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Code · REGISTER · 2006-11-13 · PROPOSED RULES · Agricultural Agricultural Marketing Service RULES Apricots grown in Washington, 66093-66095 E6-19079 Cherries (tart) grown in Michigan, et al., 66095-66098 E6-19078 Agriculture Agriculture Department · Unknown

Unknown. Final rule

19,354 words·~88 min read·/register/2006/11/13/06-9113

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2006-11-13.xml --- 71 218 Monday, November 13, 2006 Contents Agricultural Agricultural Marketing Service RULES Apricots grown in Washington, 66093-66095 E6-19079 Cherries
(tart)grown in Michigan, et al., 66095-66098 E6-19078 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Commodity Credit Corporation See Forest Service Animal Animal and Plant Health Inspection Service NOTICES Meetings: Imported plants; evaluating invasive potential; electronic public discussion, 66156-66157 E6-18768 Centers Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 66173 E6-19100 National Center for Environmental Health/Agency for Toxic Substances and Disease Registry— Scientific Counselors Board, 66173-66174 E6-19088 National Institute for Occupational Safety and Health— Radiation and Worker Health Advisory Board, 66174 E6-19080 Centers Centers for Medicare & Medicaid Services NOTICES Medicaid: State plan amendments, reconsideration; hearings— Colorado, 66174-66175 E6-19069 Coast Guard Coast Guard RULES Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.: St. Louis River, Duluth, MN, 66110-66112 E6-19105 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Commodity Credit Corporation PROPOSED RULES Loan and purchase programs: Sugar Program— Allocation shortfalls reassignment, 66142-66143 E6-19076 NOTICES Domestic Sugar Program: 2005- and 2006-crop cane sugar and sugar beet marketing allotments and company allocations, 66157-66160 E6-19077 Consumer Consumer Product Safety Commission PROPOSED RULES Flammable Fabrics Act: Carpets and rugs; flammability standards, 66145-66147 E6-19095 Customs Customs and Border Protection Bureau NOTICES Environmental statements; notice of intent: Webb County, TX; Laredo North and South stations road improvement and non-native vegetation removal project, 66182-66183 06-9163 Defense Defense Department RULES Air traffic; emergency security control plan Correction, 66110 06-9113 Education Education Department NOTICES Meetings: Institutional Quality and Integrity National Advisory Committee, 66170 E6-18652 Energy Energy Department NOTICES Memorandums of understanding: Interior Department; migratory bird protection; implementation, 66170-66171 06-9185 EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States: Louisiana, 66113-66116 E6-19020 Hazardous waste program authorizations: Louisiana, 66116-66119 E6-19089 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: Louisiana, 66153 E6-19018 Hazardous waste program authorizations: Louisiana, 66154 E6-19090 Executive Executive Office of the President See National Drug Control Policy Office See Presidential Documents FAA Federal Aviation Administration RULES Airworthiness directives: BAE Systems (Operations) Ltd., 66104-66108 E6-18965 E6-18966 PROPOSED RULES Class D airspace, 66144-66145 06-9179 NOTICES Aeronautical land-use assurance; waivers: Bruce Campbell Field, MS, 66214-66215 06-9180 Henry Tift Myers Airport, GA, 66215 06-9178 Miami International Airport, FL, 66215-66216 06-9173 Agency information collection activities; proposals, submissions, and approvals, 66216 06-9174 Airport noise compatibility program: Fort Lauderdale-Hollywood International Airport, FL; correction, 66220 C6-8975 Exemption petitions; summary and disposition, 66216-66217 06-9183 FDIC Federal Deposit Insurance Corporation RULES Membership advertisement: New insurance logo to be used by all insured depository institutions, etc., 66098-66104 E6-18802 Federal Highway Federal Highway Administration NOTICES Environmental statements; notice of intent: Salem and Polk and Marion Counties, OR, 66217 06-9159 Federal Mediation Federal Mediation and Conciliation Service NOTICES Grants and cooperative agreements; availability, etc.: Labor-Management Cooperation Program, 66171 E6-19082 Federal Motor Federal Motor Carrier Safety Administration NOTICES Driver qualifications; vision requirement exemptions, 66217-66218 E6-19107 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Change in bank control, 66171 E6-19093 Formations, acquisitions, and mergers, 66171-66172 E6-19092 Fish Fish and Wildlife Service NOTICES Endangered and threatened species and marine mammal permit applications, 66187-66188 E6-19072 E6-19074 Environmental statements; availability, etc.: Incidental take permits— Orange County, CA; Orange County Southern Subregion Habitat Conservation Plan, 66188-66191 E6-18971 Food Food and Drug Administration RULES Human drugs: Prescription drug marketing; applicability date delay, 66108-66109 E6-18892 Forest Forest Service NOTICES National Forest System lands: Timber sale contracts; substantial overriding public interest finding; extension, 66160-66162 E6-19102 Reports and guidance documents; availability, etc.: Open Space Conservation Strategy and Implementation Plan, 66162-66163 E6-19060 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health NOTICES National Toxicology Program: Federal agency testing programs; non-animal and alternative assays for relevant and reliable integration methods; 5-year plan, 66172-66173 E6-19094 Health Health Resources and Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 66175-66176 E6-19087 Homeland Homeland Security Department See Coast Guard See Customs and Border Protection Bureau See U.S. Citizenship and Immigration Services Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 66184 E6-19054 Grant and cooperative agreement awards: Service Coordinators in Multifamily Housing Program, 66184-66187 E6-19057 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Indian Gaming Commission See Reclamation Bureau See Surface Mining Reclamation and Enforcement Office International International Trade Administration NOTICES Antidumping: Corrosion-resistant carbon steel flat products from— Germany, 66163-66165 E6-19109 Honey from— China, 66165 E6-19113 Countervailing duties: In-shell roasted pistachios from— Iran, 66165-66167 E6-19108 Scope rulings and anticircumvention determinations; list, 66167-66169 E6-19111 International International Trade Commission NOTICES Import investigations: Connecting devices for use with modular compressed air conditioning units, including filters, regulators, and lubricators, 66193-66194 E6-19070 Digital multimeters and products with multimeter functionality, 66194-66195 E6-19073 High-brightness light emitting diodes and products containing same, 66195 E6-19071 Justice Justice Department NOTICES Pollution control; consent judgments: Bill D. Stallings and Stallings Salvage, Inc., 66195-66196 06-9167 Bunge North America, Inc., 66196-66197 06-9166 Cummins Engine Co., Inc., 66197 06-9165 Greater Lawrence Sanitary District, 66197 06-9168 Land Land Management Bureau NOTICES Meetings: Resource Advisory Councils— Southwest Colorado, 66191 E6-19091 Wild Horse and Burro Advisory Board, 66191-66192 E6-19099 NASA National Aeronautics and Space Administration RULES Acquisition regulations: Earned Value Management System; implementation, 66120-66122 E6-18918 National Drug National Drug Control Policy Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 66197-66198 E6-19081 National Indian National Indian Gaming Commission PROPOSED RULES Classification standards: Class II gaming; bingo, lotto, et al. Analytical reports availability, 66147-66148 E6-19065 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 66176-66177 E6-19050 Meetings: Advisory Committee to Director, 66177-66178 06-9150 National Heart, Lung, and Blood Institute, 66178 06-9155 National Institute of Biomedical Imaging and Bioengineering, 66178 06-9153 National Institute of Child Health and Human Development, 66179 06-9170 National Institute of Diabetes and Digestive and Kidney Diseases, 66178-66179 06-9151 06-9154 National Institute of Mental Health, 66179 06-9169 Recombinant DNA Advisory Committee, 66180 06-9172 Scientific Review Center, 06-9152 66180-66182 06-9156 06-9171 Patent licenses; non-exclusive, exclusive, or partially exclusive: Sapphire Therapeutics, Inc., 66182 E6-19051 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: West Coast States and Western Pacific fisheries— Pacific Coast groundfish, 66122-66141 E6-19106 PROPOSED RULES Fishery conservation and management: Atlantic highly migratory species— Atlantic sharks, 66154-66155 06-9176 NOTICES Meetings: Caribbean Fishery Management Council, 66169-66170 E6-19068 National Science National Science Foundation NOTICES Agency information collection activities; proposals, submissions, and approvals, E6-19103 66198-66200 E6-19104 Meetings: Financial support proposals; review and evaluation, 66200-66201 06-9182 International Science and Engineering Advisory Committee, 66201 06-9181 Nuclear Nuclear Regulatory Commission NOTICES *Applications, hearings, determinations, etc.:* Exelon Generation Co., LLC, 66201 E6-19097 H&G Inspection Co., Inc., 66201-66203 E6-19098 National Office of National Drug Control Policy See National Drug Control Policy Office Presidential Presidential Documents ADMINISTRATIVE ORDERS Iran; continuation of national emergency (Notice of November 9, 2006), 66225-66227 06-9200 Vietnam; determinations under the Omnibus Trade and Competitiveness Act of 1988 (Memorandum of November 6, 2006), 66221-66224 06-9193 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 66203-66204 E6-19067 Reclamation Reclamation Bureau NOTICES Central Valley Project Improvement Act: Water management plans; evaluation criteria development, 66192-66193 E6-19083 Saint Lawrence Saint Lawrence Seaway Development Corporation RULES Seaway regulations and rules: Civil monetary penalty; inflation adjustment, 66112-66113 E6-19052 SEC Securities and Exchange Commission NOTICES Investment Company Act of 1940: Annuity Investors Life Insurance Co. et al., 66204-66211 E6-19075 Securities: Suspension of trading— FluNation, Inc., et al., 66211 06-9189 Self-regulatory organizations; proposed rule changes: NYSE Arca, Inc., 66211-66213 E6-19063 SBA Small Business Administration NOTICES Disaster loan areas: Indiana, 66213 E6-19053 Louisiana, 66213 E6-19055 Meetings: National Small Business Development Center Advisory Board, 66213-66214 E6-19062 Small business investment companies: Maximum leverage ceiling increase, 66214 E6-19058 Small business size standards: Nonmanufacturer rule; waivers— Personal computers, 66214 E6-19056 Surface Surface Mining Reclamation and Enforcement Office PROPOSED RULES Permanent program and abandoned mine land reclamation plan submissions: Indiana, 66148-66150 E6-19085 Texas, 66150-66153 E6-19084 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Saint Lawrence Seaway Development Corporation See Transportation Statistics Bureau Transportation Transportation Statistics Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 66219 E6-19096 MISSING FOR: U.S. Citizenship and Immigration Services U.S. Citizenship and Immigration Services NOTICES Agency information collection activities; proposals, submissions, and approvals, 66183-66184 E6-19048 Separate Parts In This Issue Part II Executive Office of the President, Presidential Documents, 66221-66224 06-9193 Part III Executive Office of the President, Presidential Documents, 66225-66227 06-9200 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 71 218 Monday, November 13, 2006 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 922 [Docket No. FV06-922-2 FIR] Apricots Grown in Designated Counties in Washington; Temporary Relaxation of the Minimum Grade Requirement AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The Department of Agriculture
(USDA)is adopting, as a final rule, without change, an interim final rule that relaxed the minimum grade requirement prescribed under the Washington apricot marketing order for the 2006 shipping season. The marketing order regulates the handling of fresh apricots grown in designated counties in the State of Washington, and is administered locally by the Washington Apricot Marketing Committee (Committee). This rule continues in effect the action that relaxed the fresh apricot minimum grade requirement from Washington No. 1 grade to Washington No. 2 grade. Taking into consideration pre-harvest hail damage, this change was made for the purpose of increasing the supply of marketable fresh apricots while increasing the potential for higher producer returns. EFFECTIVE DATE: December 13, 2006. FOR FURTHER INFORMATION CONTACT: Robert J. Curry or Gary D. Olson, Northwest Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1220 SW Third Avenue, Suite 385, Portland, Oregon 97204-2807; Telephone:
(503)326-2724; Fax:
(503)326-7440; or E-Mail: *Robert.Curry@usda.gov* or *GaryD.Olson@usda.gov* . Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone
(202)720-2491; Fax:
(202)720-8938; or E-mail: *Jay.Guerber@usda.gov* . SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Agreement and Order No. 922 (7 CFR part 922) regulating the handling of apricots grown in designated counties in Washington, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Department of Agriculture
