Rules and Regulations. Notice of Review and Request for Comments
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BILLING CODE 3510-22-S 73 53 Tuesday, March 18, 2008 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Parts 927, 966, and 984 [Docket Nos. AMS-FV-08-0008, FV08-927-610 Review; AMS-FV-08-0009, FV08-966-610 Review; AMS-FV-08-0010, FV08-984-610 Review] Pears Grown in Oregon and Washington; Tomatoes Grown in Florida; and Walnuts Grown in California; Section 610 Reviews AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice of Review and Request for Comments. SUMMARY: This document announces that the Agricultural Marketing Service
(AMS)plans to review Marketing Order 927 (Pears Grown in Oregon and Washington), Marketing Order 966 (Tomatoes Grown in Florida), and Marketing Order 984 (Walnuts Grown in California) under the criteria contained in section 610 of the Regulatory Flexibility Act (RFA). DATES: Written comments on this notice must be received by May 19, 2008. ADDRESSES: Interested persons are invited to submit written comments concerning this notice of review. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., Stop 0237, Washington, DC 20250-0237; Fax:
(202)720-8938, or Internet: *http://www.regulations.gov.* All comments should reference the docket number and the date and page number of this issue of the **Federal Register** and will be made available for public inspection in the Office of the Docket Clerk during regular business hours, or may be viewed at *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Gary D. Olson, Northwest Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, Portland, Oregon; Telephone:
(503)326-2724; Fax:
(503)326-7440; or E-mail: *GaryD.Olson@usda.gov* regarding the Oregon-Washington pear marketing order; Christian Nissen, Southeast Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, Winter Haven, Florida; Telephone:
(863)324-3375; Fax:
(863)325-8793; or E-mail: *Christian.Nissen@usda.gov* regarding the Florida tomato marketing order; or Kurt J. Kimmel, California Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, Fresno, California; Telephone:
(559)487-5901; Fax:
(559)487-5906; or E-mail: *Kurt.Kimmel@USDA.gov* regarding the California walnut marketing order. SUPPLEMENTARY INFORMATION: Marketing Order No. 927, as amended (7 CFR part 927), regulates the handling of pears grown in Oregon and Washington. Marketing Order No. 966, as amended (7 CFR part 966), regulates the handling of tomatoes grown in Florida. Marketing Order No. 984, as amended (7 CFR part 984), regulates the handling of walnuts grown in California. These marketing orders are effective under the Agricultural Marketing Agreement Act of 1937 (AMAA), as amended (7 U.S.C. 601-674). AMS initially published in the **Federal Register** on February 18, 1999 (64 FR 8014), its plan to review certain regulations, including Marketing Order Nos. 927, 966, and 984, under criteria contained in section 610 of the RFA (5 U.S.C. 601-612). Due to certain changes and additions, updated plans were published in the **Federal Register** on January 4, 2002 (67 FR 525), August 14, 2003 (68 FR 48574), and finally on March 24, 2006 (71 FR 14827). Because many AMS regulations impact small entities, AMS has decided, as a matter of policy, to review certain regulations which, although they may not meet the threshold requirement under section 610 of the RFA, warrant review. The Florida tomato marketing order originally was scheduled for review in 2002. A notice of review and request for comments was published in the **Federal Register** on June 24, 2002 (67 FR 425303). One comment was received as a result of that notice. To the extent relevant, that comment will be taken into consideration in this review. The purpose of the review will be to determine whether the marketing orders for Oregon and Washington pears, Florida tomatoes, and California walnuts should be continued without change, amended, or terminated (consistent with the objectives of the AMAA) to minimize the impacts on small entities. In conducting these reviews, AMS will consider the following factors:
(1)The continued need for each of the marketing orders;
(2)the nature of complaints or comments received from the public concerning these marketing orders;
(3)the complexity of these marketing orders;
(4)the extent to which these marketing orders overlap, duplicate, or conflict with other Federal rules, and, to the extent feasible, with State and local governmental rules; and
(5)the length of time since these marketing orders have been evaluated, or the degree to which technology, economic conditions, or other factors have changed in the areas affected by these marketing orders. Written comments, views, opinions, and other information regarding the impact these marketing orders have on small businesses are invited. Dated: March 12, 2008. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E8-5360 Filed 3-17-08; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 955 [Docket No. AMS-FV-07-0159; FV08-955-1 PR] Vidalia Onions Grown in Georgia; Increased Assessment Rate AGENCY: Agricultural Marketing Service, USDA. ACTION: Proposed rule. SUMMARY: This rule would increase the assessment rate established for the Vidalia Onion Committee (Committee) for the 2008 and subsequent fiscal periods from $0.10 to $0.13 per 40-pound container of Vidalia onions handled. The Committee locally administers the marketing order which regulates the handling of Vidalia onions grown in Georgia. Assessments upon Vidalia onion handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins January 1 and ends December 31. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated. DATES: Comments must be received by April 17, 2008. ADDRESSES: Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Fax:
(202)720-8938; or Internet: *http://www.regulations.gov.* Comments should reference the docket number and the date and page number of this issue of the **Federal Register** and will be available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Manager, Southeast Marketing Field Office, Fruit and Vegetable Programs, AMS, USDA; Telephone:
(863)324-3375, Fax:
(863)325-8793, or E-mail: *Doris.Jamieson@usda.gov,* or *Christian.Nissen@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. 955, both as amended (7 CFR part 955), regulating the handling of Vidalia onions grown in Georgia, 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. Under the marketing order now in effect, Vidalia onion handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable Vidalia onions beginning on January 1, 2008, and continue until amended, suspended, or terminated. 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. This rule would increase the assessment rate established for the Committee for the 2008 and subsequent fiscal periods from $0.10 to $0.13 per 40-pound container of Vidalia onions. The Vidalia onion marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of Vidalia onions. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input. For the 2005 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA. The Committee met on December 13, 2007, and unanimously recommended 2008 expenditures of $712,000 and an assessment rate of $0.13 per 40-pound container of Vidalia onions. In comparison, last year's budgeted expenditures were $835,200. The assessment rate of $0.13 is $0.03 higher than the rate currently in effect. Over the past few years, the Committee has been using funds from reserves rather than increasing assessments to cover their expanded marketing program. This has reduced the reserve fund. The increase in the assessment rate would allow the Committee to fund its recommended level of promotion, while reducing the amount drawn from its authorized reserve fund. The major expenditures recommended by the Committee for the 2008 fiscal year include $410,000 for marketing, $86,350 for salaries, $42,800 for compliance, and $37,200 for research. Budgeted expenses for these items in 2007 were $505,000, $82,000, $20,000, and $65,500, respectively. The assessment rate recommended by the Committee was derived by considering available reserves, and dividing anticipated expenses by expected shipments of Vidalia onions. Vidalia onion shipments for the year are estimated at 4,300,000 40-pound containers, which should provide $559,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, would be adequate to cover budgeted expenses. Funds in the reserve (currently $204,000) would be kept within the maximum permitted by the order (according to § 955.44, approximately three fiscal periods' expenses). The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information. Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2008 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA. Initial 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 initial 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. There are approximately 86 producers of Vidalia onions in the production area and approximately 65 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration
(SBA)as those having annual receipts less than $750,000, and small agricultural service firms, which include handlers, are defined as those whose annual receipts are less than $6,500,000 (13 CFR 121.201). Based on the Georgia Agricultural Statistical Service and Committee data, the average annual grower price for fresh Vidalia onions during the 2007 season was around $15 per 40-pound container. Total Vidalia onions shipments for the 2007 season were around 4,868,000 40-pound containers. Using available data, more than 90 percent of Vidalia onion handlers could be considered small businesses under the SBA definition. In addition, based on information from the Georgia Department of Agriculture, Committee data, and the National Agricultural Statistics Service, the majority of producers could be considered small entities. Thus, the majority of handlers and producers of Vidalia onions may be classified as small entitles. This rule would increase the assessment rate established for the Committee and collected from handlers for the 2008 and subsequent fiscal periods from $0.10 to $0.13 per 40-pound container of Vidalia onions. The Committee unanimously recommended 2008 expenditures of $712,000 and an assessment rate of $0.13 per 40-pound container. The proposed assessment rate of $0.13 is $0.03 higher than the 2007 rate. The quantity of assessable Vidalia onions for the 2008 fiscal year is estimated at 4,300,000. Thus, the $0.13 rate should provide $559,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, would be adequate to cover budgeted expenses. The major expenditures recommended by the Committee for the 2008 fiscal year include $410,000 for marketing, $86,350 for salaries, $42,800 for compliance, and $37,200 for research. Budgeted expenses for these items in 2007 were $505,000, $82,000, $20,000, and $65,500, respectively. Over the past few years, the Committee has been using funds from reserves rather than increasing assessments to cover their expanded marketing program. This has reduced the reserve fund. The increase in the assessment rate would allow the Committee to fund its recommended level of promotion, while reducing the amount drawn from its authorized reserve fund. Funds in the reserve (currently $204,000) would be kept within the maximum permitted by the order. The Committee reviewed and unanimously recommended 2008 expenditures of $712,000 which included increases in administrative expenses, and compliance programs. Prior to arriving at this budget, the Committee considered information from various sources, including the Executive Committee and the Research Subcommittee. Alternative expenditure levels were discussed by the Committee based upon the relative value of various research and promotion projects to the Vidalia onion industry. The Committee also discussed keeping the current $0.10 per 40-pound bag or equivalent assessment rate. However, keeping the assessment rate at $0.10 per 40-pound bag would not allow the Committee to fund many of the proposed promotional projects. The assessment rate of $0.13 per 40-pound container of assessable Vidalia onions was then determined by considering available reserves, and dividing the total recommended budget by the quantity of assessable Vidalia onions, estimated at 4,300,000 40-pound containers for the 2008 fiscal year. This is approximately $138,000 below the anticipated expenses, which the Committee determined to be acceptable. A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the grower price for the 2008 season could range between $10.00 and $34.00 per 40-pound container of Vidalia onions. Therefore, the estimated assessment revenue for the 2008 fiscal period as a percentage of total grower revenue could range between .4 and 1 percent. This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs would be offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the Vidalia onion industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the December 13, 2007, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses. This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large Vidalia onion 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. 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. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with 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. A 30-day comment period is provided to allow interested persons to respond to this proposed rule. Thirty days is deemed appropriate because:
(1)The 2008 fiscal period began on January 1, 2008, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable Vidalia onions handled during such fiscal period;
(2)the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and
(3)handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years. List of Subjects in 7 CFR Part 955 Onions, Marketing agreements, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, 7 CFR part 955 is proposed to be amended as follows: PART 955—VIDALIA ONIONS GROWN IN GEORGIA 1. The authority citation for 7 CFR part 955 continues to read as follows: Authority: 7 U.S.C. 601-674. 2. Section 955.209 is revised to read as follows: § 955.209 Assessment rate. On and after January 1, 2008, an assessment rate of $0.13 per 40-pound carton or equivalent is established for Vidalia onions. Dated: March 12, 2008. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E8-5358 Filed 3-17-08; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 2 and 3 [Docket No. 99-014-3] RIN 0579-AC41 Animal Welfare; Climatic and Environmental Conditions for Transportation of Warmblooded Animals Other Than Marine Mammals ACTION: Proposed rule; reopening of comment period. SUMMARY: We are reopening the comment period for our proposed rule that would remove the current ambient temperature requirements in the Animal Welfare Act regulations for various stages in the transportation of live animals other than marine mammals. The proposal would replace those requirements with a single performance standard for climatic and environmental conditions during their transportation. This action will allow interested persons additional time to prepare and submit comments. DATES: We will consider all comments that we receive on or before April 17, 2008. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0150* to submit or view comments and to view supporting and related materials available electronically. • *Postal Mail/Commercial Delivery:* Please send two copies of your comment to Docket No. 99-014-2, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 99-014-2. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov.* FOR FURTHER INFORMATION CONTACT: Dr. Jerry D. DePoyster, Veterinary Medical Officer, Animal Care, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737-1234;
(301)734-7586. SUPPLEMENTARY INFORMATION: On January 3, 2008, we published in the **Federal Register** (73 FR 413-420, Docket No. 99-014-2) a proposal to remove the current ambient temperature requirements in the Animal Welfare Act regulations for various stages in the transportation of live animals other than marine mammals. The proposal would replace those requirements with a single performance standard under which the animals would be transported under climatic and environmental conditions that are appropriate for their welfare. Comments on the proposed rule were required to be received on or before March 3, 2008. We are reopening the comment period on Docket No. 99-014-2 for an additional 30 days. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between March 4, 2008, and the date of this notice. Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7. Done in Washington, DC, this 12th day of March 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8-5394 Filed 3-17-08; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0301; Directorate Identifier 2007-NM-284-AD] RIN 2120-AA64 Airworthiness Directives; Dassault Model Falcon 2000EX and 900EX Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above. This proposed AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: On early FALCON airplanes featuring the EASy cockpit, a new oxygen controller has been installed. An internal review has determined that the passenger oxygen mask boxes do not fit this new controller. In OVERRIDE mode, that is to say, when the internal pressure reducer is by-passed, oxygen (O <sup>2</sup> ) flow is nominal, while in NORMAL mode O <sup>2</sup> flow is reduced by half compared to what it should be. Consequently, in NORMAL mode the minimum mass flow of supplemental O2 for each passenger, as required by Certification Specifications, is no longer met. This could lead to passenger incommodation due to insufficient body oxygenation. The unsafe condition is incorrectly fitted passenger oxygen mask boxes for the new controllers, which could result in incapacitation of passengers due to insufficient oxygen in the event of rapid depressurization of the airplane when the controller is in NORMAL mode. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by April 17, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0301; Directorate Identifier 2007-NM-284-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments. We will post all comments we receive, without change, to *http://www.regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued Airworthiness Directive 2007-0073, dated March 22, 2007 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: On early FALCON airplanes featuring the EASy cockpit, a new oxygen controller has been installed. An internal review has determined that the passenger oxygen mask boxes do not fit this new controller. In OVERRIDE mode, that is to say, when the internal pressure reducer is by-passed, oxygen (O <sup>2</sup> ) flow is nominal, while in NORMAL mode O <sup>2</sup> flow is reduced by half compared to what it should be. Consequently, in NORMAL mode the minimum mass flow of supplemental O <sup>2</sup> for each passenger, as required by Certification Specifications, is no longer met. This could lead to passenger incommodation due to insufficient body oxygenation. The purpose of this Airworthiness Directive
(AD)is to mandate the replacement of the passenger oxygen mask boxes by new-design ones [boxes] adapted to the controller. The unsafe condition is incorrectly fitted passenger oxygen mask boxes for the new controllers, which could result in incapacitation of passengers due to insufficient oxygen in the event of rapid depressurization of the airplane when the controller is in NORMAL mode. You may obtain further information by examining the MCAI in the AD docket. Relevant Service Information Dassault has issued Service Bulletins F900EX-257 and F2000EX-61, both Revision 1, both dated March 22, 2007. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. FAA's Determination and Requirements of This Proposed AD This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD. Costs of Compliance Based on the service information, we estimate that this proposed AD would affect about 27 products of U.S. registry. We also estimate that it would take about 16 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Required parts would cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $34,560, or $1,280 per product. 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 determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the 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 proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 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 FAA amends § 39.13 by adding the following new AD: **Dassault Aviation:** Docket No. FAA-2008-0301; Directorate Identifier 2007-NM-284-AD. Comments Due Date
(a)We must receive comments by April 17, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Dassault Model Falcon 2000EX and 900EX airplanes, certificated in any category, as identified in paragraphs (c)(1) and (c)(2) of this AD.
