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Code · REGISTER · 2008-02-08 · Grain Inspection, Packers and Stockyards Administration, USDA · Rules and Regulations

Rules and Regulations. Proposed rule

25,260 words·~115 min read·/register/2008/02/08/08-566

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

BILLING CODE 3510-22-S 73 27 Friday, February 8, 2008 Proposed Rules DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 9 CFR Part 201 RIN 0580-AB01 Swine Contractors AGENCY: Grain Inspection, Packers and Stockyards Administration, USDA. ACTION: Proposed rule. SUMMARY: We propose to add “swine contractors” to the list of regulated entities subject to specific regulations under the Packers and Stockyards Act (the P&S Act). In 2002, Congress added swine contractors as entities regulated under the P&S Act.
The specific regulations we propose to amend prohibit regulated entities from circulating misleading reports about market conditions or prices. We also propose to amend regulations that address inspection of business records and facilities, information that regulated entities are required to share with the Secretary of Agriculture, and USDA's responsibility to refrain from unauthorized disclosure of that information. The goal of these regulations is to ensure fairness in the marketing of livestock, meat, and poultry.
Adding swine contractors to specific regulations under the P&S Act will assist swine contractors and swine production contract growers with determining which regulations apply to them. Adding swine contractors to specific regulations will also make it easier for GIPSA to identify potential violations and to enforce the provisions of the P&S Act and regulations. DATES: We will consider comments we receive by April 8, 2008. ADDRESSES: We invite you to submit comments on this proposed rule.
You may submit comments by any of the following methods: • E-Mail: Send comments via electronic mail to *comments.gipsa@usda.gov.* • Mail: Send hardcopy written comments to Tess Butler, GIPSA, USDA, 1400 Independence Avenue, SW., Room 1643-S, Washington, DC 20250-3604. • Fax: Send comments by facsimile transmission to:
(202)690-2173. • Hand Delivery or Courier: Deliver comments to: Tess Butler, GIPSA, USDA, 1400 Independence Avenue, SW., Room 1643-S, Washington, DC 20250-3604. • Federal e-Rulemaking Portal: Go to *http://www.regulation.gov.* Follow the on-line instruction for submitting comments. *Instructions:* All comments should make reference to the date and page number of this issue of the **Federal Register** . *Background Documents:* Regulatory analyses and other documents relating to this action will be available for public inspection in Room 1643-S, 1400 Independence Avenue, SW., Washington, DC 20250-3604 during regular business hours. *Read Comments:* All comments will be available for public inspection in the above office during regular business hours (7 CFR 1.27(b)). Please call the GIPSA Management Support Services staff at
(202)720-7486 to arrange a public inspection of comments. FOR FURTHER INFORMATION CONTACT: S. Brett Offutt, Director, Policy and Litigation Division, P&SP, GIPSA, 1400 Independence Ave., SW., Washington, DC 20250,
(202)720-7363, *s.brett.offutt@usda.gov.* SUPPLEMENTARY INFORMATION: Background The Grain Inspection, Packers and Stockyards Administration (GIPSA) enforces the Packers and Stockyards (P&S) Act of 1921 (the P&S Act). Under authority granted the Secretary of Agriculture (Secretary) and delegated to us, we are authorized (7 U.S.C. 228) to make those regulations necessary to carry out the provisions of the P&S Act. The Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171) amended the P&S Act to define and add “swine contractors” as a regulated entity. A swine contractor is defined as “any person engaged in the business of obtaining swine under a swine production contract for the purpose of slaughtering the swine or selling the swine for slaughter, if
(A)the swine is obtained by the person in commerce; or
(B)the swine (including products from the swine) obtained by the person is sold or shipped in commerce.” ((7 U.S.C. 182 (12)) Adding swine contractors to specific regulations under the P&S Act will assist swine contractors and swine production contract growers with determining which regulations apply to them. It will also make it easier for GIPSA to identify potential violations and enforce the provisions of the P&S Act and regulations. Description of Proposed Changes We now propose to amend the following regulations (9 CFR part 201) under the P&S Act to add the words “swine contractors” to the list of those subject to the regulations: • Section 201.53 Persons subject to the Act not to circulate misleading reports about market conditions or prices. • Section 201.94 Information as to business; furnishing of by packers, live poultry dealers, stockyard owners, market agencies, and dealers. • Section 201.95 Inspection of business records and facilities. • Section 201.96 Unauthorized disclosure of business information prohibited. The proposed modification to § 201.53 would inform swine contractors that they are prohibited from knowingly making, issuing, or circulating false or misleading reports, records, or representations about market conditions, about prices, or about the sale of livestock, meat, or live poultry. The proposed modification to § 201.94 would require swine contractors to furnish the Secretary or his duly authorized representatives, if requested by such representatives, with business information required in order to carry out provisions of the P&S Act and regulations in 9 CFR part 201. The proposed modification to § 201.95 would require swine contractors to permit authorized representatives of the Secretary to enter their places of business to examine and copy business records, and to inspect facilities. The proposed modification