(USDA)is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. The interim final rule being adopted by this rule relaxed the minimum grade requirement for fresh apricots produced in Washington State from Washington No. 1 grade to Washington No. 2 grade. Based on pre-harvest hail damage, this change was made for the purpose of increasing the supply of marketable fresh apricots while increasing the potential for higher producer returns. The minimum grade requirement will revert to Washington No. 1 grade on April 1, 2007, for the 2007 and future seasons. Section 922.52 of the order authorizes the issuance of regulations for grade, size, quality, maturity, pack, and container for any variety of apricots grown in the production area. Section 922.53 further authorizes the modification, suspension, or termination of regulations issued pursuant to § 922.52. Section 922.55 provides that whenever apricots are regulated pursuant to §§ 922.52 or 922.53, such apricots must be inspected by the Federal-State Inspection Service, and certified as meeting the applicable requirements of such regulations. Minimum grade, maturity, color, and size requirements for Washington apricots regulated under the order are specified in § 922.321 *Apricot Regulation 21* . Section 922.321 provides, in part, that no handler shall handle any container of apricots unless such apricots grade not less than Washington No. 1, except for shipments subject to exemption under the regulation. In addition, the section provides that the Moorpark variety in open containers must be generally well matured. That section also provides that, with the exception of exempt shipments, apricots must be at least reasonably uniform in color, and be not less than 1 5/8 inches in diameter, except for the Blenheim, Blenril, and Tilton varieties which must be not less than 1 1/4 inches in diameter. Individual shipments of apricots are exempt from these requirements if sold for home use only, do not, in the aggregate, exceed 500 pounds net weight, and each container is stamped or marked with the words “not for resale.” The interim final rule being adopted by this action revised paragraph (a)(1) of § 922.321 by temporarily changing the minimum grade requirement for fresh shipments of apricots from Washington No. 1 grade to Washington No. 2 grade for the 2006 shipping season only. This change was based on a request from a handler representing several producers and recommended by the Committee in a vote of nine to one to facilitate the handling of fruit damaged by hail. The 2006 Washington apricot shipping season started in late June and ended in early September, with most shipments made by early August. The Washington No. 1 minimum grade requirement will resume April 1, 2007, for the 2007 season and future seasons. The Committee meets prior to and during each season to consider recommendations for modification, suspension, or termination of the regulatory requirements for Washington apricots which have been issued on a continuing basis. Committee meetings are open to the public and interested persons may express their views at these meetings. The USDA reviews information submitted by, and recommendations from, the Committee and other available information to determine whether modification, suspension, or termination of the regulatory requirements would tend to effectuate the declared policy of the Act. Last spring, the Committee conveyed to USDA that widely scattered hail damage was reported within the Washington apricot production area as a result of late spring storms. The severe weather conditions resulted in damage to the crop making it difficult for apricots to meet the minimum grade requirements of Washington No. 1. The relaxation in the grade requirement provided for the handling of a larger portion of the Washington apricot crop than would have been permitted if the minimum grade requirement had remained at Washington No. 1. This action helped the industry meet consumer demand while providing for better producer returns. Final Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service
(AMS)has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. There are approximately 300 apricot producers within the regulated production area and approximately 22 regulated handlers. Small agricultural producers are defined by the Small Business Administration
(SBA)(13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,500,000. For the 2005 apricot shipping season, the Washington Agricultural Statistics Service prepared a preliminary report showing that the total 5,600 ton apricot utilization sold for an average of $997 per ton. Based on the number of producers in the production area (300), the average annual producer revenue from the sale of apricots in 2005 can thus be estimated at approximately $18,611. Average revenue per handler can be estimated using f.o.b. prices. According to USDA's Market News Service, 2005 fresh apricot f.o.b. prices ranged from $15.00 to $20.00 per 24-pound loose-pack container, and from $14.00 to $24.00 for 2-layer tray pack containers (which weigh an average of about 20 pounds each). Total apricot sales revenue at the f.o.b. shipper level can be estimated by taking the midpoints of each of the two ranges ($17.50 and $19.00) as representative annual average prices for each of the container types. The 2005 season fresh apricot pack-out of 4,471 tons can be assumed to be equally divided between the two container types, yielding an estimated quantity packed in each container type of 2,235.5 tons, or 4.471 million pounds. Dividing this quantity by the pounds per container yields the following handler sales revenue estimates:
(a)186,292 24-pound loose-pack containers, with an average price of $17.50, valued at $3,260,110 and
(b)223,550 two-layer tray pack containers, with an average price of $19.00, valued at $4,246,500. Combining the estimated handler sales revenue for the two container types ($7,506,610) and dividing by the number of handlers
(22)yields an annual average fresh apricot sales revenue estimate per handler of $341,210. Since both the average annual producer and handler revenue figures are under the limits established by SBA, it is reasonable to assume that the majority of producers and handlers of Washington apricots may be classified as small entities. This rule adopts, as a final rule, an interim final rule that revised paragraph (a)(1) of § 922.321 by temporarily changing the minimum grade requirement for fresh shipments of apricots from Washington No. 1 grade to Washington No. 2 grade for the 2006 season only. The Washington No. 1 minimum grade requirement will resume April 1, 2007, for the 2007 season and future seasons. Section 922.52 of the order authorizes the issuance of regulations for grade, size, quality, maturity, pack, and container for any variety of apricots grown in the production area. Section 922.53 further authorizes the modification, suspension, or termination of regulations issued pursuant to § 922.52. The Committee believes that this action has not negatively impacted small businesses. The interim final rule relaxed the minimum grade requirement in the order's handling regulations and was intended to provide enhanced marketing opportunities for the Washington apricot industry. Given the emergency nature of the relaxation, the Committee's recommendation was made via the vote-by-mail procedures of the order. With ten of the twelve members responding, nine members supported the temporary grade change and one member opposed it. The only alternative to a grade relaxation offered on the ballot was to leave the minimum grade at Washington No. 1, which was not adopted. AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. This rule will not impose any additional reporting or recordkeeping requirements on either small or large apricot handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, as noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. An interim final rule regarding this action was published in the **Federal Register** on August 2, 2006. Copies of the rule were made available to the apricot industry by the Committee's staff, as well as through the Internet by USDA and the Office of the Federal Register. That rule provided for a 60-day comment period which ended October 2, 2006. No comments were received. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http://www.ams.usda.gov/fv/moab.html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that the interim final rule, without change, as published in the **Federal Register** (71 FR 43643, August 2, 2006) will tend to effectuate the declared policy of the Act. List of Subjects in 7 CFR Part 922 Apricots, Marketing agreements, Reporting and recordkeeping requirements. PART 922—APRICOTS GROWN IN DESIGNATED COUNTIES IN WASHINGTON Accordingly, the interim final rule amending 7 CFR part 922 which was published at 71 FR 43643 on August 2, 2006, is adopted as a final rule without change. Dated: November 7, 2006. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E6-19079 Filed 11-9-06; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 930 [Docket No. FV06-930-1 FIR] Tart Cherries Grown in the States of Michigan, et al.; Change in Certain Provisions/Procedures Under the Handling Regulations for Tart Cherries AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The Department of Agriculture
(USDA)is adopting, as a final rule, with a change, an interim final rule removing volume limitations on new product development, new market development and market expansion activities to facilitate such activities; allowing handlers to receive diversion credit for the voluntary destruction of finished, marketable products that have deteriorated in condition to provide handlers more flexibility; adding a procedure to keep Cherry Industry Administrative Board (Board) representation in line with current district production levels; and revising grower application and mapping procedures under the grower diversion program to make the process less burdensome. These changes are intended to improve the operation of the marketing order and to increase the demand for tart cherries and tart cherry products. The changes were unanimously recommended by the Board, the body that locally administers the marketing order. The marketing order regulates the handling of tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. EFFECTIVE DATE: December 13, 2006. FOR FURTHER INFORMATION CONTACT: Patricia A. Petrella or Kenneth G. Johnson, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, Unit 155, 4700 River Road, Riverdale, MD 20737; Telephone:
(301)734-5243, or Fax:
(301)734-5275. Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone:
(202)720-2491, Fax:
(202)720-8938, or e-mail: *Jay.Guerber@usda.gov.* SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Agreement and Order No. 930 (7 CFR part 930), regulating the handling of tart cherries produced in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Department of Agriculture
(USDA)is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempt therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction in equity to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. This rule continues in effect changes to § 930.162, Exemptions, that removed volume limitations on new product development, new market development, and market expansion activities utilized by handlers to earn diversion credits to meet restricted percentage regulation withholding requirements. Handler diversion is authorized under § 930.59 of the order and, when volume regulation is in effect, handlers may fulfill restricted percentage requirements by diverting cherries or cherry products rather than placing tart cherries in an inventory reserve. Volume regulation is intended to help the tart cherry industry stabilize supplies and prices in years of excess production. Volume regulation percentages are in effect for the 2005-2006 crop year (71 FR 1915, January 12, 2006). This rule also continues in effect an action that allowed handlers to receive diversion credit for the voluntary destruction of finished marketable product; added a procedure to keep Board representation in line with district production levels; and revised grower application and mapping procedures. Section 930.62 provides that the Board, with the approval of the Secretary, may exempt from the provisions of §§ 930.41 (Assessments), 930.44 (Quality control), 930.51 (Issuance of volume regulations), 930.53 (Modification, suspension, or termination of regulations), and 930.55 through 930.57 (Reserve regulations) cherries which are diverted in accordance with § 930.59. According to § 930.62, cherries that are diverted in accordance with § 930.59 may be used for new product development and new market development, used for experimental purposes, or used for any other purpose designated by the Board, including cherries processed into products for markets for which less than 5 percent of the preceding 5-year average production of cherries were utilized. Section 930.162 specifies procedures for obtaining approval for exempt uses which include new product development, new market development, and market