(1)Falcon 900EX airplanes, serial number (S/N) 120 through 146 inclusive, on which Dassault Service Bulletin F900EX-257 has not been implemented.
(2)Falcon 2000EX airplanes, S/N 28 through 55 inclusive, on which Dassault Service Bulletin F2000EX-61 has not been implemented. Subject
(d)Air Transport Association
(ATA)of America Code 35: Oxygen. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: On early FALCON airplanes featuring the EASy cockpit, a new oxygen controller has been installed. An internal review has determined that the passenger oxygen mask boxes do not fit this new controller. In OVERRIDE mode, that is to say, when the internal pressure reducer is by-passed, oxygen (O <sup>2</sup> ) flow is nominal, while in NORMAL mode O <sup>2</sup> flow is reduced by half compared to what it should be. Consequently, in NORMAL mode the minimum mass flow of supplemental O <sup>2</sup> for each passenger, as required by Certification Specifications, is no longer met. This could lead to passenger incommodation due to insufficient body oxygenation. The purpose of this Airworthiness Directive
(AD)is to mandate the replacement of the passenger oxygen mask boxes by new-designed ones [boxes] adapted to the controller. The unsafe condition is incorrectly fitted passenger oxygen mask boxes for the new controllers, which could result in incapacitation of passengers due to insufficient oxygen in the event of rapid depressurization of the airplane when the controller is in NORMAL mode. Actions and Compliance
(f)Unless already done do the following actions:
(1)Within 15 months after the effective date of this AD, replace the passenger oxygen mask boxes in accordance with Dassault Service Bulletins F900EX-257 or F2000EX-61, both Revision 1, both dated March 22, 2007, as applicable.
(2)Actions done before the effective date of this AD in accordance with Dassault Service Bulletins F900EX-257 dated March 15, 2006, and F2000EX-61, dated March 22, 2006; are acceptable for compliance with the corresponding actions of this AD. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, International Branch, ANM-116, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI EASA Airworthiness Directive 2007-0073, dated March 22, 2007, and Dassault Service Bulletins F900EX-257 and F2000EX-61, both Revision 1, both dated March 22, 2007, for related information. Issued in Renton, Washington, on March 9, 2008. Stephen P. Boyd, Assistant Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-5371 Filed 3-17-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0302; Directorate Identifier 2007-NM-323-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 767-200, -300, and -400ER Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to supersede an existing airworthiness directive
(AD)that applies to certain Boeing Model 767-200, -300, and -400ER series airplanes. The existing AD currently requires an inspection to determine if the door-mounted escape slide/rafts have certain part numbers. For those door-mounted escape slide/rafts having certain part numbers, the existing AD also currently requires an inspection for excessive tension of the firing cable, and procedures for providing slack in the firing cable or rerouting the firing cable if necessary. For certain airplanes, this proposed AD would require a review of the airplane maintenance records to determine if a certain service bulletin has been incorporated, or an inspection to determine if certain door-mounted escape slide/rafts are installed. This proposed AD would also require modification of certain escape slide/rafts. This proposed AD results from reports of uncommanded inflation inside the airplane of a door-mounted escape slide/raft located in the passenger compartment. We are proposing this AD to prevent injury to maintenance personnel, passengers, and crew during otherwise normal operating conditions and to prevent interference with evacuation of the airplane during an emergency, due to uncommanded inflation of a door-mounted escape slide/raft. DATES: We must receive comments on this proposed AD by May 2, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Keith Ladderud, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6435; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0302; Directorate Identifier 2007-NM-323-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion On June 7, 2005, we issued AD 2005-12-14, amendment 39-14130 (70 FR 34638, June 15, 2005), for certain Boeing Model 767-200, -300, and -400ER series airplanes. That AD requires an inspection to determine if the door-mounted escape slide/rafts have certain part numbers. For those door-mounted escape slide/rafts having certain part numbers, that AD also requires an inspection for excessive tension of the firing cable, and procedures for providing slack in the firing cable or rerouting the firing cable if necessary. That AD resulted from reports of uncommanded inflation inside the airplane of a door-mounted escape slide/raft located in the passenger compartment. We issued that AD to prevent injury to maintenance personnel, passengers, and crew during otherwise normal operating conditions and to prevent interference with evacuation of the airplane during an emergency, due to uncommanded inflation of a door-mounted escape slide/raft. Actions Since Existing AD Was Issued The preamble to AD 2005-12-14 specified that we considered the requirements “interim action” and that the manufacturer was developing a modification to address the unsafe condition. That AD explained that we might consider further rulemaking if a modification is developed, approved, and available. The manufacturer now has developed such a modification, and we have determined that further rulemaking is indeed necessary; this proposed AD follows from that determination. Boeing has issued Alert Service Bulletin 767-25A0395, Revision 1, dated January 25, 2007, to provide instructions for accomplishing the modification. Relevant Service Information We have reviewed Revision 1 of Boeing Alert Service Bulletin 767-25A0395. For Group 1 and 2 airplanes, the service bulletin describes procedures for doing either a records verification to determine if Boeing Service Bulletin 767-25-0266 has been incorporated, or a general visual inspection to determine if any door-mounted escape slide/raft having part number (P/N) 5A3294-1, 5A3294-2, 5A3295-1, or 5A3295-3 is installed. For Group 1 and 2 airplanes, the service bulletin also describes procedures for doing the corrective action, which is to modify the escape slide/rafts, if Boeing Service Bulletin 767-25-0266 has been incorporated or if P/N 5A3294-1, 5A3294-2, 5A3295-1, or 5A3295-3 is installed. For Group 3, 4, 5 and 6 airplanes, the service bulletin describes procedures for modifying the door-mounted escape slide/rafts. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The service bulletin refers to Goodrich Service Bulletin 5A3294/5A3295-25-362, dated July 25, 2006, as an additional source of service information for modifying a door-mounted escape slide/raft by replacing the firing cable with a longer cable and testing the regulator valve of the inflation trigger system for the door-mounted escape slide/raft. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to develop on other products of the same type design. For this reason, we are proposing this AD, which would supersede AD 2005-12-14 and would retain the requirements of the existing AD. This proposed AD would also require accomplishing the actions specified in the service information described previously. Costs of Compliance There are about 1,225 airplanes of the affected design in the worldwide fleet. This proposed AD would affect about 355 airplanes of U.S. registry. The actions that are required by AD 2005-12-14 and retained in this proposed AD take up to about 6 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the currently required actions for U.S. operators is $170,400, or is $480 per airplane. The new proposed actions would take up to about 6 work hours per airplane, at an average labor rate of $80 per work hour. The parts manufacturer states that it will supply the required parts to operators at no cost. Based on these figures, the estimated cost of the new actions specified in this proposed AD for U.S. operators is $170,400, or $480 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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the 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 proposed 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, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 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 removing amendment 39-14130 (70 FR 34638, June 15, 2005) and adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2008-0302; Directorate Identifier 2007-NM-323-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by May 2, 2008. Affected ADs
(b)This AD supersedes AD 2005-12-14. Applicability
(c)This AD applies to Boeing Model 767-200, -300, and -400ER series airplanes, certificated in any category, equipped with door-mounted escape slide/rafts. Unsafe Condition
(d)This AD results from reports of uncommanded inflation inside the airplane of a door-mounted escape slide/raft located in the passenger compartment. We are issuing this AD to prevent injury to maintenance personnel, passengers, and crew during otherwise normal operating conditions and to prevent interference with evacuation of the airplane during an emergency, due to uncommanded inflation of a door-mounted escape slide/raft. 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. Restatement of Requirements of AD 2005-12-14 Inspection for Part Numbers (P/Ns)
(f)Within 30 days after June 30, 2005 (the effective date of AD 2005-12-14), accomplish the actions in either paragraph (f)(1) or (f)(2) of this AD.
(1)Perform a one-time inspection to determine if any Goodrich door-mounted escape slide/raft having P/N 5A3294-1, 5A3294-2, 5A3295-1, or 5A3295-3 is installed. If no slide/raft having any of those part numbers is installed, no further action is required by this paragraph, except for the requirements of paragraph
(j)of this AD.
(2)Perform a one-time check of the airplane maintenance records to determine if any Goodrich door-mounted escape slide/raft having P/N 5A3294-1, 5A3294-2, 5A3295-1, or 5A3295-3 is installed. If it can be conclusively determined from the airplane maintenance records that no slide/raft having any of those part numbers is installed, no further action is required by this AD, except for the requirements of paragraph
(j)of this AD. Inspection for Excessive Tension on the Firing Cable
(g)If any door-mounted escape slide/raft with any part number specified in paragraph
(f)of this AD is installed: Within 30 days after June 30, 2005, perform a tension check on the firing cable of the slide/raft, in accordance with Boeing Alert Service Bulletin 767-25A0390, dated May 13, 2005. If no excessive tension is detected, no further action is required by this AD, except for the requirements of paragraph
(j)of this AD. Note 1: Boeing Alert Service Bulletin 767-25A0390, dated May 13, 2005, references Goodrich Alert Service Bulletin 5A3294/5A3295-25A356, dated May 11, 2005, as an additional source of service information. Corrective Action for Excessive Tension on the Firing Cable
(h)If any excessive tension of the firing cable is detected, before further flight, do the applicable corrective actions in accordance with the Boeing Alert Service Bulletin 767-25A0390, dated May 13, 2005. Previous Accomplishment
(i)Inspections of the firing cables for excessive tension in accordance with Boeing Alert Service Bulletin 767-25A0390, dated May 13, 2005, that were accomplished before June 30, 2005, are acceptable for compliance with the requirements of paragraph
(g)of this AD, provided that any applicable corrective action was completed. Parts Installation
(j)As of June 30, 2005, no person may install on any airplane any Goodrich door-mounted escape slide/raft having P/N 5A3294-1, 5A3294-2, 5A3295-1, or 5A3295-3, unless the tension of the firing cable has been checked and the applicable corrective action completed in accordance with Boeing Alert Service Bulletin 767-25A0390, dated May 13, 2005, or the escape slide/raft has been repacked in accordance with Goodrich Packing Instructions, Evacuation Slide/Raft, Document 501636, Revision G, dated May 16, 2005; Goodrich Packing Instructions, Evacuation Slide/Raft, LH, Document 501637, Revision E, dated May 16, 2005; or Goodrich Packing Instructions, Evacuation Slide/Raft, RH, Document 501638, Revision D, dated May 16, 2005; as applicable. New Requirements of This AD Modification
(k)For airplanes identified in Boeing Alert Service Bulletin 767-25A0395, Revision 1, dated January 25, 2007: Within 36 months after the effective date of this AD, do the applicable actions specified in paragraph (k)(1) or (k)(2) of this AD, by accomplishing all of the applicable actions specified in the service bulletin.
(1)For Group 1 and 2 airplanes as identified in the service bulletin: Review the airplane maintenance records to determine if Boeing Service Bulletin 767-25-0266 has been incorporated, or do a general visual inspection to determine if any door-mounted escape slide/raft having P/N 5A3294-1, 5A3294-2, 5A3295-1, or 5A3295-3 is installed, and before further flight do all the applicable corrective actions. Doing the inspection before the effective date of this AD in accordance with paragraph (f)(1) of this AD is acceptable for compliance with the inspection specified in this paragraph.