to § 201.96 would prohibit agents or employees of the United States from disclosing a swine contractor's business information without the consent of the swine contractor, except in the specific circumstances listed in § 201.96. Options Considered We considered not making these regulatory changes and continuing to protect the interests of swine producers indirectly through regulation of packers, dealers, and market agents. However, that option would not reflect the intent of Congress in amending the P&S Act to give the Secretary authority over swine contractors. We have the authority and the responsibility to directly regulate swine contractors. We could also take legal action against a swine contractor for alleged violations of the P&S Act without amending the regulations. However, that action would not clearly inform all swine contractors and swine production contract growers about the requirements that apply to swine contractors. Issuing the proposed regulations would make it clear to swine contractors and swine production contract growers which parts of the regulations apply to them, and would make it easier for GIPSA to identify potential violators and to enforce provisions of the P&S Act. Effects on Regulated Entities If we implement these regulatory changes, swine contractors will have to open their business records and facilities to authorized representatives of GIPSA upon request. Some swine contractors may have to change their policies to allow access and to accommodate GIPSA representatives. We are not requiring that new information or records be kept by swine contractors, unless existing information or records are false or misleading about market conditions, prices, or sales of livestock, meat, or live poultry. This proposed rule would give swine contractors assurance that business information examined by GIPSA will be kept confidential, except under specific circumstances. Furthermore, swine production contract growers will be given increased assurance of fair treatment by swine contractors. Executive Order 12866 and Regulatory Flexibility Act The Office of Management and Budget
(OMB)has designated this rule as not significant for the purposes of Executive Order 12866. We have determined that this proposed rule will not have a significant economic impact on a substantial number of small entities as defined in the Regulatory Flexibility Act (5 U.S.C. 601, *et seq.* ). The proposed rule will affect swine contractors. Most of these entities are slaughterers or processors of swine with more than 500 employees and do not meet the applicable size standards for small entities in the Small Business Administration Regulations (13 CFR 121.201). A 2007 study of U.S. pork producers found that firms that market more than 50,000 head of swine per year account for nearly all of contracted swine production in the U.S. In accordance with 5 U.S.C. 605 of the Regulatory Flexibility Act, we are not providing an initial regulatory flexibility analysis because this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. Small swine production contract growers should benefit indirectly from the proposed amendments, which should provide fairness in the marketing of swine and swine products. We have considered the effects of this rulemaking action under the Regulatory Flexibility Act and we believe that it will not have a significant impact on a substantial number of small entities. We welcome comments on the cost of compliance with this rule, and particularly on the impact of this proposed rule on small entities. We also welcome comments on alternatives to the proposed rule that could achieve the same purpose with less cost or burden. Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. These actions are not intended to have retroactive effect. This rule will not pre-empt state or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule. Paperwork Reduction Act This proposed rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). It does not involve collection of new or additional information by the federal government. E-Government Act Compliance GIPSA 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. List of Subjects in 9 CFR Part 201 Confidential business information, Reporting and recordkeeping requirements, Stockyards, Trade practices. For the reasons set forth in the preamble, we propose to amend 9 CFR part 201 to read as follows: PART 201—REGULATIONS UNDER THE PACKERS AND STOCKYARDS ACT 1. The authority citation for part 201 is revised to read as follows: Authority: 7 U.S.C. 182, 222, and 228, and 7 CFR 2.22 and 2.81. 2. Revise § 201.53 to read as follows: § 201.53 Persons subject to the Act not to circulate misleading reports about market conditions or prices. No packer, swine contractor, live poultry dealer, stockyard owner, market agency, or dealer shall knowingly make, issue, or circulate any false or misleading reports, records, or representation concerning the market conditions or the prices or sale of any livestock, meat, or live poultry. 3. Revise § 201.94 to revise the heading and to read as follows: § 201.94 Information as to business; furnishing of by packers, swine contractors, live poultry dealers, stockyard owners, market agencies, and dealers. Each packer, swine contractor, live poultry dealer, stockyard owner, market agency, and dealer, upon proper request, shall give to the Secretary or his duly authorized representatives in writing or otherwise, and under oath or affirmation if requested by such representatives, any information concerning the business of the packer, swine contractor, live poultry dealer, stockyard owner, market agency, or dealer, or which may be required in order to carry out the provisions of the Act and regulations in this part within such reasonable time as may be specified in the request for such information. 