expansion. Currently, these provisions specify volume limitations for these exempt uses. The limitations are specified in § 930.162(b)(1) which states that once total industry utilization for a new product exceeds 2 percent of the 5-year average production of tart cherries, the product shall no longer be considered under development and not be eligible for a new product development exemption. The maximum duration of any new product credit activity is three years from the first date of shipment. Section 930.162(b)(2) regarding new market development and market expansion specifies the annual industry-wide maximum diversion credit volume at 10 million pounds RPE (Raw Product Equivalent) of cherry products for all expansion activities which is allocated pro rata among participating handlers. When these limitations were added, the Board believed that these markets should be developed slowly. However, it now believes that these limitations are a disincentive to new product, market development, and market expansion activities involving large quantities. If a handler's new product activity involves moving 8 million pounds of exempt tart cherries, and 2 percent of the 5-year average production is 5 million pounds, the handler would only receive 5 million pounds of diversion credit, not 8 million pounds. The Board now believes that this unnecessarily restricts these handler activities and that handlers should receive diversion credit for the full diversion amount to stimulate handler interest and facilitate new product development activities. With respect to new market development and market expansion activities, if the same handler had a pro rata allocation representing 20 percent of the industry-wide 10 million pound limitation for all handlers participating in these activities, this handler would only receive diversion credit for 1.6 million pounds, not 8 million pounds. The Board believes that this provision should be removed to facilitate handler interest in new market development and market expansion. To facilitate these activities, the Board recommended that the volume limitations be removed from paragraphs (b)(1) and (b)(2) of § 930.162 to foster further handler interest in new product, new market development, and market expansion activities. This is expected to result in an increase in demand for tart cherries and tart cherry products. The time limitation for new product development will remain in effect. As previously stated in this document, handler diversion is authorized under § 930.59. Section 930.159 of the rules and regulations under the order allows handlers to divert cherries by destruction of the cherries at the handler's facility. At-plant diversion of cherries takes place prior to placing cherries into the processing line to ensure that the cherries diverted were not simply an undesirable or unmarketable byproduct of processing. Handlers also can receive diversion credit for finished, marketable tart cherry products that were accidentally destroyed. Finished, marketable cherry products might be accidentally destroyed in a fire, explosion, or because of a freezer malfunction. Handlers sometimes voluntarily destroy finished, marketable cherry products if the cherry products sustain a loss of condition that renders them unacceptable for use in normal market channels (free tonnage outlets). To permit handlers to recover some of their costs incurred in acquiring, processing, and storing such cherries, the Board unanimously recommended that the at-plant diversion procedures be broadened so handlers can receive diversion credit for the voluntary destruction of such cherries. The handler would not have to purchase additional cherries to meet his/her restricted percentage obligation, but could simply use the diversion credit received for the voluntarily destroyed product. To receive diversion credit under this added option, the Board recommended that the cherry products meet similar criteria as accidentally destroyed marketable product. That is, such cherry products must:
(1)Be owned by the handler at the time of the voluntary destruction;
(2)be a marketable product at the time of processing;
(3)be included in the handler's end of year handler plan; and
(4)have been assigned a Raw Product Equivalent
(RPE)by the handler to determine the volume of cherries. In addition, the condition and the voluntary destruction as well as the disposition of the finished tart cherry product must be verified by a USDA inspector or a Board agent or employee. Handlers wishing to obtain diversion certificates for finished tart cherry products that are voluntarily destroyed must apply for such diversion certificates and sign an agreement that disposition of the destroyed product will take place under the supervision of USDA's Processed Products Branch inspectors or Board inspectors. This will allow the Board to verify that the finished product was marketable, but sustained a loss of condition, and that it was disposed of properly. Once diversion is satisfactorily accomplished, handlers will receive diversion certificates from the Board stating the weight of cherries diverted. Such diversion certificates can be used to satisfy a handler's restricted percentage obligation. Section 930.158 provides that growers, in districts subject to volume regulation, may voluntarily divert their tart cherry production. Growers may then offer their diversion certificates to handlers for their use in meeting their restricted percentage obligation. The four types of grower diversion are: Random row, whole block, partial block, and in-orchard tank diversion. This action changes the procedures for grower mapping under the grower diversion program. Currently, under § 930.158 growers that wish to divert cherries using methods other than in-orchard tank must file maps every year if they intend to participate in the voluntary grower diversion program. Growers applying for diversion must sign a Grower Diversion Application which states that the grower agrees to comply with the regulations established for the tart cherry diversion program. Each map must contain the grower's name and number assigned by the Board, the grower's address, the block name or number when appropriate, the location of the orchard or orchards, and other information which may be necessary to accomplish the desired diversion. Growers then inform the Board what type of diversion will be used: Random row, partial block, whole block or in-orchard tank diversion. Growers who have filed a Grower Diversion Application but have not submitted an orchard map with the Board can only participate in in-orchard tank diversion activities. The Board has recommended that the original map and application have an ongoing, continuing effect. Annual resubmissions of the map and application would no longer be required. Growers will only submit an application and map if they are participating in the grower diversion program for the first time. Growers would need only to submit a new orchard map if he/she added a new block of trees or changed the orchard layout differently from the map previously submitted to the Board. This action will slightly decrease reporting burdens on growers participating in the grower diversion program. This action continues in effect a revision to the provisions to § 930.120 for reallocating Board representation. Currently, § 930.20 allocates producer and handler representation on the Board based upon the previous 3-year average production of each district in the production area. When the production level in a district reaches various specified thresholds, the number of representatives from that district either increases or decreases: districts with production up to and including 10 million pounds shall have one member; districts with production greater than 10 million and up to and including 40 million pounds shall have 2 members; and districts with production greater than 40 million pounds and up to and including 80 million pounds shall have 3 members; and districts with production greater than 80 million pounds shall have 4 members. The Board recommended that in the event that a district's 3-year average production decreases to a level requiring a reduction in membership on the Board, representation of the district shall be determined by:
(1)Agreement of the elected members and alternate members of the specific district; or
(2)if an agreement cannot be reached, the members and alternates having the shortest amount of time remaining in their terms of office would be removed from the Board. However, the Board's recommendation required modification. Because the Secretary of Agriculture (Secretary) has sole authority to remove and select persons who can serve on the Board, it would not be appropriate to give direct responsibility to current Board members in a specific district to determine who is removed from the Board when production levels decrease. Accordingly, when a district is faced with losing Board representation, the regulations will require the members of the specific district to make a recommendation to the Board as to who should be removed from the Board, and the Board will then submit its recommendation to the Secretary for approval. In the event a district's 3-year average production increases such that it warrants additional seats on the Board, the seats shall be allocated following the criteria in § 930.20(b)(5). Nomination and selection of members to fill the additional seats would follow the procedures specified in §§ 930.23 and 930.24. In addition, § 930.158(a) was revised to delete obsolete dates in that section and § 930.158(b) was revised to clarify the requirement to submit a map for random-row diversion use. Final Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service
(AMS)has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. There are approximately 40 handlers of tart cherries who are subject to regulation under the tart cherry marketing order and approximately 900 producers of tart cherries in the regulated area. Small agricultural service firms, which includes handlers, have been defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $6,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. A majority of the producers and handlers of tart cherries under the order are considered small entities under SBA's standards. The principal demand for tart cherries is in the form of processed products. Tart cherries are dried, frozen, canned, juiced, and pureed. During the period 2000/2001 through 2004/2005, approximately 93.4 percent of the U.S. tart cherry crop, or 216.8 million pounds, was processed annually. Of the 216.8 million pounds of tart cherries processed, 59 percent was frozen, 28 percent was canned, and 13 percent was utilized for juice and other products. Based on National Agricultural Statistics Service data, acreage in the United States devoted to tart cherry production has been trending downward. Bearing acreage has declined from a high of 50,050 acres in 1987/88 to 36,950 acres in 2004/2005. This represents a 26 percent decrease in total bearing acres. Michigan leads the nation in tart cherry acreage with 73 percent of the total and produces about 70 percent of the U.S. tart cherry crop each year. This action continues in effect a rule that removed volume limitations on market expansion activities used by handlers to earn diversion credits to meet their restricted volume obligations; allowed handlers to earn diversion credits when they voluntarily destroy finished marketable products that have been damaged or deteriorated in condition in some manner; revised grower application/mapping procedures under the grower division program to make the procedures less burdensome; and added a procedure regarding the reallocation of Board representation to reflect current district production levels. These changes to the marketing order are authorized under §§ 930.62, 930.59, 930.58, and 930.20, respectively. It is expected that the benefits resulting from this rulemaking will impact both small and large handlers positively by helping them increase market demand and by improving the operation of the marketing order. It also will benefit producers by making the in-orchard diversion application/mapping procedures less burdensome and improve the operation of the program. Regarding alternatives, the Board discussed leaving the provisions unchanged, but determined that the changes were a more viable course of action. The program improvements expected to result because of these changes will positively impact producers and handlers under the marketing order, regardless of size. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this regulation. USDA has determined that this action will have a small impact on the reporting and recordkeeping requirements imposed under the tart cherry marketing order. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are contained in this rule have been previously approved by the Office of Management and Budget