(2)For Group 3, 4, 5, and 6 airplanes as identified in the service bulletin: Modify the escape slide/rafts. Note 2: Boeing Alert Service Bulletin 767-25A0395, Revision 1, refers to Goodrich Service Bulletin 5A3294/5A3295-25-362, dated July 25, 2006, as an additional source of service information for modifying a door-mounted escape slide/raft. Alternative Methods of Compliance (AMOCs) (l)(1) The Manager, Seattle Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(3)AMOCs approved previously in accordance with AD 2005-12-14, amendment 39-14130, are approved as AMOCs for the corresponding provisions of paragraphs (f), (g), (h), (i), and
(j)of this AD. Issued in Renton, Washington, on March 9, 2008. Stephen P. Boyd, Assistant Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-5373 Filed 3-17-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2008-0131; Airspace Docket 08-AEA-12] Proposed Establishment of Class E Airspace; Philippi, WV AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking. SUMMARY: This action proposes to establish Class E airspace at Philippi, WV. Area Navigation
(RNAV)Global Positioning System
(GPS)Standard Instrument Approach Procedures
(SIAP)Runways
(RWY)08-26 has been developed for Philippi/Barbour County Regional Airport. As a result, controlled airspace extending upward from 700 feet Above Ground Level
(AGL)is needed to contain the SIAP and for Instrument Flight Rule
(IFR)operations at Philippi/Barbour County Regional Airport. The operating status of the airport will change from Visual Flight Rules
(VFR)to include IFR operations concurrent with the publication of the SIAP. This action enhances the safety and airspace management of Philippi/Barbour County Regional Airport. DATES: Comments must be received on or before May 2, 2008. ADDRESSES: Send comments on this proposal to: U. S. Department of Transportation, Docket Operations, West Building, Ground Floor, Room W12-140, 1200 New Jersey Ave., SE., Washington, DC 20590-0001; Telephone: 1-800-647-5527; Fax: 202-493-2251. You must identify the docket number FAA-2008-0131; Airspace Docket 08-AEA-12, at the beginning of your comments. You may also submit comments on the Internet at *http://www.regulations.gov* . You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia 30337. FOR FURTHER INFORMATION CONTACT: Daryl Daniels, Airspace Specialist, System Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone
(404)305-5581. SUPPLEMENTARY INFORMATION: Comments Invited Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Those wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2008-0131; Airspace Docket No. 08-AEA-12.” The postcard will be date/time stamped and returned to the commenter. All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. Availability of NPRMs An electronic copy of this document may be downloaded through the Internet at *http://www.regulations.gov* . Recently published rulemaking documents can also be accessed through the FAA's Web page at *http://www.faa.gov* or the Federal Register's Web page at *http://www.gpoaccess.gov/fr/index.html* . Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking,
(202)267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure. The Proposal The FAA is considering an amendment to Part 71 of the Code of Federal Regulations (14 CFR part 71) to establish Class E airspace at Philippi, WV. Class E airspace designations for airspace areas extending upward from 700 feet or more above the surface of the Earth are published in Paragraph 6005 of FAA Order 7400.9R, signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore,
(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)does not warrant preparation of a Regulatory Evaluation, as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it proposes to establish Class E airspace at Philippi, WV. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9R, Airspace Designations and Reporting Points, signed August 15, 2007, and effective September 15, 2007, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth AEA WV E5 Philippi, WV [New] Philippi/Barbour County Regional Airport, WV (Lat. 39°09′58″ N., long. 80°03′45″ W.) That airspace extending upward from 700 feet above the surface of the Earth within a 6.6-mile radius of Philippi/Barbour County Regional Airport. Issued in College Park, Georgia, on February 25, 2008. Mark D. Ward, Manager, System Support Group Eastern Service Center. [FR Doc. E8-5170 Filed 3-17-08; 8:45 am] BILLING CODE 4910-13-M SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA 2007-0082] RIN 0960-AG67 Revised Medical Criteria for Evaluating HIV Infection AGENCY: Social Security Administration. ACTION: Advance Notice of Proposed Rulemaking. SUMMARY: In a separate notice in today's edition of the **Federal Register** , we are publishing final rules revising the criteria we use to evaluate immune system disorders, found in sections 14.00 and 114.00 of the Listing of Impairments in appendix 1 to subpart P of part 404 of our regulations (the listings). In those rules, we indicate that we will issue an Advance Notice of Proposed Rulemaking (ANPRM) inviting public comments on how we might update and revise listings 14.08 and 114.08, our listings for evaluating HIV infection. We are now requesting your comments and suggestions about possible revisions to those listings. After we have considered your comments and suggestions, other information about advances in medical knowledge, treatment, and methods of evaluating HIV infection, and our program experience using the current listings, we will determine whether we should revise listings 14.08 and 114.08. If we propose specific revisions to the listings, we will publish a Notice of Proposed Rulemaking
(NPRM)in the **Federal Register** . DATES: To be sure that your comments are considered, we must receive them no later than May 19, 2008. ADDRESSES: You may submit comments by any of the following methods. Regardless of which method you choose, to ensure that we can associate your comments with the correct regulation for consideration, you must state that your comments refer to Docket No. SSA-2007-0082: • Federal eRulemaking Portal at *http://www.regulations.gov.* (This is the preferred method for submitting your comments.) In the Search Documents section, select “Social Security Administration” from the agency drop-down menu, then click “submit.” In the Docket ID Column, locate SSA-2007-0082 and then click “Add Comments” in the “Comments Add/Due By” column. • Telefax to
(410)966-2830. • Letter to the Commissioner of Social Security, P.O. Box 17703, Baltimore, Maryland 21235-7703. • Deliver your comments to the Office of Regulations, Social Security Administration, 922 Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, between 8 a.m. and 4:30 p.m. on regular business days. Comments are posted on the Federal eRulemaking portal, or you may inspect them on regular business days by making arrangements with the contact person shown in this preamble. FOR FURTHER INFORMATION CONTACT: Paul Scott, Office of Compassionate Allowances and Listings Improvement, Social Security Administration, 4422 Annex Building, 6401 Security Boulevard, Baltimore, MD 21235-6401,
(410)966-1192, for information about this notice. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at *http://www.socialsecurity.gov.* SUPPLEMENTARY INFORMATION: Electronic Version The electronic file of this document is available on the date of publication in the **Federal Register** at *http://www.gpoaccess.gov/fr/index.html.* What is the purpose of this ANPRM? The purpose of this ANPRM is to give you an opportunity to send us comments and suggestions on whether and how we might update and revise listings 14.08 and 114.08, our listings for evaluating HIV infection. In a separate notice in today's edition of the **Federal Register** , we are publishing final rules revising the criteria we use to evaluate immune system disorders, found in sections 14.00 and 114.00 of the listings. We proposed changes to listings 14.08 and 114.08 when we published our NPRM on August 4, 2006 (71 FR 44432 (2006)), and we received some public comments suggesting changes to those listings. Although the final rules that we are are publishing today include changes to listings 14.08 and 114.08, the criteria in these listings are not substantively different from the criteria in our proposed rules and our current rules. We have decided to publish this ANPRM partly because we need additional information and partly because we believe that some of the changes suggested in the public comments were too extensive to include in a final rule without giving the public a chance to comment on them. Which rules are we inviting comments about? We are considering whether and how to update and revise listings 14.08 and 114.08. You can find the revised rules for listing sections 14.00 and 114.00 in a separate notice that we are publishing in today's edition of the **Federal Register** . Who should send us comments and suggestions? We invite comments and suggestions from anyone who has an interest in the rules we use to evaluate claims for benefits filed by persons who have HIV infection. We are interested in getting comments and suggestions from persons who apply for or receive benefits from us, members of the general public, advocates and organizations who represent people who have HIV infection, State agencies that make disability determinations for us, experts in the evaluation of HIV infection, and researchers. What should you comment about? We are specifically interested in any comments and suggestions you have on how we might update and revise listings 14.08 and 114.08. The issues we want your comments to address are: • Should we add, change, or remove any of the criteria in listings 14.08 and 114.08? • If so, what revisions do you think we should make? Will we respond to your comments from this notice? We will not respond directly to comments you send us in response to this notice. However, after we consider your comments along with other information, such as medical research and other information about advances in medical knowledge, treatment, and methods of evaluating HIV infection and our program experience, we will decide whether and how to revise listings 14.08 and 114.08. If we propose revisions to those listings, we will publish an NPRM in the **Federal Register** . In accordance with the usual rulemaking procedures we follow, if we publish an NPRM, you will have a chance to comment on any proposed revisions to listings 14.08 and 114.08, and we will summarize and respond to the significant comments on the NPRM in the preamble to any final rules. Other Information Who can get disability benefits? Under title II of the Social Security Act (the Act), we provide for the payment of disability benefits if you are disabled and belong to one of the following three groups: • Workers insured under the Act, • Children of insured workers, and • Widows, widowers, and surviving divorced spouses (see § 404.336) of insured workers. Under title XVI of the Act, we provide for Supplemental Security Income
(SSI)payments on the basis of disability if you are disabled and have limited income and resources. How do we define disability? Under both the title II and title XVI programs, disability must be the result of any medically determinable physical or mental impairment or combination of impairments that is expected to result in death or which has lasted or is expected to last for a continuous period of at least 12 months. Our definitions of disability are shown in the following table: If you file a claim under . . . And you are . . . Disability means you have a medically determinable impairment(s) as described above that results in . . . title II An adult or child the inability to do any substantial gainful activity (SGA). title XVI An individual age 18 or older the inability to do any SGA. title XVI An individual under age 18 marked and severe functional limitations. How do we decide whether you are disabled? If you are applying for benefits under title II of the Act, or if you are an adult applying for payments under title XVI of the Act, we use a five-step “sequential evaluation process” to decide whether you are disabled. We describe this five-step process in our regulations at §§ 404.1520 and 416.920. We follow the five steps in order and stop as soon as we can make a determination or decision. The steps are: 1. Are you working, and is the work you are doing SGA? If you are working and the work you are doing is SGA, we will find that you are not disabled, regardless of your medical condition or your age, education, and work experience. If you are not, we will go on to step 2. 2. Do you have a “severe” impairment? If you do not have an impairment or combination of impairments that significantly limits your physical or mental ability to do basic work activities, we will find that you are not disabled. If you do, we will go on to step 3. 3. Do you have an impairment(s) that meets or medically equals the severity of an impairment in the listings? If you do, and the impairment(s) meets the duration requirement, we will find that you are disabled. If you do not, we will go to step 4. 4. Do you have the residual functional capacity
(RFC)to do your past relevant work? If you do, we will find that you are not disabled. If you do not, we will go on to step 5. 5. Does your impairment(s) prevent you from doing any other work that exists in significant numbers in the national economy, considering your RFC, age, education, and work experience? If it does, and it meets the duration requirement, we will find that you are disabled. If it does not, we will find that you are not disabled. We use a different sequential evaluation process for children who apply for payments based on disability under SSI. If you are already receiving benefits, we also use a different sequential evaluation process when we decide whether your disability continues. See §§ 404.1594, 416.924, 416.994, and 416.994a of our regulations. However, all of these processes include steps at which we consider whether your impairment(s) meets or medically equals one of our listings. What are the listings? The listings are examples of impairments that we consider severe enough to prevent you as an adult from doing any gainful activity. If you are a child seeking SSI payments based on disability, the listings describe impairments that we consider severe enough to result in marked and severe functional limitations. Although the listings are contained only in appendix 1 to subpart P of part 404 of our regulations, we incorporate them by reference in the SSI program in § 416.925 of our regulations, and apply them to claims under both title II and title XVI of the Act. How do we use the listings? The listings are in two parts. There are listings for adults (part A) and for children (part B). If you are an individual age 18 or over, we apply the listings in part A when we assess your claim, and we do not use the listings in part B. If you are an individual under age 18, we first use the criteria in part B of the listings. If the criteria in part B do not apply, we may use the criteria in part A when those criteria give appropriate consideration to the effects of the impairment(s) in children. (See §§ 404.1525 and 416.925.) If your impairment(s) does not meet any listing, we will also consider whether it medically equals any listing, that is, whether it is as medically severe as an impairment in the listings. (See §§ 404.1526 and 416.926.) What if you do not have an impairment(s) that meets or medically equals a listing? We use the listings only to decide that you are disabled or that you are still disabled. We will not deny your claim or decide that you no longer qualify for benefits because your impairment(s) does not meet or medically equal a listing. If you have a severe impairment(s) that does not meet or medically equal any listing, we may still find you disabled based on other rules in the “sequential evaluation process.” Likewise, we will not decide that your disability has ended only because your impairment(s) no longer meets or medically equals a listing. List of Subjects in 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old-Age, Survivors and Disability Insurance, Reporting and recordkeeping requirements, Social Security. Dated: January 15, 2008. Michael J. Astrue, Commissioner of Social Security. [FR Doc. E8-5022 Filed 3-17-08; 8:45 am] BILLING CODE 4191-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 516 [Docket No. 2008N-0011] RIN 0910-AG03 Defining Small Number of Animals for Minor Use Designation AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relied on the phrase “small number of animals” to characterize such use. At this time, FDA is proposing to amend the implementing regulations of the MUMS act. In response to Congress' charge to the agency to further define minor use, this amendment proposes a specific “small number of animals” for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use. DATES: Submit written or electronic comments on the proposed rule by July 16, 2008. Submit comments regarding information collection by April 17, 2008 to OMB (see ADDRESSES ). ADDRESSES: You may submit comments, identified by Docket No. 2008N-0011 and RIN number 0910-AG03, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following way: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to * http://www.regulations.gov* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to * http://www.regulations.gov* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. *Information Collection Provisions* : Submit written comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB).To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9005, e-mail: *Margaret.Oeller@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background A. The Definition of Minor Use The MUMS act (Public Law 108-282) amended the Federal Food, Drug, and Cosmetic Act (the act) to provide incentives for the development of new animal drugs for use in minor animal species and for minor uses in major animal species. The MUMS act defines “minor use” as “the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually” (section 201(pp) of the act (21 U.S.C. 321(pp)). The major species are cattle, horses, swine, chickens, turkeys, dogs, and cats (21 U.S.C. 321(nn)). Prior to enactment of the MUMS act, FDA defined minor use by regulation to mean, “the use of: * * *