4. Revise § 201.95 to read as follows: § 201.95 Inspection of business records and facilities. Each stockyard owner, market agency, dealer, packer, swine contractor, and live poultry dealer, upon proper request, shall permit authorized representatives of the Secretary to enter its place of business during normal business hours and to examine records pertaining to its business subject to the Act, to make copies thereof and to inspect the facilities of such persons subject to the Act. Reasonable accommodations shall be made available to authorized representatives of the Secretary by the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer for such examination of records and inspection of facilities. 5. Revise § 201.96 to read as follows: § 201.96 Unauthorized disclosure of business information prohibited. No agent or employee of the United States shall, without the consent of the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer concerned, divulge or make known in any manner, any facts or information regarding the business of such person acquired through any examination or inspection of the business or records of the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer, or through any information given by the stockyard owner, market agency, dealer, packer, swine contractor, or live poultry dealer pursuant to the Act and regulations, except to such other agents or employees of the United States as may be required to have such knowledge in the regular course of their official duties or except insofar as they may be directed by the Administrator or by a court of competent jurisdiction, or except as they may be otherwise required by law. James E. Link, Administrator, Grain Inspection, Packers and Stockyards Administration. [FR Doc. E8-2376 Filed 2-7-08; 8:45 am] BILLING CODE 3410-KD-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0147; Directorate Identifier 2007-NM-294-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 737-600, -700, -700C, -800, and -900 Series Airplanes, Equipped with CFM56-7 Engines 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 737-600, -700, and -800 series airplanes. The existing AD currently requires repetitive inspections to detect damage of the aft strut insulation blanket, and eventual replacement of the insulation blankets with new, improved blankets. This proposed AD would add airplanes to the applicability and require installation of a new heat insulation blanket and new cover plate on the left and right side engine struts. This proposed AD would not retain the requirements of the existing AD and would terminate the requirements of the existing AD. This proposed AD results from reports of damaged heat insulation blankets on the engine struts. We are proposing this AD to prevent exposure of the lower surface of the strut to extreme high temperatures, consequent creation of a source of fuel ignition, and increased risk of an uncontrollable fire and possible fuel tank explosion. DATES: We must receive comments on this proposed AD by March 24, 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: Kathrine Rask, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6505; 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-2008-0147; Directorate Identifier 2007-NM-294-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 February 4, 1999, we issued AD 99-04-11, amendment 39-11035 (64 FR 6791, February 11, 1999), for certain Boeing Model 737-600, -700, and -800 series airplanes. That AD requires repetitive inspections to detect damage of the aft strut insulation blanket. That AD also requires eventual replacement of the insulation blankets with new, improved blankets, which constitutes terminating action for the requirements of that AD. That AD resulted from reports of damaged aft strut insulation blankets. We issued that AD to prevent such damage, which could result in exposure of the lower surface of the strut to extreme high temperatures, consequent creation of a source of fuel ignition, and increased risk of an uncontrollable fire and possible fuel tank explosion. Actions Since Existing AD Was Issued Since we issued AD 99-04-11, we have received reports of failures of the insulation blankets that were installed in accordance with the requirements of that AD. A failed heat insulation blanket might go undetected in that area. Relevant Service Information We have reviewed Boeing Special Attention Service Bulletin 737-54-1045, dated July 25, 2007. The service bulletin describes procedures for installing a new heat insulation blanket, P/N S315A213-57, and a new cover plate on the left and right side engine struts. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. 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 airplanes of the same type design. For this reason, we are proposing this AD, which would supersede AD 99-04-11 and require accomplishing the actions specified in the service bulletin described previously. This proposed AD would also add Model 737-700C and -900 series airplanes to the applicability. Costs of Compliance There are about 2,148 airplanes of the affected design in the worldwide fleet. This proposed AD would affect about 740 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. The average labor rate is $80 per work hour. Estimated Costs Action Work hours Parts Cost per airplane Fleet cost Installation (new proposed action) 4 $4,730 $5,050 $3,737,000 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 39-11035 (64 FR 6791, February 11, 1999) and adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2008-0147; Directorate Identifier 2007-NM-294-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by March 24, 2008. Affected ADs
(b)This AD supersedes AD 99-04-11. Applicability
(c)This AD applies to Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 737-54-1045, dated July 25, 2007. Unsafe Condition
