avail- determined to be adversely affected by Available Elsewhere ...... 4.000 able Elsewhere ...... 5.375 Homeowners Without Credit the disaster: The number assigned to this disaster Available Elsewhere ...... 2.687 Primary Counties (Physical Damage and for physical damage is 103165 and for Businesses With Credit Available Economic Injury Loans): economic injury is 103170. Elsewhere ...... 6.557 Callahan, Cooke, Eastland, Erath, Businesses & Small Agricultural (Catalog of Federal Domestic Assistance Cooperatives Without Credit Hood, Montague, Palo, Pinto, Numbers 59002 and 59008) Available Elsewhere ...... 4.000 Tarrant, Wise. Herbert L. Mitchell, Other (Including Non-Profit Orga- Contiguous Counties (Economic Injury Associate Administrator for Disaster nizations) With Credit Available Loans Only): Assistance. Elsewhere ...... 4.750 Texas: Bosque, Brown, Clay, Coleman, [FR Doc. E6–762 Filed 1–23–06; 8:45 am] Businesses And Non-Profit Orga- Comanche, Dallas, Denton, Ellis, nizations Without Credit Avail- BILLING CODE 8025–01–P able Elsewhere ...... 4.000 Grayson, Hamilton, Jack, Johnson, Somervell, Stephens, Taylor, Young. SMALL BUSINESS ADMINISTRATION The number assigned to this disaster for physical damage is 10314 6 and for Oklahoma: Jefferson, Love. [Disaster Declaration #10314 and #10315] economic injury is 10315 0. The Interest Rates are: The States which received an EIDL Puerto Rico Disaster #PR–00001 Declaration # are Puerto Rico. Percent AGENCY: U.S. Small Business (Catalog of Federal Domestic Assistance For Physical Damage: Administration. Numbers 59002 and 59008) Homeowners with credit avail- ACTION: Notice. Dated: January 10, 2006. able elsewhere ...... 5.375 Homeowners without credit SUMMARY: This is a notice of an Hector V. Barreto, Administrator. available elsewhere ...... 2.687 Administrative declaration of a disaster Businesses with credit available for the Commonwealth of Puerto Rico [FR Doc. E6–759 Filed 1–23–06; 8:45 am] elsewhere ...... 6.557 dated January 10, 2006. BILLING CODE 8025–01–P Other (including non-profit orga- Incident: Severe Storm, Flooding and nizations) with credit avail- Mudslides. able elsewhere ...... 5.000 Incident Period: October 9, 2005 SMALL BUSINESS ADMINISTRATION Businesses and non-profit orga- nizations without credit avail- through October 15, 2005. [Disaster Declaration # 10322 and # 10323] Effective Date: January 10, 2006. able elsewhere ...... 4.000 For Economic Injury: Physical Loan Application Deadline Texas Disaster # TX–00097 Date: March 13, 2006. Businesses & small agricultural Economic Injury (EIDL) Loan AGENCY: U.S. Small Business cooperatives without credit Application Deadline Date: October 10, Administration. available elsewhere ...... 4.000 2006. Administration Action: Notice. The number assigned to this disaster ADDRESSES: Submit completed loan SUMMARY: This is a Notice of the for physical damage is 103225 and for applications to: U.S. Small Business Presidential declaration of a major economic injury is 103230. Administration, National Processing disaster for the State of Texas (FEMA– and Disbursement Center, 14925 1624–DR), dated 01/11/2006. (Catalog of Federal Domestic Assistance Kingsport Road Fort Worth, TX 76155. Incident: Extreme Wildfire Threat. Numbers 59002 and 59008) FOR FURTHER INFORMATION CONTACT: A. Incident Period: 12/01/2005 and Herbert L. Mitchell, Escobar, Office of Disaster Assistance, continuing. Associate Administrator for Disaster U.S. Small Business Administration, Effective Date: 01/11/2006. Assistance. 409 3rd Street, SW., Suite 6050, Physical Loan Application Deadline [FR Doc. E6–761 Filed 1–23–06; 8:45 am] Washington, DC 20416. Date: 03/13/2006. BILLING CODE 8025–01–P
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SOCIAL SECURITY ADMINISTRATION Dated: January 13, 2006. Department of State, the Department of Jo Anne B. Barnhart, Homeland Security, the Department of Agreement on Social Security Between Commissioner of Social Security. Education, and the Attorney General, all the United States and Japan; Entry Into [FR Doc. E6–758 Filed 1–23–06; 8:45 am] take cognizance of and undertake Force BILLING CODE 4191–02–P certain actions regarding flight training programs. The Department of State has AGENCY: Social Security Administration determined that it does not have the (SSA). DEPARTMENT OF STATE expertise and resources to fully monitor flight training programs and insure their ACTION: Notice. [Public Notice 5280] compliance with the national security concerns expressed in the Patriot Act. SUMMARY: The Commissioner of Social Title: Statement of Policy on J–1 Flight Consequently, as a matter of policy, the Security gives notice that an agreement Training Programs Department of State will henceforth not coordinating the United States (U.S.) AGENCY: Department of State. designate any new J visa flight training and Japanese social security programs ACTION: Statement of policy. programs, nor will it permit currently- entered into force on October 1, 2005. designated flight training programs to The agreement with Japan, which was DATES: Effective Date: This policy is expand their programs, pending a signed on February 19, 2004, is similar effective January 24, 2006. determination as to which Federal to U.S. social security agreements FOR FURTHER INFORMATION CONTACT: agency ultimately will be tasked with already in force with 20 other Stanley S. Colvin, Director, Office of the administering and monitoring of countries—Australia, Austria, Belgium, Exchange Coordination and such programs. Redesignation of Canada, Chile, Finland, France, Designation, U.S. Department of State, programs will continue as required by Germany, Greece, Ireland, Italy, Korea SA–44, 301 4th St., SW., Room 734, existing regulations. (South), Luxembourg, the Netherlands, Washington, DC 20547. E-mail: Dated: January 18, 2006. Norway, Portugal, Spain, Sweden, [email protected]; FAX: 202–203– Stanley S. Colvin, Switzerland, and the United Kingdom. 5087. Agreements of this type are authorized Director, Office of Exchange Coordination, SUMMARY: The Department hereby Bureau of Educational and Cultural Affairs, by section 233 of the Social Security Act announces its policy regarding flight Department of State. (42 U.S.C. 433). training programs, which are governed [FR Doc. E6–821 Filed 1–23–06; 8:45 am] Like the other agreements, the U.S.- by the Department’s Exchange Visitor BILLING CODE 4710–05–P Japanese agreement eliminates dual Program regulations appearing in 22 social security coverage—the situation CFR part 62. that exists when a worker from one Since 1949 the Department has DEPARTMENT OF STATE country works in the other country and designated private sector and [Public Notice 5262] is covered under the social security governmental entities to conduct systems of both countries for the same training programs for eligible foreign Arms Control and Nonproliferation work. When dual coverage occurs, the nationals. For the past twenty years, Advisory Board (ACNAB) Meeting worker or the worker’s employer or both flight training activities have been Notice; Closed Meeting may be required to pay social security authorized and currently, eight contributions to the two countries organizations facilitate the entry into the In accordance with section 10(a)(2) of simultaneously. Under the U.S.- United States of some 350 foreign the Federal Advisory Committee Act, 5 Japanese agreement, a worker who is nationals yearly for the purpose of flight U.S.C. app 2 section 10(a)(2), the sent by an employer in one country to training. Flight training programs Department of State announces a work in the other country for 5 years or utilizing the J visa are regulated by the meeting of the Arms Control and less remains covered only by the Department under the authority of the Nonproliferation Advisory Board sending country. The agreement Mutual Educational and Cultural (ACNAB) to take place on January 30, includes additional rules that eliminate Exchange Act of 1961, as amended 2006, at the Department of State, dual U.S. and Japanese coverage in (Fulbright-Hays Act), 22 U.S.C. 2451 et Washington, DC. other work situations. seq.; the Immigration and Naturalization Pursuant to section 10(d) of the Federal Advisory Committee Act, 5 The agreement also helps eliminate Act, 8 U.S.C. 1101(a)(15)(J); the Foreign U.S.C. app 2 section 10(d) and 5 U.S.C. situations where workers suffer a loss of Affairs Reform and Restructuring Act of 1998, Public Law 105–277; as well as 552b(c)(1), it has been determined that benefit rights because they have divided other statutory enactments, this Board meeting will be closed to the their careers between the two countries. Reorganization Plans and Executive public in the interest of national defense Under the agreement, workers may Orders. Regulations dealing specifically and foreign policy because the Board qualify for partial U.S. benefits or partial with flight training programs appear at will be reviewing and discussing Japanese benefits based on combined 22 CFR 62.22(n). Certain flight training matters classified in accordance with (totalized) work credits from both programs also utilize the M visa, which Executive Order 12958. The purpose of countries. is regulated and administered by the the ACNAB is to provide the Individuals who wish to obtain copies Department of Homeland Security’s U.S. Department with a continuing source of of the agreement or want more Citizenship and Immigration Services independent advice on all aspects of information about its provisions may (USCIS). Regulations governing the M arms control, disarmament, write to the Social Security visa appear at 8 CFR 214.2(m). international security, and public Administration, Office of International The USA Patriot Act of 2001 (‘‘The diplomacy. The Board will be briefed on Programs, Post Office Box 17741, Uniting and Strengthening Act By current U.S. policy and issues regarding Baltimore, MD 21235–7741 or visit the Providing Appropriate Tools Required Weapons of Mass Destruction and Social Security Web site at http:// to Intercept and Obstruct Terrorism’’), Counter-Terrorism, as well as issues www.socialsecurity.gov/international. Public Law 107–56, mandated that the related to the Proliferation Security
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Initiative (PSI). The Board will also In 2005, the Government Dated: January 18, 2006. review specific classified arms control Accountability Office (GAO) examined Stanley S. Colvin, and nonproliferation issues as potential the Department’s management of the J Director, Office of Exchange Coordination, first topics for the Board’s visa Summer Work Travel and Trainee Bureau of Educational and Cultural Affairs, consideration. In addition, the agenda programs to ensure that only authorized Department of State. will include administrative matters activities are carried out under the [FR Doc. E6–820 Filed 1–23–06; 8:45 am] related to the Board’s first meeting. programs and to identify potential risks BILLING CODE 4710–05–P For Further Information Contact: of the programs and the data available Matthew Zartman, Deputy Executive to the Department to assess those risks. Director of the Arms Control and (‘‘Stronger Action Needed to Improve Nonproliferation Advisory Board, Oversight and Assess Risks of the OFFICE OF THE UNITED STATES Department of State, Washington, DC Summer Work Travel and Trainee TRADE REPRESENTATIVE 20520, phone: (202) 647–0440. Categories of the Exchange Visitor Generalized System of Preferences Dated: January 9, 2006. Program,’’ GAO–06–106, October 2005.) (GSP): Notice of Closure of Case 017– George W. Look, Among other things, the GAO Report CP–05, Protection of Intellectual found that there was a potential that the Executive Director of the Secretary’s Arms Property in Pakistan, in the 2005 Control and Nonproliferation Advisory Board, trainee programs could be misused as Annual Country Practice Review Department of State. employment programs and that trainees [FR Doc. E6–822 Filed 1–23–06; 8:45 am] could be exploited by employers or AGENCY: Office of the United States other third parties. Agricultural training Trade Representative. BILLING CODE 4710–27–P programs were found to be particularly ACTION: Notice. problematic because of the potential for DEPARTMENT OF STATE fraud. Abuses of the training regulations SUMMARY: This notice announces were not hidden; there were cases closure of the review for case 017–CP– [Public Notice 5281] where there was not even an attempt to 05, Protection of Intellectual Property in represent jobs as training, and which Pakistan. Title: Statement of Policy on J–1 certain employers referred to their FOR FURTHER INFORMATION, CONTACT: Agriculture Training Programs program participants as employees, Marideth Sandler, Executive Director of rather than trainees. In one case cited, the GSP Program, Office of the United AGENCY: Department of State. four trainees were placed with dairy States Trade Representative (USTR), ACTION: Statement of policy. farms that had an agreement with the Room F–220, 1724 F Street, NW., program sponsor. Only one of the Washington, DC 20508. The telephone DATES: Effective Date: This policy is trainees had a firm grasp of English, and number is (202) 395–6971 and the effective January 24, 2006. only one of the four farms participating facsimile number is (202) 395–9481. FOR FURTHER INFORMATION CONTACT: in the program had a structured training SUPPLEMENTARY INFORMATION: The GSP Stanley S. Colvin, Director, Office of plan. There were questions as to program provides for the duty-free Exchange Coordination and whether such programs were merely importation of designated articles when Designation, U.S. Department of State, utilizing trainees for cheap labor and imported from beneficiary developing SA–44, 301 4th St., SW., Room 734, whether the trainees were simply countries. The GSP program is Washington, DC 20547. E-mail: receiving enough training to perform authorized by Title V of the Trade Act [email protected]; FAX: 202–203– their work. (GAO Report, pp. 17, 21). of 1974 (19 U.S.C. 2461, et seq.), as 5087. The Department has taken steps to amended (the ‘‘Trade Act’’), and is SUMMARY: The Department hereby address these concerns. Among other implemented in accordance with announces its policy regarding things, the Department has consulted Executive Order 11888 of November 24, agriculture training programs, which are with the Department of Labor and the 1975, as modified by subsequent governed by the Department’s Exchange Department of Agriculture in order to Executive Orders and Presidential Visitor Program regulations appearing in develop ways to better monitor Proclamations. 22 CFR part 62. agricultural training programs and to In the 2005 Annual Review, the GSP Since 1949 the Department has determine whether such agriculture Subcommittee of the Trade Policy Staff permitted designated sponsors to training programs are subject to, and if Committee (TPSC) is reviewing conduct programs designed to train so, whether they are in compliance petitions concerning the country individuals in many industrial, with, existing statutes such as the Fair practices of certain beneficiary professional, agricultural, and other Labor Standards Act, as amended, 29 developing countries of the GSP occupational skills. Training programs U.S.C. 201, et seq., and the Migrant and program. As a result of that review, the utilizing the J visa are regulated by the Seasonal Agricultural Workers TPSC has decided to close the review Department under the authority of the Protection Act, Public Law 97–470, 29 for case 017–CP–05 regarding protection Mutual Educational and Cultural U.S.C. 1801 et seq. of intellectual property rights in Exchange Act of 1961, as amended Pending the Department’s resolution Pakistan. The Petitioner was the (Fulbright-Hays Act), 22 U.S.C. 2451 et of these outstanding issues, the International Intellectual Property seq.; the Immigration and Naturalization Department of State will not designate Alliance (IIPA). The results of other Act, 8 U.S.C. 1101(a)(15)(J); the Foreign any new J visa agricultural training ongoing country practice reviews in the Affairs Reform and Restructuring Act of programs, nor will it permit currently- 2005 Annual Review will be announced 1998, Public Law 105–277; as well as designated training programs offering in the Federal Register at a later date. other statutory enactments, agricultural training to expand the Reorganization Plans and Executive agricultural training component of their Marideth J. Sandler, Orders. Regulations dealing with programs. Redesignation of programs Executive Director, GSP Program. training programs appear at 22 CFR will continue as required by existing [FR Doc. E6–809 Filed 1–23–06; 8:45 am] 62.22. regulations. BILLING CODE 3190–W6–P
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DEPARTMENT OF TRANSPORTATION A partial list of subjects includes 13, 2006, is now extended to March 14, training, error management, fatigue 2006. Federal Aviation Administration management, and additional human SUPPLEMENTARY INFORMATION: On factors metrics. Additionally, November 22,2005, the Federal Aviation Agency Information Collection Activity respondents will be asked to describe Administration (FAA) issued a notice of Under OMB Review, Request for their organization’s support of their the availability of the DSEA for the Las Comments; Approval of a New human factors program. This will Vegas McCarran International Airport. Information Collection Activity, involve collecting data from companies The notice published on December 5, International Survey of Human Factors world-wide. 2005, FR Vol. 70, page 72497, also in Maintenance Organizations ADDRESSES: Send comments to the announced the schedule for public AGENCY: Federal Aviation Office of Information and Regulatory workshops regarding the DSEA, and Administration (FAA), DOT. Affairs, Office of Management and advised that the public comment period ACTION: Notice and request for Budget, 725 17th Street, NW., would close Friday, December 30, 2005. comments. Washington, DC 20503, Attention FAA The public workshops were held on Desk Officer. November 12 and 13, 2005. A Notice of SUMMARY: Organizations that are Comments are invited on: Whether Extension of the Public Comment approved to conduct aircraft the proposed collection of information Period, published on December 16, maintenance are certified and regulated is necessary for the proper performance 2006, FR Vol. 70, page 74864, extending under CFR 14, Title 49, FAR part 145, of the functions of the Department, the public comment period to January or international equivalent (Henceforth including whether the information will 13, 2006. The public comment period is referred to as part 145). The information have practical utility; the accuracy of further extended to March 14, 2006. collected will be used to assess what the Department’s estimates of the All written comments are to be companies have done, are doing or are burden of the proposed information submitted to Ms. Sara Hassert, Landrum planning to do regarding the human collection; ways to enhance the quality, & Brown, Inc., 8755 W. Higgins Rd., Ste. factors elements of part 145. A partial utility and clarity of the information to 850, Chicago, IL 60631, fax: 773–628– list of subjects includes training, error be collected; and ways to minimize the 2901, E-mail: shassert@landrum- management, fatigue management, and burden of the collection of information brown.com and the comments must be additional human factors metrics. on respondents, including the use of postmarked and e-mail/fax must be sent Additionally, respondents will be asked automated collection techniques or by no later than midnight, Tuesday, to describe their organization’s support other forms of information technology. March 14, 2006. of their human factors program. This FOR FURTHER INFORMATION CONTACT: Ms. will involve collecting data from Issued in Washington, DC, on January 13, 2006. Kathryn Higgins, Environmental companies world-wide. The FAA Specialist, Western Terminal Service Judith D. Street, invites public comments about our Area Office, FAA Western Terminal intention to request the Office of FAA Information Collection Clearance Operations, 15000 Aviation Blvd., Management and Budget’s (OMB) Officer, Information Systems and Technology Services Staff, ABA–20. Lawndale, CA 90261, Ph. 310–725– approval of this new information 6597, E-mail: [email protected]. collection. A notice for public comment [FR Doc. 06–596 Filed 1–23–06; 8:45 am] BILLING CODE 4910–13–M Issued in Lawndale, California on January was published in the Federal Register 12, 2006. on 7/6/2005, vol. 70, #128, page 39000. Stephen Lloyd, DATES: Please submit comments by DEPARTMENT OF TRANSPORTATION Manager, Operations Support, Western February 23, 2006. Terminal Service Area. FOR FURTHER INFORMATION CONTACT: Judy Federal Aviation Administration [FR Doc. 06–590 Filed 1–23–06; 8:45 am] Street on (202) 267–9895. BILLING CODE 4910–13–M Notice of Extension of the Public SUPPLEMENTARY INFORMATION: Comment Period for the Draft Federal Aviation Administration (FAA) Supplemental Environmental DEPARTMENT OF TRANSPORTATION Title: International Survey of Human Assessment for the Proposed Factors in Maintenance Organizations. Modification to the Four Corner-Post Federal Aviation Administration Type of Request:Approval of a new Plan at Las Vegas McCarran Associate Administrator for collection. International Airport Commercial Space Transportation; OMB Control Number: 2120–xxxx. AGENCY: Federal Aviation Notice of Intent To Prepare an Form(s): Human Factors Survey Form. Administration (FAA), DOT. Affected Public: A total of 1,080 Environmental Impact Statement (EIS) respondents. ACTION: Extension of public comment and Conduct Public Scoping Meetings Frequency: Conducted on an as- period. AGENCY: The Federal Aviation needed basis. Administration (FAA), Associate SUMMARY: This notice advises the public Estimated Average Burden Per Administrator for Commercial Space that the comment period for the Draft Response: Approximately 30 minutes. Transportation (AST) is the lead Federal Supplemental Environmental Estimated Annual Burden Hours: An agency. The Bureau of Land Assessment (DSEA) for the proposed estimated 540 hours annually. Management (BLM) is a cooperating modification to the Four Corner-Post Abstract: Part 145 organizations will agency. The FAA will ask the U.S. Plan at Las Vegas McCarran receive an invitation via e-mail to Department of the Army to participate International Airport, Las Vegas, Nevada complete a web-based survey. The as a cooperating agency. is extended. information collected will be used to ACTION: Notice of Intent. assess what companies have done, are DATES: The comment period of the doing or are planning to do regarding DSEA, originally ending on December SUMMARY: This Notice provides the human factors elements of part 145. 30, 2005, and then extended to January information to Federal, State, and local
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agencies, affected Native American site does not relieve a licensee of its and supporting utility infrastructure for tribes, and other interested persons obligation to comply with any other the Southwest Regional Spaceport may regarding the FAA’s intent to prepare an laws or regulations; nor does it confer occur on lands administered by the environmental impact statement (EIS) any proprietary, property, or exclusive BLM. The impacts of all construction for the New Mexico Economic right in the use of airspace or outer activities will be analyzed in this EIS. Development Department’s (NMEDD’s) space. (14 CFR 420.41) A launch site In order to address the range of proposal to develop and operate a operator license remains in effect for launch vehicles that could be launched commercial launch site near Upham, five years from the date of issuance from the proposed facility, the EIS will New Mexico. The FAA will prepare the unless surrendered, suspended, or consider three types of horizontally EIS in accordance with the National revoked before the expiration of the launched concept vehicles and three Environmental Policy Act (NEPA) of term and is renewable upon application types of vertically launched concept 1969 (42 United States Code (U.S.C.) by the licensee. (14 CFR 420.43) vehicles. The horizontal concept 4321 et seq.), the Council on SUPPLEMENTARY INFORMATION: vehicles include: Environmental Quality Regulations for • Concept H1 vehicles—These Background Implementing the Procedural Provisions vehicles use jet-powered take off with of NEPA (40 Code of Federal The FAA is preparing an EIS to subsequent rocket engine ignition and Regulations (CFR) parts 1500–1508), analyze the environmental impacts of powered horizontal landing. and FAA Order 1050.1E, Environmental the NMEDD’s proposed operation of a • Concept H2 vehicles—These Impacts: Policies and Procedures, as launch facility near Upham, New vehicles use rocket-powered take off part of its licensing process for the Mexico. The proposed site is located and flight and unpowered horizontal proposed launch site. The BLM will approximately 45 miles north of Las landing. participate in this NEPA process as a Cruces, New Mexico. The EIS will • Concept H3 vehicles—These cooperating agency; the FAA will ask consider the environmental impacts of vehicles are carried aloft via assist the U.S. Army White Sands Missile the construction of facilities, ground aircraft with subsequent rocket engine Range to participate as a cooperating activities (e.g., component testing, ignition and unpowered horizontal agency. transportation and storage of propellants landing. Under the proposed action, the FAA and explosives, etc.), pre-flight vehicle The vertical concept vehicles include: would issue a launch site operator and payload preparation activities, • Concept V1 vehicles—These license to the NMEDD to operate a launch, and landing/recovery vehicles consist of a single-stage rocket launch facility at the proposed site, operations. in which the rocket stage and payload termed the Southwest Regional The successful completion of the or crew/passenger modules return Spaceport. The launch site operator environmental review process does not separately to Earth by parachute. • license would authorize the NMEDD to guarantee that the FAA would issue a Concept V2 vehicles—These operate a launch facility to support launch site operator license to the vehicles consist of a single-stage rocket launches of horizontally and vertically NMEDD. The project also must meet all in which the rocket stage returns to launched, suborbital rockets.1 The FAA safety, risk, and indemnification Earth by parachute and the crew/ vehicles proposed to be launched from requirements. A license to operate a passenger module returns with a the Southwest Regional Spaceport may launch site does not guarantee that a powered or unpowered horizontal carry space flight participants,2 launch license or experimental permit landing. • scientific experiments or other would be granted for any particular Concept V3 vehicles—These payloads.3 The issuance of a launch site launch proposed for the site. vehicles consist of a single-stage rocket operator license does not permit the Proposed Action with rocket-powered vertical landing. NMEDD to conduct launches, only to The proposed action is for the FAA to Alternatives offer the facility and infrastructure to issue a launch site operator license to Alternatives under consideration launch operators. All individual launch the NMEDD that would allow the operators would be subject to separate include issuance of a launch site NMEDD to operate the Southwest operator license to the NMEDD for the FAA licensing or permitting. Regional Spaceport for both horizontal A license to operate a launch site operation of a launch site to support and vertical suborbital launches. • Horizontal launch concept vehicles authorizes a licensee to offer its launch Nominally, the rockets would return site to a launch operator for each launch only, and land within the Southwest Regional • Vertical launch concept vehicles point for the type and weight class of Spaceport or adjacent areas. launch vehicle identified in the license only, or Contingency landings may occur on • A subset of the concept vehicles. application and upon which the lands administered by BLM. Based on comments received during licensing determination is based. As part of the proposed action, the the scoping period, the FAA may Issuance of a license to operate a launch NMEDD proposes to construct a vertical propose additional alternatives. The EIS launch area, airfield, spectator area, will also analyze the no action 1 A suborbital rocket is a vehicle, rocket-propelled in whole or in part, intended for flight on a landing and recovery area, and access alternative. suborbital trajectory, and the thrust of which is road. The vertical launch area would greater than its lift for the majority of the rocket- include: Storage areas for explosives Scoping Meetings powered portion of its ascent. (49 U.S.C 70102(19)) and propellants, three launch pads, two Two public scoping meetings will be Suborbital trajectory is the intentional flight path of a launch vehicle, reentry vehicle, or any portion vehicle assembly areas, launch control held to solicit input from the public on thereof whose vacuum instantaneous impact point building, and office areas. The airfield potential issues that may need to be (IIP) does not leave the surface of the Earth. would include prevailing and cross evaluated in the EIS. The first scoping 2 ‘Space flight participant’ means an individual wind runways, and a horizontal launch meeting will be held on February 15 at who is not crew, carried within a launch vehicle or hangar. The spectator area would 6:30 p.m., at the Truth or Consequences reentry vehicle. 3 Payload is the item that an aircraft or rocket include parking and viewing areas. City Council Chambers, 405 West 3rd carries over and above what is necessary for the These facilities would be constructed on St. in Truth or Consequences, New operation of the vehicle in flight. State property. Development of access Mexico. The second scoping meeting
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will be held on February 16, at 6:30 DATES: Comments on petitions received DEPARTMENT OF TRANSPORTATION p.m., at the Physical Sciences must identify the petition docket Laboratory Auditorium, New Mexico number involved and must be received Federal Aviation Administration State University in Las Cruces, New on or before February 13, 2006. Mexico. Third Meeting: RTCA Special ADDRESSES: You may submit comments Committee 206: Aeronautical DATES: The FAA invites interested [identified by DOT DMS Docket Number Information Services Data Link agencies, organizations, Native FAA–200X–XXXXX] by any of the American tribes, and members of the AGENCY: Federal Aviation public to submit comments or following methods: Administration (FAA), DOT. • suggestions to assist in identifying Web site: http://dms.dot.gov. ACTION: Notice of RTCA Special significant environmental issues and in Follow the instructions for submitting Committee 206 meeting. determining the appropriate scope of comments on the DOT electronic docket the EIS. The public scoping period starts site. SUMMARY: The FAA is issuing this notice with the publication of this notice in the • to advise the public of a meeting of Fax: 1–202–493–2251. RTCA Special Committee 206: Federal Register. To ensure sufficient • time to consider issues identified during Mail: Docket Management Facility; Aeronautical Information Services Data the public scoping period, comments U.S. Department of Transportation, 400 Link. should be submitted to Ms. Stacey M. Seventh Street, SW., Nassif Building, DATES: The meeting will be held January Zee by one of the methods listed below Room PL–401, Washington, DC 20590– 30–February 3, 2006, from 9 a.m. to 5 no later than March 3, 2006. 001. p.m. ADDRESSES: Comments, statements, or • Hand Delivery: Room PL–401 on ADDRESSES: The meeting will be held at questions concerning scoping issues or the plaza level of the Nassif Building, CASTOR Conference Room (Plenary) the EIS process should be mailed to Ms. 400 Seventh Street, SW., Washington, EUROCONTROL Headquarters, Rue de Stacey M. Zee, FAA Environmental DC, between 9 a.m. and 5 p.m., Monday la Fuse´e, 96 1130 Brussells, Belgium. Specialist, Southwest Regional through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW., Spaceport EIS c/o ICF Consulting, 9300 Docket: For access to the docket to Suite 805, Washington, DC, 20036– Lee Highway, Fairfax, VA 22031. read background documents or Comments can also be sent by e-mail to 5133; telephone (202) 833–9339; fax comments received, go to http:// [email protected] or by fax to (202) 833–9434; Web site http:// dms.dot.gov at any time or to Room PL– (703) 934–3951. www.rtca.org. 401 on the plaza level of the Nassif Dated: January 13, 2006. Building, 400 Seventh Street, SW., SUPPLEMENTARY INFORMATION: Pursuant Herbert Bachner, Washington, DC, between 9 a.m. and 5 to section 10(a)(2) of the Federal Manager, Space Systems Development p.m., Monday through Friday, except Advisory Committee Act (P.L. 92–463, 5 U.S.C., Appendix 2), notice is hereby Division. Federal holidays. [FR Doc. E6–757 Filed 1–23–06; 8:45 am] given for a Special Committee 206 FOR FURTHER INFORMATION CONTACT BILLING CODE 4910–13–P : Tim meeting. The agenda will include: Adams (202) 267–8033, Sandy Monday, January 30: • Buchanan-Sumter (202) 267–7271, or Opening Session (Chairman’s DEPARTMENT OF TRANSPORTATION John Linsenmeyer (202) 267–5174, Address, Welcome, Introductory and Office of Rulemaking (ARM–1), Federal Administrative Remarks, Review Federal Aviation Administration Aviation Administration, 800 Agenda, Approve minutes of the 2nd Independence Avenue, SW., meeting,) • Formal announcement of [Summary Notice No. PE–2006–01] Washington, DC 20591. EUROCAE participation This notice is published pursuant to • Working arrangements Petitions for Exemption; Summary of • Petitions Received 14 CFR 11.85 and 11.91. Nomination of chairman and Issued in Washington, DC, on January 11, secretary • Status of Terms of Reference AGENCY: Federal Aviation 2006. Administration (FAA), DOT. Overview and Discussions—Committee Anthony F. Fazio, Chairmen ACTION: Notice of petitions for • exemption received. Director, Office of Rulemaking. Review of actions and discussion • Presentations Petitions for Exemption • SUMMARY: Pursuant to FAA’s rulemaking Communications Strategy • Overview of the Cascade Program provisions governing the application, Docket No.: FAA–2005–23189. • processing, and disposition of petitions Future data Link applications Petitioner: Brooks Air Transport d.b.a. • Methodology and OSED for exemption part 11 of Title 14, Code Brooks Fuel, Inc. development of Federal Regulations (14 CFR), this • Breakout into Weather Data Link notice contains a summary of certain Section of 14 CFR Affected: 14 CFR 125.224. and AIS Data Link Subgroups petitions seeking relief from specified Tuesday, January 31–Thursday, requirements of 14 CFR. The purpose of Description of Relief Sought: To allow February 2: this notice is to improve the public’s Brooks Air Transport d.b.a. Brooks Fuel, • Continue in Weather Data Link and awareness of, and participation in, this Inc., to operate its Douglas C54G–DC AIS Data Link Subgroups aspect of FAA’s regulatory activities. without having a collision avoidance Friday, February 3: Neither publication of this notice nor system that meets TSO C–118 installed • Continue in Weather Data Link and the inclusion or omission of information on that aircraft. AIS Data Link Subgroups in the summary is intended to affect the • Chairman of Weather Subgroup [FR Doc. E6–753 Filed 1–23–06; 8:45 am] legal status of any petition or its final Summary Presentation of Results and disposition. BILLING CODE 4910–13–P Meeting Outcome
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• Chairwoman of AIS Subgroup policy documents, or proposed TSO that the AIR Internet Content Program Summary Presentation of Results and we make available for public comment. manager at 202–267–8361. Meeting Outcome There is no requirement to publish these • Issued in Washington, DC on January 13, Closing Session (Other Business, documents or notices in the Federal 2006. Chairman Wrap Up and Conclusions, Register. Comments on the documents Terry Allen, Data and Place of Next Meeting, Closing published on the website must be Acting Manager, Production and Remarks, Adjourn) received on or before the due date Airworthiness Division, Aircraft Certification Attendance is open to the interested specified on the web site for each Service. public but limited to space availability. document. The FAA will publish in the [FR Doc. 06–597 Filed 1–23–06; 8:45 am] With the approval of the chairmen, Federal Register a recurring generic BILLING CODE 4910–13–M members of the public may present oral Notice of Availability and Request for statements at the meeting. Persons Comments announcement reminding wishing to present statements or obtain the public to check the ‘‘Aircraft information should contact the person Certification Draft Documents Open for DEPARTMENT OF VETERANS listed in the FOR FURTHER INFORMATION Comments’’ Web site on the Internet at AFFAIRS CONTACT section. Members of the public http://www.faa.gov/aircraft/draft_docs/. may present a written statement to the National Research Advisory Council; DATES: committee at any time. This notice becomes effective the Notice of Meeting date of publication in the Federal Issued in Washington, DC, on January 13, Register. The Department of Veterans Affairs 2006. (VA) gives notice under Public Law 92– Natalie Ogletree, ADDRESSES: Send comments on draft 463 (Federal Advisory Committee Act) FAA General Engineer, RTCA Advisory ACs, other policy documents, and that the National Research Advisory Committee. proposed TSOs electronically or in hard Council will hold a meeting on [FR Doc. 06–591 Filed 1–23–06; 8:45 am] copy to the Federal Aviation Wednesday, February 1, 2006, in room BILLING CODE 4910–13–M Administration at the address specified 900 at the Greenhoot Cohen Building, on the web site to the attention of the 1722 I Street, NW., Washington, DC. individual and office identified as point The meeting will convene at 8:30 a.m. DEPARTMENT OF TRANSPORTATION of contact for the document. and conclude by 3 p.m. The meeting is open to the public. Federal Aviation Administration FOR FURTHER INFORMATION CONTACT: Roberta Katson, production and The purpose of the Council is to provide external advice and review for Draft Advisory Circulars (ACs), Other Airworthiness Division, Aircraft VA’s research mission. Policy Documents, and Proposed Certification Service, AIR–200, Room The agenda will include a review of Technical Standard Orders (TSOs) 815, Federal Aviation Administration, 800 Independence Avenue, SW., and discussion about the NRAC annual AGENCY: Federal Aviation Washington, DC 20591. Telephone (202) report for 2005, an overview of research, Administration (FAA), DOT. 493–4633, Fax (202) 267–5580. education, and clinical centers, and an ACTION: Notice of Availability of draft update on deployment health and Gulf advisory circulars (ACs), other policy SUPPLEMENTARY INFORMATION: You are War research. documents, and proposed technical invited to comment on the documents Any member of the public wishing to standard orders (TSOs). provided on the website. Comments on attend the meeting or wishing further draft ACs, other policy documents and information should contact Ms. Karen SUMMARY: This notice announces that proposed TSOs should identify the Scott, Designated Federal Officer, at the Aircraft Certification Service of the document by its number. The Director, (352) 392–8066. Oral comments from FAA maintains the ‘‘Aircraft Aircraft Certification Service, will the public will not be accepted at the Certification Draft Documents Open for consider all comments received on or meeting. Written statements or Comment’’ Web site on the Internet at before the closing date before issuing a comments should be transmitted http://www.faa.gov/aircraft/draft_docs/ final document. You can obtain a paper electronically to [email protected]. The Aircraft Certification Service will copy of the draft document by Dated: January 13, 2006. make available on this web site draft contacting the FAA individual or office ACs, other policy documents, and responsible for the document. You will By direction of the Secretary. proposed TSOs open for comment. The find the ‘‘Aircraft Certification Draft E. Philip Riggin, Aircraft Certification Service, FAA will Documents Open for Comment’’ site at Committee Management Officer. no longer publish an individual Federal http://www.faa.gov/aircraft/draft_docs/. [FR Doc. 06–604 Filed 1–23–06; 8:45 am] Register Notice for each draft AC, other For Internet retrieval assistance, contact BILLING CODE 8320–01–M
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Corrections Federal Register Vol. 71, No. 15
Tuesday, January 24, 2006
This section of the FEDERAL REGISTER 13, 2005’’ should read ‘‘February 13, ‘‘Robert.L.Roenigs’’ should read contains editorial corrections of previously 2006’’. ‘‘Robert.L.Koenigs’’. published Presidential, Rule, Proposed Rule, and Notice documents. These corrections are [FR Doc. C5–23983 Filed 1–23–06; 8:45 am] [FR Doc. C6–483 Filed 1–23–06; 8:45 am] prepared by the Office of the Federal BILLING CODE 1505–01–D BILLING CODE 1505–01–D Register. Agency prepared corrections are issued as signed documents and appear in the appropriate document categories DEPARTMENT OF DEFENSE DEPARTMENT OF DEFENSE elsewhere in the issue. Department of the Army; Corps of Department of the Army Engineers Notice of Availability (NOA) for the DEPARTMENT OF AGRICULTURE Intent to Prepare a Draft Supplemental Supplemental Final Environmental Impact Statement (SFEIS) for the Forest Service Environmental Impact Statement/ Proposed Addition of Maneuver Environmental Impact Report for the Training Land at Fort Irwin, CA RIN 0596–AC34 Yuba River Basin Project, Yuba County, CA Correction National Environmental Policy Act Documentation Needed for Oil and Gas Correction In notice document 06–475 appearing Exploration and Development on page 3059 in the issue of Thursday, In notice document 06–483 beginning Activities (Categorical Exclusion) January 19, 2006, make the following on page 3060 in the issue of Thursday, correction: Correction January 19, 2006, make the following In the second column, in the last correction: paragraph, in the 2nd and 3rd lines, In notice document 05–23983 ‘‘http://fortirwindlandexpansion.com’’ beginning on page 73722 in the issue of On page 3060, in the second column, should read ‘‘http:// Tuesday, December 13, 2005, make the under the FOR FURTHER INFORMATION fortirwinlandexpansion.com. ’’ following correction: CONTACT heading, in the third line, On page 73722, in the second column, [FR Doc. C6–475 Filed 1–23–06; 8:45 am] under the DATES heading, ‘‘February BILLING CODE 1505–01–D
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Part II
Department of Health and Human Services Food and Drug Administration
21 CFR Parts 201, 314, and 601 Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products and Draft Guidances and Two Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule and Notices
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DEPARTMENT OF HEALTH AND Evaluation and Research (HFD–7), ‘‘package circular’’) is a compilation of HUMAN SERVICES Food and Drug Administration, information about the product, 5600 Fishers Lane, Rockville, MD approved by FDA, based on the agency’s Food and Drug Administration 20857, 301–594–2041, thorough analysis of the new drug [email protected]. application (NDA) or biologics license 21 CFR Parts 201, 314, and 601 application (BLA) submitted by the [Docket No. 2000N–1269] (formerly Docket For information on labeling of applicant. This labeling contains No. 00N–1269) biological products that are information necessary for safe and regulated as prescription drugs: effective use. It is written for the health RIN 0910–AA94 Toni M. Stifano, Center for care practitioner audience, because Biologics Evaluation and Research Requirements on Content and Format prescription drugs require ‘‘professional (HFM–600), Food and Drug of Labeling for Human Prescription supervision of a practitioner licensed by Administration, 1401 Rockville Drug and Biological Products law to administer such drug’’ (section Pike, Rockville, MD 20856, 301– 503(b) of the act (21 U.S.C. 353(b))). AGENCY: Food and Drug Administration, 827–6190, [email protected], FDA-approved labeling is defined in HHS. or Kathleen Swisher, Center for section 201(m) of the act (21 U.S.C. ACTION: Final rule. Biologics Evaluation and Research 321(m)) and is subject to all applicable (HFM–17), Food and Drug provisions of section 502 of the act (21 SUMMARY: The Food and Drug Administration, 1401 Rockville U.S.C. 352). It satisfies the requirement Administration (FDA) is amending its Pike, Rockville, MD 20852, 301– of § 201.100(d) (21 CFR 201.100(d)) that regulations governing the content and 827–6210. ‘‘[a]ny labeling, as defined in section format of labeling for human SUPPLEMENTARY INFORMATION: 201(m) of the act * * * that furnishes prescription drug products (including or purports to furnish information for biological products that are regulated as Table of Contents use or which prescribes, recommends, drugs). The final rule revises current I. Background or suggests a dosage for the use of the regulations to require that the labeling II. Overview of the Final Rule Including drug * * * contains * * * [a]dequate of new and recently approved products Changes to the Proposed Rule information for such use,’’ as further include highlights of prescribing III. Implementation described in that provision. FDA- information and a table of contents. The IV. Overview of Agency Initiatives to approved labeling also accompanies final rule also reorders certain sections, Improve the Content and Format of ‘‘promotional’’ materials, as described requires minor content changes, and Prescription Drug Labeling in § 202.1(l)(2) (21 CFR 202.1(l)(2)). sets minimum graphical requirements. V. Implications of This Final Rule for FDA-approved labeling also ‘‘bears These revisions will make it easier for the Electronic Labeling Initiative adequate information’’ within the health care practitioners to access, read, VI. Comments on the Proposed Rule meaning of § 201.100(c)(1), which and use information in prescription VII. Legal Authority applies to ‘‘labeling on or within the drug labeling. The revisions will VIII. Paperwork Reduction Act of 1995 package from which a prescription drug enhance the safe and effective use of IX. Environmental Impact is to be dispensed’’, referred to in this prescription drug products and reduce X. Executive Order 13132: Federalism document as ‘‘trade labeling.’’ In this the number of adverse reactions XI. Analysis of Economic Impacts document, FDA-approved labeling for XII. Executive Order 12988: Civil Justice resulting from medication errors due to prescription drugs is referred to as Reform misunderstood or incorrectly applied ‘‘labeling’’ or ‘‘prescription drug XIII. References drug information. For both new and labeling.’’ recently approved products and older I. Background products, the final rule requires that all B. Developing the Proposed Rule In the Federal Register of December FDA-approved patient labeling be 22, 2000 (65 FR 81082), FDA issued a In recent years, there has been an reprinted with or accompany the proposed rule to revise its regulations increase in the length, detail, and labeling. The final rule also revises governing the content and format of complexity of prescription drug current regulations for prescription drug labeling for human prescription drug labeling, making it harder for health labeling of older products by clarifying products, which appear in §§ 201.56 care practitioners to find specific certain requirements. These changes and 201.57 (21 CFR 201.56 and information and to discern the most will make the labeling for older 201.57).1 critical information. Before issuing the products more informative for health proposal, the agency evaluated the care practitioners. A. FDA-Approved Prescription Drug usefulness of prescription drug labeling DATES: This rule is effective June 30, Labeling for its principal audience to determine 2006. See section III of this document A prescription drug product’s FDA- whether, and how, its content and for the implementation dates of this approved labeling (also known as format could be improved. The agency final rule. ‘‘professional labeling,’’ ‘‘package used focus groups, a national physician FOR FURTHER INFORMATION CONTACT: insert,’’ ‘‘direction circular,’’ or survey, a public meeting, and written For information on drug product comments to develop multiple labeling: Janet Norden, Center for 1 Although §§ 201.56 and 201.57 do not prototypes and to ascertain how Drug Evaluation and Research specifically mention the term ‘‘biologics’’, under the prescription drug labeling is used by Federal Food, Drug, and Cosmetic Act (the act), (HFD–40), Food and Drug most biologics are drugs that require a prescription health care practitioners, what labeling Administration, 10903 New and thus are subject to these regulations. (See information practitioners consider most Hampshire Ave., Bldg. 22, rm. 4202, section VII of this document for legal authority.) For important, and how practitioners Silver Spring, MD 20993–0002, the purposes of this document, unless otherwise believed labeling could be improved. specified, all references to ‘‘drugs’’ or ‘‘drug 301–796–2270, products’’ include human prescription drug The agency developed a prototype based [email protected], or products and biological products that are also on this accumulated information as the Elizabeth Sadove, Center for Drug drugs. model for the proposed rule.
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C. The Proposed Rule proposed § 201.80. The agency proposed • An overview of the agency’s The agency’s proposed changes were to redesignate then-current § 201.57 as prescription drug labeling initiatives designed to enhance the ability of health § 201.80 to describe labeling (section IV of this document), care practitioners to access, read, and requirements for older drugs and add • The implications of this rule for the use prescription drug labeling. new § 201.57 to describe labeling electronic labeling initiative (section V requirements for new and recently of this document), 1. Proposed Provisions for New and approved drugs. • A discussion of the comments Recently Approved Drugs 3. Proposed Provisions for All Drugs received on the proposal and the FDA proposed the following changes FDA also proposed certain revisions agency’s responses to the comments for the labeling for prescription drugs to the requirements governing the (section VI of this document), that were approved on or after the content of labeling to help ensure that • A statement of legal authority effective date of the final rule, drugs that statements appearing in labeling related (section VII of this document), had been approved in the 5 years before to effectiveness or dosage and • A description of the information the effective date of the final rule, and administration are sufficiently collection provisions of the rule (section older approved drugs for which an supported. These provisions would VIII of this document), efficacy supplement is submitted. FDA have applied to all drugs. • An statement on the environmental believed that applying the revised • The labeling for all drugs would content and format requirements only to impact of the rule (section IX of this contain all FDA-approved patient document), more recently approved products was labeling (i.e., approved printed patient • A statement on federalism (section appropriate because, among other information and Medication Guides) for X of this document), reasons, health care practitioners are the drug, not just the information • more likely to refer to the labeling of required by regulation to be distributed An analysis of the economic recently approved products (see to patients (see table 2). impacts of the rule (section XI of this comment 113). • Minor revisions would be made to document), • The addition of introductory the requirements for labels affixed to • A statement on the impact of the prescribing information, entitled prescription drug containers and rule on the civil justice system (section ‘‘Highlights of Prescribing Information’’ packaging. XII of this document), and (Highlights). The proposal called for the • • A list of references (section XIII of The addition of a table of contents. submission of comments by March 22, this document). • Reordering and reorganizing to 2001. At the request of the make the labeling easier to use and read. Pharmaceutical Research and II. Overview of the Final Rule Including • Minimum graphical requirements Manufacturers of America, and to Changes to the Proposed Rule for format. provide all interested persons additional This final rule amends part 201 (21 • Certain revisions to the content time to comment, the comment period requirements, such as modifying the CFR part 201) of FDA regulations by was reopened until June 22, 2001 (66 FR revising the requirements for the definition of ‘‘adverse reaction’’ to make 17375, March 30, 2001). After careful the ‘‘Adverse Reactions’’ section of content and format of labeling for consideration of the comments, FDA has prescription drug products (see tables 1 labeling more meaningful and useful to revised the proposal and is issuing this and 2 of this document). Table 1 lists health care practitioners. final rule. the sections required for prescription The following sections of this 2. Proposed Provisions for Older drug labeling before the effective date of document provide: Approved Drugs • An overview of the final rule this final rule (and which will remain in The agency proposed that older including changes to the proposed rule effect for older products), and, for new approved drug products would not be (section II of this document), and recently approved products, the subject to these proposed changes. • A discussion of the implementation sections FDA proposed in 2000 and These older products would, instead, be requirements for the final rule (section those required by this final rule. subject to the labeling requirements at III of this document), BILLING CODE 4160–01–S
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The final rule requires that any FDA- requirement in effect before the effective ‘‘FDA-approved patient labeling’’ will approved patient labeling either: (1) date of this final rule, the 2000 proposed be used to refer to any approved printed Accompany the prescription drug requirement, and the final requirement patient information or Medication labeling or (2) be reprinted at the end of (see comment 92 for discussion of FDA- Guide, unless a comment is addressing such labeling (§§ 201.57(c)(18) and approved patient labeling). For the one or the other specifically. 201.80(f)(2)). Table 2 lists the purposes of this document, the term
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TABLE 2.—FDA-APPROVED PATIENT LABELING WITH PRESCRIPTION DRUG LABELING
Requirement for All Products Before the Ef- fective Date of the Final Rule Proposed Requirement for All Products Final Requirement for All Products
To be reprinted at the end of labeling: To be reprinted at the end of labeling: To be reprinted at the end of labeling or to • Full text of FDA-approved patient labeling • Full text of any FDA-approved patient la- accompany the labeling: that is required to be distributed to patients beling • Full text of any FDA-approved patient la- beling
In this rulemaking, the agency drugs with pediatric patent protection that labeling in the new format is for a finalizes many of the provisions in the or exclusivity. The agency added a prescription drug product. December 2000 proposal. In addition, provision in § 201.56(d)(5) of the final • The ‘‘R’’ symbol in the FPI the final rule reflects revisions the rule to make clear that any risk (proposed § 201.56(d)(2)), which would agency made in response to comments information from the have identified the ‘‘References’’ on the December 2000 proposal and ‘‘Contraindications,’’ ‘‘Warnings and section. revisions made by the agency on its own Precautions,’’ or ‘‘Use in Specific • The ‘‘P’’ symbol in the FPI initiative. FDA also has made editorial Populations’’ section is ‘‘pediatric (proposed § 201.57(c)(18)), which would changes to clarify provisions, correct contraindications, warnings, or have identified the ‘‘Patient Counseling cross-references, and support the precautions’’ within the meaning of Information’’ section. agency’s plain language initiative. Table section 11 of the BPCA (21 U.S.C. 1. Highlights of Prescribing Information 3 lists the substantive changes made to 355A(l)(2)). By adding § 201.56(d)(5), the general provisions and Highlights the agency intends to avoid any possible Like the proposed rule, the final rule and table 4 lists the substantive changes confusion as to what information the requires that the labeling for new and made to the Full Prescribing agency may require in generic labeling more recently approved products Information (FPI). that otherwise omits a pediatric include introductory information indication or other aspect of labeling entitled ‘‘Highlights of Prescribing A. Content and Format of Labeling for pertaining to pediatric use protected by Information’’ (Highlights) New and More Recently Approved patent or exclusivity. (§§ 201.56(d)(1) and 201.57(a)) (see table Prescription Drug Products In addition, the agency declined to 1). The final rule, like the proposed rule, adopt the use of symbols that were The final rule requires the same requires that the labeling for new and proposed to emphasize or identify headings for Highlights as proposed, more recently approved drug products information in prescription drug except that, in response to comments, comply with revised content and format labeling. Based on comments, FDA FDA moved ‘‘Most Common Adverse requirements (§ 201.56(d)) (see table 1). declined to use the inverted black Reactions’’ from ‘‘Warnings and Like the proposed rule, the final rule triangle (see comment 15) and the Precautions’’ (proposed § 201.57(a)(10)) provides that new and more recently exclamation point (!) to emphasize the to a new heading entitled ‘‘Adverse approved products include drug boxed warning (see comment 43). On its Reactions’’ (§§ 201.56(d)(1) and products with an NDA, BLA, or efficacy own initiative, for the same reasons that 201.57(a)(11)) (see table 1 and comment supplement that: (1) Was approved FDA rejected use of the two symbols 28). Like the proposed rule, the final between June 30, 2001, and June 30, commented upon, FDA declined to use rule requires that Highlights, except for 2006; (2) is pending on June 30, 2006; the following three proposed symbols: the boxed warning, be limited in length or (3) is submitted anytime on or after • The Rx symbol (proposed to one-half of the page (§ 201.57(d)(8)) June 30, 2006 (§ 201.56(b)(1)). § 201.57(a)(3)) in Highlights. The agency (see comment 104). On its own initiative, the agency proposed the symbol to identify a The agency is also revising its added a provision on pediatric risk product that is available only by regulations on supplements and other information to the general labeling prescription under section 503(b) of the changes to an approved application in requirements of the final rule. Section act. The agency decided that the Rx §§ 314.70 and 601.12 (21 CFR 314.70 11 of the Best Pharmaceuticals for symbol in Highlights is unnecessary and 601.12) to require applicants to Children Act (Public Law 107–109) because the new prescription drug obtain prior approval of any labeling (BPCA), which was signed into law on labeling format is so distinct from the changes to Highlights, except for January 4, 2001, addresses labeling over-the-counter (OTC) drug labeling identified minor changes (see comment requirements for generic versions of format that it will be clear to prescribers 5).
TABLE 3.—SUBSTANTIVE CHANGES FROM THE PROPOSED RULE TO THE FINAL RULE: GENERAL PROVISIONS AND TO HIGHLIGHTS
Description of Change from Proposed Rule 21 CFR Section in Final Rule See comment or section of this document (identified in parentheses) for more detailed information regarding the change.
201.55, Container Labels 201.57(c)(4)(v), • Withdrew proposed amendments regarding content of container labels and associated proposed amendments to 201.57(c)(12)(i)(D), the labeling (106 and 107) and 201.100(b)
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TABLE 3.—SUBSTANTIVE CHANGES FROM THE PROPOSED RULE TO THE FINAL RULE: GENERAL PROVISIONS AND TO HIGHLIGHTS—Continued
Description of Change from Proposed Rule 21 CFR Section in Final Rule See comment or section of this document (identified in parentheses) for more detailed information regarding the change.
201.56(a)(2) General Requirement • Revised to clarify that the labeling must be updated when new information becomes available that causes the la- beling to become inaccurate, false, or misleading (114)
201.56(d) Product Title • Deleted proposed § 201.56(d)(4), which permitted a ‘‘Product Title’’ section to be included at the beginning of the FPI (39)
201.56(d)(4) Format of Contents • Revised to require that the Contents identify if sections have been omitted (37)
201.56(d)(5) Pediatric Risk Information • Added, on its own initiative, a provision to make clear that pediatric risk information within the meaning of the BPCA may be located in the ‘‘Use in Specific Populations’’ section (II.A)
201.57 and 201.80 Unsubstantiated Claims • Removed the 1-year implementation requirement for provisions in §§ 201.57 and 201.80 that prohibit inclusion of unsubstantiated claims in labeling (114)
201.57 Promotional Labeling • Removed, on its own initiative, the reference to statements made in promotional labeling and advertising in pro- posed 201.57(a) (111)
201.57(a)(1) Highlights Limitation Statement • Moved the Highlights limitation statement to the beginning of Highlights (35)
201.57(a)(3) Inverted Black Triangle Symbol • Instead of an inverted black triangle symbol, labeling will state the ‘‘Initial U.S. Approval’’ date (15)
201.57(a)(4) Boxed Warning • Revised to require that Highlights contain a concise summary of any boxed warning in the FPI (16)
201.57(a)(5) Recent Labeling Changes • Changed the heading to ‘‘Recent Major Changes’’ and revised to identify only substantive changes to the ‘‘Boxed Warning,’’ ‘‘Indications and Usage,’’ ‘‘Dosage and Administration,’’ ‘‘Contraindications,’’ and ‘‘Warnings and Pre- cautions’’ sections and the date of the change(s) (18–22)
201.57(a)(6) Indications and Usage • Revised to require identification of the pharmacologic class of the drug if it is a member of an established pharma- cologic class (6)
201.57(a)(8) How Supplied • Changed the heading to ‘‘Dosage Forms and Strengths’’ (41)
201.57(a)(11) Adverse Reactions • Moved ‘‘Most Common Adverse Reactions’’ from ‘‘Warnings and Precautions’’ to a new heading: ‘‘Adverse Reac- tions’’ (28) • Revised the criteria used for determining which adverse reactions to include in Highlights and that the criteria used be specified (28) • Revised to require that the adverse reactions reporting contact statement be included under the ‘‘Adverse Reac- tions’’ heading of Highlights; deleted proposed § 201.57(c)(6)(v) that would have required that this statement also be included in the FPI (28 and 30) • Revised the requirements associated with the adverse reactions reporting contact statement (31 and 32)
201.58 Waiver Provision • Revised to make clear applicants can request waivers from any requirement under §§ 201.56, 201.57, and 201.80 (104)
2. Full Prescribing Information: preceded by the numerical identifier for made this change for editorial reasons to Contents the heading or subheading (§ 201.57(b)). correctly reflect the function of the FDA has revised, on its own initiative, section. In response to comments, FDA Like the proposed rule, the final rule the heading for this portion of the added certain format requirements for requires that the labeling for new and labeling to read ‘‘Full Prescribing the Contents (see table 3 and comments recently approved products include, Information: Contents’’ (Contents) 37 and 101). after Highlights, a list of headings and instead of proposed ‘‘Comprehensive subheadings contained in the FPI Prescribing Information: Index.’’ FDA
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3. Full Prescribing Information products (see tables 1 and 2). The final requested FDA to clarify these proposed rule establishes minimum requirements requirements. FDA has revised, on its own initiative, for key graphic elements, including bold In addition, FDA has revised, on its the heading for this portion of the type, bullet points, type size, spacing own initiative, ‘‘Contraindications’’ to labeling to read ‘‘Full Prescribing and use of vertical and horizontal lines. emphasize that the section must only Information’’ instead of proposed The final rule requires the same sections describe situations in which the ‘‘Comprehensive Prescribing for the labeling of these products as potential risks associated with drug use Information.’’ FDA made this change to proposed except the major, substantive outweigh any possible benefit. FDA more accurately reflect that this portion changes listed in table 4, which the believes that including relative or of prescription drug labeling contains agency made in response to comments hypothetical hazards diminishes the the information that FDA determined is and, in a few cases as noted, on its own usefulness of the section. For clarity and necessary for the safe and effective use initiative. In addition, FDA made emphasis, FDA is requiring that ‘‘none’’ of the drug, but may not contain all revisions, none of which changed be stated when no contraindications are known information about the drug (e.g., substantive requirements, to the known. Similarly, FDA deleted, on its details of all clinical trials). ‘‘Dosage and Administration,’’ own initiative, proposed The final rule revises the ‘‘Indications and Usage,’’ ‘‘Overdosage,’’ § 201.57(c)(9)(iii) because it was requirements for the content and format ‘‘Clinical Pharmacology,’’ and ‘‘Drug redundant with requirements in of the FPI in former §§ 201.56(d) and Interactions’’ sections. FDA made these ‘‘Warnings and Precautions’’ and 201.57 for new and recently approved changes in response to comments that ‘‘Contraindications.’’
TABLE 4.—SUBSTANTIVE CHANGES FROM THE PROPOSED RULE TO THE FINAL RULE: FULL PRESCRIBING INFORMATION
Description of Change From Proposed Rule 21 CFR Section in Final Rule See comment or section of this document (identified in parentheses) for more detailed information re- garding the change.
201.57(c)(3) Dosage and Administration • Revised to make clear that this section must include dosing recommendations based on clinical phar- macologic data, certain dosage modifications, and specified compliance information (51–54)
201.57(c)(4) and 201.57(c)(17) How Supplied/Storage and Handling • Reorganized information in proposed ‘‘How Supplied/Storage and Handling’’ (§ 201.57(c)(4)) such that the information is now contained in two sections: § 201.57(c)(4) retitled ‘‘Dosage Forms and Strengths’’ and ‘‘How Supplied/Storage and Handling’’ at § 201.57(c)(17) (41)
201.57(c)(7) Adverse Reactions • Moved the ‘‘Adverse Reactions’’ section (proposed § 201.57(c)(9)) to follow ‘‘Warnings and Pre- cautions’’ (38) • Withdrew the proposed definition of adverse reaction and retained the definition at former § 201.57(g) (designated in this final rule at § 201.80(g)), with a minor modification (68) • Revised the requirements on how to classify and categorize adverse reactions and how to describe adverse reaction rates (71-75) • Revised to require a description of the overall adverse reaction profile based on entire safety data- base (70 and 77)
201.57(c)(9) Use in Specific Populations • Withdrew the proposed warning statements at §§ 201.57(c)(8)(i)(A)(4) and (c)(8)(i)(A)(5) for pregnancy categories D and X and will continue to require the warning statements at former §§ 201.57(f)(6)(i)(d) and (f)(6)(i)(e) be used (66) • Withdrew the proposed revisions for the ‘‘Nursing Mothers’’ subsection at § 201.57(c)(8)(iii) and will continue to use the language at former § 201.57(f)(8) (66)
201.57(c)(13)(ii) and 201.80(b)(2) In Vitro Data for Anti-infectives • Deferred action on proposed §§ 201.57(c)(13)(ii) and 201.80(b)(2) that would have only permitted in vitro data for anti-infective drugs not shown by adequate and well-controlled studies to be pertinent to clinical use be included in labeling if a waiver was granted (81)
201.57(c)(18) and 201.80(f)(2) Patient Counseling Information • Revised to require that the full text of FDA-approved patient labeling either accompany labeling or be reprinted at the end of the labeling and clarified the type size requirements that apply (93 and 94)(see table 7)
201.57(d)(6) Font size • Revised to require that font for trade labeling be a minimum of 6-point type instead of 8-point type (102)
201.57(c)(16) and 201.80(l) References • Clarified requirements for including a reference (89)
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B. Content and Format for Older approved patient labeling immediately information’’ on the product label in Prescription Drug Products following the last section of the cases when it is currently required to be Like the proposed rule, the final rule prescription drug labeling or having it used. These proposed requirements redesignates former § 201.57 as § 201.80. accompany such labeling (proposed § 201.57(c)(4)(v) and New § 201.80 provides content and (§ 201.80(f)(2))(see table 4 and comment (c)(12)(i)(D)) were also withdrawn. 93). format requirements for labeling of older • The agency intends to conduct a prescription drug products (older Addition of the font size provision to redesignated § 201.80(f)(2) (on the comprehensive evaluation of products) that are not subject to the information required to be contained on labeling requirements at new § 201.57 agency’s own initiative with modifications made in response to product labels. If necessary, FDA will (see tables 1 and 2). propose changes to these requirements Section 201.80 is the same as former comments) (see table 4 and comments after that evaluation has been § 201.57 with the following exceptions 93 and 94). completed. that are the same as the changes for new C. Content of Prescription Drug Product and more recently approved products: Labels III. Implementation • Modifications that help ensure that statements currently appearing in FDA has reconsidered its proposal to The final rule is effective June 30, labeling for older products relating to revise the requirements for the content 2006. The final rule has the same effectiveness or dosage and of prescription drug product labels implementation plan as proposed for administration are sufficiently (proposed §§ 201.55 and 201.100(b)). In the revised labeling content and format response to comments, FDA has decided supported (§ 201.80(c)(2)(i), (c)(2)(ii), (j), requirements at §§ 201.56(d) and 201.57 to withdraw these proposed revisions at and (m)(1)). for new and more recently approved • this time (see comments 106 and 107). Deletion of proposed § 201.80(b)(2) products (see table 5). Manufacturers of The agency had proposed to move regarding in vitro data for anti-infectives older products that voluntarily elect to (see table 4 and comment 81). certain information about inactive revise the format and content of their • Deletion of ‘‘induced emesis’’ as an ingredients and storage conditions from example of treatment procedures in the the product label to the prescription labeling to be consistent with ‘‘Overdosage’’ section of labeling. drug labeling and to remove the §§ 201.56(d) and 201.57 may submit a • Revisions that allow manufacturers requirement to include the statement supplement with proposed labeling at the option of either reprinting the FDA- ‘‘See package insert for dosage any time (see table 5).
TABLE 5.—IMPLEMENTATION PLAN
Applications (NDAs, BLAs, and Efficacy Supplements) Required to Time by Which Conforming Labeling Must Be Submitted to the Conform to New Labeling Requirements Agency for Approval
Applications submitted on or after June 30, 2006 Time of submission
Applications pending on June 30, 2006 and applications approved 0 to June 30, 2009 1 year before June 30, 2006
Applications approved 1 to 2 years before June 30, 2006 June 30, 2010
Applications approved 2 to 3 years before June 30, 2006 June 30, 2011
Applications approved 3 to 4 years before June 30, 2006 June 30, 2012
Applications approved 4 to 5 years before June 30, 2006 June 30, 2013
Applications approved more than 5 years before June 30, 2006 Voluntarily at any time
As indicated in the proposed rule, the As the agency proposed (65 FR at drug labeling to make the information in implementation plan for revised 81099), the provisions requiring FDA- labeling easier for health care labeling for products approved or approved patient labeling to accompany practitioners to access, read, and use. submitted for approval under an ANDA labeling (§§ 201.57(c)(18) and Elsewhere in this issue of the Federal depends on the labeling of the listed 201.80(f)(2) of the final rule) will be Register, the agency is announcing the drug referenced in the ANDA. In implemented by June 30, 2007. The availability of four guidance documents accordance with § 314.94(a)(8) (21 CFR agency clarified this provision at on content and format of labeling.2 314.94(a)(8)), the labeling of a drug §§ 201.57 and 201.56(e)(6). These guidances are intended to assist product submitted for approval under IV. Overview of Agency Initiatives to manufacturers and FDA reviewers in an ANDA must be the same as the Improve the Content and Format of developing clear, concise, and labeling of the listed drug referenced in Prescription Drug Labeling the ANDA, except for changes required 2 The agency announces the availability of because of differences approved under a The agency is engaged in a broad guidances in the Federal Register. Draft and final suitability petition (§ 314.93 (21 CFR effort to improve the communication to guidances for the Center for Drug Evaluation and 314.93)) or because the drug product health care practitioners of information Research (CDER)-related information are posted on and the reference listed drug are necessary for the safe and effective use the Internet at http://www.fda.gov/cder/guidance/ index.htm. The Center for Biologics Evaluation and produced or distributed by different of prescription drugs. A major Research (CBER)-related information is posted at manufacturers. component of this effort is improvement http://www.fda.gov/cber/guidelines.htm (21 U.S.C. of the content and format of prescription 371(h), 21 CFR 10.115).