(b)new animal drugs in any animal species for the control of a disease that ( *1* ) occurs infrequently or ( *2* ) occurs in limited geographical areas” (48 FR 1922; January 14, 1983 (former § 514.1(d)(1) (21 CFR 514.1(d)(1))). The MUMS act narrowed this definition by restricting it to uses “in only a small number of animals annually” (21 U.S.C. 321(pp)). The legislative history of the MUMS act indicates that Congress intended that FDA further define minor use in a major species by regulation and that it do so “by evaluating, in the context of the drug development process, whether the incidence of a disease or condition occurs so infrequently that the sponsor of a drug intended for such use has no reasonable expectation of its sales generating sufficient revenues to offset the cost of development” (S. Rpt. 108-226 at 12-13). The legislative history also notes that the new statutory definition for minor use “incorporates the existing definition in the Code of Federal Regulations (21 CFR 514.1(d)(1)) with a further limitation to small numbers to assure that such intended uses will not be extended to a wider use” (S. Rept. 108-226 at 12-13). Therefore, while the MUMS act establishes incentives for animal drug development for minor uses, it also limits the availability of those incentives in order to prevent them from stimulating “wider use” of new animal drugs marketed under the MUMS act provisions. Consistent with these dual aims of stimulating animal drug development for minor uses in major species and at the same time preventing “wider use” of such new animal drugs, the agency is proposing to define the term “small number of animals” for each major species that would constitute the upper limit of a “minor use” under the MUMS act. In keeping with the goal of creating a drug development incentive, the proposed definition would establish the number of animals eligible to be treated annually based on the number of animals that represents a drug market value that (relative to drug development costs) would not be likely to be pursued in the absence of the MUMS act incentives. Furthermore, as explained in the following section I.B of this document, FDA believes it is necessary to establish “small number of animals” differently for companion animals than for food-producing animals. B. Companion Animals vs. Food-Producing Animals The issue of considering companion animals and food-producing animals separately in the context of establishing small numbers of animals was raised in comments on the MUMS designation proposed rule (70 FR 56394; September 27, 2005). One of the comments stated that the agency and sponsors would be best served by separating requirements for companion and food-producing animals because “this separation would provide information clearly focused on the information necessary for each group” (Ref. 1). A second comment requested that the agency “consider separation of the requirements for companion animals from that for food-producing animals, as it is difficult to generalize across the two categories” (Ref. 2). A third comment urged FDA to establish different sets of criteria for major species of food-producing animals and companion animals because “economic criteria play differently into decisions to administer drugs to these two types of animals” (Ref. 3). The agency generally agrees that food-producing and companion animals should be considered separately with respect to establishing small numbers, and notes that one of the principal reasons for considering food-producing and companion animals differently is that the decision to treat food-producing animals is almost exclusively based on an assessment of the economic value of the animals at the time treatment is needed. In addition, very often this decision involves administering a drug to all animals in a herd or flock, not just those showing signs of disease. Because the decision to administer a drug may be made more conservatively than for companion animals but, once made, often involves the exposure of more animals, there is no clear basis for estimating the likelihood of drug administration to individual food-producing animals. Other factors to consider are that there are much larger absolute numbers of food-producing animals than companion animals (in the case of chickens, approximately 9 billion) (Ref. 4), and that food-producing animals tend to be geographically concentrated to a greater extent than companion animals (Ref. 5). Each of these factors supports establishing “small numbers of animals” for companion animals differently than “small numbers of animals” for food-producing animals. When FDA proposed regulations to implement the designation provision of the MUMS act, the preamble contained considerable discussion regarding the definition of “minor use,” including the issues surrounding the use of the phrase “small number of animals” in the statutory definition of minor use. (See section II.A.2 Minor Use of 70 FR 56394 at 56395.) Ultimately, the agency indicated that it did not have enough information to propose a “small number of animals” for each major species at that time, but indicated its intention to do so in the future, and requested information to facilitate that process. In response to this request, FDA received four comments concerning “small numbers of animals” and minor use which the agency responded to in the preamble of the MUMS designation final rule. (See section III.B of 72 FR 41010 at 41013.) These comments were general in nature. This may be attributed, in part, to animal drug sponsors considering specific information regarding the cost of drug development, and the process by which they make decisions to pursue drug development, to be, “for the most part, confidential” (Ref. 2). However, the agency was able to obtain information regarding average animal drug development costs as well as typical drug treatment costs for the seven major species. This information was obtained by contracting with a source with significant knowledge of the animal pharmaceutical industry that was also capable of collecting information from a large number of other sources (Ref. 6). From this source, the agency was also able to obtain general information regarding the incidence or prevalence of a large number of diseases and conditions of dogs, cats, and horses. Similar information regarding disease incidence or prevalence was not readily available for major food-producing species. In fact, in spite of repeated agency requests to the animal health industry to identify potential conditions of food-producing animals that might qualify as minor uses, very few conditions have been suggested; for example babesiosis in cattle. Therefore, following a careful analysis of the information noted previously, and based on early experience making designation determinations on a case-by-case basis, the agency is now proposing the establishment of a “small number of animals” for each of the seven major animal species. II. Proposed Regulation A. “Small Numbers” for Major Species of Companion Animals 1. The Value of Exclusivity There are three drug development incentives established by the Orphan Drug Act (Public Law 97-414) that are associated with human orphan product development: Seven years of exclusive marketing, an approximately 50 percent reduction in development costs via tax reductions, and eligibility for grants to support development costs. Designated MUMS drugs are currently eligible for 7 years of exclusive marketing (section 573(c) of the act) (21 U.S.C. 360ccc-2(c)), and eventually will be eligible for grants (section 102(b)(8) of the MUMS act). A tax incentive for animal drug development was not included in this legislation. The designation provisions of the MUMS act went into effect upon enactment. Therefore, FDA must define “small numbers” as soon as possible. Consistent with the intent and the language of the MUMS act, “small number” for each major companion animal species (horses, dogs, and cats) should represent a drug market value that (relative to drug development costs) would not be likely to be pursued in the absence of the MUMS act incentives. While incentives in addition to marketing exclusivity, such as the MUMS grant provisions, should they become available, would be expected to increase the likelihood of developing drugs for markets smaller than the proposed small number thresholds, the increase in incentives would not alter the small numbers themselves. To estimate the value of 7 years of exclusive marketing rights, we have examined the marketing exclusivity established by the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) (Public Law 100-670) as a benchmark for MUMS exclusivity. GADPTRA provides 5 years of exclusivity for the first-time approval of a drug in animals (section 512(c)(2)(F) of the act) (21 U.S.C. 360b(c)(2)(F)). In enacting GADPTRA, Congress indicated that it viewed this term of exclusivity as a sufficient return on investment prior to generic competition to provide an incentive for the pioneer sponsor to develop a drug. Together with information regarding average animal drug development costs obtained by the agency (Ref. 6), we can calculate the relative value of the 5-year GADPTRA incentive. A basic principle of animal drug product development embedded in these data is that a sponsor will generally need to perceive a market potential in the third year of marketing equal to the development cost of the product in order to pursue development (Ref. 6). This third year market is apparently considered the mature market for the drug or, in industry parlance, the “going” market (Ref. 6) and can serve as a basis for calculating the entire market potential of a drug prior to generic competition. As a hypothetical example, for a drug with a $15,000,000 ($15M) development cost for a particular intended use, the third year market would need to be perceived to be $15M in order to support product development. In this example, we project a ramp up to this “going” market value of $5M in the first year of marketing and $10M in the second. This means that under the 5-year term of exclusivity provided by GADPTRA, for a first-time approval of a drug in animals, a market prior to generic competition sufficient to justify pioneer sponsor investment relative to a $15M investment is $60M (i.e., $5M in year 1 + 10M in year 2 + 15M in year 3 + 15M in year 4 + $15M in year 5). There may be a number of ways of interpreting the value of the additional 2 years of exclusivity provided to MUMS drugs; but, the most useful interpretation of the value of this extended marketing exclusivity is that it provides a sponsor an opportunity to lower its perception of an acceptable “going” market value to support drug development because the sponsor has longer to recoup development costs without competition. In the previous example, this would mean that the $60M fair and reasonable market value prior to competition established under GADPTRA could be spread over 7 years instead of 5 with the result that the “going” market value (third year market value) for a drug with development costs of $15M would only need to be $10M in order to support drug development (i.e., $3.5M + 6.5M + 10M + 10M + 10M + 10M + 10M). Therefore, assuming for the purposes of a general estimate that the ramp-up to a going market is roughly linear as shown in the example, in a practical sense, the economic value of the 7 years of exclusive marketing rights for MUMS drugs is to lower the “going” market value needed to support drug development by about one-third. It should be noted that MUMS exclusive marketing rights provide protection from competition from all products with the same drug, same dosage form, and same intended use rather than just from generics under GADPTRA and this provides additional value to this incentive. Having estimated the market value of this MUMS incentive as a one third reduction in the “going” market value, in order to define “small number,” the agency's task is then to estimate the number of animals of each major companion animal species the drug treatment of which represents a drug market value, that is about two-thirds of the estimated cost of drug development for each of these species. The agency is well aware of the enormous variability that will be encompassed by one estimate of drug development cost for each major companion animal species. For companion animals, an estimated range of drug development costs for first-time approval of an animal drug is $10 to $20 million, with additional estimates as low as $5 million (Ref. 6). Based on these estimates, the agency believes $15 million represents the average drug development cost. 2. Additional Factors Unique to Companion Animals The number of major species companion animals eligible for treatment on an annual basis that represents a drug market value roughly equivalent to two-thirds of the estimated drug development cost for these major species depends on a large number of factors affecting the drug treatment value of individual animals. For purposes of this discussion, drug treatment value means the portion of the cost of treating an animal with a given drug that is returned to the sponsor of the drug. Again, the agency acknowledges the great variability that will be encompassed in one estimate of drug treatment value for individual animals of each major companion animal species. The drug treatment value of individual animals is a portion of the cost that animal owners are willing to pay to have animals treated for a given condition. The sum of the drug treatment values of all of the animals treated with a given drug over the course of a year represents the sponsor's annual market value of that drug. Two of the most basic factors affecting drug market value are the species involved, which significantly affects the amount that people are willing to pay to treat an individual animal, and the percentage of the eligible population of animals that is actually treated under typical circumstances. Drug treatment values must be considered in the context of the cost of ancillary veterinary services associated with diagnosis and subsequent treatment. Clearly, costs ancillary to drug costs may decrease the likelihood of a decision to treat a given animal. For a given drug, the drug treatment value, the ancillary cost of treatment, the practitioner's decision to markup the drug cost to the client, and the decision of the client to accept the total cost of treating an animal are all inter-related. As the drug treatment value increases, other costs may decrease in order for the total cost of treatment to be made acceptable to a given client. Available information regarding the amount that people are willing to pay to treat representative conditions in the three major companion animal species is quite variable (Ref. 6). However, based on available information, the agency concludes that companion animal owners generally will pay more to treat a horse than a dog, and more to treat a dog than a cat (Ref. 6). Based on available information, the agency further concludes that a reasonable annual drug treatment value for conditions significantly affecting the health of individual animals of these species is about $500 for horses, about $350 for dogs, and about $200 for cats (Ref. 6). For any given condition, many animals that are eligible to be treated will not actually be treated and the decision to treat will depend to a large extent on the nature of the condition and the cost of treatment. While an estimate of the likelihood of treatment must be very general to represent the large variability encompassed by that estimate, based on the factors described previously and currently available information (Ref. 7), the agency believes that it is reasonable to estimate a 50 percent non-treatment rate across all major companion animal species. Defining small numbers for companion animal species must take into account the uncertainty inherent in the estimates of prevalence or incidence of diseases or conditions that occur in relatively small numbers of animals. Therefore, a disease prevalence or incidence estimate submitted with a request for minor use designation will be considered relative to its degree of uncertainty to enable the agency to be 90 percent confident that the actual prevalence or incidence of the disease at issue is at or below the estimate, and that the resulting estimate is below the small number threshold. Even reasonably good estimates, such as those based on published articles involving actual tabulation of a number of cases of the disease or condition at issue gathered at multiple sites or over an extended time, or results of surveys involving about a hundred respondents, appear to present uncertainties on the order of +/- 10 percent around the estimate. Since at least +/- 10 percent uncertainty is likely to exist for most estimates, based on an assumption of normal distribution, the agency has also increased the proposed small numbers for companion animals by approximately 13 percent to account for this. The practical effect of this approach is that an estimated prevalence or incidence that is on the order of 12 percent below the proposed threshold could be accepted as a small number with 90 percent confidence that it is truly below the threshold when the uncertainty associated with the estimate is on the order of +/- 10 percent or less, but could be rejected as a small number if the uncertainty associated with the estimate is sufficiently above 10 percent. Finally, proposed thresholds were somewhat increased to achieve “round” numbers. Given the variability associated with several of its assumptions, the agency believes that this is acceptable. In summary, the following assumptions underlie the proposed “small numbers” definition for companion animals:
(1)A reasonably representative development cost for a new companion animal drug is about $15 million.
(2)Without incentives, a sponsor will generally need to perceive a market potential in the third year of marketing equal to the development cost of the product in order to pursue development.
(3)Due to the extended exclusive marketing rights, the “going market” for a MUMS product can be about one-third less than the market normally required for a sponsor to pursue drug development.
(4)Although the amount individual animal owners spend on companion animals is highly variable, companion animal owners generally will pay more for the treatment of a horse than for a dog and more for a dog than a cat.
(5)Treatment costs ancillary to drug treatment value decrease the likelihood of a decision to treat a given animal and provide no return on investment to sponsors.
(6)The drug treatment value for a horse is about $500, for a dog about $350, and for a cat about $200.
(7)There is about a 50 percent non-treatment rate across all major companion animal species.
(8)There is about 10 percent uncertainty in even the best published estimates of disease incidence or prevalence in companion animals. A “small number of animals” for each of the three major companion animal species can be calculated by incorporating these assumptions into the following formula: [average companion animal drug development cost in dollars] - 1/3 = [minor use “going market” in dollars] ÷ [average drug treatment value in dollars for each species] = [a preliminary small number of animals] x 2 (untreated factor) + 13% (uncertainty factor) + (increase to “round” number) = [species specific “small number of animals”] The agency recognizes that there is considerable variability within each of these assumptions. However, in order to consistently and fairly implement the designation provision of the MUMS act, FDA believes it is vital to establish one “small number” for each major species. The agency's task is to set these numbers so that they can be applied to a wide variety of requests for minor use designation. This is the same task that Congress undertook when it established by statute a threshold number of 200,000 for human orphan drugs (section 526(a)(2) of the act) (21 U.S.C. 360bb(a)(2)). Following this approach, the agency proposes defining “small numbers” for the major companion animal species as: 50,000 horses, 70,000 dogs, and 120,000 cats affected annually. B. “Small Numbers” for Major Species of Food-Producing Animals For the reasons discussed in Background section I.B. of this document, FDA is proposing to establish “small numbers” in a different manner for food-producing animals than for companion animals. Just as it did with respect to establishing “small numbers” for companion animals, the agency looked for a benchmark to serve as a basis for quantifying a threshold small number for each food-producing major species. Consistent with comments received on the MUMS designation proposed rule (Refs. 1 and 3), the benchmark that the agency found to be most appropriate for food-producing animals is based on a comparison between major and minor food-producing species, and the minor food-producing species most directly comparable to major food-producing species with respect to drug development costs, animal husbandry, and the nature and scope of drug use is sheep. The market for new animal drug sales represented by that portion of the U.S. sheep population that could reasonably be treated on an annual basis qualifies for the incentives of MUMS designation because sheep are a minor species. The market for sheep drugs thus represents a market for food-producing animal species that Congress determined merited MUMS act incentives in order to stimulate drug development. Therefore, it is reasonable that an intended use in a major food-producing species that represents a similar size market should also qualify for these incentives. To serve as a reasonable estimate of the size of the drug market for sheep, and to permit an equitable comparison across all major food-producing species, the agency used the biomass of sheep presented to slaughter facilities in the United States in 2004 (the year of passage of the MUMS act) as the basis for extrapolation to establish small numbers for major food-producing species. Because new animal drugs are usually dosed by weight, biomass serves as a reasonable basis for extrapolation because the amount of drug sold to treat a particular food-producing species over the course of a year roughly correlates to the total weight, or biomass, of the animal species being treated during that year. The biomass of sheep going to slaughter in 2004 represents slightly less than 50 percent of the total biomass of sheep existing in that year and, therefore, represents an assumption that 50 percent of sheep existing in 2004 might have been treated with a given drug during that year. Given the limited amount of information available regarding disease prevalence or incidence in food-producing animals, treatment of 50 percent of the sheep population by a given drug is considered by the agency to be a reasonable estimate of the maximum drug market for the species. As previously noted, this estimate also represents a food-producing species drug market that Congress established as eligible for MUMS act incentives. The amount of biomass from sheep (including lambs) arriving at slaughter facilities in 2004 (the total live weight of animals presented for slaughter) is reported by the U.S. Department of Agriculture