(d)This AD results from reports of damaged heat insulation blankets on the engine struts. We are issuing this AD to prevent exposure of the lower surface of the strut to extreme high temperatures, consequent creation of a source of fuel ignition, and increased risk of uncontrollable fire and possible fuel tank explosion. 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. Installation
(f)Within 60 months after the effective date of this AD, install a new heat insulation blanket, P/N S315A213-57, and a new cover plate on the left and right side engine struts in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-54-1045, dated July 25, 2007. Parts Installation
(g)As of the effective date of this AD, no person may install a heat insulation blanket, P/N S315A213-42 or -47, on any airplane. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle Aircraft Certification Office (ACO), 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. Issued in Renton, Washington, on January 31, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-2351 Filed 2-7-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0148; Directorate Identifier 2007-NM-299-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 747 Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for all Boeing Model 747 airplanes. This proposed AD would require a one-time inspection of certain fuselage skins at section 41 to find any external doublers that cover the inspection areas and to identify the external doublers that end on a stringer and those that do not, and related investigative and corrective actions if necessary. This proposed AD results from reports of cracks found at fastener locations in the fuselage skins at section 41. We are proposing this AD to detect and correct fuselage skin cracks at fastener locations along the skin-to-stringer attachments, which could join together and become large and consequently result in rapid decompression of the cabin. DATES: We must receive comments on this proposed AD by March 24, 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: Ivan Li, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6437; 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-2008-0148; Directorate Identifier 2007-NM-299-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 We have received two reports of cracks found at fastener locations in the fuselage skins at section 41. One operator reported finding skin cracks at a fastener location at stringer 5 (S-5) near station
(STA)365, on a Model 747-200F series airplane. These cracks were found during incorporation of the skin modification specified in Boeing Service Bulletin 747-53-2272. The cracks were 0.25 inch long and located on the forward and aft side of the fastener hole. The airplane had accumulated 13,726 total flight cycles. In the other report, multiple skin cracks were found during Boeing Model 747-400 series airplane fatigue testing. That test article had accumulated 40,000 test cycles. The cracks were found at locations where there are no internal doublers, at stringers 10 and 13, and between STA 260 and STA 300. Fuselage skin cracks at fastener locations along the skin-to-stringer attachments, if not corrected, could join together and become large and consequently result in rapid decompression of the cabin. Relevant Service Information We have reviewed Boeing Alert Service Bulletin 747-53A2704, dated October 4, 2007. The service bulletin describes procedures for doing a one-time general visual inspection of certain fuselage skins at section 41 to find any external doublers that cover the inspection area and to identify the external doublers that end on a stringer and those that do not; and related investigative and corrective actions if necessary. The related investigative actions include the following: • Removing any external doubler and doing a one-time detailed inspection and an open-hole high frequency eddy current
(HFEC)inspection for any crack in the skin at the skin-to-stringer attachments, for an inspection area where the skin-to-stringer attachment is covered by an external doubler that ends on a stringer in the inspection area. • Doing repetitive external HFEC inspections for any crack in the skin at the skin-to-stringer attachments, for an inspection area where the skin-to-stringer attachment is not covered by an external doubler. For the one-time general visual inspection, one-time detailed inspection, one-time open-hole HFEC inspection, and the initial external HFEC inspection, the service bulletin specifies a compliance time of 16,000 or 25,000 total flight cycles depending on the airplane configuration, or 2,000 flight cycles after the date on the service bulletin, whichever occurs later. The service bulletin also specifies that if a skin panel was replaced, the inspection threshold for the affected area can be calculated from the time it was replaced. For the repetitive external HFEC inspections, the service bulletin specifies a repeat interval of 3,000 flight cycles. The corrective actions include repairing any crack found in an inspection area, and installing a new external doubler where any external doubler has been removed from the inspection area. The service bulletin specifies accomplishing the corrective actions before further flight. FAA's Determination and Requirements of This Proposed AD We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the(se) same type design(s). This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the Proposed AD and Service Bulletin.” Differences Between Proposed AD and Service Bulletin Although Figure 19 of the service bulletin specifies doing a “detailed visual inspection” of the fastener holes, this proposed AD would require doing a “detailed inspection.” This proposed AD expands the inspection area at certain skin-to-stringer attachments. In Figure 3 of the service bulletin, S-5 and S-5A from STA 340 to STA 360 should be bold in the illustration to include those areas as part of the recommended inspection (similar to Figure 8 for the right side). Also, in Figure 15 of the service bulletin, S-14A from STA 200 to STA 220 should be bold in the illustration to include that area as part of the recommended inspection (similar to Figure 17 for the right side). Boeing is aware of these discrepancies, concurs with the changes, and has issued Information Notice