(OMB)under OMB No. 0581-0177, Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, M.O. No. 930. This rule, which changes procedures for growers submitting applications and maps, will result in a slight decrease in reporting and recordkeeping requirements on growers who participate in the voluntary diversion program. In addition, a slight increase in reporting and recordkeeping requirements for handlers who voluntarily destroy tart cherry products would be within the current information collection burden approved by OMB. Reporting and recordkeeping requirements are necessary for compliance purposes and for developing statistical data for maintenance of the program. The forms require information which is readily available from handler records and which can be provided without data processing equipment or trained statistical staff. As with other, similar marketing order programs, reports and forms are periodically studied to reduce or eliminate duplicate information collection burdens by industry and public sector agencies. AMS is committed to compliance with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. An interim final rule concerning this action was published in the **Federal Register** on April 5, 2006 (71 FR 16982). Copies of the rule were mailed by the Board's staff to all Board members and tart cherry handlers. In addition, the rule was made available through the Internet by USDA and the Office of the Federal Register. That rule provided for a 60-day comment period which ended June 5, 2006. Two comments were received. One comment was received from a tart cherry grower and the other comment was from the Executive Director of the Board. The comment from the grower supported USDA's modification to the Board's recommendation concerning the authority of the Secretary to remove or select members of the Board. The Board had recommended that current Board members in a specific district determine who is removed from the Board when production levels decrease. USDA modified the recommendation so it stated that when a district falls below the threshold level, members from the district should make a recommendation to the Board. The Board would then submit its recommendation to the Secretary for approval. The commenter agreed with this modification. The comment from the Executive Director of the Board concerned two issues contained in the interim final rule:
(1)Grower mapping requirements; and
(2)reallocating Board representation. With respect to the first issue, the commenter urges USDA to remove the requirement now included in § 930.158(b) that if a grower decides not to participate in the grower diversion program for a year, the grower must inform the Board of his/her non-participation. USDA agrees that this requirement is not necessary for the operation of the grower diversion program. As such, this requirement is being deleted from § 930.158(b). The second issue the Executive Director addressed concerned the reallocation of Board membership. The commenter asserted that the recommendation of the Board, concerning reallocation, should be adopted without the USDA modification that the Secretary will make the final decision based on a Board recommendation. The Board's recommendation, however, did not take into account the Secretary's sole authority to remove and select persons to serve on the Board. As previously discussed, it would not be appropriate to give direct responsibility to current Board members in a specific district to determine who is removed from the Board when production levels decrease. Therefore, the commenter's second suggestion is not adopted in this rule. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http://www.ams.usda.gov/fv/moab.html* . Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, including the Board's recommendation, and other information, it is found that finalizing the interim final rule, with a change, as published in the **Federal Register** (71 FR 16982, April 5, 2006) will tend to effectuate the declared policy of the Act. List of Subjects in 7 CFR Part 930 Marketing agreements, Reporting and recordkeeping requirements, Tart cherries. For the reasons set forth in the preamble, 7 CFR part 930 is amended as follows: PART 930—TART CHERRIES GROWN IN THE STATES OF MICHIGAN, NEW YORK, PENNSYLVANIA, OREGON, UTAH, WASHINGTON, AND WISCONSIN Accordingly, the interim final rule amending 7 CFR part 930 which was published at 71 FR 16982 on April 5, 2006, is adopted as a final rule with the following change. PART 930—TART CHERRIES GROWN IN THE STATES OF MICHIGAN, NEW YORK, PENNSYLVANIA, OREGON, UTAH, WASHINGTON, AND WISCONSIN 1. The authority citation for part 930 continues to read as follows: Authority: 7 U.S.C. 601-674. 2. In § 930.158, the introductory text of paragraph
(b)is revised to read as follows: § 930.158 Grower diversion and grower diversion certificates.
(b)*Application and mapping for diversion.* Any grower desiring to divert cherries using methods other than in-orchard tank shall submit a map of the orchard or orchards to be diverted, along with a completed Grower Diversion Application, to the Board by April 15 of each crop year. The application includes a statement which must be signed by the grower which states that the grower agrees to comply with the regulations established for a tart cherry diversion program. Each map shall contain the grower's name and number assigned by the Board, the grower's address, block name or number when appropriate, location of orchard or orchards and other information which may be necessary to accomplish the desired diversion. On or before July 1, the grower should inform the Board of such grower's intention to divert in-orchard and what type of diversion will be used. The four types of diversion are random row diversion, whole block diversion, partial block diversion and in-orchard tank diversion. A grower who informs the Board about the type of diversion he or she wishes to use by July 1 can elect to use any diversion method or combination of diversion methods. Only random row or in-orchard tank diversion methods may be used if the Board is not so informed by July 1. Trees that are four years or younger do not qualify for diversion. Annual resubmissions of either the map or application will no longer be required. Growers will only submit a new application and map if they are participating in the grower diversion program for the first time. Growers will need only to submit a new orchard map if he/she adds a new block of trees to the orchard or changes the orchard layout differently from the map previously submitted to the Board. Dated: November 7, 2006. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E6-19078 Filed 11-9-06; 8:45 am] BILLING CODE 3410-02-P FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 328 RIN 3064-AD05 Advertisement of Membership AGENCY: Federal Deposit Insurance Corporation (FDIC). ACTION: Final rule. SUMMARY: The FDIC is promulgating a final rule revising its regulation governing official FDIC signs and advertising of FDIC membership. The final rule replaces the separate signs used by Bank Insurance Fund
(BIF)and Savings Association Insurance Fund
(SAIF)members with a new sign, or insurance logo, to be used by all insured depository institutions. In addition, the final rule extends the advertising requirements to savings associations, consolidates the exceptions to those requirements, and restricts the use of the official advertising statement when advertising non-deposit products. The final rule also restructures the text in certain sections in order to make them easier to read. Lastly, the final rule places the current prohibition pertaining to receipt of deposits at the same teller station or window as noninsured institutions in its own section. DATES: The final rule will become effective on November 13, 2007. FOR FURTHER INFORMATION CONTACT: David P. Lafleur, Policy Analyst,
(202)898-6569, Division of Supervision and Consumer Protection (DSC); John M. Jackwood, Acting Chief, Compliance Section,
(202)898-3991, DSC; Kathleen G. Nagle, Supervisory Consumer Affairs Specialist,
(202)898-6541, DSC; or Richard B. Foley, Counsel,
(202)898-3784, Legal Division, Federal Deposit Insurance Corporation, Washington, DC 20429. SUPPLEMENTARY INFORMATION: I. Background A notice of proposed rulemaking
(NPR)was published in the **Federal Register** at 71 FR 40440 (July 17, 2006). The public comment period ended on September 15, 2006. The FDIC received a total of twelve comments. Nine of the comments were from insured depository institutions and three were from trade associations. II. The Final Rule A. Section 328.0—Scope
(i)*Proposed rule.* Under the proposed rule, the scope provision would be revised by the proposed rule to reflect that there would now be one sign used by all insured depository institutions and the advertising requirements in § 328.3 would be extended to savings associations.
(ii)*Comments.* No comments were received on this aspect of the proposed rule.
(iii)*Final rule.* No changes were made to this aspect of the proposed rule. B. Section 328.1—Official Sign
(i)*Proposed rule.* Pursuant to section 18(a) of the Federal Deposit Insurance Act (FDI Act), as amended by section 2(c)(2) of the Federal Deposit Insurance Reform Conforming Amendments Act of 2005, Public Law 109-173, 119 Stat. 3601-19 (FDIRCA Act), the proposed rule would revise § 328.1 to eliminate the separate official bank sign and official savings association sign, and to display a black and white version of the new official sign that would be used by all insured depository institutions. Under the proposed rule, the official sign would be 7″ by 3″ in size, with black lettering and gold background. The design is similar in color scheme and layout to the current bank sign but with the following differences: First, the language above “FDIC” states “Each depositor insured to at least $100,000,” instead of “Each depositor insured to $100,000.” The revised language more accurately reflects the new deposit insurance coverage limits in the FDIRCA Act and the Federal Deposit Insurance Reform Act of 2005, Public Law 109-171, title II, subtitle B, 120 Stat. 9-21. Second, the proposed sign includes the FDIC's internet Web site and leaves out the FDIC seal. Finally, the full faith and credit statement required by the FDIRCA Act is in italics on the left side of the proposed sign and is bordered by a semi-circle of stars, a design that partially reflects the current savings association sign. Section 328.1 also describes the “symbol” of the Corporation that insured depository institutions could use at their option as the official advertising statement. Under the proposed rule, the symbol would be that portion of the proposed official sign consisting of “FDIC” and the two lines of smaller type above and below “FDIC.”
(ii)*Comments.* Some commenters expressed support for having one official sign for all insured depository institutions, but one of those commenters objected to the language “Each depositor insured to at least $100,000,” arguing that the language may require changing the official sign every five years if the insurance limit changes.
(iii)*Final rule.* No changes were made to this aspect of the proposed rule. The FDIC believes that the proposed language indicating the minimum dollar amount of insurance coverage provides customers with important information, despite the fact that a depositor may in some situations have greater insurance coverage and the minimum dollar amount of insurance coverage may increase in the future. By saying that each depositor is insured to “at least”—rather than “up to”—$100,000, the new official sign will remain accurate even if there are future increases in insurance coverage. C. Section 328.2—Display and Procurement of Official Sign
(i)*Proposed rule.* The proposed rule would make conforming changes to this section so that it applies to all insured depository institutions, not just insured banks. The proposed rule also restructures this section to make it easier to read but without making any substantive changes. Part 328 uses the term “automatic service facilities” in some places, and the term “remote service facilities” in other places, although the two terms have the same meaning within that part. The proposed rule uses the term “remote service facility” in each place and defines that term in § 328.2(a)(1)(ii) to include any automated teller machine, cash dispensing machine, point-of-sale terminal, or other remote electronic facility where deposits are received. The current §§ 328.2 and 328.4 are virtually identical, except that one applies to insured banks and the other applies to insured savings associations. The key difference between these provisions is that § 328.4 has a paragraph
(e)prohibiting insured savings associations from using the official bank sign. As the new official sign would be applicable to all insured depository institutions, the proposed rule would combine current §§ 328.2 and 328.4 into a new § 328.2. As in the current § 328.2, the proposed revision would allow an insured depository institution to vary the size, color, or material of the official sign at its expense, and to display such altered signs within the institution at locations other than where insured deposits are received. However, under the proposed rule, only the official sign adhering to the specifications of § 328.1 could have been displayed where insured deposits are received. The proposed rule refers to the FDIC's internet Web site, *http://www.fdic.gov* , for information on obtaining the official sign.