(USDA)(Ref. 8) to be 380,000,000
(380M)pounds (lbs). Therefore, we propose to define the “small number” that represents “minor use” for each major food-producing animal species as the number of animals going to slaughter in 2004 that produced a cumulative biomass equivalent to 380M lbs/year. Following this approach, based on USDA statistics for 2004 for cattle, pigs, turkeys and chickens (Refs. 4 and 8), 380M pounds of biomass (live weight at slaughter) roughly equates to 310,000 cattle (at 1,240 lbs/animal); 1,450,000 pigs (at 266 lbs/animal); 14,000,000 turkeys (at 27 lbs/bird); and 72,000,000 chickens (at 5.3 lbs/bird). C. Small Numbers as a Limitation to “Wider Use” As noted previously, the legislative history of the MUMS act states that the statutory definition for minor use “incorporates the existing definition in the Code of Federal Regulations (21 CFR 514.1(d)(1)) with a further limitation to small numbers to assure that such intended uses will not be extended to a wider use” (S. Rept. 108-226 at 12 13). The agency believes that the “small number of animals” of each major species being proposed to clarify the definition of “minor use” meets the dual goals that Congress established in the legislative history of the MUMS act to provide added incentives for animal drug development while assuring that the proposed “small numbers” will not result in minor uses being “extended to a wider use” in major animal species. D. Proposed “Small Numbers” Based on an assessment of all of the factors noted previously, and for the purpose of further defining “minor use” under the Minor Use and Minor Species Animal Health Act of 2004 and 21 CFR 516.3, the agency proposes to define “small numbers” for each major species as equal to or less than each of the following numbers: **Table 1.—Proposed Small Numbers for Each Major Species** Species Small Number Horses 50,000 Dogs 70,000 Cats 120,000 Cattle 310,000 Pigs 1,450,000 Turkeys 14,000,000 Chickens 72,000,000 Finally, as noted in the response to comments on the proposed MUMS designation rule (see 72 FR 41010 at 41012), paragraph
(c)of § 516.21 (21 CFR 516.21) (Documentation of minor use status) is unnecessary once small numbers of animals have been established. Because the agency is proposing to establish small numbers of animals at this time, the agency is also proposing to remove § 516.21(c) and its associated burden on the animal pharmaceutical industry. III. Legal Authority FDA's authority for issuing this proposed rule is provided by the Minor Use and Minor Species Animal Health Act of 2004 (section 571 of the act) (21 U.S.C. 360ccc *et seq.* ). When Congress passed the MUMS act, it directed FDA to publish implementing regulations (see 21 U.S.C. 360ccc note). In the context of the MUMS act, the statutory requirements of section 573 of the act, along with section 701(a) of the act (21 U.S.C. 371(a)) provide authority for this proposed rule. Section 701(a) authorizes the agency to issue regulations for the efficient enforcement of the act. IV. Analysis of Economic Impacts FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (Public Law 104-4). 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; and distributive impacts and equity). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule is only expected to slightly reduce the administrative effort of “minor use” requestors while imposing no additional costs, the agency does not believe that this proposed rule would have a significant economic impact on a substantial number of small entities. FDA requests comment on this issue. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceeded this amount. FDA previously published both a proposed rule and final rule on the MUMS designation system. Each of these publications included analyses of the expected economic impacts of the creation and administration of the MUMS designation system as required by the Executive order and two statutes mentioned in the previous paragraphs. The final rule presented estimates of the annual costs of the MUMS designation system of about $65,000 annually. Additionally, the final rule provided some discussion of, but was not able to quantify, the expected benefits of the rule. The final rule included a statement that it would address the issue of establishing a definition of “small number” of animals in a future rulemaking. This proposed rule proposes that definition of “small number” of animals for each of the seven major animal species as defined by the MUMS act, based on the data and analysis as described previously in this preamble. This proposed rule would set an upper limit on the number of animals of each of the seven major animal species for which a request for designation could be made under the “minor use” provisions of the MUMS designation final rule. FDA does not have any additional information to show that these proposed threshold numbers would significantly affect the expected number of MUMS designation requests that are received by the agency each year (estimated at 75 requests per year in the MUMS designation final rule). The proposed definition of a “small number” of each of the seven major species reduces the ambiguity for “minor use” requestors. Additionally, this proposed rule would provide for a small reduction in administrative effort by “minor use” requestors who would no longer be required to provide additional information on potential markets and drug development costs due to the proposed deletion of § 516.21(c). As such, FDA has determined that the proposed rule would not impose any additional costs or provide any further health benefits beyond those contained in the MUMS designation final rule. V. Paperwork Reduction Act of 1995 This proposed rule does not contain new information collection provisions that would be subject to review by OMB, under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). *Title* : Setting “Small Numbers of Animals” for Determining Minor Use *Description* : This proposed rule is intended to revise the minor use provisions of 21 CFR part 516, subpart B. Part 516 contains the implementing regulations for the Minor Use and Minor Species Animal Health Act of 2004, and subpart B contains the designation provisions for minor use and minor species new animal drugs. Currently, requests for minor use designation are considered case-by-case by the agency based on product-specific financial information supporting minor use status included in the request. In order to further define minor use, this rule proposes seven threshold “small numbers of animals,” one for each major species, based on industry-wide economic or animal production data. With these numbers in place, drug sponsors requesting minor use designation will no longer be required to submit confidential product-specific financial information, as currently required in § 516.21(c), thus lowering their reporting burden somewhat. However, we anticipate that most requests for designation will be for minor species, not minor use, and furthermore, the current requirement for financial information is only one part of a request for designation, therefore, the paperwork burden currently assigned to 21 CFR 516.20 will not be affected significantly. Information collection requirements in this section were approved by OMB and assigned OMB control number 0910-0605. VI. Environmental Impact We have carefully determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VII. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule does not contain policies that have substantial direct effects 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. Accordingly, the agency has tentatively concluded that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. VIII. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. IX. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Public comment to Docket No. 2005N-0329, comment EC3, received February 2, 2006, submitted by American Veterinary Medical Association (AVMA), signed by Elizabeth Curry-Galvin. 2. Public comment to Docket No. 2005N-0329, comment C5, received January 26, 2006, submitted by Animal Health Institute, signed by Richard Carnevale. 3. Public comment to Docket No. 2005N-0329, comment EMC3, received December 12, 2005, submitted by Keep Antibiotics Working, signed by Rebecca Goldburg and Steve Roach. 4. USDA/National Agricultural Statistics Service, “Poultry Slaughter 2004 Annual Summary,” February 2005. 5. USDA/Animal and Plant Health Inspection Service, “2004 United States Animal Health Report,” August 2005. 6. Brakke Consulting, Inc., “Disease Incidence Rates, Drug Development and Treatment Costs,” September 2005. 7. AVMA, “U.S. Pet Ownership & Demographics Sourcebook,” 2002. 8. USDA/National Agricultural Statistics Service, “2004 Livestock Slaughter Report,” March 2005. List of Subjects in 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 516 be amended as follows: PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 1. The authority citation for 21 CFR part 516 continues to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. 2. Amend § 516.3 by adding a new definition in alphabetical order to paragraph
(b)as follows: § 516.3 Definitions.
(b)* * * *Small number of animals* means equal to or less than 50,000 horses, 70,000 dogs, 120,000 cats, 310,000 cattle, 1,450,000 pigs, 14,000,000 turkeys, and 72,000,000 chickens. § 516.21 [Amended] 3. Amend § 516.21 by removing paragraph (c). Dated: January 29, 2008. Jeffrey Shuren, Associate Commissioner for Policy. [FR Doc. E8-5385 Filed 3-17-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-149856-03] RIN 1545-BD01 Dependent Child of Divorced or Separated Parents or Parents Who Live Apart; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of public hearing on proposed rulemaking. SUMMARY: This document contains a notice of public hearing on proposed regulations relating to a claim that a child is a dependent by parents who are divorced, legally separated under a decree of separate maintenance, agreement, or who live apart at all times during the last 6 months of the calendar year. DATES: The public hearing is being held on April 3, 2008, at 10 a.m. The IRS must receive outlines of the topics to be discussed at the hearing by March 26, 2008. ADDRESSES: The public hearing is being held in Room 2615, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. Send submissions to: CC:PA:LPD:PR (REG-149856-03), Room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-149856-03), Couriers Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC or sent electronically, via the IRS internet site via the Federal eRulemaking Portal at *http://www.regulations.gov* (IRS-REG-149856-03). FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Victoria Driscoll
(202)622-4920; concerning submissions of comments, the hearing, and/or to be placed on the building access list to attend the hearing, Regina Johnson
(202)622-7180 (not toll free numbers). SUPPLEMENTARY INFORMATION: The subject of the public hearing is the notice of proposed regulations (REG-149856-03) that was published in the **Federal Register** on Wednesday, May 2, 2007 (72 FR 24192). The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing that submitted written comments by July 31, 2007, must submit an outline of the topics to be discussed and the amount of time to be devoted to each topic (signed original and eight
(8)copies). A period of 10 minutes is allotted to each person for presenting oral comments. After the deadline for receiving outlines has passed, the IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing. Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT section of this document. LaNita Van Dyke, Chief, Publications and Regulations Branch, Associate Chief Counsel, Legal Processing Division (Procedures and Administration). [FR Doc. E8-5451 Filed 3-17-08; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-127391-07] RIN 1545-BH02 Guidance Under Section 664 Regarding the Effect of Unrelated Business Taxable Income on Charitable Remainder Trusts; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to a notice of proposed rulemaking. SUMMARY: This document contains corrections to a notice of proposed rulemaking (REG-127391-07) that was published in the **Federal Register** on Friday, March 7, 2008 (73 FR 12313) providing guidance under Internal Revenue Code section 664 on the tax effect of unrelated business taxable income
(UBTI)on charitable remainder trusts. FOR FURTHER INFORMATION CONTACT: Cynthia Morton at
(202)622-3060 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The correction notice that is the subject of this document is under section 664 of the Internal Revenue Code. Need for Correction As published, a notice of proposed rulemaking (REG-127391-07) contains errors that may prove to be misleading and are in need of clarification. Correction of Publication Accordingly, the publication of a notice of proposed rulemaking (REG-127391-07), which was the subject of FR Doc. E8-4576, is corrected as follows: 1. On page 12314, column 3, in the preamble, under the paragraph heading “Comments and Public Hearing”, line 2 of the second paragraph, the language “for April 11, 2007, at 10 a.m., in the IRS” is corrected to read “for April 11, 2008, at 10 a.m., in the IRS”. 2. On page 12314, column 3, in the preamble, under the paragraph heading “Comments and Public Hearing”, line 8 of the third paragraph, the language “and eight
(8)copies) by March 28, 2007.” is corrected to read “and eight
(8)copies) by March 28, 2008.”. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E8-5336 Filed 3-17-08; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-151135-07] RIN 1545-BH39 Multiemployer Plan Funding Guidance AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking. SUMMARY: This document contains proposed regulations under section 432 of the Internal Revenue Code (Code). These proposed regulations provide additional rules for certain multiemployer defined benefit plans that are in effect on July 16, 2006. These proposed regulations affect sponsors and administrators of, and participants in multiemployer plans that are in either endangered or critical status. These regulations are necessary to implement the new rules set forth in section 432 that are effective for plan years beginning after 2007. The proposed regulations reflect changes made by the Pension Protection Act of 2006. DATES: Written or electronic comments and requests for public hearing must be received by June 16, 2008. ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-151135-07), room 5203, Internal Revenue Service, PO Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-151135-07), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC 20224, or sent electronically via the Federal eRulemaking Portal at *www.regulations.gov* (IRS REG-151135-07). FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Bruce Perlin,
(202)622-6090; concerning submissions and requests for a public hearing, *Richard.A.Hurst@irscounsel.treas.gov* or at
(202)622-7180 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Paperwork Reduction Act The collection of information contained in this notice of proposed rulemaking have been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d). Comments on the collection of information should be sent to the Office of Management and Budget, *Attn:* Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies to the Internal Revenue Service, *Attn:* IRS Reports Clearance Officer, SE:CAR:MP:T:T:SP, Washington, DC 20224. Comments on the collection of information should be received by May 19, 2008. Comments are specifically requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Internal Revenue Service, including whether the information will have practical utility; The accuracy of the estimated burden associated with the collection of information; How the quality, utility, and clarity of the information to be collected may be enhanced; How the burden of complying with the collection of information may be minimized, including through the application of automated collection techniques or other forms of information technology; and Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of service to provide information. The collection of information in this regulation is in § 1.432(b)-1(d) and (e). This information is required in order for a qualified multiemployer defined benefit plan's enrolled actuary to provide a timely certification of the plan's funding status. In addition, if it is certified that a plan is or will be in critical or endangered status, the plan sponsor is required to notify the Department of Labor, the Pension Benefit Guaranty Corporation, the bargaining parties, participants, and beneficiaries of the status designation. For plans in critical status, the plan sponsor is required to include in the notice an explanation of the possibility that adjustable benefits may be reduced at a later date and that certain benefits are restricted as of the date the notice is sent. The annual certification by the enrolled actuary for the plan will be used to provide an accurate determination and certification of the plan's funded status and to provide notice to the required parties of the status designation. The collection of information is mandatory. The likely respondents are multiemployer plan sponsors and enrolled actuaries. *Estimated total annual reporting burden:* 1,200 hours. *Estimated average annual burden hours per respondent:* 0.75 hours. *Estimated number of respondents:* 1,600. *Estimated annual frequency of responses:* Occasional. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. Background This document contains proposed Income Tax Regulations (26 CFR part 1) under section 432, as added to the Internal Revenue Code by the Pension Protection Act of 2006 (PPA 06), Public Law 109-280, 120 Stat 780. Section 412 contains minimum funding rules that generally apply to pension plans. Section 431 sets forth the funding rules that apply specifically to multiemployer defined benefit plans. Section 432 sets forth additional rules that apply to multiemployer plans in effect on July 16, 2006, that are in endangered or critical status. 1 1 Section 302 and section 304 of the Employee Retirement Income Security Act of 1974, as amended (ERISA) sets forth funding rules that are parallel to those in section 412 and section 431 of the Code. Section 305 of ERISA sets forth additional rules for multiemployer plans that are parallel to those in section 432 of the Code. Under section 101 of Reorganization Plan No. 4 of 1978 (43 FR 47713) and section 302 of ERISA, the Secretary of the Treasury has interpretive jurisdiction over the subject matter addressed in these proposed regulations for purposes of ERISA, as well as the Code. Thus, these Treasury Department regulations issued under section 432 of the Code apply as well for purposes of ERISA section 305. Section 432 generally provides for a determination by the enrolled actuary for a multiemployer plan as to whether the plan is in endangered status or in critical status for a plan year. In the first year that the actuary certifies that the plan is in endangered status, section 432(a)(1) requires that the plan sponsor adopt a funding improvement plan. The funding improvement plan must meet the requirements of section 432(c) and the plan must apply the rules of section 432(d) during the period that begins when the plan is certified to be in endangered status and ends when the plan is no longer in that status. In the first year that the actuary certifies that the plan is in critical status, section 432 (a)(2) requires that the plan sponsor adopt a rehabilitation plan. The rehabilitation plan must meet the requirements of section 432(e) and the plan must apply the rules of section 432(f) during the period that begins when the plan is certified to be in critical status and ends when the plan is no longer in that status. In addition, section 432(f)(2) requires that the plan suspend certain actions as described more fully in this preamble. Section 432(b)(3)(A) requires an actuarial certification of whether or not a multiemployer plan is in endangered status, and whether or not a multiemployer plan is or will be in critical status, for each plan year. This certification must be completed by the 90th day of the plan year and must be provided to the Secretary of the Treasury and to the plan sponsor. If the certification is with respect to a plan year that is within the plan's funding improvement period or rehabilitation period arising from a prior certification of endangered or critical status, the actuary must also certify whether or not the plan is making scheduled progress in meeting the requirements of its funding improvement or rehabilitation plan. Failure of the plan's actuary to certify the status of the plan is treated as a failure to file the annual report under section 502(c)(2) of the Employee Retirement Income Security Act of 1974 (ERISA). Thus, a penalty of up to $1,100 per day applies. Under section 432(b)(1), a multiemployer plan is in endangered status if the plan is not in critical status and, as of the beginning of the plan year,