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accessible prescription drug labeling. The agency is also engaged in an this final rule, could dramatically The four guidances are as follows: effort to revise the regulations improve the way practitioners obtain 1. A draft guidance entitled ‘‘Labeling concerning the content and format of information about prescription drugs for Human Prescription Drug and the ‘‘Pregnancy’’ subsection of and, as a consequence, significantly Biological Products—Implementing the prescription drug labeling (see the improve patient care. notice of a 21 CFR part 15 hearing to New Content and Format VI. Comments on the Proposed Rule Requirements’’ (the new labeling format discuss the pregnancy category guidance). This guidance, which is requirements (62 FR 41061, July 31, The agency received 97 comments on intended to assist manufacturers in 1997) and the notice of a public the December 22, 2000, proposal. complying with the provisions of this advisory committee meeting to discuss Comments were received from final rule, includes, among other things, possible changes to pregnancy labeling prescription drug manufacturers and how to determine what information (64 FR 23340, April 30, 1999)). related companies; trade organizations from the FPI should be included in representing prescription drug V. Implications of This Final Rule for manufacturers and other interested Highlights. the Electronic Labeling Initiative 2. A draft guidance entitled parties; professional associations and ‘‘Warnings and Precautions, Developing standards for the organizations representing health care Contraindications, and Boxed Warning conversion of paper labeling to an practitioners; health care and consumer Sections of Labeling for Human electronic format is a high priority for advocacy organizations; individual Prescription Drug and Biological the agency. On December 11, 2003, FDA physicians, pharmacists, and Products—Content and Format’’ (the published its final rule in the Federal consumers; and others. Register entitled ‘‘Requirements for ‘‘Warnings and Precautions’’ section A. General Comments on the Proposed Submission of Labeling for Human guidance). Rule Prescription Drugs and Biologics in 3. A guidance entitled ‘‘Adverse Electronic Format’’ (68 FR 69009). The Most comments expressed broad Reactions Section of Labeling for final rule requires the content of agreement that prescription drug Human Prescription Drug and Biological prescription drug labeling, including labeling could be more effective in Products—Content and Format ‘‘ (the text, tables, and figures, to be submitted communicating drug information to ‘‘Adverse Reactions’’ section guidance). to FDA in an electronic format that the health care practitioners and The agency issued a draft of this agency can process, review, and archive. overwhelming support for the agency’s guidance on June 21, 2000 (65 FR The agency views this final rule on goal of improving the content and 38563). the content and format of labeling as an format of prescription drug labeling to 4. A guidance entitled ‘‘Clinical essential step towards the success of its make information easier for health care Studies Section of Labeling for electronic labeling initiative. The practitioners to access, read, and use. Prescription Drug and Biological labeling format required by this rule for Many comments expressed approval Products—Content and Format’’ (the new and more recently approved of all the major features of the proposal, ‘‘Clinical Studies’’ section guidance). products should facilitate transition to indicating that the proposed changes The agency issued a draft of this an electronic format. The agency represent an important improvement in guidance on July 9, 2001 (66 FR 35797). believes that an electronic version of the organization, clarity, and overall The agency is also developing two labeling in the new format, particularly usefulness of prescription drug labeling. additional guidances on the content and Highlights and Contents, will For example, there was near universal format of specific sections of labeling— significantly expand health care support for the proposal to place at the the ‘‘Clinical Pharmacology’’ and practitioners’ ability to access front of labeling those sections that ‘‘Dosage and Administration’’ sections. information in prescription drug practitioners refer to most frequently In the future, the agency may develop labeling, enable them to rapidly obtain and consider most important, although guidance for additional sections of answers to questions for a range of drug some comments recommended prescription drug labeling, if necessary. products, and ultimately facilitate the sequences slightly different from those FDA has undertaken additional development of a comprehensive proposed by FDA (see section VI.G of rulemaking related to prescription drug repository for drug labeling. For this document). There was also broad labeling. The agency published a final example, FDA envisions that an support for restructuring the old rule in the Federal Register entitled electronic version of the new format ‘‘Precautions’’ section into new sections ‘‘Labeling Requirements for Systemic will eventually enable health care devoted to use in specific populations, Antibacterial Drug Products Intended practitioners to quickly access labeling drug interactions, and patient for Human Use’’ that became effective information for all drugs in a counseling information and for on February 4, 2004 (68 FR 6062, pharmacologic or therapeutic class with combining the remainder of the February 6, 2003). This rule requires a single electronic query. ‘‘Precautions’’ section with the that the labeling for all systemic FDA realizes that this final rule will ‘‘Warnings’’ section. antibacterial drug products (i.e., affect the agency’s existing electronic Comments from manufacturers, while antibiotics and their synthetic labeling requirements and guidances strongly supportive of the agency’s counterparts) intended for human use and will work to ensure consistency efforts to improve the content and include certain statements about using with the electronic labeling initiative.3 format of labeling, generally expressed antibiotics in a way that will reduce the The agency believes the electronic concerns about some of the major development of drug-resistant bacterial labeling initiative, in conjunction with elements of the proposal. In particular, strains. The rule encourages health care this new format for labeling described in as discussed in greater detail in sections practitioners: (1) To prescribe systemic VI.C and VI.D of this document, many antibacterial drugs only when clinically 3 See http://www.fda.gov/cder/guidance/ manufacturers were concerned about indicated and (2) to counsel their index.htm under ‘‘Electronic Submissions’’ and the inclusion of Highlights. http://www.fda.gov/cber/guidelines.htm for the patients about the proper use of such most recent guidances on submission of labeling in Manufacturers also expressed concern drugs and the importance of taking them an electronic format for drug and biological about the proposed requirements to re- exactly as directed. products, respectively. evaluate, within 1 year of the effective
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date of the final rule, all prescription broad range of health care practitioners proposed format for Highlights is a good drug labeling to identify and remove that rely on prescription drug labeling, design because it makes use of multiple any claims for indications and dosing and has determined the optimal formats (e.g., text, tables, bulleted lists) regimens that are not supported by ordering for labeling sections, as and bolded headings, which make the substantial evidence and to remove in reflected in this final rule. labeling information more accessible. vitro data that are not supported by FDA notes that the sections most One comment noted that, because clinical data. commonly referred to by pharmacists in Highlights contains pointers to the Specific issues raised by the the cited survey are the same as those location of more detailed information in comments and the agency’s responses most commonly referred to by the FPI, the pointers will increase the follow. physicians, although in a somewhat likelihood that health care practitioners different rank order. FDA believes that, B. Comments on the Process for will refer to the FPI. The comment also although the rank order of the sections Development of the Proposed Rule stated that the user-friendly Highlights is not identical for the two groups, the format would be likely to increase the As discussed in detail in the preamble formatting improvements required by frequency with which health care to the proposed rule, FDA relied on this final rule make the information in practitioners consult the labeling for focus group testing of physicians, a these sections readily accessible to all drug information and would enhance national physician survey, and a public health care practitioners who use their ability to use the information. meeting held in 1995 to develop the prescription drug labeling. Comments opposing inclusion of labeling prototype that was used as the Highlights stated that manufacturers C. Highlights of Prescribing basis for the proposal (65 FR 81082 at would be forced to pick certain Information—General Comments 81083 through 81085). important warnings listed in the FPI for (Comment 1) Several comments FDA proposed to require that inclusion in Highlights and, because of questioned the process that FDA used to prescription drug labeling for products space limitations, exclude other develop the proposed rule. A number of described in proposed § 201.56(b)(1) important information. These comments comments expressed concern that (i.e., new and more recently approved maintained that, by extracting from the health care practitioners other than prescription drug products) contain FPI only selected portions of the physicians were not surveyed or introductory prescribing information information needed for safe and otherwise consulted. Two comments entitled ‘‘Highlights of Prescribing effective use, Highlights would omit indicated that a majority of pharmacists Information’’ (proposed §§ 201.56(d) important information and lack detail refer to prescription drug labeling at and 201.57(a)). and context, and might, therefore, be least once a day. The comments cited a (Comment 2) Comments expressed misleading. They contended that these survey finding that the sections most different opinions about the utility and shortcomings might outweigh any frequently referred to by pharmacists patient care implications of Highlights. convenience derived from condensing are, in descending order, ‘‘Dosage and Physicians, pharmacists, other health information into Highlights. One Administration,’’ ‘‘Adverse Reactions,’’ care practitioners, health care advocacy comment maintained that the FPI is ‘‘Contraindications,’’ ‘‘Indications and groups, and professional societies and itself a condensation of a complex body Usage,’’ ‘‘Warnings and Precautions,’’ organizations representing health care of information and that it is problematic and ‘‘How Supplied/Storage and practitioners expressed unequivocal and illogical to try to further condense Handling.’’ The comments urged FDA to enthusiasm about and uniform support the information from the FPI into consult with all relevant audiences to for Highlights. Manufacturers, with Highlights. revise prescription drug labeling and some exceptions, were opposed, or Several comments from labels. strongly opposed, to the inclusion of manufacturers stated that the limited FDA recognizes the important roles Highlights. content of Highlights is of concern that health care practitioners other than Comments supporting Highlights because practitioners would have a physicians play in the health care stated that it would be an excellent tendency to rely only on the information delivery system and recognizes that vehicle for drawing attention to the in Highlights when making prescribing prescription drug information is relied most important information about a decisions, even though that information upon by health care practitioners other product, a useful and convenient source alone would not be an adequate basis than physicians. The agency focused its for quick reminder information in for making such decisions. Some of research efforts on how physicians use routine prescribing situations, and a these comments maintained that there is labeling, because they are the principal useful vehicle to efficiently direct a lack of evidence to support the intended audience (i.e., they use practitioners to the more detailed premise that Highlights will facilitate labeling for prescribing decisions). The information in the FPI. Several practitioners’ access to more detailed agency also sought input from all comments stated that Highlights is information in the FPI. They asserted interested parties in the development of probably the most important innovation that there is a high likelihood that the proposed rule, especially those in the proposed rule. One comment Highlights would be the only part of the whose use of labeling could be expected stated that Highlights is the element of labeling read by practitioners. to impact patient safety. Panelists and the proposal that will most enhance the Another comment stated that, rather participants in the 1995 public meeting clinical utility of prescription drug than requiring inclusion of Highlights in included nurse practitioners, labeling. Several comments stated that labeling, the agency and manufacturers pharmacists, and physician assistants. by making prescription drug labeling should work together to make the FPI Their comments and observations easier to navigate, Highlights would better. directly contributed to refining the third help to make labeling easier for patients FDA has determined that the version of FDA’s prototype into the and health care practitioners to Highlights provisions of the final rule version that was the basis for the understand. are an essential element of the agency’s proposed rule. Moreover, the agency has Several comments endorsed the efforts to improve the accessibility, carefully reviewed and considered all Highlights format as a means of making readability, and usefulness of comments received on the proposed labeling information more accessible. information in prescription drug rule, which included comments from a Some comments stated that the labeling and reduce the number of
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adverse reactions resulting from large amounts of complex information. (Comment 3) Some comments stated medication errors due to misunderstood Highlights summarizes the information that FDA should do additional testing to or incorrectly applied drug information. from the FPI that is most important for determine whether Highlights is By means of focus group testing, a prescribing the drug safely and necessary to accomplish FDA’s goal of nationwide physician survey, and a effectively and organizes it into logical making information in prescription drug public meeting, the agency carefully groups, or ‘‘chunks,’’ to enhance labeling more useful and accessible or evaluated the drug information needs of accessibility, retention, and access to whether the other proposed format physicians and ways to best address the more detailed information. This changes, without Highlights (i.e., an those needs in prescription drug design, combined with the use of index, reordering of the sections of the labeling. Some of the principal findings multiple formats (e.g., tables, bulleted FPI, and enhanced formatting) would be were that: (1) The relative importance of lists) and graphic emphasis (e.g., bolded adequate to accomplish the agency’s information in labeling varies, (2) text), improves visual and cognitive goal. One comment requested that FDA physicians typically refer to labeling to access to the information so that evaluate whether simply reordering the answer a specific question, (3) practitioners can more easily find sections of the prescribing information physicians have considerable difficulty information, and improves recall of the would be adequate to accomplish the locating the information they need to information. agency’s goal. Some comments stated make prescribing decisions, and (4) Importantly, Highlights must include that the agency should test whether the physicians strongly prefer to have a identifying numbers indicating where in proposed format would change separate introductory summary of the the FPI to find details of the information prescriber behavior as intended and most important information contained that is cited or concisely summarized in lead to a reduction in medication errors. in the full prescribing information, Highlights. In the final rule, FDA has The agency believes it is unnecessary located at the beginning of labeling, to revised proposed § 201.57(a)(17) to compare the prototype labeling with make it easier to find the information (§ 201.56(d)(3) in the final rule) to Highlights to the prototype labeling necessary to prescribe the drug safely require that any information referenced without Highlights (i.e., a version with and effectively (65 FR 81082 at 81083 in Highlights, not just subheadings, be a table of contents, reordered sections in through 81085; see also Ref. 11). Many accompanied by the identifying number the FPI, and enhanced graphics, or a of the comments submitted in response corresponding to the location of the version with only reordered sections to the proposed rule concur with these information in the FPI. The agency and enhanced graphics). The requirements of this final rule are built findings, particularly those from health believes that these identifying numbers on extensive testing conducted by FDA, care practitioners and their will facilitate access to the detailed established principles of cognitive organizations. information in the FPI. This preference for highlighting the processing, previous research conducted most important information that is part The Highlights design—a broad array by FDA for OTC drug labeling, and of a larger body of information is of important information in a discrete, evaluation of comments submitted in consistent with good risk visually accessible location—also response to this proposal. FDA has communication practices and with well- increases the variety of information that determined that Highlights, because it established cognitive principles. The a practitioner is exposed to in a typical will efficiently and effectively convey agency employed these principles in labeling referral. That is, the Highlights information about a drug product and designing Highlights. design increases the likelihood that will help to facilitate the transition to For example, cognitive research has practitioners will be exposed to and electronic labeling, is a vital component shown that, because there is a limit to retain critical information about a drug of the efforts to reduce the numbers of the amount of information that an in addition to the information that the adverse reactions from medication individual can hold in memory at one practitioner sought in referring to the errors due to misunderstood or time, individuals tend to organize labeling, such as the recommended incorrectly applied drug information. similar information into ‘‘chunks’’ to: dose. The practitioner therefore is likely (Comment 4) In the proposed rule, (1) Increase the amount of available to know more about a drug after FDA specifically sought comment on space in memory and (2) facilitate exposure to labeling with Highlights whether, and under what retrieval of information (Refs. 1 through than after exposure to labeling without circumstances, it might be inappropriate 3). ‘‘Chunking’’ complex information Highlights. In addition, by making to include the proposed Highlights in into smaller, more manageable units labeling easier to use and an overall the labeling of a particular drug or drug makes it easier to remember and process better source of drug information, the class. information efficiently and effectively Highlights design is likely to increase The vast majority of comments (decreases ‘‘cognitive load’’). the frequency with which practitioners supported Highlights for all products or FDA research conducted during rely on labeling for prescription drug no products. One comment stated that if development of new rules for OTC drug information. In a survey regarding the agency retains the requirement to labeling demonstrated that ‘‘chunking’’ labeling for vaccines, 71 percent of include Highlights, all products information in a standardized format physicians surveyed indicated that they required to have the new format should with graphic emphasis on the most would increase their use of labeling if a be required to have Highlights. One important information helped summary of prescribing information comment stated it would not be useful individuals make correct product use were included in labeling (65 FR 81082 to include Highlights if the entire decisions, decreased reading time, and at 81084). Highlights should result in labeling is very short (e.g., one page). increased the individuals’ confidence in health care practitioners being better The agency concludes that there their ability to use that information (Ref. informed about prescription drugs. should be no exceptions to the 4). This research supports the approach Therefore, the agency concludes that Highlights requirement for drugs subject adopted in this final rule for prescription drug labeling with to the new content and format prescription drug labeling. Highlights more effectively requirements at §§ 201.56(d) and 201.57. In designing Highlights, the agency communicates drug information to The agency acknowledges that employed established techniques to prescribers than labeling without prescription drug labeling for some enhance effective communication of Highlights. drugs may be very short and that this
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may result in short Highlights. However, about the difficulty involved in TABLE 6.—LOCATION OF STATEMENTS as discussed previously, the agency has summarizing the complex and often REQUIRED TO BE INCLUDED IN LA- determined that Highlights improves the lengthy information in the FPI (see e.g., BELING—Continued usefulness, readability, and accessibility comments 16, 23 and 27), the agency of information in prescription drug believes that it is essential for FDA to Location—Old Location—New Format labeling and is consistent with good risk review and approve most proposed Format communication practices. changes to the information in (Comment 5) Several comments stated Highlights. Accordingly, the agency is Precautions (Spe- Use in Specific Popu- cific Populations) lations that there should be more specific revising its regulations on supplements criteria for selecting information for and other changes to an approved Precautions (Infor- Patient Counseling In- inclusion in Highlights to ensure application. Under §§ 314.70(b)(2)(v)(C) mation for pa- formation consistency for all drug products. These and (c)(6)(iii), and 601.12(f)(1) and tients) comments stated that, without specific (f)(2)(i), applicants are required to criteria, the information in Highlights obtain prior approval of any labeling How Supplied (or How Supplied/Storage for different drugs within the same drug changes to Highlights, except for after How Sup- and Handling plied) class may be different, and these editorial or similar minor changes, differences could be used to the including removal of a listed section(s) Where statements are required in competitive advantage or disadvantage from ‘‘Recent Major Changes’’ or a of some products. Some comments labeling but not in a specific labeling change to the most recent revision date section, the agency may specify the stated that the agency should designate of the labeling. Sections 314.70(d)(2)(x) the precise information that must be location in the FPI for the statements for and 601.12(f)(3)(i)(D) allow these included in Highlights. One comment the drug or class of drugs to ensure editorial and similar minor changes in said that, for products with class consistency within drug classes. the labeling to be reported in an annual labeling, FDA must designate which Whether a specific statement required report. class labeling statements must be by regulation must appear in Highlights included in Highlights to ensure In addition, as noted, the agency is will be determined by the agency. consistency among drugs in the class. making available guidance to assist (Comment 6) Several comments stated Another comment stated that the manufacturers and FDA reviewers in that Highlights should mention the relative importance of drug information, developing prescription drug labeling. drug’s therapeutic or pharmacologic and, as a result, the basis for selecting This guidance addresses, among other class. They maintained that this information for inclusion in the section, things, how to select information for information is informative to can vary depending on a drug’s inclusion in Highlights (section IV of practitioners when the drug is a member indication. The comment maintained this document). of an established class because it puts the drug in a context with other that Highlights would have to provide In some instances, a statement for a for differences in safety profiles for therapies and helps prevent duplicative drug or class of drugs is currently therapy. drugs with multiple indications and required by regulation to be included in those that are used in different The agency agrees that information a specific section of prescription drug about a drug’s therapeutic or populations. labeling (e.g., § 201.21). In these cases, The agency believes that these pharmacologic class is important and when converting labeling to the new concerns are not unique to Highlights. appropriate for inclusion in Highlights. format, the statements must be included The agency agrees that, for a given drug, If a drug is a member of an established if there are significant differences in in the corresponding section in the new therapeutic or pharmacologic class, the safety profiles or dosing considerations format (e.g., a statement required to be identity of that class can provide a for different indications or populations, included in the ‘‘Boxed Warning’’ practitioner with important information Highlights must reflect these section in the old format must be about what to expect from that product differences. The agency also agrees that included in the ‘‘Boxed Warning’’ and how it relates to other therapeutic it is critical to ensure accuracy and section in the new format). However, options. The agency also agrees with the consistency in the information included some statements are currently required comment that making the identity of a in Highlights because it contains a to be included in labeling sections that drug’s class more prominent could summary of the most important have been altered or eliminated by this reduce the likelihood of prescribers information for prescribing the drug final rule. In these instances, the placing a patient on more than one safely and effectively. statements must be located in the FPI as therapy within the same class when In general, however, the agency outlined in table 6. such use would not be appropriate. believes that it would not be The agency believes that information appropriate, or possible, to specify in TABLE 6.—LOCATION OF STATEMENTS about drug class is an important the final rule the precise content of REQUIRED TO BE INCLUDED IN LA- supplement to the information Highlights. Judgment will continue to be BELING contained in a drug’s ‘‘Indications and necessary to determine what Usage’’ section and should be placed information from the broad range of under that heading in Highlights. Location—Old Location—New Format information necessary for the safe and Format Accordingly, the agency has revised effective use of the prescription drug proposed § 201.57(a)(6) to require that appearing in the FPI must also appear Warnings Warnings and Pre- when a drug is a member of an in Highlights (e.g., differences in safety cautions established pharmacologic class, the profiles or dosing considerations for class must be identified in the Precautions (Gen- Warnings and Pre- differing indications or populations). eral) cautions ‘‘Indications and Usage’’ section in However, because Highlights is a Highlights. summary of the most important Precautions (Drug Drug Interactions (Comment 7) One comment stated information for prescribing decisions interactions) that Highlights should also include and some comments expressed concerns information about managing drug
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overdose (recommended a new section which sections they reference most D. Comments on Product Liability entitled ‘‘Toxicity and Overdose’’) and frequently. Implications of the Proposed Rule characteristics by which a tablet can be The agency believes that the order of In the proposal, FDA requested identified (color, markings, shape, etc.). information in Highlights required by The agency acknowledges the comments on the product liability the final rule gives sufficient implications of revising the labeling for importance of information about prominence to risk information. The managing drug overdose and prescription drugs. agency also believes that the formatting (Comment 12) In comments, some characteristics by which a tablet can be requirements, the one-half page length identified and took care to make this manufacturers expressed concerns that, restriction for Highlights (excluding by highlighting selected information information prominent in the FPI. space for a boxed warning, if one is However, space for Highlights is limited from the FPI to the exclusion of required) (§ 201.57(d)(8)), and the information not highlighted, they make and the agency has made judgments limitations on the amount of about which information is most themselves more vulnerable to product information that can be included in liability claims. Some of these important for safe and effective use and Highlights will ensure that all the thus must appear in Highlights. The comments also stated that the Highlights information in Highlights has adequate limitation statement, which states that agency has concluded that information prominence and is visually accessible. about managing overdose or product Highlights does not contain all the identification characteristics (except (Comment 10) One comment information needed to prescribe a drug scoring) will not be required in expressed concern about the safely and effectively and that Highlights. The agency has retained implications of Highlights for FDA’s practitioners should also refer to the scoring in Highlights because this initiative to improve pregnancy FPI, would not constitute an adequate information is needed to appropriately labeling. The comment stated that the legal defense in a case alleging failure to tailor a dose for some patients (e.g., a preliminary format FDA has discussed provide adequate warning of a drug’s patient is unable to take two tablets of in public meetings (which would risks. a drug because of a particular side replace the pregnancy category Based on the agency’s research and effect, but is able to take one-and-one- designations) could not be readily analysis in developing the prototype half tablets). condensed into an informative single labeling that was the basis for the (Comment 8) One comment stated sentence in Highlights. The comment proposed rule (see comment 2), the that the information presented in suggested that electronic labeling could agency has concluded that a labeling Highlights should be in bulleted format potentially solve this problem by format that includes Highlights is more to the extent possible to avoid linking to additional information about effective than a format that omits redundancy with the information in the prescribing in specific patient Highlights. In response to the comments FPI. populations and by linking to pregnancy and as discussed in the response to FDA agrees that information registry databases and tertiary specialty comment 35, FDA has taken steps to presented in Highlights, not otherwise texts as well. enhance the prominence of the required to be bulleted under The agency anticipates that the Highlights limitation statement. FDA § 201.57(d)(4), should be succinctly planned revisions to the requirements believes the statement will be effective summarized and in a format (e.g., for the ‘‘Pregnancy’’ subsection of in reminding prescribers that the bulleted) that calls attention, and labeling are unlikely to affect the information in the Highlights should not provides easy access, to the more information in Highlights about use of be relied on exclusively in making detailed information in the FPI. drugs during pregnancy. The agency prescribing decisions and that it is Highlights is not a verbatim repetition of agrees that the electronic labeling important to consult the more detailed selected information contained in the initiative holds great promise for information in the FPI. We also believe FPI. providing rapid access to related that this limitation statement will help (Comment 9) One comment requested information of varying levels of to ensure that the labeling will be that the sections in Highlights be complexity and detail, including considered in its entirety in any product reordered to lend more prominence to information about drug exposure during liability action. FDA acknowledges the risk information. The comment stated pregnancy. comment’s concerns and, as discussed that all risk information, including more fully in response to comment 13, (Comment 11) Several comments contraindications and drug interactions, believes that under existing preemption should be placed before the ‘‘Dosage recommended that there be an principles such product liability claims and Administration’’ and ‘‘How educational campaign in conjunction would be preempted. with the publication of the final rule to Supplied’’ sections. (Comment 13) Some comments stated ensure that practitioners understand The order of the sections in Highlights that the new format requirements might tracks the order of the corresponding that Highlights contains only limited have product liability implications for sections in the FPI. The agency believes information and should not be relied on drugs that are not subject to the new the order of information in Highlights without reference to the FPI. requirements. These comments must be consistent with the FPI so that The agency agrees that there should expressed concern that labeling in the practitioners can efficiently navigate be, and it plans to initiate, an old format might be characterized by from Highlights to the corresponding educational campaign to familiarize plaintiffs as inferior to labeling in the section of the FPI. As discussed in more health care practitioners with the new new format and, as a result, could be detail in the preamble to the proposed labeling format. The agency also agrees used as evidence that a manufacturer rule (65 FR 81082 at 81084), the revised that an important component of the did not provide adequate warnings. order of the sections in the FPI was educational message should be that They requested that the agency state in based on extensive focus group testing Highlights alone does not contain all the the final rule that FDA approval of and surveys of physicians to determine information FDA has determined is labeling, whether it be in the old or new which sections they believe are most needed to use a drug safely and format, preempts conflicting or contrary important to prescribing decisions and effectively. State law, regulations, or decisions of a
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court of law for purposes of product scientific information to monitor the of these cases, the court determined that liability litigation. safety of products and to incorporate the State law claim could not proceed, FDA believes that under existing information into the product’s labeling on the ground that the claim was preemption principles, FDA approval of when appropriate. preempted by Federal law,5 or was not labeling under the act, whether it be in Changes to labeling typically are properly before the court by operation of the old or new format, preempts initiated by the sponsor, subject to FDA the doctrine of primary jurisdiction.6 In conflicting or contrary State law. review, but are sometimes initiated by some cases, however, the court has Indeed, the Department of Justice (DOJ), FDA. Under FDA regulations, to change permitted the claim to proceed.7 on behalf of FDA, has filed a number of labeling (except for editorial and other State law actions can rely on and amicus briefs making this very point. In minor revisions), the sponsor must propagate interpretations of the act and order to more fully address the submit a supplemental application fully FDA regulations that conflict with the comments expressing concern about the explaining the basis for the change agency’s own interpretations and product liability implications of revising (§§ 314.70 and 601.12(f) (21 CFR 314.70 frustrate the agency’s implementation of the labeling for prescription drugs, we and 601.12(f))). FDA permits two kinds its statutory mandate. For example, believe it would be useful to set forth in of labeling supplements: (1) Prior courts have rejected preemption in State some detail the arguments made in approval supplements, which require law failure-to-warn cases on the ground those amicus briefs. The discussion that FDA approval before a change is made that a manufacturer has latitude under follows, therefore, represents the (§§ 314.70(b) and 601.12(f)(1)); and (2) FDA regulations to revise labeling by government’s long standing views on ‘‘changes being effected’’ (CBE) adding or strengthening warning preemption, with a particular emphasis supplements, which may be statements without first obtaining on how that doctrine applies to State implemented before FDA approval, but permission from FDA. (See, e.g., Eve v. laws that would require labeling that after FDA notification (§§ 314.70(c) and Sandoz Pharm. Corp., 2002 U.S. Dist. conflicts with or is contrary to FDA- 601.12(f)(2)). While a sponsor is LEXIS 23965 (S.D. In. Jan. 28, 2002); approved labeling. permitted to add risk information to the Ohler v. Purdue Pharma, L.P., 2002 U.S. Under the act, FDA is the expert FPI without first obtaining FDA Dist. LEXIS 2368 (E.D. La. Jan. 22, Federal public health agency charged by approval via a CBE supplement, FDA 2002); Motus v. Pfizer Inc., 127 F. Supp. Congress with ensuring that drugs are reviews all such submissions and may 2d 1085 (C.D. Cal. 2000); Bansemer v. safe and effective, and that their labeling later deny approval of the supplement, Smith Labs., Inc., 1988 U.S. Dist. LEXIS adequately informs users of the risks and the labeling remains subject to 16208 (E.D. Wis. Sept. 12, 1988); and benefits of the product and is enforcement action if the added McEwen v. Ortho Pharm Corp., 528 P.2d truthful and not misleading. Under the information makes the labeling false or 522 (Ore. 1974).) In fact, the act and FDA regulations, the agency misleading under section 502(a) of the determination whether labeling makes approval decisions based not on act (21 U.S.C. 352). Thus, in practice, revisions are necessary is, in the end, an abstract estimation of its safety and manufacturers typically consult with squarely and solely FDA’s under the act. effectiveness, but rather on a FDA prior to adding risk information to A manufacturer may, under FDA comprehensive scientific evaluation of labeling. As noted in response to regulations, strengthen a labeling the product’s risks and benefits under comment 5, however, a sponsor may not warning, but in practice manufacturers the conditions of use prescribed, use a CBE supplement to make most typically consult with FDA before doing recommended, or suggested in the changes to Highlights. so to avoid implementing labeling labeling (21 U.S.C. 355(d)). FDA Since the proposed rule was changes with which the agency considers not only complex clinical published, FDA has learned of several ultimately might disagree (and that issues related to the use of the product instances in which product liability therefore might subject the in study populations, but also important lawsuits have directly threatened the manufacturer to enforcement action). and practical public health issues agency’s ability to regulate manufacturer Another misunderstanding of the act pertaining to the use of the product in dissemination of risk information for encouraged by State law actions is that day-to-day clinical practice, such as the prescription drugs in accordance with FDA labeling requirements represent a nature of the disease or condition for the act. In one case, for example, an minimum safety standard. According to which the product will be indicated, individual plaintiff claimed that a drug many courts, State law serves as an and the need for risk management manufacturer had a duty under appropriate source of supplementary measures to help assure in clinical California State law to label its products safety regulation for drugs by practice that the product maintains its with specific warnings that FDA had encouraging or requiring manufacturers favorable benefit-risk balance. The specifically considered and rejected as to disseminate risk information beyond centerpiece of risk management for scientifically unsubstantiated.4 In some that required by FDA under the act. prescription drugs generally is the (See, e.g., Brochu v. Ortho Pharm. Corp., labeling which reflects thorough FDA 4 Dowhal v. SmithKline Beecham Consumer 642 F.2d 652 (1st Cir. 1981); Salmon v. review of the pertinent scientific Healthcare, 2002 Cal. App. LEXIS 4384 (Cal. Ct. Parke-Davis and Co., 520 F.2d 1359 (4th evidence and communicates to health App. 2002), reversed, 2004 Cal. LEXIS 3040 (Cal. April 15, 2004). Cir. 1975); Caraker v. Sandoz Pharm. care practitioners the agency’s formal, 5 E.g., Ehlis v. Shire Richwood, Inc., 233 F. Supp. Corp., 172 F. Supp. 2d 1018 (S.D. Ill. authoritative conclusions regarding the 2d 1189, 1198 (D.N.D. 2002), aff’d on other grounds, conditions under which the product can 367 F.3d 1013 (8th Cir. 2004). 7 Dowhal v. SmithKline Beecham Consumer be used safely and effectively. FDA 6 E.g., Bernhardt v. Pfizer, Inc., 2000 U.S. Dist. Healthcare, 2002 Cal. App. LEXIS 4384 (Cal. Ct. carefully controls the content of labeling LEXIS 16963 (S.D.N.Y. Nov. 16, 2000). This App. 2002), reversed, 2004 Cal. LEXIS 3040 (Cal. doctrine allows a court to refer a matter to an April 15, 2004); Bernhardt v. Pfizer, Inc., 2000 U.S. for a prescription drug, because such administrative agency for an initial determination Dist. LEXIS 16963 (S.D.N.Y. November 16, 2000); labeling is FDA’s principal tool for where the matter involves technical questions of Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085 (C.D. educating health care professionals fact and policy within the agency’s jurisdiction. If Cal. 2000), summary judgment granted, 196 F. about the risks and benefits of the a court finds that the agency has primary Supp. 2d 984, 986 (C.D. Cal. 2001), aff’d, 2004 U.S. jurisdiction, the court stays the matter and instructs App. LEXIS 1944 (9th Cir. February 9, 2004); In re approved product to help ensure safe the plaintiff to initiate an action with the agency. Paxil Litigation, 2002 U.S. Dist. LEXIS 16221 (C.D. and effective use. FDA continuously See, e.g., Israel v. Baxter Labs., Inc., 466 F.2d 272, Cal. August 16, 2002), transferred, 296 F. Supp. 2d works to evaluate the latest available 283 (D.C. Cir. 1972); see also 21 CFR 10.60. 1374 (J.P.M.L. 2003).
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2001); Mazur v. Merck & Co., Inc., 742 encourage, and in fact require, lay that the doctrine of preemption F. Supp. 239 (E.D. Pa. 1990); In re judges and juries to second-guess the precluded the plaintiff’s claim from Tetracycline Cases, 747 F. Supp. 543 assessment of benefits versus risks of a proceeding.8 The practice of addressing (W.D. Mo. 1989).) In fact, FDA interprets specific drug to the general public—the conflicting State requirements through the act to establish both a ‘‘floor’’ and central role of FDA—sometimes on participation in litigation (including a ‘‘ceiling,’’ such that additional behalf of a single individual or group of product liability cases) in which the disclosures of risk information can individuals. That individualized Government is not a party is not new. expose a manufacturer to liability under reevaluation of the benefits and risks of For example, DOJ participated on FDA’s the act if the additional statement is a product can result in relief—including behalf in favor of pre-emption in Jones unsubstantiated or otherwise false or the threat of significant damage awards v. Rath Packing Company, 430 U.S. 519 misleading. Given the or penalties—that creates pressure on (1977), Grocery Manufacturers of comprehensiveness of FDA regulation of manufacturers to attempt to add America, Inc. v. Gerace, 755 F.2d 993 drug safety, effectiveness, and labeling warnings that FDA has neither approved (2d Cir. 1985), Eli Lilly & Co., Inc. v. under the act, additional requirements nor found to be scientifically required. Marshall, 850 S.W.2d 155 (Tex. 1993), for the disclosure of risk information are This could encourage manufacturers to and Buckman Co. v. Plaintiffs’ Legal not necessarily more protective of propose ‘‘defensive labeling’’ to avoid Comm., 531 U.S. 341, 352–53 (2001). patients. Instead, they can erode and State liability, which, if implemented, FDA believes that State laws conflict disrupt the careful and truthful could result in scientifically with and stand as an obstacle to representation of benefits and risks that unsubstantiated warnings and achievement of the full objectives and prescribers need to make appropriate underutilization of beneficial purposes of Federal law when they judgments about drug use. Exaggeration treatments. purport to compel a firm to include in of risk could discourage appropriate use FDA has previously preempted State labeling or advertising a statement that of a beneficial drug. law requirements relating to drugs in FDA has considered and found State law requirements can rulemaking proceedings. For example: scientifically unsubstantiated. In such undermine safe and effective use in • In 1982, FDA issued regulations cases, including the statement in other ways. In the preamble requiring tamper-resistant packaging for labeling or advertising would render the accompanying the proposal, FDA noted OTC drugs. In the preamble drug misbranded under the act (21 that liability concerns were creating accompanying the regulations, FDA U.S.C. 352(a) and (f)). The agency pressure on manufacturers to expand stated its intention that the regulations believes that State law conflicts with labeling warnings to include speculative preempt any State or local requirements and stands as an obstacle to risks and, thus, to limit physician that were ‘‘not identical to * * * [the achievement of the full objectives and appreciation of potentially far more rule] in all respects’’ (47 FR 50442 at purposes of Federal law if it purports to significant contraindications and side 50447, November 5, 1982). preclude a firm from including in effects (65 FR 81082 at 81083). FDA has • In 1986, FDA issued regulations labeling or advertising a statement that previously found that labeling that requiring aspirin manufacturers to is included in prescription drug includes theoretical hazards not well- include in labeling a warning against labeling. By complying with the State grounded in scientific evidence can use in treating chicken pox or flu law in such a case and removing the cause meaningful risk information to symptoms in children due to the risk of statement from labeling, the firm would ‘‘lose its significance’’ (44 FR 37434 at Reye’s Syndrome. In the accompanying be omitting a statement required under 37447, June 26, 1979). Overwarning, just preamble, FDA said the regulations § 201.100(c)(1) as a condition on the like underwarning, can similarly have a preempted ‘‘State and local packaging exemption from the requirement of negative effect on patient safety and requirements that are not identical to it adequate directions for use, and the public health. (See section X of this with respect to OTC aspirin-containing omission would misbrand the drug document.) Similarly, State-law products for human use’’ (51 FR 8180 at under 21 U.S.C. 352(f)(1). The drug attempts to impose additional warnings 8181, March 7, 1986). might also be misbranded on the ground • can lead to labeling that does not In 1994, FDA amended 21 CFR that the omission is material within the accurately portray a product’s risks, 20.63 to preempt State requirements for meaning of 21 U.S.C. 321(n) and makes thereby potentially discouraging safe the disclosure of adverse event-related the labeling or advertising misleading and effective use of approved products information treated as confidential under 21 U.S.C. 352(a) or (n). or encouraging inappropriate use and under FDA regulations (59 FR 3944, Consistent with its court submissions undermining the objectives of the act. January 27, 1994). (See also 47 FR and existing preemption principles, (See, e.g., Dowhal v. SmithKline 54750, December 3, 1982) (‘‘FDA FDA believes that at least the following Beecham Consumer Healthcare, 2002 believes that differing State OTC drug Cal. App. LEXIS 4384 (Cal. Ct. App. pregnancy-nursing warning 8 The DOJ submissions in these cases relied on 2002) (allowing to proceed a lawsuit requirements would prevent the doctrine of implied preemption or primary accomplishment of the full purpose and jurisdiction. Although the act itself contains no involving a California State law general express pre-emption provision for drugs, a requiring warnings in the labeling of objectives of the agency in issuing the provision of legislation amending the drug nicotine replacement therapy products regulation and that, under the doctrine provisions addresses the relationship of the that FDA had specifically found would of implied preemption, these State legislation to State law. Section 202 of the Drug Amendments of 1962 (Public Law 87-781, Title II, misbrand the products under the act), requirements are preempted by the section 202, 76 Stat. 793 (October 10, 1962)) reversed, 2004 Cal. LEXIS 3040 (Cal. regulation as a matter of law.’’) provides: ‘‘Nothing in the amendments made by April 15, 2004).) As noted previously, DOJ has made this Act to the Federal Food, Drug, and Cosmetic State law actions also threaten FDA’s submissions to courts in a number of Act shall be construed as invalidating any provision of State law which would be valid in the absence statutorily prescribed role as the expert cases in which private litigants asserted of such amendments unless there is a direct and Federal agency responsible for a State law basis for challenging the positive conflict between such amendments and evaluating and regulating drugs. State adequacy of risk information provided such provision of State law.’’ The existence of a actions are not characterized by by manufacturers for drugs in legislative provision addressing pre-emption does not bar the operation of ordinary principles of centralized expert evaluation of drug accordance with FDA requirements implied preemption (Geier v. American Honda regulatory issues. Instead, they under the act. In each case, DOJ argued Motor Co., Inc., 529 U.S. 861, 869 (2000)).
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claims would be preempted by its 495 (1996) (holding that the presence of by a new route of administration, or regulation of prescription drug labeling: a State law damages remedy for with a novel drug delivery system. (1) Claims that a drug sponsor breached violations of FDA requirements does not (Comment 15) Several comments an obligation to warn by failing to put impose an additional requirement upon opposed, or expressed reservations in Highlights or otherwise emphasize medical device manufacturers but about, the use of an inverted black any information the substance of which ‘‘merely provides another reason for triangle to identify a product, appears anywhere in the labeling; (2) manufacturers to comply with * * * indication, or dosage form that has been claims that a drug sponsor breached an federal law’’); id. at 513 (O’Connor, J., approved for less than 3 years. There obligation to warn by failing to include concurring in part and dissenting in were concerns that the symbol is not in an advertisement any information the part); id)). But see Buckman Co. v. universally understood and could substance of which appears anywhere in Plaintiffs’ Legal Comm., 531 U.S. 341, therefore be confusing to practitioners. the labeling, in those cases where a 352–53 (2001) (holding that ‘‘fraud on One comment stated that use of icons to drug’s sponsor has used Highlights the FDA’’ claims are preempted by convey public health information has consistently with FDA draft guidance Federal law); 21 U.S.C. 337(a) historically been unsuccessful. Some of regarding the ‘‘brief summary’’ in direct- (restricting the act enforcement to suits the comments stated that if the inverted to-consumer advertising (‘‘Brief by the United States); In re Orthopedic black triangle were retained, the agency Summary: Disclosing Risk Information Bone Screw Prods. Liability Litig., 159 would need to conduct an extensive in Consumer-Directed Print F.3d 817, 824 (3d Cir. 1998) (‘‘Congress educational campaign to educate Advertisements,’’ 69 FR 6308 (February has not created an express or implied practitioners about its meaning and 2004)) (see comment 112); (3) claims private cause of action for violations of purpose. Some comments also that a sponsor breached an obligation to the FDCA or the MDA [Medical Device expressed the concern that labeling warn by failing to include Amendments]’’). containing the symbol could be in contraindications or warnings that are circulation much longer than 3 years E. Highlights—Comments on Specific not supported by evidence that meets after approval, which would undermine Provisions the standards set forth in this rule, the significance of the symbol. One including § 201.57(c)(5) (requiring that The agency received comments on the comment stated that the symbol implies, contraindications reflect ‘‘[k]nown following provisions of the proposed without basis, that newer drugs are hazards and not theoretical rule relating to the content of inherently less safe than older drugs. possibilities’’) and (c)(7); (4) claims that Highlights: Some comments stated that the criteria a drug sponsor breached an obligation to • Drug names, dosage form, route of for when a new indication would warn by failing to include a statement administration, and controlled extend the time for which a product in labeling or in advertising, the substance symbol (proposed must have the inverted black triangle substance of which had been proposed § 201.57(a)(1)) are not clear. Two comments stated that a bold to FDA for inclusion in labeling, if that In proposed § 201.57(a)(1), FDA approval date might be more statement was not required by FDA at specified the information concerning informative than the inverted black the time plaintiff claims the sponsor had the identity of the product that would triangle. Another comment an obligation to warn (unless FDA has be included at the beginning of recommended using the designation made a finding that the sponsor Highlights. ‘‘New-Rx’’ to identify a product that has withheld material information relating (Comment 14) One comment been approved for less than 3 years. to the proposed warning before plaintiff recommended that this information be Other comments expressed strong claims the sponsor had the obligation to moved above the title ‘‘Highlights of support for the inverted black triangle as warn); (5) claims that a drug sponsor Prescribing Information’’ in Highlights. a mechanism to prompt practitioners to breached an obligation to warn by The agency does not agree that the more carefully scrutinize the labeling of failing to include in labeling or in information required by § 201.57(a)(1) newer products and more diligently advertising a statement the substance of should be placed above the title report adverse events. The comments which FDA has prohibited in labeling or ‘‘Highlights of Prescribing Information.’’ maintained that use of the inverted advertising; and (6) claims that a drug’s The agency believes that the title of each black triangle could lead to earlier sponsor breached an obligation to of the three major portions of detection of rare, serious adverse plaintiff by making statements that FDA prescription drug labeling (‘‘Highlights reactions and, thus, could potentially approved for inclusion in the drug’s of Prescribing Information,’’ ‘‘Full save lives. One comment suggested label (unless FDA has made a finding Prescribing Information: Contents,’’ and extending the time that the inverted that the sponsor withheld material ‘‘Full Prescribing Information’’) should black triangle would be required to 5 information relating to the statement). be placed at the beginning of the years. Preemption would include not only corresponding information so that the The agency has reconsidered its claims against manufacturers as title is readily apparent to users. proposal to require use of the inverted described above, but also against health • Inverted black triangle (proposed black triangle to identify products that care practitioners for claims related to § 201.57(a)(2)) have been marketed for less than 3 dissemination of risk information to FDA proposed to require that years. The agency continues to believe patients beyond what is included in the products that contain a new molecular strongly in the goals of the inverted labeling. (See, e.g., Bowman v. Songer, entity, new biological product, or new black triangle—to help ensure that 820 P.2d 1110 (Col. 1991).) combination of active ingredients have prescribers use a product with FDA recognizes that FDA’s regulation in their labeling an inverted black particular care during its initial years of of drug labeling will not preempt all triangle to indicate that the drug or drug marketing and to make prescribers more State law actions. The Supreme Court combination had been approved in the diligent in reporting suspected adverse has held that certain State law United States for less than 3 years reactions for newer products. However, requirements that parallel FDA (proposed § 201.57(a)(2)). This proposal the agency agrees with comments that, requirements may not be preempted also applied to marketed products in prescription drug labeling, the (Medtronic, Inc. v. Lohr, 518 U.S. 470, approved for a new indication, for use inverted black triangle is not universally
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understood, could be confusing to the that alerting a practitioner to the fact warnings be summarized concisely in prescriber (even with a concerted that a drug has been marketed for an Highlights. educational effort) and therefore may extended period could provide some (Comment 17) Several comments not serve its intended purpose. The added assurance about the drug’s safety stated that inclusion of the full boxed agency acknowledges that the margin based on cumulative, safe warning in Highlights and in the FPI recommended ‘‘New-Rx’’ designation experience with the product. Therefore, was needlessly duplicative and may be more informative than the the requirement to include the initial recommended that the boxed warning inverted black triangle, but is concerned date of U.S. approval in Highlights will be included in only one location. One that the ‘‘New-Rx’’ designation might not lapse 3 years after approval of the comment maintained the boxed warning also be confusing because practitioners product for marketing. should appear only in the ‘‘Warnings are not familiar with it. • Boxed warnings or and Precautions’’ section in the FPI. The agency agrees with comments contraindications (proposed As discussed in the response to the that use of the initial date of approval § 201.57(a)(4)) previous comment, the boxed warning in the United States would be a better FDA proposed to require that the full in Highlights is required to be a mechanism than the inverted black text of boxed warning(s) or summary of the complete boxed triangle to call attention to the relative contraindication(s) required by warning in the FPI. Thus, the boxed newness of a product. Therefore, the proposed § 201.57(c)(1) be included in warning in Highlights will not duplicate final rule requires that Highlights Highlights unless the boxed warning the boxed warning in the FPI. The include the year in which a drug was was longer than 20 lines, in which case agency believes that a summarized initially approved in the United States. a summary of the contents of the boxed boxed warning must be included in Highlights must contain the phrase warning would be required (proposed Highlights to ensure that practitioners ‘‘Initial U.S. Approval’’ followed by the § 201.57(a)(4)). The agency specifically are exposed to critical information at the four-digit year of initial approval in bold sought comment on whether the full beginning of prescription drug labeling face type (§ 201.57(a)(3) and (d)(5)). text of a boxed warning should be and that the complete boxed warning is Because this statement takes up more included in Highlights, regardless of needed to expand on the summary in space than the proposed inverted black length. Highlights. triangle, the final rule requires that the (Comment 16) Some comments The agency does not agree that the statement be placed on its own line supported the proposed 20-line complete boxed warning in the FPI directly below the established name of limitation on the length of a boxed should be placed in the ‘‘Warnings and the product (proper name of the product warning in Highlights. Other comments Precautions’’ section rather than at the for biological products) rather than on recommended that the boxed warning in beginning of the FPI. Placement of the the same line as the proprietary name Highlights always be a summarized complete boxed warning at the (§ 201.57(a)(3)). version of the boxed warning in the FPI. beginning of the FPI, where it can be In contrast to the proposed rule, the Others expressed concern that easily located, is consistent with good final rule does not require identification summarizing boxed warnings might risk communication practices, as well as of the initial date of U.S. approval of a result in the omission of key health care practitioner preferences new indication for a new population, information or lead to articulated in public comments and new route of administration, or novel misinterpretations of the warning. They FDA’s physician surveys and focus delivery system. The agency agrees with stated that the boxed warning is already group research. comments that expressed concerns that succinct and the language is carefully • Recent labeling changes (proposed also requiring the inverted black triangle negotiated with FDA and, therefore, that § 201.57(a)(5)) for new indications, routes of the boxed warning should always be FDA proposed to require in Highlights administration, and novel delivery included in its entirety in Highlights. a heading entitled ‘‘Recent Labeling systems could diminish the significance The agency has retained the 20-line Changes’’ that identifies the sections in of the inverted black triangle and could length limitation on boxed warnings in the FPI that contain recent FDA- be confusing to practitioners. Similarly, Highlights. The agency believes that 20 approved or authorized substantive the agency believes that referring to lines is sufficient space to alert labeling changes (proposed multiple dates, including the date of practitioners to the critical risk § 201.57(a)(5)). initial approval of a new indication, information contained in a boxed (Comment 18) In general, comments new route of administration, or a novel warning and to refer them to more supported the addition of a ‘‘Recent delivery system for a drug would be detailed information in the FPI Labeling Changes’’ heading to labeling confusing and would diminish the (complete boxed warning and other and many comments thought the significance of these references. The sections in the FPI). information would be very useful to agency is, therefore, limiting The agency agrees with the comments practitioners. However, one comment identification of the initial date of U.S. that stated that manufacturers should recommended that the proposed approval to new molecular entities, new always be required to present heading ‘‘Recent Labeling Changes’’ be biological products, or new summarized boxed warning information changed to ‘‘Sections Revised’’ to combinations of active ingredients in Highlights. The agency has accommodate changes that, although no because this is sufficient to accomplish determined that information from boxed longer truly recent, would be important the goals of increasing prescriber warnings can readily be condensed to call to the attention of practitioners vigilance and reporting of suspected without omitting critical risk for an extended period of time (e.g., adverse reactions when using newer information. The agency believes a through multiple labeling revisions). products. summarized boxed warning in Another comment recommended that The agency believes the date of initial Highlights, with references to more the heading be changed to ‘‘Last U.S. approval will continue to be detailed information in the FPI, is the Labeling Revisions’’ to accommodate informative throughout a product’s life most effective way to communicate changes that could no longer reasonably cycle. Although the agency does not critical risk information to practitioners. be considered recent (e.g., a situation in subscribe to the view that newer drugs The agency has revised proposed which years elapse between labeling are inherently less safe, it does believe § 201.57(a)(4) to require that boxed changes).
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The agency agrees that the proposed calendar year, some comments subheadings (proposed § 201.57(a)(6)). heading should be changed to better recommended that each change This information would include major reflect the function of including the appearing under ‘‘Recent Major limitations of use (e.g., particular information. Thus, the final rule Changes’’ be dated in a month/year subsets of the populations, second line requires the heading ‘‘Recent Major format so that practitioners can readily therapy status). The agency specifically Changes’’ (§ 201.57(a)(5)). FDA believes identify the most recent changes. sought comment on whether the that it is important to characterize the The agency agrees that it would be information required under the changes listed under the heading as useful to date the labeling changes ‘‘Indications and Usage’’ heading of both ‘‘recent’’ and ‘‘major’’ to draw identified under this heading. The Highlights should be presented verbatim attention to the relative newness of the agency has, therefore, revised proposed from the FPI or summarized in a changes and to let practitioners know § 201.57(a)(5) to require that sections of bulleted format. that identified changes are significant to prescription drug labeling listed under (Comment 23) Several comments clinical use of the drug (i.e., ‘‘Recent Major Changes’’ be followed by stated that it was important to substantive), and not merely editorial. the month and year in which the change reproduce the ‘‘Indications and Usage’’ (Comment 19) In the proposal, the was incorporated in the labeling. section verbatim to prevent confusion or agency specifically sought comment on (Comment 21) One comment misinterpretations. Other comments whether there should be a time limit by recommended that the rule specify that maintained that there should be which information under the proposed changes should be listed flexibility to reproduce the information heading (now ‘‘Recent Major Changes’’) chronologically beginning with most in the ‘‘Indications and Usage’’ section must be removed. Some comments recent. verbatim or summarize it in a bulleted supported a 1-year time limit for The agency does not agree. Where format, depending on factors such as the inclusion of information under the there are multiple recent changes and amount of information in the proposed heading. Other comments those changes appear in more than one ‘‘Indications and Usage’’ section and stated that there should be no fixed time section, to avoid confusion, the order in whether the information can be limit for removal of information which the sections are listed under summarized and still effectively identified as a recent labeling change. ‘‘Recent Major Changes’’ should be communicate what a practitioner should These comments expressed concern that consistent with the order of the sections know about a drug’s indications. Other requiring labeling to be revised for the in the FPI. FDA has revised proposed comments recommended that there be sole purpose of removing information § 201.57(a)(5) accordingly. bulleted summaries of the indications in from under the heading would lead to (Comment 22) Some comments all cases. One of these comments unnecessary expense, and that such requested that the agency clarify how it suggested that each bullet be preceded information be removed at the next will determine whether a labeling by an index number that corresponds substantive labeling revision. Other change is substantive and thus required with the index number of the full comments stated that no time limit to be included under ‘‘Recent Major description of the indication in the FPI. should be imposed for removal, but that Changes.’’ The agency has determined that the removal should occur at the first The agency recognizes that a product amount of information that must be convenient opportunity after 1 year may have a large number of labeling included in Highlights from the from the date of the labeling change. changes ranging from inclusion of very ‘‘Indications and Usage’’ section of the Another comment stated that important new risk information to FPI will vary. In most cases, the information should remain under the typographical or editorial changes. ‘‘Indications and Usage’’ section can be ‘‘Recent Major Changes’’ heading for 1 Identifying all these changes under readily condensed (e.g., bulleted format) to 3 years after the change to keep ‘‘Recent Major Changes’’ would obscure to provide prescribers with an accurate practitioners up-to-date on labeling the most significant changes and would and informative summary, even if there changes. not be informative for practitioners. is space available in Highlights to The agency agrees that, although there Therefore, the agency has revised reproduce the ‘‘Indications and Usage’’ should not be a rigid time limit for proposed § 201.57(a)(5) to require that section from the FPI in its entirety (i.e., removal of information from ‘‘Recent only substantive labeling changes in the the one-half page limit requirement Major Changes,’’ the information should ‘‘Boxed Warning,’’ ‘‘Indications and would not be exceeded). not remain in Highlights indefinitely. Usage,’’ ‘‘Dosage and Administration,’’ The agency recognizes that for some The purpose of the heading is to alert ‘‘Contraindications,’’ and ‘‘Warnings products with many indications, it may practitioners to recent substantive and Precautions’’ sections be included not be possible to limit Highlights to labeling changes. The agency is under ‘‘Recent Major Changes.’’ These one-half page in length (§ 201.57(d)(8)), concerned that the information might be would include only those changes that even using a summarized version of the ignored by practitioners if it often are significant to the clinical use of the ‘‘Indications and Usage’’ section. In identifies changes that are no longer drug and, therefore, have significant such cases, FDA may waive the one-half recent. The agency will, therefore, clinical implications for practitioners page requirement and approve the require that labeling changes identified (i.e., substantive changes). Thus, labeling with slightly longer Highlights under this heading be deleted at the first ‘‘Recent Major Changes’’ would not (see comment 104). reprinting of the labeling after the include any changes in the sections • Dosage and administration change has been in labeling for 1 year. subject to this requirement that are (proposed § 201.57(a)(7)) This requirement should ensure that typographical or editorial. FDA proposed that Highlights labeling changes identified under the • Indications and usage (proposed include, under a ‘‘Dosage and ‘‘Recent Major Changes’’ heading are § 201.57(a)(6)) Administration’’ heading, the most current without imposing unnecessary FDA proposed to require that important information in the ‘‘Dosage costs on industry by requiring labeling Highlights include an ‘‘Indications and and Administration’’ section of the FPI revisions solely for the purpose of Usage’’ heading that contains a concise (proposed § 201.57(a)(7)). removing the information. statement of each of the product’s (Comment 24) One comment (Comment 20) Because there could be indications, as specified in proposed recommended that ‘‘Dosage and multiple changes to labeling in a § 201.57(c)(2), with any appropriate Administration’’ in Highlights include,
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in addition to the usual recommended about how to adjust dosages for various Precautions’’ section of the FPI. Rather, doses, a range of doses known to be specific populations would in many they are more likely to be discussed in effective, and in particular, doses lower cases require a great deal of space. the ‘‘Adverse Reactions’’ section of the than the usual recommended doses. The Therefore, FDA is not requiring that FPI. The comment recommended that comment stated that 76.2 percent of all such information be included in the most common adverse reactions be adverse reactions are dose-related and Highlights. listed under a separate section in many patients respond to lower doses • Warnings and precautions Highlights immediately following the than those recommended in labeling. (proposed § 201.57(a)(10)) contact information for reporting Therefore, the comment suggested, FDA proposed to require that suspected serious adverse reactions. lower doses may prevent adverse Highlights include, under a ‘‘Warnings The agency agrees that it may be reactions. and Precautions’’ heading, a concise confusing to include under the FDA agrees that it is important to summary of the most clinically ‘‘Warnings and Precautions’’ heading in include in labeling the full range of significant aspects of the ‘‘Warnings and Highlights information that is derived doses that FDA has concluded are Precautions’’ section of the FPI from both the ‘‘Warnings and effective. The agency has revised (proposed § 201.57(a)(7)). The Precautions’’ and ‘‘Adverse Reactions’’ proposed § 201.57(a)(7) to clarify the information chosen from the FPI would sections of the FPI. The agency is, range of doses to be included under the include those warnings and precautions therefore, revising proposed § 201.57(a) ‘‘Dosage and Administration’’ heading that affect prescribing because of their by adding to Highlights a heading in Highlights. severity and consequent influence on entitled ‘‘Adverse Reactions’’ (Comment 25) Several comments the decision to use the drug, because (§ 201.57(a)(11)) that is required to supported tabular presentation of monitoring of them is critical to safe use follow the ‘‘Warnings and Precautions’’ dosage and administration information of the drug, or because measures can be section. Information under the ‘‘Adverse in Highlights. One comment proposed taken to prevent or mitigate harm. Reactions’’ heading must include: (1) A the use of a titration dose column (a (Comment 27) Some comments listing of the most frequently occurring visual tool to depict a drug’s titration requested clarification of the scope of adverse reactions identified in the regimen) in Highlights for drugs for information to be included in Highlights ‘‘Adverse Reactions’’ section in the FPI which titration is relevant. One under the ‘‘Warnings and Precautions’’ and (2) contact information for reporting comment maintained that the dosage heading. Comments expressed concern suspected adverse reactions. The adjustment statement in the prototype that summarizing selected safety sequence in which the information is that accompanied the proposed rule information from the ‘‘Warnings and presented in Highlights—the most should be highlighted and enlarged. Precautions’’ section of the FPI might frequently occurring adverse reactions FDA agrees with the comment that cause some important safety followed by contact information for supported use of a tabular format for information to be omitted from reporting suspected adverse reactions— ‘‘Dosage and Administration’’ in Highlights. is unchanged from the proposed rule. Highlights. However, because a tabular ‘‘Warnings and Precautions’’ in (Comment 29) One comment format or a titration dose column may Highlights serves to: (1) Identify the requested clarification about whether not be appropriate for all drug products, most clinically significant risks only information that is supported by FDA is not requiring use of these discussed in the ‘‘Warnings and clinical data would be appropriate for formats under the ‘‘Dosage and Precautions’’ section in the FPI, (2) inclusion in Highlights. Administration’’ heading. concisely summarize the salient features In most cases, the risk information in With respect to highlighting and of those risks, and (3) direct the Highlights would be based on clinical enlarging the dosage adjustment practitioner to the more detailed data. However, risk information derived statement in the prototype, FDA discussion of risks in the FPI. from animal data could be appropriate believes that bolded type is sufficient to Information under the ‘‘Warnings and for inclusion in Highlights. For draw attention to particularly important Precautions’’ heading in Highlights will example, warnings about a drug’s risks dosage adjustment statements and that typically include those risks that: (1) in pregnancy could be based entirely on enlarging the statement is not necessary. Affect decisions about whether to animal data and might be appropriate Enlarging only dosage adjustment prescribe a drug, (2) require monitoring for inclusion in Highlights. In such information in Highlights would make of patients to ensure safe use of the cases, Highlights must present only the this information appear more significant drug, or (3) require that measures be clinically significant conclusions about than other information in Highlights, taken to prevent or mitigate harm. The risk in pregnancy (e.g., significant which would not be appropriate. agency has revised § 201.57(a)(10) to teratogen) and not include a discussion Therefore, FDA is not requiring that make clear the scope of information to of the animal data that are the basis for dosage adjustment statements in include under this heading. the risk information presented. Highlights be in larger font than other Because the risks identified under the • ADR reporting contacts (proposed information in Highlights. ‘‘Warnings and Precautions’’ heading in § 201.57(a)(11)) (Comment 26) One comment Highlights will refer the prescriber to FDA proposed (proposed requested that when the labeling states the full discussion in the ‘‘Warnings and § 201.57(a)(11)) to require that that there may be a need for dosage Precautions’’ section of the FPI, the Highlights include, for drug products adjustments in patients with renal or agency believes that important risk other than vaccines, a statement hepatic impairment, it also specify how information will not be overlooked by following the information under the to adjust the dose or dosing interval. practitioners. ‘‘Warnings and Precautions’’ heading: Highlights identifies important (Comment 28) One comment stated ‘‘To report SUSPECTED SERIOUS information about the need for dosage that it would be misleading to include ADRs, call (insert name of adjustments in specific populations and the most common adverse reactions manufacturer) at (insert manufacturer’s refers to the section of the FPI where under ‘‘Warnings and Precautions’’ in phone number) or FDA’s MedWatch at more detailed information about how to Highlights because the most common (insert the current FDA MedWatch adjust doses can be obtained. FDA adverse reactions are not likely to be number).’’ For vaccines, the following believes that complete information discussed in the ‘‘Warnings and statement would be required: ‘‘To report
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SUSPECTED SERIOUS ADRs, call reporting contact information. The to also include the phone number of the (insert name of manufacturer) at (insert agency does not believe that also FDA review division that approved the manufacturer’s phone number) or including contact information in the drug. FDA review divisions are not the VAERS at (insert the current VAERS FPI, even if moved to the beginning of initial point of contact for postmarketing number).’’ The agency specifically the FPI, would result in meaningfully adverse reaction reports; therefore, requested comment on whether it is expanding the number of practitioners manufacturers and practitioners should necessary to include a contact number who become aware of the contact not send these reports to the review for reporting suspected adverse information. Therefore repeating the divisions for processing. It is critical reactions in both Highlights and the contact information in the FPI would that these reports be directed to the ‘‘Warnings and Precautions’’ section of not have a meaningful effect on the location(s) in FDA that are responsible the FPI. extent to which practitioners report for receiving and processing these (Comment 30) Some comments stated adverse events. The agency also does reports so that they are evaluated and that the contact information should be not believe that placing the contact analyzed in an appropriate manner. in both Highlights and FPI to make it information for reporting suspected The agency agrees with comments more convenient to access and increase adverse reactions only in the FPI would recommending that, in addition to their the likelihood that practitioners will be afford the information adequate phone number, manufacturers include prompted to report suspected adverse prominence. Accordingly, the final rule the direct link to the section of their reactions. Other comments stated that it was revised to delete the proposed Web site for voluntary reporting of would not be necessary to include requirement at § 201.57(c)(6)(v) that adverse reactions. The agency has contact information in both places contact information for adverse reaction revised proposed § 201.57(a)(11) to because prominent placement of the reporting be included in the ‘‘Warnings require the address of the Web site, if information in Highlights alone would and Precautions’’ section in the FPI. The one is available. The agency will not be sufficient to encourage practitioners agency believes it is unnecessary to require that manufacturers create a Web to report adverse reactions. Some further increase the prominence of the site to meet this requirement. comments agreed that one location adverse reaction reporting contact The agency has also decided to would be sufficient, but because those information. Its current location— require that the adverse reaction comments also opposed inclusion of immediately following the listing of the reporting contact information include Highlights in labeling, they most common adverse reactions—is the the FDA Web site address for voluntary recommended including the contact appropriate location, and the bolding reporting of adverse reactions information in the FPI. Other comments and use of capitalization are sufficient (currently, http://www.fda.gov/ suggested locating the contact to call attention to the information and medwatch for drug products except information at the beginning of the distinguish it from adjacent information. vaccines and http://www.fda.gov/vaers labeling or in a ‘‘box’’ to increase its The agency does not agree that the for vaccines). This Web site has become prominence. One comment adverse reaction reporting contact an increasingly important source of recommended that the information be information should be omitted from adverse reaction reports. The agency has included only once and in close labeling because it is not considered concluded that providing practitioners proximity to the name and address of prescribing information. Including with the convenience of being able to the manufacturer in the FPI. The adverse reaction reporting contact submit an adverse reaction report comment maintained that it is not information in labeling enables electronically may encourage reporting intuitive to look for adverse reaction practitioners to report adverse reactions of adverse reactions that might not reporting contact information under to FDA promptly. The agency monitors otherwise be reported. Thus, the agency ‘‘Warnings and Precautions.’’ One these reports and analyzes the adverse believes it is very important to require comment objected to inclusion of any reactions data to determine whether identification of this Web site address in adverse reaction reporting contact labeling revisions are necessary for safe labeling, in addition to the FDA information in labeling. That comment and effective use. telephone number. maintained that contact information is (Comment 31) Some comments (Comment 32) Two comments stated not prescribing information and thus recommended that only the that all adverse reactions should be not appropriate for inclusion in labeling manufacturer’s phone number be reported, and not just serious adverse and, moreover, that there is no evidence included in prescription drug labeling, reactions. that inclusion of such information in while others agreed that including the The agency agrees that practitioners labeling will facilitate reporting of MedWatch phone number is important should not be discouraged from adverse reactions. because manufacturers’ phone numbers reporting adverse reactions that might The agency agrees with the comments are subject to change. One comment not be considered serious. Certain that support inclusion of contact requested that a telephone number for adverse reactions that are not information for reporting adverse the relevant FDA review division also considered serious can be clinically reactions only in Highlights. Because be included. Two comments significant. Moreover, practitioners may the contact information is featured recommended including the not always be able to determine whether prominently in Highlights—bolded and manufacturer’s Web site in the reporting an adverse reaction meets the regulatory set apart from other information—the contact information. definition of serious (21 CFR 310.305(b), agency believes that this is sufficient to The agency agrees that it is important 21 CFR 312.32(a), 21 CFR 314.80(a), and make practitioners aware of the to include both the manufacturer’s 21 CFR 600.80(a)). Also, there are appropriate contacts to report adverse phone number and FDA’s phone limitations on the extent to which a reactions and to encourage them to number for voluntary reporting of drug’s risks (serious and nonserious report suspected adverse reactions. The adverse reactions. The agency believes adverse reactions) can be delineated agency also believes that as prescribers that providing practitioners two options before marketing. The agency, therefore, become familiar with the content of for reporting adverse reactions will help believes that practitioners should be Highlights, they will become ensure that they always have someone encouraged to submit all suspected increasingly aware of and familiar with to contact about an adverse reaction. adverse reactions to the manufacturer or the location of the adverse reaction The agency believes it is not appropriate FDA, without regard to the seriousness
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of the reaction, to facilitate faster and result, may be confusing. Decisions it is necessary to require both an index more accurate characterization of a about use of a drug in pregnancy should and Highlights. As discussed in section drug’s risk profile. Accordingly, FDA be based on careful consideration of II of this document, the agency has has revised proposed § 201.57(a)(11) to available data, not simply on a reference decided, on its own initiative, to change require that the statement for adverse to the pregnancy category. the title (now ‘‘Full Prescribing reaction reporting contact information • Highlights limitation statement Information: Contents’’) to better reflect refer to all suspected adverse reactions, (proposed § 201.57(a)(15)) the function of this portion of the not just serious ones. FDA proposed (proposed labeling. • Drug interactions (proposed § 201.57(a)(15)) to require that (Comment 36) Most comments § 201.57(a)(12)) Highlights include the statement: supported inclusion of an index FDA proposed to require that ‘‘These highlights do not include all the (hereafter Contents). They maintained Highlights contain a ‘‘Drug Interactions’’ information needed to prescribe (insert that Highlights alone cannot be relied heading that would include, with any name of drug product) safely and upon to help locate all drug information appropriate subheadings, a concise effectively. See (insert name of drug in the FPI because Highlights is not summary of the drug interaction product)’s comprehensive prescribing comprehensive (Highlights includes information in the FPI (i.e., prescription information provided below.’’ information from only certain sections or over-the-counter drugs or foods that (Comment 35) Several comments of the FPI). They stated that a table of interact in clinically significant ways recommended that the Highlights contents is necessary to quickly and with the product)(proposed limitation statement be made more easily direct the reader to sections of the § 201.57(a)(12)). prominent by moving the statement to FPI that are not referred to in Highlights. (Comment 33) Several comments the beginning of Highlights. In addition, Other comments stated that, despite the strongly supported inclusion of ‘‘Drug several comments recommended distinct purposes served by Highlights Interactions’’ as a separate heading in revisions to the language of the and Contents, the agency should Highlights. One comment recommended statement, such as including that consider consolidating them to save requiring separate subheadings for drug- practitioners ‘‘must’’ consult the space. Some comments stated that there drug, drug-food, drug-laboratory, and comprehensive prescribing information, need not be both because they have possibly drug-herbal interactions. in addition to Highlights, to use a drug similar functions and recommended FDA will not require that ‘‘Drug safely and effectively. that Contents be deleted if Highlights is Interactions’’ in Highlights include The agency agrees that it is important retained. One comment recommended specific subheadings depending on to emphasize to prescribers that that prescription drug labeling include whether the interaction is a drug-drug, Highlights does not include all the neither Contents nor Highlights. The drug-food, drug-herbal, or drug- information needed to use a drug safely comment stated that the reordered and laboratory interaction. Use of these and effectively and that placement of reformatted FPI itself is adequate to subheadings is typically most the statement at the beginning of facilitate practitioners’ access to appropriate when a drug has a large Highlights increases the prominence of information in labeling. number of interactions in each of these this message. Therefore, FDA has FDA continues to believe that categories. In other cases, it is unlikely revised proposed § 201.57(a)(15) to Highlights and Contents serve different to provide additional clarification require that the statement appear at the purposes and has determined that both sufficient to justify use of space for the beginning of Highlights (§ 201.57(a)(1)). should be retained. Highlights presents subheadings. The agency does not agree, however, a succinct summary of the information • Use in specific populations that it is necessary to revise the in the FPI that is most crucial for safe (proposed § 201.57(a)(13)) language of the Highlights limitations and effective use, with cross-references FDA proposed to require that statement. Recognizing that FDA cannot to direct prescribers to more details in Highlights contain a ‘‘Use in Specific require practitioners to consult the FPI, the FPI. In contrast, Contents serves as Populations’’ heading (proposed the agency believes that the language in a navigational tool that references all the § 201.57(a)(13)). The agency proposed this statement, with two minor editorial sections and subsections in the FPI, that this heading include, with any changes, very clearly states the some of which will not be referenced in appropriate subheadings, a concise limitations of Highlights. Highlights. Therefore, the agency summary of information from this believes Contents has a unique and section of the FPI on any clinically F. Comments on the Index (Proposed meaningful function in making important differences in response or use § 201.57(b)) information in the FPI accessible to of the drug in specific populations. FDA proposed to require that practitioners. (Comment 34) One comment prescription drug labeling for products In addition, Highlights and Contents requested that the agency specify that described in proposed § 201.56(b)(1) both figure prominently in FDA’s plans the pregnancy category designation be (i.e., new and more recently approved to convert prescription drug labeling to included under the ‘‘Use in Specific prescription drug products) contain an an electronic format (see section V of Populations’’ heading in Highlights index entitled ‘‘Comprehensive this document). The Contents will because the pregnancy category quickly Prescribing Information: Index’’ provide hyperlinks to all sections and communicates whether use of a drug is (proposed § 201.57(b)). The index would subsections of the FPI, enabling appropriate during pregnancy. list the subheadings required under practitioners to navigate the labeling The agency does not agree that proposed § 201.56(d)(1), if not omitted more easily. Highlights will provide pregnancy category designations are under proposed § 201.56(d)(3), and each hyperlinks to the most frequently appropriate for inclusion in Highlights optional subheading included in the FPI referenced and, typically, most or that they are effective in quickly under proposed § 201.56(d)(5). Each important prescribing information, communicating whether use of a drug is subheading would be required to be allowing rapid access to more detailed appropriate during pregnancy. The preceded by its corresponding index information on these critical topics. agency believes the pregnancy category, number or identifier. (Comment 37) One comment in isolation, tends to oversimplify the In the proposal, the agency recommended that, for sections of risks of drugs in pregnancy and, as a specifically sought comment on whether labeling that are omitted from the FPI