(ii)*Comments.* Some commenters opposed the requirement in the proposed rule that only the official sign— *i.e.* , the black and gold design specified in § 328.1—could be displayed at each station or window where insured deposits are received. Those commenters maintained that the FDIC currently allows institutions to display signs that vary in color or material at stations or windows where insured deposits are received. Some commenters noted that section 18(a)(1)(A) of the FDI Act, 12 U.S.C. 1828(a)(1)(A), requires an insured depository institution to display a sign “at each place of business maintained by that institution,” not at each station or window where insured deposits are received. Therefore, according to those commenters, the FDIC could simply require that the official sign be displayed at each customer entrance to an institution's office. Some commenters stated that they assumed the FDIC would provide insured depository institutions, without charge, as many official signs as they need to comply with the final rule. However, one of those commenters suggested that current signage could be “grandfathered,” since providing the new signs would impose a cost on taxpayers for what could be considered a non-substantive change.
(iii)*Final rule.* The final rule retains the longstanding requirement that the official sign be displayed at each station or window where insured deposits are received. Requiring that signs be displayed at each station or window where insured deposits are received, rather than at each customer entrance to an institution's office, is consistent with section 18(a)(1)(A) of the FDI Act. Moreover, because depository institutions offer uninsured non-deposit products in other parts of their premises, the requirement better informs customers about where FDIC-insured deposits are received. 1 1 Insured depository institutions are required to disclose that certain non-deposit products are not FDIC-insured, and such products generally must be sold at physical locations distinct from the area where retail deposits are taken. *See* 12 CFR part 343 (Consumer Protection in Sales of Insurance—rules applicable to FDIC-supervised institutions) and the *Interagency Policy Statement on Retail Sales of Nondeposit Investment Products* , issued on February 15, 1994 (NDIP Policy Statement). The final rule permits an institution to display signs varying in size, color, or material from the specifications for the official sign in § 328.1 at stations or windows where insured deposits are received. However, in locations where display of the official sign is required under § 328.2(a), the final rule prohibits variations in size that are smaller than the official sign. In the required locations, signs must also use the same color for the text and symbols. These requirements are intended to ensure that customers are able to recognize the sign. A new sub-paragraph
(2)of § 328.2(a) implements these changes, and § 328.2(a)(2) of the proposed rule has been redesignated as § 328.2(a)(3). Finally, § 328.2(a)(1)(i) of the proposed rule has been revised to provide that, in addition to those locations where the official sign must be displayed under § 328.2(a), an institution may display the official sign in other locations at the institution. Like the proposed rule, the final rule will allow insured depository institutions to obtain from the FDIC, at no charge, the official signs they need to comply with part 328. The final rule does not adopt the suggestion by one commenter that current signage could be “grandfathered,” since that would be inconsistent with section 18(a) of the FDI Act. D. Section 328.3—Official Advertising Statement Requirements
(1)Proposal To Extend Official Advertising Statement Requirement to Savings Associations
(i)*Proposed rule.* Section 328.3 requires insured banks to include the official advertising statement in all their advertisements (with certain exceptions). The basic form of the statement is “Member of the Federal Deposit Insurance Corporation,” which may be shortened to “Member FDIC.” There is no equivalent requirement for insured savings associations. The proposed rule would revise § 328.3 to provide for consistent treatment of banks and savings associations by requiring all insured depository institutions to include the official advertising statement in their advertisements.
(ii)*Comments.* One commenter voiced support for this aspect of the proposed rule. No commenters objected to it.
(iii)*Final rule.* No changes were made to this aspect of the proposed rule.
(2)Proposals To Consolidate Exceptions to the Required Use of the Official Advertising Statement
(i)*Proposed rule.* There are currently twenty exceptions to the required use of the official advertising statement. The proposed rule would have simplified the advertising requirements by reducing the number of exceptions to five. The proposed rule would have done this by limiting the applicability of § 328.3 to advertisements that specifically promote deposit products or generally promote banking services offered by an insured depository institution. The latter would have included advertisements that contain an institution's name and a statement about the availability of general banking services. The term “advertisement” would have been defined as a commercial message, in any medium, that is designed to attract public attention or patronage to a product or business. By limiting the applicability of § 328.3 in this way, the NPR asserted that most of the current exceptions to the advertising requirements would become unnecessary. The exemptions eliminated from the proposed rule would have been for: Statements and reports of condition; bank supplies; listings in directories; and advertisements relating to loan services, safekeeping box services, trust services, real estate services, armored car services, service or analysis charges, securities services, travel department business, and savings bank life insurance.
(ii)*Comments.* Some commenters found the phrase “generally promote banking services” ambiguous enough to be interpreted to include advertisements that fall within the current exceptions— *e.g.* , the exceptions for bank supplies, listings in directories, and advertisements for loan and safekeeping box services. Those commenters maintained that the advertising requirements should only apply to advertisements promoting deposit products. One commenter suggested clarifying the final rule by explaining that promoting only non-deposit banking products is not “generally promoting banking services.” Another commenter suggested substituting the phrase “promote non-specific banking services” for “generally promoting banking services.” Some commenters advocated retaining the current list of exceptions to the advertising requirements. One commenter thought that the paragraph heading for 328.3(c)—“Use of official advertising statement in all advertisements”—should be revised by deleting the word “all,” since there will no longer be a laundry list of exceptions.
(iii)*Final rule.* In order to avoid ambiguity as to the scope of the advertising requirements, the final rule substitutes the phrase, “promote non-specific banking products and services,” for the phrase, “generally promote banking services.” In addition, the final rule explains that an advertisement promotes non-specific banking products and services if it includes the name of the insured depository institution but does not list or describe particular products or services offered by the institution— *e.g.* , “Anytown Bank, offering a full range of banking services.” Lastly, the final rule explicitly references the exceptions listed at § 328.3(c)(1), (2), (4),
(5)and
(6)of the current rule. The word “all” has been deleted from the heading for § 328.3(c), as suggested by one commenter. Taken together, these revisions clarify when the advertising requirements apply and when they do not apply. The final rule is not intended to expand the applicability of the advertising requirements.
(3)Other Proposed Revisions
(i)*Proposed rule.* The proposed rule also would make certain clarifying, non-substantive, and conforming editorial changes in § 328.3. In addition, three provisions in the current rule have not been included in the proposed rule because they address narrow situations that rarely occur. The first provision, § 328.3(a)(2), allows the Board to grant temporary exemptions from the advertising requirements for good cause. The second provision, § 328.3(a)(3), concerns advertising copy not including the official advertising statement that is on hand on the date the advertising requirements become operative. The third provision, § 328.3(d), addresses how to handle outstanding billboard advertisements that require use of the official advertising statement.
(ii)*Comments.* One commenter voiced no objection to this aspect of the proposed rule.
(iii)*Final rule.* No changes were made to this aspect of the proposed rule. E. Section 328.3(e)—Restrictions on Using the Official Advertising Statement When Advertising Non-Deposit Products
(i)*Proposed rule.* The NPR solicited comment on whether the final rule should include a provision that would:
(1)Prohibit use of the official advertising statement in advertisements relating solely to non-deposit products
(NDPs)or hybrid products containing NDP and deposit features ( *e.g.* , sweep accounts); and
(2)require that the official advertising statement be clearly segregated from information about NDPs in advertisements containing information about both NDPs and insured deposit products.
(ii)*Comments.* Several commenters supported having a provision in the final rule setting forth the requirements for using, not using, and/or segregating the official advertising statement in advertisements for NDPs only, advertisements for hybrid products, and advertisements for both NDPs and insured deposit products. Some commenters advocated clarification of the advertising requirements in the final rule. One commenter recommended that the final rule clarify the advertising requirements by providing that the official advertising statement is not mandatory in advertisements for NDPs only or in advertisements for hybrid products. One commenter thought the proposal is consistent with the NDIP Policy Statement except with regard to hybrid products. That commenter opposed the prohibition against displaying the official advertising statement in advertisements for hybrid products only. Another commenter asserted that the proposed provision is unnecessary, but argued that if the FDIC acted in this area, it should do so through a separate rulemaking.
(iii)*Final rule.* The final rule includes a new provision, in § 328.3(e), restricting use of the official advertising statement when advertising NDPs, as described above and in the NPR. The final rule defines the term “non-deposit product” to include, without limitation, insurance products, annuities, mutual funds, and securities. The products specifically included in the definition of non-deposit product are products that, in the FDIC's experience, have been mistakenly viewed by customers as being FDIC-insured. Credit products are excluded from this definition. The term “hybrid product” is defined as a product or service that has both deposit and non-deposit product features— *e.g.* , a sweep account. Under § 328.3(e), insured depository institutions will be prohibited from using the official advertising statement in advertisements containing information only about NDPs or hybrid products. In mixed advertisements, containing information about both NDPs or hybrid products and insured deposit products, the official advertising statement will have to be clearly segregated from information about the NDPs or hybrid products in order to make it clear that the statement refers only to the insured deposit products. Since the new provision is consistent with the proposal set forth in the NPR, the FDIC does not believe that a separate rulemaking is necessary for this provision. Section 328.3(e) of the proposed rule has been redesignated as § 328.3(f). F. Section 328.4—Prohibition Against Receiving Deposits at Same Teller Station or Window as Noninsured Institution
(i)*Proposed rule.* Section 328.2 currently has a provision that prohibits banks from receiving deposits at the same teller station or window where a noninsured institution receives deposits, except for a remote service facility. Since this provision does not relate directly to the display and procurement of the official sign and is significant enough that it should be set apart in a separate section, the proposed rule would move the provision to § 328.4.
(ii)*Comments.* One commenter voiced no objection to this aspect of the proposed rule.
(iii)*Final rule.* No changes were made to this aspect of the proposed rule. G. Effective Date
(i)*Proposed rule.* The NPR also solicited comment on whether the proposed effective date of six months after publication of the final rule in the **Federal Register** would give insured depository institutions sufficient time to adjust to the new requirements in the proposed revision of part 328.