(1)the plan's funded percentage for the plan year is less than 80 percent, or
(2)the plan has an accumulated funding deficiency for the plan year or is projected to have an accumulated funding deficiency in any of the six succeeding plan years (taking into account amortization extensions under section 431(d)). Under section 432(i), a plan's funded percentage is the percentage determined by dividing the value of the plan's assets by the accrued liability of the plan. Under section 432(b)(2), a multiemployer plan is in critical status for a plan year if it meets any of four specified tests. Under section 432(b)(2)(A), a plan is in critical status if, as of the beginning of the plan year:
(1)The funded percentage of the plan is less than 65 percent and
(2)the sum of
(A)the market value of plan assets, plus
(B)the present value of reasonably anticipated employer contributions for the current plan year and each of the six succeeding plan years is less than the present value of all nonforfeitable benefits projected to be payable under the plan during the current plan year and each of the six succeeding plan years (plus administrative expenses). For this purpose, employer contributions are determined assuming that the terms of all collective bargaining agreements pursuant to which the plan is maintained for the current plan year continue in effect for succeeding plan years. Under section 432(b)(2)(B), a plan is in critical status if the plan has an accumulated funding deficiency for the current plan year or is projected to have an accumulated funding deficiency for any of the three succeeding plan years. For purposes of this test, the determination of accumulated funding deficiency is made not taking into account any amortization extension under section 431(d). In addition, if a plan has a funded percentage of 65 percent or less, the three-year period for projecting whether the plan will have an accumulated funding deficiency is extended to four years. Under section 432(b)(2)(C), a plan is in critical status for the plan year if
(1)the plan's normal cost for the current plan year, plus interest for the current plan year on the amount of unfunded benefit liabilities under the plan as of the last day of the preceding year, exceeds the present value of the reasonably anticipated employer and employee contributions for the current plan year,
(2)the present value of nonforfeitable benefits of inactive participants is greater than the present value of nonforfeitable benefits of active participants, and
(3)the plan has an accumulated funding deficiency for the current plan year, or is projected to have an accumulated funding deficiency for any of the four succeeding plan years (not taking into account amortization period extensions under section 431(d)). Under section 432(b)(2)(D), a plan is in critical status for a plan year if the sum of
(A)the market value of plan assets, and
(B)the present value of the reasonably anticipated employer contributions for the current plan year and each of the four succeeding plan years is less than the present value of all benefits projected to be payable under the plan during the current plan year and each of the four succeeding plan years (plus administrative expenses). For this purpose, employer contributions are determined assuming that the terms of all collective bargaining agreements pursuant to which the plan is maintained for the current plan year continue in effect for succeeding plan years. In making the determinations and projections applicable under the endangered and critical status rules, the plan actuary must make projections for the current and succeeding plan years of the current value of the assets of the plan and the present value of all liabilities to participants and beneficiaries under the plan for the current plan year as of the beginning of such year. The actuary's projections must be based on reasonable actuarial estimates, assumptions, and methods that offer the actuary's best estimate of anticipated experience under the plan. An exception to this rule applies in the case of projected industry activity. Any projection of activity in the industry or industries covered by the plan, including future covered employment and contribution levels, must be based on information provided by the plan sponsor, and the plan sponsor must act reasonably and in good faith. The projected present value of liabilities as of the beginning of the year must be based on either the most recent actuarial statement required with respect to the most recently filed annual report or the actuarial valuation for the preceding plan year. Under section 432(b)(3)(B)(ii), any actuarial projection of plan assets must assume
(1)reasonably anticipated employer contributions for the current and succeeding plan years, assuming that the terms of one or more collective bargaining agreements pursuant to which the plan is maintained for the current plan year continue in effect for the succeeding plan years, or
(2)that employer contributions for the most recent plan year will continue indefinitely, but only if the plan actuary determines that there have been no significant demographic changes that would make continued application of such terms unreasonable. The first year that an actuary certifies that a plan is in endangered or critical status establishes a timetable for a number of actions. Under section 432(b)(3)(D), within 30 days after the date of certification, the plan sponsor must notify the participants and beneficiaries, the bargaining parties, the PBGC and the Secretary of Labor of the plan's endangered or critical status. If it is certified that a plan is or will be in critical status, the plan sponsor must include in the notice an explanation of the possibility that
(1)adjustable benefits (as defined in section 432(e)(8)) may be reduced and
(2)such reductions may apply to participants and beneficiaries whose benefit commencement date is on or after the date such notice is provided for the first plan year in which the plan is in critical status. If a plan is certified to be in critical status, the plan must take certain actions after notifying the plan participants of the critical status. Specifically, section 432(f)(2) restricts the payment of benefits that are in excess of a single life annuity (plus any social security supplement) effective on the date the notice is sent. Section 432(f)(2)(B) provides that this restriction does not apply to amounts that may be immediately distributed without the consent of the employee under section 411(a)(11) and to any makeup payment in the case of a retroactive annuity starting date or a similar payment of benefits owed with respect to a prior period. In addition, the plan sponsor must refrain from making any payment for the purchase of an irrevocable commitment from an insurer to pay benefits. Sections 432(c)(1) and 432(e)(1) provide that in the first year that a plan is certified to be in endangered or critical status, the plan sponsor must adopt a funding improvement plan (in the case of a plan that is in endangered status) or a rehabilitation plan (in the case of a plan that is in critical status). The deadline for adoption of the funding improvement plan or rehabilitation plan is 240 days after the deadline for the certification. Accordingly, if the actuarial certification is made after the 90-day deadline, the amount of time for adopting the funding improvement plan or rehabilitation plan is shortened. Section 432(c)(3) defines a funding improvement plan as a plan which consists of the actions, including options or a range of options, to be proposed to the bargaining parties, formulated to provide, based on reasonably anticipated experience and reasonable actuarial assumptions, for the attainment by the plan of certain requirements. Those requirements are based on a statutorily specified improvement in the plan's funding percentage from the percentage that applied on the first day of the funding improvement period. The first day of the funding improvement period is defined in section 432(c)(4) as the first day of the first plan year beginning after the earlier of
(1)the second anniversary of the date of the adoption of the funding improvement plan or
(2)the expiration of the collective bargaining agreements in effect on the due date for the actuarial certification of endangered status for the initial endangered year and covering, as of such due date, at least 75 percent of the active participants in such multiemployer plan. Section 432(d)(1) sets forth rules that apply after the certification of endangered status and before the first day of the funding improvement period. After the adoption of the funding improvement plan, section 432(d)(2) prohibits any amendments that are inconsistent with the funding improvement plan. In addition, section 432(d)(2) provides special rules for acceptance of collective bargaining agreements and plan amendments that increase benefits. A rehabilitation plan is a plan which consists of the actions, including options or a range of options, to be proposed to the bargaining parties, formulated to provide, based on reasonably anticipated experience and reasonable actuarial assumptions, for the attainment by the plan of certain requirements. Generally, the rehabilitation plan should enable the plan to emerge from critical status by the end of a 10-year period that begins after the earlier of
(1)the second anniversary of the date of the adoption of the rehabilitation plan or
(2)the expiration of the collective bargaining agreements in effect on the due date for the actuarial certification of critical status for the initial critical year and covering, as of such due date, at least 75 percent of the active participants in such multiemployer plan. For this purpose a plan emerges from critical status when the plan actuary certifies that the plan is not projected to have an accumulated funding deficiency for the plan year or any of the nine succeeding plan years, without regard to the use of the shortfall method and taking into account amortization period extensions under section 431(d). As an alternative, if the plan sponsor determines that, based on reasonable actuarial assumptions and upon exhaustion of all reasonable measures, the plan cannot reasonably be expected to emerge from critical status by the end of the 10-year period, the requirements for a rehabilitation plan are that the plan include reasonable measures to emerge from critical status at a later time or to forestall possible insolvency (within the meaning of section 4245 of ERISA). Section 432(e)(8) allows a rehabilitation plan for a plan that is in critical status to provide for a reduction of certain “adjustable” benefits that would otherwise be protected by section 411(d)(6). These adjustable benefits include early retirement benefits and retirement-type subsidies within the meaning of section 411(d)(6)(B)(i). Under section 432(e)(8)(A)(ii), no reduction will apply to a participant whose benefit commencement date is before the date the notice under section 432(b)(3)(D) for the initial critical year is provided. Under section 432(e)(8)(B), except with respect to certain benefit increases described in 432(e)(8)(A)(iv)(III), a plan is not permitted to reduce the level of a participant's accrued benefit payable at normal retirement age. Furthermore, section 432(e)(8)(C) prohibits any reduction until 30 days after plan participants and beneficiaries, employers and employee organizations are notified of the reduction. In years after the initial critical year or initial endangered year, sections 432(c)(6) and 432(e)(3)(B) provide that the plan sponsor must annually update the funding improvement or rehabilitation plan. This includes updating the schedule of contribution rates. Updates are required to be filed with the plan's annual report. Section 432(f)(4) sets forth rules that apply after the certification of critical status and before the first day of the rehabilitation period. After the adoption of the rehabilitation plan, section 432(f)(1) prohibits any amendments that are inconsistent with the rehabilitation plan. Section 432(h) provides rules for the treatment of employees who participate in the plan even though they are not covered by a collective bargaining agreement. Section 432(i) provides a number of definitions that apply for purposes of section 432. For example, under section 432(i)(8), the actuary's determination with respect to a plan's normal cost, actuarial accrued liability, and improvements in a plan's funded percentage must be based on the unit credit funding method (whether or not that method is used for the plan's actuarial valuation). Section 432 is effective for plan years beginning on or after January 1, 2008. Section 212(e)(2) of PPA '06 provides a special rule permitting a plan to provide the notice described in section 432(b)(3)(D) on an early basis. Specifically, if the plan actuary certifies that the plan is reasonably expected to be in critical status for the first plan year beginning after 2007, the plan is permitted to provide the notice described in section 432(b)(3)(D) at any time between the enactment of PPA '06 and the date the notice is otherwise required to be provided. Explanation of Provisions Overview These regulations provide guidance with respect to certain of the provisions of section 432. Specifically, these regulations provide guidance regarding the determination of when a plan is in endangered status or critical status and the associated notices. These regulations do not provide guidance with respect to all issues relating to a multiemployer plan that is in endangered or critical status. For example, no guidance is provided on the parameters for the adoption of a funding improvement plan or rehabilitation plan. Guidance with respect to additional issues will be included in a second set of regulations that are expected to be issued this year. § 1.432(a)-1 General Rules Relating to Section 432 Section 1.432-1 provides general rules relating to section 432, including definitions of certain terms used for purposes of section 432 and the special rules that apply to participants in multiemployer plans who are not participating pursuant to a collective bargaining agreement. The regulations provide that effective on the date that a notice of critical status for the initial critical year is sent to the plan participants, the plan must not pay any benefit in excess of the monthly amount paid under a single life annuity (plus any social security supplement) and is not permitted to purchase an irrevocable commitment from an insurer to pay benefits. The restriction does not apply to the small-dollar cash-outs allowed under section 411(a)(11) nor to the make-up payments under a retroactive annuity starting date. The regulations provide that if the notice described in section 432(b)(3)(D) has been sent and the restrictions provided under section 432(f)(2) have been applied, and it is later determined that the restrictions should not have been applied, then the plan must correct any benefit payments that were restricted in error. The regulations provide two examples of situations requiring this correction, each of which involves an actuary certifying that the plan is reasonably expected to be in critical status for the first plan year beginning after 2007, followed by an early notification of critical status that is made to employees under the rules of section 212(e)(2) of PPA '06. In one example of a plan taking actions that require correction, the plan restricts benefits before the first plan year beginning after 2007 (the effective date of section 432). In the second such example, the plan is not in critical status for the first plan year beginning after 2007 (even though the enrolled actuary for the plan had certified that it is reasonably expected that the plan will be in critical status with respect to that year). The regulations incorporate a number of definitions listed in section 432(i) along with other definitions that are located in sections 432(c) and (e). The regulations do not include the broad provision under section 432(i)(8) to use the unit credit funding method for purposes of the plan's “normal cost, actuarial accrued liability, and improvements in a plan's funded percentage.” Instead, consistent with the intended scope of section 432(i)(8), the regulations require the use of this funding method solely for purposes of determining a plan's funded percentage and the section 432(b)(2)(C)(i) comparison of contributions with the sum of the plan's normal cost and interest on the amount of unfunded liability. Thus, the determination of whether a plan is projected to have an accumulated funding deficiency in the determination of a plan's status under section 432 is based on the plan's actual funding method, rather than the unit credit funding method. The regulations substitute the term “initial endangered year” for the statutory term “initial determination year.” In addition, the regulations provide guidance for plans that change their status in subsequent years. For example, a plan that is in critical status may emerge from that status and later reenter critical status. In such a circumstance, the year of reentry into critical status is treated as the initial critical year. Similarly, a plan that is in endangered status may have a status change and at a later date reenter endangered status. In such a circumstance, the year of reentry into endangered status is treated as the initial endangered year. § 1.432(b)-1 Determination of Status and Adoption of a Plan The regulations provide rules for the determination of whether a plan is in endangered status or critical status within the meaning of section 432(b)(1) and (2). These rules reflect the different ways a plan can be in endangered status under section 432(b)(1)(A) or