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because they are not applicable, the groups, public comments, and its own information in the section will be agency consider including the section experience) to be most important to, and related to risk. The section is, therefore, number and heading in Contents most commonly referenced by, health more appropriately placed among the followed by the statement ‘‘not care practitioners. For example, other labeling sections related to risk. In applicable,’’ rather than omitting the proposed § 201.57(c)(1) would require addition, the agency believes that all section number and heading. The that any boxed warning(s) be the first dosing information should be comment noted that the prototype substantive information to appear in the consolidated in a single section. If there labeling in the proposed rule omitted a FPI, proposed § 201.57(c)(2) would are specific recommendations for dosage section and also omitted the listing of require that the ‘‘Indications and Usage’’ regimen modifications for use in the section heading in Contents, and section follow any boxed warnings in specific populations, those that this omission might confuse the FPI, and proposed § 201.57(c)(3) modifications must be described in the practitioners. would require that the ‘‘Dosage and ‘‘Dosage and Administration’’ section The purpose of Contents is to set forth Administration’’ section follow the (see § 201.57(c)(3)). the sections and subsections included in ‘‘Indications and Usage’’ section in the (Comment 39) One comment the FPI. For many drug products, some FPI. requested that the agency require a sections and subsections are not (Comment 38) Virtually all the ‘‘Product Title’’ section at the beginning applicable (e.g., ‘‘Drug Abuse and comments supported the proposed of the FPI. The comment maintained Dependence,’’ ‘‘References’’). Currently, reordering of the FPI to give greater that the title is short and repeating it these sections are, in most cases, simply prominence to the sections that would be useful to practitioners to avoid omitted from the labeling without practitioners consider most important confusion. discussion in accordance with former and refer to most often. Many comments The option to include a ‘‘Product § 201.56(d)(3). The agency believes that agreed that the reordering, by better Title’’ section is a vestige of the this practice should continue, but reflecting the way the information in the prescription drug labeling rule finalized recognizes that because identifying FPI is used, would make the FPI more in 1979 (44 FR 37434, June 26, 1979). numbers are now required to be used for useful and accessible to practitioners. The optional ‘‘Product Title’’ section labeling of new and recently approved Some comments, while supportive of was incorporated in the labeling products, this practice may initially be the reordering generally, recommended regulations at that time in response to a confusing for some. The agency certain changes to the sequence of the comment to the proposed rule that was considered the comment’s suggestion sections. One comment requested that the basis for the 1979 final rule (44 FR that the section identifying number and the ‘‘Adverse Reactions’’ section be 37440). The comment stated that the heading be included in Contents moved from its present location proposed labeling requirements did not followed by the statement ‘‘not following the ‘‘Use in Specific require identification of the product at applicable’’ for labeling that omits a Populations’’ section and be placed the beginning of labeling. Instead, the required section or subsection, but immediately after the ‘‘Warnings and first required element in the proposed believes that this is not the best Precautions’’ section. The comment also labeling regulations was the approach because of space recommended that the ‘‘Use in Specific ‘‘Description’’ section. The comment considerations. Instead, to minimize any Populations’’ section be moved from its recommended, and the agency agreed, potential confusion regarding omitted location following the ‘‘Drug that certain sections of the sections, the agency has revised Interactions’’ section and be placed ‘‘Description’’ section could be pulled proposed § 201.56(d)(3) (designated in immediately after the ‘‘Dosage and out of that section and used as a this final rule as § 201.56(d)(4)) to Administration’’ section. The comment ‘‘Product Title’’ section at the beginning require in these cases that the Contents maintained that use in specific of labeling. heading be followed by an asterisk and populations frequently involves Under this final rule, a ‘‘Product that the following statement be included modifications to dose or dosage Title’’ section is not needed for labeling at the end of Contents: ‘‘* Sections or regimen, so it would be logical to place subject to the requirements of new subsections omitted from the full the section in close proximity to the § 201.57, because under final prescribing information are not listed.’’ ‘‘Dosage and Administration’’ section. § 201.57(a)(2), Highlights includes the In addition, for legal clarity, FDA The agency agrees that it would be name of the drug, dosage form, and revised proposed § 201.56(d)(3) and advantageous to group together the two route of administration and, for (e)(3) (§ 201.56(d)(4) and (e)(3) in this major risk information sections—the controlled substances, the controlled final rule) to make clear that clearly ‘‘Warnings and Precautions’’ and substance symbol. Because this inapplicable sections, subsections, or ‘‘Adverse Reactions’’ sections. Placing information will appear at the beginning specific information are omitted from the two sections sequentially of labeling and is similar to the labeling. consolidates risk information in one information required under the location and helps put in context the ‘‘Product Title’’ section, the agency G. Full Prescribing Information— relative seriousness of the adverse believes it is not necessary or useful to Comments on the Reorganization reactions discussed in labeling. Thus, provide the option to include a FDA proposed to revise, for products FDA has revised proposed § 201.57(c) to ‘‘Product Title’’ section at the beginning described in proposed § 201.56(b)(1) require that the ‘‘Adverse Reactions’’ of the FPI. Accordingly, the agency has (new and more recently approved section follow the ‘‘Warnings and deleted proposed § 201.56(d)(4) from the prescription drug products), the content Precautions’’ section. requirements for products described in and format requirements of prescription The agency does not agree with the § 201.57(b)(1) (new and more recently drug labeling at then-current recommendation to place the ‘‘Use in approved drug products). This revision §§ 201.56(d) and 201.57. These revisions Specific Populations’’ section does not have any effect on the ‘‘Product included, in proposed §§ 201.56(d) and immediately after the ‘‘Dosage and Title’’ provision in current regulations 201.57(c), reordering the information in Administration’’ section. Although (§ 201.56(e)(4)), which this final rule the FPI to make more prominent those some of the information in the ‘‘Use in retains for products subject to § 201.80. sections that the agency identified Specific Populations’’ section will have (Comment 40) One comment stated (based on the physician surveys, focus implications for dosing, most of the that, if the agency retains the
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requirement for the boxed warning in section toward the end of the labeling agency recognizes the complexity of both Highlights and the FPI, the boxed (§ 201.57(c)(17)). (See comments 55 and these issues and, therefore, is making warning in the FPI should be placed in 107 for discussion of revisions (i.e., available the new labeling format the ‘‘Warnings and Precautions’’ section addition of imprinting as an example of guidance to assist in determining how to rather than at the beginning of the FPI. an identifying characteristic and reorganize existing labeling information The agency disagrees. The agency deletion of proposed § 201.57(c)(4)(v)).) into the new format (see section IV of believes that the summary sections in FDA also has decided to require that this document). Highlights should appear in the same information identified by prescribers as H. Full Prescribing Information— order as the corresponding sections in frequently referenced (i.e., dosage forms Comments on Specific Provisions the FPI to facilitate access to the more and strengths and some product detailed information contained in the identification information) be included As noted previously, for products corresponding sections in the FPI. The in a section entitled ‘‘Dosage Forms and described in proposed § 201.56(b)(1) risk information presented in a boxed Strengths’’ (§ 201.57(c)(4)) following the (new and more recently approved warning is of such importance that it ‘‘Dosage and Administration’’ section. prescription drug products), FDA warrants placement in the most The agency believes that moving the proposed to revise the content and prominent locations. ‘‘How Supplied/Storage and Handling’’ format requirements at then-current (Comment 41) Some comments section toward the end of labeling will § 201.57 (proposed § 201.57(c)). A recommended that the ‘‘How Supplied/ make it easier for pharmacists to locate discussion of the comments pertaining Storage and Handling’’ section be kept product identification, packaging, and to these provisions and the agency’s at the end of the FPI, rather than moved storage information. Retaining critical responses follow. toward the front of the FPI, as proposed. prescribing information in the ‘‘Dosage • Boxed warning (proposed The comments expressed concern that, Forms and Strengths’’ section will § 201.57(c)(1)) because of the variable length of the continue to meet the needs of FDA proposed to require that a boxed three labeling sections that precede the prescribers by keeping available dosage warning in the FPI be preceded by an ‘‘How Supplied/Storage and Handling’’ forms and strengths information exclamation point (!) for indexing section, it would not be in a consistent together with information about dosage purposes (proposed § 201.57(c)(1)). The location; therefore, practitioners would and administration. Under this final agency specifically requested comment have more difficulty locating the section rule, some product identification on the different types of icons that could than if it were always at the end of the information (e.g., shape, color, coating, be used to signal the boxed warning and FPI. One comment stated that scoring, and imprinting) may be on the costs and benefits of different pharmacists frequently access this required to appear in both the ‘‘Dosage icon types. section for information about storage Forms and Strengths’’ and ‘‘How (Comment 43) Several comments conditions and that it would be more Supplied/Storage and Handling’’ stated that an icon is unnecessary appropriate to place the section just sections. FDA believes that the product because practitioners are familiar with before the ‘‘Patient Counseling identification information should be the meaning of a boxed warning and the Information’’ near the end of the included in both sections to preserve box itself is sufficient to call attention labeling, where pharmacists are the integrity and comprehensibility of to the warning. Some comments accustomed to finding it. each section. observed that the exclamation point was The proposed placement of the ‘‘How (Comment 42) One comment not a sufficiently distinct symbol Supplied/Storage and Handling’’ section requested that the agency clarify the because it could be confused with the following the ‘‘Dosage and conditions under which it would be numeral 1 and might be particularly Administration’’ section was based on appropriate, when amending existing difficult to recognize in small font. input from physicians who were labeling to the new labeling format, to Some comments expressed concern surveyed about which information in move certain information from a section about using any icon that is not labeling is most important and in old labeling to a different section in universally understood. One comment frequently referenced. Physicians new labeling. For example, the recommended that a stop sign be used indicated that their use of the ‘‘Dosage comment asked what criteria would be as it has a universally recognized and Administration’’ section and the used to determine whether information meaning. Other comments expressed ‘‘How Supplied/Storage and Handling’’ on use in specific populations, currently concern about added printing and section is linked. Physicians commonly contained in the ‘‘Clinical software costs associated with any icon refer to the ‘‘Dosage and Pharmacology’’ section, should be requirement. Administration’’ section for dosing moved to the new ‘‘Use in Specific FDA has reconsidered requiring an information and then to the ‘‘How Populations’’ section. exclamation point, or any other icon, to Supplied/Storage and Handling’’ section The agency expects that, in many identify a boxed warning. FDA agrees for available dosage strengths and cases, amending labeling to meet new that the single black line box around the dosage forms. For this reason, the § 201.57(c) will involve rearranging warning information is understood by agency believes that keeping dosing and large segments (sections and practitioners in the United States and is dosage forms and strengths information subsections) of information in existing sufficient to draw attention to the together in the labeling is important. labeling without substantially changing warning information. Therefore, the However, the agency recognizes that, the content. In some cases, however, it agency is not requiring an exclamation under proposed § 201.57(c)(4), the will be necessary to parse information point or any other icon preceding the ‘‘How Supplied/Storage and Handling’’ from several parts of the existing boxed warning in the FPI. Sections section would often have contained labeling into a new section. When 201.56(d)(1), 201.57(a)(4), and (c)(1) of lengthy lists of available packaging and information is to be consolidated into a the final rule have been revised to product identification information that new section, or when information is remove the requirement. may distract prescribers from other required in several places, there may be • Indications and usage (proposed important information. For this reason, uncertainty about how the information § 201.57(c)(2)(i)) and in view of the comments received, should be divided into portions for FDA proposed to require that the the agency has decided to move this clarity and to avoid redundancy. The ‘‘Indications and Usage’’ section of the
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FPI (proposed § 201.57(c)(2)(i)) contain require that this section of the FPI who need a drug (e.g., microbe the same information as required at identify specific tests needed for susceptibility testing). The comment then-current § 201.57(c)(1) except that selection or monitoring of the patients stated that it is not practical to outdated examples of indications were who need the drug and describe, if recommend specific microbial removed. available, information on the susceptibility testing when empirical (Comment 44) One comment approximate kind, degree, and duration diagnosis is common. recommended that the ‘‘Indications and of improvement to be anticipated. Specific tests for selecting and Usage’’ section be retitled ‘‘Food and (Comment 46) One comment monitoring patients would be described Drug Administration—Approved Uses.’’ requested that the ‘‘Indications and when they are necessary for safe and The comment stated that the phrase Usage’’ section specify the type of effective use. Therefore, the requirement ‘‘indications and usage’’ is regulatory clinical trial that has been conducted to in final § 201.57(c)(2)(i)(C) that the jargon that is not meaningful to support each indication (e.g., placebo- ‘‘Indications and Usage’’ section practitioners or patients. controlled, active-controlled). identify specific tests needed for The agency does not believe it would The agency believes that the ‘‘Clinical selecting and monitoring patients does be worthwhile to change the title of the Studies’’ section is the appropriate not require that the ‘‘Indications and section in the manner recommended by section of labeling to discuss the details Usage’’ section routinely state that the comment. The agency does not agree (e.g., trial design, outcome) of clinical microbial susceptibility testing must be that ‘‘indications and usage’’ is jargon trials, not the ‘‘Indications and Usage’’ done. The requirement addresses and not meaningful to practitioners. section. The agency has concluded that situations in which a drug is indicated FDA believes practitioners are familiar greater clarity about the scope of the for a specific therapeutic niche that can with the section heading and information to be included in the be identified by microbe susceptibility understand that the uses described in ‘‘Indications and Usage’’ section is testing. For example, the ‘‘Indications this section are those for which FDA has warranted and has revised proposed and Usage’’ section might specify that a found to be safe and effective. § 201.57(c)(2) accordingly. This revision drug is indicated to treat penicillin- (Comment 45) One comment stated is consistent with having, as stated in resistant pneumococci. The description that the ‘‘Indications and Usage’’ section the preamble to the proposed rule, a of the drug’s activity provides critical should include approved uses in more focused ‘‘Indications and Usage’’ prescribing information. pregnancy. section (65 FR 81082 at 81091). • Indications and usage—lack of The agency agrees, in part. Uses that (Comment 47) FDA received one evidence statement (proposed have been specifically studied for comment that strongly supported the § 201.57(c)(2)(iv)(D)) conditions unique to pregnancy and for proposed modification of the FDA proposed to revise then-current which a drug has been demonstrated to ‘‘Indications and Usage’’ section to § 201.57(c)(3)(iv), which provided that be safe and effective (e.g., to induce require that limitations in usefulness or in situations where there is a common labor) would be appropriate for in data supporting approval be belief that a drug may be effective for a inclusion in the ‘‘Indications and specified. One comment stated that the certain use or condition or the drug is Usage’’ section. Ordinarily, however, requirement should be modified to commonly used for that condition but special considerations about the use of specifically require discussion of the preponderance of the evidence a drug in pregnancy for indications that differential drug effects in shows the drug is ineffective, the do not differ from the general subpopulations with varying genetic ‘‘Indications and Usage’’ section must population would be placed in the ‘‘Use characteristics. state that the drug is ineffective in Specific Populations’’ section. FDA agrees that the ‘‘Indications and (proposed § 201.57(c)(2)(iv)(D)). The • Indications and usage—scope of Usage’’ section must discuss differences revision proposed to expand this information (proposed in drug effectiveness in subgroups for requirement to situations in which a § 201.57(c)(2)(iv)(A)) which there is substantial evidence for drug may be effective for a use but the FDA proposed to revise the such differences. The proposed preponderance of the evidence shows requirement at then-current language was not intended to limit the that the therapeutic benefits of the § 201.57(c)(3)(i) to state that if evidence scope of the requirement to particular product do not generally outweigh its is available to support the safety and subgroups. The provision applies to any risks. In such situations, under sections effectiveness of the drug only in identifiable subgroup with a clearly 201(n) (21 U.S.C. 321) and 502(a) of the selected subgroups of the larger different response to a drug. The agency act, the agency can require that the population with the disease or believes the language in final ‘‘Indications and Usage’’ section state condition (e.g., patients with mild § 201.57(c)(2)(i)(B) and (c)(2)(i)(D) that there is a lack of evidence that the disease or patients in a special age makes clear that the section must drug is effective or safe for that use. group) or if evidence to support the discuss differential drug effects for all (Comment 49) One comment indication is based on surrogate types of patient subgroups for which requested that the agency provide endpoints, then the available evidence there is substantial evidence examples to clarify what it intends by and the limitations on the usefulness of establishing differences in effects. If this new requirement. the drug (or in the case of surrogate dosage modification is necessary based Anti-arrhythmia drugs are an example endpoints, the limitations of the on genetic characteristics, this must be of a category of drugs to which the new supporting efficacy data) must be described in the ‘‘Dosage and requirement in final § 201.57(c)(2)(ii) described succinctly in the ‘‘Indications Administration’’ section. FDA has could apply. They are typically effective and Usage’’ section (proposed revised proposed § 201.57(c)(3) in restoring or maintaining normal sinus § 201.57(c)(2)(iv)(A)). FDA proposed, accordingly (see § 201.57(c)(3)(i)(H) of rhythm for a variety of types of rhythm further, to require reference to the final rule). disturbances, but because of the ‘‘Clinical Studies’’ section of the FPI (Comment 48) One comment potential for pro-arrhythmic effects, (proposed § 201.57(c)(15)) for a detailed requested that FDA make clear when the they are typically indicated for only the discussion of the methodology and ‘‘Indications and Usage’’ section must more serious clinical situations in results of clinical studies relevant to include specific tests needed for which their benefits outweigh their such limitation(s). FDA also proposed to selection and monitoring of patients risks. For example, an anti-arrhythmic
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drug may be indicated for sustained interaction be included in the ‘‘Dosage include a statement indicating that there ventricular arrhythmia, but specifically and Administration’’ section. is no such information. not indicated for premature ventricular (Comment 52) One comment The agency agrees that information contractions. requested that all intravenous dosing about appropriate time of day to take a • Dosage and administration regimens in labeling be expressed in medication or other dosing (proposed § 201.57(c)(3)) rates of milligrams per hour. The considerations must be included in the FDA proposed to require that the comment pointed out that rates are ‘‘Dosage and Administration’’ section if ‘‘Dosage and Administration’’ section of expressed in milligrams per minute and this information is necessary for safe the FPI (proposed § 201.57(c)(3)) contain milligrams per hour. The comment and effective use (e.g., if a significant the same information as required in maintained that expressing all such amount of a therapeutic effect is lost if then-current § 201.57(j), except that the rates in milligrams per hour would the drug is not taken on an empty section must include efficacious or toxic avoid the need to recalculate rates and stomach). Therefore, the agency has drug or metabolite concentration ranges thus reduce the likelihood of revised proposed § 201.57(c)(3) to and therapeutic concentration windows medication errors. require that clinically significant dosing for drug or metabolite(s) where The agency does not agree that always information (e.g., clinically significant established and when clinically requiring rates of administration for food effects) be included in the ‘‘Dosage important. FDA proposed to require intravenous medications to be expressed and Administration’’ section. Similarly, information on therapeutic drug in milligrams per hour would avoid the the agency has revised proposed concentration monitoring (TDM), when need to recalculate rates of infusion and § 201.57(c)(13)(i)(B) of the ‘‘Clinical clinically necessary. The proposed thus reduce medication errors. The Pharmacology’’ section to clarify that provision also specified that dosing agency believes that these rates should certain recommendations regarding regimens must not be implied or be expressed per time unit that is most pharmacodynamic effects included in suggested in other sections of labeling if appropriate to the interval over which a other sections of labeling, such as the medication is to be administered. This not included in this section. FDA has ‘‘Dosage and Administration’’ section, approach will eliminate, to the extent retained this provision in the final rule must not be repeated in the ‘‘Clinical possible, the need to recalculate rates with some editorial revisions Pharmacology’’ section. and should, therefore, minimize error. The agency agrees that rigid (§ 201.57(c)(3)). (Comment 53) One comment stated compliance with the dosage regimen (Comment 50) One comment asked that, with respect to clinically important can be critical to safe and effective drug the agency to clarify whether the effectiveness and/or toxic drug and/or therapy and information about how to language in proposed § 201.57(c)(3), metabolite concentration ranges and manage noncompliance is important for ‘‘upper limit beyond which safety and therapeutic concentration windows in practitioners. Therefore, FDA has effectiveness have not been the ‘‘Dosage and Administration’’ revised proposed § 201.57(c)(3) to make established,’’ is referring to maximum section, effectiveness information other clear that important considerations tolerated dose. than information on TDM would more concerning compliance with the dosage The language does not refer to the appropriately be placed in the ‘‘Clinical regimen must be included. maximum tolerated dose. The upper Pharmacology’’ section. The comment The agency believes that the labeling limit beyond which safety and further stated that, if the concentration should not include a separate section effectiveness have not been established range concerned safety, it would more devoted to the importance of would ordinarily refer to: (1) The largest appropriately be included in the compliance with a drug’s dosage dose demonstrated to be safe and ‘‘Warnings and Precautions’’ section. regimen or information on what to do effective in controlled clinical trials, (2) The ‘‘Dosage and Administration’’ about missed doses, because this the largest dose evaluated that showed section must identify efficacious or information is most appropriately an increase in effectiveness (i.e., where toxic concentration windows of the drug contained in other sections of the studied larger doses provided no or its metabolites, if established and labeling (e.g., ‘‘Dosage and additional benefit), or (3) the largest clinically significant, and information Administration,’’ ‘‘Clinical dose beyond which safety has not been on TDM, when TDM is necessary. Pharmacology,’’ ‘‘Patient Counseling established or an unacceptable risk has Clinically relevant background Information’’). The agency believes that been demonstrated. information supporting the need for it would not be useful to include a (Comment 51) One comment TDM could appear in other sections of statement in the labeling indicating that requested that the agency make it clear labeling as appropriate (e.g., ‘‘Clinical there is no information available about that any dosage adjustments discussed Pharmacology,’’ ‘‘Clinical Studies,’’ management of noncompliance (e.g., in the ‘‘Drug Interactions’’ section ‘‘Adverse Reactions’’). missed doses). should also be presented in the ‘‘Dosage (Comment 54) Two comments • How supplied/storage and handling and Administration’’ section. recommended including instructions on (proposed § 201.57(c)(4)) The agency agrees that when there is the appropriate time of day to take a FDA proposed to require that the specific information about how to adjust drug and other dosing conditions (e.g., ‘‘How Supplied/Storage and Handling’’ dosage because of a drug interaction, take with food, take on an empty section of the FPI (proposed this information must be included in the stomach) in the ‘‘Dosage and § 201.57(c)(4)) contain the same ‘‘Dosage and Administration’’ section. Administration’’ section of the labeling. information as required at then-current The ‘‘Dosage and Administration’’ One comment requested that the § 201.57(k), except that a new provision section should also refer the reader to labeling include a section concerning was added at proposed § 201.57(c)(4)(v). the more detailed discussion of the drug the importance of compliance with the Proposed § 201.57(c)(4)(v) would interaction in the ‘‘Drug Interactions’’ dosage regimen and instructions on require a statement specifying the type and ‘‘Clinical Pharmacology’’ sections. what to do about missed doses and of container to be used by pharmacists In response to this comment, FDA has noncompliance in general. The in dispensing the product. Comments modified proposed § 201.57(c)(3) to comment requested that, in the absence pertaining to proposed § 201.57(c)(4)(v) require that information on dosage of data to support instructions on what are addressed in section VI.J of this adjustments needed because of a drug to do about noncompliance, the labeling document (‘‘Comments on Revisions to
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Container Labels’’; see comments 106 Precautions’’ section. The comments adverse reactions in the ‘‘Warnings and through 110). Comment 41 addresses agreed with FDA’s findings, based on Precautions’’ section from ‘‘serious’’ to relocation of the ‘‘How Supplied/ physician surveys and focus testing, that ‘‘clinically significant’’ adverse Storage and Handling’’ section to the distinction between warnings and reactions. There was concern that the § 201.57(c)(17) and the retention of precautions is not meaningful to significance of the adverse reactions critical prescribing information in the practitioners who use labeling. The discussed in the ‘‘Warnings and ‘‘Dosage Forms and Strengths’’ section comments stated that the combined Precautions’’ section would be diluted at § 201.57(c)(4). A comment pertaining section would make the discussion of by the inclusion of less serious adverse to the format for and type of information risk information in labeling less reactions in the section, thus contained in these sections is discussed repetitive, less confusing, and more undermining the value of the section. here. accessible. Other comments expressed concern that (Comment 55) One comment (Comment 56) In the proposal, the ‘‘clinically significant’’ is subject to recommended including product agency specifically sought comment on interpretation and could, in application, identity markings in this section. The whether there should be standardized result in inconsistency across labeling comment also recommended bulleted or headings for categories of adverse for different products. tabular presentation of product identity reactions in the proposed ‘‘Warnings As discussed in the preamble markings, color, flavor, package sizes, and Precautions’’ section and, if there accompanying the proposed rule (65 FR strengths, storage conditions, etc., to should be, what standardized headings 81082 at 81092), ‘‘serious’’ was changed make such information more accessible. would be appropriate. to ‘‘clinically significant’’ to expand the FDA agrees with the comment that Comments uniformly opposed scope of the ‘‘Warnings and product identity markings are useful for standardized headings to categorize Precautions’’ section to allow for practitioners and, therefore, now adverse reactions in the ‘‘Warnings and inclusion of adverse reactions that may includes imprinting as an example of an Precautions’’ section. Comments not meet the regulatory definition of identifying characteristic in both the expressed concern that standardized ‘‘serious’’ (§ 312.32(a)), but nonetheless ‘‘Dosage Forms and Strengths’’ and the headings would not provide sufficient have a significant impact on clinical use ‘‘How Supplied/Storage and Handling’’ flexibility to accommodate the diversity of the drug. The agency believes that sections of the final rule. FDA also of risk information that might be information on both types of adverse agrees that presenting information about appropriate for inclusion in the reactions is necessary for practitioners product identity markings, color, flavor, ‘‘Warnings and Precautions’’ section. to prescribe products safely and package sizes, strengths, storage FDA agrees that standardized effectively and must, therefore, be conditions, and other identifying headings should not be required in the included in the ‘‘Warnings and information in a bulleted or table format ‘‘Warnings and Precautions’’ section Precautions’’ section. The agency will make the information more because a requirement to place risk acknowledges that inclusion of less accessible, particularly where the information under prescribed headings serious but clinically significant adverse product has many dosage forms and could make the information less clear or reactions may add to the overall length strengths. However, because the amount more difficult to find. of the ‘‘Warnings and Precautions’’ and content of information can vary (Comment 57) One comment section of labeling for certain drugs. The significantly from product to product, requested clarification of the agency does not agree, however, that the FDA is not requiring a specific format. requirement in proposed effect will be to dilute or deemphasize • Warnings and precautions § 201.57(c)(6)(iii) that the ‘‘Warnings the importance of serious adverse (proposed § 201.57(c)(6)) and Precautions’’ section identify any reactions contained in the section. The FDA proposed to revise the content of laboratory tests that ‘‘may be helpful’’ in agency believes that limiting inclusion the ‘‘Warnings’’ and ‘‘Precautions’’ following a patient’s response or of nonserious adverse reactions to only sections. First, FDA proposed to require identifying possible adverse reactions. those that have significant impact on that information on drug interactions, The comment maintained that the therapeutic decisionmaking (e.g., may information on specific populations language ‘‘may be helpful’’ is too vague reduce compliance with drug therapy) (i.e., pregnancy, labor and delivery, and recommended that the language be ensures that the intended scope of the nursing mothers, pediatric, and geriatric changed to specify that only laboratory ‘‘Warnings and Precautions’’ section is use information), and information for tests that ‘‘have been shown to be preserved. patients be moved from the helpful’’ be required in the ‘‘Warnings (Comment 59) One comment ‘‘Precautions’’ section to three new and Precautions’’ section. recommended that the agency describe sections (described in proposed The agency is concerned that limiting parameters upon which to base § 201.57(c)(7), (c)(8), and (c)(17) the scope of laboratory testing decisions about the sequence in which respectively). Second, FDA proposed to recommendations identified in labeling adverse reactions are presented in the require that the remainder of the to only those tests that have been ‘‘Warnings and Precautions’’ section. information in the ‘‘Precautions’’ ‘‘shown to be helpful’’ in monitoring There are multiple factors that could section, with the information from the patients could exclude sensible and influence the sequence in which ‘‘Warnings’’ section, be combined into a potentially important laboratory testing adverse reactions should be presented new section entitled ‘‘Warnings and recommendations. The agency agrees, in the ‘‘Warnings and Precautions’’ Precautions’’ (proposed § 201.57(c)(6)). however, that ‘‘may be helpful’’ is a section. The most significant include FDA also proposed to require that the vague standard and, therefore, has the relative seriousness of the adverse ‘‘Warnings and Precautions’’ section amended the provision to require reaction, the ability to prevent or include information on contacts for identifying any laboratory tests mitigate the adverse reaction, the adverse reaction reporting (proposed ‘‘helpful’’ in following a patient’s likelihood the adverse reaction will § 201.57(c)(6)(v)). See comment 30 response or identifying possible adverse occur, and the size of the population regarding deletion of proposed reactions. affected. In general, the sequence of the § 201.57(c)(6)(v). (Comment 58) Several comments adverse reactions should reflect the Several comments supported expressed concern about the proposal to relative public health significance, and reorganizing the ‘‘Warnings and change the criteria for inclusion of the seriousness of the adverse reaction
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should weigh more heavily than the included in the ‘‘Clinical ranked by order of the strength of the likelihood of occurrence or the size of Pharmacology’’ section. Thus, the data supporting the existence of an the affected population. The agency has agency has revised proposed interaction. added clarifying language to this § 201.57(c)(7)(i) and (c)(13)(i)(D) to FDA believes that relative clinical requirement to assist in selecting and provide this clarification (see significance of the drug interaction organizing information in this section. § 201.57(c)(8)(i) and (c)(13)(i)(C)). would ordinarily be the most reasonable The agency is also making available (Comment 61) One comment stated basis for determining the order of guidance on the ‘‘Warnings and that the labeling example published presentation of drug interactions. Precautions’’ section, which provides with the proposed rule included Because, for certain products, this recommendations on sequencing of recommended dosage adjustments for section can be lengthy and complex, the adverse reactions (see section IV of this drug interactions that are not based on agency will not designate a specific document). clinical experience and requested order in the regulations. In addition, the final rule clarification about whether the (Comment 64) One comment (§ 201.57(c)(6)(i)) states that FDA may manufacturer must include speculative recommended that, in the following require labeling to include a specific interactions and dosage adjustments in language from the proposed provision warning relating to a use that is not this section. The comment also asked to for the ‘‘Drug Interactions’’ section, the provided for under the ‘‘Indications and what extent sponsors would be required word ‘‘patients’’ be replaced with the Usage’’ section if the drug is commonly to develop clinical data to support word ‘‘humans’’: ‘‘Information in this prescribed for a disease or condition dosage adjustments for drug section must be limited to that and such usage is associated with interactions. pertaining to clinical use of the drug in clinically significant risk or hazard. Manufacturers must not speculate in patients.’’ The comment maintained that FDA deleted language from proposed labeling. Information from clinical drug interaction studies often involve § 201.57(c)(6)(i), (i.e., ‘‘and there is a experience is clearly the most healthy volunteers, rather than patients, lack of substantial evidence of persuasive, but other relevant data, such and the language in the regulation effectiveness for that disease or as pharmacokinetic data, in vitro data, should reflect the nature of the study condition’’) because the requirement for and data from other drug products in participants. a warning is based on an assessment of the same pharmacologic or chemical The agency has revised final risk. In addition, FDA also clarified that class, may reliably predict the § 201.57(c)(8)(i) to clarify the scope of its authority under this provision must likelihood of an interaction with the the information to be included in this be exercised in accordance with drug or provide a basis for a dosage section and this sentence was deleted. sections 201(n) and 502(a) of the act. adjustment recommendation. Therefore, (Comment 65) One comment • Drug interactions (proposed it would not be appropriate to limit the requested that the agency clarify the § 201.57(c)(7)) scope of the drug interactions and requirement in the proposed ‘‘Drug FDA proposed to require a ‘‘Drug dosage adjustment information in Interactions’’ section to briefly describe Interactions’’ section (proposed labeling to only those interactions or the mechanism of interaction for drugs § 201.57(c)(7)) containing the same dosage adjustments for which there are and drug classes that interact with a information as required by the ‘‘Drug clinical data. drug in vivo. The comment maintained interactions’’ subsection of the (Comment 62) One comment stated that the mechanism is not always ‘‘Precautions’’ section at then-current that including discussions of dosage understood and requested that the rule § 201.57(f)(4). adjustments to address drug interactions specify that the requirement to describe (Comment 60) Most comments in both the ‘‘Drug Interactions’’ and the mechanism applies only if the supported creation of a distinct section ‘‘Dosage and Administration’’ sections mechanism is understood. for drug interactions. These comments would add unnecessarily to the length The agency agrees. Proposed maintained that the new section would of the labeling. § 201.57(c)(7) (§ 201.57(c)(8)(i) in this improve the safety of drugs for patients FDA does not agree that discussing final rule) has been revised to state that on multiple medications. One comment dosage adjustments for drug interactions the mechanism of an interaction must asked FDA to clarify whether in both the ‘‘Drug Interactions’’ section be briefly described, if it is known. discussions of drug interaction and the ‘‘Dosage and Administration’’ • Use in specific populations pharmacokinetic studies should be section would be unnecessary or (proposed § 201.57(c)(8)) repeated in the ‘‘Clinical Pharmacology’’ repetitive because the purposes of the FDA proposed to require a new section. sections are distinct (see comment 51). section entitled ‘‘Use in Specific How to divide information on drug The ‘‘Drug Interactions’’ section alerts Populations’’ (proposed § 201.57(c)(8)) interactions between the ‘‘Clinical the prescriber to the existence of to include the information on specific Pharmacology’’ and ‘‘Drug Interactions’’ interactions and provides a place for populations required in the sections is a matter of judgment. substantive discussion of the nature of ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ Manufacturers must not include a the identified interactions, including ‘‘Nursing mothers,’’ ‘‘Pediatric use,’’ and detailed discussion of drug interaction practical advice about preventing or ‘‘Geriatric use’’ subsections of the pharmacokinetic studies in both the limiting interactions. The ‘‘Dosing and ‘‘Precautions’’ section at then-current ‘‘Drug Interactions’’ and the ‘‘Clinical Administration’’ section provides § 201.57(f)(6) through (f)(10). The Pharmacology’’ sections. Ordinarily, specific information about how to agency also proposed to revise certain clinically significant results and modify the dose to minimize the risk of required warning language in the conclusions of such studies must appear drug interactions when such labeling of drugs in pregnancy in the ‘‘Drug Interactions’’ section and information is available, but does not categories D and X (proposed clinically significant information on provide the details that are discussed in § 201.57(c)(8)(i)(A)(4) and dosing modifications in the ‘‘Dosage and the ‘‘Drug Interactions’’ section. (c)(8)(i)(A)(5)). The proposal would have Administration’’ section. If additional (Comment 63) One comment replaced the following language from details about the design or conduct of recommended revising the ‘‘Drug then-current § 201.57(f)(6)(i)(d) and the studies are relevant to the clinical Interactions’’ section to require the (f)(6)(i)(e): ‘‘If this drug is used during use of the drug, the information must be presentation of drug interaction data pregnancy, or if the patient becomes
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pregnant while taking this drug, the the pregnancy labeling with this guidance to clarify these concepts and patient should be apprised of the rulemaking to revise the requirements of conduct an educational campaign to potential hazard to the fetus.’’ The prescription drug labeling generally. explain the meaning and significance of proposed alternative language, which The comment maintained that the the new definition. Several comments was intended to address the concern pregnancy labeling requirements need maintained that the definition of an that any woman with reproductive to be changed expeditiously to require adverse reaction in then-current potential should be apprised of the risk that the labeling address the likelihood § 201.57(g) is a more accurate associated with taking the category D of harm to the fetus based on timing of description of the events that should be and X drugs during pregnancy, read: ‘‘If exposure, pharmacokinetic changes in included in labeling. this drug is administered to a woman pregnant women, and the relevance of One comment expressed concern that with reproductive potential, the patient animal data to humans. the proposed definition of adverse should be apprised of the potential The agency does not agree that the reaction could result in excluding hazard to a fetus.’’ two initiatives should be combined. The adverse events that should be included FDA also proposed some changes in pregnancy labeling initiative focuses in the labeling because there is a lack of terminology to the ‘‘Nursing mothers’’ exclusively on revising the content guidance for determining ‘‘reasonable subsection (proposed § 201.57(c)(8)(iii)). requirements for the pregnancy causality’’ to identify which adverse For example, FDA proposed to change subsection of labeling to meaningfully reactions to list. The comment said that the term ‘‘nursing mothers’’ to ‘‘lactating describe the risks associated with fetal it is commonly known that prescription women.’’ Other proposed changes and maternal exposure to a drug and the drug labeling lists all adverse reactions included making assessments based on clinical implications of those risks. In that occurred in trials, with definite, ‘‘clinically significant adverse contrast, this final rule is focused on probable, possible, and remote reactions’’ rather than ‘‘serious adverse revising the format and content of causality. The comment recommended reactions.’’ labeling to increase its usefulness for that significant adverse reactions be (Comment 66) Several comments health care practitioners. listed in Highlights and reinforced in supported creation of a section devoted • Adverse reactions—definition of the full prescribing information. The to information about use in specific adverse reaction (proposed comment also stated that all other populations. The comments indicated § 201.57(c)(9)) events that occurred should still be that placing all the information on FDA proposed to revise the definition listed, perhaps last in the specific populations in one labeling of ‘‘adverse reaction’’ to mean a comprehensive ‘‘Adverse Reactions’’ section would make the information ‘‘noxious and unintended response to section, because the loss of a much easier to locate. However, one any dose of a product for which there comprehensive listing of all reported comment stated that the revised is a reasonable possibility that the events could be detrimental to patient warning statement for drugs in product caused the response, i.e., the safety. pregnancy categories D and X no longer relationship cannot be ruled out’’ Some comments stated that the makes clear that a pregnant woman (proposed § 201.57(c)(9)). proposed new definition for an adverse receiving the drug should be apprised of (Comment 68) Several comments reaction was a marked improvement the potential hazard to the fetus. The objected to the revised definition of an because it would narrow the scope of comment expressed concern that the adverse reaction in proposed the ‘‘Adverse Reactions’’ section. These phrase ‘‘women with reproductive § 201.57(c)(9). The comments comments contended that narrowing the potential’’ could be interpreted as maintained that this definition would be scope of events considered adverse referring only to women with the too restrictive and could result in reactions for purposes of the ‘‘Adverse potential to become pregnant and not to omission of important information. Reactions’’ section would help address those who actually are pregnant. Comments expressed particular concern long-standing practitioner concerns that The agency is developing a proposal that the terms ‘‘noxious’’ and the section is not very informative that would revise the requirements for ‘‘unintended’’ could be applied to because it contains excessively long lists the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ exclude important adverse reactions. of reactions, many of which are not and ‘‘Nursing mothers’’ subsections of They also stated that important relevant to clinical use of the drug. prescription drug labeling. For this information could be excluded from the The agency has reconsidered the reason, the agency has reconsidered the ‘‘Adverse Reactions’’ section because proposed definition of an adverse need to make minor, interim changes to manufacturers could narrowly construe reaction, which was intended to the warning statements for pregnancy whether the drug caused the event. conform to the definition of adverse categories D and X in this final rule and Comments maintained, for example, drug reaction for safety reporting in the has decided to retain the language at that an adverse reaction that affects International Conference on former § 201.57(f)(6)(i)(d) and (f)(6)(i)(e). compliance could be considered Harmonisation of Technical This language clearly addresses use of clinically meaningful and thus merit Requirements for Registration of the drug by pregnant women and discussion in the ‘‘Warnings and Pharmaceuticals for Human Use (ICH) obviates the need for the changes Precautions’’ section, but be excluded guidance ‘‘E2A Clinical Safety Data advocated by the comment. from the ‘‘Adverse Reactions’’ section Management: Definitions and Standards FDA also decided not to make interim because it is not considered noxious or for Expedited Reporting’’ (60 FR 11284 changes to the ‘‘Nursing mothers’’ unintended. Some comments requested at 11285, March 1, 1995). subsection of the labeling and will clarification of elements of the Upon consideration of the comments retain the language at former definition—in particular ‘‘noxious,’’ submitted in response to this proposal, § 201.57(f)(8) for this subsection. The ‘‘unintended,’’ and ‘‘injurious to the agency concluded that it should not agency believes that it is best to address health.’’ One comment recommended require use of a new definition of all changes to the content of these that ‘‘unintended’’ be changed to adverse reaction for labeling of new and subsections at one time. ‘‘unexpected,’’ stating that recently approved products. The agency (Comment 67) One comment ‘‘unexpected’’ may more accurately believes that the language in the requested that the agency combine the reflect the intent of the definition. One definition of adverse reaction at former initiative to revise the requirements for comment requested that FDA issue § 201.57(g) (designated in the final rule
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as § 201.57(c)(7)), in particular ‘‘an The concerns expressed in these this section is organized and presented undesirable effect, reasonably associated comments are based on the proposed across different drug products. To with use of a drug, that may occur as adverse reaction definition. Because the address this problem, the agency part of the pharmacological action of the agency is not adopting this definition recommends, in the ‘‘Adverse drug or may be unpredictable in its for the purposes of labeling, FDA Reactions’’ section guidance, an occurrence’’ is appropriate for labeling, believes that the concerns expressed in organization for the typical components but that it requires clarification, as these comments are no longer of the ‘‘Adverse Reactions’’ section. described in the next paragraph, to applicable. Thus, FDA continues, as minimize including information in • Adverse reactions— recommended by the comment, to labeling that does not help prescribers characterization of adverse reactions provide general requirements in use the drug safely and effectively (i.e., (proposed § 201.57(c)(9)(ii)) regulation and detailed adverse events that are not related to use FDA proposed to retain the language recommendations in guidance. The of the drug), and that may result in from then-current § 201.57(g)(2) in ‘‘Adverse Reactions’’ section guidance diluting the usefulness of clinically proposed § 201.57(c)(9)(ii): provides recommendations for how to meaningful information. Thus, FDA In this listing, adverse reactions may be select information for inclusion in this will, as recommended by several categorized by organ system, by severity of section, how to characterize the comments, continue to use its existing the reaction, by frequency, or by toxicological information, and how to further definition for adverse reaction. mechanism, or by a combination of these, as organize it (see section IV of this The agency believes, as previously appropriate. If frequency information from document). indicated, that the definition of adverse adequate clinical studies is available, the (Comment 71) One comment reaction at former § 201.57(g) requires categories and the adverse reactions within recommended that manufacturers be each category must be listed in decreasing clarification. For this purpose, FDA has order of frequency. An adverse reaction that required to specify in the ‘‘Adverse revised this definition to make clear that is significantly more severe than the other Reactions’’ section what categorization it is specific to prescription drug reactions listed in a category, however, must scheme was employed for listing of the labeling and does not include all be listed before those reactions, regardless of adverse reactions. adverse events observed during use of a its frequency. If frequency information from The agency believes that, in most drug, but only those adverse events for adequate clinical studies is not available, the cases, the basis for the categorization of which there is some basis to believe categories and adverse reactions within each ‘‘Adverse Reactions’’ section will be there is a causal relationship between category must be listed in decreasing order of readily apparent to readers. In rare the drug and the occurrence of the severity.* * * instances in which the basis for adverse event. There are many factors to (Comment 70) One comment categorization is not apparent, it would consider in assessing the association requested that the agency reconcile be appropriate to identify the between a drug and a reported adverse apparent inconsistencies between the categorization scheme employed. The event and determining whether a draft of the ‘‘Adverse Reactions’’ section agency has, therefore, determined that it reported event is an adverse reaction guidance in development and the is not necessary to require in regulation that should be included in labeling. The language in the ‘‘Adverse Reactions’’ that the basis for categorization of agency has included clarifying language section of the proposed rule. The adverse reactions be identified for all in this final rule to assist in selecting comment maintained that the labeling. and organizing reactions. To further recommended organization in the draft The agency has revised, for the assist manufacturers and reviewers, ‘‘Adverse Reactions’’ section guidance is reasons described in the response to FDA is making available the ‘‘Adverse not consistent with the organization of comment 70, proposed § 201.57(c)(9)(ii) Reactions’’ section guidance (see section the ‘‘Adverse Reactions’’ section in the (designated in this final rule as IV of this document). proposed rule. This comment advocated § 201.57(c)(7)(ii)) to provide clarification (Comment 69) One comment that important points regarding adverse for this part of the ‘‘Adverse Reactions’’ expressed concern that inclusion of an reactions be discussed in both the section. The agency changed the term adverse reaction in the ‘‘Adverse proposed rule and the ‘‘Adverse ‘‘organ system’’ to ‘‘body system.’’ Reactions’’ section under the proposed Reactions’’ section guidance, with Although the two terms have been used definition would be tantamount to an extensive detail provided in the interchangeably, currently, the term admission that the event was caused by guidance document. ‘‘body system’’ is used most often. a drug for product liability purposes. Based on this comment and on In addition, the agency deleted the Another comment stated that having comments received on the draft option to categorize adverse reactions by two definitions for adverse reactions ‘‘Adverse Reactions’’ section guidance, toxicological mechanism. After (i.e., the definition in proposed the agency has revised the regulation on reviewing the 1975 proposed and 1979 § 201.57(c)(9) for new and recently the ‘‘Adverse Reactions’’ section at final rules, the agency concluded that approved drugs and the definition in proposed § 201.57(c)(9) (designated in the term is not clear; therefore, redesignated § 201.80(g) for older drugs) this final rule as § 201.57(c)(7)) to clarify categorization by toxicological may have implications for product the scope of information for this section mechanism is not an appropriate option liability. One comment stated that of labeling. See comments 71 through for the ‘‘Adverse Reactions’’ section. application of the proposed adverse 75. The agency also made clear that, reactions definition to drugs that have to The agency recognizes that the however categorized, adverse reactions revise their labeling to implement the ‘‘Adverse Reactions’’ section has must be listed in order of decreasing new format would require reevaluation evolved over time to a point where it frequency. of clinical data and a new safety review now typically contains several different FDA also removed the requirement by the agency. One comment requested components (e.g., information from that significantly more severe reactions the agency clarify whether controlled clinical trials, uncontrolled be listed before other reactions manufacturers would now have to clinical trials, and postmarketing regardless of frequency. In most cases, reclassify or otherwise reassess adverse experience). The agency also recognizes frequency information is paramount, but reactions profiles of products with that there exists considerable in other cases, severity information may existing labeling. inconsistency in how information in be more important or a combination of
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the two may be the best approach. The estimation of incidence calculations from one indication or population to categorization scheme selected for the difficult. another, the differences are drug related, ‘‘Adverse Reactions’’ section should be Because these differences and the data have important clinical appropriate to the drug’s safety database significantly affect the interpretation of implications. On the other hand, where and reflect the relative public health these complementary sets of data, the differences are relatively minor and not importance of the information. agency believes it is important to clinically meaningful, separate The agency also clarified that if data separate in labeling adverse reactions presentations for multiple indications are available and important for adverse identified in clinical trials from adverse would not be informative and would reactions with significant clinical reactions identified from domestic and detract from more important implications, details about the nature, foreign spontaneous reports. For information. frequency, and severity of the reaction precisely these reasons, in the draft (Comment 74) One comment must be included. This provision makes ‘‘Adverse Reactions’’ section guidance, requested that the ‘‘Adverse Reactions’’ clear that, in many cases, in addition to FDA suggested segregating adverse section discuss differences in adverse lists of adverse reactions, descriptive reactions from spontaneous reports in reaction rates among different information is appropriate for inclusion this section of the labeling. Thus, the demographic subgroups (e.g., men, in the ‘‘Adverse Reactions’’ section. agency has revised proposed women, blacks, renally-impaired). (Comment 72) One comment § 201.57(c)(9)(ii) (§ 201.57(c)(7) in this The agency agrees that the ‘‘Adverse requested that the agency require that final rule) by creating a separate listing Reactions’’ section must include adverse reactions identified from for each set of adverse reactions within information on differences in adverse postmarketing experience be listed the ‘‘Adverse Reactions’’ section. reactions among demographic separately from adverse reactions The agency clarifies that this subgroups where sufficient data are identified from clinical trials. distinction is between adverse reactions available and important. Thus, the The agency agrees that adverse identified in clinical trials and those agency has revised proposed reactions identified from domestic and identified from domestic and foreign § 201.57(c)(9) (designated in this final foreign spontaneous reports after a drug spontaneous reports after a drug is rule as § 201.57(c)(7)) to require such is marketed should be listed separately marketed. Adverse reactions that are information in the ‘‘Adverse Reactions’’ from adverse reactions identified in identified in clinical trials conducted section. clinical trials. Adverse reaction data after a drug is marketed would be listed • Adverse reactions—frequency from clinical trials and spontaneous under adverse reactions identified from information (proposed § 201.57(c)(9)(ii)) reports communicate different clinical trials. FDA proposed to retain the language information to practitioners. In clinical (Comment 73) One comment from then-current § 201.57(g)(2) in trials, subjects are specifically queried requested that, for drugs with multiple proposed § 201.57(c)(9)(ii): about and evaluated for occurrence of doses or indications, the ‘‘Adverse The approximate frequency of each adverse adverse events and clinical investigators Reactions’’ section have a separate reaction must be expressed in rough have requirements for identifying and presentation of adverse reactions for estimates or orders of magnitude essentially reporting such events (21 CFR each dose or indication. as follows: 312.64(b)). Data from clinical trials The agency agrees that it is important The most frequent adverse reaction(s) to inform practitioners about the range of for the ‘‘Adverse Reactions’’ section to (name of drug) is (are) (list reactions). This call attention to adverse reactions for (these) occur(s) in about (e.g., one-third of adverse reactions that may occur. In patients; one in 30 patients; less than one- addition, because there is typically a which there are clinically significant tenth of patients). Less frequent adverse comparison to a control group, these dose-response relationships. reactions are (list reactions), which occur in data provide an estimate of the Thus, the agency has revised approximately (e.g., one in 100 patients). incidence and the ability to identify proposed § 201.57(c)(9) (designated in Other adverse reactions, which occur rarely, events that, because they are likely to be this final rule as § 201.57(c)(7)) to in approximately (e.g., one in 1,000 patients), causally related, represent adverse require manufacturers to include details are (list reactions). reactions. about the relationship of adverse Percent figures may not ordinarily be used Postmarketing experience with a drug reactions to drug dose where sufficient unless they are documented by adequate and permits observation of suspected data are available and necessary to well-controlled studies as defined in § 314.126(b) of this chapter (except for adverse reactions in a larger, often more prescribe the drug safely and effectively. biological products), they are shown to diverse, patient population. This The agency does not believe, however, reflect general experience, and they do not experience may provide an opportunity that it needs to require that separate falsely imply a greater degree of accuracy to identify low frequency reactions and presentations of adverse reactions than actually exists. reactions not previously observed always be included for different doses. For biological products, such figures because the susceptible population was If there are important differences in must be supported by substantial either excluded from the controlled adverse reaction rates for different evidence. trials or only included in small doses, the section can include a single (Comment 75) One comment asked numbers. But, to interpret this table that directly compares the adverse the agency to clarify an apparent information accurately, a practitioner reactions rates for different doses. inconsistency between the proposed must be mindful that postmarketing Presenting rates for different doses side rule and the draft ‘‘Adverse Reactions’’ experience, although more closely by side in a table, for example, is an section guidance concerning how to reflective of clinical practice, lacks the effective way to make a dose-response characterize the incidence of adverse structure of a clinical trial setting that relationship apparent. reactions. The comment pointed out permits increased precision. For The agency also does not believe that that the proposed rule (which used the postmarketing reporting, the impetus for it needs to require a separate same language as in the 1979 final rule) reporting, the frequency with which a presentation of adverse reactions for recommended grouping adverse suspected adverse reaction is reported, each indication. Such information could reactions by rough orders of magnitude and the number of exposures to the drug be appropriate for a drug with multiple and encouraged use of the terms compared to the number of suspected indications, however, when the adverse ‘‘frequent,’’ ‘‘infrequent,’’ and ‘‘rare’’ in reactions reported are unknown, making reaction profile differs substantially conjunction with orders of magnitude
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appropriate for a given drug’s safety a clearer way to communicate rough subsections—‘‘Mechanism of action,’’ database. The comment observed that rates of incidence for a group of adverse ‘‘Pharmacodynamics,’’ and agency guidance discouraged use of reactions. Therefore, the agency has ‘‘Pharmacokinetics.’’ Proposed these terms when grouping by rough revised proposed § 201.57(c)(9) to § 201.57(c)(13) also provided for an orders of magnitude. require that adverse reactions for which optional subsection for incorporation of The agency agrees that clarification is meaningful percentage rates cannot be other clinical pharmacology information needed regarding presentation of reliably determined (e.g., adverse that does not fit into one of the specified incidence information for adverse reactions were observed only in the subsections. reactions. The language in the proposed uncontrolled trial portion of the overall (Comment 78) One comment rule is not sufficiently precise to safety database), be grouped within recommended that the ‘‘Clinical accurately reflect current practices in specified frequency ranges as Pharmacology’’ section be revised to characterizing the incidence of adverse appropriate to the safety database of the require discussion of a drug’s reactions associated with the use of a drug (e.g., adverse reactions occurring at elimination half-life, indicate drug product. The preamble to the 1975 a rate of less than 1/100, adverse differences in elimination half-life as a proposed rule indicates that precise reactions occurring at a rate of less than function of age or other subpopulation, percent figures would be appropriate if 1/500) or descriptively identified, if and specify the enzyme involved in there is scientific evidence from well- frequency ranges cannot be determined. metabolism (e.g., CYP450). controlled trials substantiating such (Comment 76) One comment Under the final rule, elimination half- figures and when inclusion of percent requested clarification on how life of drugs and differences in the figures does not falsely imply a greater percentages should be used to elimination half-life as a function of degree of accuracy than actually exists characterize the frequency of adverse specific populations (including age- (40 FR 15392 at 15393, April 7, 1975). reactions when percentages are derived related populations) must be reported in The science of clinical trials has from studies that evaluated greater the ‘‘Pharmacokinetics’’ subsection of progressed so substantially over time doses than the approved dose. The the ‘‘Clinical Pharmacology’’ section of that ascertaining such rates is typically comment asked whether, in this the labeling (§ 201.57(c)(13)(i)(C)). In part of virtually all drug development circumstance, rates of adverse reactions addition, if there are clinically programs. should be omitted from the ‘‘Adverse significant differences in elimination Under current labeling practices, rates Reactions’’ section. half-lives among specific populations of incidence for most adverse reactions The agency will determine, during and those differences require special identified in controlled clinical trials review of an application, whether monitoring or alternate dosing regimens, are expressed as percentages. Current adverse reaction rates derived from such information must be included in labeling also typically includes doses greater than recommended doses other sections, such as ‘‘Use in Specific percentage rates for comparison groups would be informative for practitioners Populations,’’ ‘‘Warnings and in clinical trials (e.g., placebo group) and not misleading, and thus Precautions,’’ and ‘‘Dosage and where inclusion of such rates would not appropriate for inclusion in labeling. Administration.’’ Information about be misleading. Broader frequency ranges Where there are adverse reaction data drug metabolism, including metabolic are used only when meaningful from studies using different doses, pathways and the enzyme systems percentage rates cannot be determined. including doses greater than involved, is also required in the Therefore, the agency has revised recommended doses, the agency will ‘‘Pharmacokinetics’’ subsection of the proposed § 201.57(c)(9) (designated in evaluate whether pooling or otherwise ‘‘Clinical Pharmacology’’ section. this final rule as § 201.57(c)(7)) to make combining adverse reaction data would (Comment 79) One comment it clear that when meaningful adverse more accurately describe the frequency requested that FDA clarify the statement reaction rates can be derived (for drug of adverse reactions. in proposed § 201.57(c)(13)(i)(B): ‘‘If treatment group and comparison (Comment 77) One comment pharmacokinetic/pharmacodynamic groups) and presentation of comparator requested clarification on whether relationships are not demonstrated or rates would not be misleading, they manufacturers are required to identify are unknown, the labeling must contain must be included in labeling. the total number of patients enrolled in a statement about the lack of The agency also believes it is clinical trials in the ‘‘Adverse information.’’ The comment asked that inappropriate to use nonspecific terms Reactions’’ section. FDA clarify whether the provision is such as ‘‘frequent,’’ ‘‘infrequent,’’ and FDA has revised proposed referring to concentration versus ‘‘rare’’ when presenting adverse reaction 201.57(c)(9)(i) (designated in this final response relationships generally. information. The agency believes the rule as 201.57(c)(7)(i)) to clarify that the In response to this comment, the science of clinical trials has evolved total number of subjects or patients agency has rephrased this provision, as such that use of those terms in the exposed to the drug, and the extent of follows: ‘‘Exposure-response manner recommended by the 1979 rule exposure, must be identified in the relationships (e.g., concentration- is confusing because the terms do not ‘‘Adverse Reactions’’ section, so that response, dose-response) and time necessarily refer to the same frequency practitioners can interpret the course of pharmacodynamic response range across different drug products. For significance of the data in this section. (including short-term clinical response) example, for product A, ‘‘rare’’ might The ‘‘Adverse Reactions’’ section must be included if known.’’ (See final mean an incidence of less than 1/500, guidance provides recommendations on § 201.57(c)(13)(i)(B).) but for product B, ‘‘rare’’ might mean an how to describe the database from (Comment 80) One comment stated incidence of less than 1/1000. Moreover, which the adverse reaction data in this that the three new subsections in the the terms are imprecise and, even if section are derived (see section IV of ‘‘Clinical Pharmacology’’ section will precise meanings were defined, would this document). make it easier to find information in the reinforce the misconception that • Clinical pharmacology (proposed section. frequency is synonymous with § 201.57(c)(13)) One comment requested that in vitro seriousness. FDA proposed to require that the data supporting the ‘‘Mechanism of The agency believes that identifying ‘‘Clinical Pharmacology’’ section action’’ subsection in the ‘‘Clinical the numerical frequency range alone is (proposed § 201.57(c)(13)) contain three Pharmacology’’ section be permitted to
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be included in the subsection because process by which a waiver could be inclusion in labeling of in vitro data not such information is helpful in granted. supported by clinical data and how to understanding a drug’s physiologic Several comments expressed concern use such data in making prescribing activity and in differentiating a drug about the implications of removing in decisions. from other therapeutic agents. vitro data for devising susceptibility At this time, the agency will continue The agency agrees that the three new tests for new anti-infective drugs. They to rely on the algorithm in its current subsections should make information stated that these data are relied on by guidance on clinical development and easier to find. Because 201.56(d)(2) FDA (the Center for Devices and labeling of anti-infectives for (proposed 201.56(d)(5)) permits Radiological Health) and by determining when to include in vitro additional nonstandard subsections, manufacturers of in vitro susceptibility data in the ‘‘Clinical Pharmacology’’ FDA deleted ‘‘12.4 other clinical tests in selecting appropriate organisms section of labeling. As part of the pharmacology information’’ (proposed for which to devise tests. In addition, comprehensive evaluation of the way in 201.57(c)(13)(i)(D)) from the final rule. comments stated the data are used to which anti-infective therapies are The ‘‘Mechanism of action’’ develop quality control mechanisms for, currently developed and labeled (see subsection must include information and to help develop criteria for use in response to comment 81), the agency based on in vitro data if the information the review and clearance of, may reconsider use of the algorithm and is essential to a description of the susceptibility test devices. Some make any changes that may be needed. established mechanism of action and comments maintained that removal of in For this reason, the agency will not at the information is clinically relevant. vitro data would cause manufacturers this time undertake an educational Where in vitro information about not to develop susceptibility tests for campaign to educate prescribers about mechanism of action is included, the organisms for which such tests would the basis for inclusion of in vitro data information must not be used as the be desirable. in labeling. One comment supported exclusion of basis for a clinical comparison (i.e., to (Comment 83) Several comments in vitro data from labeling. The differentiate the drug from other recommended retaining in vitro data for comment stated that exclusion of in therapeutic agents). anti-infective drugs in the ‘‘Clinical vitro data that are not adequate to Pharmacology’’ section and (Comment 81) Many comments support therapeutic decisionmaking strengthening the current in vitro opposed the proposal (proposed will improve anti-infective therapy and disclaimer statement that indicates that § 201.57(c)(13)(ii) to revise the current help prevent inappropriate use of the clinical significance of the in vitro ‘‘Clinical Pharmacology’’ section to antibiotics. require that in vitro data related to the The agency has reconsidered its data is unknown. activity or effectiveness of an anti- proposal to exclude from the ‘‘Clinical Until FDA has developed a infective drug be included in the section Pharmacology’’ section in vitro data for comprehensive plan to address the only if a waiver is granted under anti-infectives that are not supported by broad range of issues confronting § 201.58 or § 314.126(c) (21 CFR clinical data. The agency is considering development and labeling of anti- 314.126(c)). While comments conceded a broad range of issues concerning the infective products, the agency will defer that in vitro data have their limitations, development and labeling of anti- any decisions about the content of the the comments maintained that in vitro infective products, including the types disclaimer that accompanies in vitro data for anti-infective agents can be an of data that should be obtained to data indicating that the clinical important component of the total support indications, the way that significance of the data is unknown. information available for making indications and anti-infectives data (Comment 84) One comment prescribing decisions in some should be presented in labeling, and requested that the agency clarify the situations, including: (1) In the absence ways to meaningfully address resistance scope of the proposed exclusion of in of susceptibility testing, (2) in treating to anti-infective drugs. The agency vitro data to make clear that it does not drug resistant pathogens (e.g., drug- believes a comprehensive and encompass in vitro data with clinical resistant pneumococci), and (3) in coordinated approach is needed to substantiation. The comment treating rare infections. Some comments address these issues. Thus, FDA is maintained that in vitro susceptibility stated that preventing inclusion of in deferring any action on the in vitro data data from large scale clinical trials vitro data that indicate a drug is inactive proposals in the ‘‘Clinical would provide some basis for making an against a microorganism could result in Pharmacology’’ section of labeling at informed decision about possible selection of inappropriate antibiotics §§ 201.57(c)(13)(ii) and 201.80(b)(2) effectiveness in the absence of and poor clinical outcomes. One until the agency has developed a susceptibility testing (e.g., while comment maintained that some comprehensive plan. At that time, the awaiting such testing) and that this physician organizations effectively agency may repropose changes to the information is especially important for endorse use of in vitro data by having way in which in vitro data are presented antiviral drugs. guidelines that recommend use of in in labeling. In vitro data that are supported by vitro data as an adjunct to making (Comment 82) Several comments clinical data have certain problems in educated empirical judgments about maintained that the algorithm in the common with in vitro data not appropriate anti-infective therapy. agency’s current guidance for industry supported by clinical data (e.g., Several comments stated that the (‘‘Clinical Development and Labeling of antimicrobial susceptibilities are absence of in vitro data will make it Anti-Infective Drug Products,’’ 1992) for constantly changing and vary by difficult for practitioners to identify determining when it is appropriate to location). In vitro and animal data not appropriate broad spectrum agents include in labeling in vitro data not supported by clinical data were the when broad coverage is needed. One supported by clinical data contains focus of the agency’s proposal to comment requested that in the event the adequate safeguards and should exclude in vitro and animal data from agency decides to go forward and continue to be used for determining the ‘‘Clinical Pharmacology’’ section exclude in vitro data related to when to include such data. One (§ 201.57(c)(13)(ii)). As discussed effectiveness unless a waiver has been comment suggested that labeling users previously, the agency has reconsidered granted, the agency explain in detail the be educated about the criteria for its proposal to exclude such data from
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labeling and will defer any action until extent and limitation of the product’s and Usage’’ or ‘‘Dosage and it has developed a comprehensive plan. benefits, how the drug was used in Administration’’ sections, are intended (Comment 85) Several comments clinical trials, who was studied, and for informational purposes only (i.e., not recommended that in vitro critical parameters that were monitored. to suggest claims). susceptibility data for anti-infectives be (Comment 87) One comment One comment asked that the agency retained in labeling and be placed in a requested that the agency clarify the make clear that the limitation on new labeling section entitled ‘‘Clinical extent to which secondary endpoint inclusion of information in labeling Microbiology.’’ data, quality of life data, and about unapproved doses and regimens The agency believes that a labeling pharmacoeconomic data would be would not preclude discussion of a dose section devoted specifically to clinical permitted in the ‘‘Clinical Studies’’ ranging study that supports approval microbiology data is not needed at this section. and includes dosage regimens that were time. As a result of its ongoing The ‘‘Clinical Studies’’ section must not approved for use. comprehensive evaluation of anti- describe those studies that facilitate an One comment agreed with the infectives drug development and understanding of how to use a drug proposed revision to exclude from the labeling practices, the agency may safely and effectively. Generally, this ‘‘Clinical Studies’’ section data and reconsider the need for a separate means those studies that were essential information concerning indications and section on clinical microbiology. to establishing the drug’s effectiveness dosing that are not consistent with the • Nonclinical toxicology (proposed for the purpose of obtaining marketing information in the ‘‘Indications and § 201.57(c)(14)) approval. Usage’’ and ‘‘Dosage and FDA proposed to require a new If studies were appropriately designed Administration’’ sections. The comment section in the FPI entitled ‘‘Nonclinical to evaluate secondary endpoints, it may maintained that inconsistent Toxicology’’ (proposed § 201.57(c)(14)) be appropriate to include a discussion information about indications and to contain information from then- of these secondary endpoints in the dosing creates confusion and current § 201.57(f)(5) (the section. ‘‘Carcinogenesis, mutagenesis, The agency would evaluate the contributes to uncertainty and distrust impairment of fertility’’ subsection) and appropriateness of including quality of of information in the labeling. then-current § 201.57(l) (the ‘‘Animal life and pharmacoeconomic data Some comments stated that if the Pharmacology and/or Animal according to the same standard. The agency has concerns about the Toxicology’’ section). data could be appropriate for inclusion implications of labeling on product (Comment 86) One comment in the section if all of the following promotion, these can be addressed requested that FDA provide guidance apply: (1) The data are from adequate through its existing legal authority and clarifying when it would be appropriate and well-controlled trials that should be addressed as a separate issue. to omit the ‘‘Nonclinical Toxicology’’ incorporated quality of life or The agency requires that claims in section. pharmacoeconomic endpoints in their any section of labeling, expressed or Although the final rule provides that design and carried out appropriate implied, be supported by substantial any section of labeling would be analyses, (2) for pharmacoeconomic evidence (§ 201.56(a)(3)). This omitted if it is clearly inapplicable (see studies, the findings are reasonably requirement would not preclude § 201.56(d)(4)), it is unlikely that the generalizable to most clinical discussing in labeling an adequate and ‘‘Nonclinical Toxicology’’ section, in its environments, not just the ones studied, well-controlled clinical study, including entirety, would ever be inapplicable. and (3) the information would be a dose ranging study that has treatment Animal data are often the only practical important to a practitioner’s arms with dosing regimens that are not and ethical means to understand a understanding of how to use the drug in recommended, if the data for the use of product’s potential for certain kinds of a clinical setting. The ‘‘Clinical Studies’’ such regimens are important to a toxicity (e.g., carcinogenicity, section guidance contains FDA’s practitioner’s understanding of how to mutagenicity, reproductive and recommendations on what studies are use the drug safely and effectively. For developmental toxicity). In addition, appropriate for inclusion in the instance, it might be important to even if carcinogenicity data are not ‘‘Clinical Studies’’ section (see section include such data if the data indicate available, the labeling must state that IV of this document). that a particular dosage regimen is not these studies were not done (Comment 88) Some comments effective, is minimally active, provides (§ 201.57(c)(14)(i)). The final rule requested that the agency reconsider its no benefit compared to lower doses, or provides, however, that the ‘‘Animal proposal to bar, in the ‘‘Clinical is associated with an unacceptable level toxicology and/or pharmacology’’ Studies’’ section, inclusion of data of toxicity. If data that include dosage subsection must include certain data concerning indications and doses that regimens other than recommended that do not appear elsewhere in the are not consistent with the approved regimens are discussed in the ‘‘Clinical labeling. This means that this indications and dosing regimens. Studies’’ section, the data must be subsection would be omitted if all the Comments maintained that such accompanied by a statement required information appears in one or information can be important to a appropriately qualifying the data and more of the other labeling sections practitioner’s understanding of a indicating that those dosage regimens (§ 201.57(c)(14)(ii)). product’s clinical and safety profile, as have not been found safe and effective • Clinical studies (proposed well as to an understanding of the by FDA, if such a statement is necessary § 201.57(c)(15)) approved indication. Some comments for the labeling to be truthful and not FDA proposed to require a section in stated that all studies that are misleading. the FPI entitled ‘‘Clinical Studies’’ scientifically sound and provide The agency agrees that advertising (proposed § 201.57(c)(15)). The section medically relevant information should and promotional labeling regulations would be required to contain a be included in the ‘‘Clinical Studies’’ address product promotion issues and discussion of clinical studies that are section. One comment stated that that this final rule is not an appropriate important to a prescriber’s practitioners understand that data context for discussion of these issues. understanding of the basis for approval presented in the ‘‘Clinical Studies’’ • References (proposed of the drug product, including the section, as opposed to the ‘‘Indications § 201.57(c)(16))
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FDA proposed to permit references to ‘‘Precautions’’ section (required under labeling. Under part 208 (21 CFR part be included in labeling in place of a then-current § 201.57(f)(2)) be made a 208), FDA can require a Medication detailed discussion of a subject that is separate section entitled ‘‘Patient Guide for a prescription drug product of limited interest, but nonetheless Counseling Information’’ (proposed that FDA determines poses a serious important (proposed § 201.57(c)(16)). § 201.57(c)(17)). The section would be and significant public health concern The proposed provision stated that the placed at the end of the FPI. requiring distribution of FDA-approved reference must be based on an adequate The agency also proposed to require patient information (§ 208.1(a)). and well-controlled clinical in proposed § 201.57(c)(17) that any Medication Guides are subject to investigation under § 314.126(b) or, for approved printed patient information or specific content and format a biological product, upon substantial Medication Guide be referenced in the requirements (§ 208.20). evidence of effectiveness. ‘‘Patient Counseling Information’’ (Comment 93) Some comments (Comment 89) One comment section and that the full text of the supported the proposed requirement to maintained that requiring that all approved printed patient information or reprint FDA-approved patient labeling information contained in the Medication Guide be reprinted at the end of the ‘‘Patient Counseling ‘‘References’’ section be based on immediately following the section. Information’’ section so that this adequate and well-controlled trials will (Comment 91) One comment information is readily accessible for result in omission of important supported the proposal to put healthcare practitioners. Other references for many anti-infective information for patients in its own comments requested that the agency products, including references for section and change the name from reconsider the proposal to require that standardized test methodology in in ‘‘Information for patients’’ to ‘‘Patient FDA-approved patient labeling be vitro studies. Counseling Information.’’ The comment printed at the end of the FPI. Some The agency believes that inclusion of stated that the name change is important comments asked whether attaching a reference to clinical data will be because it emphasizes the need to prescription drug labeling without FDA- unusual. Any clinical data that are counsel patients on their medications approved patient labeling to trade important to a prescriber’s and not just provide printed materials. packaging and attaching the FDA- understanding of the safe and effective As described in the proposed rule, approved patient labeling separately use of the drug must be summarized in FDA determined to change the heading would satisfy the requirement. Some the ‘‘Clinical Studies’’ section, rather of the information required under then- comments expressed concern that than referenced in the ‘‘References’’ current § 201.57(f)(2) from ‘‘Information prescription drug labeling with the section. The ‘‘References’’ section may for patients’’ to ‘‘Patient Counseling FDA-approved patient labeling cite an authoritative scientific body, Information’’ to clarify that the reprinted at the end may make it more standardized methodology, scale, information under this section is not difficult for patients to find and read the technique, or similar material important intended to be distributed to patients, patient information. One comment to prescribing decisions that are but is intended to help practitioners stated that patient information typically mentioned in another section of communicate important drug uses larger fonts and may use color and labeling, but cannot readily be information to patients. illustrations, making it difficult and summarized. The agency has revised (Comment 92) Some comments costly to reprint in the prescription drug proposed §§ 201.57(c)(16) and 201.80(l) requested that the agency clarify the labeling. Some comments also to make this clear and to delete the meaning of ‘‘any approved printed expressed concern that inclusion of requirement that limits the ‘‘References’’ patient information.’’ One comment also FDA-approved patient labeling would section to references to adequate and asked that the agency clarify make the labeling too long and impose well-controlled clinical studies. ‘‘Medication Guide.’’ additional costs because it could (Comment 90) One comment noted FDA has revised the terminology in necessitate redesign and enlarging of that, even though the conditions for the final rule to clarify the meaning of trade packaging. One comment asked including references in the proposed ‘‘any approved printed patient whether it would be sufficient to rule are essentially the same as in the information’’ and ‘‘Medication Guide.’’ provide only a reference to FDA- requirements for old labeling, there are The term ‘‘FDA-approved patient approved patient labeling in the substantial differences in the way these labeling’’ refers to any labeling that has ‘‘Patient Counseling Information’’ conditions are applied across new drug been reviewed and approved by the section instead of reprinting the reviewing divisions. agency that provides information for information in the section. As discussed in the response to the patients and is for distribution to FDA believes that it is crucial that previous comment, in this final rule, the patients who are prescribed a drug. This prescribers have ready access to FDA- agency has clarified the conditions term includes approved printed patient approved patient labeling so that they under which it is appropriate to include information specifically required by are aware that the information exists, a reference in prescription drug regulation (e.g., for oral contraceptives can familiarize themselves with the labeling. The agency appreciates the (21 CFR 310.501) and estrogens (21 CFR content of that information, and can comment’s concern about inconsistent 310.515)) and patient labeling that is explain the information to their application of the criteria for inclusion submitted voluntarily to FDA by patients. The agency believes this of references across different new drug manufacturers and approved by the objective can best be accomplished by review divisions. As part of its internal agency. FDA-approved patient labeling requiring that this information be efforts to implement this final rule and may have different functions reflected reprinted at the end of prescription drug related labeling initiatives, the agency in the type of information conveyed to labeling. Thus, it would be insufficient intends to make considerable efforts to patients. For example, some FDA- to provide only a reference to FDA- ensure consistent application of the approved patient labeling contains risk approved patient labeling in the requirements. information, and some contains only ‘‘Patient Counseling Information’’ • Patient counseling information detailed instructions about how to section. (proposed § 201.57(c)(17)) administer a drug product. However, the agency is persuaded FDA proposed that the ‘‘Information Medication Guides are a specific that reprinting the FDA-approved for patients’’ subsection of the category of FDA-approved patient patient labeling at the end of the
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labeling is not the only approach that drug labeling, additional costs will be § 201.57). For Medication Guides to be would successfully address the need to incurred by the manufacturer. To help distributed to patients, the type size familiarize prescribers with this minimize the added cost, FDA has requirements set forth at § 208.20 apply. information. Therefore, the agency has revised proposed § 201.57(c)(18) to With regard to the labeling for products revised the requirements at specify that the same type size subject to § 201.80, the agency clarifies §§ 201.57(c)(18) and 201.80(f)(2) to requirements that apply to prescription at § 201.80(f)(2) that the font size require that FDA-approved patient drug labeling (§ 201.57(d)(6)) also apply requirement for Medication Guides in labeling either accompany the to FDA-approved patient labeling that is § 208.20 does not apply to a Medication prescription drug labeling or be printed at the end of the labeling or Guide that is printed in prescription accompanies labeling, unless a reprinted at the end of such labeling drug labeling unless it is intended to (i.e., immediately following the ‘‘Patient Medication Guide is to be distributed to comply with § 208.24 (i.e., the Counseling Information’’ section of the patients in compliance with § 208.24 requirement to distribute Medication FPI for products subject to (see table 7 of this document). In most § 201.57(c)(18) or after the last section of cases, this will be a minimum type size Guides to patients). Thus, for these labeling for products subject to of 8 points. For trade labeling, this will products, there is no minimum font size § 201.80(f)(2)). be a minimum type size of 6 points (see requirement for FDA-approved patient The agency acknowledges that, in response to comment 102 for discussion labeling that is included with labeling cases for which FDA-approved patient of 6-point minimum type size for trade but not for distribution to patients (see labeling is included with prescription labeling for products subject to table 7).