(ii)*Comments.* Several commenters advocated a one-year transition period. Some commenters believed that six months would not be enough time for institutions to use their existing inventory of promotional materials containing the current official signs and to change such materials to comply with the requirements for the new sign. One commenter maintained that six months might be enough time for display of the official sign at teller windows, but at least one year should be allowed with respect to paper supplies. One commenter thought January 17, 2007, would be appropriate for site specific advertising, such as signs on teller windows or bank doors, and for modifying an institution's internet pages, but felt that for changing paper materials the effective date should be extended to January 1, 2008. One commenter was concerned that the effective date provision in the preamble to the NPR would not allow institutions to implement measures to comply with requirements of the final rule until the very end of the transition period, because doing so earlier would violate the current requirements in Part 328. That commenter also believed that institutions should be allowed to use existing stocks of printed materials until they are exhausted.
(iii)*Final rule.* The final rule extends the effective date until one year after the date when it is published in **Federal Register** . Such a transition period should give institutions sufficient time to use existing printed materials before the new requirements become mandatory. During the transition period, between publication of the final rule in the **Federal Register** and the effective date, insured depository institutions will not be deemed in violation of the current requirements in Part 328 if they implement measures to comply with requirements of the final rule. Indeed, the very purpose of the transition period is to give institutions time to implement such measures. III. Paperwork Reduction Act The final rule does not contain any “collections of information” within the meaning of section 3502(3) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3502(3)). IV. Regulatory Flexibility Act Display of the official sign is required by section 18(a) of FDI Act, as amended by section 2(c)(2) of the FDIRCA Act. There would not be any significant compliance costs with displaying the official sign, because it would be provided by the FDIC free of charge. Insured banks have complied with similar advertising requirements for over seventy years without significant expense. Although savings associations have not been subject to such advertising requirements, many have used the official advertising statement voluntarily. Moreover, mandatory compliance with the advertising requirements by savings association would not entail significant expense. Accordingly, the Board hereby certifies that the final rule would not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601-612). V. The Treasury and General Government Appropriations Act, 1999—Assessment of Federal Regulations and Policies on Families The FDIC has determined that the final rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681). VI. Small Business Regulatory Enforcement Fairness Act The Office of Management and Budget has determined that the final rule is not a “major rule” within the meaning of the relevant sections of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”) (5 U.S.C. 801 *et seq.* ). As required by SBREFA, the FDIC will file the appropriate reports with Congress and the Government Accountability Office so that the final rule may be reviewed. List of Subjects in 12 CFR Part 328 Advertising, Bank deposit insurance, Savings associations, Signs and symbols. For the reasons stated above, the Board of Directors of the Federal Deposit Insurance Corporation hereby amends title 12, chapter III of the Code of Federal Regulations by revising part 328 to read as follows: PART 328—ADVERTISEMENT OF MEMBERSHIP Sec. 328.0 Scope. 328.1 Official sign. 328.2 Display and procurement of official sign. 328.3 Official advertising statement requirements. 328.4 Prohibition against receiving deposits at same teller station or window as noninsured institution. Authority: 12 U.S.C. 1818(a), 1819 (Tenth), 1828(a). § 328.0 Scope. Part 328 describes the official sign of the FDIC and prescribes its use by insured depository institutions. It also prescribes the official advertising statement insured depository institutions must include in their advertisements. For purposes of part 328, the term “insured depository institution” includes insured branches of a foreign depository institution. Part 328 does not apply to non-insured offices or branches of insured depository institutions located in foreign countries. § 328.1 Official sign.
(a)The official sign referred to in this part shall be 7″ by 3″ in size, with black lettering and gold background, and of the following design: ER13NO06.000
(b)The “symbol” of the Corporation, as used in this part, shall be that portion of the official sign consisting of “FDIC” and the two lines of smaller type above and below “FDIC.” § 328.2 Display and procurement of official sign.
(a)*Display of official sign.* Each insured depository institution shall continuously display the official sign at each station or window where insured deposits are usually and normally received in the depository institution's principal place of business and in all its branches.
(1)*Other locations* —
(i)*Within the institution.* In addition to locations where display of the official sign is required under this § 328.2(a), an insured depository institution may display the official sign in other locations at the institution.
(ii)*Other facilities.* An insured depository institution may display the official sign on or at Remote Service Facilities. If an insured depository institution displays the official sign at a Remote Service Facility, and if there are any noninsured institutions that share in the Remote Service Facility, any insured depository institution that displays the official sign must clearly show that the sign refers only to a designated insured depository institution(s). As used in this part, the term “Remote Service Facility” includes any automated teller machine, cash dispensing machine, point-of-sale terminal, or other remote electronic facility where deposits are received.
(2)*Varied signs.* Instead of displaying the official sign, an insured depository institution may display signs that vary from the official sign in size, color, or material at any location where display of the official sign is required or permitted under this § 328.2(a). However, any such varied sign that is displayed in locations where display of the official sign is required under this § 328.2(a) must not be smaller in size than the official sign and must have the same color for the text and symbols.
(3)*Newly insured institutions.* A depository institution shall display the official sign no later than its twenty-first day of operation as an insured depository institution, unless the institution promptly requested the official sign from the Corporation, but did not receive it before that date.
(b)*Procuring official sign.* An insured depository institution may procure the official sign from the Corporation for official use at no charge. Information on obtaining the official sign is posted on the FDIC's internet Web site, *http://www.fdic.gov.* Alternatively, insured depository institutions may, at their expense, procure from commercial suppliers signs that vary from the official sign in size, color, or material. Any insured depository institution which has promptly submitted a written request for an official sign to the Corporation shall not be deemed to have violated this § 328.2 by failing to display the official sign, unless the insured depository institution fails to display the official sign after receipt thereof.
(c)*Required changes in sign.* The Corporation may require any insured depository institution, upon at least thirty
(30)days' written notice, to change the wording of the official sign in a manner deemed necessary for the protection of depositors or others. § 328.3 Official advertising statement requirements.
(a)*Advertisement defined.* The term “advertisement,” as used in this part, shall mean a commercial message, in any medium, that is designed to attract public attention or patronage to a product or business.
(b)*Official advertising statement.* The official advertising statement shall be in substance as follows: “Member of the Federal Deposit Insurance Corporation.”
(1)*Optional short title and symbol.* The short title “Member of FDIC” or “Member FDIC,” or a reproduction of the symbol of the Corporation (as described in § 328.1(b)), may be used by insured depository institutions at their option as the official advertising statement.
(2)*Size and print.* The official advertising statement shall be of such size and print to be clearly legible. If the symbol of the Corporation is used as the official advertising statement, and the symbol must be reduced to such proportions that the two lines of smaller type above and below “FDIC” are indistinct and illegible, those lines of smaller type may be blocked out or dropped.
(c)*Use of official advertising statement in advertisements—*
(1)*General requirement.* Except as provided in § 328.3(d), each insured depository institution shall include the official advertising statement prescribed in § 328.3(b) in all advertisements that either promote deposit products and services or promote non-specific banking products and services offered by the institution. For purposes of this § 328.3, an advertisement promotes non-specific banking products and services if it includes the name of the insured depository institution but does not list or describe particular products or services offered by the institution. An example of such an advertisement would be, “Anytown Bank, offering a full range of banking services.”
(2)*Foreign depository institutions.* When a foreign depository institution has both insured and noninsured U.S. branches, the depository institution must also identify which branches are insured and which branches are not insured in all of its advertisements requiring use of the official advertising statement.
(3)*Newly insured institutions.* A depository institution shall include the official advertising statement in its advertisements no later than its twenty-first day of operation as an insured depository institution.
(d)*Types of advertisements which do not require the official advertising statement.* The following types of advertisements do not require use of the official advertising statement:
(1)Statements of condition and reports of condition of an insured depository institution which are required to be published by State or Federal law;
(2)Insured depository institution supplies such as stationery (except when used for circular letters), envelopes, deposit slips, checks, drafts, signature cards, deposit passbooks, certificates of deposit, etc.;
(3)Signs or plates in the insured depository institution offices or attached to the building or buildings in which such offices are located;
(4)Listings in directories;
(5)Advertisements not setting forth the name of the insured depository institution;
(6)Entries in a depository institution directory, provided the name of the insured depository institution is listed on any page in the directory with a symbol or other descriptive matter indicating it is a member of the Federal Deposit Insurance Corporation;
(7)Joint or group advertisements of depository institution services where the names of insured depository institutions and noninsured institutions are listed and form a part of such advertisements;
(8)Advertisements by radio or television, other than display advertisements, which do not exceed thirty
(30)seconds in time;
(9)Advertisements which are of the type or character that make it impractical to include the official advertising statement, including, but not limited to, promotional items such as calendars, matchbooks, pens, pencils, and key chains; and
(10)Advertisements which contain a statement to the effect that the depository institution is a member of the Federal Deposit Insurance Corporation, or that the depository institution is insured by the Federal Deposit Insurance Corporation, or that its deposits or depositors are insured by the Federal Deposit Insurance Corporation to at least $100,000 for each depositor.
(e)*Restrictions on using the official advertising statement when advertising non-deposit products* —(1) *Definitions* —
(i)*Non-deposit product.* As used in this part, the term “non-deposit product” shall include, but is not limited to, insurance products, annuities, mutual funds, and securities. For purposes of this definition, a credit product is not a non-deposit product.
(ii)*Hybrid product.* As used in this part, the term “hybrid product” shall mean a product or service that has both deposit product features and non-deposit product features. A sweep account is an example of a hybrid product.
(2)*Non-deposit product advertisements.* Except as provided in § 328.3(e)(4), an insured depository institution shall not include the official advertising statement, or any other statement or symbol which implies or suggests the existence of Federal deposit insurance, in any advertisement relating solely to non-deposit products.
(3)*Hybrid product advertisements.* Except as provided in § 328.3(e)(4), an insured depository institution shall not include the official advertising statement, or any other statement or symbol which implies or suggests the existence of federal deposit insurance, in any advertisement relating solely to hybrid products.
(4)*Mixed advertisements.* In advertisements containing information about both insured deposit products and non-deposit products or hybrid products, an insured depository institution shall clearly segregate the official advertising statement or any similar statement from that portion of the advertisement that relates to the non-deposit products.
(f)*Official advertising statement in non-English language.* The non-English equivalent of the official advertising statement may be used in any advertisement, provided that the translation has had the prior written approval of the Corporation. § 328.4 Prohibition against receiving deposits at same teller station or window as noninsured institution.
(a)*Prohibition.* An insured depository institution may not receive deposits at any teller station or window where any noninsured institution receives deposits or similar liabilities.