(B)and in critical status under section 432(b)(2)(A), (B), (C), or (D). The regulations also provide that a plan is in critical status for a plan year if it was in critical status in the immediately preceding year and the plan does not meet the emergence from critical status rule of section 432(e)(4)(B). Thus, a plan that was in critical status for the prior year will remain in critical status if the enrolled actuary for the plan certifies that the plan is projected to have an accumulated funding deficiency for the plan year or any of the 9 succeeding plan years, without regard to the use of the shortfall funding method but taking into account any extensions of the amortization periods under section 431(d). The regulations provide limited guidance on the actuarial projections that are used for purposes of the certification of status by the enrolled actuary for the plan. The projections must generally be based on reasonable actuarial assumptions and methods that, as under section 431(c)(3), offer the actuary's best estimate of anticipated experience under the plan. The actuarial projection of future contributions and assets must assume either that the terms of the one or more collective bargaining agreements pursuant to which the plan is maintained for the current plan year continue in effect for succeeding plan years, or that the dollar amount of employer contributions for the most recent plan year will continue indefinitely. If the actuarial projections assume the continued maintenance of the collective bargaining agreements, the plan sponsor must provide a projection of activity in the industry, including future covered employment, to the plan actuary, and the actuary is permitted to rely on those projections. In making these projections, the plan sponsor must act reasonably and in good faith. The alternative assumption that the dollar amount of contributions remains unchanged into the future is only available if the enrolled actuary for the plan determines there have been no significant demographic changes that would make such assumption unreasonable. In addition, the regulations provide that the alternative assumption is not available for purposes of determining whether the plan is in critical status under the tests in section 432(b)(2)(A) and (D). The projected present value of liabilities as of the beginning of such year is determined based on the most recent information reported on the most recent of either the actuarial statement required under section 103(d) of ERISA that has been filed with respect to the most recent year, or the actuarial valuation for the preceding plan year. The regulations provide that, for purposes of section 432, if the plan received an extension of any amortization period under section 412(e), the extension is treated the same as an extension under section 431(d). Thus, such an extension is taken into account in determining endangered status under section 432(b)(1)(B) and emergence from critical status under section 432(e)(4)(B). In contrast, such an extension is not taken into account in determining whether a plan has or will have an accumulated funding deficiency for purposes of determining critical status under section 432(b)(2)(B) and (C). The regulations describe the content of the annual certification required under section 432(b)(3) that must be sent to the plan sponsor and the IRS. The annual certification must be provided regardless of whether the plan is in endangered or critical status. If the plan is certified to be in endangered or critical status, then the certification must identify the plan, the plan sponsor, and the enrolled actuary who signs the certification; provide contact information for the plan sponsor and actuary; state whether or not the plan is in endangered or critical status for the plan year; and, if the certification is for a year other than the initial endangered year or the initial critical year, whether the plan is making the scheduled progress described in the plan's funding improvement plan or rehabilitation plan. The regulations also provide an IRS address to which the certification is to be mailed. The regulations also provide that the content of the annual certification and the IRS address to which it is mailed may be added to or modified in guidance of general applicability to be published in the Internal Revenue Bulletin. Such additional information may include, for instance, which endangered status or critical status standard(s) applies to the plan; supporting information for the classification; a description of the actuarial assumptions used in making the certification; and a projection of the plan's funded percentage for future years. The guidance may also require additional supporting information for certifications made prior to the issuance of the guidance. The regulations provide guidance on the notice required under section 432(b)(3)(D). 2 In particular the regulations require that, in the case of a plan that is in critical status and which provides for benefits that would be restricted under section 432(f)(2), the notice for the initial critical year must tell participants about the restriction. A plan sponsor that sends the model notice provided by the Secretary of Labor pursuant to section 432(b)(3)(D)(iii) satisfies this requirement. 2 Under section 432(b)(3)(D)(ii), the Secretary of Labor is to prescribe a model notice that a multiemployer plan may use to satisfy this notice requirement. If a section 432(b)(3)(D) notice for such a plan was sent prior to the deadline in that section and the notice did not contain the disclosure regarding the immediate restriction on benefits under section 432(f)(2), then the regulations provide that the notice does not satisfy the requirements for notice under section 432(b)(3)(D). Accordingly, the restrictions under section 432(f)(2) do not apply as a result of the issuance of such a notice and the plan will not be treated as having issued the notice for purposes of the section 432(e)(8)(A)(ii) restriction on reducing adjustable benefits for participants whose benefit commencement dates are prior to the issuance of that notice. However, if additional notice that includes all of the information required under the regulations is provided prior to the required date for notice for the initial critical year under section 432(b)(3)(D) (that is, 30 days after the certification for the plan year), then the notice requirements of section 432(b)(3)(D) are satisfied as of the date of the later notice. In such a case, if the earlier notice contained the information described in section 432(b)(3)(D)(ii), then the date of that earlier notice will apply for purposes of the section 432(e)(8)(A)(ii) restriction. The regulations reflect the rules of section 212(e)(2) of PPA under which a plan sponsor is permitted to send an early notice to plan participants. This early notice, which applies solely to the first plan year beginning after 2007, is only available if the plan actuary certifies to the plan sponsor that the plan is reasonably expected to be in critical status for that initial plan year. This preliminary certification that the plan is reasonably expected to be in critical status is different from the annual certification that the plan actuary must make; accordingly, the plan actuary must still certify whether the plan is in critical or endangered status (or in neither critical nor endangered status) for that plan year by the normal 90-day deadline for the certification. Proposed Legislation As of the date of the issuance of these proposed regulations, bills have been introduced in the House of Representatives and the Senate that would exclude from the section 432(f)(2) limitation on accelerated benefits a distribution with an annuity starting date that is before the date that the notice under section 432(b)(3)(D) is provided. 3 Section 1.432(a)-1(a)(3)(iii)(C) has been reserved in order to accommodate any enacted changes. 3 See H.R. 3361(August 3, 2007) and S. 1974 (August 2, 2007) at sections 3(b)(1)(E) and 3(b)(2)(E)(ii). However, S. 1974, as amended and passed by the Senate on December 19, 2007, did not include this provision. Effective/Applicability Dates These regulations apply to plan years ending after [INSERT DATE OF PUBLICATION OF THESE REGULATIONS IN THE **Federal Register** ], but only with respect to plan years that begin on or after January 1, 2008. These regulations do not address the sunset provision provided by PPA 06 section 221(c). Special Analyses It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that the collection of information imposed by these proposed regulations will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required. The estimated burden imposed by the collection of information contained in these proposed regulations is 0.75 hours per respondent. Moreover, most of this burden is attributable to the requirement for a qualified multiemployer defined benefit plan's enrolled actuary to provide a timely certification of the plan's funding status. In addition, if a plan is certified that it is or will be in critical or endangered status, the plan sponsor is required to notify the Department of Labor, the Pension Benefit Guaranty Corporation, the bargaining parties, participants, and beneficiaries of the status designation. For plans in critical status, the plan sponsor is required to include an explanation of the possibility that adjustable benefits may be reduced and that certain benefits are restricted as of the date the notice is sent. Pursuant to section 7805(f) of the Internal Revenue Code, this regulations has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Comments and Requests for a Public Hearing Before these proposed regulations are adopted as final regulations, consideration will be given to any written (one signed and eight
(8)copies) or electronic comments that are submitted timely to the IRS. The IRS and the Treasury Department request comments on the clarity of the proposed rules and how they may be made easier to understand. All comments will be available for public inspection and copying. A public hearing will be scheduled if requested in writing by any person who timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place of the public hearing will be published in the **Federal Register** . Drafting Information The principal author of this regulation is Bruce Perlin, Office of Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development. List of Subjects in 29 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Proposed Amendments to the Regulations Accordingly, 26 CFR part 1 is proposed to be amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.432(a)-1 is added to read as follows: § 1.432(a)-1 General rules relating to section 432.
(a)*In general* —(1) *Overview.* This section provides rules relating to multiemployer plans (within the meaning of section 414(f)) that are in endangered status or critical status under section 432. Section 432 and this section only apply to multiemployer plans that are in effect on July 16, 2006. Paragraph
(b)of this section sets forth definitions of terms that apply for purposes of section 432. Paragraph
(c)of this section sets forth special rules for plans described in section 404(c) and for the treatment of nonbargained participation.
(2)*Plans in endangered status* —(i) *Plan sponsor must adopt funding improvement plan.* If a plan is in endangered status, the plan sponsor must adopt and implement a funding improvement plan that satisfies the requirements of section 432(c).
(ii)*Restrictions applicable to plans in endangered status.* If a plan is in endangered status, the plan and plan sponsor must satisfy the requirements of section 432(d)(1) during the funding plan adoption period specified in section 432(c)(8).
(iii)*Restrictions applicable after the adoption of funding improvement plan.* In the case of a plan that is in endangered status after adoption of the funding improvement plan, the plan and the plan sponsor must satisfy the requirements of section 432(d)(2) until the end of the funding improvement period.
(3)*Plans in critical status* —(i) *Plan sponsor must adopt rehabilitation plan.* If a plan is in critical status, the plan sponsor must adopt and implement a rehabilitation plan that satisfies the requirements of section 432(e).
(ii)*Restrictions applicable to plans in critical status.* If a plan is in critical status, the plan and the plan sponsor must satisfy the requirements of section 432(f)(4) during the rehabilitation plan adoption period as defined in section 432(e)(5). The plan must also apply the restrictions on single sum and other accelerated benefits set forth in paragraph (a)(3)(iii) of this section.
(iii)*Restrictions on single sums and other accelerated benefits* —(A) *In general.* A plan in critical status is required to provide that, effective on the date the notice of certification of the plan's critical status for the initial critical year under § 1.432(b)-1(e) is sent, no payment in excess of the monthly amount payable under a single life annuity (plus any social security supplements described in the last sentence of section 411(a)(9)), and no payment for the purchase of an irrevocable commitment from an insurer to pay benefits, may be made except as provided in section 432(f)(2). A plan amendment that provides for these restrictions does not violate section 411(d)(6).
(B)*Exceptions.* Pursuant to section 432(f)(2)(B), the restrictions under this paragraph (a)(3)(iii) do not apply to a benefit which under section 411(a)(11) may be immediately distributed without the consent of the participant or to any makeup payment in the case of a retroactive annuity starting date or any similar payment of benefits owed with respect to a prior period.
(C)[Reserved.]
(D)*Correction of erroneous restrictions.* If the notice described in § 1.432(b)-1(e) has been sent and the restrictions provided under this paragraph (a)(3)(iii) have been applied, and it is later determined that the restrictions should not have been applied, then the plan must correct any benefit payments that were restricted in error. Thus, for example, if pursuant to section 212(e)(2) of the Pension Protection Act of 2006, Public Law 109-280, 120 Stat. 780 the enrolled actuary for the plan certified that it was reasonably expected that the plan would be in critical status with respect to the first plan year beginning after 2007, and the notice described in § 1.432(b)-1(e)(3)(i) was sent, but the plan is not later certified to be in critical status for that plan year, then the plan must correct any benefit payments that were restricted after the notice was sent. Similarly, if the enrolled actuary for the plan certified that it was reasonably expected that the plan would be in critical status with respect to the first plan year beginning after 2007, and the notice described in § 1.432(b)-1(e)(3)(i) was sent before the first day of that plan year, the restriction on benefits under section 432(f)(2) first applies beginning on the first day of the first plan year beginning after 2007. If the plan restricts benefits before that date, then the plan must correct any improperly restricted benefits.
(iv)*Restrictions applicable after the adoption of rehabilitation plan.* In the case of a plan that is in critical status after the adoption of the rehabilitation plan, the plan and the plan sponsor must satisfy the requirements of section 432(f)(1) until the end of the rehabilitation period.
(b)*Definitions.* The following definitions apply for purposes of section 432 and the regulations:
(1)*Accumulated funding deficiency.* The term accumulated funding deficiency has the same meaning as the term accumulated funding deficiency under section 431(a).
(2)*Active participant.* The term active participant means a participant who is in covered service under the plan.
(3)*Bargaining party.* Except as provided in paragraph (c)(1) of this section, the term bargaining party means an employer who has an obligation to contribute under the plan and an employee organization which, for purposes of collective bargaining, represents plan participants employed by an employer which has an obligation to contribute under the plan.
(4)*Benefit commencement date.* The term benefit commencement date means the annuity starting date (or in the case of a retroactive annuity starting date, the date on which benefit payments begin).
(5)*Critical status.* A multiemployer plan is in critical status if the plan meets one of the tests set forth in § 1.432(b)-1(c).
(6)*Endangered status.* A plan is in endangered status if the plan meets one of the tests set forth in § 1.432(b)-1(b).
(7)*Funded percentage.* The term funded percentage means a fraction (expressed as a percentage) the numerator of which is the actuarial value of the plan's assets as determined under section 431(c)(2) and the denominator of which is the accrued liability of the plan, determined using the actuarial assumptions described in section 431(c)(3) and the unit credit funding method.
(8)*Funding improvement period for endangered or seriously endangered plans.* The term funding improvement period means the period that begins on the first day of the first plan year beginning after the earlier of the second anniversary of the date of the adoption of the funding improvement plan, or the expiration of the collective bargaining agreements that are in effect on the due date for the actuarial certification of endangered status for the initial endangered year and which cover, as of such due date, at least 75 percent of the active participants in the plan. The funding improvement period ends on the last day of the 10th year (15 years for seriously endangered plans, except as provided in section 432(c)(5)) after it begins or, if earlier, the date of the change in status described in section 432(c)(4)(C).
(9)*Funding plan adoption period.* The term funding plan adoption period means the period that begins on the date of the actuarial certification for the initial endangered year and ends on the day before the first day of the funding improvement period.
(10)*Inactive participant.* The term inactive participant means —
(i)A participant who is not an active participant,
(ii)A beneficiary under the plan, or
(iii)An alternate payee under the plan.
(11)*Initial critical year.* The term initial critical year means the first year for which the enrolled actuary for the plan has certified that the plan is or will be in critical status. If a plan is in critical status in one year, emerges from critical status in a subsequent year and then returns to critical status, the year of reentry into critical status is treated as the initial critical year with respect to subsequent years.
(12)*Initial endangered year.* The term initial endangered year means the first year for which the enrolled actuary for the plan has certified that the plan is in endangered status. If a plan is in endangered status in one year, changes from endangered status in a subsequent year and then returns to endangered status, the year of reentry into endangered status is treated as the initial endangered year with respect to subsequent years.
(13)*Nonbargained participant.* The term nonbargained participant means a participant in the plan whose participation is other than pursuant to a collective bargaining agreement within the meaning of section 7701(a)(46). A participant will not be treated as a nonbargained participant merely because the participant is no longer covered by the collective bargaining agreement solely as a result of retirement or severance from employment.
(14)*Obligation to contribute.* The term obligation to contribute means an obligation to contribute arising under one or more collective bargaining (or related) agreements or as a result of a duty under applicable labor-management relations law.
(15)*Plan sponsor.* Except as provided in paragraph (c)(1) of this section, the term plan sponsor means the association, committee, joint board of trustees, or other similar group of representatives of the parties who establish or maintain the plan.
(16)*Rehabilitation period.* The term rehabilitation period means the period that begins on the first day of the first plan year beginning after the earlier of the second anniversary of the date of the adoption of the rehabilitation plan, or the expiration of the collective bargaining agreements that are in effect on the due date for the actuarial certification of critical status for the initial critical year and which cover, as of such due date, at least 75 percent of the active participants in the plan. The rehabilitation period ends on the last day of the 10th year after it begins or, if earlier, the plan year preceding the plan year in which the plan has emerged from critical status as described in section 432(e)(4)(B).
(17)*Rehabilitation plan adoption period.* The term rehabilitation plan adoption period means the period that begins on the date of the actuarial certification for the initial critical year and ends on the day before the first day of the rehabilitation period.
(18)*Seriously endangered status.* A plan is in seriously endangered status if the plan is in endangered status and is described in both § 1.432(b)-1(b)(2) and (3).