TABLE 7.—TYPE SIZE REQUIREMENTS FOR LABELING AND FDA-APPROVED PATIENT LABELING INCLUDED WITH LABELING
Type Size Requirements for Labeling Type Size Require- FDA-Approved Patient Labeling Included with Labeling FDA-Approved Patient La- ments for Labeling beling
New Format (§ 201.57)
Trade Labeling (i.e., labeling Minimum 6-point type FDA-approved patient labeling that is not for distribution Minimum 6-point type on or within the package to patients from which the drug is to be dispensed)
Any FDA-approved patient labeling except a Medication Minimum 6-point type Guide that is for distribution to patients
Medication Guide that is for distribution to patients Minimum 10-point type
Other Labeling (e.g., label- Minimum 8-point type FDA-approved patient labeling that is not for distribution Minimum 8-point type ing accompanying pro- to patients motional materials)
Any FDA-approved patient labeling except a Medication Minimum 8-point type Guide that is for distribution to patients
Medication Guide that is for distribution to patients Minimum 10-point type
Old Format (§ 201.80)
Trade Labeling and Other No minimum require- FDA-approved patient labeling that is not for distribution No minimum requirement Labeling ment to patients
Any FDA-approved patient labeling except a Medication No minimum requirement Guide that is for distribution to patients
Medication Guide that is for distribution to patients Minimum 10-point type
(Comment 94) One comment asked prescription drug labeling in a way that The agency does not mean for whether the agency meant for the would facilitate it being torn off (e.g., prescription drug labeling with the prescription drug labeling with the along a perforation line) would satisfy FDA-approved patient labeling FDA-approved patient labeling these requirements. One comment noted reprinted at the end to replace the reprinted at the end to replace the that if the FDA-approved patient stand-alone FDA-approved patient stand-alone FDA-approved patient labeling is appended to the prescription labeling required to be distributed to labeling required to be distributed to drug labeling as a perforated patients. FDA has long stressed the patients. The comment asked if the attachment, it might be more difficult importance of providing such combined document would satisfy the for the patient to receive information at information to consumers. requirement to distribute the FDA- the pharmacy because the pharmacist However, if the FDA-approved patient approved patient labeling to patients would have to separate the patient labeling is appended to the prescription who have been prescribed the drug. information from the prescription drug drug labeling (e.g., as a perforated Other comments asked whether FDA- labeling. attachment that can be torn off and approved patient labeling attached to given to patients) and is formatted as
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required for distribution to patients Including only the FDA-approved products that will be required to have a (§ 208.20), it would meet the patient labeling in the ‘‘Patient ‘‘Patient Counseling Information’’ requirement to provide information to Counseling Information’’ section is not section will already have an patients. For example, for a product sufficient to meet the requirements of ‘‘Information for patients’’ subsection in subject to § 201.57 with a Medication this section. This section, like the other their existing labeling on which to base Guide, trade labeling for the product sections of prescription drug labeling, is the ‘‘Patient Counseling Information’’ would be required to be in at least 6- specifically written for health care section. Thus, this new requirement is point type (see comment 102 of this practitioners. Its purpose is to inform anticipated to impose minimal burdens document), while the Medication Guide, practitioners about what information is on manufacturers. if reprinted as a perforated attachment important to convey to the patient at the I. Comments on the Format to the labeling for distribution to time of prescribing for the drug to be Requirements (Proposed § 201.57(d)) patients, would be required to be in a used safely and effectively. FDA- minimum 10-point type (see table 7). approved patient labeling, in contrast, is FDA proposed new format For products subject to § 201.80 with a specifically written for a lay audience requirements for prescription drug Medication Guide, there is no minimum and is intended to be read by patients. labeling (proposed § 201.57(d)). The font size requirement for the labeling, The agency emphasizes how proposed provisions set forth minimum while the Medication Guide, if reprinted important it is that prescribers be standards and requirements for many of as a perforated attachment to the informed about what they should the key graphic elements of labeling labeling for distribution to patients, communicate to their patients. On the (e.g., type size, letter and line spacing, would be required to be in a minimum basis of a series of national telephone and contrast). 10-point type (see table 7). The agency surveys conducted by FDA to assess (Comment 98) Some comments does not agree that distributing how patients receive information about recommended implementation of the prescription drug labeling with the their prescription medicines, the agency proposed changes solely or primarily as FDA-approved patient labeling determined that the prescribing part of the electronic labeling initiative. appended as a perforated attachment physician is the primary source of drug Some comments requested that the new will make it more difficult for the information for patients (Ref. 5). The format requirements not be patient to receive information at the most recent survey, conducted in 1998, implemented for prescription drug pharmacy because the pharmacists showed that more patients received labeling required to be distributed with would have to detach the patient verbal prescription medicine a drug in trade packaging. They pointed information. information at their physician’s office out that using an electronic format (Comment 95) One comment sought (69 percent) than at the pharmacy (43 would permit use of larger print size, clarification of what information should percent) (Ref. 5). In addition, although hypertext linking to all sections of be included in the ‘‘Patient Counseling 74 percent of patients reported receiving labeling, links to newly revised sections Information’’ section. The comment written information at the pharmacy, of of labeling, key word searches, and links expressed concern about how the those who received written information to patient information without affecting information in this section is to be at the pharmacy, 85 percent received the size of trade packaging. The communicated to patients. instruction sheets and 83 percent comments maintained that larger trade The ‘‘Patient Counseling Information’’ received stickers on the medicine packaging will be required to section contains information that the container, but only 38 percent received accommodate larger labeling that will practitioner may decide to convey to the brochures about the medicine. These result from the new format patient at the time of prescribing for the results indicate that most consumers requirements. drug to be used safely and effectively who receive product information, other The agency agrees that use of the (e.g., warnings about driving if the than instructions for use or the sticker required format in conjunction with an product causes drowsiness, or the information, receive it orally from their electronic medium may have benefits concomitant use of other substances that physicians during an office visit. over paper labeling. As discussed in may have harmful additive effects). The (Comment 97) One comment asked section V of this document, the agency information in this section will vary whether products with existing labeling believes that, in the future, the Internet depending on the safety and efficacy that will be required to convert to the and other electronic sources for labeling characteristics of the product and how new labeling format will be required to will most likely be the primary means it is taken. have a ‘‘Patient Counseling for delivering drug information to FDA believes that requiring a separate Information’’ section if the product’s practitioners. At the present time, ‘‘Patient Counseling Information’’ existing labeling does not contain an however, some practitioners may not section and a reminder message in ‘‘Information for patients’’ subsection in have the requisite computer equipment Highlights directing practitioners to this its ‘‘Precautions’’ section. or skills to access prescription drug section will make patient counseling If a product that does not have an labeling in an electronic format. The information in labeling more accessible ‘‘Information for patients’’ subsection agency anticipates that it will be several to health care practitioners. These becomes subject to the new content and years before the phase-out of paper requirements will increase the format requirements at § 201.57, the labeling as the major source of accessibility of the section and should product’s manufacturer would be prescribing information can begin. reinforce the need for practitioners to required to develop a ‘‘Patient Therefore, the agency believes that it is counsel their patients, thereby fostering Counseling Information’’ section for the important to establish minimum format communication between practitioners product’s prescription drug labeling requirements for paper labeling. and patients about prescribed drugs. unless a ‘‘Patient Counseling (Comment 99) One comment (Comment 96) One comment asked Information’’ section would be clearly recommended the use of more blank whether including the FDA-approved inapplicable (see § 201.56(d)(4)) and space among sections of Highlights. The patient labeling in the ‘‘Patient thus not required. The agency comment expressed concern that, Counseling Information’’ section would anticipates that few products would because Highlights contains a be sufficient to meet the content qualify for such an exception. The significant amount of information in a requirements for the section. agency believes that the vast majority of constrained space and uses a variety of
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formatting techniques, the overall effect the requirement in proposed section titles and subheadings in each would be confusing. One comment § 201.57(d)(5) to bold the information section, underlining section titles, stated that the placement of the ‘‘Patient required by proposed § 201.57(a)(1) indenting subheadings under each Counseling Information Statement’’ through (a)(4), (a)(11), and (a)(15) (i.e., section title, and providing more blank above the ‘‘Highlights Limitation the following information in Highlights: space between each section. Another Statement’’ in Highlights is not ideal Drug names, dosage form, route of comment also recommended indenting because it appears that the ‘‘Patient administration, and controlled the subheadings under the major Counseling Information Statement’’ is substance symbol; the inverted black sections to more readily distinguish the title of the limitation statement. The triangle symbol; the prescription drug between the major sections and the comment also requested that the FPI be symbol; boxed warnings or subheadings within the sections. required to be in a two-column format contraindications; adverse reaction The agency agrees that all the because such a format enables users to reporting contacts; and Highlights recommended revisions to the format of stay better aware of the overall limitation statement) would ensure the Contents could make the information information structure, as well as read visual prominence of the bolded easier to read and use. Because of cost individual sections more easily. information or whether different and space constraints, however, the The agency believes that use of more highlighting methods would be more agency believes that it is impractical to blank space in Highlights would not be effective. implement all of the recommended feasible because additional blank space (Comment 100) Most comments changes. FDA has revised the format would increase the length of Highlights expressed satisfaction that bolding was requirements at proposed § 201.57(d) to and of labeling generally. The one-half adequate to ensure the visual now require that the subheadings under page length limitation for Highlights is prominence of the specified each section heading in Contents be based on the strong preferences of information. Some comments stated that indented (§ 201.57(d)(10). In addition, physicians surveyed in developing the capitalization, italics, and underlining, the final rule now requires that only the prototype for the new labeling format in also effective methods of ensuring headings in Contents be bolded, not the the proposed rule. Physicians reacted prominence and flexibility, should be subheadings (§ 201.57(d)(10)). The negatively to prototype Highlights that maintained. Some comments expressed agency believes these changes make the were one or one and one-half pages concern that possible alternative Contents easier to read and use without long. They indicated that the utility of methods of ensuring visual prominence increasing its length or attendant costs. Highlights decreased significantly as its (e.g., color printing) would add (Comment 102) In the proposal, the length increased. In addition, there was unnecessary costs. One comment agency specifically sought comment on significant concern from manufacturers requested that, if color is required, whether the proposed requirement about the costs associated with adding specific Pantone colors be assigned to (proposed § 201.57(d)(6)) for a minimum to the length of labeling. specific types of information to ensure type size of 8 points for all typeface The agency also believes that the consistency in all product labeling. information in labeling is sufficient or formatting techniques used in The agency recognizes that use of whether a minimum type size of 10 Highlights help make the information different methods to ensure prominence points would be more appropriate. accessible, notwithstanding the density may decrease their impact and Currently, prescribing information is of the section. Therefore, the agency significance. Therefore, FDA concludes usually printed in 6- or 7-point type. does not believe that it is necessary to that bolding alone is adequate to One manufacturer stated that 6-point include more blank space in Highlights. achieve visual prominence for the type was generally adequate for The agency agrees that the formatting specified information in Highlights. The prescribing information, and another and placement of the ‘‘Patient agency also agrees that color printing manufacturer stated that it typically Counseling Information Statement’’ and would add cost and impose an uses 4- to 6-point type. Some the ‘‘Highlights Limitation Statement’’ additional burden on manufacturers that manufacturers were concerned that a in Highlights could be improved to would not be offset by meaningful minimum 8-point type would increase better communicate the discrete improvement in visual prominence. the length of labeling to such an extent information provided by each statement. Therefore, § 201.57(d)(5) requires the that trade packaging would have to For this reason, and in response to following Highlights information to be increase in size to accommodate the comments recommending greater in bold type: Highlights limitation longer labeling and the increase in size prominence for the ‘‘Highlights statement; drug names, dosage form, would impose substantial costs. One Limitation Statement,’’ the agency route of administration, and controlled comment recommended that prescribing moved this statement to appear at the substance symbol; the initial U.S. information that accompanies trade beginning of Highlights (see comment approval statement and year of this packaging not be subject to the 8-point 35). The agency also removed the approval; boxed warnings; adverse type minimum, while prescribing requirement at proposed § 201.57(d)(3) reaction reporting contacts; and the information that is distributed in other that the ‘‘Patient Counseling patient counseling information contexts, where it is more likely to be Information Statement’’ be presented in statement. referenced by the prescriber (e.g., the center of a horizontal line, so that it (Comment 101) One comment prescribing information in electronic does not appear to be a section title. requested that the agency revise the format, prescribing information The agency agrees that a two-column format of Contents to make it easier to accompanying promotional materials format is effective, but believes other read and use. The comment stated that and product samples), be required to be formats may be equally effective in the information in Contents is not as in at least 8-point type. Some conveying prescription drug accessible as it could be because it uses manufacturers stated that 8-point type information and, therefore, is not straight columns, which make it hard to was adequate for prescribing requiring a two-column format for the distinguish the major labeling sections information included in trade FPI. (e.g., ‘‘Use in Specific Populations’’) packaging, but that a minimum 10-point • Bolding (Proposed § 201.57(d)(5)) from subsections (e.g., ‘‘Pregnancy’’). type would increase the length of In the proposal, the agency The comment recommended use of labeling to such an extent that trade specifically sought comment on whether contrasting font types and sizes for the packaging would have to increase in
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size to accommodate the larger size requirement is satisfactory for such there are alternatives that would be prescribing information. labeling. FDA’s telephone survey of more appropriate and under what Some consumers and health care office-based physicians showed that the circumstances such alternatives should advocacy organizations requested that prescribing information in trade labeling be considered. the agency reconsider whether the is referred to by physicians substantially Some comments stated that the one- increase to an 8-point minimum type less frequently than other sources of half page length restriction should be size was sufficient to achieve the prescribing information (Ref. 11, p. 30). required for all products (i.e., there are agency’s goal of improving the Because manufacturers could incur no circumstances in which the readability of the prescribing substantial costs in converting trade limitation should be waived). Other information. They stated that, to labeling to 8-point type and the public comments maintained that it might be improve readability, labeling should be health benefits of such conversion may difficult to consistently accommodate printed in a type size larger than 8 not justify these costs, the agency the information required to be in points and with more white space. They believes it is reasonable to allow a 6- Highlights within one-half page. These urged the agency to test prototypes to point minimum type size for trade comments stated that the final rule compare the relative readability of 8- labeling (see comment 124). Thus, should allow for some flexibility in the point versus 10-point type. Some proposed § 201.57(d)(6) was revised to length of Highlights in those cases comments advocated that the minimum permit a 6-point minimum type size for where one-half page may not be type size should be at least 10 points, trade labeling. practical or possible. These comments and preferably 12 points, for all patient The agency disagrees with the indicated that some manufacturers had information. comment that recommended use of type done mockups of Highlights and had In the preamble accompanying the sizes smaller than 6 points because such been unable to get the required proposed rule, FDA summarized studies labeling would not be sufficiently information on one-half page. Some that demonstrated the importance of readable. The final rule on OTC drug comments stated that the length type size in evaluating readability of labeling requirements summarized restriction should be flexible enough to written information and its effect on research on smaller font sizes, noting accommodate as many disclaimers and visibility and reading speed (see 65 FR that a significant portion of the adult qualifying messages as are necessary to 81082 at 81096 and Refs. 6 through 9). population is not able to read OTC drug guide the physician to the more detailed Type size combined with other product labeling with 4.5-point type discussion of the desired information in graphical elements (e.g., letter and line size (see 64 FR 13254 at 13264 and the FPI. These comments maintained spacing, contrast, print and background 13265, March 17, 1999). that the limitation on length could color, and type style) also affect The agency acknowledges those result in increased medication errors readability (Ref. 10). comments that urge even larger because important information would The agency carefully considered the minimum type sizes to further increase be too compressed or might be excluded literature, the comments submitted in readability. The agency agrees that, from Highlights. response to the font size proposal, and absent any cost or space constraints, a The agency believes that a one-half the estimated costs of using various font 10- or 12-point minimum type size page Highlights is adequate for the vast sizes for labeling, and has determined would be preferable to 8-point. majority of products. As discussed that permitting different font sizes for However, the agency believes that the 8- previously, Highlights provides trade labeling (i.e., labeling on or within point minimum type size requirement introductory information to the more the package from which the drug is to for all labeling except trade labeling and detailed FPI. The agency does not agree be dispensed) and labeling disseminated the variety of formatting techniques that multiple disclaimers or qualifying in other settings (e.g., labeling that incorporated into the new labeling statements would be useful or accompanies prescription drug format will substantially improve the appropriate. promotional materials) best achieves the readability of labeling without imposing The agency acknowledges, however, agency’s objective of ensuring an unreasonable costs on manufacturers. that there may be situations in which it acceptable base level of readability for Moreover, this final rule establishes may not be possible to accommodate all prescription drug labeling while, at the minimum type sizes, but does not the information that should go into same time, minimizing costs to prevent manufacturers from printing Highlights within one-half page. In such manufacturers. Even though a larger labeling in larger type sizes. cases, the agency may waive the one- font size may improve readability, the (Comment 103) One comment half page requirement and approve the agency believes that an 8-point requested that the agency require labeling with slightly longer Highlights. minimum type size, combined with Roman typeface in labeling for optimal Accordingly, FDA has revised § 201.58 other required graphical elements (e.g., legibility. The comment stated that in this final rule to make clear that FDA bold type, bullets, demarcation lines), is Roman is a major improvement over can waive any of the requirements adequate for prescription drug labeling currently used sans serif, and that sans under § 201.56 or § 201.57. disseminated in settings where it is serif is only appropriate in applications The agency strongly believes that likely to be referred to by prescribers where appearance is more important limiting the length of Highlights is (e.g., labeling that accompanies drug than legibility (e.g., advertising). critical to preserving its usefulness. In promotional materials). The agency The agency does not agree that FDA the physician surveys relied on by the believes that the 8-point minimum type should require a specific typeface for all agency in developing and refining the size reasonably balances the agency’s prescription drug labeling. The agency new labeling format, 80 percent of objective of improving the readability of believes that any typeface that is clear physicians indicated that a summary or labeling with the costs associated with and legible should be acceptable in highlights section should be no more the resultant increase in the length of labeling. than one-half page. The surveys found the labeling. (Comment 104) In the proposal, the that the perceived usefulness of The agency also agrees with the agency specifically sought comment on Highlights declined considerably with comments requesting that there be an whether the requirement in proposed increasing length. Accordingly, the exception for trade labeling. FDA § 201.57(d)(8) for a one-half page limit labeling format was designed to believes that a minimum 6-point type on Highlights is adequate or whether accommodate, on a single page, a one-
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half page Highlights and a one-half page explanatory footnote with the asterisk overcrowding on prescription drug Contents. To test the feasibility of would not overcome the confusion labels by removing certain information limiting Highlights to one-half of a page, arising from use of an asterisk for from the container label. the agency did numerous mockups of multiple purposes in labeling. Current § 201.100(b)(2) requires that Highlights for a wide range of products The agency acknowledges that a the label on a prescription drug and found that the one-half page limit vertical line in the margin might not be container bear a statement of the provided adequate space in each case. universally understood as an indication recommended or usual dosage. Where it Thus, the agency anticipates that the that the text adjacent to the mark has is not possible to present an informative length restriction will be feasible in the been changed. The agency believes, or useful statement about the vast majority of cases. however, that a significant percentage of recommended or usual dosage in the (Comment 105) In the proposal, the practitioners have had some experience space available on the container label, agency specifically sought comment on with commercial word processing current § 201.55 states that the whether there are means other than a software and thus some exposure to requirements of § 201.100(b)(2) may be vertical line that would facilitate access revision marks, including the use of the met by including the statement ‘‘See to, and identification of, new labeling vertical line to identify changed text. package insert for dosage information.’’ information in the FPI. The agency also intends to develop for The agency proposed to eliminate Some comments agreed that it was practitioners a comprehensive § 201.55. The agency also proposed to highly desirable to call attention to new educational campaign to accompany the eliminate the requirement in information in the FPI and that the introduction of the revised labeling § 201.100(b)(5) that the label of a vertical line is adequate to identify the format. This educational campaign will prescription drug for other than oral use new information. Other comments address, among other issues, the must bear the names of all inactive stated that it was desirable to call significance of the vertical line in the ingredients. The agency proposed to attention to new information, but that a margin. eliminate the requirement in vertical line in the FPI might not be the The agency does not believe the § 201.100(b)(7) that the container label best mechanism because it might not be vertical line will unnecessarily call bear a statement directed to the understood as a revision mark by attention to minor changes in labeling. pharmacist specifying the type of practitioners. Some comments The vertical line will be applied only to container to be used in dispensing the maintained that use of a vertical line substantive changes that are identified product to maintain its identity, would make the printing and graphics in the ‘‘Recent Major Changes’’ (‘‘Recent strength, quality, and purity. The agency process for labeling more complex and Labeling Changes’’ in the proposed rule) proposed to require instead that these costly. One comment recommended section in Highlights. In response to instructions be placed in the ‘‘How italicizing new or revised text in the comments requesting that the agency Supplied/Storage and Handling’’ section FPI. One comment recommended use of clarify what is meant by substantive of prescription drug labeling (proposed an asterisk to identify changes, along changes, the agency specified in the § 201.57(c)(4)(v)). with a footnote explaining what was final rule that only significant changes (Comment 106) Several comments changed. Some comments maintained in the ‘‘Boxed Warning,’’ ‘‘Indications opposed the proposal to eliminate the that identifying recent changes in and Usage,’’ ‘‘Dosage and requirement that the label of a narrative in a section of the FPI devoted Administration,’’ ‘‘Contraindications,’’ prescription drug product for other than to labeling changes or in the proposed and ‘‘Warnings and Precautions’’ oral use bear the name of all inactive ‘‘Recent Labeling Changes’’ section in sections of the FPI be listed in the ingredients. The comments stated that Highlights (now called ‘‘Recent Major ‘‘Recent Major Changes’’ section. identification of inactive ingredients is Changes’’) would alone be adequate to Nonsubstantive changes such as important because of their potential to call attention to changes in the FPI. typographical or editorial changes be allergens. Some comments Some comments stated that the vertical should not be identified. The agency maintained that manufacturers should line will call unnecessary attention to believes that focusing on substantive be able to list on product labels selected minor changes. Some comments stated changes in only these sections will inactive ingredients (e.g., ingredients that, by stressing labeling changes, the avoid calling unnecessary attention to that are known allergens or are identification of changes in the FPI minor changes and will ensure that the associated with adverse reactions). One could dilute the significance of significance of unmarked text is not comment recommended listing the unmarked text. diluted. diluent that should be used for The agency has retained the proposed The agency believes that it would not admixture or those diluents that are requirement at § 201.57(d)(9) to mark be adequate to identify labeling changes contraindicated. Two comments major changes in the FPI with a vertical only in a section of the labeling devoted supported eliminating the list of line in the left margin. The agency to changes. The agency believes it is inactive ingredients from the container agrees that it is highly desirable to call important to also identify the specific label of products for other than oral use. attention to new information in the FPI text that has been changed so that They agreed that the presence of such and that the vertical line is adequate to practitioners will be able to locate information in the ‘‘Description’’ section identify the new information. The changes and access the complete text. of prescription drug labeling would be agency considered bolding, underlining, sufficient and that eliminating the and italicizing as means to emphasize J. Comments on Revisions to Container information from the container label changes. These formatting techniques Labels could make other information on the are all currently used in labeling to add In addition to revising its regulations label more accessible and legible. emphasis for purposes other than governing the content and format of Several comments also opposed the identifying new information, so they labeling for prescription drugs, the proposal to eliminate the requirement would not be readily understood as agency also proposed certain revisions that the label of a prescription drug identifying labeling changes. Asterisks to the information required to appear on product bear a statement directed to the are also used in labeling for purposes prescription drug product labels pharmacist specifying the type of other than identifying labeling changes. (proposed § 201.100). The proposed container to be used in dispensing the The agency believes that use of an revisions were intended to lessen product to maintain its identity,
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strength, quality, and purity. The and Handling’’ section the type of statutory (section 502(c) of the act) and comments maintained that eliminating container to be used in dispensing a regulatory provisions (§ 201.15) dispensing information from the product to maintain a product’s requiring that information on product container label, and placing it in identity, strength, quality, and purity labels be prominent and conspicuous so prescription drug labeling, would make (information formerly presented on the as to render it likely to be read and the information less accessible to product label) should apply only if the understood by the ordinary individual pharmacists and would thus be product cannot be dispensed in the under customary conditions of purchase inefficient and frustrating for standard amber vial. The comment and use provide the agency adequate pharmacists. The comments were maintains that limiting the scope of the authority to ensure that the symbol is concerned that making information on requirement to situations in which visually accessible. The agency does not storage and handling less accessible exceptional storage conditions are believe it is necessary to specify the could lead to inappropriate storage and required would serve to highlight the location of the symbol or its font size to handling. Some comments urged that need for special considerations when ensure that the symbol achieves the label at least be required to state any dispensing. adequate prominence. special or unusual conditions for As discussed in the previous (Comment 110) One comment storage. One comment recommended comment, the agency has reconsidered expressed concern about the mandatory use of a symbol that signifies its proposed changes to the container proliferation of artwork on label when a product requires special label, including the proposal to remove containers and the potential for that handling. Two comments supported from the container label information artwork to make the label more difficult removal of information on storage and directed at the pharmacist concerning to read and cause medication errors. handling from product labels, agreeing the appropriate container in which to The agency acknowledges the that less information on the container dispense a product. The agency will potential for artwork to obscure label could make other information on continue to require that dispensing important information on the label. The the label more accessible and legible. instructions appear on the container agency believes, however, that its One comment maintained that label. Accordingly, proposed existing authority under 502(c) of the manufacturers should be able to remove § 201.57(c)(4)(v) was deleted from the act and § 201.15 is adequate to ensure from the label the statement referring final rule. Storage and special handling that artwork does not compromise the practitioners to the full prescribing conditions have to be specified in prominence and conspicuousness of information for dosage information labeling consistent with the information required to be on the label. before the manufacturer is required to requirements of § 201.57(c)(17)(iv) of revise its label in accordance with this this final rule. K. Miscellaneous Comments final rule. (Comment 108) One comment (Comment 111) One comment The agency has reconsidered its requested that the container label also requested that the agency clarify how proposals to eliminate from container be required to disclose when the the content and format of the brief labels: (1) The list of inactive container or some component of the summary required to accompany ingredients for products other than for container contains latex or polyvinyl prescription drug advertising under oral use, (2) the statement directed to chloride (PVCs). § 202.1 would be affected by the As discussed in the response to the pharmacist concerning the type of proposed revisions to prescription drug comment 106, the agency intends to container in which a product should be labeling. Another comment suggested conduct a comprehensive evaluation of dispensed, and (3) the statement that the agency entertain the idea that the product label and may repropose referring practitioners to the package Highlights could serve as an alternative changes in the content of the product insert for dosage information in to the brief summary because the agency situations in which it is not possible to label at a later time, including changes has noted that Highlights contains the include information about the concerning the presence of latex and most important information about drug- recommended or usual dose on the PVCs in drug containers. related risks. label. The agency decided to withdraw (Comment 109) One comment urged The proposed regulations were not these proposed revisions to container that there be a mandatory location for designed to affect either the content or labels. The agency believes that what is the ‘‘Rx Only’’ symbol on the main part the format of the brief summary of appropriate content for product of the label and that there be a specified prescribing information required to container labels and how to make that minimum font size for the symbol. accompany prescription drug information as accessible as possible In rulemaking (initiated under section advertisements under § 202.1 (21 U.S.C. need to be further evaluated. The agency 126 of the Food and Drug 352(n)). As discussed in the proposed intends to conduct a comprehensive Administration Modernization Act of rule (65 FR 81082 at 81087), statements evaluation of information required to be 1997), the agency amended its made in promotional labeling and included on container labels and, if regulation requiring that container advertisements must be consistent with necessary, will propose changes to these labels contain the statement ‘‘Caution: all information included in labeling requirements at that time. Federal law prohibits dispensing At this time, the agency will not without prescription’’ by replacing the under proposed § 201.57(c) to comply require placement of a symbol on the statement with the symbol ‘‘Rx Only’’ with current §§ 201.100(d)(1) and 9 container label indicating that the (67 FR 4904, February 1, 2002). 202.1(e). The agency does believe, product has special storage and Comments submitted to the agency in however, that Highlights communicates handling requirements. The agency will response to this proposed change important information about a drug. The consider this possibility during its requested that FDA specify the font size agency therefore will explore further, in evaluation of the content of product and the location of the symbol on the conjunction with other prescription labels. It would be premature to adopt container label. The agency declined drug advertising initiatives, the concept such a symbol at this time. this request in the final rule of February 9 This requirement at proposed § 201.57(a) has (Comment 107) One comment 1, 2002, and declines it again in this been removed because it is not pertinent to the requested that the proposed requirement final rule. As discussed in the preamble contents of § 201.57 and is redundant with to specify in the ‘‘How Supplied/Storage to the February 2002 final rule, existing provisions at §§ 202.1 and 201.100.
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that Highlights could serve as a brief L. Comments on the Proposed the implementation plan also apply to summary (see also FDA’s response to Implementation Plan all drugs that are among the 150 most comment 112 about the brief summary For new and more recently approved frequently prescribed drugs that would for consumer directed advertisements). drugs, FDA proposed a staggered not otherwise be covered by the (Comment 112) Some comments implementation schedule for the implementation plan. The comment stated that prescription drug labeling labeling requirements, with revised maintained that under the proposed should be written in language that a lay labeling required for newer products implementation plan only 1 of the audience can comprehend. The first (proposed § 201.56(c)). The current top 15 drugs used in the elderly comments noted that consumers need to schedule is being finalized as proposed would be required to implement the be able to read and understand the (see table 5 in section III of this revised content and format. Some comments expressed concern labeling because it accompanies the document). Revised labeling for ANDA that having different labeling formats product, and because it is often used to products depends on the labeling for the would be confusing to physicians. One provide information for direct-to- reference listed drug. The agency comment expressed concern that having consumer (DTC) advertisements. proposed to implement no later than 1 two different formats might impact The purpose of prescription drug year after the effective date of the final labeling is to provide health care prescribing behavior, arguing that rule the revised content requirements prescribers might favor newer, more practitioners information necessary for regarding unsubstantiated claims in safe and effective use. The agency expensive drugs. Some comments labeling for newer and older drugs. The maintained that a single standard format believes that use of medical and agency also proposed to implement by scientific terminology is necessary to is needed to facilitate access to labeling 1 year after the effective date of the final in electronic formats. One comment also effectively communicate to practitioners rule the requirement that any FDA- information about a product’s risks and questioned FDA’s underlying approved patient labeling be reprinted assumption that there is a lesser need benefits as required under 21 U.S.C. immediately following the ‘‘Patient 352(n) and § 201.100. Requiring that for improved labeling for older products Counseling Information’’ section of the because practitioners are more familiar language used in prescription drug FPI for newer products or immediately with older products and refer to older labeling be tailored to a lay audience following the last section of the labeling product labeling less frequently than would result in a loss of the clarity and for older products. The agency also newer product labeling. The comment precision needed to effectively proposed to implement by 1 year after maintained that newer practitioners communicate to practitioners a the effective date of the final rule the would need to refer to the labeling of product’s benefits and risks. For requirement that in vitro or animal data older drugs to the same extent as for example, if a drug is associated with a related to activity or efficacy of a drug newer drugs. One comment suggested risk of a specific type of blood disorder, that have not been shown by adequate that manufacturers be given the option the disorder must be identified by its and well-controlled studies to be to revise labeling for older products. technical name (e.g., thrombotic pertinent to clinical use be removed Some comments from manufacturers thrombocytopenic purpura) so the from the labeling unless a waiver is maintained that it would be most practitioner can more quickly diagnose granted. practical to apply the new format and treat the disorder when symptoms In the proposal, the agency requirements only to products whose present. Scientific terminology may specifically sought comment on whether applications are submitted on or after help to identify types of patients that the revised content and format the effective date of the final rule. They might be at increased risk or otherwise requirements should be applied, as stated that broader implementation manage the risk of that blood disorder. proposed, to drug products with an would place a substantial burden on If the risk can only be described in NDA, BLA, or efficacy supplement that FDA resources and could interfere with terms that a lay audience can is pending at the effective date of the review of new drugs. One comment comprehend (e.g., blood disorder), the final rule, that was submitted on or after stated that the new format should apply labeling would lack the precision the effective date of the final rule, or only to drugs that are not a member of needed to communicate the specific risk that has been approved from 0 up to and an existing drug class (i.e., products that to prescribers. including 5 years prior to the effective would be considered the original For many products, the final rule will date of the final rule, or whether member of a drug class) or that are a improve the usefulness of the brief alternative application criteria should new and novel member of an existing summary to consumers and health care be used. drug class and whose applications are practitioners by improving the (Comment 113) Several comments submitted on or after the effective date usefulness of the prescription drug agreed with the categories of of the final rule. The comment labeling, on which the brief summary is prescription drugs that would be subject maintained that having different based. To this end, FDA has issued a to the new labeling content and format labeling formats for similar drugs within draft guidance document entitled ‘‘Brief requirements in the agency’s proposed the same drug class would be a Summary: Disclosing Risk Information implementation plan. Other comments competitive disadvantage for one format in Consumer-Directed Print expressed concern that the proposed or the other. Advertisements’’ that describes various implementation plan is too narrow. The agency believes the options for presenting this information These comments maintained that the implementation plan as proposed for in DTC print advertisements (69 FR new format is superior to the old format new and more recently approved drug 6308, February 10, 2004). By providing and the scope of the proposed products is the best option for recommendations on use of alternatives implementation of the new format implementing the new format to prescription drug labeling to fulfill would leave large numbers of products requirements. The agency agrees that it the brief summary requirement, FDA is with inferior labeling. Some comments is desirable for all prescription drugs to encouraging manufacturers to develop requested that the revised content and be subject to the same labeling rules. brief summaries for use in consumer- format requirements eventually be However, the agency has carefully directed advertisements using language applied to all marketed prescription considered the costs and benefits of they can understand. drugs. One comment recommended that implementing the revised labeling
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format and determined that requiring implementation plan did not encompass labeling for unsubstantiated claims and broader implementation (e.g., to all all prescription drugs. remove all such claims from labeling prescription drugs) of the new format FDA is cognizant that the presence of within 1 year of the effective date of the requirements would be an excessive two labeling formats will present final rule. The agency agrees that a regulatory burden. important challenges when requirement to scrutinize all existing This initiative will require substantial implementing electronic labeling but is labeling within that timeframe would resource allocation by the agency and confident that these challenges can be place substantial burdens on industry for a period of several years. successfully addressed. For example, manufacturers and the agency and that The agency’s proposed implementation the ways in which information will be such burdens might not be justified. In plan, which is being finalized in this formatted, tagged, and stored in the the preamble to the proposed rule, the rule as proposed, is intended to make contemplated electronic format will agency estimated that no more than 25 the best use of these resources. As permit access to labeling information in percent of labeling for drugs other than discussed in the preamble to the both the old and new labeling formats. antibiotics might contain proposed rule (65 FR 81082 at 81098), The agency does not agree that the unsubstantiated claims. Based on a the plan targets newer products because new format should be applied only recent review of a sample of practitioners are more likely to refer to prospectively or that it should be prescription drug labeling, however, the the labeling for newer products. In optional for the currently approved agency believes the percentage of FDA’s survey of physicians, newness of drugs that would be subject to the new products whose labeling might contain the product was a reason rated by 87 format requirements under the proposed such claims is considerably lower than percent of physicians as very likely to implementation plan. This narrower 25 percent and not high enough to trigger a labeling referral for a drug (Ref. application of the new format justify a requirement that manufacturers 11, p. 35). In addition, the labeling for requirements would fail to reach a scrutinize all existing labeling to newer products is typically longer and significant number of products whose identify those claims, particularly in a more complex and, thus, more likely to labeling is frequently referenced and short timeframe. could benefit from the new format benefit from a new format that makes The agency is eliminating only the requirements. the information more accessible. The requirement that manufacturers (Comment 114) Several comments implementation plan will also capture scrutinize all labeling for the presence objected to the proposed requirement of unsubstantiated claims within 1 year many older products that would not that, within 1 year of the effective date otherwise be covered by the plan when of the effective date of the final rule. of the final rule, manufacturers review The language in proposed § 201.57(c)(2), manufacturers seek new indications for all existing labeling and remove any their products (i.e., submit an efficacy (c)(3), and (c)(15) and § 201.80(c)(2), (j), express or implied unsubstantiated and (m)(1) remains in the final rule, supplement). For these reasons, the claims from the ‘‘Indications and requiring that the ‘‘Indications and agency believes the implementation as Usage,’’ ‘‘Dosage and Administration,’’ Usage,’’ ‘‘Dosage and Administration,’’ proposed is the most reasonable ‘‘Clinical Pharmacology,’’ and ‘‘Clinical and ‘‘Clinical Studies’’ sections must approach to maximizing the public Studies’’ sections. Some comments not imply or suggest uses not supported health benefit and best utilizing maintained that this requirement would by substantial evidence and/or dosing available resources in requiring the new be very burdensome for industry and regimens not included in the ‘‘Dosage content and format for labeling. In the agency. They disagreed with the and Administration’’ section. This addition, manufacturers of older agency’s contention in the preamble to language accurately reflects the existing products not covered by the the proposed rule that the labeling regulatory standard for claims presented implementation plan may voluntarily changes to remove unsubstantiated in prescription drug labeling. revise, and submit for review, labeling claims could usually be accomplished While the agency will not require a for their products in the new format at without prior approval by the agency systematic evaluation of all existing any time. (i.e., with a ‘‘Changes Being Effected’’ labeling to identify unsubstantiated The agency does not believe that an labeling supplement). They stated that claims within 1 year of the effective date implementation plan based on volume these changes would more often than of the final rule, the agency wishes to of prescriptions would be prudent. not require prior approval and extensive make it clear that manufacturers have an Prescription volume can fluctuate negotiations between the agency and a ongoing obligation to ensure that claims considerably over time, and the agency manufacturer. Some comments in labeling have adequate substantiation is not aware that there are standardized maintained that there would be a and are not false or misleading. When prescription volume data that are substantial number of requests for new information comes to light that generally accepted as accurate. Thus, waivers under § 201.58 or § 314.126(c) causes information in labeling to the agency believes it would be very and these requests would also be a become inaccurate, manufacturers must difficult to fairly implement and enforce burden on the agency. Some comments act to change the content of their an implementation plan based on agreed with the requirement to remove labeling, in accordance with §§ 314.70 prescription volume. unsubstantiated claims from existing and 601.12 (21 CFR 314.70 and 21 CFR The agency also acknowledges that labeling, but stated that 1 year was not 601.12). To clarify this obligation, the the existence of two different labeling enough time for manufacturers to agency has revised § 201.56 to specify formats may lead to some frustration accomplish the task. One comment that manufacturers must act to correct among practitioners. The agency maintained that the burden on the labeling that, in light of new believes, however, that any potential agency would compromise the drug information, has become inaccurate (see confusion can be minimized. approval process. One comment § 201.56(a)(2)). Practitioners are already aware of the requested that the agency clarify what (Comment 115) One comment content and format of existing labeling. types of statements would have to be recommended an implementation The agency intends to engage in a removed. period of 3 years, rather than 1 year as comprehensive educational campaign to The agency has reconsidered the proposed, to append any FDA-approved educate practitioners about the major proposed requirement to have patient labeling to the end of the features of the new format and why the manufacturers scrutinize all existing labeling for trade packages. The
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comment maintained that additional exclusivity. This final rule does not comment requested that the agency time was needed for reconfiguration and change the requirement to exclude any amend the rule to include labeling that replacement of packaging equipment. condition of use or indication from the is distributed with prescription drug The agency believes that the proposed labeling of a generic product when samples. The comment maintained that implementation plan is appropriate and necessary (e.g., when the reference free prescription drug samples do not in the best interest of public health. listed drug has patent protection or contain adequate information in their Including the FDA-approved patient market exclusivity for an indication), packaging to keep consumers safe from labeling in prescription drug labeling nor does it prevent, as described at harm. ensures that this information is § 314.127(a)(7), approval of an ANDA FDA has often emphasized the available to health care practitioners to when the reference listed drug has importance of providing patients with reinforce the discussions they have with protected labeling. useful written prescription drug their patients concerning the risks and In the scenario described, the information (e.g., FDA-approved patient benefits of prescription drugs. The reference listed drug and the generic labeling) in a variety of settings (see e.g., agency considers improving physician- product would both be required to use 63 FR 66378, December 1, 1998; 68 FR patient communication crucial for the new labeling format. The NDA 33724, June 5, 2003). Prescription drug public health. Furthermore, the agency holder could not prevent the samples must be accompanied by trade believes that this requirement should manufacturer of the generic product labeling (§ 201.100(c)), which is subject not place an undue burden on from using the new labeling format of to this final rule. If FDA-approved manufacturers because of the the reference listed drug, but the NDA patient labeling for a product is required approximately 200 products that would holder would still have exclusivity for to be distributed to the patient, the be affected by this provision of the final the new indication. manufacturer or distributor of that rule, the labeling of more than 60 (Comment 117) One comment product must provide it with the percent of them already conform with recommended that all generic drugs samples. the requirement (see section XI.C.1 of pending approval or approved on or this document). after the effective date of the final rule M. Comments on Environmental Impact (Comment 116) Manufacturers of be required to submit labeling based on (Comment 120) One comment products subject to an ANDA (generic the new format. The comment maintained that FDA failed to products) expressed concern that NDA maintained that the content of labeling adequately consider the environmental holders will use the rule’s is not significantly changed, just impact of the additional paper that will implementation provisions as a reordered, so this requirement would be required for labeling and the increase mechanism to delay approval of not be burdensome for manufacturers of in size of packaging and shipping generics. The specific concern was that generic products and the information in containers. NDA holders will obtain approval for a the labeling of the reference listed drug As stated in section IX of the new indication near the end of their product and the generic product would proposed rule (65 FR 81082 at 81103), marketing exclusivity for their drug’s still be essentially the same. the agency determined that it is not original indication, revise the labeling The agency does not believe that required to do an environmental for the drug to the new format, and manufacturers of generic products assessment or an environmental impact receive 3 years’ marketing exclusivity should be required to provide labeling statement. This is an action excluded for the new indication. The comments in the new format when seeking under § 25.30(h) and (k) (21 CFR asked FDA to make it clear that, in such approval for their product if the 25.30(h) and (k)) (i.e., does not situations, manufacturers of generic reference listed drug product is not individually or cumulatively have a products would be permitted to base required to have its labeling in the new significant effect on the human their labeling on the old format until the format. As discussed in the response to environment). The changes made to the marketing exclusivity for the new comment 115, the act and regulations proposal in this final rule do not change indication has expired. currently require that a generic product this conclusion. Therefore, neither an The agency wishes to make clear that have the same labeling as the reference environmental assessment nor the requirement to revise the labeling of listed drug product. Moreover, the environmental impact statement is a reference listed drug in the new format agency believes that, to avoid confusion, required. does not have any impact on the the labeling of a generic product should duration of exclusivity for the drug and, be in the same format as the labeling of VII. Legal Authority therefore, does not prevent a the reference listed drug. In this rule, FDA is addressing legal manufacturer of a generic product from (Comment 118) One comment urged issues relating to the agency’s action to using the revised labeling of the FDA to compile a list of products that revise the regulations prescribing reference listed drug. Under section would be subject to the new format content and format requirements for 505(j)(2)(A)(v) of the act (21 U.S.C. requirements and make the list publicly prescription drug labeling. 355(j)(2)(A)(v)) and §§ 314.94(a)(8) and available. 314.127(a)(7) (21 CFR 314.127(a)(7)) of FDA does not believe that it is A. Statutory Authority the agency’s regulations, the labeling of necessary to compile such a list. FDA’s revisions to the content and a drug product submitted for approval Manufacturers can readily determine format requirements for prescription under an ANDA must be the same as the whether their products are subject to drug labeling are authorized by the act labeling of the listed drug referenced in these requirements by referring to the and by the Public Health Service Act the ANDA, except for changes required implementation plan and the effective (the PHS Act). Section 502(a) of the act because of differences approved under a date of the rule (see section III of this deems a drug to be misbranded if its suitability petition (§ 314.93), because document). labeling is false or misleading ‘‘in any the generic drug product and the (Comment 119) Some comments particular.’’ Under section 201(n) of the reference listed drug are produced or requested that the agency clarify act, labeling is misleading if it fails to distributed by different manufacturers, whether this final rule has implications reveal facts that are material with or because aspects of the listed drug’s for labeling that is distributed with respect to consequences which may labeling are protected by patent or prescription drug samples. One result from the use of the drug under the
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conditions of use prescribed in the they are reasonably related to the supplied information, is necessary labeling or under customary or usual government’s interest in ensuring the because it provides adequate directions conditions of use. Section 502(f) of the safe and effective use of prescription for use. Because not all of the act deems a drug to be misbranded if its drug products and because they do not information required in labeling clearly labeling lacks adequate directions for impose ‘‘unjustified or unduly is necessary to prevent the labeling from use and adequate warnings against use burdensome’’ disclosure requirements. being false or misleading, it is necessary in those pathological conditions where (See Zauderer v. Office of Disciplinary for FDA to apply the remaining parts of its use may be dangerous to health, as Counsel, 471 U.S. 626, 651 (1985); see the Central Hudson analysis. well as adequate warnings against also Ibanez v. Florida Dep’t of Bus. and FDA’s interest in protecting the public unsafe dosage or methods or duration of Prof’l Regulation, 512 U.S. 136, 146 health has been previously upheld as a administration or application, in such (1994).) The information required by the substantial government interest under manner and form, as are necessary for final rule to appear in labeling is the Central Hudson. (See Pearson v. the protection of users. Section 502(j) of information necessary to provide facts Shalala, 164 F.3d 650, 656 (D.C. Cir. the act deems a drug to be misbranded that are material with respect to 1999) (citing Rubin v. Coors Brewing if it is dangerous to health when used consequences which may result from Co., 514 U.S. 476, 484–85 (1995).) The in the dosage or manner, or with the the use of the drug under the conditions final rule’s labeling requirements frequency or duration, prescribed, of use prescribed in the labeling or directly advance this interest, thereby recommended, or suggested in its under customary or usual conditions of satisfying the third part of Central labeling. use (sections 201(n) and 502(a) of the Hudson, because by requiring disclosure In addition, the premarket approval act); adequate directions for use and of complete information on the provisions of the act authorize FDA to adequate warnings (section 502(f) of the conditions under which a product can require that prescription drug labeling act); and information on the conditions be used safely and effectively, the provide the practitioner with adequate of use in which the product would be requirements help to ensure that information to permit safe and effective dangerous (section 502(j) of the act). In prescription drug products will be use of the drug product. Under section addition, pursuant to section 505 of the prescribed properly by health care 505 of the act, FDA will approve an act, the labeling sets forth information practitioners and will be used safely and NDA only if the drug is shown to be on the conditions in which the product effectively by patients. both safe and effective for use under the is safe and effective. By its terms, the Finally, under the fourth part of the conditions set forth in the drug’s final rule requires disclosure of the Central Hudson test, there are not labeling. Section 701(a) of the act (21 essential scientific information numerous and obvious alternatives (in U.S.C. 371(a)) authorizes FDA to issue necessary for safe and effective use of fact, there are no reasonable regulations for the efficient enforcement the labeled drug product. Consequently, alternatives) (Cincinnati v. Discovery of the act. FDA believes the final rule passes Network, 507 U.S. 410, 418 n.13 (1993)) Under 21 CFR 314.125, FDA will not muster under the First Amendment. to the content and format requirements approve an NDA unless, among other In Central Hudson Gas & Electric of this final rule that directly advance things, there is adequate safety and Corporation v. Public Service the government’s interest but are less effectiveness information for the labeled Commission 447 U.S. 557 (1980), the burdensome to speech. Health care uses and the product labeling complies Supreme Court established a four-step practitioners are accustomed to looking with the requirements of part 201. analysis for assessing the to the prescription drug labeling as their Under § 201.100(d) of FDA’s constitutionality of government primary source of information about a regulations, prescription drug products restrictions on the content of product, and patients rely for their drug must bear labeling that contains commercial speech. information primarily on practitioners. adequate information under which [First,] we must determine whether the Neither a public education campaign, licensed practitioners can use the drug expression is protected by the First nor encouraging sponsors to provide safely for their intended uses. This final Amendment. For commercial speech to come information on the risks and benefits of rule amends the regulations specifying within that provision, it at least must concern drugs but not requiring such the format and content for such labeling. lawful activity and not be misleading. information, would ensure that Section 351 of the PHS Act (42 U.S.C. [Second,] we ask whether the asserted practitioners have the information they 262) provides legal authority for the governmental interest is substantial. If both inquiries yield positive answers, we must need about the conditions in which agency to regulate the labeling and determine [third] whether the regulation prescription drugs can be used safely shipment of biological products. directly advances the government interest and effectively. Requiring disclosures Licenses for biological products are to asserted, and [fourth,] whether it is not more meets the fourth part of the test. be issued only upon a showing that they extensive than is necessary to serve that Accordingly, the agency believes it meet standards ‘‘designed to insure the interest. has complied with its burdens under the continued safety, purity, and potency of This rule also survives scrutiny under First Amendment to support the content such products’’ prescribed in the four-part test in Central Hudson. and format requirements for regulations (section 351(d) of the PHS FDA believes that much information prescription drug labeling. Act). The ‘‘potency’’ of a biological required to appear in prescription drug VIII. Paperwork Reduction Act of 1995 product includes its effectiveness (21 labeling is necessary for labeling to be CFR 600.3(s)). Section 351(b) of the PHS nonmisleading. The risk information The final rule contains information Act prohibits false labeling of a contained in such labeling, for example, collection provisions that are subject to biological product. FDA’s regulations in constitutes material facts within the review by the OMB under the part 201 apply to all prescription drug meaning of sections 201(n) and 502(a) of Paperwork Reduction Act of 1995 (44 products, including biological products. the act. Risk information can also U.S.C. 3501–3520). The title, qualify as warnings compelled by description and respondent description B. First Amendment section 502(f) and (j) of the act. Other of the information collection provisions FDA’s requirements for the content information, such as information on are shown below with an estimate of the and format of prescription drug labeling indications for the product, dosage and reporting burdens. Included in the are constitutionally permissible because administration information, and how estimate is the time for reviewing
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instructions, searching existing data Prescribing Information.’’ Highlights they were previously incurred to sources, gathering and maintaining the provides a concise extract of the most produce existing labeling. data needed, and completing and important information required under 2. Annual Burden for Labeling Design, reviewing each collection of § 201.57(c) (the FPI), as well as certain Testing, and Submitting to FDA for information. The OMB and FDA additional information important to NDAs Submitted on or After the received no comments concerning the prescribers. Section 201.57(b) requires a Effective Date of the Final Rule information collection provisions of the table of contents to prescribing (§§ 201.56 and 201.57) proposed rule. information, entitled ‘‘Full Prescribing Title: Requirements on Content and Information: Contents,’’ consisting of a New drug product applicants must: Format of Labeling for Human list of each heading and subheading (1) Design and create prescription drug Prescription Drug and Biological along with its identifying number to labeling containing Highlights, Products facilitate health care practitioners’ use Contents, and FPI, (2) test the designed Description: The final rule amends of labeling information. Section labeling (e.g., to ensure that the FDA’s regulations governing the format 201.57(c) specifies the contents of the designed labeling fits into carton- and content of labeling for human FPI. The final rule reorders information enclosed products), and (3) submit it to prescription drug products. It revises required at former § 201.57, makes FDA for approval. current regulations to require that the minor content changes, and provides Based on information received from labeling of new and recently approved standardized identifying numbers for the pharmaceutical industry, FDA products contain highlights of the required information. Section estimated that it took applicants prescribing information, a table of 201.57(d) mandates new minimum approximately 3,200 hours to design, contents for prescribing information, specifications for the format of test, and submit prescription drug reordering of certain sections, minor prescription drug labeling and labeling to FDA as part of an NDA or content changes, and minimum establishes minimum requirements for BLA under former labeling requirements graphical requirements. The final rule key graphic elements such as bold type, (see row 1 of table 8a). FDA estimates does not subject older drugs to the bullet points, type size, and spacing. revised labeling requirements. However, that it will take an additional 149 hours it does require, as for new and recently In accordance with the final rule, to generate Highlights and Contents and approved products, that FDA-approved older drugs not subject to the revised otherwise comply with the additional patient labeling accompany or be labeling content and format requirements of the final rule (see row reprinted immediately following the last requirements in § 201.57 remain subject 2 of table 8a). Therefore, it will take a section of prescription drug labeling. to labeling requirements at former total of approximately 3,349 hours to As discussed in section VII of this § 201.57, which is redesignated as design, test, and submit new labeling. document, FDA’s legal authority to § 201.80 by this final rule. Section Approximately 85 applicants would amend its regulations governing the 201.80 contains minor clarifications. In submit approximately 107 new content and format of labeling for addition, § 201.80(f)(2) requires that applications (NDAs and BLAs) to FDA human prescription drugs derives from within 1 year, any FDA-approved per year, totaling 358,343 hours (see sections 201, 301, 502, 503, 505, and patient labeling be referenced in the Total of table 8a). 701 of the act and from section 351 of ‘‘Precautions’’ section of the labeling of 3. Burden Associated with Labeling the PHS Act. older products and either accompany or Supplements for Applications be reprinted immediately following the Approved Within 5 Years Prior to the A. Summary of Prescription Drug labeling. Labeling Content and Format Effective Date of the Rule (§ 201.57) Requirements in this Final Rule That B. Estimates of Reporting Burden The final rule requires that Contain Collections of Information 1. The Reporting Burdens for the prescription drug applications approved Section 201.56 requires that General Requirements (§ 201.56) during the 5 years before, or pending on, prescription drug labeling contain the effective date conform to format and certain information in the format The reporting burdens for the general content requirements at § 201.57. For specified in either § 201.57 or § 201.80, requirements in § 201.56(a) are the same these products, applicants must depending on when the drug was as those for former § 201.56(a) through redesign and negotiate the labeling, approved for marketing. Section (c) and are estimated in tables 8a and 8b including Highlights and Contents, test 201.56(a) sets forth general labeling as part of the burdens associated with the redesigned labeling, and prepare requirements applicable to all § 201.57. Section 201.56(b) and (c) sets and submit that labeling to FDA for prescription drugs. Section 201.56(b) forth the categories of affected drugs and approval. Based on information specifies the categories of new and more their implementation schedule, provided in the ‘‘Analysis of Economic recently approved prescription drugs generating no reporting burdens. Impacts’’ (economic analysis) (see subject to the revised content and Section 201.56(d) sets forth the required section XI.D.2.a of this document), format requirements in §§ 201.56(d) and sections and subsections associated labeling supplements for a total of 201.57. Section 201.56(c) sets forth the with the revised format in § 201.57; approximately 344 innovator products schedule for implementing these revised therefore, its associated reporting would be submitted to the FDA over a content and format requirements. burdens are estimated in tables 8a and 5-year period (beginning in year 3 and Section 201.56(e) specifies the sections 8b under the requirements at § 201.57. ending in year 7 after the effective date and subsections, required and optional, Sections 201.56(e) and 201.80 codify of the rule). Approximately 172 for the labeling of older prescription former labeling requirements at applicants would submit these labeling drugs not subject to the revised format §§ 201.56(d) and (e) and 201.57, with supplements. The time required for and content requirements. minor clarifications, for older redesigning, testing, and submitting the Section 201.57(a) requires that prescription drugs. The requirements in labeling to FDA is estimated to be prescription drug labeling for new and these sections impose no new reporting approximately 196 hours per more recently approved prescription burdens (except those accounted for in application, totaling 67,424 hours (see drug products include ‘‘Highlights of section VIII.B.6 of this document), as row 1 of table 8b).
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4. Burden Associated with Revised 5. Burden Associated with Revised or be reprinted immediately following Labeling Efficacy Supplements Labeling for Efficacy Supplements for the prescription drug labeling Submitted on or After the Effective Date Generic Drug Products (§ 201.57) (§§ 201.57(c)(18) and 201.80(f)(2)). As of the Rule (§§ 201.56(d) and 201.57) The reporting burden for generic indicated in the economic analysis products subject to the requirements of (section XI.D.1 of this document), an Efficacy supplemental applications the final rule has only been estimated estimated 80 products will need to for older drugs submitted on or after the for those products requiring revisions to revise labeling as a result of this effective date of the final rule are subject their existing labeling. Reporting requirement. Approximately 18 to the content and format requirements burdens for generating newly approved applicants would be subject to this at §§ 201.56(d) and 201.57. To meet labeling for generic products requirement. The agency estimates these requirements, applicants must (§ 314.94(8)) is already approved under approximately 38 hours per product as revise the existing labeling for these OMB control number 0910–0001. a one-time labeling revision, totaling products. Each year an increasing According to the data in the economic 3,040 hours (see row 4 of table 8b). number of innovator drug labeling will analysis, beginning in year 3 and have been revised, and over time, very continuing throughout the 10-year C. Capital Costs few efficacy supplements independently period analyzed, approximately 42 A small number of carton-enclosed will generate labeling revisions as a generic applications per year must products may require new packaging to result of this final rule. According to submit labeling supplements to comply accommodate longer inserts (see section information in the economic analysis, with the final rule (see section XI.D.2.a XI.D.2.c and comment 124 of this the total number of affected efficacy of this document). For purposes of this document). As described in more detail supplements over 10 years is estimated analysis, approximately 336 already in the economic analysis (section at 324, with a decreasing number each approved generic drug applications XI.D.2.c.ii), up to 5 percent of the year over the 10-year period (see section must submit labeling supplements over the 10-year period after the effective existing products affected by the rule XI.D.2.a. of this document). For date of the rule (see section XI.D.2.a of (i.e., products with new efficacy purposes of this analysis, the total this document). The time required to supplements, products approved in the burden for efficacy supplements is revise and submit this labeling to FDA 5 years prior to the effective date of the summarized in row 2 of table 8b. Over would be approximately 27 hours per rule, and affected ANDAs) may require 10 years, approximately 172 applicants application, totaling 9,072 hours (see equipment changes at an estimated cost will trigger approximately 324 efficacy row 3 of table 8b). In addition to this of $200,000 each product. As shown in supplements, each one requiring burden, a minimal reporting burden table 17, the estimated value of approximately 196 hours to revise the associated with a very small number of equipment changes totals $7.2 million labeling in the application, totaling generic applications referencing older and $8.7 million over 10 years 63,504 hours. In addition to this burden, drugs may continue indefinitely. discounted at 7 and 3 percent, a minimal annual reporting burden, 6. Requirement That FDA-Approved respectively. probably even lower than the 7 per year Patient Labeling Accompany Description of Respondents: Persons estimated in year 10 of table 13 of this Prescription Drug Labeling Within 1 document, will continue indefinitely. and businesses, including small Year (§§ 201.57 and 201.80) businesses and manufacturers. Within 1 year, all FDA-approved patient labeling must either accompany
TABLE 8A.—ESTIMATED REPORTING BURDEN FOR NEW DRUG APPLICATIONS1
Number of Number of Responses Total Hours Category (21 CFR section) Respondents per Respondent Responses per Response Total Hours
Annual burden associated with former labeling requirements (former 201.56(d) and 201.57) 85 1 .26 107 3,200 342,400
Additional annual burden associ- ated with requirements of this final rule (201.56(d) and 201.57) 85 1.26 107 149 15,943
Total 3,349 358,343 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 8B.—ESTIMATED REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG PRODUCTS1
Number of Year(s) In Which Bur- Number of Responses Total Re- Hours per Total Total Capital Category (21 CFR section) dens Occur Following Respond- per Re- sponses Response Hours Costs Rule’s Effective Date ents spondent
Burden associated with re- Beginning year 3, 172 2.0 344 196 67,424 $3.3 million vised labeling for applica- ending year 7 tions approved within 5 years prior to the rule’s ef- fective date (201.57)
Burden associated with re- Beginning year 1, di- 172 1 .88 324 196 63,504 $2.5 million vised labeling for efficacy minishing over time supplements submitted on or after the rule’s effective date (201.56(d) and 201.57)
Burden associated with re- Beginning year 3, 42 8 336 (for years 27 9,072 $2.5 million vised labeling for efficacy continuing annually 1–10) supplements for generic thereafter drug products (201.57)
Burden as a result of having Year 1 only 18 4.44 80 38 3,040 $400,000 FDA-approved patient label- ing accompany drug label- ing within 1 year (201.57(c)(18) and 201.80(f)(2))
Total 143,040 Up to $8.7 million (see table 17) 1 There are no operating and maintenance costs associated with this collection of information.
The information collection provisions the Federal statute.’’10 Here, FDA has An NDA must include the ‘‘proposed in this final rule have been approved determined that the exercise of State text of the labeling,’’ together with under OMB control number 0910–0572. authority conflicts with the exercise of ‘‘annotations to the information in the This approval expires December 31, Federal authority under the act. summary and technical sections of the 2008. An agency may not conduct or The act gives FDA comprehensive application that support the inclusion of sponsor, and a person is not required to authority over drug safety, effectiveness, each statement in the labeling * * *’’ respond to, a collection of information and labeling. FDA is the expert Federal (21 CFR 314.50(c)(2)(i)). The proposed unless it displays a currently valid OMB agency charged by Congress with labeling must also provide ‘‘adequate ensuring that drugs are safe and control number. directions for use’’ (section 502(f) of the effective and that product labeling is act). FDA by regulation has defined this IX. Environmental Impact truthful and not misleading (sections to mean ‘‘directions under which the 505(d) and 903(b)(2)(B) of the act (21 layman can use a drug safely * * *’’ (21 The agency has determined under 21 U.S.C. 393(b)(2)(B))). According to the CFR 201.5). Because a prescription drug, CFR 25.30(h) and (k) that this action is act, a manufacturer of a drug must by definition, cannot be used safely by of a type that does not individually or submit an NDA containing ‘‘full reports a layperson without professional cumulatively have a significant effect on of investigations which have been made supervision, FDA regulations afford an the human environment. Therefore, to show whether or not such drug is safe exemption from the statutory neither an environmental assessment for use and whether such drug is requirement of adequate directions for nor an environmental impact statement effective in use’’ (section 505(b)(1)(A) of use for a prescription drug whose is required. the act; see also 21 CFR 314.50; see also labeling includes ‘‘any relevant hazards, United States v. Rutherford, 442 U.S. contraindications, side effects, and X. Executive Order 13132: Federalism 544, 555 (1979) (‘‘Few if any drugs are precautions under which practitioners We have analyzed this final rule in completely safe in the sense that they licensed by law to administer the drug may be taken by all persons in all accordance with the principles set forth can use the drug safely and for the circumstances without risk. Thus, the purposes for which it is intended in Executive Order 13132. Section 4(a) Commissioner generally considers a ***’’ (§ 201.100(c)(1)). If labeling of the Executive order requires agencies drug safe when the expected therapeutic lacks this information, or is otherwise to ‘‘construe * * * a Federal statute to gain justifies the risk entailed by its false or misleading in any particular, preempt State law only where the use’’ (citations omitted))). FDA is authorized to refuse to approve statute contains an express preemption the NDA (section 505(d) of the act; 21 provision or there is some other clear 10 Because we have determined that the act CFR 314.125(b)(6) and (b)(8)). evidence that the Congress intended preempts State law because the exercise of State The FDA review process for an NDA preemption of State law, or where the authority conflicts with the exercise of Federal is thorough and scientifically rigorous. exercise of State authority conflicts with authority under that statute, we need not construe our statutory rulemaking authority as required by An NDA must contain proposed the exercise of Federal authority under section 4(b) of the Executive order. labeling and all information about the
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drug (whether favorable or unfavorable) they need to prescribe the drug safely and commerce without having submitted the that is pertinent to evaluating the effectively for the care of patients. required premarket information has application and that is received or (65 FR 81082 at 81082 and 81083). What violated the act (section 505(a) of the otherwise obtained by the applicant distinguishes the prescription drug act) and is subject to FDA enforcement from any source (21 CFR 314.50 and labeling from other information action. Similarly, if a manufacturer fails 601.2(a)). FDA scientists evaluate this available to practitioners about a to submit information required by 21 information, and may request additional prescription drug is that the CFR 314.80 and 314.81, it is subject to information as necessary to provide a prescription drug labeling ‘‘is intended enforcement action under 21 U.S.C. complete and accurate picture of the to provide physicians with a clear and 331(e). FDA is authorized to investigate product. FDA may supplement the concise statement of the data and suspected fraud using its general expertise of its in-house scientific information necessary for the safe and statutory investigative authority (section personnel with advice from scientific effective use of the drug.’’ Moreover, the 702 of the act (21 U.S.C. 372)). The advisory committees of outside experts act ‘‘permits labeling statements with agency is also empowered to address (21 CFR 14.171). respect to safety only if they are fraud by seeking injunctive relief and Under the act and FDA regulations, supported by scientific evidence and are civil penalties (21 U.S.C. 332, the agency determines that a drug is not false or misleading in any 333(g)(1)(A)), and has authority to approvable based not on an abstract particular’’ (44 FR 37434 at 37435 and invoke the general federal prohibition estimation of its safety and 37441). on making false statements to the effectiveness, but rather on a Under this final rule, risk information Federal Government (18 U.S.C. 1001). In must appear in different sections of the comprehensive scientific evaluation of sum, FDA has a variety of enforcement prescription drug labeling in a the product’s benefits and risks under options that allow it to make a particular order and must be based on the conditions of use prescribed, calibrated response to suspected data derived from human experience recommended, or suggested in the violations of the act’s information whenever possible. For example, labeling (section 505(d) of the act). FDA submission requirements. information included in the considers not only complex clinical The agency carefully reviews all the contraindications section of prescription issues related to the use of the product information submitted by a sponsor in drug labeling must include only in study populations, but also important a marketing application to make its ‘‘[k]nown hazards and not theoretical and practical public health issues statutorily required judgment as to possibilities’’ (§ 201.57(c)(5)). The whether the product is safe and effective pertaining to use of the product in day- adverse reactions section must include to-day clinical practice, such as the and otherwise in compliance with the those adverse events for which there is act. It also reviews adverse event nature of the disease or condition for some basis to believe there is a causal which the product will be indicated, information submitted after marketing relationship between the event and the approval and determines what action, if and the need for risk management drug (§ 201.57(c)(7)). measures to help assure in clinical any, should be taken. In rare cases, FDA The act and FDA regulations prescribe finds that the information supports a practice that the product maintains its several procedures to ensure that FDA favorable benefit-risk balance. The determination to withdraw the product receives information about risks that from the market (section 505(e) of the centerpiece of risk management for become apparent after approval. prescription drugs generally is the act; 21 CFR 601.5(b)(1)). In other Because clinical trials involve time- instances, FDA uses other risk labeling, which reflects thorough FDA limited administration of the review of the pertinent scientific management techniques. One such investigational product to a relatively technique is incorporating additional evidence and communicates to health small and homogeneous population of care practitioners the agency’s formal, risk information into, or otherwise study subjects, adverse events that were modifying, the prescription drug authoritative conclusions regarding the not observed during clinical trials may conditions under which the product can labeling (§ 201.57(e)). In many cases, be recognized or identified following review of the submitted reports does not be used safely and effectively in approval. The act provides that a accordance with the act. lead to any change, e.g., because FDA manufacturer must establish and determines that the event reported is not FDA carefully controls the content of maintain such records, and make such prescription drug labeling, because such causally related to the product. reports, as FDA may require by Changes to prescription drug labeling labeling is FDA’s principal tool for regulation (section 505(k) of the act). To typically are initiated by the sponsor, educating health care practitioners implement this provision, FDA has subject to FDA review, but are about the risks and benefits of the issued regulations requiring prompt sometimes initiated by FDA. Under FDA approved product to help ensure safe reports of serious, unexpected drug regulations, to change prescription drug and effective use. As FDA noted in the experiences and periodic reports of all labeling (except for editorial and other preamble accompanying the December information relating to the safety and minor revisions), the sponsor must 2000 proposed rule amending the 1979 effectiveness of the drug (21 CFR 314.80 submit a supplemental application fully physician labeling regulations: and 314.81). Manufacturers may also The part of a prescription drug product’s explaining the basis for the change approved labeling directed to health care commit to conduct additional safety and (§§ 314.70 and 601.12(f)). FDA permits practitioners * * * is the primary effectiveness studies following approval two kinds of labeling supplements: (1) mechanism through which FDA and drug and submit data from these studies to Prior approval supplements, which manufacturers communicate essential, the agency. (See section 506B of the act require FDA approval before a change is science-based prescribing information to (21 U.S.C. 356b).) made (§§ 314.70(b) and 601.12(f)(1)), health care professionals. This part of The statutory and regulatory and (2) CBE supplements, which may be approved labeling is a compilation of requirements for the submission of implemented before FDA approval, but information based on a thorough analysis of information to FDA are accompanied by the new drug application (NDA) or biologics after FDA notification (§§ 314.70(c) and license application (BLA) submitted by the statutory provisions addressing the 601.12(f)(2)). Labeling changes to the applicant * * * . [T]he primary purpose of failure of a sponsor to comply with FPI to add or strengthen a warning, prescription drug labeling is to provide these requirements. A manufacturer that precaution, contraindication, or adverse practitioners with the essential information introduces a new drug into interstate reaction statement are within the
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category of changes for which CBE more detail above, it preempts state law Section 202(a) of the Unfunded supplements are required by FDA only to the extent required to preserve Mandates Reform Act of 1995 requires regulations (§§ 314.70(c)(6)(iii) and Federal interests. Section 4(d) of that agencies prepare a written 601.12(f)(2)(i)) (see comment 5). While a Executive Order 13132 states that when statement of anticipated costs and sponsor is permitted to add risk an agency foresees the possibility of a benefits before proposing any rule that information to the FPI without first conflict between State law and federally may result in an expenditure by State, obtaining FDA approval via a CBE protected interests within the agency’s local, and tribal governments, in the supplement, FDA reviews all such area of regulatory responsibility, the aggregate, or by the private sector, of submissions and may later deny agency ‘‘shall consult, to the extent $100 million in any one year (adjusted approval of the supplement, and the practicable, with appropriate State and annually for inflation). labeling remains subject to enforcement local officials in an effort to avoid such The agency believes that this rule is action if the added information makes a conflict.’’ Section 4(e) of Executive consistent with the regulatory the labeling false or misleading under Order 13132 adds that, when an agency philosophy and principles identified in section 502(a) of the act. To mitigate this proposes to act through adjudication or Executive Order 12866 and in these two risk, manufacturers often consult with rulemaking to preempt State law, the statutes. The final rule would amend FDA before adding risk information to agency ‘‘shall provide all affected State current requirements for the format and labeling. As noted in response to and local officials notice and an content of human prescription drug comment 5, however, a sponsor may not opportunity for appropriate product labeling. Although the use a CBE supplement to make most participation in the proceedings.’’ effectiveness of the revised labeling in changes to Highlights. FDA sought input from all achieving time savings and reductions As FDA has long recognized, its role stakeholders on new requirements for in adverse reactions is uncertain, based is not to regulate medical practice. The the content and format of prescription on the following analysis as agency’s actions nevertheless affect drug labeling through publication of the summarized in table 9, FDA projects medical practice in a variety of ways. proposed rule in the Federal Register. that the present value of the quantifiable For example, FDA approval decisions Although the proposed rule did not benefits of the final rule over 10 years affect the availability of drugs and propose to preempt state law, it did range from $330 million to $380 million medical devices. Also, FDA decisions as solicit comment on product liability and from $420 million to $480 million to the content and format of prescription issues. FDA received no comments on at a 7 and 3 percent discount rate, drug labeling affect health care the proposed rule from State and local respectively. Direct costs of the final practitioners’ communications with governmental entities. rule are projected to range from patients, to the extent such labeling is Officials at FDA consulted with a approximately $7 million to $17 million relied upon by such practitioners to number of organizations representing in any one year, for a total present value guide their discussions of risk with the interests of state and local of approximately $90 million and $120 patients. FDA strongly believes that governments and officials about the million over 10 years at a 7 and 3 health care practitioners should be able interaction between FDA regulation of percent discount rate, respectively. The to rely on prescription drug labeling for prescription drug labeling (including agency thus concludes that the benefits authoritative risk information and that this rule) and state law. of this final rule outweigh the costs. health care practitioners should not be In conclusion, the agency believes Furthermore, the agency has determined required to convey risk information to that it has complied with all of the that the final rule is not an economically patients that is not included in the applicable requirements under significant rule as described in the labeling. Executive Order 13132 and has Executive order, because annual If State authorities, including judges determined that this final rule is impacts on the economy are and juries applying State law, were consistent with the Executive order. permitted to reach conclusions about substantially below $100 million. the safety and effectiveness information XI. Analysis of Economic Impacts Because the rule does not impose any disseminated with respect to drugs for FDA has examined the impacts of the mandates on State, local or tribal which FDA has already made a series of final rule under Executive Order 12866, governments, or the private sector that regulatory determinations based on its the Regulatory Flexibility Act (5 U.S.C. will result in an expenditure in any one considerable institutional expertise and 601–612), and the Unfunded Mandates year of $100 million or more, FDA is not comprehensive statutory authority, the Reform Act of 1995 (Public Law 104–4). required to perform a cost-benefit federal system for regulation of drugs Executive Order 12866 directs agencies analysis according to the Unfunded would be disrupted. Where a drug has to assess all costs and benefits of Mandates Reform Act. The current not been reviewed by FDA and available regulatory alternatives and, inflation-adjusted statutory threshold is decisions with respect to safety, when regulation is necessary, to select about $115 million. effectiveness, and labeling have not regulatory approaches that maximize The agency believes that this rule been made by the agency, expert net benefits (including potential would not have a significant impact on determinations would not yet have been economic, environmental, public health most small entities. However, it is made by FDA, and such disruption and safety, and other advantages; possible that some small firms that would not occur. distributive impacts; and equity). Under produce several affected drugs, or small Section 4(c) of Executive Order 13132 the Regulatory Flexibility Act, unless firms that might be required to instructs us to restrict any Federal the agency certifies that the rule is not undertake packaging modifications, may preemption of State law to the expected to have significant economic be significantly affected by this rule. ‘‘minimum level necessary to achieve impact on a substantial number of small Therefore, the following analysis, in the objectives of the statute pursuant to entities, an agency must consider conjunction with the preamble, which the regulations are promulgated.’’ alternatives that would minimize any constitutes the agency’s final regulatory This final rule meets the preceding significant impact of the rule on small flexibility analysis as required by the requirement because, as discussed in entities. Regulatory Flexibility Act.
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TABLE 9.—SUMMARY OF PROJECTED QUANTIFIABLE BENEFITS AND COSTS OVER 10 YEARS1
Present Value ($ million) Total ($ million) 3 percent 7 percent
Benefits: Health Care Practitioner Time Saved 150 120 90 Cost of Adverse Drug Events Avoided 360 to 430 300 to 360 240 to 290
Total Potential Benefits 510 to 580 420 to 480 330 to 380
Costs: Design and Produce Trade Labeling; Modify Packaging Equipment 42 36 29 Reformat and Produce Labeling Not Accompanying Drug Products 36 30 25 Print Longer PDR 59 49 39
Total Costs 140 120 90 1 Numbers may not sum due to rounding.
A. Purpose of the Final Rule Although our analysis did not stated that because the proposal has the The purpose of the final rule is to separate administrative costs from other potential to substantially affect larger make it easier for health care labeling design costs, the agency companies (could double the length of practitioners to find and read anticipated that manufacturers would labeling and require extensive re- information important for the safe and require some ‘‘detailed discussions and engineering and re-design of packaging effective use of prescription drugs. As drug-specific decisions’’ during the lines and ancillary equipment), its described elsewhere in this preamble, design phase of labeling (e.g., regarding impact would be even greater on smaller the agency has found that the current exactly which adverse reactions should companies. format of prescription drug labeling can be listed in Highlights) (65 FR 81082 at Although the agency had requested be improved to more optimally 81106). Currently, manufacturers input from small companies that might communicate important drug submitting new applications (i.e., NDAs be affected by the rule, all comments on information (see section I of this and BLAs) and efficacy supplements this question came from large document). Enhanced communication have to negotiate the content of labeling companies. FDA believes it is difficult of drug information to physicians as part of the review process. Because to predict the effect of the rule on small should make them better informed any information in Highlights is also in firms. While small firms may have prescribers. The final rule is designed to the FPI, the agency does not agree that lower sales volume over which to achieve these objectives by amending negotiating the content of Highlights spread the fixed costs of compliance, the current content and format of the will impose significant administrative some industry consultants have found labeling for certain human prescription costs beyond what is currently incurred that small pharmaceutical firms have drug products to, among other things, by these manufacturers. As noted, to less organizational layers and incur highlight frequently accessed and new facilitate this process, the agency is lower costs for the same activity than information, include a table of contents making available guidance to assist large pharmaceutical firms (Ref. 12). for the detailed information in labeling, manufacturers in selecting information Table 22 in section XI.E.2 of this and reorder this detailed information. for inclusion in Highlights (section IV of document illustrates the potential this document). impact that the final rule might have on B. Comments on the Economic Impact On the other hand, manufacturers of small firms. Analysis recently approved innovator drugs (i.e., (Comment 123) One comment Most comments on the economic approved within 5 years prior to the maintained that there is no support for analysis of the proposed rule came from effective date of the final rule) will incur FDA’s identified benefit of reducing the pharmaceutical manufacturers. costs to: (1) Prepare and submit their time it takes a prescriber to use labeling Although many manufacturers redesigned labeling to FDA for approval, by 15 seconds. The comment argued expressed concerns that the agency had which may include negotiations that Highlights, because it contains significantly underestimated the costs to concerning the content of Highlights, incomplete information, would actually industry, especially the additional and (2) replace existing labeling with increase physician reading time and packaging costs that would be necessary redesigned labeling. To account for asserts that FDA’s assumption would be with labeling printed in 8 points, only these additional actions, the one-time true only if physicians read just a few provided detailed information design costs for labeling of recently Highlights. about the potential burden they approved products are estimated to be The agency acknowledges that there is expected the rule to impose. The agency about 50 percent higher than for not direct empirical support for the welcomes these comments and, labeling of new products (see section estimate of 15 seconds time savings, but whenever possible, has incorporated XI.D.2 of this document). is persuaded based on consultation with data from these examples in the final (Comment 122) The agency sought physicians that the labeling changes analysis of economic impacts. specific comment on whether the would save time. The agency consulted (Comment 121) Several comments potential impact of the proposed rule on physicians in a national survey, focus argued that manufacturers would incur small entities has been accurately groups, and a public meeting to design significant administrative costs when estimated by the agency, and whether labeling that provides easier and faster negotiating the content of Highlights small business concerns have been access to the most important and with FDA. adequately addressed. One comment commonly referenced prescribing
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information (65 FR 81082 at 81083 points, on average, trade labeling is in impact of each of these requirements through 81085; see also Ref. 11). Using 6 points, and thus requiring a minimum separately. a standard format with frequently type size of 6-point will not increase the Within 1 year of the effective date of accessed sections at the beginning of size of most trade labeling. However for the final rule, any FDA-approved labeling will help physicians find the few products currently printed in 4 patient labeling must either be reprinted important information quickly and points, labeling will require immediately following the end of retain that information. Inclusion of approximately 33 percent more paper to labeling or accompany the labeling Contents and references in Highlights to conform with the 6-point minimum size (§§ 201.57(c)(18) and 201.80(f)(2)). An the full prescribing information that is requirement at § 201.57(d)(6). The estimated 150-square inches of surface cited or concisely summarized will agency believes that the additional area would be needed to print this speed access to detailed information in resources associated with longer information, adding an additional 75- the FPI. In the absence of quantitative labeling are warranted by the ease of use square inches to the size of the labeling evidence suggesting a different estimate and speed of comprehension by having (65 FR 81082 at 81109). The agency of time savings, the agency is retaining labeling printed in 6 rather than 4 identified up to 200 products with some 15 seconds as a conservative estimate of points. form of FDA-approved patient labeling the amount of time health care Highlights and Contents will increase that will be affected by the final rule. A practitioners can save when seeking trade labeling by approximately 40 sample of these affected products shows drug product information in labeling. square inches, requiring an additional that the labeling of more than 60 percent (Comment 124) Some comments 20 square inches of paper. already conforms to this provision of the argued that FDA’s estimate significantly Manufacturers submitting NDAs and final rule. For the final analysis, the underestimates increased costs for trade BLAs have not yet designed product agency increased the estimate of the packaging, shipping containers, and labeling or packaging. Thus, the agency number of affected products from 50 to new packaging and shipping equipment does not agree that the final rule will 80, thus increasing the incremental to accommodate the larger labeling that impose additional packaging costs on printing costs for this provision of the will result from the new format. Some these manufacturers. In contrast, final rule to $0.4 million annually (see comments argued that the agency’s manufacturers submitting efficacy section XI.D.1 of this document). initial estimate of $200,000 to adjust or supplements or having existing labeling More space will be needed to print retool existing packaging equipment for drug products affected by the final longer trade labeling and labeling underestimates the impact on industry rule will need to determine if their distributed with promotional materials by almost fourfold. Moreover, one redesigned trade labeling fits on or for new and recently approved comment stated it could cost large within existing packaging. products. The length will depend on the manufacturers with many product lines The final rule will affect less than 15 minimum type size requirements for the up to $40 million to change all percent of existing products in the labeling. For trade labeling printed in a packaging lines. Several comments United States.11 The agency agrees that minimum of 6 points, an estimated 20 stated that increases of this magnitude some packaging lines of these products square inches of paper is necessary to will require retooling or replacing will require adjustment to accommodate accommodate Highlights and Contents. existing equipment, increasing longer trade labeling, but disagrees that In contrast, product labeling distributed containers to accommodate longer this will be necessary for all packaging with promotional materials must be outserts, or, in some cases, adding a lines. Based on an analysis of printed in a minimum 8-point type size, carton. Comments also stated that longer ophthalmic products, the agency requiring about 93 square inches of labeling would increase administrative increased the proportion of existing paper (65 FR 81082 at 81107). costs. products expected to incur one-time Furthermore, for labeling with FDA- FDA allows each manufacturer some production costs from 1 to 5 percent approved patient labeling which is not flexibility to determine the size and (see section XI.D.2.c.ii of this currently appended to the product shape of a product’s trade labeling and document). labeling, after all provisions of the final packaging. A survey of labeling printed (Comment 125) One comment insisted rule are implemented, product labeling in the Physicians’ Desk Reference (PDR) that FDA’s estimate of 92.6 square will be approximately 168 square inches for 200 products showed that, on inches of additional labeling space is or 65 square inches longer when printed average, labeling requires 200 square not sufficient to accommodate the in 8-point or 6-point type, respectively. inches of surface area when printed in proposed new labeling sections, (Comment 126) One comment asked 6.5-point type size. Since prescription increase in white space, increase in type the agency to consider the impact of the increased number of calls on drug labeling is printed on both sides of size, and inclusion of patient companies, and possible increases in the paper, these findings suggest that information in the FPI. The comment personnel to process calls, as a result of current trade labeling averages 100 suggested that FDA’s presentation of requiring companies to include their square inches. From this baseline, the how much additional labeling space phone number in the package inserts. agency calculates that about an would be needed was confusing. additional 92.6 square inches of paper The implementation schedule to add Another comment raised concerns that would be needed to print labeling in 8- FDA-approved patient labeling to requiring corporate telephone numbers point type size and to add Highlights prescription drug labeling differs from for reporting of serious adverse and Contents to the labeling. the implementation schedule for the reactions in Highlights would require To reduce the burden on industry, the formatting and content changes affecting companies to change their labeling with final rule requires that trade labeling be labeling for new and recently approved each change of their corporate telephone printed in at least 6-point type size (see products (i.e., approved within 5 years number. The agency believes that health care comment 102), similar to the size of the of the effective date of the final rule). practitioners have varied access to baseline case used in the original Consequently, the agency analyzed the analysis and a size generally supported company information via the Internet by industry comments on the proposed 11 Data derived from information in ‘‘Approved and other sources, thus including the rule. Even though some trade labeling is Drug Products with Therapeutic Equivalence phone number is unlikely to overly currently printed in a size as small as 4 Evaluations,’’ December 2001. burden a company’s ability to handle
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incoming calls. The agency believes that Moreover, comments from a pharmacy manufacturers agreed that including a changes in corporate phone numbers are association, submitted in response to comprehensive table of contents and an ordinary business expense. the proposed rule, reported that a recent reordering of the detailed information informal survey of pharmacists found would improve clarity of the labeling C. Benefits of Regulation that 30 percent refer to prescription and quickly direct the reader to the The expected economic benefits of drug labeling several times each day, 36 appropriate section of the FPI, but this final rule are the sum of the present percent refer at least once per day, and expressed reservations about the utility values of: (1) The reduced time needed 34 percent refer at least once per week. of Highlights (see comment 2). by health care practitioners to seek If representative, these findings suggest Comments, including one by an desired information in prescription drug that the average pharmacist in the expert in human cognition, supported labeling; (2) the increased effectiveness United States seeks information from Highlights as a way to improve the of drug treatment; and (3) the avoided prescription drug labeling at least 257 accessibility of the most heavily used costs of treating drug-related errors due times each year.13 To put this estimate information (see comment 2). Moreover, to misunderstood or incorrectly applied in perspective, approximately 2.85 by including references in Highlights to drug information. billion prescriptions were dispensed by specific sections of the FPI, Highlights We acknowledge that the information retail pharmacies in 2001 (Ref. 17). will also enhance the effective use of the to estimate the benefits of this rule is About 60 percent of the 212,660 information in the detailed sections of quite limited. In particular, we do not pharmacists in the United States work the labeling. Therefore, based on have direct estimates of how much time in retail pharmacies (Refs. 18 and 19) comments from health care practitioners might save by using the and cumulatively seek information from practitioners, professional organizations new labeling, or how the new labeling prescription drug labeling about 32.8 and consumer groups, the agency might improve doctors’ understanding million times each year (212,660 believes that the new format will reduce of risks of prescription drugs. There is pharmacists x 0.6 x 257 labeling the time physicians, pharmacists, and no formal study that tested how consultations per year), approximately other practitioners must spend seeking alternative labeling formats affect 12 times for every 1,000 prescriptions specific information in prescription physicians’ speed or quality of dispensed. drug labeling and increase the extent comprehension of information related to For the analysis of the proposed rule, they rely on labeling for drug potential adverse effects of drugs. FDA was aware of no data estimating information. A recent study in Oregon found that 1. Decreased Health Care Practitioner the total time physicians spend reading primary care physicians on average will Time prescription drug labeling. It also had no estimates of how much time savings consult two sources of information, one Prescription drug labeling is a major might result from possible changes in of which is usually the PDR, and spend source of information about the risks drug labeling. It therefore conservatively an average of 12 minutes seeking and benefits of prescription drugs. Each assumed that physicians could save an information to answer patient questions year health care practitioners spend average of 15 seconds each time they (Ref. 16). Another study in Finland considerable time seeking medical refer to prescription drug labeling in the logged the time physicians spent knowledge about the therapeutic risks new format (65 FR 81082 at 81104). One searching a computerized set of and benefits of the drugs prescribed to comment from a pharmaceutical guidelines, the ‘‘Physicians’ Desk treat patients. However, only a few manufacturing organization requested Reference and Database,’’ and found the studies have focused on the justification for this assumption (see average time needed to find and read an information-seeking behavior of health comment 123). The comment stated that article was 4.9 minutes (Ref. 20). care practitioners. Four studies using rather than save time, the new format Although these studies may not be family practice physicians reported that with Highlights would lengthen the representative of the average the PDR, a compilation of prescription time practitioners spend looking for practitioner in the United States, they drug labeling, was the most frequently information. suggest that the agency’s estimate of a used reference book in a clinical setting The agency disagrees it will take 15-second time savings with the new (Refs. 13 through 16). In one study health care practitioners more time to format (once drug labeling is at hand) is published in 1990, physicians reported find information with the new format plausible and conservative in that it is using the PDR almost daily (Ref. 13). In compared to the old format. As only a small improvement relative to addition to the PDR, physicians receive described elsewhere in the preamble, time currently spent for most labeling prescription drug labeling directly from the agency solicited input from health referrals. If the new format were drug manufacturers and their care practitioners to develop a format implemented for all prescription drug representatives. that presents complex drug information products, the nation’s 625,100 A 1994 FDA survey of physicians in a manner that will enable them to physicians active in patient care (Ref. found that 42 percent referred to find information more rapidly, 21) could save a total of about 552,100 prescription drug labeling at least once improving the communication of the hours per year (625,100 physicians x a day, 33 percent less often than once risks and benefits of the drug (see 212 labeling consultations per year x 15 a day but more often than once a week, section I of this document). In seconds saved per labeling consultation/ and 25 percent once a week or less (Ref. comments on the proposed rule, 3600 seconds per hour). Likewise, 11, pp. 30–31). These findings suggest organizations representing health care pharmacists could save an additional that a physician seeks drug information practitioners and consumer groups 227,700 hours per year (212,660 from prescription drug labeling on strongly supported the new format as pharmacists x 257 labeling average 212 times each year.12 being easier and quicker to use (see consultations per year x 15 seconds comment 2). Comments from many drug saved per labeling consultation/ 3,600 12 On average, physicians work 47 weeks per year seconds per hour). and consult prescription drug labeling 4.51 times 13 On average, it is assumed that pharmacists The final rule only applies to new and each week [(7 consultations per week x 42 percent) work 50 weeks per year and consult labeling 5.14 recently approved products. Moreover, + (4 consultations per week x 33 percent) + (1 times per week [(10 consultations per week x 30 consultation per week x 25 percent)] (65 FR 81082 percent) + (5 consultations per week x 36 percent) implementation for recently approved at 81104 through 81105). + (1 consultation per week x 34 percent)]. products is phased in over several years.