(b)*Exception.* This § 328.4 does not apply to deposits received at a Remote Service Facility. By order of the Board of Directors. Dated at Washington, DC, this 2nd day of November, 2006. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. E6-18802 Filed 11-9-06; 8:45 am] BILLING CODE 6714-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25388; Directorate Identifier 2006-NM-086-AD; Amendment 39-14824; AD 2006-23-12] RIN 2120-AA64 Airworthiness Directives; BAE Systems (Operations) Limited Model BAe 146 and Avro 146-RJ Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive
(AD)for all BAE Systems (Operations) Limited Model BAe 146 and Avro 146-RJ airplanes equipped with certain hydraulic accumulators. This AD requires inspecting the hydraulic accumulators to identify certain serial numbers, and replacing any affected accumulator with a new or serviceable accumulator. Operators may delay doing the replacement by doing repetitive inspections of the affected hydraulic accumulators for signs of failure (leaking or cracking), and replacing any failed accumulator with a new or serviceable unit. This AD results from a report that one hydraulic accumulator failed in service, which caused the loss of the yellow hydraulic system when the airplane was configured for landing. We are issuing this AD to prevent damage to the pressure skin, failure of certain hydraulic systems, contamination of the cabin with hydraulic mist, increased workload for the flightcrew associated with the loss of one or more hydraulic circuits, and consequent reduced controllability of the airplane. DATES: This AD becomes effective December 18, 2006. The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of December 18, 2006. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. Contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2125; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive
(AD)docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to all BAE Systems (Operations) Limited Model BAe 146 and Avro 146-RJ airplanes equipped with certain hydraulic accumulators. That NPRM was published in the **Federal Register** on July 19, 2006 (71 FR 40940). That NPRM proposed to require inspecting the hydraulic accumulators to identify certain serial numbers, and replacing any affected accumulator with a new or serviceable accumulator. Operators may delay doing the replacement by doing repetitive inspections of the affected hydraulic accumulators for signs of failure (leaking or cracking), and replacing any failed accumulator with a new or serviceable unit. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comment received. Request To Change Incorporation of Certain Information The Modification and Replacement Parts Association (MARPA) states that, typically, airworthiness directives are based on service information originating with the type certificate holder or its suppliers. MARPA adds that manufacturer service documents are privately authored instruments generally having copyright protection against duplication and distribution. MARPA notes that when a service document is incorporated by reference into a public document, such as an airworthiness directive, it loses its private, protected status and becomes a public document. MARPA adds that, if a service document is used as a mandatory element of compliance, it should not simply be referenced, but should be incorporated into the regulatory document; by definition, public laws must be public, which means they cannot rely upon private writings. MARPA is concerned that the failure to incorporate essential service information could result in a court decision invalidating the AD. MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Document Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the **Federal Register** needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts § 21.303 (“Parts manufacturer approval”) of the Federal Aviation Regulations (14 CFR part 21). MARPA adds that the concept of brevity is now nearly archaic as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument, and published in the DMS. We do not agree that documents should be incorporated by reference during the NPRM phase of rulemaking. The Office of the Federal Register
(OFR)requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the document necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information. Additionally, we do not publish service documents in DMS. We are currently reviewing our practice of publishing proprietary service information. Once we have thoroughly examined all aspects of this issue, and have made a final determination, we will consider whether our current practice needs to be revised. However, we consider that to delay this AD action for that reason would be inappropriate, since we have determined that an unsafe condition exists and that the requirements in this AD must be accomplished to ensure continued safety. Therefore, we have not changed the AD in this regard. Conclusion We have carefully reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD as proposed. Costs of Compliance This AD affects 42 airplanes of U.S. registry. The inspection to determine the serial number takes about 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $3,360, or $80 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. *See* the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-23-12 BAE Systems (Operations) Limited (Formerly British Aerospace Regional Aircraft):** Amendment 39-14824. Docket No. FAA-2006-25388; Directorate Identifier 2006-NM-086-AD. Effective Date
(a)This AD becomes effective December 18, 2006. Affected ADs
(b)None. Applicability
(c)This AD applies to all BAE Systems (Operations) Limited Model BAe 146-100A, -200A, and -300A series airplanes; and Model Avro 146-RJ70A, 146-RJ85A, and 146-RJ100A airplanes; certificated in any category; equipped with hydraulic accumulators part number (P/N) AIR91666-0, -1, or -2 installed. Unsafe Condition
(d)This AD results from report that one hydraulic accumulator failed in service, which caused the loss of the yellow hydraulic system when the airplane was configured for landing. We are issuing this AD to prevent damage to the pressure skin, failure of certain hydraulic systems, contamination of the cabin with hydraulic mist, increased workload for the flightcrew associated with the loss of one or more hydraulic circuits, and consequent reduced controllability of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Inspection To Determine Serial Number (S/N)
(f)Within 48 hours after the effective date of this AD, inspect all P/N AIR91666-0, -1, and -2 hydraulic accumulators to determine whether any hydraulic accumulator is installed that has an S/N identified in paragraph C of the Accomplishment Instructions of BAE Systems (Operations) Limited Inspection Service Bulletin ISB.29-A046, dated March 14, 2006. A review of airplane maintenance records is acceptable in lieu of this inspection if the S/N can be conclusively determined from that review. Replacement or Repetitive Inspections
(g)If any accumulator with an affected S/N is identified during the inspection required by paragraph
(f)of this AD, do the action in paragraph (g)(1) or (g)(2) of this AD. Do all actions in accordance with the Accomplishment Instructions of BAE Systems (Operations) Limited Inspection Service Bulletin ISB.29-A046, dated March 14, 2006, except where the service bulletin specifies to submit certain information to the manufacturer, this AD does not include that requirement.
(1)Before further flight: Replace the hydraulic accumulator with a new or serviceable accumulator.
(2)Before further flight: Do a detailed inspection for signs of failure (leaking or cracking) of the hydraulic accumulator, and replace any failed accumulator before further flight. If there is no sign of failure, repeat the inspection thereafter at the applicable interval in paragraph (g)(2)(i) or (g)(2)(ii) of this AD. Within 75 days after the effective date of this AD, replace the affected hydraulic accumulator with a new or serviceable accumulator. Doing the replacement terminates the repetitive inspections.
(i)At intervals not to exceed 48 hours.
(ii)Before further flight following a report of hydraulic fumes in the cabin air supply, or after a hydraulic fluid low-level warning; and thereafter at intervals not to exceed 48 hours.
(h)For airplanes on which more than one affected accumulator is identified during the inspection required by paragraph
(f)of this AD: Within 12 days after the effective date of this AD, replace any affected accumulator in accordance with paragraph (g)(1) of this AD, so that no more than one accumulator with an affected S/N remains on the airplane; and inspect any remaining accumulator at the applicable interval in paragraph (g)(2) of this AD. Note 1: BAE Systems (Operations) Limited Service Bulletin ISB.29-A046, dated March 14, 2006, refers to APPH Service Bulletin AIR91666-29-02, dated March 2006, as an additional source of service information for determining if an accumulator is a serviceable accumulator. The procedures include disassembling the accumulator cylinder, and testing it for cracking. Note 2: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, *etc.* , may be necessary. Surface cleaning and elaborate procedures may be required.” Parts Installation
(i)Except as provided by paragraph (g)(2) of this AD: As of the effective date of this AD, no hydraulic accumulator having P/N AIR91666-0, -1, or -2 that has an S/N identified in paragraph C. of the Accomplishment Instructions of BAE Systems (Operations) Limited Inspection Service Bulletin ISB.29-A046, dated March 14, 2006, may be installed on any airplane except for accumulators on which the actions specified in the Accomplishment Instructions of APPH Service Bulletin AIR91666-29-02, dated March 2006, have been done. Special Flight Permit Limited
(j)Using special flight permits (14 CFR 21.197 and 21.199) before all affected hydraulic actuators are replaced on the airplane is allowed only if the airplane has not flown more than 5 flight cycles since the last inspection done in accordance with paragraph (g)(2) or
(h)of this AD, as applicable; and if the flight can be accomplished in one flight cycle with the airplane unpressurized. Alternative Methods of Compliance (AMOCs) (k)(1) The Manager, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information
(l)European Aviation Safety Agency
(EASA)emergency airworthiness directive 2006-0061—E [Corrected], dated March 17, 2006, also addresses the subject of this AD. Material Incorporated by Reference
(m)You must use BAE Systems (Operations) Limited Inspection Service Bulletin ISB.29-A046, dated March 14, 2006, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov;* or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call
(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* Issued in Renton, Washington, on October 31, 2006. Kalene C. Yanamura, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-18965 Filed 11-9-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25337; Directorate Identifier 2006-NM-138-AD; Amendment 39-14825; AD 2006-23-13] RIN 2120-AA64 Airworthiness Directives; BAE Systems (Operations) Limited Model BAe 146 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive
(AD)for all BAE Systems (Operations) Limited Model BAe 146 airplanes. This AD requires inspecting the three-phase circuit breakers and three-phase circuit breaker panels for discrepancies; and fixing any discrepancy and replacing unserviceable units with new units, if necessary. This AD results from reports of three-phase circuit breakers overheating on in-service airplanes. We are issuing this AD to prevent failure of a three-phase circuit breaker. Such failure could prevent an electrical load from being isolated from its electrical supply, which could result in smoke or fire in the flight deck. DATES: This AD becomes effective December 18, 2006. The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of December 18, 2006. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. Contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1175; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive
(AD)docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to all BAE Systems (Operations) Limited Model BAe 146 airplanes. That NPRM was published in the **Federal Register** on July 13, 2006 (71 FR 39595). That NPRM proposed to require inspecting the three-phase circuit breakers and three-phase circuit breaker panels for discrepancies; and fixing any discrepancy and replacing unserviceable units with new units, if necessary. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comments received. Request To Consider Electronic Test in Place of Visual Inspection The commenter, a private citizen who is also an airplane mechanic, believes that a physical inspection will not adequately determine an operational deficiency. The commenter recommends adding a periodic electrical test of the affected circuit breakers. In support of his recommendation, the commenter describes his experience as a helicopter operator, and states that he built a bench check unit that could verify an operational deficiency of circuit breakers. We disagree with requiring an electrical test in place of a detailed (physical) inspection of the circuit breakers. Both the original equipment manufacturer and the European Aviation Safety Agency (EASA), which is the airworthiness authority for the European Union, have determined that a detailed inspection is adequate to ensure safety. The commenter did not provide factual or statistical data to show that damaged circuit breakers could remain on the airplane even though the detailed inspection shows no damage. However, the commenter presents some interesting information that we will share with the EASA. We have not changed the AD in this regard. Request To Change Incorporation of Certain Information The Modification and Replacement Parts Association (MARPA) states that, typically, airworthiness directives are based on service information originating with the type certificate holder or its suppliers. MARPA adds that manufacturer service documents are privately authored instruments generally having copyright protection against duplication and distribution. MARPA notes that when a service document is incorporation by reference into a public document, such as an airworthiness directive, it loses its private, protected status and becomes a public document. MARPA adds that, if a service document is used as a mandatory element of compliance, it should not simply be referenced, but should be incorporated into the regulatory document; by definition, public laws must be public, which means they cannot rely upon private writings. MARPA is concerned that the failure to incorporate essential service information could result in a court decision invalidating the AD. MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Document Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporated by reference method is brevity, to keep from expanding the **Federal Register** needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts under § 21.303 (“Parts manufacturer approval”) of the Federal Aviation Regulations (14 CFR part 21). MARPA adds that the concept of brevity is now nearly archaic as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument, and published in the DMS. We do not agree that documents should be incorporated by reference during the NPRM phase of rulemaking. The Office of the Federal Register
(OFR)requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the document necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information. Additionally, we do not publish service documents in DMS. We are currently reviewing our practice of publishing proprietary service information. Once we have thoroughly examined all aspects of this issue, and have made a final determination, we will consider whether our current practice needs to be revised. However, we consider that to delay this AD action for that reason would be inappropriate, since we have determined that an unsafe condition exists and that the requirements in this AD must be accomplished to ensure continued safety. Therefore, we have not changed the AD in this regard. Clarification of Costs of Compliance We have clarified the Costs of Compliance section in this AD to reflect a revised number of U.S.-registered airplanes. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD as proposed. Costs of Compliance This AD affects about 16 airplanes of U.S. registry. The inspection takes about 5 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $6,400, or $400 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. *See* the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-23-13 BAE Systems (Operations) Limited (Formerly British Aerospace Regional Aircraft):** Amendment 39-14825. Docket No. FAA-2006-25337; Directorate Identifier 2006-NM-138-AD. Effective Date
(a)This AD becomes effective December 18, 2006. Affected ADs
(b)None. Applicability
(c)This AD applies to all BAE Systems (Operations) Limited Model BAe 146-100A, -200A, and -300A series airplanes, certificated in any category. Unsafe Condition
(d)This AD results from reports of three-phase circuit breakers overheating on in-service airplanes. We are issuing this AD to prevent failure of a three-phase circuit breaker. Such failure could prevent an electrical load from being isolated from its electrical supply, which could result in smoke or fire in the flight deck. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Detailed Inspection and Corrective Actions
(f)Within 12 months after the effective date of this AD, do a detailed inspection of the three-phase circuit breakers and three-phase circuit breaker panels for discrepancies (including but not limited to physical damage, cracks, deterioration, corrosion, discoloration, contamination by foreign objects, and missing or improperly installed terminal connections or attachments), in accordance with the Accomplishment Instructions of BAE Systems (Operations) Limited Inspection Service Bulletin ISB.24-141, dated August 15, 2005. If any discrepancy is found, before further flight, fix the discrepancy and replace unserviceable units with new units, as applicable, in accordance with the inspection service bulletin. Note 1: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.” No Reporting
(g)Although the inspection service bulletin referenced in this AD specifies to submit certain information to the manufacturer, this AD does not include that requirement. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information
(i)The European Aviation Safety Agency airworthiness directive 2006-0132, dated May 18, 2006, also addresses the subject of this AD. Material Incorporated by Reference
(j)You must use BAE Systems (Operations) Limited Inspection Service Bulletin ISB.24-141, dated August 15, 2005, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov* ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call
(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* Issued in Renton, Washington, on October 31, 2006. Kalene C. Yanamura, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-18966 Filed 11-9-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 203 [Docket No. 1992N-0297 (formerly 92N-0297)] RIN 0905-AC81 Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; delay of applicability date. SUMMARY: The Food and Drug Administration
(FDA)is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the **Federal Register** of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent **Federal Register** notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a “health care entity.” In the **Federal Register** of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of § 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes. DATES: The applicability date for § 203.3(q) to the wholesale distribution of blood derivatives by health care entities is delayed until December 1, 2008. FOR FURTHER INFORMATION CONTACT: Denise Sánchez, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: The PDMA (Pub. L. 100-293) was enacted on April 22, 1988, and was modified by the PDA (Pub. L. 102-353, 106 Stat. 941) on August 26, 1992. The PDMA, as modified, amended the Federal Food, Drug, and Cosmetic Act (the act) to, among other things, prohibit, with certain exceptions, the sale, purchase, or trade (or offer to sell, purchase, or trade) of prescription drugs that were purchased by hospitals or other health care entities (section 503(c)(3)(A)(ii)(I) of the act (21 U.S.C. 353(c)(3)(A)(ii)(I))). Section 503(c)(3) of the act also states that “[f]or purposes of this paragraph, the term ‘entity’ does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law * * *.” On December 3, 1999, the agency published final regulations in part 203 (21 CFR part 203) implementing PDMA (64 FR 67720) that were to take effect on December 4, 2000. Most of the provisions of the final rule took effect on this date. Certain provisions of the final rule, including § 203.3(q) which defines the term “health care entity,” were delayed on account of concerns raised by the affected parties. The agency received several letters on, and held several meetings to discuss, the implications of the final rule for blood centers that distribute blood derivative products and provide health care to hospitals and patients. Under the final rule as written, blood establishments functioning as health care entities would not be allowed to engage in wholesale distribution of prescription drugs except for blood and blood components intended for transfusion, which are exempted from the regulations under § 203.1. As discussed in the preamble to the final rule (64 FR 67720 at 67725 to 67727), blood derivatives are not blood components. Therefore, under the final rule as written, registered blood establishments that qualify as health care entities could not distribute blood derivatives. Based on comments from interested parties, FDA decided to delay the applicability of § 203.3(q), until October 1, 2001, and reopened the administrative record to give interested persons until July 3, 2000, to submit written comments on this provision (65 FR 25639, May 3, 2000). FDA has delayed the applicability date of § 203.3(q) four more times, most recently until December 1, 2006. On these occasions, the applicability date was delayed to give the agency time to consider whether regulatory changes were warranted (66 FR 12850, March 1, 2001; 67 FR 6645, February 13, 2002; 68 FR 4912, January 31, 2003; 69 FR 8105, February 23, 2004). In the **Federal Register** of February 1, 2006 (71 FR 5200), FDA issued a proposed rule that would amend the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. FDA has received substantive comments on the proposed rule from affected parties. Today, FDA is further delaying the applicability of § 203.3(q) to the wholesale distribution of blood derivatives by health care entities to give FDA additional time to address comments on the proposed rule and consider the appropriate regulatory changes. FDA has examined the impacts of this delay of the applicability date under Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this action is consistent with the regulatory philosophy and principles identified in the Executive order. This action will ease the burden on industry by delaying the applicability of § 203.3(q) to the wholesale distribution of blood derivatives by health care entities while FDA continues to address comments on the proposed rule and consider regulatory changes. Thus, this action is not a significant action as defined by the Executive order. To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, the agency's implementation of this action without opportunity for public comment, effective immediately upon publication today in the **Federal Register** , is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Seeking public comment is impracticable, unnecessary, and contrary to the public interest. Given the imminence of the current December 1, 2006, compliance date, seeking prior public comment on this delay is contrary to the public interest in the orderly issuance and implementation of regulations. This action is being taken under FDA's authority under 21 CFR 10.35(a). The Commissioner of Food and Drugs finds that this delay of the applicability date is in the public interest. Dated: October 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18892 Filed 11-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF DEFENSE Office of the Secretary [DOD-2006-OS-0133; RIN 0790-AI06] 32 CFR Part 245 Plan for the Emergency Security Control of Air Traffic (ESCAT) AGENCY: Department of Defense. ACTION: Final rule; correction. SUMMARY: This document amends the final rule published on the national plan for security control of air traffic during air defense emergencies to make administrative adjustments and includes correcting the effective date of the final rule, and removes references to State and regional disaster airlift (SARDA), rescinded by the Federal Aviation Administration on March 17, 2005. DATES: The effective date for the final rule published at 71 FR 61889, October 20, 2006, is corrected to read: January 18, 2007. FOR FURTHER INFORMATION CONTACT: Mr. Gerald F. Pease, Jr.,
(703)697-6937. SUPPLEMENTARY INFORMATION: On October 20, 2006 the Department of Defense published a final rule on Plan for the Emergency Security Control of Air Traffic (ESCAT) which contained errors and outdated criteria. In rule FR Doc. E6-17179 published on October 20, 2006, (71 FR 61889), make the following corrections: 1. On page 61889, in the first column, in the DATES section, revise the effective date to read January 18, 2007. § 245.5 [Corrected] 2. On page 61890, in the third column, remove the term *State and regional disaster airlift* ( *SARDA* ) and its definition from § 245.5. § 245.6 [Corrected] 3. On page 61891, in the first column, remove “SARDA—State and Regional Disaster Airlift” from the list of acronyms in § 245.6. § 245.22 [Corrected] 4. On page 61894, under § 245.22, in the second column, remove paragraph
(d)and redesignate paragraph
(e)as paragraph (d). Dated: November 2, 2006. L.M. Bynum, Alternate OSD Federal Register Liaison Officer, DoD. [FR Doc. 06-9113 Filed 11-9-06; 8:45 am]
Connectionstraces to 17
Traces to 17 documents
19 references not yet in our index
  • 7 CFR 922
  • 7 USC 601-674
  • 7 CFR 930
  • 12 CFR 328
  • Pub. L. 109-173
  • 119 Stat. 3601
  • Pub. L. 109-171
  • 120 Stat. 9
  • 12 CFR 343
  • 5 USC 601-612
  • Pub. L. 105-277
  • 14 CFR 39
  • 14 CFR 21
  • 1 CFR 51
  • 21 CFR 203
  • Pub. L. 100-293
  • Pub. L. 102-353
  • 106 Stat. 941
  • 32 CFR 245
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C.F.R.§ 121.201
U.S.C.§ 1828
U.S.C.§ 3502
Pub. L.Public Law 118-137
U.S.C.§ 801
U.S.C.§ 1818
Fed. Reg.Proposed Rules
Cite7 CFR 922
Cite7 USC 601-674
Cite7 CFR 930
Cites 36 · showing 12Cited by 0 across 0 sources
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