(c)*Special rules* —(1) *Plan described in section 404(c).* In the case of a plan described in section 404(c), or a continuation of such a plan, the association of employers that is the employer settlor of the plan is treated as a bargaining party and is treated as the plan sponsor for purposes of section 432.
(2)*Plans covering both bargained and nonbargained participants.* In the case of an employer that contributes to a plan with respect to both employees who are covered by one or more collective bargaining agreements and employees who are nonbargained participants, if the plan is in endangered status or critical status, benefits of and contributions for the nonbargained participants (including surcharges on those contributions) are determined as if those nonbargained participants were covered under the employer's collective bargaining agreement in effect when the plan entered endangered or critical status that is the first to expire.
(3)*Plans covering nonbargained participants only.* In the case of an employer that contributes to a multiemployer plan only with respect to employees who are not covered by a collective bargaining agreement, section 432 and the regulations thereunder are applied as if the employer were the bargaining party, and its participation agreement with the plan were a collective bargaining agreement with a term ending on the first day of the plan year beginning after the employer is provided the schedules described in sections 432(c) and (e).
(d)*Effective/applicability date.* These regulations apply to plan years ending after March 18, 2008, but only with respect to plan years that begin on or after January 1, 2008. **Par. 3.** Section 1.432(b)-1 is added to read as follows: § 1.432(b)-1 Determination of status and adoption of a plan.
(a)*In general.* This section provides rules relating to multiemployer plans (within the meaning of section 414(f)) that are in endangered status or critical status under section 432. Section 432 and this section only apply to multiemployer plans that are in effect on July 16, 2006. Paragraph
(b)of this section sets forth the factors for determining whether a plan is in endangered status. Paragraph
(c)of this section sets forth the factors for determining whether a plan is in critical status. Paragraph
(d)sets forth the requirements for the annual certification by the plan's enrolled actuary. Paragraph
(e)of this section describes the notice to employees that is required for plans that are in endangered or critical status.
(b)*Determination of endangered status* —(1) *In general.* A plan is in endangered status for a plan year if, as determined by the enrolled actuary for the plan, the plan is not in critical status for the plan year and if, as of the beginning of the plan year, the plan is described either in paragraph (b)(2) of this section or paragraph (b)(3) of this section. The enrolled actuary's determination of whether a plan is in endangered status is made under the rules of paragraph (d)(5) of this section.
(2)*Endangered status based on funding percentage.* A plan is described in this paragraph (b)(2) for a plan year if the plan's funded percentage for such plan year is less than 80 percent.
(3)*Endangered status based on projection of funding deficiency.* A plan is described in this paragraph (b)(3) for a plan year if the plan has an accumulated funding deficiency for such plan year (or is projected to have such an accumulated funding deficiency for any of the 6 succeeding plan years), taking into account any extension of amortization periods under section 431(d).
(c)*Critical Status* —(1) *In general.* A multiemployer plan is in critical status for a plan year if, as determined by the enrolled actuary for the plan, the plan is described in one or more of paragraphs (c)(2) through (c)(6) of this section as of the beginning of the plan year. The enrolled actuary's determination of critical status must be made in accordance with the rules of paragraph (d)(5) of this section. Notwithstanding paragraph (d)(5)(iii) of this section, for purposes of applying the critical status tests described in paragraphs (c)(2) and (c)(5) of this section, the actuary must assume that the terms of all collective bargaining agreements pursuant to which the plan is maintained for the current plan year continue in effect for succeeding plan years.
(2)*Critical status based on 6-year projection of benefit payments.* A plan is described in this paragraph (c)(2) if the funded percentage of the plan is less than 65 percent, and the present value of all nonforfeitable benefits projected to be payable under the plan during the current plan year and each of the 6 succeeding plan years (plus administrative expenses for such plan years) is greater than the sum of—
(i)The fair market value of plan assets, plus
(ii)The present value of the reasonably anticipated employer contributions for the current plan year and the 6 succeeding plan years.
(3)*Critical status based on short term funding deficiency.* A plan is described in this paragraph (c)(3) if—
(i)The plan has an accumulated funding deficiency for the current plan year, not taking into account any extension of amortization periods under section 431(d), or
(ii)The plan is projected to have an accumulated funding deficiency for any of the 3 succeeding plan years (4 succeeding plan years if the funded percentage of the plan is 65 percent or less), not taking into account any extension of amortization periods under section 431(d).
(4)*Critical status based on contributions less than normal cost plus interest.* A plan is described in this paragraph (c)(4) if—
(i)The present value of the reasonably anticipated employer and employee contributions for the current plan year is less than the sum of
(A)The plan's normal cost (determined under the unit credit funding method), and
(B)Interest (determined at the rate used for determining costs under the plan) on the excess if any of— ( *1* ) The accrued liability of the plan (determined using the actuarial assumptions described in section 431(c)(3) and the unit credit funding method) over ( *2* ) The actuarial value of assets determined under section 431(c)(2),
(ii)The present value, as of the beginning of the current plan year, of nonforfeitable benefits of inactive participants is greater than the present value of nonforfeitable benefits of active participants, and
(iii)The plan has an accumulated funding deficiency for the current plan year (or is projected to have such a deficiency for any of the 4 succeeding plan years), not taking into account any extension of amortization periods under section 431(d).
(5)*Critical status based on 4-year projection of benefit payments.* A plan is described in this paragraph (c)(5) if the present value of all benefits projected to be payable under the plan during the current plan year or any of the 4 succeeding plan years (plus administrative expenses for such plan years) is greater than the sum of—
(i)The fair market value of plan assets, plus
(ii)The present value of the reasonably anticipated employer contributions for the current plan year and each of the 4 succeeding plan years.
(6)*Critical status based on failure to meet emergence criteria.* A plan is described in this paragraph (c)(6) if—
(i)The plan was in critical status for the immediately preceding plan year, and
(ii)The enrolled actuary for the plan has certified that the plan is projected to have an accumulated funding deficiency for the plan year or any of the 9 succeeding plan years, without regard to the use of the shortfall funding method but taking into account any extensions of the amortization periods under section 431(d).
(d)*Annual certification by the plan's enrolled actuary* —(1) *In general.* Not later than the 90th day of each plan year of a multiemployer plan, the enrolled actuary for the plan must certify to the Secretary of the Treasury and to the plan sponsor—
(i)Whether or not the plan is in endangered status for such plan year;
(ii)Whether or not the plan is or will be in critical status for such plan year, and
(iii)In the case of a plan which is in a funding improvement or rehabilitation period, whether or not the plan is making the scheduled progress in meeting the requirements of its funding improvement or rehabilitation plan.
(2)*Transmittal of certification* —(i) *Transmittal to the plan sponsor.* The certification of plan status described in paragraph (d)(1) must be submitted to the plan sponsor at the address stated by the plan sponsor on their Annual Report (Form 5500) or such other address as the plan sponsor may designate in writing for receipt of this certification.
(ii)*Transmittal to the Secretary of the Treasury.* Except as provided in guidance of general applicability to be published in the Internal Revenue Bulletin, the annual certification of plan status described in paragraph (d)(1) must be transmitted to the Secretary of the Treasury by mailing the certification to: Internal Revenue Service, Employee Plans Compliance Unit, Group 7602 (SE:TEGE:EP), Room 1700—17th Floor, 230 S. Dearborn Street, Chicago, IL 60604.
(3)*Content of annual certification* —(i) *In general.* The annual certification must contain the information described in this paragraph (d)(3). The Secretary may add to or otherwise modify the requirements in this paragraph (d)(3) in guidance of general applicability to be published in the Internal Revenue Bulletin.
(ii)*Plan identification.* The annual certification must include the name of the plan; the plan number; the name, address, and telephone number of the plan sponsor; and the plan year for which the certification is being made.
(iii)*Enrolled actuary identification.* The annual certification must include the name, address and telephone number of the enrolled actuary signing the certification; the actuary's enrollment identification number; the actuary's signature, and the date of the signature.
(iv)*Information on plan status.* The annual certification must state whether the plan is in endangered status (which includes seriously endangered status); critical status, or neither endangered nor critical status.
(v)*Information on scheduled progress.* If the annual certification is made with respect to a plan year that is within the plan's funding improvement period or rehabilitation period arising from a prior certification of endangered or critical status, the actuary must also certify whether or not the plan is making scheduled progress in meeting the requirements of its funding improvement or rehabilitation plan.
(4)*Penalty for failure to secure timely actuarial certification.* A failure of a plan's actuary to certify the plan's status under this paragraph
(d)by the date specified in paragraph (d)(1) of this section is treated as a failure or refusal by the plan administrator to file the annual report required to be filed with the Secretary of Labor under section 101(b)(4) of the Employee Retirement Income Security Act of 1974.
(5)*Actuarial projections of assets and liabilities* —(i) *In general.* In making the determinations and projections under section 432(b) and this section, the enrolled actuary for the plan must make projections required for the current and succeeding plan years of the current value of the assets of the plan and the present value of all liabilities to participants and beneficiaries under the plan for the current plan year as of the beginning of such year. These projections must be based on reasonable actuarial estimates, assumptions, and methods in accordance with section 431(c)(3) and that offer the actuary's best estimate of anticipated experience under the plan. Notwithstanding the previous sentence, the actuary is permitted to rely on the plan sponsor's projection of activity in the industry provided under paragraph (d)(5)(iii) of this section. The projected present value of liabilities as of the beginning of such year must be determined based on the most recent information reported on the most recent of either—
(A)The actuarial statement required under section 103(d) of the Employee Retirement Income Security Act of 1974 that has been filed with respect to the most recent year, or
(B)The actuarial valuation for the preceding plan year.
(ii)*Determinations of future contributions.* Any actuarial projection of plan assets shall assume either—
(A)Reasonably anticipated employer contributions for the current and succeeding plan years, assuming that the terms of the one or more collective bargaining agreements pursuant to which the plan is maintained for the current plan year continue in effect for succeeding plan years, or
(B)That employer contributions for the most recent plan year will continue indefinitely, but only if the enrolled actuary for the plan determines there have been no significant demographic changes that would make such assumption unreasonable.
(iii)*Projected industry activity.* The plan sponsor shall provide any necessary projection of activity in the industry, including future covered employment, to the plan actuary. For this purpose, the plan sponsor must act reasonably and in good faith.
(6)*Treatment of amortization extensions under section 412(e).* For purposes of section 432, if the plan received an extension of any amortization period under section 412(e), the extension is treated the same as an extension under section 431(d). Thus, such an extension is not taken into account in determining whether a plan has or will have an accumulated funding deficiency under paragraph (c)(3) and (c)(4) of this section, but it is taken into account in determining whether a plan has or will have an accumulated funding deficiency under paragraph (b)(3) of this section.
(e)*Notice of endangered or critical status* —(1) *In general.* In any case in which the enrolled actuary for the plan certifies that a multiemployer plan is or will be in endangered or critical status for a plan year, the plan sponsor must, not later than 30 days after the date of the certification, provide notification of the endangered or critical status to the participants and beneficiaries, the bargaining parties, the Pension Benefit Guaranty Corporation, and the Secretary of Labor.
(2)*Plans in critical status.* If it is certified that a multiemployer plan is or will be in critical status for a plan year, the plan sponsor must include in the notice an explanation of the possibility that adjustable benefits (as defined in section 432(e)(8)) may be reduced, and such reductions may apply to participants and beneficiaries whose benefit commencement date is on or after the date such notice is provided for the first plan year in which the plan is in critical status. If the plan provides benefits that are restricted under section 432(f)(2), the notice must also include an explanation that the plan cannot pay single sums and similar benefits described in section 432(f)(2) that are greater than the monthly amount due under a single life annuity. A plan sponsor that sends the model notice issued by the Secretary of Labor pursuant to section 432(b)(3)(D)(iii) satisfies this requirement.
(3)*Transition rules* —(i) *Early notice permitted.* If, after August 17, 2006, the enrolled actuary for the plan certifies that a plan is reasonably expected to be in critical status with respect to the first plan year beginning after 2007, then the notice described in this paragraph
(e)may be provided before the date the actuary certifies the plan is in critical status for that plan year. The ability to provide early notice does not extend the otherwise applicable deadline for providing the notice under paragraph (e)(1) of this section.
(ii)*Reformation of prior notice.* If notice has been provided prior to the date required under paragraph (e)(1) of this section, but the notice did not include all of the information described in paragraph (e)(2) of this section, then that notice will not satisfy the requirements for notice under section 432(b)(3)(D). Accordingly, the restrictions under section 432(f)(2) will not apply as a result of the issuance of such a notice. However, if prior to the date notice is required to be provided under paragraph (e)(1) of this section additional notice is provided that includes all of the information required under paragraph (e)(2) of this section, then the notice requirements of section 432(b)(3)(D) are satisfied as of the date of that additional notice and the restrictions of section 432(f)(2) will apply beginning on that date. In such a case, the date of the earlier notice will still apply for purposes of section 432(e)(8)(A)(ii) provided that the earlier notice included all of the information required under section 432(b)(3)(D)(ii).
(f)*Effective applicability date.* These regulations apply to plan years ending after [ *INSERT DATE OF PUBLICATION OF THESE REGULATIONS IN THE FEDERAL REGISTER* ] but only with respect to plan years that begin on or after January 1, 2008. Linda E. Stiff, Deputy Commissioner for Services and Enforcement. [FR Doc. 08-1044 Filed 3-14-08; 9:03 am]
Connectionstraces to 23
Traces to 23 documents
CFR
- What size standards has SBA identified by North American Industry Classification System codes?§ 121.201
- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
- Applicability.§ 71.1
- Applications.§ 514.1
- Definitions.§ 516.3
- Documentation of minor use status.§ 516.21
- Content and format of a request for MUMS-drug designation.§ 516.20
- General.§ 25.30
- Rules and regulations.§ 601.601
U.S. Code
- Federal Aviation Administration§ 106
- Definitions; generally§ 321
- Designated new animal drugs for minor use or minor species§ 360ccc–2
- New animal drugs§ 360b
- Designation of drugs for rare diseases or conditions§ 360bb
- Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs§ 360ccc
- Regulations and hearings§ 371
- Index of legally marketed unapproved new animal drugs for minor species§ 360ccc–1
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Confidentiality and disclosure of returns and return information§ 6103
- Rules and regulations§ 7805
21 references not yet in our index
- 7 CFR 927
- 7 CFR 966
- 7 CFR 984
- 7 USC 601-674
- 5 USC 601-612
- 7 CFR 955
- 7 USC 2131-2159
- 7 CFR 2.22
- 14 CFR 39
- 14 CFR 71
- 20 CFR 404
- 21 CFR 516
- Pub. L. 108-282
- Pub. L. 97-414
- Pub. L. 100-670
- Pub. L. 104-4
- 44 USC 3501-3520
- 26 CFR 1
- Pub. L. 109-280
- 120 Stat. 780
- 29 CFR 1
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Cite7 CFR 966
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