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Thus, the final rule will initially apply remain unchanged (65 FR 81082 at To estimate the monetary value of the only to a small percentage of 81104). This analysis, therefore, time saved, an hourly loaded wage for prescription drug labeling. The rule’s assumes that the rule will begin physicians is calculated using data from focus on newer products includes the affecting the length of time needed for the American Medical Association prescription drug labeling that health prescription drug labeling consultations (AMA) on the average net annual care practitioners consult most in the second year of implementation, income of all non-Federal physicians frequently. In FDA’s survey of only affecting 5 percent of all (excluding residents), the average physicians, newness of the product was consultations in that year. The weekly workload, average number of the factor most often rated by physicians percentage of reformatted prescription weeks worked per year and benefits as ‘‘very likely’’ to trigger referral to drug labeling consulted by physicians is adjusted by the proportion of self- prescription drug labeling (Ref. 11, p. assumed to increase to 10, 15, and 25 employed physicians (Refs. 22 and 23). 35). Similarly, the pharmacy percent in years 3, 4, and 5 respectively. The loaded wage for pharmacists is association’s survey found that pharmacists were most likely to consult Thereafter, it is assumed to increase an calculated from Bureau of Labor labeling if the drug was recently additional 5 percent each year, reaching Statistics data (Ref. 18). At $88.16 per approved (48 percent). 50 percent in year 10. Thus, in year 10, hour for physicians ([$194,400 x (1 + Although the average practitioner the time savings for physicians and 0.2)] / [47 weeks x 56.3 hours / week]) regularly prescribes from 40 to 100 pharmacists is projected to equal about and $46.75 per hour for pharmacists pharmaceutical products (Ref. 24), the 276,000 and 113,900 hours, ($33.39 / hour x (1 + 0.4)), table 10 proportion of these that are new drugs respectively. FDA has not attempted to shows the annual monetary value of is unknown. Because the agency project impacts beyond 10 years, due to time saved and indicates that the received no comments and has no other the uncertainty of the longer term present value over 10 years equals information on the percentage of technological changes that would affect approximately $90 million or $120 reformatted labeling that practitioners these estimates (see section V of this million using a 7 or 3 percent discount will consult, the initial assumptions document). rate, respectively.
TABLE 10.—VALUE OF HEALTH CARE PRACTITIONER TIME SAVED1
Current Value ($ million) Present Value ($ million) Year Physicians Pharmacists Total Total Discounted at 3 percent Total Discounted at 7 percent
1 0 0 0 0 0
2 2 1 3 3 3
3 5 1 6 5 5
4 7 2 9 8 7
5 12 3 15 13 11
6 15 3 18 15 12
7 17 4 21 17 13
8 19 4 24 19 14
9 22 5 27 20 15
10 24 5 30 22 15
Total 120 30 150 120 90 1 Numbers may not sum due to rounding.
2. Improved Effectiveness of Treatment Highlights would emphasize those The initial U.S. approval date will characteristics of drugs that physicians alert practitioners to newer products The final rule will improve report are the most important for that should be used with greater prescription drug labeling to make it decisionmaking. With the Contents and vigilance. There are over 100 NDAs, easier to find and use information about references to the FPI in Highlights, including about 30 new molecular the product. More effective practitioners can more quickly find all entities, approved every year in the communication of drug information will relevant facts about the drug that are United States. Initial approval is based better inform practitioners about the specific to their patients. Each format on data from clinical trials conducted to risks and benefits of drugs prescribed to change required by the final rule is determine the safety and effectiveness of patients. Prescription drug labeling can contain hundreds of facts about a drug, intended, therefore, to present the a product. These trials typically include increasing the time needed to find complex drug information contained in only enough subjects to detect 1 adverse specific information, relative to simpler labeling in a way that will improve the reaction in every 300 to 500 patients labeling. For example, labeling of the ability of practitioners to select and (Ref. 25). It is not uncommon for drugs drug cisapride contains over 470 facts prescribe drugs to their patients safely to have significant adverse effects that (Ref. 24). Under the final rule, and effectively. occur at lower frequencies than can be
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detected in premarketing clinical trials. labeling follow a standardized format dollars. If all hospitals incur similar Adding contact information where will better inform health care costs for preventable adverse events, the practitioners can report suspected practitioners about the drugs that are potentially preventable annual costs adverse reactions will facilitate the prescribed to patients, improve the from this source could total from collection of drug safety information effectiveness of treatment, and reduce between $1.4 billion to $2.2 billion and make it easier for the agency and the number of preventable adverse nationally (in 2000 dollars). manufacturers to identify significant reactions experienced by patients. Few studies on adverse reactions in safety concerns that can emerge after a No national study on the incidence or outpatient or long-term care settings drug is marketed and a much larger associated costs of adverse reactions has have been conducted. A report from a population is exposed to the product. been conducted. Furthermore, it is multidisciplinary conference held in Moreover, by identifying those sections difficult to compare published studies 2000 to discuss a national research of the labeling in which there have been because they are either too limited in agenda for ambulatory patient safety important recent changes, the new scope or differ in methodology. described a diverse and complex format will also alert practitioners to Nevertheless, studies of hospitalized outpatient system that was prone to the significant new safety concerns and patients suggest that the rate of same types of errors observed in other significant changes to labeling preventable adverse events that occur hospital studies (Ref. 32). In 1995, FDA once a product has been approved. during hospitalization is approximately estimated that hospitalizations In addition, any FDA-approved 1.2 to 1.8 adverse events per 100 associated with outpatient adverse patient labeling must be printed at the patients admitted (Refs. 27 through 29). reactions cost $4.4 billion per year (60 end of the labeling, or accompany the Moreover, 1 of these studies conducted FR 44182 at 44232; August 24, 1995), labeling, regardless of when the product in the early 1990s in the northeastern equaling $5.2 billion in 2000 dollars. If was approved. Including patient United States found that a majority of the causes of errors in the outpatient information enhances the likelihood preventable adverse events (about 1 setting are similar to the causes in that physicians will communicate adverse event per 100 hospital hospitals, half of these costs are related important information to patients, admissions) were related to errors or to physician ordering errors. Thus, improving patient understanding and miscalculations in physician ordering, about $2.6 billion (in 2000 dollars) per adherence to treatment the stage most likely to be affected by year in additional hospital costs result recommendations. FDA is unable to improved prescription drug labeling from errors likely to be influenced by quantify the magnitude of these information (Ref. 28). A more recent improved prescribing information. expected improvements in treatment study conducted in the southwestern effectiveness and health outcomes, but FDA lacks data to estimate the actual United States reported 4.2 adverse the agency believes they could be proportion of the adverse reaction costs events per 100 patients, of which only significant. that would be prevented under the final 15 percent where deemed preventable rule. Combining the projected hospital 3. Decrease in Costs to Treat Avoidable (Ref. 29). Given the approximately 36 costs attributable to preventable in- Adverse Reactions million annual hospitalizations in the hospital and outpatient adverse Although there are multiple causes of United States (Ref. 30), these data reactions, from $4.0 billion to $4.8 adverse reactions, some are potentially suggest that between 229,000 and billion per year may be potentially preventable and can result from 364,000 adverse reactions among avoided through measures that provide misunderstood or incorrectly applied hospitalized patients are potentially better information to doctors, such as drug information (e.g., prescribing too preventable each year. prescription drug labeling. If the final high a dose for a patient with poor A number of studies show that the rule reduced these costs by even 1 kidney function, or prescribing a drug to occurrence of an adverse event in a percent, between $40 million and $48 a patient with known hospitalized patient increases the costs million of the costs of hospitalization contraindications). According to a 2000 of caring for the patient by an average could be prevented each year. Over 10 GAO report on adverse drug events, of between $2,162 and $2,595 (Refs. 28, years, the present value of these avoided standardized packaging is one of many 29, and 31). Costs associated with costs would total from $240 million to approaches that can be adopted to preventable adverse events were even $290 million with a 7 percent discount reduce medication errors (Ref. 26). higher, averaging about $4,685 per rate, and from $300 to $360 with a 3 Requiring that prescription drug patient (Ref. 31), or $6,075 in 2000 percent discount rate (table 11).
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As illustrated in table 12, the percent, the total present value of value of the compliance costs for the magnitude of the potential benefits of avoided hospital costs for preventable final rule at both 3 and 7 percent the final rule will be sensitive to the in-hospital and outpatient adverse drug discount rates. assumed level of effectiveness. At 0.4 events will exceed the total present
TABLE 12.—IMPACT OF DIFFERENT EFFECTIVENESS LEVELS ON THE TOTAL PRESENT VALUE OF AVOIDED HOSPITAL COSTS TO TREAT PREVENTABLE ADVERSE DRUG EVENTS1
Discounted at 3 percent Discounted at 7 percent Effectiveness Estimate (percent) ($ million) ($ million) From: To: From: To:
0.1 30 36 24 29
0.42 120 140 97 120
0.5 150 180 120 150
1.0 300 360 240 290
5.0 1,500 1,800 1,200 1,500 1 Numbers may not sum due to rounding. 2 Corresponds to the breakeven point where over 10 years, the total present value of hospital costs avoided exceeds the total present value of the compliance costs of the final rule.
When compared with other published be quite large. Using a restrictive 33). In contrast, a 2001 revision of the studies, the agency’s estimate of the cost definition of adverse events and 1995 Johnson and Bootman cost-of- of adverse reactions is likely less than including direct and indirect costs, a illness model used current costs the total social cost of such events. In large study of hospital discharge records whenever possible and predicted that particular, FDA’s estimates include only conducted by Thomas and others in drug-related illness occurring in hospital costs, and exclude the Utah and Colorado was published in ambulatory care settings cost about willingness to pay of patients to reduce 1999 and estimated that preventable $177.4 billion each year, or more than these risks. Because these risks include adverse events cost society at least $17 40 times the estimate of avoided costs fatality risks, the willingness to pay may billion (in 1996 dollars) each year (Ref. that was used in the rest of this analysis
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(Refs. 34 and 35). While we including any equipment adjustments, inches to the length of trade labeling acknowledge that we have no direct (3) layout and artwork for labeling not when printed on two sides (65 FR 81082 evidence about how the rule would accompanying drug products, (4) at 81109). Updating the unit printing reduce preventable adverse reactions, if producing longer labeling for labeling costs for inflation, this additional length the final rule avoided at least one-tenth not accompanying drug products, and would increase the incremental printing of a percent of the costs predicted by the (5) printing longer labeling in the PDR. costs by approximately $6.84 for 1,000 Thomas study, annual benefits of the pieces of labeling (75-square inches per 1. Labeling Changes for All Approved rule would approximately equal annual piece x $0.0000912 per square inch x Prescription Drug Products costs. 1,000 pieces) (68 FR 6062 at 6074). For a. Affected products. The agency will the final analysis, FDA estimates that for D. Costs of Regulation require that FDA-approved patient affected products, up to 650,000 pieces Except as noted below, the methods labeling accompany the prescription of trade labeling would be distributed used to estimate costs for the proposed drug labeling, or be printed following each year (section XI.D.2.c.i of this rule remain the same for the final the last section of the prescription drug document). For each of the affected impact analysis (65 FR 81082 at 81103 labeling within 1 year after the effective products, manufacturers will incur through 81112). When possible, unit date of the final rule. The agency annual incremental costs averaging costs have been updated. identified up to 200 products with some about $4,440 to print the longer trade The proposed rule would have form of FDA-approved patient labeling labeling (650,000 pieces per product per required two broad types of changes to that will be affected by the final rule. A year x $6.84 per 1,000 pieces). For all the labeling of prescription drug sample of these affected products shows 80 affected products, annual products. First, labeling of that the labeling of more than 60 percent incremental printing costs for trade approximately one-third of products already conforms to this provision of the labeling will increase by $0.4 million. already approved for marketing would final rule. Therefore, the labeling of an Furthermore, manufacturers distributing have been revised to delete or add estimated 80 products will need to be longer prescription drug labeling with information within 1 year. Several revised. promotional materials and samples will comments argued that these changes b. Prescription drug labeling design spend up to an additional $5,125 in would be quite costly relative to the costs. On average, prescription drug annual incremental printing costs each limited benefits that would be derived manufacturers will incur about $2,220 year for 3 years (750,000 pieces per year and difficult to accomplish in the per product in design and x $6.84 per 1,000 pieces (approximation proposed implementation period (see implementation costs to append FDA- based on information in footnote 17 in comment 114). In response to these approved patient labeling to existing section XI.D.2.e of this document)). comments, the agency removed the prescription drug labeling. Because Therefore, industry will incur requirements to delete certain changes must be made within 1 year of additional printing costs with a present information from all existing the effective date of the final rule, not value of approximately $3.6 million or prescription drug labeling. Only those all firms will have sufficient time to $4.2 million over 10 years at a 7 or 3 products with existing labeling that deplete their inventories of existing percent discount rate, respectively (table have FDA-approved patient labeling prescription drug labeling. With a 12- 13). will be required to revise the labeling month implementation period, FDA d. Physicians’ Desk Reference (PDR) within 1 year. consultants estimate per product Costs. The agency estimates that 75 Second, the proposed rule would inventory losses of approximately $630. percent of prescription drug products have revised the content and established Thus, including excess inventory losses, have labeling already printed in the format requirements for labeling of new the cost to change prescription drug PDR. In 2002, an additional page in the and recently approved applications. labeling is estimated at $2,850 per PDR costs manufacturers $9,750.14 Although the agency modified some product (65 FR 81082 at 81109; and 68 Thus, the per product annual cost to specific content and format FR 6062 at 6074, reflecting updated print two additional pages is about requirements, the staggered costs). As shown in table 13, in the first $19,500 ($9,750 x 2). For the estimated implementation schedule and most year firms may incur one-time costs of 60 affected products (80 products x provisions were retained for the final $0.2 million to add FDA-approved 0.75), the annual PDR costs would rule. Therefore, direct costs incurred to patient labeling to the labeling of the increase by $1.2 million ($19,500 x 60), change prescription drug labeling affected products. equaling a present value of include the costs of: (1) Designing or c. Incremental printing costs for approximately $8.2 million or $10.0 revising prescription drug labeling and prescription drug labeling. Printed million over 10 years with a 7 or 3- submitting the new labeling to FDA, (2) patient information would add an percent discount rate, respectively (table producing longer trade labeling estimated 2 pages or about 75-square 13).
TABLE 13.—COSTS TO INCLUDE FDA-APPROVED PATIENT LABELING WITH LABELING OF EXISTING PRESCRIPTION PRODUCTS1, 2
One-Time Labeling Annual Incremental Year Revision Costs Printing Costs Annual PDR Costs Total Costs ($ million) ($ million) ($ million) ($ million)
1 0.2 0.8 1.2 2.2
2 0.0 0.8 1.2 1.9
14 Not all of these costs to manufacturers are selling additional pages at more than its true opportunity cost. The excess is a transfer, but we social costs, as the PDR publisher is presumably do not know its magnitude.
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TABLE 13.—COSTS TO INCLUDE FDA-APPROVED PATIENT LABELING WITH LABELING OF EXISTING PRESCRIPTION PRODUCTS1, 2—Continued
One-Time Labeling Annual Incremental Year Revision Costs Printing Costs Annual PDR Costs Total Costs ($ million) ($ million) ($ million) ($ million)
3 0.0 0.8 1.2 1.9
4 0.0 0.4 1.2 1.5
5 0.0 0.4 1.2 1.5
6 0.0 0.4 1.2 1.5
7 0.0 0.4 1.2 1.5
8 0.0 0.4 1.2 1.5
9 0.0 0.4 1.2 1.5
10 0 .0 0 .4 1 .2 1 .5
Total Cost 0 .2 4 .8 11 .7 16 .7
Present Value of Total Discounted at 3 per- cent 0 .2 4 .2 10 .0 14.4
Present Value of Total Discounted at 7 per- cent 0 .2 3 .6 8 .2 12 .0 1 Numbers may not sum due to rounding. 2 This estimate assumes that products with Medication Guides already conform to this requirement of the final rule.
2. Labeling Changes for New and This rule does not cover labeling for The initial analysis of impacts did not Recently Approved Prescription Drug OTC products (including those include estimates of the number of Products approved under an NDA). generic products that would be affected a. Affected products. The final rule Estimates of the number of new because the period of exclusivity for would require that prescription drug applications that would be affected by most innovator products covered by the labeling conform to format and content the rule are updated and based on rule would extend beyond the 10-year requirements for three categories of application approvals since 1997. horizon. However, a subsequent products: (1) All NDAs, BLAs, and During this period, an average of 97 analysis of data from ‘‘Approved Drug efficacy supplements submitted to FDA NDAs and 10 BLAs were approved each Products with Therapeutic Equivalence on or after the effective date, (2) NDAs, year. FDA assumes that this average rate Evaluations’’ (the Orange Book) found BLAs, and efficacy supplements will continue. The number of affected that some older innovator products with approved over the 5 years preceding the products approved within 5 years before generic equivalents have recent effective date or pending on the the effective date are estimated as the approvals of efficacy supplements or number of NDAs approved during the 5- effective date of the final rule, and (3) NDAs for new dosage strengths that year period from 1997 through 2001 any ANDA that references a listed drug could trigger revision of the labeling of without subsequent efficacy with labeling conforming to the some reference listed drugs. Although requirements of the final rule. For the supplements. the overall number of older innovator first category of products, the Most efficacy supplements are filed products affected by the final rule is prescription drug labeling requirements and approved within 5 years of the would apply when a sponsor files an approval date of their original anticipated to be small, normally there NDA, BLA or efficacy supplement. application. Over time, prescription are multiple generic products for each Products in the second category must drug labeling of most products affected reference listed drug. Therefore, file supplemental applications within 3 by the final rule will already conform to beginning in year 3, the final rule is to 7 years of the issuance of the rule, the requirements of the final rule when estimated to affect an average of 42 according to the implementation plan an efficacy supplement is submitted. generic products annually. Table 14 described in the preamble (see Table 5). Beginning in year 3, therefore, the shows the number of products projected For ANDA products (generic products), number of labeling revisions as a result to be affected by the final rule during the implementation schedule for the of an efficacy supplement will decline the 10-year period following the affected reference listed drug applies. over time. effective date.
TABLE 14.—ESTIMATED NUMBER OF AFFECTED PRODUCTS BY APPLICATION TYPE
Approvals 5 Years Year New NDAs and BLAs Efficacy Supplements Prior to Effective Date ANDAs Total
1 107 69 0 0 176
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TABLE 14.—ESTIMATED NUMBER OF AFFECTED PRODUCTS BY APPLICATION TYPE—Continued
Approvals 5 Years Year New NDAs and BLAs Efficacy Supplements Prior to Effective Date ANDAs Total
2 107 69 0 0 176
3 107 52 69 42 270
4 107 39 69 42 257
5 107 29 68 42 246
6 107 22 69 42 240
7 107 16 69 42 234
8 107 12 0 42 161
9 107 9 0 42 158
10 107 7 0 42 156
Total 1,070 324 344 336 2,074
b. Prescription drug labeling design Highlights and Contents does not labeling frequently during the first 5 costs. The cost of designing prescription increase this time burden on years a product is marketed. During this drug labeling that conforms to the final manufacturers or the agency. Therefore, period, the agency anticipates that format and content requirements will the time required to revise labeling manufacturers would remove recent depend heavily on when, during a conforming to the requirements of the major changes from Highlights at the product’s life cycle, labeling design final rule will fall between the time same time they voluntarily change occurs. Costs will be highest for required to design a novel patient labeling and, thus, would incur no products already marketed with information guide and time required to additional costs. After 5 years on the approved prescription drug labeling that redesign a guide. Although sponsors of market, however, some manufacturers otherwise would not be changed. new applications and efficacy would incur additional costs to remove Conversely, design costs will be lowest supplements would incur many of the recent major changes in the timeframe for products that are closely related to same design costs as sponsors of specified by the final rule. The earliest a prior product application that has existing innovator products, they would this might occur is in year 7 after the already had its prescription drug experience no additional testing, initial redesign of the labeling.15 Based labeling changed to the new format or preparation, and application costs. For on the agency’s experience with for generic drug labeling. Costs for the initial analysis, it was anticipated products that have been on the market currently marketed products that would that manufacturers would incur one- for more than 5 years, up to 10 percent be undergoing relabeling for other time costs up to $5,000 for each new of the products affected by the final rule reasons (e.g., related to an efficacy product and $7,500 for each existing might be required to remove recent supplement) will be in between these product to conform to the format and major changes in year 7 or later, at a per extremes. content provisions of the rule (65 FR product cost of approximately $1,600. FDA has previously estimated that it 81082 at 81106 through 81107). These Over 10 years, the present value of these takes about 2 months of full-time effort one-time per product costs are updated costs could equal about $0.1 million to design a novel patient information to $6,190 and $8,700, respectively. with either a 7 percent or 3 percent guide (for the first prescription drug in Modifying prescription drug labeling for discount rate. a therapeutic class), but less than 1 ANDAs is anticipated to cost generic As shown in table 15, the total first- week to redesign a guide following a drug manufacturers about $1,300 per year costs would amount to $1.1 previously approved prototype (i.e., product, including $830 in labor costs million. Costs increase to a high of $1.6 innovator drugs in the same therapeutic and $470 in material costs for artwork million in years 3 and 4. After the class for which patient information was and scrap (68 FR 6062 at 6074). seventh year, when all products already developed) (60 FR 44232). The Once product labeling contains approved within 5 years prior to the final rule requires reordering of the Highlights, any substantive revisions of rule’s effective date or pending on the detailed information in the prescription key sections of the labeling must be effective date have redesigned drug labeling and addition of Highlights listed in the recent major changes prescription drug labeling, the costs and Contents. Although FDA designates section along with the month and year decline to about $0.8 million per year. the new order, detailed discussion and the revision was incorporated. However, As a result, the estimated total present drug-specific decisions (e.g., regarding the final rule also requires that after 1 value of the costs of redesigning exactly what should be listed in year, the information about recent major prescription drug labeling over 10 years Highlights) may be necessary. Because changes must be removed the next time is about $8.8 million and $10.5 million negotiation of labeling is a routine part the labeling is reprinted. Manufacturers with a 7 and 3 percent discount rate, of the review process, including voluntarily change drug product respectively.
15 Recent major changes must remain in the after year 5 would therefore remain on the labeling Highlights for at least 1 year. Any major change through year 6 or later.
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TABLE 15.—ESTIMATED PRESCRIPTION DRUG LABELING DESIGN COSTS1
Current Value ($ million) Present Value ($ million) Year Approvals 5 Years NDAs and Efficacy Prior to Effective ANDAs Total Total Discounted Total Discounted BLAs Supplements Date at 3 percent at 7 percent
1 0.7 0.4 0.0 0.0 1.1 1.1 1.0
2 0.7 0.4 0.0 0.0 1.1 1.0 1.0
3 0.7 0.3 0.6 0.1 1.6 1.5 1.3
4 0.7 0.2 0.6 0.1 1.6 1.4 1.2
5 0.7 0.2 0.6 0.1 1.5 1.3 1.1
6 0.7 0.1 0.6 0.1 1.5 1.2 1.0
7 0.7 0.1 0.6 0.1 1.5 1.2 0.9
8 0.7 0.1 0.0 0.1 0.8 0.7 0.5
9 0.7 0.1 0.0 0.1 0.8 0.6 0.4
10 0 .7 0 .0 0 .0 0 .1 0 .8 0 .6 0 .4
Total 6.7 2.0 3.0 0.4 12 .2 10 .5 8.8 1 Numbers may not sum due to rounding.
c. Costs associated with producing requirements of the final rule will with 2,900 generic products.16 Using longer labeling accompanying drug lengthen trade labeling by 650,000 pieces per innovator product products and drug samples (trade approximately 20 square inches when and 370,000 pieces per generic product, labeling). The proposed rule would have printed on two sides. Longer at a cost of $0.18 and $0.19 per 100 required that trade labeling be printed prescription drug labeling increases the pieces, respectively, yields annual per in 8-point minimum type size, almost cost of paper, ink, and other ongoing product cost estimates of $1,165 and doubling the current average length for incremental printing costs. As discussed $700, respectively. Table 16 shows the the labeling. Several comments from below, even in 6 points, a small number estimated number of revised labelings pharmaceutical manufacturers stated of products are still expected to incur and annual incremental printing costs that the agency had underestimated the some equipment costs (e.g., different over 10 years. retooling and packaging line costs that insert-folding machinery). Trade labeling must also accompany would be incurred to include this longer i. Incremental printing costs for trade drug product samples. However, the trade labeling (see comment 124). A few labeling. U.S. retail pharmacies number of samples distributed for a large firms estimated that new specific product depends on a equipment would cost between dispense about 3.3 billion prescriptions per year, of which an estimated 790 manufacturer’s marketing strategy and $135,000 and $700,000 per packaging may vary from year to year. Although line and could total up to $40 million million are for unit-of-use products that include prescription drug labeling IMS Health (IMS) reported that the for a large firm if trade labeling of all volume of samples distributed in the products were affected. As discussed in within the package (65 FR 81082 at 81107, updated using IMS data at http:// United States between 1997 and 2000 section XI.F of this document ranged from 860 million to 920 million (‘‘Alternatives Considered’’), the agency www.ims-health.com). If the non-unit- of-use prescriptions average one piece of (Ref. 36), sales representatives normally recognized that including all products leave one piece of labeling for every 10 in the final rule would substantially labeling per 3.3 prescriptions, the total number of labelings accompanying samples they distribute. Even though increase costs to industry and, therefore, new products are sampled more often limited the final rule to new and retail products equals roughly 1.5 billion. Further, adding hospital than older products, some recently approved products (see section manufacturers continue to distribute XI.F.3 of this document). Furthermore, pharmaceutical volume, estimated at approximately 54 percent of retail samples throughout the life cycle of approximately half of the affected their product. While the actual number products shown in table 14 will be new volume, yields an annual total of 2.4 billion pieces of trade labeling of samples including reformatted trade approvals that have not yet established labeling is uncertain, we anticipate that packaging. Nevertheless, based on the accompanying prescribed products. manufacturers may spend up to $0.2 potential economic impact the larger Allowing 10 percent for wastage type size might have on pharmaceutical indicates that manufacturers distribute roughly 2.6 billion pieces of labeling 16 Derived from ‘‘Approved Drug Products with manufacturers, for the final rule the Therapeutic Equivalence Evaluations,’’ CDER, FDA, agency reduced the minimum size with prescribed products each year. 2001. The estimate is a count of all branded requirement for trade labeling to 6 Since 60 percent of all prescriptions are products marketed under an NDA and points, a size generally reported as for branded products, about 1.6 billion differentiated by active ingredient, therapeutic pieces of labeling are currently included equivalence, dosage form, or manufacturer, not acceptable in comments from including multiple dosage strengths. Although not manufacturers (see comment 102). Thus, with about 2,440 branded products and counted, adding biologicals would not significantly the new format and content about 1.0 billion pieces are included alter results.
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million annually to print longer trade labeling to accompany drug samples (table 16).
ii. Equipment costs. The original new packaging equipment. However, in final analysis, 5 percent of existing analysis estimated that 1 percent of a few cases where existing labeling is products affected by the rule (i.e., affected existing products would be printed in type sizes between 4.5 points products with new efficacy required to adjust packaging equipment and 6 points, firms may need to adjust supplements, products approved in the with trade labeling printed in 8 points. packaging lines for longer labeling. 5 years prior to the effective date of the According to several comments, trade Since the labeling of many ophthalmic rule, and affected ANDAs) will incur labeling is currently printed in type drug products is printed in type sizes costs of $200,000 each product. As sizes of 4.5 points and larger (see smaller than 6 points, the proportion of shown in table 17, the estimated present comment 102). Thus, it is unlikely that recent approvals for ophthalmic value of equipment changes totals $7.2 the minimum type size requirement of products was used as a proxy for the million and $8.7 million over 10 years the final rule (i.e., 6 points for trade proportion of affected products that will discounted at 7 and 3 percent labeling) will require firms to purchase incur some equipment costs. For the respectively.
TABLE 17.—COST OF ADJUSTMENTS TO PACKAGING LINES TO ACCOMMODATE LONGER TRADE LABELING1, 2
Present Value ($ million) Year Estimated Number of Affected Total Cost Products ($ million) Total Discounted at 3 Percent Total Discounted at 7 Percent
1 3 0 .7 0 .7 0 .6
2 3 0 .7 0 .7 0 .6
3 8 1 .6 1 .5 1 .3
4 8 1 .5 1 .3 1 .1
5 7 1 .4 1 .2 1 .0
6 7 1 .3 1 .1 0 .9
7 6 1 .3 1 .0 0 .8
8 3 0 .5 0 .4 0 .3
9 3 0 .5 0 .4 0 .3
10 2 0.5 0.4 0.2
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TABLE 17.—COST OF ADJUSTMENTS TO PACKAGING LINES TO ACCOMMODATE LONGER TRADE LABELING1, 2—Continued
Present Value ($ million) Year Estimated Number of Affected Total Cost Products ($ million) Total Discounted at 3 Percent Total Discounted at 7 Percent
Total 50 10.0 8.7 7.2 1 Numbers may not sum due to rounding. 2 For products with labeling printed in type sizes smaller than 6 points, the final rule may require that some packaging lines be retooled. Based on NDA, ANDA or efficacy supplements approvals for ophthalmic drug products between 1997 and 2001, an estimated 5 percent of the existing products affected by the rule will require some change to packaging equipment at an average cost of $200,000 per product.
d. Layout and design costs for prescription drug labeling for a product will print labeling in different type prescription drug labeling not in the same type size (8 points or larger) sizes. However, if all new and recently accompanying drug products. The final will incur no additional design costs. approved innovator products are rule specifies a minimum type size of 6 However, if trade labeling is printed in affected, the total present value of the points for trade labeling and 8 points for a type size smaller than 8 points, a firm additional design costs is approximately all other prescription drug labeling will incur additional costs of $810 per $1.0 million or $1.2 million over 10 distributed by a manufacturer (e.g., product to change and proof read the years discounted at 7 or 3 percent labeling required to be distributed with layout, and to prepare artwork for the respectively (table 18). promotional materials or in promotional labeling not accompanying the drug settings). Firms choosing to print all product. It is uncertain how many firms
TABLE 18.—ESTIMATED ONE-TIME LAYOUT AND DESIGN COSTS FOR LABELING NOT ACCOMPANYING DRUG PRODUCTS1,2
Present Value ($ million) Year Number of Affected Total Costs Products ($ million) Total Discounted at 3 Percent Total Discounted at 7 Percent
1 176 0 .1 0 .1 0 .1
2 176 0 .1 0 .1 0 .1
3 228 0 .2 0 .2 0 .2
4 215 0 .2 0 .2 0 .1
5 204 0 .2 0 .1 0 .1
6 198 0 .2 0 .1 0 .1
7 192 0 .2 0 .1 0 .1
8 119 0 .1 0 .1 0 .1
9 116 0 .1 0 .1 0 .1
10 114 0.1 0.1 0.0
Total 1,738 1.4 1.2 1.0 1 Firms are expected to only print this type of labeling for 3 years after the launch of a new innovator drug product. 2 Numbers may not sum due to rounding.
e. Costs associated with producing labeling annually. Because most approval of a new drug.17 As shown in longer prescription drug labeling not detailing involves relatively new table 19, annual total costs peak at $4.4 accompanying drug products. In products, the products most affected by million in year 5. Over 10 years with a contrast to trade labeling, with the new this rule, FDA assumed that 7 or 3 percent discount rate, the present content and format requirements the manufacturers would incur additional value of the incremental printing costs length of current labeling will increase printing costs for all of this labeling, an average of about 93 percent when amounting to about $0.4 million 17 For each approval, it was assumed that all printed in 8-point type size. At this annually. physicians involved in primary care and 25 percent of physicians practicing a medical specialty would length, the incremental printing costs Finally, FDA estimated that about receive two mailings per year, or an estimated will increase by $0.85 per 100 pieces. 730,000 pieces of prescription drug 646,150 pieces (i.e., (222,400 x 2) + (0.25 x 402,700 To calculate the annual cost to print labeling per approval would be x 2)), for 3 years following product launch. An prescription drug labeling not additional 10 percent or 64,615 pieces are estimated distributed each year by mail or at to be distributed annually for 3 years to other health accompanying drug products, FDA conferences to physicians, other health care practitioners or consumers. Furthermore, FDA estimated that pharmaceutical care practitioners, consumers, retail assumes that 55,581 retail pharmacy outlets and representatives detailing drug products 8,020 hospital pharmacies would receive 1 mailing pharmacy outlets, and hospital to announce the launch of a new innovator product would distribute approximately 50 pharmacies for 3 years following in the year of approval (65 FR 81082 at 81108, million pieces of prescription drug updated).
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for longer prescription drug labeling not about $24 million or $29 million, accompanying drug products would be respectively.
f. Physicians’ Desk Reference (PDR) pharmaceutical industry via publishing prescription drug labeling changes made Costs. FDA estimates that the new fees paid to Medical Economics. The as a result of the 5-year rule Highlights, including any boxed agency assumed that 75 percent of the (applications approved in the 5 years warnings, and Contents would add new drugs and efficacy supplements preceding the effective date of the final about a half page to the PDR labeling of would be published in the PDR (some rule) would not be included in the PDR each affected prescription drug product. smaller firms decline to publish labeling supplements. Based on these Based on conversations with Medical in the PDR). FDA also assumed that 90 assumptions, the estimated cost of Economics (the publisher of the PDR) on percent of the new drugs published publishing the extended prescription the cost per printed page, FDA estimates would be included in the PDR drug labeling in the PDR would be about that the annual publishing costs of the supplements and 33 percent of the $1.2 million for year 1. These costs extra space required for printing the published efficacy supplements would would continue to increase over time as expanded prescription drug labeling be included in the PDR supplements all drug approvals after the effective would be about $5,550 for each affected (about half are actually included, but product, plus an additional cost if the only two-thirds of these include full date of the rule would have longer PDR product was included in one of two prescription drug labeling; the listings. The estimated annual and total annual supplements. FDA assumed that remainder include only the added costs of printing longer PDR listings are these costs would be incurred by the indication). FDA also assumed that the shown in table 20.
TABLE 20.—COST TO PRINT LONGER LISTINGS IN THE PDR1, 2
Current Value ($ million) Present Value ($ million) Year PDR Bound PDR Supplement Total Costs Total Discounted at 3 Percent Total Discounted at 7 Percent
1 0.7 0.5 1.2 1.2 1.1
2 1.5 0.5 2.0 1.8 1.7
3 2.4 0.5 2.9 2.6 2.4
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TABLE 20.—COST TO PRINT LONGER LISTINGS IN THE PDR1, 2—Continued
Current Value ($ million) Present Value ($ million) Year PDR Bound PDR Supplement Total Costs Total Discounted at 3 Percent Total Discounted at 7 Percent
4 3.3 0.5 3.8 3.3 2.9
5 4.2 0.4 4.6 4.0 3.3
6 5.0 0.4 5.4 4.5 3.6
7 5.8 0.4 6.2 5.0 3.9
8 6.3 0.4 6.7 5.3 3.9
9 6.8 0.4 7.2 5.5 3.9
10 7 .2 0 .4 7 .6 5 .7 3 .9
Total 43 .1 4 .5 47 .6 39.1 30 .5 1 Numbers may not sum due to rounding. 2 Printed in 6.5-point type size at an average per page cost of $9,755.
Table 21 summarizes the estimated compliance costs for the three major cost categories over a 10-year period.
TABLE 21.—COMPLIANCE COSTS OVER 10-YEAR PERIOD1
Cost Category ($ million) Total Year Design and Producing Trade Labeling; Reformat and Producing Labeling Not Costs Modify Packaging Equipment Accompanying Drug Products Printing PDR ($ million)
1 3.1 1.7 2.4 7.3
2 3.1 2.8 3.1 9.0
3 4.9 4.2 4.1 13 .2
4 4.6 4.4 4.9 13 .9
5 4.6 4.6 5.8 15 .0
6 4.8 4.4 6.6 15 .8
7 5.0 4.3 7.4 16 .6
8 3.8 3.6 7.9 15 .3
9 4.0 3.1 8.3 15 .5
10 4 .0 2 .7 8 .8 15 .5
Total Current Value 42.0 35 .9 59 .3 137.2
Total Present Value Dis- counted at 3 Percent 35 .7 30 .5 49.0 115.3
Total Present Value Dis- counted at 7 Percent 29 .2 24 .9 38.8 92 .9 1 Numbers may not sum due to rounding.
E. Impacts on Small Entities specific information about a drug. and use labeling information about Therefore, practitioners expend time prescription drug products. The agency 1. The Need for and the Objective of the that could be spent with patients and Rule believes that having better access to may miss critical information about the critical information will improve the Developments in recent years have safe and effective use of prescription use of prescription drugs and lead to a contributed to an increase in the length drug products. The objective of the decrease in the number of preventable and complexity of prescription drug requirements is to improve prescription adverse reactions that occur in the labeling, making it more difficult for drug labeling by making it easier for United States each year. health care practitioners to quickly find health care practitioners to access, read,
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2. Description and Estimate of the approved 5 years prior to the effective small firms with a single, low-volume Number of Small Entities Affected date of the final rule must submit product would have lower costs of reformatted prescription drug labeling compliance, but the incremental cost This final rule would affect all small for approval. Only six firms will have per unit sold would be higher. entities required to design their more than two existing products prescription drug labeling to comply Although the agency solicited affected by the rule. Of these six, four comment on the initial regulatory with this rule. The Small Business firms will have two products affected in Administration (SBA) considers flexibility analysis from small entities, the same year and one firm will have the only comments submitted Pharmaceutical Preparation three products affected in a single year. Manufacturing firms (NAICS 325412) specifically about the impact on small The compliance requirements for entities were from large firms (see and Biological Product Manufacturing small entities under this final rule are firms (NAICS 325414) with fewer than comment 122). The following examples the same as those described above for illustrate possible impacts on small 750 and 500 employees, respectively, to other affected entities. Compliance be small. U.S. Census reports in 1999 entities with different production primarily involves: (1) designing volumes. Prescription drug labeling there were 265 biological product prescription drug labeling that conforms costs are estimated for a small firm with manufacturing firms (Ref. 37) and 749 to the content and format requirements, a single carton-enclosed product pharmaceutical preparation and (2) once the labeling is approved by (marketed under an NDA) that must: (1) manufacturing firms (Ref. 38). However, FDA, ensuring that all future printed Have its labeling reformatted in year 3 employment size classes for prescription drug labeling is in the new of the rule and (2) add patient pharmaceutical preparation format with the required minimum type information in year 1. Table 22 outlines manufacturing do not correspond to size. Because manufacturers already the projected per-unit and total costs to SBA size categories. Nevertheless, 1999 submit labeling with NDAs, BLAs and the firm with 3 different levels of Census data suggest that approximately efficacy supplements to FDA, no production: 1,000, 10,000, and 100,000 94 percent of biological product additional skills will be required to manufacturing firms and at least 87 comply with the final rule. units produced per year. percent of the pharmaceutical The group of small entities likely to In addition to the costs identified in preparation manufacturing firms could bear the highest total costs under this table 22, a very small number of small be considered small. Despite the large final rule are those firms that have: (1) firms might incur equipment costs to number of small manufacturers, large Existing products with prescription include longer prescription drug companies manufacture most drug labeling that must be revised in the labeling in carton-enclosed products. It prescription drug products. Although first year or (2) more than one affected is likely, however, that this one-time the agency cannot predict the number of high-volume product per year, such as capital cost (estimated at $200,000) will new approvals granted to small entities, a small firm with two or three recently affect a total of no more than two or the following estimates are based on 5 approved, high-volume products that three small firms in the 10 years years of recent submissions (65 FR must undergo prescription drug labeling following implementation of the rule. 81082 at 81110, updated for 1997– reformatting simultaneously in the same Based on this analysis, FDA believes 2001). On average, 17 small entities will year. However, the high-cost small that the final rule would not have a receive product approvals each year. In entities are also the small firms with the significant impact on most small entities addition, about 64 small entities will be highest sales of affected product; thus, in this industry, but it is possible that affected during years 3 to 7 of the rule, their incremental cost per unit sold is a few small firms may be significantly when applicants with products likely to be relatively low. In contrast, affected by the final rule.
TABLE 22.—ESTIMATED COSTS FOR HYPOTHETICAL SMALL FIRM WITH A SINGLE PRODUCT, UNDER THREE ALTERNATIVE LEVELS OF PRODUCTION1
Number of Units Produced and Sold Each Year Cost Category 100,000 10,000 1,000
Example 1—Revise labeling of product approved less than 1 year prior to effective date: Prescription drug labeling redesign/application $8,700 $8,700 $8,700 Printing trade labeling2 $200 $20 $2 Printing prescription drug labeling not accompanying drug products3 $1,050 $105 $10
Total $9,950 $8,825 $8,712
Additional cost per unit sold $0 .10 $0.88 $8 .71
Example 2—Add printed patient information to existing labeling for a product: Prescription drug labeling redesign $2,850 $2,850 $2,850 Printing trade labeling4 $750 $75 $8 Printing longer PDR5 $19,500 $19,500 N/A
Total $23,100 $22,425 $2,858
Additional cost per unit sold $0 .23 $2.24 $2 .86 1 Numbers may not sum due to rounding. 2 Number of pieces of trade labeling printed is calculated as units produced/year plus 10 percent wastage factor, at an incremental printing cost of $0.001791 per labeling.
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3 To calculate the cost for printing labeling not accompanying drug products, the number of units is adjusted by the ratio of the average num- ber of pieces printed for mailings to the average number printed as trade labeling (i.e., 1.126), and multiplied by the incremental printing cost of $0.0085 per piece. 4 Number of pieces of trade labeling printed is calculated as units produced/year plus 10 percent wastage factor, at an incremental printing cost of $0.006837 per labeling. 5 Assume that prescription drug labeling is already being printed in the PDR. Most low-volume products (i.e., less than 10,000 units per year) will not have labeling in the PDR.
F. Alternatives Considered for trade labeling instead of the 6-point gradual implementation schedule of up requirement in the final rule. At 6 to 7 years to reduce the cost impact of 1. Do Nothing points, the average revised labeling will the rule, especially on small entities. The agency considered and rejected increase by about 20-square inches. XII. Civil Justice Reform this option. The current prescription Requiring the larger minimum size drug labeling is complex, requiring would take another 70-square inches of This rule has been reviewed under health care practitioners to spend paper and cost industry about $6,000 Executive Order 12988, Civil Justice unnecessary time seeking information per million pieces of trade labeling. Reform. This regulation meets the they need for the safe and effective use Because this requirement would be applicable standards set forth in of drug products by their patients. burdensome on industry, the agency sections 3(a) and 3(b)(2) of Executive Preventable adverse reactions have rejected the 8-point minimum type size. Order 12988. many causes and are a serious public XIII. References health issue. Changing prescription drug 3. Alternative Categories of Affected labeling to meet the needs of health care Products The following references have been practitioners that use it is one of many Three alternative categories of placed on display in the Division of public health initiatives aimed at products to be covered by the rule were Dockets Management (HFA–305), Food reducing these adverse reactions and considered: (1) All drugs, (2) a set of and Drug Administration, 5630 Fishers improving health care. innovator and generic drugs on a ‘‘top Lane, rm. 1061, Rockville, MD 20857, 200 most prescribed’’ list, and (3) the and may be seen by interested persons 2. Formatting Alternatives ‘‘top 100’’ or ‘‘top 200’’ drugs with the between 9 a.m. and 4 p.m., Monday FDA has considered numerous most adverse reactions. The agency through Friday. (FDA has verified the alternative formats, including a longer believes including only labeling of new Web site addresses, but FDA is not Highlights. Highlights is limited to one- and more recently approved drug responsible for any subsequent changes half page in 8 points to respond to products is the best option for to the Web sites after this document health care practitioners’ concerns about implementing the new format publishes in the Federal Register.) length as well as to reduce the requirements (see comment 113). Even 1. Miller, G. A., ‘‘The Magical Number incremental printing costs to Seven, Plus or Minus Two: Some Limits on this limited set of products will require Our Capacity for Processing Information,’’ manufacturers. substantial resources from both industry Psychological Review, 101(2):343–352, 1994. The agency also considered requiring and the agency for a period of several 2. Shiffrin, R. M., and R. M. Nosofsky, larger minimum type sizes. A 10-point years. The agency’s proposed ‘‘Seven Plus or Minus Two: A Commentary minimum size requirement would implementation plan, which is being On Capacity Limitations,’’ Psychological increase the amount of paper needed to finalized in this rule as proposed, is Review, 101(2):357–361, 1994. print the average reformatted labeling by intended to make the best use of these 3. Allen, P. A., and L. C. Crozier, ‘‘Age and about 200-square inches at an Ideal Chunk Size,’’ Journal of Gerontology: resources. Because there is a lack of Psychological Sciences, 47(1):47–51, 1992. incremental cost of $18,000 per million standardized data on prescription 4. Food and Drug Administration, pieces. Over 10 years, the total present volume and volumes can fluctuate ‘‘Consumer Comprehension and Preference value of producing longer trade labeling considerably over time, the agency does for Variations in the Proposed Over-the- in 10 points compared to 6 points not believe that categories based on Counter Drug Labeling Format,’’ in OTC vol. would equal $95 million or $120 volume would be prudent or feasible. 28, Docket No. 96N–0420, Division of million with a 7- or 3-percent discount As discussed in the preamble to the Dockets Management. rate, respectively. In addition to higher 5. National Surveys of Prescription proposed rule (65 FR 81082 at 81098), Medicine Information Received by incremental printing costs, requiring 10- the plan targets newer products because Consumers, http://www.fda.gov/cder/ddmac/ point minimum type size would make practitioners are more likely to refer to y2ktable.htm. labeling so large that many the labeling for newer products. Internal http://www.fda.gov/cder/ddmac/ manufacturers would be forced to agency analysis finds that fully 40 y2kTITLE.htm. modify or replace packaging equipment. percent of adverse reaction reports 6. Kripalani, S., ‘‘The Write Stuff: Simple The agency therefore rejected this submitted to the FDA are for drugs Guidelines Can Help You Write and Design option because the potential benefits of approved within the last 3 years. Effective Patient Education Materials,’’ Texas the larger type size did not outweigh the Medicine, 91:40–45, 1995. Therefore, the agency rejected these 7. Backinger, C. L., and P. A. Kingsley, costs. three alternative categories in order to ‘‘Write It Right: Recommendations for The agency also considered and focus efforts on recently approved drug Developing User Instructions for Medical rejected a 10-point minimum size products whose labeling is more likely Devices Used in Home Health Care,’’ requirement for labeling not to be consulted by physicians. Department of Health and Human Services, accompanying drug products. Compared Publication No. FDA 93–4258, 1993. to the minimum requirement of 8 points 4. Alternative Implementation Schedule 8. Mettger, W., and J. Mara, ‘‘Clear & in the final rule, this larger type size FDA considered a shorter Simple: Developing Effective Print Materials would have taken about 100-square implementation schedule of 3 years for Low-Literate Readers,’’ Bethesda, MD, National Cancer Institute, Publication No. inches more paper at an incremental after the effective date for all NIH 95–3594, 1994, http://oc.nci.nih.gov/ cost of $9,000 per million pieces. applications and efficacy supplements services/Clear_and_Simple/HOME.htm. Finally, the agency proposed a approved 5 years prior to the effective 9. Silver, N. C., and C. C. Braun, minimum size requirement of 8 points date. The agency selected the more ‘‘Perceived Readability of Warning Labels
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with Varied Font Sizes and Styles,’’ Safety Drug Events,’’ Journal of the American authority delegated to the Commissioner Science, 16:615–625, 1993. Medical Association, 274(1):29–34, 1995. of Food and Drugs, 21 CFR parts 201, 10. Wilkins, A. G., and M. I. Nimmo-Smith, 28. Classen, D. C. et al., ‘‘Adverse Drug 314, and 601 are amended as follows: ‘‘The Clarity and Comfort of Printed Text,’’ Events in Hospitalized Patients: Excess Ergonomics, 30:1705–1720, 1987. Length of Stay, Extra Costs, and Attributable PART 201—LABELING 11. Transcript of public meeting on Mortality,’’ Journal of the American Medical prescription drug labeling, Docket No. 95N– Association 277(4):301–306, 1997. I 1. The authority citation for 21 CFR 0314, October 30, 1995. 29. Senst, B. L. et al., ‘‘Practical Approach part 201 continues to read as follows: 12. Eastern Research Group, Inc., ‘‘Cost to Determining Costs and Frequency of Impacts of the Over-the-Counter Adverse Drug Events in a Health Care Authority: 21 U.S.C. 321, 331, 351, 352, Pharmaceutical Labeling Rule,’’ appendix A, Network,’’ American Journal of Health- 353, 355, 358, 360, 360b, 360gg–360ss, 371, March 5, 1999. Systems Pharmacy, 58:1126–1132, 2001. 374, 379e; 42 U.S.C. 216, 241, 262, 264. 13. Connelly, D. P. et al., ‘‘Knowledge 30. 2000 hospital discharges data from the I 2. Section 201.56 is revised to read as Resource Preferences of Family Physicians,’’ Agency for Health Care Policy and Research follows: Journal of Family Practice, 31(2):121–122, (AHCPR), June 25, 1998, http:// 1990. www.ahrq.gov/HCUPnet.htm (last viewed 8/ § 201.56 Requirements on content and 14. Ely, J. W. et al., ‘‘What Clinical 13/02). format of labeling for human prescription Information Resources Are Available in 31. Bates, D. W. et al., ‘‘The Costs of drug and biological products. Family Physicians’ Offices?’’ Journal of Adverse Drug Events in Hospitalized (a) General requirements. Prescription Family Practice, 48(2):135–139, 1999. Patients,’’ Journal of the American Medical 15. Ely, J. W. et al., ‘‘The Information drug labeling described in § 201.100(d) Association, 277(4):307–311, 1997. must meet the following general Needs of Family Physicians: Case-Specific 32. Medical Group Management Clinical Questions,’’ Journal of Family Association, AHRQ, CMS and Partnership for requirements: Practice, 35(3):265–269, 1992. Patient Safety, ‘‘Ambulatory Patient Safety: (1) The labeling must contain a 16. Gorman, P., ‘‘Information Needs in What Do We Know?’’ An Agenda for summary of the essential scientific Primary Care: A Survey of Rural and Research in Ambulatory Patient Safety— information needed for the safe and Nonrural Primary Care Physicians,’’ Medinfo, Synthesis of a Multidisciplinary Conference, effective use of the drug. 10 (Pt. 1):338–342, 2001. 2000, http://www.ahcpr.gov/about/cpcr/ (2) The labeling must be informative 17. National Association of Chain Drug ptsafety/ambpts2.htm (last viewed 10/10/02). and accurate and neither promotional in Stores, ‘‘Industry Facts-at-a-Glance—Rx Sales 33. Thomas, E. J. et al., ‘‘Costs of Medical tone nor false or misleading in any 2001,’’ http://www.nacds.org/ Injuries in Utah and Colorado,’’ Inquiry, particular. In accordance with §§ 314.70 wmspage.cfm?parm1=507#rx (last viewed 8/ 36:255–264, 1999. 27/02). and 601.12 of this chapter, the labeling 34. Johnson, J. A., and J. L. Bootman, must be updated when new information 18. U.S. Department of Labor, Bureau of ‘‘Drug-Related Morbidity and Mortality: A Labor Statistics, ‘‘2000 National Cost-of-Illness Model,’’ Archives of Internal becomes available that causes the Occupational Employment and Wage Medicine, 155:1949–1956, 1995. labeling to become inaccurate, false, or Estimates—29–1051 Pharmacists,’’ http:// 35. Ernst, F. R., and A. J. Grizzle, ‘‘Drug- misleading. www.bls.gov/oes/2000/oes291051.htm (last Related Morbidity and Mortality: Updating (3) The labeling must be based viewed 8/27/02). the Cost-of-Illness Model,’’ Journal of the whenever possible on data derived from 19. U.S. Department of Labor, Bureau of American Pharmaceutical Association, human experience. No implied claims Labor Statistics, Occupational Outlook 41(2):192–199, 2001. Handbook, 2002–03, Pharmacists (occupation or suggestions of drug use may be made 36. IMS Health, ‘‘Product Sampling code 29–1051), 2002, http://www.bls.gov/ if there is inadequate evidence of safety Continues to Spike in U.S.,’’ 2001, http:// oco/ocos079.htm (last viewed 9/13/02). or a lack of substantial evidence of www.imshealth.com/public/structure/ 20. Jousimaa, J. et al., ‘‘Physicians’ Patterns effectiveness. Conclusions based on of Using a Computerized Collection of dispcontent/1,2779,1362–1362– animal data but necessary for safe and Guidelines for Primary Care,’’ International 143626,00.html (last viewed 9/23/02). 37. U.S. Census Bureau, ‘‘Statistics of U.S. effective use of the drug in humans Journal of Technology Assessment in Health must be identified as such and included Care, 14(3):484–493, 1998. Businesses; 1999; Pharmaceutical preparation mfg, United States,’’ http:// with human data in the appropriate 21. U.S. Census Bureau, ‘‘Table 153, section of the labeling. Physicians by Selected Activity: 1980 to www.census.gov/epcd/susb/1999/us/ 1999,’’ Statistical Abstract of the United US325412.htm (last viewed 9/12/02). (b) Categories of prescription drugs States: 2001, p. 106. 38. U.S. Census Bureau, ‘‘Statistics of U.S. subject to the labeling content and 22. U.S. Census Bureau, ‘‘Table 157, Businesses; 1999; Biological product (except format requirements in §§ 201.56(d) and Medical Practice Characteristics by Selected diagnostic) mfg, United States,’’ http:// 201.57. (1) The following categories of Specialty: 1985 to 1998,’’ Statistical Abstract www.census.gov/epcd/susb/1999/us/ prescription drug products are subject to of the United States: 2001, p. 108. US325414.htm (last viewed 9/12/02). the labeling requirements in paragraph 23. American Medical Association, List of Subjects (d) of this section and § 201.57 in ‘‘Medical Education FAQs,’’ http:// accordance with the implementation www.ama-assn.org/ama/pub/category/ 21 CFR Part 201 schedule in paragraph (c) of this section: 3627.html (last viewed 9/13/02). (i) Prescription drug products for 24. Woosley, R. L., ‘‘Drug Labeling Drugs, Labeling, Reporting and Revisions—Guaranteed to Fail?’’ Journal of recordkeeping requirements. which a new drug application (NDA), biologics license application (BLA), or the American Medical Association, 21 CFR Part 314 284(23):3047–3049, 2000. efficacy supplement was approved by 25. Friedman, M. A. et al., ‘‘The Safety of Administrative practice and procdure, the Food and Drug Administration Newly Approved Medicines: Do Recent Confidential business information, (FDA) between June 30, 2001 and June Market Removals Mean There Is a Problem?’’ Drugs, Reporting and recordkeeping 30, 2006; Journal of the American Medical Association, requirements. (ii) Prescription drug products for 281(18):1728–1734, 1999. which an NDA, BLA, or efficacy 21 CFR 601 26. U.S. General Accounting Office, supplement is pending on June 30, ‘‘Adverse Drug Events: The Magnitude of Adminstrative practice and 2006; or Health Risk Is Uncertain Because of Limited procedure, Biologics, Confidential Incidence Data,’’ GAO/HEHS–00–21, (iii) Prescription drug products for January, 2000. business information. which an NDA, BLA, or efficacy 27. Bates, D. W. et al., ‘‘Incidence of I Therefore, under the Federal Food, supplement is submitted anytime on or Adverse Drug Events and Potential Adverse Drug, and Cosmetic Act and under after June 30, 2006.
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(2) Prescription drug products not following headings and subheadings prescribing information must be described in paragraph (b)(1) of this and in the following order: accompanied by the identifying number section are subject to the labeling Highlights of Prescribing Information (in parentheses) corresponding to the requirements in paragraph (e) of this Product Names, Other Required location of the information in the full section and § 201.80. Information prescribing information. (c) Schedule for implementing the (4) Omit clearly inapplicable sections, labeling content and format Boxed Warning subsections, or specific information. If requirements in §§ 201.56(d) and Recent Major Changes sections or subsections required under 201.57. For products described in Indications and Usage paragraph (d)(1) of this section are paragraph (b)(1) of this section, labeling Dosage and Administration omitted from the full prescribing conforming to the requirements in Dosage Forms and Strengths information, the heading ‘‘Full paragraph (d) of this section and Contraindications Prescribing Information: Contents’’ must § 201.57 must be submitted according to Warnings and Precautions be followed by an asterisk and the the following schedule: Adverse Reactions following statement must appear at the (1) For products for which an NDA, Drug Interactions end of Contents: ‘‘* Sections or BLA, or efficacy supplement is Use in Specific Populations subsections omitted from the full submitted for approval on or after June Full Prescribing Information: Contents prescribing information are not listed.’’ (5) Any risk information that is 30, 2006, proposed conforming labeling Full Prescribing Information required under § 201.57(c)(9)(iv) is must be submitted as part of the Boxed Warning considered ‘‘appropriate pediatric application. 1 Indications and Usage contraindications, warnings, or (2) For products for which an NDA, 2 Dosage and Administration precautions’’ within the meaning of BLA, or efficacy supplement is pending 3 Dosage Forms and Strengths section 505A(l)(2) of the Federal Food, on June 30, 2006, or that has been 4 Contraindications Drug, and Cosmetic Act (the act) (21 approved any time from June 30, 2005, 5 Warnings and Precautions U.S.C. 355A(l)(2)), whether such up to and including June 30, 2006, a 6 Adverse Reactions information appears in the supplement with proposed conforming 7 Drug Interactions labeling must be submitted no later than 8 Use in Specific Populations ‘‘Contraindications,’’ ‘‘Warnings and June 30, 2009. 8.1 Pregnancy Precautions,’’ or ‘‘Use in Specific (3) For products for which an NDA, 8.2 Labor and delivery Populations’’ section of labeling. (e) Labeling requirements for older BLA, or efficacy supplement has been 8.3 Nursing mothers approved anytime from June 30, 2004, 8.4 Pediatric use prescription drug products. This up to and including June 29, 2005, a 8.5 Geriatric use paragraph applies only to approved supplement with proposed conforming 9 Drug Abuse and Dependence prescription drug products not labeling must be submitted no later than 9.1 Controlled substance described in paragraph (b)(1) of this June 30, 2010. 9.2 Abuse section. (4) For products for which an NDA, 9.3 Dependence (1) Prescription drug labeling BLA, or efficacy supplement has been 10 Overdosage described in § 201.100(d) must contain approved anytime from June 30, 2003, 11 Description the specific information required under up to and including June 29, 2004, a 12 Clinical Pharmacology § 201.80 under the following section supplement with proposed conforming 12.1 Mechanism of action headings and in the following order: labeling must be submitted no later than 12.2 Pharmacodynamics Description Clinical Pharmacology June 30, 2011. 12.3 Pharmacokinetics Indications and Usage (5) For products for which an NDA, 13 Nonclinical Toxicology Contraindications BLA, or efficacy supplement has been 13.1 Carcinogenesis, mutagenesis, Warnings approved anytime from June 30, 2002, impairment of fertility Precautions up to and including June 29, 2003, a 13.2 Animal toxicology and/or Adverse Reactions supplement with proposed conforming pharmacology Drug Abuse and Dependence labeling must be submitted no later than 14 Clinical Studies Overdosage June 30, 2012. 15 References Dosage and Administration (6) For products for which an NDA, 16 How Supplied/Storage and How Supplied BLA, or efficacy supplement has been Handling (2) The labeling may contain the approved anytime from June 30, 2001, 17 Patient Counseling Information following additional section headings if up to and including June 29, 2002, a (2) Additional nonstandard appropriate and if in compliance with supplement with proposed conforming subheadings that are used to enhance § 201.80(l) and (m): labeling must be submitted no later than labeling organization, presentation, or Animal Pharmacology and/or Animal June 30, 2013. ease of use (e.g., for individual warnings Toxicology (d) Labeling requirements for new and or precautions, or for each drug Clinical Studies more recently approved prescription interaction) must be assigned a decimal References drug products. This paragraph applies number that corresponds to their (3) Omit clearly inapplicable sections, only to prescription drug products placement in labeling. The decimal subsections, or specific information. described in paragraph (b)(1) of this numbers must be consistent with the (4) The labeling may contain a section and must be implemented standardized identifying numbers listed ‘‘Product Title’’ section preceding the according to the schedule specified in in paragraph (d)(1) of this section (e.g., ‘‘Description’’ section and containing paragraph (c) of this section. subheadings added to the ‘‘Warnings only the information required by (1) Prescription drug labeling and Precautions’’ section must be § 201.80(a)(1)(i), (a)(1)(ii), (a)(1)(iii), and described in § 201.100(d) must contain numbered 5.1, 5.2, and so on). (a)(1)(iv) and § 201.100(e). The the specific information required under (3) Any reference in Highlights to information required by § 201.80(a)(1)(i) § 201.57(a), (b), and (c) under the information appearing in the full through (a)(1)(iv) must appear in the
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‘‘Description’’ section of the labeling, statement must be placed on the line significant clinical pharmacologic whether or not it also appears in a immediately beneath the established information. ‘‘Product Title.’’ name or, for biological products, proper (8) Dosage forms and strengths. A (5) The labeling must contain the date name of the product. concise summary of the information of the most recent revision of the (4) Boxed warning. A concise required under paragraph (c)(4) of this labeling, identified as such, placed summary of any boxed warning required section, with any appropriate prominently immediately after the last by paragraph (c)(1) of this section, not subheadings (e.g., tablets, capsules, section of the labeling. to exceed a length of 20 lines. The injectable, suspension), including the (6) The requirement in § 201.80(f)(2) summary must be preceded by a strength or potency of the dosage form to reprint any FDA-approved patient heading, in upper-case letters, in metric system (e.g., 10-milligram labeling at the end of prescription drug containing the word ‘‘WARNING’’ and tablets) and whether the product is labeling or accompany the prescription other words that are appropriate to scored. drug labeling must be implemented no identify the subject of the warning. The (9) Contraindications. A concise later than June 30, 2007. heading and the summary must be statement of each of the product’s I 3. Section 201.57 is redesignated as contained within a box and bolded. The contraindications, as required under § 201.80 and new § 201.57 is added to following verbatim statement must be paragraph (c)(5) of this section, with any read as follows: placed immediately following the appropriate subheadings. heading of the boxed warning: ‘‘See full (10) Warnings and precautions. A § 201.57 Specific requirements on content prescribing information for complete concise summary of the most clinically and format of labeling for human boxed warning.’’ prescription drug and biological products significant information required under (5) Recent major changes. A list of the paragraph (c)(6) of this section, with any described in § 201.56(b)(1). section(s) of the full prescribing The requirements in this section appropriate subheadings, including information, limited to the labeling information that would affect decisions apply only to prescription drug sections described in paragraphs (c)(1), about whether to prescribe a drug, products described in § 201.56(b)(1) and (c)(2), (c)(3), (c)(5), and (c)(6) of this recommendations for patient monitoring must be implemented according to the section, that contain(s) substantive that are critical to safe use of the drug, schedule specified in § 201.56(c), except labeling changes that have been and measures that can be taken to for the requirement in paragraph (c)(18) approved by FDA or authorized under prevent or mitigate harm. of this section to reprint any FDA- § 314.70(c)(6) or (d)(2), or § 601.12(f)(1) (11) Adverse reactions. (i) A list of the approved patient labeling at the end of through (f)(3) of this chapter. The prescription drug labeling or accompany heading(s) and, if appropriate, the most frequently occurring adverse the prescription drug labeling, which subheading(s) of the labeling section(s) reactions, as described in paragraph must be implemented no later than June affected by the change must be listed (c)(7) of this section, along with the 30, 2007. together with each section’s identifying criteria used to determine inclusion (a) Highlights of prescribing number and the date (month/year) on (e.g., incidence rate). Adverse reactions information. The following information which the change was incorporated in important for other reasons (e.g., must appear in all prescription drug labeling. These labeling sections must because they are serious or frequently labeling: be listed in the order in which they lead to discontinuation or dosage (1) Highlights limitation statement. appear in the full prescribing adjustment) must not be repeated under The verbatim statement ‘‘These information. A changed section must be this heading in Highlights if they are highlights do not include all the listed under this heading in Highlights included elsewhere in Highlights (e.g., information needed to use (insert name for at least 1 year after the date of the Warnings and Precautions, of drug product) safely and effectively. labeling change and must be removed at Contraindications). See full prescribing information for the first printing subsequent to the 1 (ii) For drug products other than (insert name of drug product).’’ year period. vaccines, the verbatim statement ‘‘To (2) Drug names, dosage form, route of (6) Indications and usage. A concise report SUSPECTED ADVERSE administration, and controlled statement of each of the product’s REACTIONS, contact (insert name of substance symbol. The proprietary name indications, as required under manufacturer) at (insert manufacturer’s and the established name of the drug, if paragraph (c)(2) of this section, with any phone number) or FDA at (insert current any, as defined in section 502(e)(3) of appropriate subheadings. Major FDA phone number and Web address the Federal Food, Drug, and Cosmetic limitations of use (e.g., lack of effect in for voluntary reporting of adverse Act (the act) or, for biological products, particular subsets of the population, or reactions).’’ the proper name (as defined in § 600.3 second line therapy status) must be (iii) For vaccines, the verbatim of this chapter) including any briefly noted. If the product is a member statement ‘‘To report SUSPECTED appropriate descriptors. This of an established pharmacologic class, ADVERSE REACTIONS, contact (insert information must be followed by the the concise statement under this name of manufacturer) at (insert drug’s dosage form and route of heading in Highlights must identify the manufacturer’s phone number) or administration. For controlled class in the following manner: ‘‘(Drug) VAERS at (insert the current VAERS substances, the controlled substance is a (name of class) indicated for phone number and Web address for symbol designating the schedule in (indication(s)).’’ voluntary reporting of adverse which the controlled substance is listed (7) Dosage and administration. A reactions).’’ must be included as required by concise summary of the information (iv) For manufacturers with a Web site § 1302.04 of this chapter. required under paragraph (c)(3) of this for voluntary reporting of adverse (3) Initial U.S. approval. The verbatim section, with any appropriate reactions, the Web address of the direct statement ‘‘Initial U.S. Approval’’ subheadings, including the link to the site. followed by the four-digit year in which recommended dosage regimen, starting (12) Drug interactions. A concise FDA initially approved a new molecular dose, dose range, critical differences summary of the information required entity, new biological product, or new among population subsets, monitoring under paragraph (c)(8) of this section, combination of active ingredients. The recommendations, and other clinically with any appropriate subheadings.
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(13) Use in specific populations. A recognized disease or condition, or of a evidence that the drug is effective or concise summary of the information manifestation of a recognized disease or safe for that use or condition. required under paragraph (c)(9) of this condition, or for the relief of symptoms (iii) Any statements comparing the section, with any appropriate associated with a recognized disease or safety or effectiveness of the drug with subheadings. condition. other agents for the same indication (14) Patient counseling information (i) This section must include the must, except for biological products, be statement. The verbatim statement ‘‘See following information when the supported by substantial evidence 17 for Patient Counseling Information’’ conditions listed are applicable: derived from adequate and well- or, if the product has FDA-approved (A) If the drug is used for an controlled studies as defined in patient labeling, the verbatim statement indication only in conjunction with a § 314.126(b) of this chapter unless this ‘‘See 17 for Patient Counseling primary mode of therapy (e.g., diet, requirement is waived under § 201.58 or Information and (insert either FDA- surgery, behavior changes, or some § 314.126(c) of this chapter. For approved patient labeling or Medication other drug), a statement that the drug is biological products, such statements Guide).’’ indicated as an adjunct to that mode of must be supported by substantial (15) Revision date. The date of the therapy. evidence. most recent revision of the labeling, (B) If evidence is available to support (iv) For drug products other than identified as such, placed at the end of the safety and effectiveness of the drug biological products, all indications Highlights. or biological product only in selected listed in this section must be supported (b) Full prescribing information: subgroups of the larger population (e.g., by substantial evidence of effectiveness Contents. Contents must contain a list of patients with mild disease or patients in based on adequate and well-controlled each heading and subheading required a special age group), or if the indication studies as defined in § 314.126(b) of this in the full prescribing information is approved based on a surrogate chapter unless the requirement is under § 201.56(d)(1), if not omitted endpoint under § 314.510 or § 601.41 of waived under § 201.58 or § 314.126(c) of under § 201.56(d)(4), preceded by the this chapter, a succinct description of this chapter. Indications or uses must identifying number required under the limitations of usefulness of the drug not be implied or suggested in other § 201.56(d)(1). Contents must also and any uncertainty about anticipated sections of the labeling if not included contain any additional subheading(s) clinical benefits, with reference to the in this section. included in the full prescribing ‘‘Clinical Studies’’ section for a (v) For biological products, all information preceded by the identifying discussion of the available evidence. indications listed in this section must be number assigned in accordance with (C) If specific tests are necessary for supported by substantial evidence of § 201.56(d)(2). selection or monitoring of the patients effectiveness. Indications or uses must (c) Full prescribing information. The who need the drug (e.g., microbe not be implied or suggested in other full prescribing information must susceptibility tests), the identity of such sections of the labeling if not included contain the information in the order tests. in this section. required under paragraphs (c)(1) (D) If information on limitations of (3) 2 Dosage and administration. (i) through (c)(18) of this section, together use or uncertainty about anticipated This section must state the with the headings, subheadings, and clinical benefits is relevant to the recommended dose and, as appropriate: identifying numbers required under recommended intervals between doses, (A) The dosage range, § 201.56(d)(1), unless omitted under to the appropriate duration of treatment (B) An upper limit beyond which § 201.56(d)(4). If additional subheadings when such treatment should be limited, safety and effectiveness have not been are used within a labeling section, they or to any modification of dosage, a established, or beyond which increasing must be preceded by the identifying concise description of the information the dose does not result in increasing number assigned in accordance with with reference to the more detailed effectiveness, § 201.56(d)(2). information in the ‘‘Dosage and (C) Dosages for each indication and (1) Boxed warning. Certain Administration’’ section. subpopulation, contraindications or serious warnings, (E) If safety considerations are such (D) The intervals recommended particularly those that may lead to death that the drug should be reserved for between doses, or serious injury, may be required by the specific situations (e.g., cases refractory (E) The optimal method of titrating FDA to be presented in a box. The to other drugs), a statement of the dosage, boxed warning ordinarily must be based information. (F) The usual duration of treatment on clinical data, but serious animal (F) If there are specific conditions that when treatment duration should be toxicity may also be the basis of a boxed should be met before the drug is used limited, warning in the absence of clinical data. on a long term basis (e.g., demonstration (G) Dosing recommendations based on The box must contain, in uppercase of responsiveness to the drug in a short clinical pharmacologic data (e.g., letters, a heading inside the box that term trial in a given patient), a statement clinically significant food effects), includes the word ‘‘WARNING’’ and of the conditions; or, if the indications (H) Modification of dosage needed conveys the general focus of the for long term use are different from because of drug interactions or in information in the box. The box must those for short term use, a statement of special patient populations (e.g., in briefly explain the risk and refer to more the specific indications for each use. children, in geriatric age groups, in detailed information in the (ii) If there is a common belief that the groups defined by genetic ‘‘Contraindications’’ or ‘‘Warnings and drug may be effective for a certain use characteristics, or in patients with renal Precautions’’ section, accompanied by or if there is a common use of the drug or hepatic disease), the identifying number for the section or for a condition, but the preponderance (I) Important considerations subsection containing the detailed of evidence related to the use or concerning compliance with the dosage information. condition shows that the drug is regimen, (2) 1 Indications and usage. This ineffective or that the therapeutic (J) Efficacious or toxic concentration section must state that the drug is benefits of the product do not generally ranges and therapeutic concentration indicated for the treatment, prevention, outweigh its risks, FDA may require that windows of the drug or its metabolites, mitigation, cure, or diagnosis of a this section state that there is a lack of if established and clinically significant.
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Information on therapeutic drug hypersensitivity to the drug has not (7) 6 Adverse reactions. This section concentration monitoring (TDM) must been demonstrated, it should not be must describe the overall adverse also be included in this section when listed as a contraindication). If no reaction profile of the drug based on the TDM is necessary. contraindications are known, this entire safety database. For purposes of (ii) Dosing regimens must not be section must state ‘‘None.’’ prescription drug labeling, an adverse implied or suggested in other sections of (6) 5 Warnings and precautions. (i) reaction is an undesirable effect, the labeling if not included in this General. This section must describe reasonably associated with use of a section. clinically significant adverse reactions drug, that may occur as part of the (iii) Radiation dosimetry information (including any that are potentially fatal, pharmacological action of the drug or must be stated for both the patient are serious even if infrequent, or can be may be unpredictable in its occurrence. receiving a radioactive drug and the prevented or mitigated through This definition does not include all person administering it. appropriate use of the drug), other adverse events observed during use of a (iv) This section must also contain potential safety hazards (including those drug, only those adverse events for specific direction on dilution, that are expected for the which there is some basis to believe preparation (including the strength of pharmacological class or those resulting there is a causal relationship between the final dosage solution, when from drug/drug interactions), limitations the drug and the occurrence of the prepared according to instructions, in in use imposed by them (e.g., avoiding adverse event. terms of milligrams of active ingredient certain concomitant therapy), and steps (i) Listing of adverse reactions. This per milliliter of reconstituted solution, that should be taken if they occur (e.g., section must list the adverse reactions unless another measure of the strength dosage modification). The frequency of that occur with the drug and with drugs is more appropriate), and administration all clinically significant adverse in the same pharmacologically active of the dosage form, if needed (e.g., the reactions and the approximate mortality and chemically related class, if rate of administration of parenteral drug and morbidity rates for patients applicable. The list or lists must be in milligrams per minute; storage experiencing the reaction, if known and preceded by the information necessary conditions for stability of the necessary for the safe and effective use to interpret the adverse reactions (e.g., reconstituted drug, when important; of the drug, must be expressed as for clinical trials, total number exposed, essential information on drug provided under paragraph (c)(7) of this extent and nature of exposure). incompatibilities if the drug is mixed in section. In accordance with §§ 314.70 (ii) Categorization of adverse vitro with other drugs or diluents; and and 601.12 of this chapter, the labeling reactions. Within a listing, adverse the following verbatim statement for must be revised to include a warning reactions must be categorized by body parenterals: ‘‘Parenteral drug products about a clinically significant hazard as system, by severity of the reaction, or in should be inspected visually for soon as there is reasonable evidence of order of decreasing frequency, or by a particulate matter and discoloration a causal association with a drug; a combination of these, as appropriate. prior to administration, whenever causal relationship need not have been Within a category, adverse reactions solution and container permit.’’) definitely established. A specific must be listed in decreasing order of (4) 3 Dosage forms and strengths. This warning relating to a use not provided frequency. If frequency information section must contain information on the for under the ‘‘Indications and Usage’’ cannot be reliably determined, adverse available dosage forms to which the section may be required by FDA in reactions must be listed in decreasing labeling applies and for which the accordance with sections 201(n) and order of severity. manufacturer or distributor is 502(a) of the act if the drug is commonly (A) Clinical trials experience. This responsible, including: prescribed for a disease or condition section must list the adverse reactions (i) The strength or potency of the and such usage is associated with a identified in clinical trials that occurred dosage form in metric system (e.g., 10 clinically significant risk or hazard. at or above a specified rate appropriate milligram tablets), and, if the apothecary (ii) Other special care precautions. to the safety database. The rate of system is used, a statement of the This section must contain information occurrence of an adverse reaction for the strength in parentheses after the metric regarding any special care to be drug and comparators (e.g., placebo) designation; and exercised by the practitioner for safe must be presented, unless such data (ii) A description of the identifying and effective use of the drug (e.g., cannot be determined or presentation of characteristics of the dosage forms, precautions not required under any comparator rates would be misleading. including shape, color, coating, scoring, other specific section or subsection). If adverse reactions that occurred below and imprinting, when applicable. The (iii) Monitoring: Laboratory tests. This the specified rate are included, they National Drug Code number(s) for the section must identify any laboratory must be included in a separate listing. drug product must not be included in tests helpful in following the patient’s If comparative rates of occurrence this section. response or in identifying possible cannot be reliably determined (e.g., (5) 4 Contraindications. This section adverse reactions. If appropriate, adverse reactions were observed only in must describe any situations in which information must be provided on such the uncontrolled trial portion of the the drug should not be used because the factors as the range of normal and overall safety database), adverse risk of use (e.g., certain potentially fatal abnormal values expected in the reactions must be grouped within adverse reactions) clearly outweighs any particular situation and the specified frequency ranges as possible therapeutic benefit. Those recommended frequency with which appropriate to the safety database for the situations include use of the drug in tests should be performed before, drug (e.g., adverse reactions occurring at patients who, because of their particular during, and after therapy. a rate of less than 1/100, adverse age, sex, concomitant therapy, disease (iv) Interference with laboratory tests. reactions occurring at a rate of less than state, or other condition, have a This section must briefly note 1/500) or descriptively identified, if substantial risk of being harmed by the information on any known interference frequency ranges cannot be determined. drug and for whom no potential benefit by the product with laboratory tests and For adverse reactions with significant makes the risk acceptable. Known reference the section where the detailed clinical implications, the listings must hazards and not theoretical possibilities information is presented (e.g., ‘‘Drug be supplemented with additional detail must be listed (e.g., if severe Interactions’’ section). about the nature, frequency, and
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severity of the adverse reaction and the (1) Pregnancy category A. If adequate appear that the possibility of fetal harm relationship of the adverse reaction to and well-controlled studies in pregnant is remote, if the drug is used during drug dose and demographic women have failed to demonstrate a risk pregnancy. Nevertheless, because the characteristics, if data are available and to the fetus in the first trimester of studies in humans cannot rule out the important. pregnancy (and there is no evidence of possibility of harm, (name of drug) (B) Postmarketing experience. This a risk in later trimesters), the labeling should be used during pregnancy only section of the labeling must list the must state: ‘‘Pregnancy Category A. if clearly needed.’’ The labeling must adverse reactions, as defined in Studies in pregnant women have not also contain a description of the human paragraph (c)(7) of this section, that are shown that (name of drug) increases the studies and a description of available identified from domestic and foreign risk of fetal abnormalities if data on the effect of the drug on the later spontaneous reports. This listing must administered during the first (second, growth, development, and functional be separate from the listing of adverse third, or all) trimester(s) of pregnancy. If maturation of the child. reactions identified in clinical trials. this drug is used during pregnancy, the (3) Pregnancy category C. If animal (iii) Comparisons of adverse reactions possibility of fetal harm appears remote. reproduction studies have shown an between drugs. For drug products other Because studies cannot rule out the adverse effect on the fetus, if there are than biological products, any claim possibility of harm, however, (name of no adequate and well-controlled studies comparing the drug to which the drug) should be used during pregnancy in humans, and if the benefits from the labeling applies with other drugs in only if clearly needed.’’ The labeling use of the drug in pregnant women may terms of frequency, severity, or must also contain a description of the be acceptable despite its potential risks, character of adverse reactions must be human studies. If animal reproduction the labeling must state: ‘‘Pregnancy based on adequate and well-controlled studies are also available and they fail Category C. (Name of drug) has been studies as defined in § 314.126(b) of this to demonstrate a risk to the fetus, the shown to be teratogenic (or to have an chapter unless this requirement is labeling must also state: ‘‘Reproduction embryocidal effect or other adverse waived under § 201.58 or § 314.126(c) of studies have been performed in (kinds effect) in (name(s) of species) when this chapter. For biological products, of animal(s)) at doses up to (x) times the given in doses (x) times the human any such claim must be based on human dose and have revealed no dose. There are no adequate and well- substantial evidence. evidence of impaired fertility or harm to controlled studies in pregnant women. (8) 7 Drug interactions. (i) This the fetus due to (name of drug).’’ The (Name of drug) should be used during section must contain a description of labeling must also contain a description pregnancy only if the potential benefit justifies the potential risk to the fetus.’’ clinically significant interactions, either of available data on the effect of the The labeling must contain a description observed or predicted, with other drug on the later growth, development, of the animal studies. If there are no prescription or over-the-counter drugs, and functional maturation of the child. animal reproduction studies and no classes of drugs, or foods (e.g., dietary (2) Pregnancy category B. If animal adequate and well-controlled studies in supplements, grapefruit juice), and reproduction studies have failed to humans, the labeling must state: specific practical instructions for demonstrate a risk to the fetus and there ‘‘Pregnancy Category C. Animal preventing or managing them. The are no adequate and well-controlled reproduction studies have not been mechanism(s) of the interaction, if studies in pregnant women, the labeling conducted with (name of drug). It is also known, must be briefly described. must state: ‘‘Pregnancy Category B. not known whether (name of drug) can Interactions that are described in the Reproduction studies have been cause fetal harm when administered to ‘‘Contraindications’’ or ‘‘Warnings and performed in (kind(s) of animal(s)) at a pregnant woman or can affect Precautions’’ sections must be discussed doses up to (x) times the human dose reproduction capacity. (Name of drug) in more detail under this section. and have revealed no evidence of should be given to a pregnant woman Details of drug interaction impaired fertility or harm to the fetus only if clearly needed.’’ The labeling pharmacokinetic studies that are due to (name of drug). There are, must contain a description of any included in the ‘‘Clinical however, no adequate and well- available data on the effect of the drug Pharmacology’’ section that are controlled studies in pregnant women. on the later growth, development, and pertinent to clinical use of the drug Because animal reproduction studies are functional maturation of the child. must not be repeated in this section. not always predictive of human (4) Pregnancy category D. If there is (ii) This section must also contain response, this drug should be used positive evidence of human fetal risk practical guidance on known during pregnancy only if clearly based on adverse reaction data from interference of the drug with laboratory needed.’’ If animal reproduction studies investigational or marketing experience tests. have shown an adverse effect (other or studies in humans, but the potential (9) 8 Use in specific populations. This than decrease in fertility), but adequate benefits from the use of the drug in section must contain the following and well-controlled studies in pregnant pregnant women may be acceptable subsections: women have failed to demonstrate a risk despite its potential risks (for example, (i) 8.1 Pregnancy. This subsection to the fetus during the first trimester of if the drug is needed in a life- may be omitted only if the drug is not pregnancy (and there is no evidence of threatening situation or serious disease absorbed systemically and the drug is a risk in later trimesters), the labeling for which safer drugs cannot be used or not known to have a potential for must state: ‘‘Pregnancy Category B. are ineffective), the labeling must state: indirect harm to the fetus. For all other Reproduction studies in (kind(s) of ‘‘Pregnancy Category D. See ‘Warnings drugs, this subsection must contain the animal(s)) have shown (describe and Precautions’ section.’’ Under the following information: findings) at (x) times the human dose. ‘‘Warnings and Precautions’’ section, (A) Teratogenic effects. Under this Studies in pregnant women, however, the labeling must state: ‘‘(Name of drug) subheading, the labeling must identify have not shown that (name of drug) can cause fetal harm when administered one of the following categories that increases the risk of abnormalities when to a pregnant woman. (Describe the applies to the drug, and the labeling administered during the first (second, human data and any pertinent animal must bear the statement required under third, or all) trimester(s) of pregnancy. data.) If this drug is used during the category: Despite the animal findings, it would pregnancy, or if the patient becomes
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pregnant while taking this drug, the (B) If a drug is absorbed systemically pediatric dosage information must be patient should be apprised of the and is known to be excreted in human given under the ‘‘Dosage and potential hazard to a fetus.’’ milk, this subsection must contain one Administration’’ section. The ‘‘Pediatric (5) Pregnancy category X. If studies in of the following statements, as use’’ subsection must cite any animals or humans have demonstrated appropriate. If the drug is associated limitations on the pediatric indication, fetal abnormalities or if there is positive with serious adverse reactions or if the need for specific monitoring, specific evidence of fetal risk based on adverse drug has a known tumorigenic potential, hazards associated with use of the drug reaction reports from investigational or the labeling must state: ‘‘Because of the in any subsets of the pediatric marketing experience, or both, and the potential for serious adverse reactions in population (e.g., neonates), differences risk of the use of the drug in a pregnant nursing infants from (name of drug) (or, between pediatric and adult responses woman clearly outweighs any possible ‘‘Because of the potential for to the drug, and other information benefit (for example, safer drugs or other tumorigenicity shown for (name of related to the safe and effective pediatric forms of therapy are available), the drug) in (animal or human) studies), a use of the drug. Data summarized in this labeling must state: ‘‘Pregnancy decision should be made whether to subsection should be discussed in more Category X. See ‘Contraindications’ discontinue nursing or to discontinue detail, if appropriate, under the section.’’ Under ‘‘Contraindications,’’ the drug, taking into account the ‘‘Clinical Pharmacology’’ or ‘‘Clinical the labeling must state: ‘‘(Name of drug) importance of the drug to the mother.’’ Studies’’ section. As appropriate, this may (can) cause fetal harm when If the drug is not associated with serious information must also be contained in administered to a pregnant woman. adverse reactions and does not have a the ‘‘Contraindications’’ and/or (Describe the human data and any known tumorigenic potential, the ‘‘Warnings and Precautions’’ section(s). pertinent animal data.) (Name of drug) labeling must state: ‘‘Caution should be (C) If there are specific statements on is contraindicated in women who are or exercised when (name of drug) is pediatric use of the drug for an may become pregnant. If this drug is administered to a nursing woman.’’ indication also approved for adults that used during pregnancy, or if the patient (C) If a drug is absorbed systemically are based on adequate and well- becomes pregnant while taking this and information on excretion in human controlled studies in the pediatric drug, the patient should be apprised of milk is unknown, this subsection must population, they must be summarized in the potential hazard to a fetus.’’ contain one of the following statements, the ‘‘Pediatric use’’ subsection and (B) Nonteratogenic effects. Under this as appropriate. If the drug is associated discussed in more detail, if appropriate, with serious adverse reactions or has a subheading the labeling must contain under the ‘‘Clinical Pharmacology’’ and known tumorigenic potential, the other information on the drug’s effects ‘‘Clinical Studies’’ sections. Appropriate labeling must state: ‘‘It is not known on reproduction and the drug’s use pediatric dosage must be given under whether this drug is excreted in human during pregnancy that is not required the ‘‘Dosage and Administration’’ milk. Because many drugs are excreted specifically by one of the pregnancy section. The ‘‘Pediatric use’’ subsection in human milk and because of the categories, if the information is relevant of the labeling must also cite any potential for serious adverse reactions in to the safe and effective use of the drug. limitations on the pediatric use nursing infants from (name of drug) (or, Information required under this heading statement, need for specific monitoring, ‘‘Because of the potential for must include nonteratogenic effects in specific hazards associated with use of tumorigenicity shown for (name of the fetus or newborn infant (for the drug in any subsets of the pediatric drug) in (animal or human) studies), a population (e.g., neonates), differences example, withdrawal symptoms or decision should be made whether to hypoglycemia) that may occur because between pediatric and adult responses discontinue nursing or to discontinue to the drug, and other information of a pregnant woman’s chronic use of the drug, taking into account the the drug for a preexisting condition or related to the safe and effective pediatric importance of the drug to the mother.’’ use of the drug. As appropriate, this disease. If the drug is not associated with serious (ii) 8.2 Labor and delivery. If the drug information must also be contained in adverse reactions and does not have a the ‘‘Contraindications’’ and/or has a recognized use during labor or known tumorigenic potential, the delivery (vaginal or abdominal ‘‘Warnings and Precautions’’ section(s). labeling must state: ‘‘It is not known (D)(1) When a drug is approved for delivery), whether or not the use is whether this drug is excreted in human stated in the Indications and Usage pediatric use based on adequate and milk. Because many drugs are excreted well-controlled studies in adults with section, this subsection must describe in human milk, caution should be the available information about the other information supporting pediatric exercised when (name of drug) is use, the ‘‘Pediatric use’’ subsection of effect of the drug on the mother and the administered to a nursing woman.’’ fetus, on the duration of labor or the labeling must contain either the (iv) 8.4 Pediatric use. (A) Pediatric following statement or a reasonable delivery, on the possibility that forceps population(s)/pediatric patient(s): For delivery or other intervention or alternative: the purposes of paragraphs (c)(9)(iv)(B) The safety and effectiveness of (drug name) resuscitation of the newborn will be through (c)(9)(iv)(H) of this section, the have been established in the age groups ___ necessary, and the effect of the drug on terms pediatric population(s) and to ___ (note any limitations, e.g., no data for the later growth, development, and pediatric patient(s) are defined as the pediatric patients under 2, or only applicable functional maturation of the child. If pediatric age group, from birth to 16 to certain indications approved in adults). any information required under this years, including age groups often called Use of (drug name) in these age groups is subsection is unknown, it must state neonates, infants, children, and supported by evidence from adequate and that the information is unknown. well-controlled studies of (drug name) in adolescents. adults with additional data (insert wording (iii) 8.3 Nursing mothers. (A) If a drug (B) If there is a specific pediatric that accurately describes the data submitted is absorbed systemically, this subsection indication different from those to support a finding of substantial evidence must contain, if known, information approved for adults that is supported by of effectiveness in the pediatric population). about excretion of the drug in human adequate and well-controlled studies in (2) Data summarized in the preceding milk and effects on the nursing infant. the pediatric population, it must be prescribed statement in this subsection Pertinent adverse effects observed in described under the ‘‘Indications and must be discussed in more detail, if animal offspring must be described. Usage’’ section, and appropriate appropriate, under the ‘‘Clinical
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Pharmacology’’ or the ‘‘Clinical an increased risk of toxic effects to such differences, the ‘‘Geriatric use’’ Studies’’ section. For example, pediatric neonates or other pediatric subgroups, a subsection must include the following pharmacokinetic or pharmacodynamic special note of this risk must be made, statement: studies and dose response information generally in the ‘‘Contraindications’’ or Clinical studies of (name of drug) did should be described in the ‘‘Clinical ‘‘Warnings and Precautions’’ section. not include sufficient numbers of Pharmacology’’ section. Pediatric dosing (v) 8.5 Geriatric use. (A) A specific subjects aged 65 and over to determine instructions must be included in the geriatric indication, if any, that is whether they respond differently from ‘‘Dosage and Administration’’ section. supported by adequate and well- younger subjects. Other reported Any differences between pediatric and controlled studies in the geriatric clinical experience has not identified adult responses, need for specific population must be described under the differences in responses between the monitoring, dosing adjustments, and ‘‘Indications and Usage’’ section, and elderly and younger patients. In general, any other information related to safe appropriate geriatric dosage must be dose selection for an elderly patient and effective use of the drug in pediatric stated under the ‘‘Dosage and should be cautious, usually starting at patients must be cited briefly in the Administration’’ section. The ‘‘Geriatric the low end of the dosing range, ‘‘Pediatric use’’ subsection and, as use’’ subsection must cite any reflecting the greater frequency of appropriate, in the ‘‘Contraindications,’’ limitations on the geriatric indication, decreased hepatic, renal, or cardiac ‘‘Warnings and Precautions,’’ and need for specific monitoring, specific function, and of concomitant disease or ‘‘Dosage and Administration’’ sections. hazards associated with the geriatric other drug therapy. (E) If the requirements for a finding of indication, and other information (2) If clinical studies (including substantial evidence to support a related to the safe and effective use of studies that are part of marketing pediatric indication or a pediatric use the drug in the geriatric population. applications and other relevant studies statement have not been met for a Unless otherwise noted, information available to the sponsor that have not particular pediatric population, the contained in the ‘‘Geriatric use’’ been submitted in the sponsor’s ‘‘Pediatric use’’ subsection must contain subsection must pertain to use of the applications) included enough elderly an appropriate statement such as drug in persons 65 years of age and subjects to make it likely that ‘‘Safety and effectiveness in pediatric older. Data summarized in this differences in safety or effectiveness patients below the age of (__) have not subsection must be discussed in more between elderly and younger subjects been established.’’ If use of the drug in detail, if appropriate, under ‘‘Clinical would have been detected, but no such this pediatric population is associated Pharmacology’’ or the ‘‘Clinical differences (in safety or effectiveness) with a specific hazard, the hazard must Studies’’ section. As appropriate, this were observed, and other reported be described in this subsection, or, if information must also be contained in clinical experience has not identified appropriate, the hazard must be stated the ‘‘Warnings and Precautions’’ and/or such differences, the ‘‘Geriatric use’’ in the ‘‘Contraindications’’ or ‘‘Contraindications’’ section(s). subsection must contain the following ‘‘Warnings and Precautions’’ section (B) Specific statements on geriatric statement: and this subsection must refer to it. use of the drug for an indication Of the total number of subjects in clinical (F) If the requirements for a finding of approved for adults generally, as studies of (name of drug), __ percent were 65 substantial evidence to support a distinguished from a specific geriatric and over, while __ percent were 75 and over. pediatric indication or a pediatric use indication, must be contained in the (Alternatively, the labeling may state the total statement have not been met for any ‘‘Geriatric use’’ subsection and must number of subjects included in the studies pediatric population, this subsection reflect all information available to the who were 65 and over and 75 and over.) No must contain the following statement: sponsor that is relevant to the overall differences in safety or effectiveness were observed between these subjects and ‘‘Safety and effectiveness in pediatric appropriate use of the drug in elderly younger subjects, and other reported clinical patients have not been established.’’ If patients. This information includes experience has not identified differences in use of the drug in premature or neonatal detailed results from controlled studies responses between the elderly and younger infants, or other pediatric subgroups, is that are available to the sponsor and patients, but greater sensitivity of some older associated with a specific hazard, the pertinent information from well- individuals cannot be ruled out. hazard must be described in this documented studies obtained from a (3) If evidence from clinical studies subsection, or, if appropriate, the hazard literature search. Controlled studies and other reported clinical experience must be stated in the include those that are part of the available to the sponsor indicates that ‘‘Contraindications’’ or ‘‘Warnings and marketing application and other use of the drug in elderly patients is Precautions’’ section and this subsection relevant studies available to the sponsor associated with differences in safety or must refer to it. that have not been previously submitted effectiveness, or requires specific (G) If the sponsor believes that none in the investigational new drug monitoring or dosage adjustment, the of the statements described in application, new drug application, ‘‘Geriatric use’’ subsection must contain paragraphs (c)(9)(iv)(B) through biologics license application, or a a brief description of observed (c)(9)(iv)(F) of this section are supplement or amendment to one of differences or specific monitoring or appropriate or relevant to the labeling of these applications (e.g., postmarketing dosage requirements and, as a particular drug, the sponsor must studies or adverse drug reaction appropriate, must refer to more detailed provide reasons for omission of the reports). The ‘‘Geriatric use’’ subsection discussions in the ‘‘Contraindications,’’ statements and may propose alternative must contain the following statement(s) ‘‘Warnings and Precautions,’’ ‘‘Dosage statement(s). FDA may permit use of an or reasonable alternative, as applicable, and Administration,’’ or other sections. alternative statement if FDA determines taking into account available (C)(1) If specific pharmacokinetic or that no statement described in those information: pharmacodynamic studies have been paragraphs is appropriate or relevant to (1) If clinical studies did not include carried out in the elderly, they must be the drug’s labeling and that the sufficient numbers of subjects aged 65 described briefly in the ‘‘Geriatric use’’ alternative statement is accurate and and over to determine whether elderly subsection and in detail under the appropriate. subjects respond differently from ‘‘Clinical Pharmacology’’ section. The (H) If the drug product contains one younger subjects, and other reported ‘‘Clinical Pharmacology’’ and ‘‘Drug or more inactive ingredients that present clinical experience has not identified Interactions’’ sections ordinarily contain
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information on drug/disease and drug/ (ii) 9.2 Abuse. This subsection must or, for biological products, the proper drug interactions that is particularly state the types of abuse that can occur name (as defined in § 600.3 of this relevant to the elderly, who are more with the drug and the adverse reactions chapter) and any appropriate likely to have concomitant illness and to pertinent to them, and must identify descriptors; use concomitant drugs. particularly susceptible patient (B) The type of dosage form(s) and the (2) If a drug is known to be populations. This subsection must be route(s) of administration to which the substantially excreted by the kidney, the based primarily on human data and labeling applies; ‘‘Geriatric use’’ subsection must include human experience, but pertinent animal (C) The same qualitative and/or the statement: data may also be used. quantitative ingredient information as This drug is known to be substantially (iii) 9.3 Dependence. This subsection required under § 201.100(b) for drug excreted by the kidney, and the risk of must describe characteristic effects labels or §§ 610.60 and 610.61 of this adverse reactions to this drug may be greater resulting from both psychological and chapter for biological product labels; in patients with impaired renal function. physical dependence that occur with (D) If the product is sterile, a Because elderly patients are more likely to the drug and must identify the quantity statement of that fact; have decreased renal function, care should be of the drug over a period of time that (E) The pharmacological or taken in dose selection, and it may be useful may lead to tolerance or dependence, or therapeutic class of the drug; to monitor renal function. (F) For drug products other than (D) If use of the drug in the elderly both. Details must be provided on the adverse effects of chronic abuse and the biological products, the chemical name appears to cause a specific hazard, the and structural formula of the drug; and hazard must be described in the effects of abrupt withdrawal. Procedures necessary to diagnose the dependent (G) If the product is radioactive, a ‘‘Geriatric use’’ subsection, or, if statement of the important nuclear appropriate, the hazard must be stated state and the principles of treating the effects of abrupt withdrawal must be physical characteristics, such as the in the ‘‘Contraindications’’ or principal radiation emission data, ‘‘Warnings and Precautions’’ section, described. (11) 10 Overdosage. This section must external radiation, and physical decay and the ‘‘Geriatric use’’ subsection must be based on human data. If human data characteristics. refer to those sections. are unavailable, appropriate animal and (ii) If appropriate, other important (E) Labeling under paragraphs in vitro data may be used. The following chemical or physical information, such (c)(9)(v)(A) through (c)(9)(v)(C) of this specific information must be provided: as physical constants or pH, must be section may include statements, if they (i) Signs, symptoms, and laboratory stated. are necessary for safe and effective use findings associated with an overdosage (13) 12 Clinical pharmacology. (i) of the drug, and reflect good clinical of the drug; This section must contain information practice or past experience in a (ii) Complications that can occur with relating to the human clinical particular situation, e.g., for a sedating the drug (for example, organ toxicity or pharmacology and actions of the drug in drug, it could be stated that: delayed acidosis); humans. Pharmacologic information Sedating drugs may cause confusion and (iii) Concentrations of the drug in based on in vitro data using human over-sedation in the elderly; elderly patients biologic fluids associated with toxicity biomaterials or pharmacologic animal generally should be started on low doses of models, or relevant details about in vivo (name of drug) and observed closely. or death; physiologic variables influencing excretion of the drug, such study designs or results (e.g., drug (F) If the sponsor believes that none interaction studies), may be included in of the requirements described in as urine pH; and factors that influence the dose response relationship of the this section if essential to understand paragraphs (c)(9)(v)(A) through dosing or drug interaction information (c)(9)(v)(E) of this section are drug, such as tolerance. The pharmacokinetic data given in the presented in other sections of the appropriate or relevant to the labeling of labeling. This section must include the a particular drug, the sponsor must ‘‘Clinical Pharmacology’’ section also may be referenced here, if applicable to following subsections: provide reasons for omission of the (A) 12.1 Mechanism of action. This statements and may propose an overdoses; (iv) The amount of the drug in a single subsection must summarize what is alternative statement. FDA may permit dose that is ordinarily associated with known about the established omission of the statements if FDA symptoms of overdosage and the mechanism(s) of the drug’s action in determines that no statement described amount of the drug in a single dose that humans at various levels (e.g., receptor, in those paragraphs is appropriate or is likely to be life threatening; membrane, tissue, organ, whole body). If relevant to the drug’s labeling. FDA may (v) Whether the drug is dialyzable; the mechanism of action is not known, permit use of an alternative statement if and this subsection must contain a statement the agency determines that such (vi) Recommended general treatment about the lack of information. statement is accurate and appropriate. procedures and specific measures for (B) 12.2 Pharmacodynamics. This (vi) Additional subsections. support of vital functions (e.g., proven subsection must include a description of Additional subsections may be antidotes, gastric lavage, forced diuresis, any biochemical or physiologic included, as appropriate, if sufficient or as per Poison Control Center). Such pharmacologic effects of the drug or data are available concerning the use of recommendations must be based on data active metabolites related to the drug’s the drug in other specified available for the specific drug or clinical effect in preventing, diagnosing, subpopulations (e.g., renal or hepatic experience with pharmacologically mitigating, curing, or treating disease, or impairment). related drugs. Unqualified those related to adverse effects or (10) 9 Drug abuse and dependence. recommendations for which data are toxicity. Exposure-response This section must contain the following lacking for the specific drug or class of relationships (e.g., concentration- information, as appropriate: drugs must not be stated. response, dose-response) and time (i) 9.1 Controlled substance. If the (12) 11 Description. (i) This section course of pharmacodynamic response drug is controlled by the Drug must contain: (including short-term clinical response) Enforcement Administration, the (A) The proprietary name and the must be included if known. If this schedule in which it is controlled must established name, if any, as defined in information is unknown, this subsection be stated. section 502(e)(2) of the act, of the drug must contain a statement about the lack
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of information. Detailed dosing or shown by adequate and well-controlled well-controlled as described in monitoring recommendations based on studies, as defined in § 314.126(b) of § 314.126(b) of this chapter and must pharmacodynamic information that this chapter, to be necessary for the safe not imply or suggest indications or uses appear in other sections (e.g., ‘‘Warnings and effective use may be included in or dosing regimens not stated in the and Precautions’’ or ‘‘Dosage and this section only if a waiver is granted ‘‘Indications and Usage’’ or ‘‘Dosage and Administration’’) must not be repeated under § 201.58 or § 314.126(c) of this Administration’’ section. For biological in this subsection, but the location of chapter. products, any clinical study that is such recommendations must be (14) 13 Nonclinical toxicology. This discussed that relates to an indication referenced. section must contain the following for or use of the biological product must (C) 12.3 Pharmacokinetics. This subsections as appropriate: constitute or contribute to substantial subsection must describe the clinically (i) 13.1 Carcinogenesis, mutagenesis, evidence and must not imply or suggest significant pharmacokinetics of a drug impairment of fertility. This subsection indications or uses or dosing regimens or active metabolites, (i.e., pertinent must state whether long term studies in not stated in the ‘‘Indications and absorption, distribution, metabolism, animals have been performed to Usage’’ or ‘‘Dosage and Administration’’ and excretion parameters). Information evaluate carcinogenic potential and, if section. regarding bioavailability, the effect of so, the species and results. If results (ii) Any discussion of a clinical study food, minimum concentration (Cmin), from reproduction studies or other data that relates to a risk from the use of the maximum concentration (Cmax), time to in animals raise concern about drug must also refer to the other maximum concentration (Tmax), area mutagenesis or impairment of fertility in sections of the labeling where the risk under the curve (AUC), pertinent half- either males or females, this must be is identified or discussed. lives (t1/2), time to reach steady state, described. Any precautionary statement (16) 15 References. When prescription extent of accumulation, route(s) of on these topics must include practical, drug labeling must summarize or elimination, clearance (renal, hepatic, relevant advice to the prescriber on the otherwise rely on a recommendation by total), mechanisms of clearance (e.g., significance of these animal findings. an authoritative scientific body, or on a specific enzyme systems), drug/drug Human data suggesting that the drug standardized methodology, scale, or and drug/food (e.g., dietary may be carcinogenic or mutagenic, or technique, because the information is supplements, grapefruit juice) suggesting that it impairs fertility, as important to prescribing decisions, the pharmacokinetic interactions (including described in the ‘‘Warnings and labeling may include a reference to the inhibition, induction, and genetic Precautions’’ section, must not be source of the information. characteristics), and volume of included in this subsection of the (17) 16 How supplied/storage and distribution (Vd) must be presented if labeling. handling. This section must contain clinically significant. Information (ii) 13.2 Animal toxicology and/or information on the available dosage regarding nonlinearity in pharmacology. Significant animal data forms to which the labeling applies and pharmacokinetic parameters, changes in necessary for safe and effective use of for which the manufacturer or pharmacokinetics over time, and the drug in humans that is not distributor is responsible. The binding (plasma protein, erythrocyte) incorporated in other sections of information must include, as parameters must also be presented if labeling must be included in this appropriate: clinically significant. This section must section (e.g., specifics about studies (i) The strength or potency of the also include the results of used to support approval under dosage form in metric system (e.g., 10 pharmacokinetic studies (e.g., of § 314.600 or § 601.90 of this chapter, the milligram tablets) and, if the apothecary metabolism or interaction) that establish absence of chronic animal toxicity data system is used, a statement of the the absence of an effect, including for a drug that is administered over strength in parentheses after the metric pertinent human studies and in vitro prolonged periods or is implanted in the designation; data. Dosing recommendations based on body). (ii) The units in which the dosage clinically significant factors that change (15) 14 Clinical studies. This section form is ordinarily available for the product’s pharmacokinetics (e.g., must discuss those clinical studies that prescribing by practitioners (e.g., bottles age, gender, race, hepatic or renal facilitate an understanding of how to of 100); dysfunction, concomitant therapy) that use the drug safely and effectively. (iii) Appropriate information to appear in other sections (e.g., ‘‘Warnings Ordinarily, this section will describe the facilitate identification of the dosage and Precautions,’’ ‘‘Dosage and studies that support effectiveness for the forms, such as shape, color, coating, Administration’’ or ‘‘Use in Specific labeled indication(s), including scoring, imprinting, and National Drug Populations’’) must not be repeated in discussion of study design, population, Code number; and this subsection, but the location of such endpoints, and results, but must not (iv) Special handling and storage recommendations must be referenced. include an encyclopedic listing of all, or conditions. (ii) Data that demonstrate activity or even most, studies performed as part of (18) 17 Patient counseling effectiveness in in vitro or animal tests the product’s clinical development information. This section must contain and that have not been shown by program. If a specific important clinical information necessary for patients to use adequate and well-controlled clinical study is mentioned in any section of the the drug safely and effectively (e.g., studies to be pertinent to clinical use labeling required under §§ 201.56 and precautions concerning driving or the may be included under this section only 201.57 because the study is essential to concomitant use of other substances that under the following circumstances: an understandable presentation of the may have harmful additive effects). Any (A) In vitro data for anti-infective information in that section of the FDA-approved patient labeling must be drugs may be included if the data are labeling, any detailed discussion of the referenced in this section and the full immediately preceded by the statement study must appear in this section. text of such patient labeling must be ‘‘The following in vitro data are (i) For drug products other than reprinted immediately following this available but their clinical significance biological products, any clinical study section or, alternatively, accompany the is unknown.’’ that is discussed in prescription drug prescription drug labeling. Any FDA- (B) For other classes of drugs, in vitro labeling that relates to an indication for approved patient labeling printed and animal data that have not been or use of the drug must be adequate and immediately following this section or
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accompanying the labeling is subject to full prescribing information by the supported by substantial evidence of the type size requirements in paragraph inclusion of a vertical line on the left effectiveness. Indications or uses must (d)(6) of this section, except for a edge of the new or modified text. not be implied or suggested in other Medication Guide to be detached and (10) For the information required by sections of labeling if not included in distributed to patients in compliance paragraph (b) of this section, each this section. with § 208.24 of this chapter. section heading must be in bold print. * * * * * Medication Guides for distribution to Each subheading within a section must (f) * * * patients are subject to the type size be indented and not bolded. (2) Information for patients. This requirements set forth in § 208.20 of this I 4. Section 201.58 is revised to read as subsection must contain information chapter. follows: necessary for patients to use the drug (d) Format requirements. All labeling § 201.58 Waiver of labeling requirements. safely and effectively (e.g., precautions information required under paragraphs concerning driving or the concomitant An applicant may ask the Food and (a), (b), and (c) of this section must be use of other substances that may have Drug Administration to waive any printed in accordance with the harmful additive effects). Any FDA- requirement under §§ 201.56, 201.57, following specifications: approved patient labeling must be (1) All headings and subheadings and 201.80. A waiver request must be referenced in this section and the full required by paragraphs (a) and (c) of this submitted in writing to the Director (or text of such patient labeling must be section must be highlighted by bold the Director’s designee), Center for Drug reprinted immediately following the last type that prominently distinguishes the Evaluation and Research, Food and section of labeling or, alternatively, headings and subheadings from other Drug Administration, 5600 Fishers accompany the prescription drug labeling information. Reverse type is not Lane, Rockville, MD 20857, or, if labeling. The type size requirement for permitted as a form of highlighting. applicable, the Director (or the the Medication Guide set forth in (2) A horizontal line must separate the Director’s designee), Center for Biologics § 208.20 of this chapter does not apply information required by paragraphs (a), Evaluation and Research, Food and to the Medication Guide that is (b), and (c) of this section. Drug Administration, 1401 Rockville reprinted in or accompanying the (3) The headings listed in paragraphs Pike, suite 200 North, Rockville, MD prescription drug labeling unless such (a)(5) through (a)(13) of this section 20852–1448. The waiver must be Medication Guide is to be detached and must be presented in the center of a granted or denied in writing by the distributed to patients in compliance horizontal line. Director or the Director’s designee. (4) If there are multiple subheadings with § 208.24 of this chapter. listed under paragraphs (a)(4) through § 201.59 [Removed] * * * * * (a)(13) of this section, each subheading I 5. Section 201.59 is removed. (j) Dosage and administration. *** must be preceded by a bullet point. I 6. Newly redesignated § 201.80 is Dosing regimens must not be implied or (5) The labeling information required amended by: suggested in other sections of labeling if by paragraphs (a)(1) through (a)(4), a. Revising the section heading; not included in this section. * * * (a)(11)(ii) through (a)(11)(iv), and (a)(14) b. Amending paragraphs (b)(2)(ii), * * * * * of this section must be in bold print. (c)(3)(i), (c)(3)(v), and (g)(4) by removing (m) * * * (6) The letter height or type size for the phrase ‘‘§ 314.126(b)’’ the second (1)(i) If the clinical study is cited in all labeling information, headings, and time it appears and by adding in its the labeling in place of a detailed subheadings set forth in paragraphs (a), place the phrase ‘‘§ 314.126(c)’’; discussion of data and information (b), and (c) of this section must be a c. Removing the phrase ‘‘induced concerning an indication for use of the minimum of 8 points, except for emesis,’’ in paragraph (i)(6); drug, the clinical study must constitute labeling information that is on or within d. Revising paragraphs (c)(2), (f)(2), an adequate and well-controlled study the package from which the drug is to and (m)(1); and as described in § 314.126(b) of this be dispensed, which must be a e. Adding a new sentence after the chapter, except for biological products, minimum of 6 points. first sentence of paragraph (j). (7) The identifying numbers required and must not imply or suggest The additions and revisions read as indications or uses or dosing regimens by § 201.56(d) and paragraphs (c)(1) follows: through (c)(18) of this section must be not stated in the ‘‘Indications and Usage’’ or ‘‘Dosage and Administration’’ presented in bold print and must § 201.80 Specific requirements on content precede the heading or subheading by at and format of labeling for human section. least two square em’s (i.e., two squares prescription drug and biological products; (ii) When prescription drug labeling of the size of the letter ‘‘m’’ in 8 point older drugs not described in § 201.56(b)(1). must summarize or otherwise rely on a type). * * * * * recommendation by an authoritative (8) The information required by (c) * * * scientific body, or on a standardized paragraph (a) of this section, not (2)(i) For drug products other than methodology, scale, or technique, including the information required biological products, all indications because the information is important to under paragraph (a)(4) of this section, listed in this section must be supported prescribing decisions, the labeling may must be limited in length to an amount by substantial evidence of effectiveness include a reference to the source of the that, if printed in 2 columns on a based on adequate and well-controlled information. standard sized piece of typing paper (8 studies as defined in § 314.126(b) of this * * * * * 1/2 by 11 inches), single spaced, in 8 chapter unless the requirement is I 7. Section 201.100 is amended by point type with 1/2-inch margins on all waived under § 201.58 or § 314.126(c) of revising paragraph (d)(3) to read as sides and between columns, would fit this chapter. Indications or uses must follows: on one-half of the page. not be implied or suggested in other (9) Sections or subsections of labeling sections of labeling if not included in § 201.100 Prescription drugs for human that are identified as containing recent this section. use. major changes under paragraph (a)(5) of (ii) For biological products, all * * * * * this section must be highlighted in the indications listed in this section must be (d) * * *
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(3) The information required, and in (iii) Changes in the labeling, except (f) * * * the format specified, by §§ 201.56, for changes to the information required (1) * * * An applicant cannot use 201.57, and 201.80. in § 201.57(a) of this chapter (which paragraph (f)(2) of this section to make * * * * * must be made pursuant to paragraph any change to the information required (b)(2)(v)(C) of this section), to in § 201.57(a) of this chapter. An PART 314—APPLICATIONS FOR FDA accomplish any of the following: applicant may report the minor changes APPROVAL TO MARKET A NEW DRUG * * * * * to the information specified in (d) * * * paragraph (f)(3)(i)(D) of this section in I 8. The authority citation for 21 CFR (2) * * * an annual report. * * * part 314 continues to read as follows: (x) An editorial or similar minor (2) * * * Authority: 21 U.S.C. 321, 331, 351, 352, change in labeling, including a change (i) An applicant shall submit, at the 353, 355, 355a, 356, 356a, 356b, 356c, 371, to the information allowed by 374, 379e. time such change is made, a supplement paragraphs (b)(2)(v)(C)(1) and (2) of this for any change in the package insert, I 9. Section 314.70 is amended by: section. package label, or container label, except a. Removing from paragraph * * * * * (b)(2)(v)(B) the phrase ‘‘(b)(8)(iv) of this for changes to the package insert required in § 201.57(a) of this chapter chapter.’’ and adding in its place the PART 601—LICENSING phrase ‘‘(b)(8)(iv) of this chapter; and’’; (which must be made pursuant to b. Adding paragraph (b)(2)(v)(C); I 10. The authority cite for 21 CFR part paragraph (f)(1) of this section), to c. Revising the introductory text of 601 continues to read as follows: accomplish any of the following: paragraph (c)(6)(iii); and Authority: 15 U.S.C. 1451–1561; 21 U.S.C. * * * * * d. Revising paragraph (d)(2)(x). 321, 351, 352, 353, 355, 356b, 360, 360c– (f) * * * The additions and revisions read as 360f, 360h–360j, 371, 374, 379e, 381; 42 (3) * * * follows: U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. (i) * * * L. 105–115, 111 Stat. 2322 (21 U.S.C. 355 § 314.70 Supplements and other changes note). (D) A change to the information to an approved application. required in § 201.57(a) of this chapter as I 11. Section 601.12 is amended by: * * * * * a. Adding two sentences after the follows: (b) * * * second sentence and before the third (1) Removal of a listed section(s) (2) * * * sentence in paragraph (f)(1); specified in § 201.57(a)(5) of this (v) * * * b. Revising the introductory text of chapter; and (C) Any change to the information paragraph (f)(2)(i); (2) Changes to the most recent required by § 201.57(a) of this chapter, c. Removing from paragraph revision date of the labeling as specified with the following exceptions that may (f)(3)(i)(B) the word ‘‘and’’; in § 201.57(a)(15) of this chapter. be reported in an annual report under d. Removing from paragraph * * * * * paragraph (d)(2)(x) of this section: (f)(3)(i)(C) the phrase ‘‘Medication Dated: December 7, 2005. (1) Removal of a listed section(s) Guide.’’ and adding in its place the specified in § 201.57(a)(5) of this phrase ‘‘Medication Guide; and’’; and Andrew C. von Eschenbach, chapter; and e. Adding paragraph (f)(3)(i)(D). Acting Commissioner of Food and Drugs. (2) Changes to the most recent The additions and revisions read as Dated: December 7, 2005. revision date of the labeling as specified follows: in § 201.57(a)(15) of this chapter. Michael O. Leavitt, * * * * * § 601.12 Changes to an approved Secretary of Health and Human Services. (c) * * * application. [FR Doc. 06–545 Filed 1–18–06; 10:28 am] (6) * * * * * * * * BILLING CODE 4160–01–C
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DEPARTMENT OF HEALTH AND 1061, Rockville, MD 20852. Submit • The draft guidance entitled HUMAN SERVICES electronic comments to http:// ‘‘Labeling for Human Prescription Drug www.fda.gov/dockets/ecomments. See and Biological Products—Implementing Food and Drug Administration the SUPPLEMENTARY INFORMATION section the New Content and Format [Docket No. 2005D–0011] for electronic access to the draft Requirements’’ provides guidance documents. recommendations on issues to consider Draft Guidances for Industry on the FOR FURTHER INFORMATION CONTACT: when revising labeling for approved Content and Format of Labeling for Janet Norden, Center for Drug products to meet the new requirements, Human Prescription Drug and Evaluation and Research (HFD–40), issues to consider when developing Biological Products; Availability Food and Drug Administration, highlights of prescribing information, 10903 New Hampshire Ave., bldg. how to format labeling, and other AGENCY: Food and Drug Administration, W022, rm. 4202, Silver Spring, MD procedural information. HHS. 20993, 301–796–2270, or • The draft guidance entitled ACTION: Notice. Toni Stifano, Center for Biologics ‘‘Warnings and Precautions, Evaluation and Research (HFM– Contraindications, and Boxed Warning SUMMARY: The Food and Drug 600), Food and Drug Sections of Labeling for Human Administration (FDA) is announcing the Administration, 1401 Rockville Prescription Drug and Biological availability of two draft guidances for Pike, Rockville, MD 20852–1448, Products—Content and Format’’ industry entitled ‘‘Labeling for Human 301–827–6190. provides recommendations on how to Prescription Drug and Biological SUPPLEMENTARY INFORMATION: select, characterize, and organize Products—Implementing the New information for inclusion in the Content and Format Requirements’’ and I. Background ‘‘Warnings and Precautions’’ and ‘‘Warnings and Precautions, In the Federal Register of December ‘‘Contraindications’’ sections, as well as Contraindications, and Boxed Warning 22, 2000 (65 FR 81082), FDA published what information to include in a boxed Sections of Labeling for Human a proposed rule to revise the content warning. Prescription Drug and Biological and format of prescription drug labeling. Elsewhere in this issue of the Federal Products—Content and Format.’’ These The agency’s final rule amending the Register, the agency is announcing the draft guidances are two of a series of requirements for the content and format availability of guidances on the content guidance documents intended to assist of labeling for human prescription drug and format of the ‘‘Clinical Studies’’ and applicants in complying with the new and biological products is published ‘‘Adverse Reactions’’ sections of requirements in the final rule on the elsewhere in this issue of the Federal labeling. These final guidances were content and format of labeling for Register. The new regulations are previously published in draft for prescription drug and biological designed to make information in comment. products published elsewhere in this prescription drug labeling easier for These draft guidances are being issue of the Federal Register. Elsewhere health care practitioners to access, read, issued consistent with FDA’s good in this issue of the Federal Register, the and use; thereby increasing the extent to guidance practices regulation (21 CFR agency is announcing the availability of which practitioners rely on labeling for 10.115). The draft guidances, when two guidances on the content and prescribing decisions. The final rule finalized, will represent the agency’s format of the ‘‘Clinical Studies’’ and requires that labeling of new and current thinking on these topics. They ‘‘Adverse Reactions’’ sections of recently approved products include do not create or confer any rights for or labeling. highlights of prescribing information on any person and do not operate to and a table of contents. It reorders bind FDA or the public. An alternative DATES: Submit written or electronic certain sections of labeling, based on the comments on the draft guidances by approach may be used if such approach importance of the information to April 24, 2006. General comments on satisfies the requirements of the practitioners and the frequency with agency guidance documents are applicable statutes and regulations. which practitioners refer to a section, welcome at any time. and makes minor content changes. III. Comments ADDRESSES: Submit written requests for Interested persons may submit to the single copies of the draft guidances to II. The Draft Guidances Division of Dockets Management (see the Division of Drug Information (HFD– FDA is developing guidance on how ADDRESSES) written or electronic 240), Center for Drug Evaluation and to implement the new requirements as comments on the draft guidances. Research, Food and Drug well as a series of guidances on selected Submit a single copy of electronic Administration, 5600 Fishers Lane, sections of prescription drug labeling. commments or two paper copies of any Rockville, MD 20857, or to the Office of This document announces the mailed comments, except that Communication, Training, and availability of two draft guidances individuals may submit one paper copy. Manufacturers Assistance (HFD–040), entitled ‘‘Labeling for Human Comments should identify clearly Center for Biologics Evaluation and Prescription Drug and Biological which guidance they are commenting Research (CBER), Food and Drug Products—Implementing the New on and should be identified with the Administration, 1401 Rockville Pike, Content and Format Requirements’’ and docket number found in brackets in the Rockville, MD 20852–1448. The draft ‘‘Warnings and Precautions, heading of this document. The draft guidances may also be obtained by Contraindications, and Boxed Warning guidances and received comments are calling CBER at 1–800–835–4709 or Sections of Labeling for Human available for public examination in the 301–827–1800. Send one self-addressed Prescription Drug and Biological Division of Dockets Management adhesive label to assist that office in Products—Content and Format.’’ FDA between 9 a.m. and 4 p.m., Monday processing your requests. Submit developed these draft guidances to through Friday. written comments on the draft accompany the publication of the final guidances to the Division of Dockets rule, published elsewhere in this issue IV. Paperwork Reduction Act of 1995 Management (HFA–305), Food and Drug of the Federal Register, on the content These draft guidances contain Administration, 5630 Fishers Lane, rm. and format of prescription drug labeling. information collection provisions that
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are subject to review by the Office of Research, Food and Drug requirements. This notice announces Management and Budget (OMB) under Administration, 5600 Fishers Lane, the availability of two guidance the Paperwork Reduction Act of 1995 Rockville, MD 20857, or to the Office of documents, entitled ‘‘Clinical Studies (44 U.S.C. 3501–3520). The collection(s) Communication, Training, and Section of Labeling for Human of information in the draft guidances are Manufacturers Assistance (HFM–40), Prescription Drug and Biological estimated in section ‘‘VIII. Paperwork Center for Biologics Evaluation and Products—Content and Format’’ and Reduction Act of 1995’’ of the final rule Research (CBER), Food and Drug ‘‘Adverse Reactions Section of Labeling entitled ‘‘Requirements on Content and Administration, 1401 Rockville Pike, for Human Prescription Drug and Format of Labeling for Human Rockville, MD 20852–1448. The Biological Products—Content and Prescription Drug and Biological guidances may also be obtained by Format.’’ As described later in this Products,’’ published elsewhere in this calling CBER at 1–800–835–4709 or 301 document, these two guidances were issue of the Federal Register. 827–1800. Send one self-addressed previously published for comment. adhesive label to assist that office in The guidances are intended to help V. Electronic Access processing your requests. Submit applicants and reviewers do the Persons with access to the Internet written comments on the guidances to following: (1) Select information for may obtain the document at http:// the Division of Dockets Management inclusion in the ‘‘Adverse Reactions’’ www.fda.gov/cder/guidance/index.htm, (HFA–305), Food and Drug and ‘‘Clinical Studies’’ sections of http://www.fda.gov/cber/ Administration, 5630 Fishers Lane, rm. prescription drug labeling; (2) guidelines.htm, or http://www.fda.gov/ 1061, Rockville, MD 20852. Submit characterize information selected for ohrms/dockets/default.htm. electronic comments to http:// inclusion in these sections; and (3) Dated: September 1, 2005. www.fda.gov/dockets/ecomments. See organize and present the information, the SUPPLEMENTARY INFORMATION section including use of graphs and tables, Jeffrey Shuren, within these sections. Assistant Commissioner for Policy. for electronic access to guidance • documents. The guidance entitled ‘‘Adverse [FR Doc. 06–543 Filed 1–18–06; 10:28 am] Reactions Section of Labeling for BILLING CODE 4160–01–S FOR FURTHER INFORMATION CONTACT: Human Prescription Drug and Biological Janet Norden, Center for Drug Products—Content and Format’’ Evaluation and Research, Food and provides recommendations on the DEPARTMENT OF HEALTH AND Drug Administration, 10903 New ‘‘Adverse Reactions’’ section of labeling. HUMAN SERVICES Hampshire Ave., bldg. WO22, rm. In the Federal Register of June 21, 2000 4202, Silver Spring, MD 20993, (65 FR 38563), FDA published a Food and Drug Administration 301–796–2270, or document announcing the availability of [Docket Nos. 2000D–1306 (formerly 00D– Toni Stifano, Center for Biologics a draft guidance for industry entitled 1306) and 2001D–0269 (formerly 01D–0269)] Evaluation and Research (HFM– ‘‘Content and Format of the Adverse 600), Food and Drug Reactions Section of Labeling for Two Guidances for Industry on the Administration, 1401 Rockville Human Drugs and Biologics.’’ The Content and Format of Labeling for Pike, Rockville, MD 20852–1448, agency received 14 comments from nine Human Prescription Drug and 301–827–6190. pharmaceutical firms, a trade Biological Products; Availability SUPPLEMENTARY INFORMATION: organization, a pharmacy professional society, a health insurance company, a AGENCY: Food and Drug Administration, I. Background HHS. medical publishing company, and a In the Federal Registerof December consumer. In response to these ACTION: Notice. 22, 2000 (65 FR 81082), FDA published comments, the agency made a number SUMMARY: The Food and Drug a proposed rule to revise the content of revisions to the draft guidance. Most Administration (FDA) is announcing the and format of prescription drug labeling. significantly, the final guidance makes availability of two guidances for The agency’s final rule amending the recommendations on how to make the industry entitled ‘‘Clinical Studies requirements for the content and format most clinically important information Section of Labeling for Human of labeling for human prescription drug accessible to health care practitioners. It Prescription Drug and Biological and biological products is published provides recommendations on how to Products—Content and Format’’ and elsewhere in this issue of the Federal characterize and organize information ‘‘Adverse Reactions Section of Labeling Register. The new regulations are and it clarifies the recommended for Human Prescription Drug and designed to make information in criteria for determining when to include Biological Products—Content and prescription drug labeling easier for low frequency adverse events in the Format.’’ These guidances are two of a health care practitioners to access, read, ‘‘Adverse Reactions’’ section. • The guidance entitled ‘‘Clinical series of guidance documents intended and use, thereby increasing the extent to Studies Section of Labeling for Human to assist applicants in complying with which practitioners rely on labeling for Prescription Drug and Biological the new requirements in the final rule prescribing decisions. Among other Products—Content and Format’’ on the content and format of labeling for changes, the final rule makes minor provides recommendations on the human prescription drug and biological content changes and reorders certain ‘‘Clinical Studies’’ section of labeling. In products published elsewhere in this sections of labeling, based on the the Federal Register of July 9, 2001 (66 issue of the Federal Register. importance of the information to practitioners and the frequency with FR 35797), FDA published a document DATES: Submit written or electronic which practitioners refer to a section. announcing the availability of a draft comments on agency guidances at any guidance for industry entitled ‘‘Content time. II. The Guidances and Format of the Clinical Studies ADDRESSES: Submit written requests for FDA is developing a series of Section of Labeling for Human Drugs single copies of these guidances to the guidances on selected sections of and Biologics.’’ The agency received Division of Drug Information (HFD– prescription drug labeling, as well as seven comments from six 240), Center for Drug Evaluation and guidance on how to implement the new pharmaceutical firms and one trade
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organization. In response to these requirements of the applicable statutes Budget (OMB) under the Paperwork comments, the agency has made and regulations. Reduction Act of 1995 (PRA) (44 U.S.C. revisions to the draft guidance. The final III. Comments 3501–3520). The collection(s) of guidance provides several examples of information in the guidances are the types of studies that can be included Interested persons may submit to the estimated in section ‘‘VIII. Paperwork in the ‘‘Clinical Studies’’ section. The Division of Dockets Management (see Reduction Act of 1995’’ of the final rule final guidance also provides ADDRESSES) written or electronic entitled ‘‘Requirements on Content and clarification on when it is appropriate to comments on the guidances. Submit a Format of Labeling for Human include comparative data. single copy of electronic comments or Prescription Drug and Biological two paper copies of any mailed Elsewhere in this issue of the Federal Products,’’ published elsewhere in this comments, except that individuals may Register, the agency is making available issue of the Federal Register. submit one paper copy. Comments for comment draft guidances on should identify clearly which guidance V. Electronic Access implementing the content and format they are commenting on and should be requirements and on the ‘‘Warnings and identified with the docket number Persons with access to the Internet Precautions,’’ ‘‘Contraindications,’’ and found in brackets in the heading of this may obtain the document at http:// ‘‘Boxed Warning’’ sections of labeling. document. The guidances and received www.fda.gov/cder/guidance/index.htm, These guidances are being issued comments are available for public http://www.fda.gov/cber/ consistent with FDA’s good guidance examination in the Division of Dockets guidelines.htm, or http://www.fda.gov/ practices regulation (21 CFR 10.115). Management between 9 a.m. and 4 p.m., ohrms/dockets/default.htm. They represent the agency’s current Monday through Friday. Dated: September 1, 2005. thinking on this topic. They do not confer any rights for or on any person IV. Paperwork Reduction Act of 1995 Jeffrey Shuren, and do not operate to bind FDA or the These guidances contain information Assistant Commissioner for Policy. public. An alternative approach may be collection provisions that are subject to [FR Doc. 06–544 Filed 1–18–06; 10:29 am] used if such approach satisfies the review by the Office of Management and BILLING CODE 4160–01–S
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Part III
Department of the Treasury Internal Revenue Service
26 CFR Parts 1, 301, and 602 Reporting for Widely Held Fixed Investment Trusts; Final Rule
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DEPARTMENT OF THE TREASURY Books or records relating to a fixed investment trust (WHFIT). (See collection of information must be section IA below.) Internal Revenue Service retained as long as their contents might In general, the final regulations retain become material in the administration the structure of the Reproposed 26 CFR Parts 1, 301, and 602 of any internal revenue law. Generally, Regulations. Paragraph (c) of the [TD 9241] tax returns and tax return information reproposed and final regulations are confidential, as required by 26 RIN 1545–BA83 provides general reporting requirements U.S.C. 6103. for trustees to provide information to Reporting for Widely Held Fixed Background requesting persons, which include: (1) Investment Trusts Middlemen, (2) beneficial owners who This document contains amendments are brokers, (3) exempt recipients who AGENCY: Internal Revenue Service (IRS), to 26 CFR parts 1, 301 and 602. On June hold their trust interests directly (and Treasury. 20, 2002, the Internal Revenue Service not through a middleman), (4) ACTION: Final regulations. (IRS) and the Treasury Department noncalendar-year beneficial owners who withdrew proposed regulations (REG– hold their trust interests directly, and SUMMARY: This document contains final 209813–96) relating to the reporting (5) a representative or agent of any of regulations that define widely held requirements for widely held fixed the above. Paragraphs (d) and (e) of the fixed investment trusts, clarify the investment trusts (WHFITs) previously reproposed and final regulations reporting obligations of the trustees and published in the Federal Register (63 describe the responsibility of trustees the middlemen connected with these FR 43354) on August 13, 1998 (1998 and middlemen for information trusts, and provide for communication Proposed Regulations) and published a reporting to the IRS and beneficial of tax information to beneficial owners new notice of proposed rulemaking owners. Paragraphs (f) and (g) of the of trust interests. The regulations will (REG–106871–00) in the Federal reproposed and final regulations affect trustees of, and middlemen Register (67 FR 41892) on June 20, 2002 provide reporting safe harbors. holding interests on behalf of beneficial (Reproposed Regulations). No public owners of trust interests with respect to, hearing was requested or held with Explanation of Revisions to Reproposed widely held fixed investment trusts. respect to the Reproposed Regulations. Regulations and Summary of DATES: Effective Date: These regulations Comments responding to the Comments are effective January 24, 2006. Reproposed Regulations were received. I. Definitions Applicability Date: For dates of After consideration of the comments, applicability of these regulations, see the Reproposed Regulations, with A. Definition of a Widely Held Fixed § 1.671–5(m). certain revisions, are adopted as final Investment Trust and Classification as a FOR FURTHER INFORMATION CONTACT: regulations by this Treasury decision. Widely Held Mortgage Trust or a Non- Faith Colson, (202) 622–3060 (not a toll- Section 301.7701–4(c) of the Mortgage Widely Held Fixed Investment free number). Procedure and Administration Trust Regulations provides grantor trust SUPPLEMENTARY INFORMATION: The Reproposed Regulations define a treatment to an investment trust with a WHFIT as an arrangement classified as Paperwork Reduction Act single class of ownership interests, a trust under § 301.7701–4(c) in which representing undivided beneficial The collection of information at least one interest is held by a interests in the assets of the trust, if contained in these final regulations has middleman, provided that the trust is there is no power to vary the investment been previously reviewed and approved classified as a United States person of the owners (a fixed investment trust). by the Office of Management and under section 7701(a)(30)(E). The final An investment trust with multiple Budget in accordance with the regulations retain this definition. Paperwork Reduction Act (44 U.S.C. classes of ownership interests, in which 3507) under control number 1545–1540. there is no power to vary the investment The Reproposed Regulations Response to this collection of of the owners will also be treated as a introduced the term widely held information is mandatory. grantor trust, if the trust is formed to mortgage trust (WHMT) to describe a An agency may not conduct or facilitate direct investment in the assets WHFIT, the assets of which are sponsor, and a person is not required to of the trust and the existence of multiple mortgages, amounts received on respond to, a collection of information classes is incidental to that purpose. mortgages, and reasonably required unless it displays a valid control Beneficial owners of trust interests are reserve funds, as measured by value. number assigned by the Office of treated as grantors. See § 301.7701–4(c); The final regulations expand the Management and Budget. see also Rev. Rul. 84–10, (1984–1 C.B. definition of a WHMT, to provide that The estimated annual burden per 155); Rev. Rul. 61–175, (1961–2 C.B. a WHFIT is also a WHMT if recordkeeper varies from 1 to 4 hours, 128). substantially all its assets also include depending on individual circumstances, Trustees of fixed investment trusts trust interests in one or more WHMTs with an estimated average of 2 hours. frequently do not know the identities of and regular interests in one or more real Comments concerning the accuracy of the beneficial owners of the trust estate mortgage investment conduits this burden estimate and suggestions for interests and are unable to communicate (REMICs). reducing this burden should be sent to tax information directly to them because The final regulations also introduce a the Internal Revenue Service, Attn: IRS trust interests often are held in street new term, non-mortgage widely held Reports Clearance Officer, name, i.e., in the name of a middleman. fixed investment trust (NMWHFIT), to SE:W:CAR:MP:T:T:SP, Washington DC The reproposed and final regulations clarify and distinguish the requirements 20224, and to the Office of Management provide rules that specifically require and reporting safe-harbor for WHMTs and Budget, Attn: Desk Officer for the the sharing of tax information among from the requirements and reporting Department of Treasury, Office of trustees, middlemen, and beneficial safe harbor applicable to other WHFITS. Information and Regulatory Affairs, owners of fixed investment trusts that A NMWHFIT is any WHFIT that is not Washington, DC 20503. meet the definition of a widely held a WHMT.
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B. Definition of a Mortgage individual item or to a group of items requesting persons throughout the The Reproposed Regulations provide depending on whether the item must be calendar year at the trustee’s discretion. a reporting safe harbor for WHMTs that reported individually under § 1.671– For example, if a trustee uses a monthly directly hold interests in mortgages; the 5(c)(1)(i) and (e)(1). calculation period, the trustee must safe harbor is not available to tiered provide a single statement to requesting E. Definition of Start-Up Date persons at the end of the year that arrangements. The IRS and the Treasury The Reproposed Regulations define contains the information required to be Department, after considering the the start-up date of a WHFIT as the date reported under these regulations for comments received with respect to the on which substantially all of the assets each month of the calendar year. In Reproposed Regulations, have and the contracts for the purchase of addition to the calendar year statement, determined that the definition of a assets are deposited with the trustee of the trustee may, but is not required to, mortgage should be clarified in the final the WHFIT. The Reproposed provide additional statements to regulations to provide that an interest in Regulations also define an asset to requesting persons during the calendar a WHMT is not a mortgage under the include an interest in a contract. year. regulations. Accordingly, the final Because the definition of an asset To further clarify that a trustee may regulations define a mortgage as an includes an interest in a contract, the choose the period for calculating the obligation that is principally secured by definition of the start-up date in the information required to be reported an interest in real property within the Reproposed Regulations is revised in under these regulations, but in all meaning of § 1.860G–2(a)(5) of the the final regulations to provide that the events must report that information to Income Tax Regulations, except that a start-up date is the date on which requesting persons on a calendar year mortgage does not include an interest in substantially all of the assets are basis, the final regulations refer to the another WHMT or an interest in a deposited with the trustee. period chosen by the trustee for mortgage held by another WHMT. The calculating trust information as the principal effect of this change is to II. General Reporting and Record calculation period rather than the clarify that, although a WHFIT investing Retention Obligations reporting period. in another WHMT is classified as a A. Requirement That the Trustee WHMT and is subject to the general B. Trustee’s Burden To Retain Provide Trust Information on a reporting provisions that apply only to Information and Supplemental Data Calendar Year Basis WHMTs, it is not eligible for the WHMT The Reproposed Regulations provide safe harbor reporting rules for the In general, the reproposed and final that, throughout the duration of the trust reasons discussed in section VI(B) regulations require the trustee to and for a period of five years following below. provide information regarding the the termination of the trust, a trustee WHFIT to requesting persons. The must retain: (1) A copy of the C. Definition of Trust Interest Holders, Reproposed Regulations provide that information required to be provided to Beneficial Owners and Middleman the trustee could choose either a requesting persons each year; and (2) Under the Reproposed Regulations, a calendar month, calendar quarter, or any supplemental data necessary to unit interest holder is defined as any half or full calendar year reporting establish that the information provided person who holds a direct or indirect period, provided that the information to requesting persons is correct and interest in a WHFIT at any time during furnished by the trustee under the meets the requirements of paragraph (c) the calendar year. The final regulations chosen reporting period allowed the (supplemental data). replace the term unit interest holder recipient to determine the WHFIT items One commentator noted that some with two new terms: Trust interest attributable to a particular beneficial WHFITs, particularly WHMTs, may be holder (TIH) and beneficial owner. A owner with reasonable accuracy, in existence for up to 30 years and that TIH is any person who holds a direct or regardless of the owner’s taxable year or the requirement in the Reproposed indirect interest in a WHFIT at any time the period of time during the calendar Regulations for a trustee to maintain the during the calendar year. A beneficial year that the owner held the unit WHFIT’s records for up to 35 years is owner is a TIH who holds a beneficial interest. overly burdensome. The commentator interest in a WHFIT. As in the One commentator was concerned that acknowledged that the IRS and Reproposed Regulations, in the final if a trustee choose a reporting period investors may need to obtain WHFIT regulations, the term middleman refers shorter than a full calendar year, the information from the trustee before the to a TIH that holds a trust interest on trustee might also report trust limitations period applicable to a behalf of, or for the account of, another information to middlemen more than beneficial owner’s taxable year expires person, or who otherwise acts in a once a year and because of this, and suggested that the final regulations capacity as an intermediary for the middlemen would be required to provide that a trustee only be required account of another person. process WHFIT information more than to retain information for a certain period once a year. Another commentator was after the close of the calendar year to D. Definition of Item concerned that, if a trustee chose a which the information relates. The Reproposed Regulations use the reporting period shorter than a calendar The IRS and the Treasury Department term item without defining that term. year, the trustee could be required to adopt this suggestion with respect to Item as used in the final regulations report trust information more than once supplemental data. However, refers broadly to an item of income, a year. information with respect to each expense, or credit as well as any trust In response to these comments, the calendar year of the WHFIT may be event (for example, the sale of an asset) final regulations provide that, regardless required by the IRS and by beneficial or any characteristic or attribute of the of the period chosen by the trustee for owners in order to determine tax items above that affects the income, calculating trust information, the trustee of a beneficial owner (for example, deductions, or credits reported by a must provide the information required market discount or basis) for the entire beneficial owner in any taxable year that under these regulations on a calendar life of the WHFIT and for several years the beneficial owner holds a trust year basis. The trustee, of course, may after its termination. For this reason, the interest. Item also may refer to an provide additional trust information to final regulations continue to require the
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trustee to retain a copy of the trustee calculates and provides identifying investment trusts as WHFITs information required to be provided to information on the basis of a trust and in locating the WHFIT’s requesting persons for the duration of interest with respect to that trust item representatives. the WHFIT and for at least five years under paragraph (c) of the regulations. In response to these comments, the after its termination. The IRS and the D. Elimination of Separate General final regulations require a trustee to Treasury Department believe that this Reporting Rules for WHMTs identify the WHFIT as either a WHMT requirement is not overly burdensome The Reproposed Regulations include or a NMWHFIT when identifying the because this information can be trust representative. Further, the IRS maintained electronically. The final separate reporting requirements for trustees and middlemen of WHMTs and and the Treasury Department are regulations modify the requirement with studying whether a directory or list of respect to supplemental data by trustees and middlemen of WHFITs other than WHMTs (i.e., non-mortgage WHFITs can be compiled by the IRS. providing that trustees need only retain The IRS and Treasury Department are supplemental data for five years after widely-held fixed investment trusts or NMWHFITs as defined in these final concerned that such a directory is not the close of the calendar year to which currently feasible because of the large the supplemental data relates. regulations), with respect to market discount, bond premium, and principal number of WHMTs. However, the IRS C. Manner in Which WHFIT Information payments. The final regulations include and Treasury request additional Is To Be Provided general reporting requirements with comments from middlemen regarding The Reproposed Regulations provide respect to market discount, bond the type of WHFITs that should be that WHFIT information may be premium, and non pro-rata partial included in any directory, the type of provided in any manner that enables a principal payment information that information needed by middlemen requesting person to determine, with apply to all WHFITs. As under the (especially, middlemen holding WHMT reasonable accuracy, the WHFIT items Reproposed Regulations, the final interests), and the format of a directory that are attributable to a beneficial regulations require WHMTs to provide that would be most helpful. The IRS and owner for the taxable year of that market discount, bond premium, and Treasury Department also request beneficial owner. The Reproposed non pro-rata partial principal payment comments from trustees regarding how Regulations further require that this information regardless of whether the the IRS could obtain the trust information be furnished in a format WHMT meets one of the de minimis information needed for the directory that generally conforms to industry tests described in section III of the from the trustees in the least practice for the reporting of a particular Preamble. Under the final regulations, burdensome manner for taxpayers as item of income, deduction, or credit for however, NMWHFITs that meet the well as the Government. the type of asset or assets held by the general de minimis test or the qualified III. Reporting of Asset Sales and WHFIT. NMWHFIT exception (also described in Dispositions One commentator suggested that, if section III of the Preamble) are not the trustee is not providing trust required to provide information A. General Information Reporting information under a safe harbor, regarding bond premium and market Requirements information could be shared more discount. accurately and processed more Under the Reproposed Regulations, efficiently if trustees were required to E. Requirement That a Trustee Identify the trustee is required to provide calculate and provide trust information a Representative of the WHFIT and information that would enable a on the basis of trust interests. The IRS Identify the WHMT or as a NMWHFIT requesting person to calculate the and the Treasury Department do not The Reproposed Regulations require a amount of trust sales proceeds agree that calculating and providing trustee of a WHFIT to provide the name, attributable to a beneficial owner with trust information on a per trust interest address and telephone number of the respect to each sale or disposition of an basis is always the best method for WHFIT representative in a publication asset by the trust. In addition, consistent conveying information with respect to widely available to middlemen, in the with grantor trust treatment, unless a trust items that are not reported under trust’s prospectus, or at the trustee’s WHFIT meets the ‘‘de minimis test,’’ the safe harbors. The requirement that Internet website. The final regulations (discussed in III(B) of this Preamble), the trustee provide information retain this requirement. Further, if the the trustee is required under the consistent with industry practice is trustee provides trust information at an Reproposed Regulations to provide intended to ensure that trustees provide Internet website, the final regulations information that would enable a WHFIT information in a format that can also require trustees, in addition to beneficial owner to allocate with be processed by the systems used by the providing information regarding the reasonable accuracy a portion of its majority of middlemen. Accordingly, WHFIT representative, to provide the basis in its trust interest and to allocate the final regulations do not adopt the address of the Internet website at which a portion of its market discount or bond suggestion. the trustee provides WHFIT premium, if any, to each sale or One commentator also suggested that information. disposition of an asset by the trust. The middlemen be permitted to furnish Two commentators were concerned final regulations retain these general beneficial owners with information that middlemen would not be able to information reporting requirements for calculated on a trust interest basis rather identify a client’s investment as an asset sales and dispositions. Although than the amount of the item that is investment in a WHFIT and suggested the requirements to provide market attributable to the beneficial owner. The that the IRS publish a directory or list discount and bond premium final regulations permit a middleman or of WHFITs that would include the name information (discussed in section II(D) a trustee to furnish information and CUSIP number of each WHFIT, of this Preamble), are the same as those calculated on a trust interest basis to a along with the name, address and in the Reproposed Regulations, in the beneficial owner with respect to a trust telephone number of the WHFIT’s final regulations, for purposes of clarity, item, if: (1) The amount of the item is representative. Commentators noted that these requirements are provided not required to be provided to the IRS a publicly available directory or list separately from the requirement to on an information return; and (2) the would assist middlemen and brokers in provide information with respect to
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sales and dispositions of assets by the C. Extension of Simplified Reporting to NMWHFIT meets either the general trust. NMWHFITs That Meet the Qualified WHFIT de minimis test for the calendar The final regulations retain the NMWHFIT Exception year, or the qualified NMWHFIT exception from the general information Several commentators requested that exception, the final regulations require: reporting requirements for WHFITs that the final regulations except WHFITs (1) Trustees to report information that meet the general de minimis test. In having a start-up date prior to the date will enable middlemen to determine the addition, the final regulations provide of publication of these final regulations amount of trust sales proceeds an exception for WHMTs that meet a from the requirement to report basis, distributed to each beneficial owner special de minimis test for WHMTs that market discount, and bond premium during the calendar year; and (2) directly hold interests in mortgages (the information with respect to sales and middlemen and trustees to report to the WHMT de minimis test is discussed in dispositions. These commentators also IRS and to each beneficial owner the section III(E) of this Preamble). The final requested that trustees and middlemen amount of trust sales proceeds that are regulations also provide an exception be permitted to report information distributed to that beneficial owner. regarding distributed trust sales from the general information reporting E. Simplified Reporting for WHMTs requirements for NMWHFITs that meet proceeds rather than attributable trust That Meet the General de minimis Test the qualified NMWHFIT exception, sales proceeds. or the Special WHMT de minimis Test which is applicable only to NMWHFITs To accommodate the industry’s concerns regarding existing with a start up date that is on or before In addition to the general WHFIT de February 23, 2006. NMWHFITs, the final regulations add an exception for qualified NMWHFITs minimis test, the final regulations also B. Simplified Reporting for WHFITs (the qualified NMWHFIT exception). provide a special WHMT de minimis That Meet the General WHFIT de The qualified NMWHFIT exception is test that applies to WHMTs that directly minimis Test met if a NMWHFIT has a start-up date hold interests in mortgages (the special that is on or before February 23, 2006 WHMT de minimis test). The special For WHFITs that meet a de minimis and the calendar year for which the WHMT de minimis test is met if the test, the Reproposed Regulations trustee is reporting begins before trust sales proceeds received by the substantially simplified reporting with January 1, 2011. NMWHFITs that meet WHMT for the calendar year are not respect to the sale or disposition of a the qualified NMWHFIT exception are more than five percent of the aggregate trust asset from that required under the excepted from the requirement that outstanding principal balance of the 1998 Proposed Regulations. These trustees and middlemen provide WHMT (as defined in paragraph simplified rules balanced current information regarding basis, market (g)(1)(iii)(D) of the final regulations) as industry practice with the need for discount, and bond premium. of January 1 of that year. In applying the beneficial owners to accurately report special WHMT de minimis test, the tax consequences of ownership of a D. Distributed Trust Sales Proceeds May Be Reported by Trustees and Middlemen amounts that result from the complete trust interest. Under the Reproposed or partial payment of the outstanding Regulations, the WHFIT de minimis test of Trusts Meeting the General de minimis Test or the Qualified principal balance of the mortgages held is satisfied for the calendar year if the NMWHFIT Exception by the WHMT are not included in the aggregate amount of trust sales proceeds amount of trust sales proceeds. A for that calendar year is not more than Several commentators noted that the WHMT that holds interests in another requirement in the Reproposed five percent of the fair market value of WHMT or that holds interests in a Regulations that trustees of WHFITs the assets of the trust as of January 1 of REMIC may not use the special WHMT other than WHMTs (NMWHFITs in that year (the general WHFIT de de minimis test, but may use the general minimis test). The Reproposed these final regulations) report information to enable a requesting WHFIT de minimis test (discussed in Regulations define trust sales proceeds section III(B), above). as the gross proceeds received by the person to determine the amount of trust WHFIT with respect to a sale or sales proceeds attributable to a If a WHMT meets the special WHMT disposition of an asset by the WHFIT. beneficial owner would impose an de minimis test or the general WHFIT undue burden. These commentators de minimis test, trustees and Under the Reproposed Regulations, if noted that, under current industry middlemen are excepted from the the trust meets the general WHFIT de practice, trustees and middlemen of general requirement to report minimis test, the trustee is excepted WHFITs other than WHMTs only report information to enable a beneficial owner from the requirement to report to the IRS and the beneficial owner the to allocate basis to a sale or disposition information regarding basis, market amount of trust sales proceeds and are only required to report discount and bond premium. The IRS distributed to the beneficial owner. and Treasury Department recognize that information regarding the trust sales The IRS and Treasury Department proceeds that are attributable to a this method of reporting will likely have determined that if a NMWHFIT result in some deferral of both gain and particular beneficial owner. If a WHMT meets either the general WHFIT de does not meet a de miminis test, trustees loss for investors, but have determined minimis test for the calendar year or the and middlemen must report information that, in cases where the WHFIT has de qualified NMWHFIT exception, the to enable a beneficial owner to allocate minimis sales and dispositions, the purpose of reporting trust sales proceeds basis to the sale or disposition as well level of deferral is acceptable given the information to beneficial owners (e.g., to costs of fully accurate reporting of sales enable beneficial owners to adjust their as the trust sales proceeds that are and dispositions. The final regulations basis in their trust interest to account for attributable to the beneficial owner. retain this exception from the general the sale or disposition of the trust asset) requirement to provide basis, market is met if the beneficial owner is given discount and bond premium information regarding the amount of information for WHFITs that meet the trust sales proceeds distributed to the general de minimis test. beneficial owner. Accordingly, if a
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IV. Exception for Certain Equity Trusts middlemen provide information to safe harbor requirements on or before From the Requirement That Trustees determine the trust income that should January 1, 2007 and does so for the life and Middlemen Report Information To be attributed to a redeeming, selling, or of the WHFIT. Enable a Requesting Person To purchasing beneficial owner. Under the Reproposed Regulations Determine the Income That Is The IRS and the Treasury Department and the final regulations, a WHMT must Attributable to a Redeeming or Selling recognize, however, that if an equity meet the eligibility requirements of Beneficial Owner Up to the Date of trust frequently distributes its income, § 1.671–5(g)(1)(ii) and report Redemption or Sale the trust is not likely to accumulate consistently with the safe harbor The Reproposed Regulations require significant undistributed dividend reporting rules to be deemed to have trustees and middlemen to report income. In such a case, the increased met its reporting requirements under paragraph (c) of the regulations with information to enable requesting accuracy that results from providing respect to the trust items described in persons to determine the income of the beneficial owners with accurate income the safe harbor. The final regulations WHFIT attributable to a selling, information up to the date of sale or eliminate two of the eligibility purchasing, or redeeming beneficial redemption does not warrant the burden requirements in the Reproposed owner for the portion of the calendar of compiling and reporting this Regulations that are inconsistent with year that the beneficial owner held its information. Accordingly, under the the rule that the safe harbor must be trust interest. Commentators objected to final regulations, trustees or middlemen used for the life of the WHMT. this requirement for WHFITs if of equity trusts that are required by their substantially all the income of the governing documents to distribute all B. Request for Comments Regarding the WHFIT is comprised of dividends cash (less reasonably required reserve Need for Safe Harbors for NMWHFITs (equity trusts). These commentators funds) held by the NMWHFIT at least That Are Outside the Safe Harbor in the noted that although trustees and monthly need not provide information Final Regulations regarding the income that is attributable middlemen report interest income The Reproposed Regulations include earned by the WHFIT up to the date of to a redeeming, selling, or purchasing beneficial owner up to the date of sale safe harbor reporting rules available to redemption or sale of a trust interest, WHFITs other than WHMTs (i.e., providing this information with respect or redemption. The final regulations also except trustees and middlemen of NMWHFITs). If the trustee of a WHFIT to dividend income is inconsistent with other than a WHMT reports consistently long-standing WHFIT industry reporting an equity trust that meets the qualified NMWHFIT exception (described in with the safe harbor, the trustee is practice. Currently there is no deemed to have met the requirements of section III of this Preamble) from the mechanism in place for communicating paragraph (c)(1) of the Reproposed requirement that trustees and this information between trustees and Regulations. Those safe harbor reporting middlemen provide information middlemen of equity trusts. Under rules were developed in response to regarding the income that is attributable current industry practice, the entire comments received on the 1998 to a redeeming, selling, or purchasing amount paid to a beneficial owner who Proposed Regulations describing the beneficial owner up to the date of sale sells or redeems an interest in an equity current reporting practices of WHFITs or redemption. trust, including the amount paid for that primarily receive dividend and undistributed dividends held by the V. Safe Harbor Reporting for WHFITs interest income. trust at the time of the sale or Upon reconsideration of those safe redemption, is reported to the IRS and A. The Safe Harbors Must Be Used harbor reporting rules and the various to the beneficial owner as gross Consistently types of NMWHFITs, the IRS and the proceeds. As a result, a selling or Under the Reproposed Regulations, a Treasury Department recognize that the redeeming beneficial owner may report trustee of a WHFIT can decide whether type of information reported under the ordinary dividend income portion of or not to use the safe harbor reporting those reporting rules is only relevant to the payment as a capital gain. The practices on a year-by-year basis. The NMWHFITs that hold stock and debt purchasing beneficial owner also IRS and the Treasury Department have instruments and that information receives incorrect income information concluded, however, that middlemen reported under the safe harbor probably that may lead the purchasing beneficial and beneficial owners should receive would not be useful to middlemen and owner to overstate its dividend income. WHFIT information that is calculated beneficial owners of NMWHFITs that Commentators objected to expending consistently from one calendar year to hold other types of assets. As a result, resources for the development and the next because, assuming beneficial the IRS and Treasury concluded that testing of new tax reporting systems to owners report trust items consistent safe harbor treatment should only be accurately report dividend income to with the WHFIT information provided available to NMWHFITs for which the selling, purchasing, and redeeming to them, a trustee’s change in reporting safe harbors were designed (e.g., beneficial owners, especially with could result in changes in the timing NMWHFITs that hold stock and debt respect to existing equity trusts. that may impact beneficial owners. instruments) and that other safe harbor Commentators acknowledge, Further, allowing trustees to report reporting rules should govern however, that the net asset value of an under the safe harbor one year and not NMWHFITs that are outside the safe equity trust, including the cash held for the next, likely would confuse and harbor. Accordingly, in the final distribution, generally is calculated on a burden the middlemen and beneficial regulations only NMWHFITs daily basis. Because in the final owners that must process WHFIT substantially all the income of which is regulations, the cash held for information. Accordingly, the final comprised of dividends (as defined in distribution is a key component in regulations require trustees that choose section 6042(b) and the regulations calculating the amount of income to use the safe harbor to report under thereunder) or interest (as defined in attributable to a selling, purchasing, or the safe harbor for the life of the WHFIT. section 6049(b) and the regulations redeeming beneficial owner under the WHFITs that have a start-up date prior thereunder) that report as provided in safe harbor for NMWHFITs, the final to January 1, 2007 may choose to report the NMWHFIT safe harbor will be regulations retain the general under the safe harbor provided the deemed to have met the requirements of requirement that trustees and trustee begins to report according to the paragraph (c)(1) of the final regulations.
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The IRS and the Treasury Department treated for federal income tax purposes mortgages held by the WHMT as of the are considering providing additional as having a proportionate share of beginning of the month. The safe harbor reporting rules for equitable ownership in each of the Reproposed Regulations require trustees NMWHFITs that are not under the mortgages of the WHMT. If a taxpayer to utilize a method that takes into NMWHFIT safe harbor in the final owns mortgages outright and not in account the prepayment assumption regulations and encourage trustees and trust, the taxpayer does not report used in pricing the original issue of trust middlemen to submit comments mortgage sales proceeds or the complete interests. The Reproposed Regulations regarding NMWHFITs for which further prepayment of a mortgage in the same also include a WHMT safe harbor reporting safe harbors should be manner as the receipt of a non pro-rata provision for OID information that provided, including information partial principal payment. That is, a required the use of the same regarding current industry reporting taxpayer that owns two mortgages does prepayment assumption. practice for NMWHFITs that do not not combine the sale of one mortgage Commentators reported that they qualify for the NMWHIFIT safe harbor with the receipt of non pro-rata partial assumed that the Reproposed in the final regulations. principal payments from the other Regulations permit trustees to use the mortgage for purposes of calculating the safe harbor for reporting only sales and C. Safe Harbor Reporting for WHMTs taxpayer’s federal income tax liability. dispositions and the receipt of principal 1. Reporting Sales and Dispositions For this reason and the reasons payments and to ignore other trust Under the WHMT Safe Harbor discussed in section V(B)(3) of this items, such as market discount and OID, Preamble, the IRS and Treasury when reporting under the safe harbor. The 1998 Proposed Regulations did Department do not adopt the The WHMT safe harbor in the final not allow trustees and middlemen to commentators’ request. regulations permits trustees and aggregate sales and dispositions of trust middlemen of WHMTs that meet the assets, even fungible trust assets, for 2. Requirement That Trustees Use a requirements of § 1.671–5(g)(1)(ii), to reporting purposes. In response to Prepayment Assumption When aggregate the trust sales proceeds comments on the 1998 Proposed Providing Market Discount and OID received from sales and dispositions of Regulations, as well as the addition of Information Under the WHMT Safe some mortgages with non pro-rata section 1272(a)(6)(C)(iii) to the Code in Harbor partial principal payments on other 1997, the Reproposed Regulations The Reproposed Regulations require mortgages, but the safe harbor also permit aggregate reporting for sales and trustees and middlemen of all WHMTs requires trustees and middlemen to dispositions and principal receipts for to report information to enable report market discount and OID WHMTs eligible to report under the beneficial owners to calculate market information consistent with section WHMT safe harbor. Under the WHMT discount in any reasonable manner that 1272(a)(6). Safe harbor treatment is safe harbor, a trustee is permitted to is consistent with section 1276(a)(3). available to WHMTs that meet the combine, for reporting purposes, Regulations have not been issued under requirements of § 1.671–5(g)(1)(ii) amounts received as trust sales proceeds the market discount provisions of the because the IRS and the Treasury from the sale or disposition of some Code (sections 1276 to 1278). The Department have determined that, for mortgages (including principal receipts preamble to the Reproposed Regulations those WHMTs, if market discount and that completely retire a mortgage) with notes that, in the absence of regulations OID are reported as provided in the safe non pro-rata partial principal payments governing accrual of market discount, harbor, mortgage-by-mortgage reporting from other mortgages. Thus, the safe guidance regarding the accrual of with respect to sales and dispositions harbor permits trustees and middlemen market discount with respect to the and principal payments is unnecessary. to report trust information as if the partial payment of a debt instrument is Accordingly, the final regulations clarify WHMT, in effect, held only one provided in the conference report (see that, for a trustee to be deemed to have mortgage, and to report the aggregate of H.R. Rep. No. 841, 99th Cong., 2nd met the requirements of paragraph (c)(1) trust sales proceeds and non pro-rata Sess., at II–842 (1986)) accompanying of the regulations, the trustee must partial principal payments as though the the amendment that enacted section report all items identified in the WHMT trustee had received a non pro-rata 1276(a)(3) (see section 1803(a)(13)(A) of safe harbor consistent with the WHMT partial principal payment on that the Tax Reform Act of 1986, Public Law safe harbor. mortgage. 99–514, 100 Stat. 2085) (the Conference 3. Reporting for WHMTs That Are The WHMT safe harbor in the Report). Consistent with Congressional Outside the Safe Harbor Reproposed Regulations is only intent expressed in the Conference available to WHMTs that met the Report indicating that holders must Some commentators may view the requirements of § 1.671–5(g)(1)(ii) of report market discount in the absence of Conference Report as providing those regulations. Commentators regulations, the Reproposed Regulations authority to report market discount requested that the final regulations impose a general requirement that information using a single composite provide that trustees of all WHMTs, not trustees and middlemen of WHMTs fraction, regardless of whether the just those meeting the eligibility report market discount information. trustee is permitted to, and does in fact, requirements of § 1.671–5(g)(1)(ii), be The WHMT safe harbor provision for report under the WHMT safe harbor. allowed to apply this treatment for reporting market discount information The IRS and the Treasury Department reporting purposes. The commentators in the Reproposed Regulations is based disagree with the commentators’ reading suggested that reporting sales and on the Conference Report. Under that of the Conference Report as applied to dispositions separately from principal safe harbor, trustees report market WHMTs. The Conference Report simply payments is unnecessary because discount by providing one market provides that, until such time as the receipt by the trust of trust sales discount fraction for the WHMT that is Treasury Department issues regulations proceeds and receipt of principal the ratio of, either: (1) The OID accrued regarding the computation of the accrual payments have identical tax during the month to the total remaining of market discount, holders may elect to consequences for a beneficial owner. OID as of the beginning of the month; accrue market discount using either a Under Rev. Rul. 84–10 (1984–1 C.B. or (2) the interest paid during the month constant interest method or a market 155), a beneficial owner of a WHMT is to the remaining interest payable on the discount fraction.
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The Conference Report may implicitly Regulations or the final regulations. Regarding the applicability of these discuss aggregate reporting in that it Nothing in the Reproposed Regulations reporting rules to existing WHFITs, one states that, in the case of debt or these final regulations alters the commentator requested that the final instruments that would be subject to the application of section 6048 to United regulations except all WHFITs in OID rules contained in section States investors in a foreign fixed existence as of the effective date of the 1272(a)(6) (without regard to whether investment trust. The preamble to the final regulations from the new reporting the debt instruments have OID), the Reproposed Regulations notes that the rules. Other commentators requested same prepayment assumption that IRS and the Treasury Department that WHFITs in existence as of the would be made in computing OID continue to study how to facilitate the effective date of the final regulations be would be made in computing the application of section 6048 rules to excepted from specific provisions. The accrual of market discount (whether or foreign fixed investment trusts and final regulations apply to all WHFITs, not the taxpayer elects to accrue market requested comments on this issue, including those in existence as of the discount on the basis of a constant including how forms 3520 and 3520A effective date. However, in response to interest rate). Section 1272(a)(6)(C)(iii) could be adapted for use with foreign the comments, the final regulations provides that section 1272(a)(6) applies fixed investment trusts. except certain NMWHFITs that have a to any pool of debt instruments, the Commentators suggested that many start-up date on or before February 23, yield on which may be affected by beneficial owners of interests in a 2006 from specific reporting reason of prepayments. However, no foreign fixed investment trust cannot requirements regarding market discount, guidance has been issued regarding the comply with the reporting requirements bond premium, sales and dispositions, application of section 1272(a)(6)(C)(iii). of section 6048 because they cannot redemptions, and sales of trust interests Until guidance is issued under section obtain the necessary information from until January 1, 2011. The details of 1272(a)(6)(C)(iii), the IRS and Treasury the trustee. These commentators these exceptions have been discussed in Department believe that it is appropriate suggested that, rather than adapting sections IID, III, and IV of this preamble. to provide safe harbor treatment only for Forms 3520 and 3520A to foreign fixed Special Analysis trustees of relatively straight forward investment trusts, the IRS and the It has been determined that this arrangements who report information Treasury Department should permit consistent with the application of Treasury decision is not a significant certain foreign fixed investment trusts to regulatory action as defined in section 1272(a)(6) as provided by the report pursuant to the reporting rules in safe harbor reporting rules. Executive Order 12866. Therefore, a these regulations. The commentators regulatory assessment is not required. It 4. Reporting Bond Premium Under the also suggested that the final regulations is hereby certified that these regulations WHMT Safe Harbor provide that, if a foreign fixed will not have a significant economic The Reproposed Regulations include investment trust reports pursuant to impact on a substantial number of small a general requirement that trustees and these reporting rules, United States entities. This certification is based on middlemen of all WHMTs report investors in the trust be excepted from the fact that the regulations generally information to enable beneficial owners the reporting rules in section 6048. The clarify existing reporting obligations and to determine the amount of amortizable IRS and the Treasury Department intend are expected, for the most part, to have bond premium, if any, in any manner to provide guidance in the area of minimal impact on industry practice, that is reasonably consistent with foreign trust reporting and will consider and to not have a significant economic section 171. The Reproposed whether any of the suggested impact on entities subject to the Regulations reserve the portion of the approaches for WHFITs are more regulations. Further, the reporting WHMT safe harbor on reporting appropriate in this context. burdens in these regulations will fall information regarding bond premium. VII. Effective Date of Final Regulations primarily on large brokerage firms, large None of the comments on the and Applicability to Existing WHFITs banks, and other large entities acting as Reproposed Regulations specifically trustees or middlemen, most of which addressed bond premium issues. The Reproposed Regulations provide are not small entities within the Accordingly, the final regulations that the reporting rules were to be meaning of the Regulatory Flexibility continue to reserve guidance on the applicable beginning January 1, 2004. Act (5 U.S.C. chapter 6). Thus, a issue while the IRS and the Treasury Most commentators requested that the substantial number of small entities are Department study how bond premium applicability date be delayed until not expected to be affected. Therefore, a information is to be appropriately January 1, 2005, to enable trustees and Regulatory Flexibility Analysis under reported for WHMTs. The IRS and the middlemen to change their reporting the Regulatory Flexibility Act (5 U.S.C. Treasury Department welcome systems to comply with the new chapter 6) is not required. Pursuant to comments on this issue. Until safe reporting rules. To ensure that there is section 7805(f) of the Code, the harbor reporting rules are provided for sufficient time to comply with the proposed and the Reproposed bond premium, a trustee will not be reporting requirements, the final Regulations preceding these regulations penalized if the trustee reports regulations provide that these were submitted to the Chief Counsel for information that enables a beneficial regulations are effective January 1, 2007. Advocacy of the Small Business owner to determine, in any manner Accordingly, beginning with the 2007 Administration for comment on their reasonably consistent with section 171, calendar year, trustees must report trust impact on small business. the amount of the beneficial owner’s information in accordance with Drafting Information amortizable bond premium, if any, for paragraph (c) of the final regulations. the calendar year. Trustees and middlemen must file The principal author of these Forms 1099 with the IRS and furnish tax regulations is Faith Colson of the Office VI. Application of Reporting Rules to information statements to beneficial of Associate Chief Counsel Foreign Fixed Investment Trusts owners that meet the requirements of (Passthroughs and Special Industries). A fixed investment trust that is not paragraphs (d) and (e) of the final However, other personnel from the IRS classified as a United States person is regulations with respect to the 2007 and the Treasury Department not a WHFIT under the Reproposed calendar year and all subsequent years. participated in their development.
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List of Subjects (iv) Gross income requirement. (vi) Reporting the sale of a trust interest (2) Information to be reported by all WHFITs. under the safe harbor. 26 CFR Part 1 (i) Trust identification and calculation period (vii) Reporting OID information under the Income taxes, Reporting and chosen. safe harbor. recordkeeping requirements. (ii) Items of income, expense, and credit. (viii) Reporting market discount information (iii) Non pro-rata partial principal payments. under the safe harbor. 26 CFR Part 301 (iv) Asset sales and dispositions. (ix) Reporting bond premium information (v) Redemptions and sales of WHFIT under the safe harbor. Employment taxes, Estate taxes, interests. (x) Reporting additional information. Excise taxes, Gift taxes, Income taxes, (vi) Information regarding bond premium. (2) Use of information provided by trustees Penalties, Reporting and recordkeeping (vii) Information regarding market discount. under the safe harbor for NMWHFITs. requirements. (viii) Other information. (i) In general. (3) Identifying the representative who will (ii) Determining NMWHFIT income and 26 CFR Part 602 provide trust information. expenses under the safe harbor. Reporting and recordkeeping (4) Time and manner of providing (iii) Reporting non pro-rata partial principal requirements. information. payments under the safe harbor. (i) Time. (iv) Reporting sales and dispositions of Adoption of the Amendments to the (ii) Manner. NMWHFIT assets under the safe harbor. Regulations (iii) Inclusion of information with respect to (v) Reporting redemptions under the safe all calculation periods. harbor. I Accordingly, 26 CFR parts 1, 301, and (5) Requesting information from a WHFIT. (vi) Reporting sales of trust interests under 602 are amended as follows: (i) In general. the safe harbor. (ii) Manner of requesting information. (vii) Reporting OID information under the PART 1—INCOME TAXES (iii) Period of time during which a requesting safe harbor. person may request WHFIT information. (viii) Reporting market discount information I Paragraph 1. The authority citation (6) Trustee’s requirement to retain records. under the safe harbor. for part 1 continues to read, in part, as (d) Form 1099 requirement for trustees and (ix) Reporting bond premium information follows: middlemen. under the safe harbor. Authority: 26 U.S.C. 7805 * * * (1) Obligation to file Form 1099 with the IRS. (3) Example of the use of the safe harbor for (i) In general. NMWHFITs. I Par. 2. Section 1.671–4 is amended by (ii) Forms 1099 not required for exempt (i) Facts. revising paragraph (a) to read as follows: recipients. (ii) Trustee reporting. (iii) Reporting and withholding with respect (iii) Brokers’ use of information provided by § 1.671–4 Method of reporting. to foreign persons. Trustee. (a) Portion of trust treated as owned (2) Information to be reported. (g) Safe Harbor for certain WHMTs. by the grantor or another person. Except (i) Determining amounts to be provided on (1) Safe harbor for trustees of certain WHMTs as otherwise provided in paragraph (b) Forms 1099. for reporting information. (ii) Information to be provided on Forms (i) In general. of this section and § 1.671–5, items of 1099. (ii) Requirements. income, deduction, and credit (3) Time and manner of filing Forms 1099. (iii) Reporting WHMT income, expenses, non attributable to any portion of a trust (i) Time and place. pro-rata partial principal payments, and that, under the provisions of subpart E (ii) Reporting trust sales proceeds, sales and dispositions under the safe (section 671 and following), part I, redemption asset proceeds, redemption harbor. subchapter J, chapter 1 of the Internal proceeds, sales asset proceeds, sales (iv) Reporting OID information under the safe Revenue Code, is treated as owned by proceeds, and non pro-rata partial harbor. the grantor or another person, are not principal payments. (v) Reporting market discount information reported by the trust on Form 1041, (e) Requirement to furnish a written tax under the safe harbor. information statement to the TIH. (vi) Reporting bond premium information ‘‘U.S. Income Tax Return for Estates and (1) In general. under the safe harbor. Trusts,’’ but are shown on a separate (2) Information required. (2) Use of information provided by a trustee statement to be attached to that form. (i) WHFIT information. under the safe harbor. Section 1.671–5 provides special (ii) Identification of the person furnishing the (i) In general. reporting rules for widely held fixed statement. (ii) Reporting WHMT income, expenses, non investment trusts. Section 301.7701– (iii) Items of income, expense, and credit. pro-rata partial principal payments, and 4(e)(2) of this chapter provides guidance (iv) Non pro-rata partial principal payments. sales and dispositions under the safe regarding the application of the (v) Asset sales and dispositions. harbor. reporting rules in this paragraph (a) to (vi) Redemption or sale of a trust interest. (iii) Reporting OID information under the (vii) Information regarding market discount safe harbor. an environmental remediation trust. and bond premium. (iv) Requirement to provide market discount * * * * * (viii) Other information. information under the safe harbor. I Par. 3. Section 1.671–5 is added to (ix) Required statement. (v) Requirement to provide bond premium read as follows: (3) Due date and other requirements. information under the safe harbor. (4) Requirement to retain records. (3) Example of safe harbor in paragraph (g)(1) § 1.671–5 Reporting for widely held fixed (f) Safe harbor for providing information for of this section. investment trusts. certain NMWHFITs. (i) Facts. (a) Table of contents. This table of (1) Safe harbor for trustee reporting of (ii) Trustee reporting. contents lists the major paragraph NMWHFIT information. (iii) Broker’s use of the information provided (i) In general. by Trustee. headings for this section. (ii) Reporting NMWHFIT income and (h) Requirement that middlemen furnish (a) Table of contents. expenses. information to beneficial owners that are (b) Definitions. (iii) Reporting non pro-rata partial principal exempt recipients and non calendar year (c) Trustee’s obligation to report information. payments under the safe harbor. beneficial owners. (1) In general. (iv) Reporting sales and dispositions of (1) In general. (i) Calculation. NMWHFIT assets under the safe harbor. (2) Time for providing information. (ii) Calculation period. (v) Reporting redemptions under the safe (3) Manner of providing information. (iii) Accounting method. harbor. (4) Clearing organization.
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(i) Reserved. group of items depending on whether (iv) A noncalendar-year beneficial (j) Coordination with other information the item must be reported separately owner who holds a trust interest reporting rules. under paragraphs (c)(1)(i) and (e)(1) of directly and not through a middleman; (k) Backup withholding requirements. this section. or (l) Penalties for failure to comply. (10) A middleman is any TIH, other (v) A representative or agent of a (m) Effective date. than a qualified intermediary as defined person specified in this paragraph (b) Definitions. Solely for purposes of in § 1.1031(k)–1(g), who, at any time (b)(16). this section: during the calendar year, holds an (17) The sales asset proceeds equal (1) An asset includes any real or interest in a WHFIT on behalf of, or for the sales proceeds (as defined in personal, tangible or intangible property the account of, another TIH, or who paragraph (b)(18) of this section) less the held by the trust, including an interest otherwise acts in a capacity as an cash held for distribution with respect in a contract. intermediary for the account of another to the sold trust interest at the time of (2) An affected expense is an expense person. A middleman includes, but is the sale. described in § 1.67–2T(i)(1). not limited to— (18) The sales proceeds equal the total (3) A beneficial owner is a trust (i) A custodian of a person’s account, amount paid to a selling TIH in interest holder (TIH) (as defined in such as a bank, financial institution, or consideration for the sale of a trust paragraph (b)(20) of this section) that brokerage firm acting as custodian of an interest. holds a beneficial interest in a widely account; (19) The start-up date is the date on held fixed investment trust (WHFIT) (as (ii) A nominee; which substantially all of the assets defined in paragraph (b)(22) of this (iii) A joint owner of an account or have been deposited with the trustee of section.) instrument other than— the WHFIT. (4) The calculation period is the (A) A joint owner who is the spouse (20) A trust interest holder (TIH) is period the trustee chooses under of the other owner; and any person who holds a direct or paragraph (c)(1)(ii) of this section for (B) A joint owner who is the indirect interest, including a beneficial calculating the trust information beneficial owner and whose name interest, in a WHFIT at any time during required to be provided under appears on the Form 1099 filed with the calendar year. paragraph (c) of this section. respect to the trust interest under (21) Trust sales proceeds equal the (5) The cash held for distribution is paragraph (d) of this section; and amount paid to a WHFIT for the sale or the amount of cash (other than trust (iv) A broker (as defined in section disposition of an asset held by the sales proceeds) that would be payable to 6045(c)(1) and § 1.6045–1(a)(1)), holding WHFIT, including principal payments TIHs if the amount of a distribution an interest for a customer in street received by the WHFIT that completely were required to be determined as of the name. retire a debt instrument (other than a date in question. (11) A mortgage is an obligation that final scheduled principal payment) and (6) A clean-up call is the redemption is principally secured by an interest in pro-rata partial principal prepayments of all trust interests in termination of the real property within the meaning of described under § 1.1275–2(f)(2). Trust WHFIT when the administrative costs of § 1.860G–2(a)(5), except that a mortgage sales proceeds do not include amounts the WHFIT outweigh the benefits of does not include an interest in another paid for any interest income that would maintaining the WHFIT. WHFIT or mortgages held by another be required to be reported under (7) An exempt recipient is— WHFIT. § 1.6045–(d)(3). (i) Any person described in § 1.6049– (12) A non-mortgage widely held fixed (22) A widely held fixed investment 4(c)(1)(ii); investment trust (NMWHFIT) is a trust (WHFIT) is an arrangement classified as a trust under § 301.7701– (ii) A middleman (as defined in WHFIT other than a widely held 4(c) of this chapter, provided that— paragraph (b)(10) of this section); mortgage trust (as defined in paragraph (i) The trust is a United States person (iii) A real estate mortgage investment (b)(23) of this section). conduit (as defined in section 860(D)(a)) under section 7701(a)(30)(E); (13) A non pro-rata partial principal (ii) The beneficial owners of the trust (REMIC); payment is any partial payment of (iv) A WHFIT; or are treated as owners under subpart E, principal received on a debt instrument part I, subchapter J, chapter 1 of the (v) A trust or an estate for which the which does not retire the debt trustee or middleman of the WHFIT is Internal Revenue Code; and instrument and which is not a pro-rata (iii) At least one interest in the trust also required to file a Form 1041, ‘‘U.S. prepayment described in § 1.1275– Income Tax Return for Estates and is held by a middleman. 2(f)(2). (23) A widely held mortgage trust Trusts,’’ in its capacity as a fiduciary of (14) The redemption asset proceeds (WHMT) is a WHFIT, the assets of that trust or estate. equal the redemption proceeds (as which consist only of one or more of the (8) An in-kind redemption is a defined in paragraph (b)(15) of this following— redemption in which a beneficial owner section) less the cash held for (i) Mortgages; receives a pro-rata share of each of the distribution with respect to the (ii) Regular interests in a REMIC; assets of the WHFIT that the beneficial redeemed trust interest. (iii) Interests in another WHMT; owner is deemed to own under section (15) The redemption proceeds equal (iv) Reasonably required reserve 671. the total amount paid to a redeeming funds; (9) An item refers to an item of TIH as the result of a redemption of a (v) Amounts received on the assets income, expense, or credit as well as trust interest. described in paragraphs (b)(23)(i), (ii), any trust event (for example, the sale of (16) A requesting person is— (iii), and (iv) of this section pending an asset) or any characteristic or (i) A middleman; distribution to TIHs; and attribute of the trust that affects the (ii) A beneficial owner who is a (vi) During a brief initial funding income, deductions, and credits broker; period, cash and short-term contracts for reported by a beneficial owner in any (iii) A beneficial owner who is an the purchase of the assets described in taxable year that the beneficial owner exempt recipient who holds a trust paragraphs (b)(23)(i), (ii), and (iii). holds an interest in the trust. An item interest directly and not through a (c) Trustee’s obligation to report may refer to an individual item or a middleman; information—(1) In general. Upon the
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request of a requesting person (as trust’s sponsor knows or reasonably completely retires a debt instrument defined in paragraph (b)(16) of this should know that a WHFIT is marketed (including a mortgage held by a WHMT) section), a trustee of a WHFIT must primarily to accrual method TIHs and or a pro-rata prepayment on a debt report the information described in the WHFIT holds assets for which the instrument (see § 1.1275–2(f)(2)) held by paragraph (c)(2) of this section to the timing of the recognition of income is a WHFIT must be reported as a full or requesting person. The trustee must materially affected by the use of the partial sale or disposition of the debt determine such information in accrual method of accounting, the instrument. accordance with the following rules— trustee must calculate and report trust (A) General rule. Except as provided (i) Calculation. WHFIT information information using the accrual method of in paragraph (c)(2)(iv)(B) (regarding the may be calculated in any manner that accounting. exception for certain NMWHFITs) or enables a requesting person to (iv) Gross income requirement. The (c)(2)(iv)(C) (regarding the exception for determine with reasonable accuracy the amount of income required to be certain WHMTs) of this section, the WHFIT items described in paragraph reported by the trustee is the gross trustee must report with respect to each (c)(2) of this section that are attributable income (as defined in section 61) sale or disposition of a WHFIT asset— (or, if permitted under paragraphs generated by the WHFIT’s assets. Thus, (1) The date of each sale or (c)(2)(iv)(B) or (f)(2)(iii) of this section, in the case of a WHFIT that receives a disposition; distributed) to a beneficial owner for the payment of income from which an (2) Information that enables a taxable year of that owner. The manner expense (or expenses) has been requesting person to determine the of calculation must generally conform deducted, the trustee, in calculating the amount of trust sales proceeds (as with industry practice for calculating income to be reported under paragraph defined in paragraph (b)(21) of this the WHFIT items described in (c)(2)(ii) of this section, must report the section) attributable to a beneficial paragraph (c)(2) of this section for the income earned on the trusts assets owner as a result of each sale or type of asset or assets held by the unreduced by the deducted expense or disposition; and (3) Information that enables a WHFIT, and must enable a requesting expenses and separately report the beneficial owner to allocate, with person to separately state any WHFIT deducted expense or expenses. See reasonable accuracy, a portion of the item that, if taken into account paragraph (c)(2)(iv) of this section owner’s basis in its trust interest to each separately by a beneficial owner, would regarding reporting with respect to sales result in an income tax liability different sale or disposition. and dispositions. (B) Exception for certain NMWHFITs. from that which would result if the (2) Information to be reported by all If a NMWHFIT meets either the general owner did not take the item into WHFITs. With respect to all WHFITs— WHFIT de minimis test of paragraph account separately. (i) Trust identification and (c)(2)(iv)(D)(1) of this section for a (ii) Calculation period—WHFIT calculation period chosen. The trustee calendar year, or the qualified information may be calculated on the must report information identifying the NMWHFIT exception of paragraph basis of a calendar month, calendar WHFIT, including— quarter, or half or full calendar year, (A) The name of the WHFIT; (c)(2)(iv)(E) of this section, the trustee is provided that a trustee uses the same (B)The employer identification not required to report under paragraph calculation period for the life of the number of the WHFIT; (c)(2)(iv)(A) of this section. Instead, the WHFIT and the information provided by (C) The name and address of the trustee must report sufficient the trustee meets the requirements of trustee; information to enable a requesting paragraph (c)(1)(i) of this section. (D) The Committee on Uniform person to determine the amount of trust Regardless of the calculation period Security Identification Procedure sales proceeds distributed to a beneficial chosen by the trustee, the trustee must (CUSIP) number, account number, serial owner during the calendar year with provide information requested by a number, or other identifying number of respect to each sale or disposition of a requesting person under paragraph the WHFIT; trust asset. The trustee also must (c)(5) on a calendar year basis. The (E) The classification of the WHFIT as provide requesting persons with a trustee may provide additional either a WHMT or NMWHFIT; and statement that the NMWHFIT is information to requesting persons (F) The calculation period used by the permitted to report under this paragraph throughout the calendar year at the trustee. (c)(2)(iv)(B). trustee’s discretion. (ii) Items of income, expense, and (C) Exception for certain WHMTs. If a (iii) Accounting method—(A) General credit. The trustee must report WHMT meets either of the de minimis rule. WHFIT information must be information detailing— tests of paragraph (c)(2)(iv)(D) of this calculated and reported using the cash (A) All items of gross income section for the calendar year, the trustee receipts and disbursements method of (including OID); is not required to report under accounting unless another method is (B) All items of expense (including paragraph (c)(2)(iv)(A) of this section. required by the Internal Revenue Code affected expenses); and Instead, the trustee must report or regulations with respect to a specific (C) All items of credit. information to enable a requesting trust item. Accordingly, a trustee must (iii) Non pro-rata partial principal person to determine the amount of trust provide information necessary for TIHs payments. The trustee must report sales proceeds attributable to a to comply with the rules of subtitle A, information detailing non pro-rata beneficial owner as a result of the sale chapter 1, subchapter P, part V, subpart partial principal payments (as defined or disposition. The trustee also must A of the Internal Revenue Code, which in paragraph (b)(13) of this section) provide requesting persons with a require the inclusion of accrued received by the WHFIT. statement that the WHMT is permitted amounts with respect to OID, and (iv) Asset sales and dispositions. The to report under this paragraph section 860B(b), which requires the trustee must report information (c)(2)(iv)(C). inclusion of accrued amounts with regarding sales and dispositions of (D) De minimis tests—(1) General respect to a REMIC regular interest. WHFIT assets as required in this WHFIT de minimis test. The general (B) Exception for WHFITs marketed paragraph (c)(2)(iv). For purposes of this WHFIT de minimis test applies to a predominantly to taxpayers on the paragraph (c)(2)(iv), a payment (other NMWHFIT or to a WHMT that does not accrual method. If the trustee or the than a final scheduled payment) that meet the requirements for the special
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WHMT de minimis test in paragraph (2) In-kind redemptions. The value of WHFIT de minimis test of paragraph (c)(2)(iv)(D)(2) of this section. The the assets received with respect to an in- (c)(2)(iv)(D)(1) of this section or the general WHFIT de minimis test is kind redemption (as defined in qualified NMWHFIT exception of satisfied if trust sales proceeds for the paragraph (b)(8) of this section) is not paragraph (c)(2)(iv)(E) of this section, calendar year are not more than five required to be reported under this the trustee of such NMWHFIT is not percent of the aggregate fair market paragraph (c)(2)(v)(A). Information required to report information regarding value of all assets held by the trust as regarding the income attributable to a bond premium. of the later of January 1st of that year or redeeming beneficial owner must, (vii) Information regarding market the trust’s start-up date (as defined in however, be reported under paragraph discount. The trustee generally must paragraph (b)(19) of this section). (c)(2)(v)(A)(1)(iii) of this section. report information that enables a (2) Special WHMT de minimis test. A (B) Sale of a trust interest—Unless beneficial owner to determine, in any WHMT that meets the asset requirement paragraph (c)(2)(v)(C) (regarding certain manner reasonably consistent with of paragraph (g)(1)(ii)(D) of this section NMWHFITs with dividend income) of section 1276 (including section satisfies the special WHMT de minimis this section applies, if a secondary 1276(a)(3)), the amount of the market test in this paragraph (c)(2)(iv)(D)(2) if market for trust interests in the WHFIT discount that has accrued during the trust sales proceeds for the calendar is established, the trustee must provide, calendar year. However, if for the year are not more than five percent of for each day of the calendar year, calendar year, a NMWHFIT meets either the aggregate outstanding principal information to enable a requesting the general WHFIT de minimis test of balance of the WHMT (as defined in person to determine— paragraph (c)(2)(iv)(D)(1) of this section paragraph (g)(1)(iii)(D) of this section) as (1) The sale asset proceeds (as defined or the qualified NMWHFIT exception of of the later of January 1st of that year or in paragraph (b)(17) of this section) per paragraph (c)(2)(iv)(E) of this section, the trust’s start-up date. For purposes of trust interest on that date; and the trustee of such NMWHFIT is not (2) The gross income that is applying the special WHMT de minimis required to provide information attributable to a selling beneficial owner test in this paragraph (c)(2)(iv)(D)(2), regarding market discount. and to a purchasing beneficial owner for amounts that result from the complete (viii) Other information. The trustee the portion of the calendar year that or partial payment of the outstanding must provide any other information each held the trust interest. necessary for a beneficial owner of a principal balance of the mortgages held (C) Exception for certain NMWHFITs by the trust are not included in the trust interest to report, with reasonable with dividend income. The trustee of a accuracy, the items (as defined in amount of trust sales proceeds. NMWHFIT to which this paragraph (3) Effect of clean-up call. If a WHFIT paragraph (b)(9) of this section) applies is not required to report the attributable to the portion of the trust fails to meet either de minimis test information described in paragraph described in this paragraph (c)(2)(iv)(D) treated as owned by the beneficial (c)(2)(v)(A) (regarding redemptions) or owner under section 671. solely as the result of a clean-up call, as (c)(2)(v)(B) (regarding sales) of this defined in paragraph (b)(6) of this (3) Identifying the representative who section. However, the trustee must will provide trust information. The section, the WHFIT will be treated as report to requesting persons, for each having met the de minimis test. trustee must identify a representative of date on which the amount of the WHFIT who will provide the (E) Qualified NMWHFIT exception. redemption proceeds to be paid for the The qualified NMWHFIT exception is information specified in this paragraph redemption of a trust interest is (c). The trustee also may identify an satisfied if a NMWHFIT has a start-up determined, information that will date that is before February 23, 2006 Internet website at which the trustee enable requesting persons to determine will provide the information specified and the calendar year for which the the redemption proceeds per trust trustee is reporting begins before in this paragraph (c). This information interest on that date. The trustee also must be— January 1, 2011. must provide requesting persons with a (v) Redemptions and sales of WHFIT (i) Printed in a publication generally statement that this paragraph applies to read by, and available to, requesting interests—(A) Redemptions—(1) In the NMWHFIT. This paragraph applies general. Unless paragraph (c)(2)(v)(C) of persons; to a NMWHFIT if substantially all the (ii) Stated in the trust’s prospectus; or this section (regarding certain income of the NMWHFIT consists of (iii) Posted at the trustee’s Internet NMWHFITs with dividend income) dividends (as defined in section 6042(b) website. applies, for each date on which the and the regulations thereunder) and— (4) Time and manner of providing amount of redemption proceeds for the (1) The trustee is required by the information—(i) Time—(A) In general. redemption of a trust interest is governing document of the NMWHFIT Except as provided in paragraph determined, the trustee must provide to make distributions of all cash (less (c)(4)(i)(B) of this section, a trustee must information to enable a requesting reasonably required reserve funds) held provide the information specified in this person to determine— by the NMWHFIT no less frequently paragraph (c) to requesting persons on (i) The redemption proceeds (as than monthly; or or before the later of— defined in paragraph (b)(15) of this (2) The qualified NMWHFIT (1) The 30th day after the close of the section) per trust interest on that date; exception of paragraph (c)(2)(iv)(E) of calendar year to which the request (ii) The redemption asset proceeds (as this section is satisfied. relates; or defined in paragraph (b)(14) of this (vi) Information regarding bond (2) The day that is 14 days after the section) per trust interest on that date; premium. The trustee generally must receipt of the request. and report information that enables a (B) Trusts holding interests in other (iii) The gross income that is beneficial owner to determine, in any WHFITs or in REMICs. If the WHFIT attributable to the redeeming beneficial manner that is reasonably consistent holds an interest in one or more other owner for the portion of the calendar with section 171, the amount of the WHFITs or holds one or more REMIC year that the redeeming beneficial beneficial owner’s amortizable bond regular interests, or holds both, a trustee owner held its interest (including premium, if any, for each calendar year. must provide the information specified income earned by the WHFIT after the However, if for the calendar year, a in this paragraph (c) to requesting date of the last income distribution). NMWHFIT meets either the general persons on or before the later of—
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(1) The 44th day after the close of the may be necessary to establish that the or middleman on the appropriate Form calendar year to which the request information provided to requesting 1099 must be consistent with the relates; or persons is correct and meets the information provided by the trustee (2) The day that is 28 days after the requirements of this paragraph (c). under paragraph (c) of this section and receipt of the request. (d) Form 1099 requirement for must reflect with reasonable accuracy (ii) Manner. The information specified trustees and middlemen—(1) Obligation the amount of each item required to be in this paragraph (c) must be provided— to file Form 1099 with the IRS—(i) In reported on a Form 1099 that is (A) By written statement sent by first general. Except as provided in attributable (or if permitted under class mail to the address provided by paragraphs (d)(1)(ii) and (iii) of this paragraphs (d)(2)(ii)(D) and (E) of this the requesting person; section— section, distributed) to the TIH. If the (B) By causing it to be printed in a (A) The trustee must file with the IRS trustee, in providing WHFIT publication generally read by and the appropriate Forms 1099, reporting information, uses the safe harbors in available to requesting persons and by the information specified in paragraph paragraph (f)(1) or (g)(1) of this section, notifying requesting persons in writing (d)(2) of this section with respect to any then the trustee or middleman must of the publication in which it will TIH who holds an interest in the WHFIT calculate the information to be provided appear, the date on which it will appear, directly and not through a middleman; to the IRS on the Forms 1099 in and, if possible, the page on which it and accordance with paragraph (f)(2) or will appear; (B) Every middleman must file with (g)(2) of this section, as appropriate. (C) By causing it to be posted at an the IRS the appropriate Forms 1099, (ii) Information to be provided on Internet website, provided the trustee reporting the information specified in Forms 1099. The trustee or middleman identifies the website under paragraph paragraph (d)(2) of this section with must include on the appropriate Forms (c)(3) of this section; respect to any TIH on whose behalf or 1099: (D) By electronic mail provided that account the middleman holds an (A) Taxpayer information. The name, the requesting person requests that the interest in the WHFIT or acts as an address, and taxpayer identification trustee furnish the information by intermediary. number of the TIH; electronic mail and the person furnishes (ii) Forms 1099 not required for (B) Information regarding the person an electronic address; or exempt recipients—(A) In general. A (E) By any other method agreed to by Form 1099 is not required with respect filing the Form 1099. The name, the trustee and the requesting person. to a TIH who is an exempt recipient (as address, taxpayer identification number, (iii) Inclusion of information with defined in paragraph (b)(7) of this and telephone number of the person respect to all calculation periods. If a section), unless the trustee or required to file the Form 1099; trustee calculates WHFIT information middleman backup withholds under (C) Gross income. All items of gross using a calculation period other than a section 3406 on payments made to an income of the WHFIT attributable to the calendar year, the trustee must provide exempt recipient (because, for example, TIH for the calendar year (including OID information for each calculation period the exempt recipient has failed to and all amounts of income attributable that falls within the calendar year furnish a Form W–9 on request). If the to a selling, purchasing, or redeeming requested. trustee or middleman backup TIH for the portion of the calendar year (5) Requesting information from a withholds, then the trustee or that the TIH held its interest (unless WHFIT—(i) In general. Requesting middleman is required to file a Form paragraph (c)(2)(v)(C) of this section persons may request the information 1099 under this paragraph (d) unless the (regarding certain NMWHFITs with specified in this paragraph (c) from a trustee or middleman refunds the dividend income) applies)); WHFIT. amount withheld in accordance with (D) Non pro-rata partial principal (ii) Manner of requesting information. § 31.6413(a)–3 of this chapter. payments. All non pro-rata partial In requesting WHFIT information, a (B) Exempt recipients must include principal payments (as defined in requesting person must specify the WHFIT information in computing paragraph (b)(13) of this section) WHFIT and the calendar year for which taxable income. A beneficial owner who received by the WHFIT that are information is requested. is an exempt recipient must obtain attributable (or distributed, in the case (iii) Period of time during which a WHFIT information and must include of a trustee or middleman reporting requesting person may request WHFIT the items (as defined in paragraph (b)(9) under paragraph (f)(2)(iii) of this information. For the life of the WHFIT of this section) of the WHFIT in section) to the TIH; and for five years following the date of computing its taxable income on its (E) Trust sales proceeds. All trust the WHFIT’s termination, a requesting federal income tax return. Paragraphs sales proceeds (as defined in paragraph person may request the information (c)(3) and (h) of this section provide (b)(21) of this section) that are specified in this paragraph (c) for any rules for exempt recipients to obtain attributable to the TIH for the calendar calendar year of the WHFIT’s existence information from a WHFIT. year, if any, or, if paragraph (c)(2)(iv)(B) beginning with the 2007 calendar year. (iii) Reporting and withholding with of this section (regarding certain (6) Trustee’s requirement to retain respect to foreign persons. The items of NMWHFITs) applies, the amount of records. For the life of the WHFIT and the WHFIT attributable to a TIH who is trust sales proceeds distributed to the for five years following the date of not a United States person must be TIH for the calendar year; termination of the WHFIT, the trustee reported, and amounts must be (F) Reporting redemptions. All must maintain in its records a copy of withheld, as provided under subtitle A, redemption asset proceeds (as defined the information required to be provided chapter 3 of the Internal Revenue Code in paragraph (b)(14) of this section) paid to requesting persons this paragraph (c) (sections 1441 through 1464) and the to the TIH for the calendar year, if any, for each calendar year beginning with regulations thereunder and not reported or, if paragraph (c)(2)(v)(C) of this the 2007 calendar year. For a period of under this paragraph (d). section (regarding certain NMWHFITs five years following the close of the (2) Information to be reported—(i) with dividend income) applies, all calendar year to which the data Determining amounts to be provided on redemption proceeds (as defined in pertains, the trustee also must maintain Forms 1099. The amounts reported to paragraph (b)(15) of this section) paid to in its records such supplemental data as the IRS for a calendar year by a trustee the TIH for the calendar year;
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(G) Reporting sales of a trust interest trust item reported to a TIH under this (3) Information that will enable the on a secondary market. All sales asset paragraph (e) must be consistent with TIH to allocate with reasonable accuracy proceeds (as defined in paragraph the information reported to the IRS with a portion of the TIH’s basis in the TIH’s (b)(17) of this section) paid to a TIH for respect to the TIH under paragraph (d) trust interest to the sale or disposition. the sale of a trust interest or interests on of this section. Information provided in (B) Special rule for certain a secondary market established for the this written statement must be NMWHFITs and WHMTs. In the case of WHFIT for the calendar year, if any, or, determined in accordance with the rules a NMWHFIT to which paragraph if paragraph (c)(2)(v)(C) of this section provided in paragraph (d)(2)(i) of this (c)(2)(iv)(B) of this section applies or in (regarding certain NMWHFITs with section (regardless of whether the the case of a WHMT to which paragraph dividend income) applies, all sales information was required to be provided (c)(2)(iv)(C) of this section applies, the proceeds (as defined in paragraph on a Form 1099). Further, the trustee or written tax information statement must (b)(18) of this section) paid to the TIH middleman must separately state on the include, with respect to asset sales and for the calendar year; and written tax information statement any dispositions, only the information (H) Other information. Any other items that, if taken into account required to be reported to the IRS on information required by the Form 1099. separately by that TIH, would result in Form 1099 under paragraph (d)(2)((ii)(E) (3) Time and manner of filing Forms an income tax liability that is different of this section. 1099—(i) Time and place. The Forms from the income tax liability that would (vi) Redemption or sale of a trust 1099 required to be filed under this result if the items were not taken into interest. The written tax information paragraph (d) must be filed on or before account separately. statement must include the information February 28 (March 31, if filed (2) Information required. For the required to be reported to the IRS on electronically) of the year following the calendar year, the written tax Forms 1099 under paragraphs year for which the Forms 1099 are being information statement must meet the (d)(2)(ii)(F) and (G) of this section filed. The returns must be filed with the following requirements: (regarding the sales and redemptions of appropriate Internal Revenue Service (i) WHFIT information. The written trust interests made by the TIH for the Center, at the address listed in the tax information statement must include calendar year); instructions for the Forms 1099. For the name of the WHFIT and the (vii) Information regarding market extensions of time for filing returns identifying number of the WHFIT ; discount and bond premium. The under this section, see § 1.6081–1, the (ii) Identification of the person written tax information statement must instructions for the Forms 1099, and furnishing the statement. The written include the information required to be applicable revenue procedures (see tax information statement must include reported by the trustee under § 601.601(d)(2) of this chapter). For the name, address, and taxpayer paragraphs (c)(2)(vi) and (vii) of this magnetic media filing requirements, see identification number of the person section (regarding bond premium and § 301.6011–2 of this chapter. required to furnish the statement; market discount); (ii) Reporting trust sales proceeds, (iii) Items of income, expense, and (viii) Other information. The written redemption asset proceeds, redemption credit. The written tax information tax information statement must include proceeds, sale asset proceeds, sales statement must include information any other information necessary for the proceeds and non pro-rata partial regarding the items of income (that is, TIH to report, with reasonable accuracy principal payments—(A) Form to be the information required to be reported for the calendar year, the items (as used. Trust sales proceeds, redemption to the IRS on Forms 1099), expense defined in paragraph (b)(9) of this asset proceeds, redemption proceeds, (including affected expenses), and credit section) attributable to the portion of the sale asset proceeds, sales proceeds, and that are attributable to the TIH for the trust treated as owned by the TIH under non pro-rata partial principal payments calendar year; section 671. The written tax information are to be reported on the same type of (iv) Non pro-rata partial principal statement may include information with Form 1099 as that required for reporting payments. The written tax information respect to a trust item on a per trust gross proceeds under section 6045. statement must include the information interest basis if the trustee has reported (B) Appropriate reporting for in-kind required to be reported to the IRS on (or calculated) the information with redemptions. The value of the assets Forms 1099 under paragraph respect to that item on a per trust distributed with respect to an in-kind (d)(2)(ii)(D) of this section (regarding the interest basis and information with redemption is not required to be non pro-rata partial principal payments respect to that item is not required to be reported to the IRS. Unless paragraph that are attributable (or distributed, in reported on a Form 1099; and (c)(2)(v)(C) of this section applies, the the case of a trustee or middleman (ix) Required statement. The written trustee or middleman must report the reporting under paragraph (f)(2)(iii) of tax information statement must inform gross income attributable to the this section) to the TIH for the calendar the TIH that the items of income, redeemed trust interest for the calendar year). deduction, and credit, and any other year up to the date of the redemption (v) Asset sales and dispositions—(A) information shown on the statement under paragraph (d)(2)(ii)(C) of this General rule. Unless paragraph must be taken into account in section. (c)(2)(iv)(B) (regarding the exception for computing the taxable income and (e) Requirement to furnish a written certain NMWHFITs) or (c)(2)(iv)(C) credits of the TIH on the Federal income tax information statement to the TIH— (regarding the exception for certain tax return of the TIH. If the written tax (1) In general. Every trustee or WHMTs) of this section applies, the information statement reports that an middleman required to file appropriate written tax information statement must amount of qualified dividend income is Forms 1099 under paragraph (d) of this include, with respect to each sale or attributable to the TIH, the written tax section with respect to a TIH must disposition of a WHFIT asset for the information statement also must inform furnish to that TIH (the person whose calendar year— the TIH that the TIH must meet the identifying number is required to be (1) The date of sale or disposition; requirements of section 1(h)(11)(B)(iii) shown on the form) a written tax (2) Information regarding the trust to treat the dividends as qualified information statement showing the sales proceeds that are attributable to dividends. information described in paragraph the TIH as a result of the sale or (3) Due date and other requirements. (e)(2) of this section. The amount of a disposition; and The written tax information statement
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must be furnished to the TIH on or the calendar year. The trustee must total amount of NMWHFIT distributions before March 15 of the year following determine the total amount of for the calendar year; and the calendar year for which the NMWHFIT distributions (actual and (2) Expense factors. For each item of statement is being furnished. deemed) for the calendar year. If the expense paid by a NMWHFIT during the (4) Requirement to retain records. For calculation of the total amount of calendar year, the trustee must a period of no less than five years from NMWHFIT distributions under this determine the ratio of the gross amount the due date for furnishing the written paragraph (f)(1)(ii)(A) results in a zero or of that item of expense to the total tax information statement, a trustee or a negative number, the trustee may not amount of NMWHFIT distributions for middleman must maintain in its records determine income and expense the calendar year. a copy of any written tax information information under this paragraph (C) Step Three: Determine statement furnished to a TIH, and such (f)(1)(ii)(A) (but may report all other adjustments for reconciling the total supplemental data as may be required to applicable items under this paragraph amount of NMWHFIT distributions establish the correctness of the (f)(1)). The total amount of NMWHFIT (determined under Step One) with statement. distributions equals the amount of amounts actually paid to TIHs. (f) Safe harbor for providing NMWHFIT funds paid out to all TIHs Paragraph (f)(1)(ii)(B) of this section information for certain NMWHFITs—(1) (including all trust sales proceeds, all (Step Two) requires an item of income Safe harbor for trustee reporting of principal receipts, and all redemption or expense to be expressed as a ratio of NMWHFIT information—The trustee of proceeds) for the calendar year— that item to the total amount of a NMWHFIT that meets the (1) Increased by— NMWHFIT distributions as determined requirements of paragraph (f)(1)(i) of (i) All amounts that would have been in paragraph (f)(1)(ii)(A) of this section this section is deemed to satisfy distributed during the calendar year, but (Step One). A TIH’s share of the total paragraph (c)(1)(i) of this section, if the were instead reinvested pursuant to a amount of NMWHFIT distributions may trustee calculates and provides WHFIT reinvestment plan; and differ from the amount actually paid to information in the manner described in (ii) All cash held for distribution to that TIH. A trustee, therefore, must this paragraph (f) and provides a TIHs as of December 31 of the year for provide information that can be used to compute a TIH’s share of the total statement to a requesting person giving which the trustee is reporting; and amount of NMWHFIT distributions notice that information has been (2) Decreased by— based on the amount actually paid to calculated in accordance with this (i) All cash distributed during the the TIH. A trustee satisfies this paragraph (f)(1). current year that was included in a year- requirement by providing a current (i) In general. (A) Eligibility to report end cash allocation factor (see year-end cash allocation factor, a prior under this safe harbor. Only paragraph (f)(1)(ii)(C)(1) of this section) NMWHFITs that meet the requirements year cash allocation factor, and the date for a prior year; on which the prior year cash was set forth in paragraphs (f)(1)(i)(A)(1) and (ii) All redemption asset proceeds (2) of this section may report under this distributed to TIHs (prior year cash paid for the calendar year, or if distribution date). safe harbor. paragraph (c)(2)(v)(C) of this section (1) Substantially all of the (1) The current year-end cash applies to the NMWHFIT, all NMWHFIT’s income is from dividends allocation factor. The current year-end redemption proceeds paid for the (as defined in section 6042(b) and the cash allocation factor is the amount of calendar year; regulations thereunder) or interest (as cash held for distribution to TIHs by the (iii) All trust sales proceeds defined in section 6049(b) and the NMWHFIT as of December 31 of the distributed during the calendar year; regulations thereunder); and calendar year for which the trustee is (2) All trust interests have identical and reporting, divided by the number of value and rights (iv) All non pro-rata partial principal trust interests outstanding as of that (B) Consistency requirements. The payments distributed during the date. trustee must— calendar year. (2) The prior year cash allocation (1) Calculate all trust items subject to (3) For the purpose of determining the factor. The prior year cash allocation the safe harbor consistent with the safe amount of all redemption asset proceeds factor is the amount of the distribution harbor; and, (2) Report under this or redemption proceeds paid for the during the calendar year for which the paragraph (f)(1) for the life of the calendar year with respect to paragraph trustee is reporting that was included in NMWHFIT; or, if the NMWHFIT has a (f)(1)(ii)(A)(2)(ii) of this section, the determining a year-end cash allocation start-up date before January 1, 2007, the value of the assets (not including cash) factor for a prior year, divided by the NMWHFIT must begin reporting under distributed with respect to an in-kind number of trust interests outstanding on this paragraph (f)(1) as of January 1, redemption is disregarded. Any cash the date of the distribution. 2007 and must continue to report under distributed as part of the redemption (iii) Reporting non pro-rata partial this paragraph for the life of the must be included in the total amount of principal payments under the safe NMWHFIT. NMWHFIT distributions. harbor. The trustee must provide a list (ii) Reporting NMWHFIT income and (B) Step Two: Determine factors that of dates on which non pro-rata partial expenses. A trustee must first determine express the ratios of NMWHFIT income principal payments were distributed by the total amount of NMWHFIT and expenses to the total amount of the trust, and the amount distributed, distributions (both actual and deemed) NMWHFIT distributions. The trustee per trust interest. for the calendar year and then express must determine factors that express the (iv) Reporting sales and dispositions each income or expense item as a ratios of NMWHFIT income and of NMWHFIT assets under the safe fraction of the total amount of expenses to the total amount of harbor—(A) NMWHFITs that must NMWHFIT distributions. These NMWHFIT distributions as follows: report under the general rule—(1) In fractions (hereinafter referred to as (1) Income factors. For each item of general. If a NMWHFIT must report factors) must be accurate to at least four income generated by the NMWHFIT’s under the general rule of paragraph decimal places. assets for the calendar year, the trustee (c)(2)(iv)(A) of this section, the trustee (A) Step One: Determine the total must determine the ratio of the gross must provide a list of dates (from amount of NMWHFIT distributions for amount of that item of income to the earliest to latest) on which sales or
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dispositions of NMWHFIT assets of this section applies to the NMWHFIT, reasonable accuracy the trust items that occurred during the calendar year for the amount of the redemption proceeds are attributable to a TIH, the requesting which the trustee is reporting and, for determined for that date; and person must request, and the trustee each date identified, provide— (B) Paragraph (c)(2)(v)(C) statement. If must provide, additional information to (i) The trust sales proceeds received paragraph (c)(2)(v)(C) of this section enable the requesting person to by the trust, per trust interest, with applies to the NMWHFIT, the trustee determine the trust items that are respect to the sales and dispositions, on must provide a statement to requesting attributable to the TIH. See, for example, that date; persons to the effect that the trustee is paragraph (f)(2)(ii)(A)(4) of this section (ii) The trust sales proceeds providing information consistent with which requires a middleman to request distributed to TIHs, per trust interest, paragraph (c)(2)(v)(C) of this section. additional information from the trustee with respect to the sales and (vi) Reporting the sale of a trust when the total amount of WHFIT dispositions on that date, and the date interest under the safe harbor. If distributions attributable to a TIH equals that the trust sales proceeds were paragraph (c)(2)(v)(C) of this section zero or less. distributed to the TIHs; and does not apply to the NMWHFIT, the (2) Use of information provided by (iii) The ratio (expressed as a trustee must provide, for each day of the trustees under the safe harbor for percentage) of the assets sold or calendar year, the amount of cash held NMWHFITs—(i) In general. If a trustee disposed of on that date to all assets for distribution, per trust interest, by the reports NMWHFIT items in accordance held by the NMWHFIT. NMWHFIT on that date. If the trustee is with paragraph (f)(1) of this section, the (2) Determination of the portion of all able to identify the date on which trust information provided with respect to assets held by the NMWHFIT that the interests were sold on the secondary those items on the Forms 1099 required assets sold or disposed of represented— market, the trustee alternatively may under paragraph (d) of this section to be (i) If a NMWHFIT terminates within provide information for each day on filed with the IRS and on the statement twenty-four months of its start-up date, which sales of trust interests occurred required under paragraph (e) of this the ratio of the assets sold or disposed rather than for each day during the section to be furnished to the TIH must of on that date to all assets held by the calendar year. If paragraph (c)(2)(v)(C) of be determined as provided in this NMWHFIT is based on the fair market this section applies to the NMWHFIT, paragraph (f)(2). value of the NMWHFIT’s assets as of the the trustee is not required to provide (ii) Determining NMWHFIT income start-up date; or any information under this paragraph and expense under the safe harbor. The (ii) If a NMWHFIT terminates more (f)(1)(vi), other than a statement that the trustee or middleman must determine than twenty-four months after its start- NMWHFIT meets the requirements to the amount of each item of income and up date, the ratio of the assets sold or report under paragraph (c)(2)(v)(C) of expense attributable to a TIH as disposed of on that date to all assets this section. follows— held by the NMWHFIT is based on the (vii) Reporting OID information under fair market value of the NMWHFIT’s the safe harbor. The trustee must (A) Step One: Determine the total assets as of the date of the sale or provide, for each calculation period, the amount of NMWHFIT distributions disposition. average aggregate daily accrual of OID attributable to the TIH. To determine (B) NMWHFITs excepted from the per $1,000 of original principal amount. the total amount of NMWHFIT general rule. If paragraph (c)(2)(iv)(B) of (viii) Reporting market discount distributions attributable to a TIH for this section applies to the NMWHFIT, information under the safe harbor—(A) the calendar year, the total amount paid the trustee must provide a list of dates In general. If the trustee of a NMWHFIT to, or credited to the account of, the TIH on which trust sales proceeds were is required to provide information during the calendar year (including distributed, and the amount of trust regarding market discount under amounts paid as trust sales proceeds or sales proceeds, per trust interest, that paragraph (c)(2)(vii) of this section, the partial non-pro rata principal payments, were distributed on that date. The trustee must provide the information redemption proceeds, and sales trustee also must also provide required under paragraph proceeds) is— requesting persons with the statement (f)(1)(iv)(A)(1)(iii) of this section. If the (1) Increased by— required by paragraph (c)(2)(iv)(B) of trustee is not required to provide market (i) All amounts that would have been this section. discount information under paragraph distributed during the calendar year to (v) Reporting redemptions under the (c)(2)(vii) of this section (because the the TIH, but that were reinvested safe harbor—(A) In general. The trustee NMWHFIT meets either the de minimis pursuant to a reinvestment plan (unless must: test of paragraph (c)(2)(iv)(D) of this another person (for example, the (1) Provide a list of dates on which section, or the qualified NMWHFIT custodian of the reinvestment plan) is the amount of redemption proceeds exception of paragraph (c)(2)(iv)(E) of responsible for reporting these amounts paid for the redemption of a trust this section), the trustee is not required under paragraph (d) of this section); and interest was determined and the amount under this paragraph (f) to provide any (ii) An amount equal to the current of the redemption asset proceeds information regarding market discount. year-end cash allocation factor determined per trust interest on that (B) Reporting market discount (provided by the trustee in accordance date, or if paragraph (c)(2)(v)(C) of this information under the safe harbor when with paragraph (f)(1)(ii)(C)(1) of this section applies to the NMWHFIT, the the yield of the debt obligations held by section) multiplied by the number of amount of redemption proceeds the WHFIT is expected to be affected by trust interests held by the TIH as of determined on that date; or prepayments. [Reserved.] December 31 of the calendar year for (2) Provide to each requesting person (ix) Reporting bond premium which the trustee is reporting; and that held (either for its own behalf or for information under the safe harbor. (2) Decreased by— the behalf of a TIH) a trust interest that [Reserved.] (i) An amount equal to the prior year was redeemed during the calendar year, (x) Reporting additional information. cash allocation factor (provided by the the date of the redemption and the If a requesting person cannot use the trustee in accordance with paragraph amount of the redemption asset information provided by the trustee (f)(1)(ii)(C)(2) of this section) multiplied proceeds per trust interest determined under paragraphs (f)(1)(ii) through (ix) by the number of trust interests held by on that date, or if paragraph (c)(2)(v)(C) of this section to determine with the TIH on the date of the distribution;
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(ii) An amount equal to all and each item of expense attributable to earliest to latest) on which sales or redemption asset proceeds paid to the a TIH is determined as follows— dispositions of trust assets occurred TIH for the calendar year, or if (1) Application of income factors. For during the calendar year and provide, paragraph (c)(2)(v)(C) of this section each income factor, the trustee or for each date identified— applies to the NMWHFIT, an amount middleman must multiply the income (i) The trust sales proceeds received equal to all redemption proceeds paid to factor by the total amount of NMWHFIT by the trust, per trust interest, with the TIH for the calendar year; distributions attributable to the TIH for respect to the sales or dispositions of (iii) An amount equal to all sale asset the calendar year (as determined in trust assets on that date; and proceeds paid to the TIH for the paragraph (f)(2)(i)(A) of this section). (ii) The information provided by the calendar year, or if paragraph (2) Application of expense factors. For trustee under paragraph (f)(1)(iv)(B)(2) (c)(2)(v)(C) of this section applies to the each expense factor, the trustee or of this section regarding the ratio of the NMWHFIT, the amount of sales middleman must multiply the expense assets sold or disposed of on that date proceeds paid to the TIH for the factor by the total amount of NMWHFIT to all the assets of the NMWHFIT held calendar year; distributions attributable to the TIH for on that date, prior to such sale or (iv) In the case of a TIH that the calendar year (as determined in disposition. purchased a trust interest in a paragraph (f)(2)(i)(A) of this section). (3) Calculating the total amount of (iii) Reporting non pro-rata partial NMWHFIT to which paragraph trust sales proceeds distributed to the principal payments under the safe (c)(2)(v)(C) of this section does not TIH. To determine the total amount of harbor. To determine the amount of non apply, an amount equal to the cash held NMWHFIT distributions attributable to pro-rata partial principal payments that for distribution per trust interest on the a TIH, the trustee or middleman must are distributed to a TIH for the calendar date that the TIH acquired its interest, calculate the amount of trust sales year, the trustee or middleman must multiplied by the trust interests proceeds distributed to the TIH for the aggregate the amount of non pro-rata acquired on that date; partial principal payments distributed calendar year. (See paragraph (v) The amount of the trust sales to a TIH for each day that non pro-rata (f)(2)(ii)(A)(2)(v) of this section.) To proceeds distributed to the TIH, principal payments were distributed. To determine the amount of trust sales calculated as provided in paragraph determine the amount of non pro-rata proceeds distributed to a TIH for the (f)(2)(iv)(A)(3) of this section; and principal payments that are distributed calendar year, the trustee or middleman (vi) The amount of non pro-rata to a TIH on each distribution date, the must aggregate the total amount of trust partial principal prepayments trustee or middleman must multiply the sales proceeds distributed to the TIH for distributed to the TIH during the amount of non-pro rata principal each date on which the NMWHFIT calendar year, calculated as provided in payments per trust interest distributed distributed trust sales proceeds. To paragraph (f)(2)(iii) of this section. on that date by the number of trust determine the total amount of trust sales (3) Treatment of in-kind distributions interests held by the TIH. proceeds distributed to a TIH for each under this paragraph (f)(2)(i). The value (iv) Reporting sales and dispositions date that the NMWHFIT distributed of the assets (not including cash) of NMWHFIT assets under the safe trust sales proceeds, the trustee or received with respect to an in-kind harbor—(A) Reporting under the safe middleman must multiply the amount redemption is not included in the harbor if the general rules apply to the of trust sales proceeds distributed by the amount used in paragraph NMWHFIT. Unless paragraph NMWHFIT per trust interest on that (f)(2)(ii)(A)(2)(ii) of this section. The (c)(2)(iv)(B) of this section applies, the date by the number of trust interests cash distributed as part of the trustee or middleman must comply with held by the TIH on that date. redemption, however, must be included paragraphs (f)(2)(iv)(A)(1), (2), and (3) of (B) Reporting under the safe harbor if in the total amount of NMWHFIT this section. paragraph (c)(2)(iv)(B) of this section distributions paid to the TIH. (1) Form 1099. The trustee or applies to the NMWHFIT. If paragraph (4) The total amount of distributions middleman must report the amount of (c)(2)(iv)(B) of this section applies, the attributable to a TIH calculated under trust sales proceeds attributable to the trustee or middleman must calculate, in this paragraph (f)(2)(i)(A) equals zero or TIH for the calendar year on Form 1099. the manner provided in paragraph less. If the total amount of distributions To determine the amount of trust sales (f)(2)(iv)(A)(3) of this section, the attributable to a TIH, calculated under proceeds attributable to a TIH for the amount of trust sales proceeds this paragraph (f)(2)(i)(A), equals zero or calendar year, the trustee or middleman distributed to the TIH for the calendar less, the trustee or middleman may not must aggregate the total amount of trust year. The trustee or middleman must report the income and expense sales proceeds attributable to the TIH for report this amount on the Form 1099 attributable to the TIH under this each date on which the NMWHFIT sold filed for the TIH and on the written tax paragraph (f)(2)(i). The trustee or or disposed of an asset or assets. To information statement furnished to the middleman must request additional determine the total amount of trust sales TIH. information from the trustee of the proceeds attributable to a TIH for each (v) Reporting redemptions under the NMWHFIT to enable the trustee or date that the NMWHFIT sold or safe harbor—(A) Except as provided in middleman to determine with disposed of an asset or assets, the paragraph (f)(2)(v)(B) or (C) of this reasonable accuracy the items of income trustee or middleman multiplies the section, if the trustee has provided a list and expense that are attributable to the amount of trust sales proceeds received of dates for which the amount of the TIH. The trustee or middleman must by the NMWHFIT per trust interest on redemption proceeds to be paid for the report the other items subject to that date by the number of trust interests redemption of a trust interest was paragraph (f)(1) of this section in held by the TIH on that date. determined and the redemption asset accordance with this paragraph (f)(2). (2) The written tax information proceeds paid for that date, the trustee (B) Step Two: Apply the factors statement furnished to the TIH. The or middleman must multiply the provided by the trustee to determine the written tax information statement redemption asset proceeds determined items of income and expense that are required to be furnished to the TIH per trust interest for that date by the attributable to the TIH. The amount of under paragraph (e) of this section must number of trust interests redeemed by each item of income (other than OID) include a list of dates (in order, from the TIH on that date.
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(B) If paragraph (c)(2)(v)(C) of this (B) If paragraph (c)(2)(iv)(B) of this equaled 20% of the aggregate fair market section applies, and the trustee has section applies, the trustee and value of the assets held by Trust on the start- provided a list of dates for which the middleman are not required under this up date of Trust. amount of the redemption proceeds to paragraph (f)(2) to provide any (6) On July 15, 2007, Trustee distributes be paid for the redemption of a trust information regarding market discount. $1,135x, which includes the $1,000x of trust interest was determined and the (ix) Reporting bond premium sales proceeds received by Trust for the sale of assets on June 1, 2007. As a result of the redemption proceeds determined per information under the safe harbor. distribution, Broker1 credits J’s account and trust interest on each date, the trustee or [Reserved] A’s account for $113.50x each. Broker 2 middleman must multiply the (3) Example of the use of the safe credits S’s account for $113.50x. redemption proceeds per trust interest harbor for NMWHFITs. The following (7) On September 30 2007, J, through for each date by the number of trust example illustrates the use of the factors Trust’s sponsor, sells a trust interest to S for interests redeemed by the TIH on that in this paragraph (f) to calculate and $115.35x. Trustee determines that the cash date. provide NMWHFIT information: held for distribution per trust interest on September 30 is $1.35x. As a result of the (C) If the trustee has provided the Example: (i) Facts—(A) In general—(1) sale, Broker1 credits J’s account for $115.35x. requesting person with information Trust is a NMWHFIT that holds common (8) On October 15, 2007, Trustee regarding the redemption asset proceeds stock in ten different corporations and has distributes $123x. As a result of the 100 trust interests outstanding. The start-up paid for each redemption of a trust distribution, Broker1 credits J’s account for date for Trust is December 15, 2006, and the interest held by the middleman for the $11.07x and A’s account for $12.30x. Broker2 termination date for Trust is March 15, 2008. calendar year, or if paragraph credits S’s account for $13.53x. The agreement governing Trust requires (c)(2)(v)(C) of this section applies and (9) On December 10, 2007, J tenders a trust Trust to distribute the cash held by Trust the trustee has provided the amount of interest to Trustee for redemption through reduced by accrued but unpaid expenses on redemption proceeds paid for each Broker1. Trustee determines that the amount April 15, July 15, and October 15 of the 2007 redemption of a trust interest held by of the redemption proceeds to be paid for a calendar year. The agreement also provides trust interest that is tendered for redemption the middleman during the calendar that the trust interests will be redeemed by on December 10, 2007, is $116x, of which year, the requesting person may use this the Trust for an amount equal to the value $115x represents the redemption asset information to determine the amount of of the trust interest, as of the close of proceeds. On December 12, 2007, Trustee the redemption asset proceeds or business, on the day that the trust interest is sells shares of common stock for $115x to redemption proceeds paid to the TIH for tendered for redemption. There is no have sufficient cash to pay J’s redemption reinvestment plan. A secondary market for the calendar year. proceeds. The stock sold on December 12, interests in Trust will be created by Trust’s (vi) Reporting sales of trust interests 2007, equaled 2% of the aggregate fair market sponsor and Trust’s sponsor will provide under the safe harbor—(A) Except as value of all the assets of Trust as of the start Trustee with a list of dates on which sales provided in paragraph (f)(2)(vi)(B) of up date. On December 17, 2007, Trustee pays occurred on this secondary market. this section, the trustee or middleman the $116x redemption proceeds (including (2) As of December 31, 2006, Trust holds the $115x trust sales proceeds received by must subtract the amount of cash held $12x for distribution to TIHs on the next Trust for the sale of the stock on December for distribution per trust interest on the distribution date and has no accrued but 12) to Broker1 on J’s behalf, and Broker1 in date of the sale from the sales proceeds unpaid expenses. Trustee includes the $12x turn pays $116x to J as redemption proceeds. paid to the TIH to determine the sale in determining the year-end cash allocation (10) On December 10, 2007, J, through asset proceeds that are to be reported to factor for December 31, 2006. Trust’s sponsor, also sells a trust interest to (B) Events occurring during the 2007 the TIH for each sale of a trust interest. S for $116x. Trustee determines that the cash calendar year—(1) As of January 1, 2007, (B) If paragraph (c)(2)(v)(C) of this held for distribution per trust interest on that Broker1 holds ten trust interests in Trust in section applies, the trustee or date is $1x. As a result of the sale, Broker1 street name for each of J and A and Broker2 middleman must report the sales credits J’s account for $116x. holds ten trust interests in Trust in street proceeds paid to the TIH as a result of (11) As of December 31, 2007, Trust holds name for S. J, A, and S; are individual, cash cash of $173x and has incurred $15x in each sale of a trust interest. method taxpayers. expenses that Trust has not paid. J is the only (vii) Reporting OID information under (2) As of January 1, 2007, the fair market TIH to redeem a trust interest during the the safe harbor—The trustee or value of the Trust’s assets equals $10,000x. calendar year. The sale of two trust interests middleman must aggregate the amounts (3) During 2007, Trust receives $588x in in Trust by J to S are the only sales that dividend income. Trustee determines that of OID that are allocable to each trust occurred on the secondary market $400x of the dividend income received interest held by a TIH for each established by Trust’s sponsor during 2007. during 2007 meets the definition of a calculation period. The amount of OID (ii) Trustee reporting—(A) Summary of qualified dividend in section 1(h)(11)(B)(i) that is allocable to a trust interest, with information provided by Trustee. Trustee and the holding period requirement in respect to each calculation period, is meets the requirements of paragraph (f)(1) of section 1(h)(11)(B)(iii) with respect to the determined by multiplying— this section if Trustee provides the following Trust. During 2007, Trust also receives $12x information to requesting persons: (A) The product of the OID factor and in interest income from investment of Trust’s (1) Income and expense information: the original principal balance of the funds pending distribution to TIHs, and pays trust interest, divided by 1,000; by $45x in expenses, all of which are affected Factor for ordinary dividend in- 0.3481 (B) The number of days during the expenses. come. Factor for qualified dividend in- 0.7407 OID calculation period in that calendar (4) On April 15, 2007, Trustee distributes $135x, which includes the $12x included in come. year that the TIH held the trust interest. Factor for interest income ...... 0.0222 (viii) Reporting market discount determining the year-end cash allocation factor for December 31, 2006. As a result of Factor for affected expenses ...... 0.0833 information under the safe harbor—(A) the distribution, Broker1 credits J’s account Current year-end cash allocation 1.5960 factor. Except as provided in paragraph and A’s account for $13.50x each. Broker2 Prior year cash allocation factor 0.1200 (f)(2)(viii)(B) of this section, the trustee credits S’s account for $13.50x. Prior year cash distribution date April 15 or middleman must provide the TIH (5) On June 1, 2007, Trustee sells shares of with the information provided under stock for $1000x to preserve the soundness (2) Information regarding asset sales and paragraph (f)(1)(vii)(B) of this section. of the trust. The stock sold on June 1, 2007, distributions:
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Trust sales proceeds distributed and Percent of Date of sale Trust sales proceeds received date distributed trust sold
June 1 ...... $10.0000x ...... $10.0000x (July 15) ...... 20 December 12 ...... 1.1616x ...... 0.0000x ...... 2
(3) Information regarding redemptions: amount of qualified dividend income ($400x) the calendar year, and provides, for each to the total amount of NMWHFIT date: the trust sales proceeds (per trust Redemption distributions for the calendar year ($540x). interest) received on that date; the trust sales Date asset (iii) Interest income factor. The interest proceeds distributed to TIHs (per trust proceeds income factor is 0.0222, which represents the interest) with respect to sales or dispositions ratio of the gross amount of interest income on that date; the date those trust sales December 10 ...... $115x ($12x) to the total amount of NMWHFIT proceeds were distributed, and the ratio of distributions for the calendar year ($540x). the assets sold or disposed of on that day to (4) Information regarding sales of trust (iv) Expense factor. The affected expenses all the assets held by Trust. Because Trust interests factor is 0.0833, which represents the ratio of will terminate within 15 months of its start- the gross amount of affected expenses paid up date, Trustee must use the fair market Cash held for by Trust for the calendar year ($45x) to the value of the assets as of the start-up date to Date distribution per total amount of NMWHFIT distributions for trust interest determine the portion of Trust sold or the calendar year ($540x). disposed of on any particular date. (3) Step Three: Trustee determines (5) Reporting redemptions. Because Trust September 30 ...... $1.35x adjustments for reconciling the total amount is not required to make distributions at least December 10 ...... 1.00x of NMWHFIT distributions with amounts as frequently as monthly, and Trust’s start-up paid to TIHs. To enable requesting persons date is after February 23, 2006, the exception (B) Trustee determines this information as to determine the total amount of NMWHFIT in paragraph (c)(2)(v)(C) of this section does follows: distributions that are attributable to a TIH not apply to Trust. To satisfy the (1) Step One: Trustee determines the total based on amounts actually paid to the TIH, amount of NMWHFIT distributions for the the trustee must provide both a current year- requirements of paragraph (f)(1) of this calendar year. The total amount of end cash allocation factor and a prior year section, Trustee provides a list of dates for NMWHFIT distributions (actual and deemed) cash allocation factor. which the redemption proceeds to be paid for for the calendar year for purposes of (i) Current year-end cash allocation factor. the redemption of a trust interest was determining the safe harbor factors is $540x. The adjustment factor for cash held by Trust determined for the 2007 calendar year and This amount consists of the amounts paid on at year end is 1.5960, which represents the the redemption assets proceeds paid for each each scheduled distribution date during the cash held for distribution as of December 31, date. During 2007, Trustee only determined calendar year ($1135x, $135x, and $123x), 2007 ($158x) (the amount of cash held by the amount of redemption proceeds to be plus the total amount paid to J as a result of Trust on December 31, 2007 ($173x) reduced paid for the redemption of a trust interest J’s redemption of a trust interest ($116x) once, for December 10, 2007, and the ($1,135x + $135x + $123x + $116x = by accrued, but unpaid, expenses ($15x)), divided by the number of trust interests redemption asset proceeds determined for $1,509x)— that date was $115x. (i) Increased by all cash held for outstanding at year-end (99). (ii) Prior Year Cash Allocation Factor. The (6) Reporting sales of trust interest. distribution to TIHs as of December 31, 2007 Because Trust is not required to make ($158x), which is the cash held as of adjustment factor for distributions of year- end cash from the prior year is 0.1200, which distributions at least as frequently as December 31, 2007 ($173x) reduced by the monthly, and Trust’s start up date is after accrued but unpaid expenses as of December represents the amount of the distribution February 23, 2006, the exception in 31, 2007 ($15x), and during the current calendar year that was paragraph (c)(2)(v)(C) of this section does not (ii) Decreased by all amounts distributed included in a year-end cash allocation factor apply to Trust. Sponsor, in accordance with during the calendar year but included in the for a prior year ($12x), divided by the year-end cash allocation factor from a prior number of trust interests outstanding at the the trust agreement, provides Trustee with a year ($12x); all redemption asset proceeds time of the distribution (100). The prior year list of dates on which sales on the secondary paid for the calendar year ($115x); and all cash distribution date is April 15, 2007. market occurred. To satisfy the requirements trust sales proceeds distributed during the (4) Reporting sales and dispositions of trust of paragraph (f)(1) of this section, Trustee calendar year ($1,000x). assets—(i) Application of the de minimis test provides requesting persons with a list of (2) Step Two: Trustee determines factors and the qualified NMWHFIT exception. The dates on which sales on the secondary that express the ratio of NMWHFIT income aggregate fair market value of the assets of market occurred and the amount of cash held (other than OID) and expenses to the total Trust as of January 1, 2007, was $10,000x. for distribution per trust interest on each amount of NMWHFIT distributions. Trustee During the 2007 calendar year, Trust received date. During 2007, two sales occurred on the determines the factors for each item of trust sales proceeds of $1115x. Trust sales secondary market. The first sale occurred on income earned by Trust and each item of proceeds received by Trust for the 2007 September 30, 2007, and the amount of cash expense as follows: calendar year equal 11.15% of Trust’s fair held for distribution, per trust interest, on (i) Ordinary dividend income factor. The market value as of January 1, 2007. that date is $1.35x. The second sale occurred ordinary dividend income factor is 0.3481, Accordingly, neither the de minimis test or on December 10, 2007, and the amount of which represents the ratio of the gross the qualified NMWHFIT exception is met for cash held for distribution, per trust interest, amount of ordinary dividends ($188x) to the the calendar year. on that date is $1.00x. total amount of NMWHFIT distributions for (ii) Information to be provided. To satisfy (iii) Brokers’ use of information provided the calendar year ($540x). the requirements of paragraph (f)(1) of this by Trustee. (A) Broker1 and Broker2 use the (ii) Qualified dividend income factor. The section with respect to sales and dispositions information furnished by Trustee under the qualified dividend income factor is 0.7407 of Trust’s assets, Trustee provides a list of safe harbor to determine that the following which represents the ratio of the gross dates on which trust assets were sold during items are attributable to J, A, and S—
With respect to J Ordinary Dividend Income ...... $17.89x Qualified Dividend Income ...... 38.07x Interest Income ...... 1.14x Affected Expenses ...... 4.28x Trust sales proceeds reported on Form 1099 ...... 108.13x
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Redemption asset proceeds For redemption on December 10 ...... 115.00x Sale asset proceeds For sale on September 30 ...... 114.00x For sale on December 10 ...... 115.00x With respect to A Ordinary Dividend Income ...... 18.82x Qualified Dividend Income ...... 40.04x Interest Income ...... 1.20x Affected Expenses ...... 4.50x Trust sales proceeds reported on Form 1099 ...... 11.62x With respect to S Ordinary Dividend Income ...... 19.54x Qualified Dividend Income ...... 41.58x Interest Income ...... 1.25x Affected Expenses ...... 4.68x Trust sales proceeds reported on Form 1099 ...... 113.94x
With respect to J, A, and S (regarding the (A) An amount equal to the prior year cash distributions attributable to J, A, and S sales and dispositions executed by Trust allocation factor (0.1200), multiplied by the ($51.39x, $54.06x, and $56.13x, respectively) during the calendar year) number of trust interests held by J (10), A by the factor for qualified dividends (0.7407). (10), and S (10) on the date of the prior year (iii) Application of factor for interest Trust sales cash distribution; that is for J, A, and S, income. The amount of interest income Date proceeds Percent of $1.20x, each; attributable to J is $1.14x, to A is $1.20x, and received per trust sold (B) An amount equal to all redemption to S is $1.25x. The brokers determine these trust interest asset proceeds paid to a TIH for the calendar amounts by multiplying the total amount of year; that is, for J, $115x; NMWHFIT distributions attributable to J, A, June 15 ...... $10.0000x ...... 20 (C) An amount equal to all sales asset and S ($51.39x, $54.06x, and $56.13x, December 12 1.1616x ...... 2 proceeds attributable to the TIH for the respectively) by the factor for interest calendar year; that is for J, $229x (for the (0.0222). (B) The brokers determine the information September 30, 2007, sale: $115.35x¥1.35x (iv) Application of factor for affected provided to J, A, and S as follows— (cash held for distribution per trust interest expenses. The amount of affected expenses (1) Step One: Brokers determine the total on that date)¥$114x; and for the December attributable to J is $4.28x, to A is $4.50x, and amount of NMWHFIT distributions 10, 2007, sale: $116x¥1.00 (cash held for to S is $4.68x. The brokers determine these attributable to J, A, and S. Broker1 distribution per trust interest on that amounts by multiplying the total amount of determines that the total amount of date)=$115x)); NMWHFIT distributions attributable to J, A, NMWHFIT distributions attributable to J is (D) In the case of a purchasing TIH, an and S ($51.39x, $54.06x, and $56.13x, $51.39x and the total amount of NMWHFIT amount equal to the amount of cash held for respectively) by the factor for affected distributions attributable to A is $54.06x. distribution per trust interest at the time the expenses (0.0833). Broker2 determines that the total amount of TIH purchased its trust interest, multiplied (3) Brokers reporting of sales and NMWHFIT distributions attributable to S is by the number of trust interests purchased; dispositions of trust assets—(i) Determining $56.13x. that is for S, $2.35x ($1.35x with respect to the amount of trust sales proceeds to be (i) To calculate these amounts the brokers the September 30, 2007, sale and $1x with reported on Form 1099 for J, A, and S. The begin by determining the total amount paid to J, A, and S for the calendar year— respect to the December 10, 2007, sale); amount of trust sales proceeds to be reported (A) The total amount paid to J for the (E) All amounts of trust sales proceeds on Form 1099 with respect to J is $108.13x, calendar year equals $485.42x and includes distributed to the TIH for the calendar year; to A is $111.62x, and to S is $113.94x. To the April 15, 2007, distribution of $13.50x, that is for J, A, and S, $100. ($100 each, with determine these amounts, the brokers the July 15, 2007, distribution of $113.50x, respect to the June 15, 2007, sale of assets by aggregate the amount of trust sales proceeds the sales proceeds for the September 30, Trust, and $0 each, with respect to the attributable to J, A, and S for each date on 2007, sale of $115.35x, the October 15, 2007, December 12, 2007, sale of assets by Trust). which Trust sold or disposed of assets. The distribution of $11.07x, and the redemption (2) Step two: The brokers apply the factors brokers determine the amount of trust sales proceeds of $116x and sales proceeds of provided by Trustee to determine the Trust’s proceeds to be reported with respect to the $116x for the redemption and sale on income and expenses that are attributable to June 15, 2007, asset sale by multiplying the December 10, 2007. J, A, and S. The amounts of each item of number of trust interests held by J (10), A (10) (B) The total amount paid to A for the income (other than OID) and expense that are and S (10) on that date by the trust sales calendar year equals $139.30x and includes attributable to J, A, and S are determined by proceeds received per trust interest on that the April 15, 2007, distribution of $13.50x, multiplying the factor for that type of income date ($10x). The brokers determine the the July 15, 2007, distribution of $113.50x or expense by the total amount of NMWHFIT amount of trust sales proceeds to be reported and the October 15, 2007, distribution of distributions attributable to J, A, and S as with respect to the December 12, 2007, asset $12.30x. follows: sale by multiplying the number of trust (C) The total amount paid to S for the (i) Application of factor for ordinary interests held by J (7), A (10) and S (12) on calendar year equals $140.53x and includes dividends. The amount of ordinary dividend that date by the trust sales proceeds received the April 15, 2007, distribution of $13.50x, income attributable to J is $17.89x, to A is per trust interest on that date ($1.1616x). the July 15, 2007, distribution of $113.50x $18.82x, and to S is $19.54x. The brokers (ii) Information provided on the tax and the October 15, 2007, distribution of determine these amounts by multiplying the information statements furnished to J, A, and $13.53x. total amount of NMWHFIT distributions S. The tax information statements furnished (ii) The brokers increase the total amount attributable to J, A, and S ($51.39x, $54.06x, to J, A, and S must include the dates of each paid to J, A, and S by an amount equal to the and $56.13x, respectively) by the factor for sale or disposition (June 15, 2007, and current year-end cash allocation factor ordinary dividends (0.3481). December 12, 2007); the amount of trust sales (1.5960) multiplied by the number of trust (ii) Application of factor for qualified proceeds per trust interest received on those interests held by J (7), A (10), and S (12) as dividend income. The amount of qualified dates ($10.00x and $1.1616x, respectively); of December 31, 2007; that is for J, $11.17x; dividend income attributable to J is $38.07x, and, the percentage of Trust sold or disposed for A, $15.96x; and for S, $19.15x. to A is $40.04x, and to S is $41.58x. The of on that date (20% and 2%, respectively). (iii) The brokers reduce the amount paid to brokers determine these amounts by (4) Reporting redemptions. Broker1 reports J, A, and S as follows— multiplying the total amount of NMWHFIT on Form 1099 and on the written tax
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information statement furnished to J that J (iii) Reporting WHMT income, provide, for each month during the received $115x in redemption asset proceeds expenses, non pro-rata partial principal calendar year, the aggregate daily for the calendar year. payments, and sales and dispositions accrual of OID per $1,000 of aggregate (5) Reporting sales of trust interests on the secondary market. Broker1 reports on J’s two under the safe harbor. A trustee must outstanding principal balance as of the sales of trust interests. With respect to the comply with each step provided in this start-up date (daily portion). For sale on September 30, 2007, the sale asset paragraph (g)(1)(iii). purposes of this paragraph (g)(1)(iv), the proceeds equals $114x ($115.35x sale (A) Step One: Determine monthly pool daily portion of OID is determined by proceeds—$1.35x cash held for distribution factors. The trustee must, for each allocating to each day of the month its on that date) and with respect to the sale on month of the calendar year and for ratable portion of the excess (if any) of— December 10, 2007, the sale asset proceeds January of the following calendar year, (i) The sum of the present value equal $115x ($116x sale proceeds—$1x cash calculate and provide the ratio (determined under section held for distribution on that date). Broker1 reports these amounts on Form 1099 and on (expressed as a decimal carried to at 1272(a)(6)(B)) of all remaining payments the tax information statement furnished to J. least eight places and called a pool under the mortgages held by the WHMT factor) of— at the close of the month, and the (g) Safe Harbor for certain WHMTs— (1) The amount of the aggregate payments during the month of amounts (1) Safe harbor for trustee of certain outstanding principal balance of the included in the stated redemption price WHMTs for reporting information—(i) WHMT as of the first business day of the of the mortgages, over In general. The trustee of a WHMT that month; to (ii) The aggregate of each mortgage’s meets the requirements of paragraph (2) The amount of the aggregate adjusted issue price as of the beginning (g)(1)(ii) of this section is deemed to outstanding principal balance of the of the month. satisfy paragraph (c)(1)(i) of this section, WHMT as of the start-up date. (2) In calculating the daily portion of if the trustee calculates and provides (B) Step Two: Determine monthly OID, the trustee must use the WHFIT information in the manner expense factors. For each month of the prepayment assumption used in pricing described in this paragraph (g) and calendar year and for each item of the original issue of trust interests. provides a statement to the requesting expense paid by the WHMT during that (B) Reporting OID after the issuance person giving notice that information month, the trustee must calculate and of final regulations under section has been calculated in accordance with provide the ratio (expressed as a 1272(a)(6)(C)(iii). [Reserved.] this paragraph (g)(1). decimal carried to at least eight places (v) Reporting market discount (ii) Requirements. A WHMT must and called an expense factor) of— information under the safe harbor— (A) meet the following requirements— (1) The gross amount, for the month, Reporting market discount information (A) The WHMT must make monthly of each item of expense; to prior to the issuance of final regulations distributions of the income and (2) The amount that represents the under sections 1272(a)(6)(C)(iii) and principal payments received by the aggregate outstanding principal balance 1276(b)(3). For calendar years prior to WHMT to its TIHs; of the WHMT as of the start-up date, the effective date of final regulations (B) All trust interests in the WHMT divided by 1,000. under sections 1272(a)(6)(C)(iii) and must represent the right to receive an (C) Step Three: Determine monthly 1276(b)(3), the trustee must provide— equal pro-rata share of both the income income factors. For each month of the (1) In the case of a WHMT holding and the principal payments received by calendar year and for each item of gross mortgages issued with OID, the ratio the WHMT on the mortgages it holds income earned by the WHMT during (expressed as a decimal carried to at (for example, a WHMT that holds or that month, the trustee must calculate least eight places) of— issues trust interests that qualify as and provide the ratio (expressed as a (i) The OID accrued during the month stripped interests under section 1286 decimal carried to at least eight places (calculated in accordance with may not report under this safe harbor); paragraph (g)(1)(iv) of this section); to (C) The WHMT must— and called an income factor) of— (ii) The total remaining OID as of the (1) Report under this paragraph (1) The gross amount, for the month, (g)(1)(ii) for the life of the WHMT; or of each item of income, to beginning of the month (as determined (2) If the WHMT has a start-up date (2) The amount that represents the under paragraph (g)(1)(v)(A)(3) of this before January 1, 2007, the WHMT must aggregate outstanding principal balance section); or begin reporting under this paragraph of the WHMT as of the start-up date, (2) In the case of a WHMT holding (g)(1)(ii) as of January 1, 2007, and must divided by 1,000. mortgages issued without OID, the ratio continue to report under this paragraph (D) Definition of aggregate (expressed as a decimal carried to at for the life of the WHMT; outstanding principal balance. For least eight places) of— (D) The WHMT must calculate all purposes of this paragraph (g)(1)(iii), the (i) The amount of stated interest paid items subject to the safe harbor amount of the aggregate outstanding to the WHMT during the month; to consistent with the safe harbor; principal balance of a WHMT is the (ii) The total amount of stated interest (E) The assets of the WHMT must be aggregate of— remaining to be paid to the WHMT as limited to— (1) The outstanding principal balance of the beginning of the month (as (1) Mortgages with uniform of all mortgages held by the WHMT; determined under paragraph characteristics; (2) The amounts received on (g)(1)(v)(A)(3) of this section). (2) Reasonably required reserve funds; mortgages as principal payments and (3) Computing the total amount of and held for distribution by the WHMT; and stated interest remaining to be paid and (3) Amounts received on mortgages or (3) The amount of the reserve fund the total remaining OID at the beginning reserve funds and held for distribution (exclusive of undistributed income). of a month. To compute the total to TIHs; and (iv) Reporting OID information under amount of stated interest remaining to (F) The aggregate outstanding the safe harbor—(A) Reporting OID be paid to the WHMT as of the principal balance (as defined in prior to the issuance of final regulations beginning of the month and the total paragraph (g)(1)(iii)(D) of this section) as under section 1272(a)(6)(C)(iii)—(1) For remaining OID as of the beginning of the of the WHMT’s start-up date must equal calendar years prior to the effective date month, the trustee must use the the aggregate of the original face of final regulations under section prepayment assumption used in pricing amounts of all issued trust interests. 1272(a)(6)(C)(iii), the trustee must the original issue of unit interests.
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(B) Reporting market discount with respect to sales and dispositions (iii) Reporting OID information under information under the safe harbor and non pro-rata partial principal the safe harbor. With respect to each following the issuance of final payments. month, trustee or middleman must regulations under sections (B) Step Two: Determine the amount determine the amount of OID that is 1272(a)(6)(C)(iii) and 1276(b)(3). of each item of expense that is attributable to each trust interest held by [Reserved.] attributable to a TIH—(1) Determine the a TIH by multiplying— (vi) Reporting bond premium monthly amounts per trust interest. For (A) The product of the OID factor information under the safe harbor. each month of the calendar year that a multiplied by the original face amount [Reserved.] trust interest was held on the record of the trust interest, divided by 1,000; by (2) Use of information provided by a date, the trustee or middleman must (B) The number of days during the trustee under the safe harbor—(i) In determine the amount of each item of month that the TIH held the trust general. If a trustee reports WHMT expense that is attributable to each trust interest. items in accordance with paragraph interest by multiplying— (g)(1) of this section, the information (i) The original face amount of the (iv) Requirement to provide market provided with respect to those items on trust interest, divided by 1000; by discount information under the safe the Forms 1099 required to be filed with (ii) The expense factor for that month harbor. The trustee or middleman must the IRS under paragraph (d) of this and that item of expense. provide the market discount section and on the statement required to (2) Determine the amount for the information in accordance with be furnished to the TIH under paragraph calendar year. The trustee or paragraph (g)(1)(v) of this section to the (e) of this section must be determined as middleman must multiply the monthly TIH in, or with, the written statement provided in this paragraph (g)(2). amount of each item of expense per required to be furnished to the TIH (ii) Reporting WHMT income, trust interest by the number of trust under paragraph (e) of this section. expenses, non pro-rata partial principal interests held by the TIH on the record (v) Requirement to provide bond payments, and sales and dispositions date of each month. The trustee or premium information under the safe under the safe harbor. The amount of middleman then must aggregate the harbor. [Reserved] each item of income, the amount of each monthly amounts for each item of (3) Example of safe harbor in item of expense, and the combined expense to determine the total amount paragraph (g)(1) of this section. The amount of non pro-rata partial principal of each item of expense that is following example illustrates the use of payments and trust sales proceeds that attributable to the TIH for the calendar the factors in this paragraph (g) to are attributable to a TIH for each month year. calculate and provide WHMT of the calendar year must be computed (C) Step Three: Determine the amount information: as follows: of each item of income that is (A) Step One: Determine the aggregate attributable to the TIH for the calendar Example. (i) Facts—(A) In general. X is a of the non pro-rata partial principal WHMT. X’s start-up date is January 1, 2007. year—(1) Determine the monthly As of that date, X’s assets consist of 100 15- payments and trust sales proceeds that amounts per trust interest. For each year mortgages, each having an unpaid are attributable to the TIH for the month of the calendar year that a trust principal balance of $125,000 and a fixed, calendar year. For each month of the interest was held on the record date, the annual interest rate of 7.25 percent. None of calendar year that a trust interest was trustee or middleman must determine the mortgages were issued with OID. X’s held on the record date— the amount of each item of income that TIHs are entitled to monthly, pro-rata (1) Determine the monthly amounts is attributable to each trust interest by distributions of the principal payments per trust interest. The trustee or multiplying— received by X. X’s TIHs are also entitled to middleman must determine the (i) The original face amount of the monthly, pro-rata distributions of the interest aggregate amount of non pro-rata partial trust interest, divided by 1,000; by earned on the mortgages held by X, reduced by expenses. Trust interests are issued in principal payments and the trust sales (ii) The income factor for that month increments of $5,000 with a $25,000 proceeds that are attributable to each and that item of income. minimum. The prepayment assumption used trust interest for each month by (2) Determine the amount for the in pricing the original issue of trust interests multiplying— calendar year. The trustee or is six percent. Broker holds a trust interest in (i) The original face amount of the middleman must multiply the monthly X, with an original face amount of $25,000, trust interest; by amount of each item of income per trust in street name, for C during the entire 2007 (ii) The difference between the pool interest by the number of trust interests calendar year. factor for the current month and the held by the TIH on the record date of (B) Trust events during the 2007 calendar pool factor for the following month. each month. The trustee or middleman year. During the 2007 calendar year, X (2) Determine the amount for the then must aggregate the monthly collects all interest and principal payments calendar year. The trustee or when due and makes all monthly amounts for each item of income to distributions when due. One mortgage is middleman must multiply the monthly determine the total amount of each item repurchased from X in July 2007 for amount per trust interest by the number of income that is attributable to the TIH $122,249, the mortgage’s unpaid principal of trust interests held by the TIH on the for the calendar year. balance plus accrued, but unpaid, interest at record date of each month. The trustee (D) Definitions for this paragraph the time. During November 2007, another or middleman then must aggregate these (g)(2). For purposes of this paragraph mortgage is prepaid in full. X earns $80 monthly amounts, and report the (g)(2)(ii)— interest income each month from the aggregate amount on the Form 1099 (1) The record date is the date used temporary investment of X’s funds pending filed with the IRS and on the tax by the WHMT to determine the owner distribution to the TIHs. All of X’s expenses information statement furnished to the of the trust interest for the purpose of are affected expenses. The aggregate outstanding principal balance of X’s TIH as trust sales proceeds. No other distributing the payment for the month. mortgages, X’s interest income, and X’s information is required to be reported to (2) The original face amount of the expenses, for each month of the 2007 the IRS or the TIH to satisfy the trust interest is the original principal calendar year, along with the aggregate requirements of paragraphs (d) and (e) amount of a trust interest on its issue outstanding principal balance of X as of of this section under this paragraph (g) date. January 2008, are as follows:
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Principal Month balance Income Expenses
January ...... $12,500,000 $75,601 $5,288 February ...... 12,461,413 75,368 5,273 March ...... 12,422,593 75,133 5,256 April ...... 12,383,538 74,897 5,240 May ...... 12,344,247 74,660 5,244 June ...... 12,304,719 74,421 5,207 July ...... 12,264,952 74,181 5,191 August ...... 12,102,696 73,200 5,122 September ...... 12,062,849 72,960 5,106 October ...... 12,022,762 72,718 5,089 November ...... 11,982,432 72,474 5,073 December ...... 11,821,234 71,500 5,006 January ...... 11,780,829 ......
(ii) Trustee reporting. (A) Trustee, X’s providing the following information to fiduciary, comes within the safe harbor of requesting persons: paragraph (g)(1)(ii) of this section by
Month Pool factor Income factor Expense factor
January ...... 1.00000000 6.04806667 0.42304000 February ...... 0.99691304 6.02941628 0.42184000 March ...... 0.99380744 6.01065328 0.42048000 April ...... 0.99068304 5.99177670 0.41920000 May ...... 0.98753976 5.97278605 0.41952000 June ...... 0.98437752 5.95368085 0.41656000 July ...... 0.98119616 5.93446013 0.41528000 August ...... 0.96821564 5.85603618 0.40976000 September ...... 0.96502792 5.83677704 0.40848000 October ...... 0.96182096 5.81740161 0.40712000 November ...... 0.95859459 5.79790896 0.40584000 December ...... 0.94569875 5.71999659 0.40048000 January ...... 0.94246631 ......
(B) Trustee determines this information as have only one expense factor for each month. (i) The gross amount of interest income follows: For example, the expense factor for the earned by X during January ($75,601); (1) Step One: Trustee determines monthly month of January 2007 is 0.42304000, which divided by pool factors. Trustee calculates and provides represents the ratio of— (ii) The amount that represents that X’s pool factor for each month of the 2007 (i) The gross amount of expenses paid aggregate outstanding principal balance of X calendar year. For example, for the month of during January by X ($5,288); divided by as of the start-up date ($12,500,000), divided January 2007 the pool factor is 1.0, which (ii) The amount that represents the by 1,000 ($12,500). represents the ratio of — aggregate outstanding principal balance of X (4) Step Four: Trustee calculates and (i) The amount that represents the as of the start-up date ($12,500,000) divided provides monthly market discount fractions. aggregate outstanding principal balance of X by 1,000 ($12,500). Trustee calculates and provides a market ($12,500,000) as of the first business day of January; divided by (3) Step Three: Trustee determines monthly discount fraction for each month of the 2007 (ii) The amount that represents the income factors. Trustee calculates and calendar year using a prepayment aggregate outstanding principal balance of X provides the income factors for each month assumption of 6% and a stated interest rate ($12,500,000) as of the start-up day. of the 2007 calendar year. During 2007, X has of 7.25%. (2) Step Two: Trustee determines monthly only interest income, and therefore, will have (iii) Broker’s use of the information expense factors. Trustee calculates and only one income factor for each month. For provided by Trustee. (A) Broker uses the provides the expense factors for each month example, the income factor for the month of information provided by Trustee under of the 2007 calendar year. During 2007, X has January 2007 is 6.04806667, which paragraph (g) of this section to determine that only affected expenses, and therefore, will represents the ratio of— the following trust items are attributable to C:
Aggregate trust sales pro- ceeds and non Affected Gross interest Month pro-rata partial expenses income principal pay- ments
January ...... $77.17 $10.58 $151.20 February ...... 77.64 10.55 150.74 March ...... 78.11 10.51 150.27 April ...... 78.58 10.48 149.79 May ...... 79.06 10.49 149.32 June ...... 79.53 10.41 148.84 July ...... 324.51 10.38 148.36 August ...... 79.69 10.24 146.40
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Aggregate trust sales pro- ceeds and non Affected Gross interest Month pro-rata partial expenses income principal pay- ments
September ...... 80.17 10.21 145.92 October ...... 80.66 10.18 145.43 November ...... 322.40 10.15 144.95 December ...... 80.81 10.01 143.00
Total ...... 1438.33 124.19 1774.22
(B) Broker determines this information as (4) Step Four: Broker provides market (iv) Any other manner agreed to by follows: discount information to C. Broker provides C the middleman and the beneficial owner (1) Step One: Broker determines the with the market discount fractions calculated requesting the information. amount of the non pro-rata partial principal and provided by the trustee of X under (4) Clearing organization. A clearing payments and trust sales proceeds received paragraph (g)(3)(ii)(D) of this section. by X that are attributable to C for the 2007 organization described in § 1.163– calendar year. Broker determines the amount (h) Requirement that middlemen 5(c)(2)(i)(D)(8) is not required to furnish of the non pro-rata partial principal furnish information to beneficial owners information to exempt recipients or payments and trust sales proceeds received that are exempt recipients and non-calendar-year TIHs under this by X that are attributable to C for each month noncalendar-year beneficial owners—(1) paragraph (h). of the 2007 calendar year. For example, for In general. A middleman that holds a (i) [Reserved.] the month of January, Broker determines that trust interest on behalf of, or for the (j) Coordination with other the amount of principal receipts and the account of, either a beneficial owner information reporting rules. In general, amount of trust sales proceeds that are that is an exempt recipient defined in attributable to C is $77.17. Broker determines in cases in which reporting is required this by multiplying the original face amount paragraph (b)(7) of this section or a for a WHFIT under both this section and of C’s trust interest ($25,000) by 0.00308696, noncalendar-year beneficial owner, subpart B, part III, subchapter A, the difference between the pool factor for must provide to such beneficial owner, chapter 61 of the Internal Revenue Code January 2007 (1.00000000) and the pool upon request, the information provided (Sections 6041 through 6050S) factor for the following month of February by the trustee to the middleman under (Information Reporting Sections), the 2007 (0.99691304). Broker reports the paragraph (c) of this section. reporting rules for WHFITs under this aggregate of the monthly amounts of non pro- (2) Time for providing information. rata partial principal payments and trust section must be applied. The provisions The middleman must provide the of the Information Reporting Sections sales proceeds that are attributable to C for requested information to any beneficial the 2007 calendar year as trust sales proceeds and the regulations thereunder are on the Form 1099 filed with the IRS. owner making a request under incorporated into this section as (2) Step Two: Broker applies the expense paragraph (h)(1) of this section on or applicable, but only to the extent that factors provided by Trustee to determine the before the later of the 44th day after the such provisions are not inconsistent amount of expenses that are attributable to close of the calendar year for which the with the provisions of this section. C for the 2007 calendar year. Broker information was requested, or the day (k) Backup withholding requirements. determines the amount of X’s expenses that that is 28 days after the receipt of the are attributable to C for each month of the Every trustee and middleman required request. A middleman must provide to file a Form 1099 under this section calendar year. For example, for the month of information with respect to a WHFIT January 2007, Broker determines that the is a payor within the meaning of amount of expenses attributable to C is holding an interest in another WHFIT, § 31.3406(a)–2, and must backup $10.58. Broker determines this by or a WHFIT holding an interest in a withhold as required under section 3406 multiplying the original face amount of C’s REMIC, on or before the later of the 58th and any regulations thereunder. day after the close of the calendar year trust interest ($25,000), divided by 1,000 (l) Penalties for failure to comply. ($25) by the expense factor for January 2007 for which the information was Every trustee and middleman who fails (0.42304000). Broker determines the requested, or the 42nd day after the to comply with the reporting obligations expenses that are attributable to C for the receipt of the request. imposed by this section is subject to 2007 calendar year by aggregating the (3) Manner of providing information. penalties under sections 6721, 6722, monthly amounts. The requested information must be (3) Step Three: Broker applies the income and any other applicable penalty factors provided by Trustee to determine the provided— (i) By written statement sent by first provisions. amount of gross interest income attributable (m) Effective date. These regulations to C for the 2007 calendar year. Broker class mail to the address provided by the person requesting the information; are applicable January 1, 2007. Trustees determines the amount of gross interest must calculate and provide trust income that is attributable to C for each (ii) By electronic mail provided that month of the calendar year. For example, for the person requesting the information information with respect to the 2007 the month of January 2007, Broker requests that the middleman furnish the calendar year and all subsequent years determines that the amount of gross interest information by electronic mail and the consistent with these regulations. income attributable to C is $151.20. Broker person furnishes an electronic address; Information returns required to be filed determines this by multiplying the original (iii) At an Internet website of the with the IRS and the tax information face amount of C’s trust interest ($25,000), middleman or the trustee, provided that statements required to be furnished to divided by 1,000 ($25), by the income factor trust interest holders after December 31, for January 2007 (6.04806667). Broker the beneficial owner requesting the information is notified that the 2007 must be consistent with these determines the amount of the gross interest regulations. income that is attributable to C for the 2007 requested information is available at the calendar year by aggregating the monthly Internet website and is furnished the I Par. 4. Section 1.6041–9 is added to amounts. address of the site; or read as follows:
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§ 1.6041–9 Coordination with reporting section 3 of the Investment Company paragraph (d)(2) of this section for the rules for widely held fixed investment trusts Act (15 U.S.C. section 80–a) and on first taxable year that the trust is no under § 1.671–5. amounts paid on pooled funds or trusts. longer owned by one grantor or one See § 1.671–5 for the reporting rules The interest to be reported with respect other person or for the first taxable year for widely held fixed investment trusts to a widely held fixed investment trust, that the trust does not report pursuant (WHFIT) (as defined under that section). as defined in § 1.671–5(b)(22), shall be to § 1.671–4(b)(2)(i)(A) of this chapter. For purposes of section 6041, the interest earned on the assets held by * * * * * middlemen and trustees of WHFITs are the trust. See § 1.671–5 for the reporting deemed to have management and rules for widely held fixed investment PART 602—OMB CONTROL NUMBERS oversight functions in connection with trusts (as defined under that section). UNDER THE PAPERWORK payments made by the WHFIT. * * * * * REDUCTION ACT I Par. 5. Section 1.6042–5 is added to I Par. 9. Section 1.6050N–2 is added to read as follows: read as follows: I Par. 12. The authority citation for part § 1.6042–5 Coordination with reporting 602 continues to read as follows: rules for widely held fixed investment trusts § 1.6050N–2 Coordination with reporting under § 1.671–5. rules for widely held fixed investment trusts Authority: 26 U.S.C. 7805. under § 1.671–5. See § 1.671–5 for the reporting rules See § 1.671–5 for the reporting rules I Par. 13. In § 602.101, paragraph (b) is for widely held fixed investment trusts for widely held fixed investment trusts amended by adding an entry in (as defined under that section). (as defined under that section). numerical order to the table to read as I Par. 6. Section 1.6045–1 is amended follows: by adding paragraph (d)(7) to read as PART 301—PROCEDURE AND follows: ADMINISTRATION § 602.101 OMB Control numbers. * * * * * § 1.6045–1 Returns of information of I Par. 10. The authority citation for part brokers and barter exchanges. 301 continues to read, in part, as (b) * * * * * * * * follows: (d) * * * CFR part or section where Current OMB (7) Coordination with reporting rules Authority: 26 U.S.C. 7805 * * * identified and described control No. for widely held fixed investment trusts I Par. 11. Section 301.6109–1 is under § 1.671–5 of this chapter. See amended by: ***** § 1.671–5 for the reporting rules for I 1. Revising the heading to paragraph 1.671–5 ...... 1545–1540 widely held fixed investment trusts (as (a)(2). defined under that section). I 2. Revising paragraph (a)(2)(i). ***** * * * * * The revisions read as follows: I Par. 7. Section 1.6049–4 is amended § 301.6109–1 Identifying numbers. Approved: January 5, 2006. by adding paragraph (c)(3) to read as (a) * * * follows: Mark E. Matthews, (2) A trust that is treated as owned by Deputy Commissioner for Services and § 1.6049–4 Return of information as to one or more persons pursuant to Enforcement. interest paid and original issue discount sections 671 through 678—(i) Obtaining Eric Solomon, includible in gross income after December a taxpayer identification number—(A) 31, 1982. General rule. Unless the exception in Acting Deputy Assistant Secretary. * * * * * paragraph (a)(2)(i)(B) of this section [FR Doc. 06–396 Filed 1–23–06; 8:45 am] (c) * * * applies, a trust that is treated as owned BILLING CODE 4830–01–U (3) Coordination with reporting rules by one or more persons under sections for widely held fixed investment trusts 671 through 678 must obtain a taxpayer under § 1.671–5 of this chapter. See identification number as provided in § 1.671–5 for the reporting rules for paragraph (d)(2) of this section. widely held fixed investment trusts (as (B) Exception for a trust all of which defined under that section). is treated as owned by one grantor or * * * * * one other person and that reports under I Par. 8. In § 1.6049–5, paragraph (a)(6) § 1.671–4(b)(2)(i)(A) of this chapter. A is revised to read as follows: trust that is treated as owned by one grantor or one other person under § 1.6049–5 Interest and original issue sections 671 through 678 need not discount subject to reporting after obtain a taxpayer identification number, December 31, 1982. provided the trust reports pursuant to (a) * * * § 1.671–4(b)(2)(i)(A) of this chapter. The (6) Interest paid on amounts held by trustee must obtain a taxpayer investment companies as defined in identification number as provided in
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Part IV
Department of Labor Establishment of the Emergency Management Center (EMC) and the Comprehensive Emergency Management Program (CEMP); Notice
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DEPARTMENT OF LABOR man-made disasters, as well as and emergency management programs supporting lead Federal agencies in before, during, and following Office of the Secretary assisting state and local governments, to emergencies; (B) program continuity [Secretary’s Order 01–2006] include international requests for U.S. and guidance on emergency assistance, to the extent permitted by preparedness; (C) development and Establishment of the Emergency law, in the event of such disasters. maintenance of an alerting system and Management Center (EMC) and the 5. Delegation of Authority and an overall regional emergency plan; (D) Comprehensive Emergency Assignment of Responsibilities. A. The conduct of liaison activities with Management Program (CEMP) Deputy Secretary of Labor is delegated Federal agencies involved in authority and assigned responsibility preparedness planning; and (E) 1. Purpose. The Department of Labor for: provision of regular information (DOL), through this Order, addresses the (1) Assuring Departmental support to regarding all such activities to the continuity of Departmental missions broader Federal government planning, ASAM or his designee; and under all operating conditions and preparedness, mitigation, response, and (6) Performing, or delegating as DOL’s roles and responsibilities in the recovery efforts under the National appropriate, any additional or similar National, homeland, and economic Response Plan; duties that may be assigned by the security arenas. DOL will formulate (2) Establishing DOL-wide procedures Secretary. plans and establish preparedness and permanent or ad hoc workgroups, C. The Assistant Secretary for Public programs to assure its capability to carry as appropriate, to study and/or Affairs is delegated authority and out its assigned functions during a implement activities and projects to assigned responsibility for developing, period of national emergency and to address needs determined through coordinating, and disseminating all DOL maintain Continuity of Operations Departmental communication and public information during emergency (COOP) and Continuity of Government coordination with other Federal activities and developing and (COG). In addition, this Order formally agencies, private sector entities, state, maintaining the Departmental Crisis establishes, within the Office of the local and tribal authorities, and the Communications Plan, consistent with Assistant Secretary for Administration public, or that develop through other delegations. and Management (OASAM), the incidents of national significance; and D. The Assistant Secretary for Emergency Management Center, which (3) Performing, or delegating as Congressional and Intergovernmental oversees DOL’s Comprehensive appropriate, any additional or similar Affairs is delegated authority and Emergency Management Program duties that may be assigned by the assigned responsibility, consistent with (CEMP). The CEMP shall consist of the Secretary. other delegations, to receive requests following programs and structures to B. The Assistant Secretary for and inquiries from congressional, state coordinate DOL capabilities, and ensure Administration and Management and local agencies relating to emergency DOL’s ability to carry out its missions (ASAM) is delegated authority and management related matters, to under any and all circumstances: assigned responsibility for: communicate all such requests and • Continuity of Government. (1) Developing, establishing and inquiries to the EMC and such DOL • Continuity of Operations. directing the dissemination of officials as may be appropriate, and to • Communications Security. standards, procedures, and instructions coordinate responses back to all such • Operations Security. relating to CEMP, and regularly congressional, state and local agencies. The CEMP provides the framework for evaluating Departmental performance The Assistant Secretary for coordination, planning, governance and measures to assess the readiness of Congressional and Intergovernmental resource allocation thus enabling DOL emergency management-related Affairs shall designate a liaison to the to fulfill its roles under all relevant programs; EMC. Federal authorities. (2) Directing the design of a E. The Assistant Secretary for 2. Authorities and Directives Affected. management information system that Occupational Safety and Health is A. Authorities. This Order is issued collects and processes all information delegated authority and assigned pursuant to the authorities listed in needs to fully effectuate CEMP, and the responsibility to ensure the Appendix A. maintenance of redundant Occupational Safety and Health-specific B. Directives Affected. This Order telecommunications and network CEMP and National Response Plan supersedes and cancels Secretary’s infrastructure as necessary for activities are carried out by providing Order 14–76, ‘‘Alerting System for coordination of emergency management safety and health advice, technical National Emergency’’ (June 1, 1976), operations; assistance, and follow-on enforcement and Secretary’s Order 23–76, (3) Coordinating all disaster and as appropriate in emergencies; and ‘‘Emergency Preparedness and Disaster emergency management investments, supporting Federal, state, and/or local Relief Functions’’ (November 18, 1976). including incident management or authorities’ efforts when determining if 3. Scope. This Order applies to all emergency management systems conditions are safe and healthy for Department personnel, organizational through e-Gov initiatives, so that they human entry or occupation, consistent components and activities. comply with the applicable federal with other delegations. 4. Establishment of the Emergency interoperability standards; F. The Assistant Secretary for Management Center. The Emergency (4) Establishing a process within DOL Employment and Training is delegated Management Center (EMC) is to ensure that acquisitions and activities authority and assigned responsibility, established within OASAM. The related to incident/emergency consistent with other delegations, for: Emergency Operations Center and all management are coordinated with the (1) Ensuring that the Employment and emergency management programs will ASAM or his designee; Training Administration-specific CEMP be directed from the EMC. EMC (5) Through the EMC, ensuring (A) the activities are carried out by assisting in oversees the CEMP and coordinates integration and coordination of achieving maximum emergency Departmental roles and responsibilities emergency management-related utilization of the civilian workforce, to adequately prepare for and respond to functions and personnel, including such as the Job Corps, and a full spectrum of potential natural or directing the management of security unemployment assistance programs and
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through job training and recruiting stabilization measures and develops 8. Effective Date. This Order is activities; and plans and programs to carry out damage effective immediately. (2) Providing overall supervision and assessments and data system programs. Dated: January 17, 2006. guidance in the development and L. The Solicitor of Labor is delegated Elaine L. Chao, coordination of programs and plans for authority and assigned responsibility for achieving maximum utilization of providing legal advice and counsel to Secretary of Labor. civilian manpower resources. the DOL agencies and offices on all Appendix A: Authorities G. The Assistant Secretary for matters arising in the administration of Employment Standards is delegated this Order. This Order is issued pursuant to: • 5 U.S.C. 301. authority and assigned responsibility, M. All Agency Heads are delegated • 6 U.S.C. 101. consistent with other delegations, for: the authority and assigned • 42 U.S.C. 5195. (1) Ensuring that the Employment responsibility for: • 36 CFR 1236, ‘‘Management of Vital Standards Administration-specific (1) Developing and maintaining Records’’ (July 1, 1998). CEMP activities are carried out; emergency plans necessary to carry out • 41 CFR 101–2, ‘‘Occupant Emergency (2) Providing overall supervision and the essential functions of their agency in Program’’ (July 1, 1998). guidance in the development and the National Office and the Field, • The Robert T. Stafford Disaster Relief coordination of programs and plans for consistent with the requirements of and Emergency Assistance Act, as amended administering the wage and salary critical infrastructure protection (CIP), by Public Law 106–390 (October 30, 2000). • stabilization and labor disputes COOP, and COG, and coordinating such Homeland Security Presidential program. plans with the EMC and other Directive 8, ‘‘National Preparedness’’ (December 17, 2003). H. The Assistant Secretary for Mine departments and agencies, as Safety and Health is delegated authority • Homeland Security Presidential appropriate; Directive 7, ‘‘Critical Infrastructure and assigned responsibility, consistent (2) Providing the necessary funds and with other delegations, for ensuring the Identification, Prioritization, and Protection’’ staff support to carry out the program (December 17, 2003). Mine Safety and Health Administration- responsibilities assigned herein; • Homeland Security Presidential specific CEMP activities are carried out (3) Coordinating all disaster and Directive 5, ‘‘Management of Domestic by advising and assisting in unique emergency management investments, Incidents’’ (February 23, 2003). emergency situations that require including incident management or • Homeland Security Presidential locating and rescuing individuals emergency management systems Directive 3, ‘‘Homeland Security Advisory trapped underground or in a mass of through e-Gov initiatives, with OASAM System’’ (March 11, 2002). • debris, to include developing and through the EMC to ensure compliance Executive Order 12345, ‘‘Providing an maintaining plans and facility readiness with the applicable federal Order of Succession within the Department of Labor’’ (December 18, 2001). for the use of the National Mine Health interoperability standards; and • and Safety Academy as part of Executive Order 13231, ‘‘Critical (4) Coordinating communications Infrastructure Protection in the Information Departmental COOP. relating to emergency management with Age’’ (October 16, 2001). I. The Assistant Secretary for congressional, state and local agencies • Executive Order 13228, ‘‘Establishing the Disability Employment Policy is through the Office of Congressional and Office of Homeland Security and the delegated authority and assigned Intergovernmental Affairs, in Homeland Security Council’’ (October 12, responsibility, consistent with other coordination with the EMC. 2001). delegations, for ensuring that the Office 6. Reservations of Authority and • Executive Order 12958 as amended, of Disability Employment Policy- Responsibility. A. The submission of ‘‘Classified National Security Information’’ specific CEMP activities are carried out (March 25, 2003). reports and recommendations to the • by ensuring that emergency President and Congress is reserved to Executive Order 12919, ‘‘National Defense Industrial Resources Preparedness’’ preparedness plans adequately address the Secretary. people with disabilities in the (June 3, 1994). B. This Secretary’s Order does not • Executive Order 12656, ‘‘Assignment of workforce. affect the authorities and Emergency Preparedness Responsibilities’’ J. The Assistant Secretary for Veterans responsibilities of the Office of (November 18, 1988). Employment and Training is delegated Inspector General under the Inspector • Executive Order 12472, ‘‘Assignment of authority and assigned responsibility to General Act of 1978, as amended, or National Security and Emergency assure veterans’ employment and under Secretary’s Order 2–90 (January Preparedness Telecommunications training service-specific CEMP activities 31, 1990). Functions’’ (April 3, 1984). are carried out by ensuring that C. This Secretary’s Order does not • Executive Order 12148, ‘‘Federal Emergency Management’’ (July 20, 1979). emergency preparedness plans address affect the Order of Succession for • the requirements and needs of veterans Executive Continuity as provided by National Security Presidential Directive 1, ‘‘Organization of the National Security and disabled veterans in the workforce. Secretary’s Order 4–2003 (October 14, Council System’’ (February 13, 2001). K. The Commissioner for Labor 2004). • Federal Preparedness Circular 65, Statistics is delegated authority and D. Heads of DOL Agencies charged ‘‘Federal Executive Branch Continuity of assigned responsibility, consistent with with direct responsibility for program Operations’’ (June 15, 2004). other delegations, for providing overall operations exercise the same authority • Presidential Decision Directive 67, supervision and guidance in the for these programs during emergencies ‘‘Enduring Constitutional Government and development and coordination of as currently delegated during normal Continuity of Government Operations’’ programs and plans for gathering operations. (October 21, 1998). • economic data (e.g., employment, 7. Re-delegation of Authority. Unless Presidential Decision Directive 62, unemployment, prices, productivity, identified as non-delegable under this ‘‘Combating Terrorism’’ (May 22, 1998). • The Initial National Response Plan wages, and earnings) as are necessary Order, authorities delegated within this (October 10, 2003). for the administration of economic Order may be re-delegated, provided, • The National Incident Management stabilization measures during an however, that re-delegation shall in no System (March 1, 2004). emergency and for the appraisal of the way diminish the delegating official’s • Deputy Secretary of Labor Memorandum, impact of proposed economic responsibility. ‘‘Department of Labor, Homeland Security
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Advisory System/Protective Measures’’ (September 18, 2002). [FR Doc. 06–619 Filed 1–23–06; 8:45 am] BILLING CODE 4510–23–U
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Part V
Department of Labor Management of United States Government Accountability Office Reports; Notice
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DEPARTMENT OF LABOR Governmental Affairs, the House (8) Maintain liaison with GAO Committee on Government Reform, the concerning all reports and responses. Office of the Secretary Committees on Appropriations of the (9) Provide oversight of DOL’s [Secretary’s Order 02–2006] Senate and the House and GAO responses to GAO reports, both draft indicating the action taken by the and final, monitor DOL’s Management of United States agency on the recommendations. Office implementation of accepted Government Accountability Office of Management and Budget (OMB) recommendations, and provide periodic Reports Circular A–50, Audit Followup, revised reports to the Deputy Secretary. September 29, 1982, provides policies (10) Provide advice and assistance to 1. Purpose. To delegate authority and and procedures for use by executive agency heads with regard to GAO assign overall responsibility for agencies when considering reports findings, recommendations, or coordinating, reviewing, and processing issued by GAO where follow-up is suggestions involving internal control, United States Government necessary. OMB Circular A–50 also accounting, and financial policies and Accountability Office (GAO) reports. specifies those GAO reports for which procedures. 2. Authority. This Order is issued agency heads will submit statements to (11) Establish policies and procedures under the authority of 5 U.S.C. 301 OMB. for DOL’s responses to GAO reviews (Departmental Regulations); 29 U.S.C. 7. Scope. These delegations apply to and reports. 551 (Establishment of Department: draft and final GAO reports as well as (12) Apprise the Deputy Secretary on Secretary; Seal); Reorganization Plan to related correspondence addressed to a quarterly basis, or as designated by the No. 6 of 1950 (5 U.S.C. Appendix 1); 31 the Secretary of Labor or other DOL Deputy Secretary, of active GAO U.S.C. 720 (Government Accountability official. reviews and reports relating to the Office, Agency Reports); and OMB 8. Policy. Findings, recommendations, Department. Circular A–50 (Audit Followup). or suggestions presented to the B. DOL Agency Heads will: (1) Expeditiously review and 3. Redelegations/Transfers of Department in a GAO report will be comment on GAO’s findings and Authority. Unless provided otherwise in given prompt and careful consideration. recommendations, and submit prepared this or another Secretary’s Order, the DOL agency heads must act promptly on responses to OCFO for final clearance authority delegated in this Order may be all recommendations that merit action. redelegated or transferred, as permitted through the Executive Secretariat. The action agency will comment on the (2) Establish sufficient controls to by law or regulation. findings in a GAO report indicating 4. Reservation of Authority. The ensure the prompt preparation of whether the recommendations will be submission of reports and comments to be furnished to adopted, considered further, or have recommendations to the President and Congressional committees, OMB, GAO, been found to be unacceptable. the Congress concerning the and implementation of Comments indicating agreement must administration of statutory or recommendations that merit action. include planned corrective actions and, administrative provisions is reserved to (3) Designate an individual within the where appropriate, dates for the Secretary. agency to serve as the central contact for 5. Directives Affected. Secretary’s implementing these actions. If the the CFO regarding GAO review and Order 04–1992 is canceled. This recommendations are found to be report activities and related matters. Secretary’s Order does not affect the unacceptable, the reasons for (4) Direct all communications authorities and responsibilities of the disagreement shall be fully explained. received from the GAO, Congress, or 9. Delegation of Authority and Office of the Inspector General under other government agencies pertaining to Assignment of Responsibilities. GAO reports to the attention of the CFO. the Inspector General Act of 1978, as A. The Chief Financial Officer (CFO) amended, or under Secretary’s Order 2– (5) Ensure that appropriate is delegated overall authority and departmental clearances on responses to 90 (January 31, 1990). assigned responsibility for the GAO 6. Background. Title 31, Chapter 7 of GAO reports are obtained, including reports and will: coordinating with SOL to obtain OMB the United States Code establishes GAO (1) Act as the DOL control official for as an independent instrumentality of clearances. Items found at issue during all GAO audits, studies, and reports and the response clearance phase will the U.S. Government independent of all correspondence received from the executive departments, and sets forth promptly be brought to the attention of Congress and other governmental the CFO for resolution. the duties and powers of its head, the agencies relating to such GAO matters. Comptroller General. Among these (6) Ensure that appropriate GAO (2) Serve as the GAO Liaison and responses with the agency heads’ duties is the responsibility to investigate point of contact for all GAO audits and the use of public money. Federal signature reach Congressional studies (hereinafter, ‘‘reviews’’). committees, OMB, and GAO within agencies are charged with giving the (3) Review and approve, or Comptroller General specified mandated time frames. disapprove, all written comments on C. The Solicitor of Labor is delegated information and permitting GAO draft and final GAO reports. inspection of agency records. In authority and assigned responsibility to: (4) Resolve all disagreements that may (1) Provide legal advice and assistance addition, GAO evaluates programs and arise between DOL agencies regarding to all officials of the Department relating activities of the U.S. Government. 31 responses to GAO reports, both draft to the authorities of this Order. U.S.C. 719 directs the Comptroller and final. (2) Review proposed agency General to report to Congress on agency (5) Act as DOL’s liaison to other submissions of records and responses. expenditures, contracts, administrative Federal agencies for GAO report 10. Effective Date. This Order is controls, and the status of fiscal matters. effective immediately. accounts. 31 U.S.C. 720 requires that (6) Notify appropriate DOL agencies following issuance of a GAO report that of planned GAO work. Dated: January 17, 2006. contains recommendations to the head (7) Designate action agencies to Elaine L. Chao, of an agency, the agency must submit a prepare responses to GAO reports and Secretary of Labor. written statement to the Senate stipulate the deadline required for such [FR Doc. 06–618 Filed 1–23–06; 8:45 am] Committee on Homeland Security and responses. BILLING CODE 4510–23–P
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CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING JANUARY
Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 1033...... 545, 3435 Presidential Documents 3 CFR 1124...... 545 Executive orders and proclamations 741–6000 Proclamations: 1126...... 545 The United States Government Manual 741–6000 6867 (See: Notice of 1131...... 545 January 10, 2006)...... 2133 Other Services 1493...... 3790 7757 (See: Notice of 1496...... 3442 Electronic and on-line services (voice) 741–6020 January 10, 2006)...... 2133 Privacy Act Compilation 741–6064 7973...... 3199 9 CFR Public Laws Update Service (numbers, dates, etc.) 741–6043 7974...... 3201 78...... 2991 TTY for the deaf-and-hard-of-hearing 741–6086 Executive Orders: 317...... 1683 12947 (See Notice of 381...... 1683 January 18, 2006)...... 3407 391...... 2135 ELECTRONIC RESEARCH 13099 (See Notice of 590...... 2135 World Wide Web January 18, 2006)...... 3407 592...... 2135 13395...... 3203 Full text of the daily Federal Register, CFR and other publications Proposed Rules: is located at: http://www.gpoaccess.gov/nara/index.html Administrative Orders: 77...... 1985 Memorandums: 318...... 2483 Federal Register information and research tools, including Public Memorandum of 381...... 2483 Inspection List, indexes, and links to GPO Access are located at: December 15, 392...... 1988 http://www.archives.gov/federallregister/ 2005 ...... 1467 439...... 2483 E-mail Presidential Determinations: 10 CFR FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is No. 2006–6 of 35...... 1926 an open e-mail service that provides subscribers with a digital December 22, Proposed Rules: form of the Federal Register Table of Contents. The digital form 2005 ...... 1469 20...... 29 of the Federal Register Table of Contents includes HTML and No. 2006–7 of 30...... 29, 275 PDF links to the full text of each document. December 30, 31...... 29, 275 To join or leave, go to http://listserv.access.gpo.gov and select 2005 ...... 871 32...... 29, 275 Online mailing list archives, FEDREGTOC-L, Join or leave the list No. 2006–8 of 33...... 29 (or change settings); then follow the instructions. December 30, 35...... 29 2005 ...... 1471 73...... 3791 PENS (Public Law Electronic Notification Service) is an e-mail Notices: 150...... 275 service that notifies subscribers of recently enacted laws. Notice of January 6, To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 2006 ...... 1681 12 CFR and select Join or leave the list (or change settings); then follow Notice of January 10, 205...... 1473, 1638 the instructions. 2006 ...... 2133 Proposed Rules: FEDREGTOC-L and PENS are mailing lists only. We cannot Notice of January 18, Ch. I ...... 287 respond to specific inquiries. 2006 ...... 3407 Ch. II ...... 287 Ch. III ...... 287 Reference questions. Send questions and comments about the 5 CFR Ch. V...... 287 Federal Register system to: [email protected] 337...... 3409 611...... 1704 The Federal Register staff cannot interpret specific documents or 1650...... 1389 regulations. Proposed Rules: 14 CFR 1651...... 1984 11...... 1483 FEDERAL REGISTER PAGES AND DATE, JANUARY 21...... 534 7 CFR 23 ...... 537, 1926, 2143 1–230...... 3 226...... 1 25...... 1485, 3753 231–536...... 4 400...... 2135 36...... 530 537–872...... 5 930...... 1915 39 ...... 231, 873, 1390, 1930, 873–1388...... 6 946...... 1919 1935, 1937, 1939, 1941, 1389–1472...... 9 982...... 1921 1947, 1949, 1951, 2453, 1740...... 3205 2455, 2857, 2859, 2993, 1473–1682...... 10 Proposed Rules: 2995, 3209, 3210, 3212, 1683–1914...... 11 56...... 2168 3214, 3216, 3754, 3757 1915–2134...... 12 70...... 2168 71 ...... 537, 2145, 2997, 2998, 2135–2452...... 13 319...... 1700 3759, 3760, 3761 2453–2856...... 17 1000...... 545 73...... 2146 2857–2990...... 18 1001...... 545 95...... 2998 2991–3204...... 19 1005...... 545 97...... 1393, 1686 3205–3408...... 20 1006...... 545 121 ...... 534, 1666, 1688 3409–3752...... 23 1007...... 545 135...... 534 3753–4032...... 24 1030...... 545 Proposed Rules: 1032...... 545 39 ...... 291, 293, 295, 297, 299,
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1718, 2491, 3021, 3023, Proposed Rules: 16...... 232 7...... 208, 211 3248, 3792 1...... 2496 35...... 17 8...... 221 71 ...... 552, 889, 1397, 1398, 31...... 46 52.....19, 21, 24, 241, 244, 541, 9...... 219, 227 3794 301 ...... 2497, 2498, 3248 1463, 1696, 3009, 3412, 11...... 211, 227 3764, 3768, 3770, 3773, 12 ...... 211, 219, 220 15 CFR 27 CFR 3776 14...... 219 930...... 788 Proposed Rules: 60...... 2472, 3776 16...... 211 9...... 1500 61...... 2472 17...... 219 17 CFR 63...... 1378 19...... 220, 221 36...... 1953 28 CFR 81...... 24, 541 22...... 219, 864 37...... 1953 16...... 16 86...... 2810 25 ...... 219, 221, 223, 224, 227, 38...... 1953 105...... 1690 141...... 388, 654 864 39...... 1953 Proposed Rules: 142...... 388, 654 27...... 227 40...... 1953 61...... 3248 180...... 2889 34...... 227 242...... 232 239...... 3779 37...... 211 Proposed Rules: 29 CFR 257...... 3779 38...... 227 4...... 1463 1926...... 2879 258...... 3779 39...... 211, 227 1952...... 2885 271...... 3220 42...... 200, 221 18 CFR 2520...... 1904 300...... 3227 43...... 227 11...... 2863 4022...... 2147 Proposed Rules: 44...... 225 2...... 1348 4044...... 2147, 2148 50...... 2620 46...... 200, 227 33...... 1348 Proposed Rules: 51...... 69 47...... 200 48...... 227 Proposed Rules: 2700...... 553 52 ...... 85, 569, 577, 890, 892, 50...... 227 35...... 303 2704...... 553 1994, 1996, 2177, 3029, 52 ...... 200, 208, 219, 221, 224, 370...... 303 2705...... 553 3795, 3796 53...... 2710 225, 226, 227, 864 19 CFR 30 CFR 58...... 2710 53...... 200 213...... 3412 12...... 3000 48...... 3613 60...... 2509 215...... 3413 101...... 2457 946...... 1488 61...... 2509 63...... 1386, 1403 219...... 3414 20 CFR 31 CFR 86...... 2843 237...... 3415 241...... 3416, 3418 404 ...... 2312, 2871, 3217 103...... 496 122...... 894 252...... 3415 416...... 2871, 3217 215...... 2149 180...... 901 253...... 3412 501...... 1971 239...... 3797 1631...... 3015 21 CFR Proposed Rules: 257...... 3797 258...... 3797 1644...... 3015 201...... 3922 103...... 516 1652...... 3015 210...... 2458 501...... 1994 745...... 1588 1604...... 309 2401...... 2432 314...... 3922 2402...... 2432 510...... 875, 2147 32 CFR 41 CFR 2406...... 2432 520...... 875 199...... 1695 2408...... 2432 522...... 1689 Proposed Rules: 105...... 3781 301–10...... 876 2409...... 2432 558...... 5, 1689 153...... 3254 2411...... 2432 Proposed Rules: 601...... 3922 2413...... 2432 33 CFR 60-2...... 3374 803...... 1488 2415...... 2432 60-300...... 3352 Proposed Rules: 110...... 3001 2416...... 2432 56...... 2493 117 ...... 1494, 2151, 3763 42 CFR 2419...... 2432 210...... 2494 165 ...... 538, 2152, 2886, 3003, 2422...... 2432 310...... 2309 3005, 3007 419...... 2617 2426...... 2432 866...... 1399 Proposed Rules: Proposed Rules: 2432...... 2432 110...... 3025 412...... 3616 22 CFR 2437...... 2432 117...... 2176 424...... 3616 2442...... 2432 122...... 3762 165...... 3027, 3442 43 CFR 2446...... 2432 129...... 3762 207...... 3446 2448...... 2432 Proposed Rules: 2452...... 2432 23 CFR 36 CFR 2930...... 2899 Proposed Rules: Proposed Rules: 223 ...... 522, 523, 3409 46 CFR 201...... 3446 1313...... 29 1011...... 2109 205...... 3446 Proposed Rules: 10...... 2154 211...... 3446 24 CFR 219...... 307 216...... 3446 47 CFR 401...... 2112 217...... 3446 402...... 2112 37 CFR 1...... 2167 219...... 3446 Proposed Rules: Proposed Rules: 64...... 2895, 3014 223...... 3446 401...... 2126 1...... 48, 61 73 ...... 245, 246, 247, 877 225...... 3446, 3448 402...... 2126 2...... 2498 Proposed Rules: 228...... 3446 1000...... 2176 20...... 3029 232...... 3446 38 CFR 54...... 1721 236...... 3446 25 CFR 17...... 2464 73...... 312, 313 237...... 3446 243...... 2426 21...... 1496 242...... 3449 48 CFR 252...... 3446, 3449 26 CFR 39 CFR Ch. 1 ...... 198, 228, 864, 866 Ch. 8 ...... 2342 1 ...... 6, 11, 1971, 2462, 4002 111...... 1976 1...... 200 2404...... 2444 20...... 2147 3001...... 2464 2...... 208, 211 2408...... 2444 31...... 11 4...... 208 2415...... 2444 301...... 3219, 4002 40 CFR 5...... 219, 220 2437...... 2444 602...... 6, 4002 9...... 388, 654 6...... 219 2439...... 2444
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2452...... 2444 219...... 1498 50 CFR 648...... 1982, 3016 9903...... 313 383...... 2897, 3613 223...... 834 679...... 1698, 3429 384...... 2897, 3613 224...... 834 Proposed Rules: 49 CFR 571...... 877, 3786 229...... 1980 17...... 315, 3158 71...... 3228 Proposed Rules: 299...... 247 223...... 3033 171...... 3418 192...... 1504 600...... 27 270...... 3797 172...... 3418 660 ...... 1998, 2510, 3254 1105...... 3030 622...... 3018 173...... 3418 635 ...... 273, 1395, 3245 679...... 386
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REMINDERS due by 1-31-06; published standard; comments due published 11-3-05 [FR 05- The items in this list were 12-2-05 [FR E5-06786] by 2-3-06; published 1-4- 21573] editorially compiled as an aid Spearmint oil produced in— 06 [FR E5-08217] INTERIOR DEPARTMENT to Federal Register users. Far West; comments due by ENVIRONMENTAL Fish and Wildlife Service PROTECTION AGENCY Inclusion or exclusion from 2-3-06; published 12-5-05 Endangered and threatened this list has no legal [FR 05-23620] Air programs: species: significance. AGRICULTURE Fuel and fuel additives— Critical habitat DEPARTMENT Renewable Fuel Program; designations— Federal Crop Insurance RULES GOING INTO 2006 default standard; California red-legged frog; Corporation comments due by 1-30- EFFECT JANUARY 24, comments due by 2-1- Crop insurance regulations: 06; published 12-30-05 2006 06; published 11-3-05 Basic provisions; written [FR 05-24611] [FR 05-21594] Renewable Fuel Program; agreements and use of INTERIOR DEPARTMENT COMMERCE DEPARTMENT similar agricultural 2006 default standard; National Oceanic and commodities; comments comments due by 1-30- Minerals Management Atmospheric Administration due by 1-30-06; published 06; published 12-30-05 Service Fishery conservation and 11-30-05 [FR 05-23509] [FR 05-24610] Royalty management: management: AGRICULTURE Air quality implementation Federal leases on takes or Caribbean, Gulf, and South DEPARTMENT plans: entitlements basis; Atlantic fisheries— Forest Service Ambient air quality reporting and paying royalties; meeting; Red grouper; published 1- National Forest System land standards, national— comments due by 1-30- 19-06 and resource management Fine particles; comments 06; published 11-29-05 planning: due by 1-31-06; ENVIRONMENTAL [FR 05-23380] PROTECTION AGENCY 2005 planning rule; published 11-1-05 [FR 05-20455] LABOR DEPARTMENT Air quality implementation amendments; comments Occupational Safety and plans; approval and due by 2-3-06; published Fine particles; hearing; Health Administration promulgation; various 1-4-06 [FR E5-08245] comments due by 1-31- States: BLIND OR SEVERELY 06; published 11-15-05 Construction and occupational [FR 05-22694] safety and health standards: Indiana; published 11-25-05 DISABLED, COMMITTEE Air quality implementation Roll-over protective Solid waste: FOR PURCHASE FROM PEOPLE WHO ARE plans; approval and structures; comments due Hazardous waste; Committee for Purchase promulgation; various by 1-30-06; published 12- identification and listing From People Who Are Blind States: 29-05 [FR 05-24462] Exclusions; published 11- or Severely Disabled Michigan; comments due by SOCIAL SECURITY 25-05 Javits-Wagner-O’Day (JWOD) 1-30-06; published 12-29- ADMINISTRATION 05 [FR E5-08036] GENERAL SERVICES Program: Social security benefits: ADMINISTRATION Montana; comments due by Nonprofit agencies and Disability benefits; 2-2-06; published 1-3-06 Privacy Act; organizational central nonprofit agencies; suspension during [FR 05-24365] changes; published 1-24-06 governance standards; continuing disability STATE DEPARTMENT comments due by 1-31- Tennessee; comments due reviews; comments due by 2-2-06; published 1-3- International Traffic in Arms 06; published 12-16-05 by 2-3-06; published 12-5- 06 [FR 05-24412] regulations: [FR E5-07439] 05 [FR 05-23615] CHEMICAL SAFETY AND Pesticides; tolerances in food, Fugitive felons and Registration fee change; animal feeds, and raw published 1-24-06 HAZARD INVESTIGATION probation or parole BOARD agricultural commodities: violators; nonpayment of TRANSPORTATION Accident investigation initiation Hexythiazox; comments due benefits; comments due DEPARTMENT notice and order to preserve by 1-30-06; published 12- by 2-3-06; published 12-5- Federal Aviation evidence; comments due by 30-05 [FR E5-08037] 05 [FR 05-23618] Administration 2-3-06; published 1-4-06 HEALTH AND HUMAN TRANSPORTATION Airworthiness directives: [FR E5-08239] SERVICES DEPARTMENT DEPARTMENT Airbus; published 12-20-05 COMMERCE DEPARTMENT Quarantine, inspection, and Air travel; nondiscrimination on Dassault; published 12-20- National Oceanic and licensing: basis of disability: 05 Atmospheric Administration Communicable diseases Medical oxygen and TREASURY DEPARTMENT Fishery conservation and control; comments due by portable respiration Internal Revenue Service management: 1-30-06; published 11-30- assistive devices; 05 [FR 05-23312] Income taxes: West Coast States and comments due by 1-30- Western Pacific HOMELAND SECURITY 06; published 10-21-05 Widely held fixed investment fisheries— DEPARTMENT [FR 05-21078] trusts; reporting requirements; published 1- Coastal pelagic species; Coast Guard TRANSPORTATION 24-06 comments due by 2-1- Drawbridge operations: DEPARTMENT 06; published 1-17-06 Washington; comments due Federal Aviation [FR E6-00419] Administration COMMENTS DUE NEXT by 2-3-06; published 12-5- ENERGY DEPARTMENT 05 [FR 05-23637] WEEK Air carrier certification and Federal Energy Regulatory Pollution: operations: Commission Pollution prevention Transport category AGRICULTURE Electric utilities (Federal Power equipment; oil discharge airplanes; enhanced DEPARTMENT Act) and natural gas reduction from vessels, airworthiness program for Agricultural Marketing companies (Natural Gas and elimination of ozone- airplane systems and fuel Service Act): depleting solvents in tank safety; comments Soybean promotion and Jurisdictional agreements equipment tests; due by 2-3-06; published research order; comments modifications; review comments due by 2-1-06; 10-6-05 [FR 05-19419]
VerDate Aug 31 2005 17:33 Jan 23, 2006 Jkt 208001 PO 00000 Frm 00004 Fmt 4712 Sfmt 4711 E:\FR\FM\24JACU.LOC 24JACU wwhite on PROD1PC61 with FRCU Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006 / Reader Aids v
Airworthiness directives: Mooney M20M and TRANSPORTATION text will also be made BAE Systems (Operations) M20R airplanes; DEPARTMENT available on the Internet from Ltd.; comments due by 2- comments due by 1-30- National Highway Traffic GPO Access at http:// 3-06; published 1-4-06 06; published 12-30-05 Safety Administration www.gpoaccess.gov/plaws/ [FR E5-08243] [FR 05-24668] Alcohol-impaired driving index.html. Some laws may Boeing; comments due by prevention programs; not yet be available. 1-30-06; published 12-15- Transport category incentive grant criteria; 05 [FR 05-24052] airplanes— comments due by 2-2-06; H.R. 4340/P.L. 109–169 United States-Bahrain Free Empresa Brasileira de Airplane performance and published 1-3-06 [FR 05- Trade Agreement Aeronautica S.A. handling qualities in 24623] Implementation Act (Jan. 11, (EMBRAER); comments icing conditions; 2006; 119 Stat. 3581) due by 2-3-06; published comments due by 2-2- 1-4-06 [FR E5-08242] LIST OF PUBLIC LAWS 06; published 11-4-05 Last List January 12, 2006 Eurocopter France; [FR 05-21793] comments due by 2-3-06; This is a continuing list of public bills from the current published 12-5-05 [FR 05- Class E airspace; comments session of Congress which Public Laws Electronic 23602] due by 2-3-06; published have become Federal laws. It Fokker; comments due by 12-20-05 [FR 05-24228] Notification Service 2-3-06; published 1-4-06 may be used in conjunction (PENS) [FR E5-08240] TRANSPORTATION with ‘‘PLUS’’ (Public Laws Gulfstream; comments due DEPARTMENT Update Service) on 202–741– PENS is a free electronic mail by 2-3-06; published 1-4- 6043. This list is also notification service of newly 06 [FR E5-08241] Federal Highway available online at http:// enacted public laws. To Learjet; comments due by Administration www.archives.gov/federal- subscribe, go to http:// 2-3-06; published 12-5-05 register/laws.html. Engineering and traffic listserv.gsa.gov/archives/ [FR 05-23510] operations: The text of laws is not publaws-l.html McCauley Propeller published in the Federal Systems; comments due Interstate system; highway Register but may be ordered Note: This service is strictly by 1-30-06; published 11- construction and in ‘‘slip law’’ (individual for E-mail notification of new 30-05 [FR 05-23430] reconstruction projects; pamphlet) form from the laws. The text of laws is not Airworthiness standards: design standards; Superintendent of Documents, available through this service. Special conditions— comments due by 1-30- U.S. Government Printing PENS cannot respond to Garmin International, Inc.; 06; published 11-30-05 Office, Washington, DC 20402 specific inquiries sent to this GFC-700 AFCS on [FR 05-23476] (phone, 202–512–1808). The address.
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