(IN)747-53A2704 IN 01, dated December 19, 2007, to inform operators of the errors. We have included this information in paragraph
(g)of this proposed AD. Clarification of Proposed Requirements The service bulletin notes that, at locations where external doublers exist that do not end on a stringer in the inspection area, repetitive inspections of the skin for cracking at critical rows of fasteners are required in accordance with Boeing Document Number D6-36181, “Repair Assessment Guidelines—Model 747.” These inspections would not be required by this AD, since compliance is already required by sections 91.410, 121.370, 125.248, and 129.32 of the Federal Aviation Regulations (14 CFR 91.410, 121.370, 125.248, and 129.32). Costs of Compliance We estimate that this proposed AD would affect 165 airplanes of U.S. registry. We also estimate that it would take up to 64 work-hours per product to comply with this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this proposed AD to the U.S. operators to be $844,800 or $5,120 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. You can find our regulatory evaluation and the estimated costs of compliance 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: **Boeing:** Docket No. FAA-2008-0148; Directorate Identifier 2007-NM-299-AD. Comments Due Date
(a)We must receive comments by March 24, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to all Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP series airplanes, certificated in any category. Unsafe Condition
(d)This AD results from reports of cracks found at fastener locations in the fuselage skins at section 41. We are issuing this AD to detect and correct fuselage skin cracks at fastener locations along the skin-to-stringer attachments, which could join together and become large and consequently result in rapid decompression of the cabin. Compliance
(e)Comply with this AD within the compliance times specified, unless already done. Repetitive Inspections and Related Investigative/Corrective Actions
(f)At the applicable compliance times specified in Tables 1 and 2 of paragraph 1.E. of Boeing Alert Service Bulletin 747-53A2704, dated October 4, 2007: Do a general visual inspection of the fuselage skins at section 41 to find any external doublers that cover the inspection area and to identify the external doublers that end on a stringer in the inspection area and those that do not, and do all the related investigative and corrective actions as applicable, by accomplishing all of the applicable actions specified in the Accomplishment Instructions of the service bulletin, except as provided by paragraph
(g)of this AD. Repeat the related investigative actions thereafter at the interval specified in Tables 1 and 2 of the service bulletin, as applicable. Exceptions to the Service Bulletin
(g)Where Tables 1 and 2 of paragraph 1.E. of Boeing Alert Service Bulletin 747-53A2704, dated October 4, 2007, specify counting the compliance time from “* * * after the date on this service bulletin,” this AD requires counting the compliance time from the effective date of this AD. Where Figure 19 of the service bulletin specifies doing a “detailed visual inspection” for any crack at fastener holes common to the stringer, this AD would require doing a detailed inspection. In Figure 3 of the service bulletin, also inspect the areas at stringer 5 (S-5) and S-5A between station
(STA)340 and STA 360 (similar to Figure 8 for the right side). In Figure 15 of the service bulletin, also inspect the area at S-14A between STA 200 and STA 220 (similar to Figure 17 for the right side). Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle Aircraft Certification Office, FAA, *ATTN:* Ivan Li, Aerospace Engineer, Airframe Branch, ANM-120S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6437; fax
(425)917-6590; has the authority to approve AMOCs for this AD, if requested using 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)An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. Issued in Renton, Washington, on January 31, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-2352 Filed 2-7-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0149; Directorate Identifier 2007-NM-319-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 737-100, -200, -200C, -300, -400, and -500 Series Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This proposed AD would require replacing the existing straight-to-90-degree hose assembly for the Lavatory “A” water supply. The replacement is a new straight hose assembly and a separate 90-degree elbow fitting. This proposed AD results from a report of a separated hose assembly for the passenger water system. We are proposing this AD to prevent a water leak into the flight deck ceiling, which could result in an electrical short and possible loss of several functions essential to safe flight. DATES: We must receive comments on this proposed AD by March 24, 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: Marcia Smith, 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)917-6484; 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-2008-0149; Directorate Identifier 2007-NM-319-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 We have received a report of a separated hose assembly for the passenger water system. The hose assembly supplies potable water through a 90-degree end fitting to Lavatory “A.” The break occurred at the 90-degree end fitting when the elbow separated at a soldered joint adjacent to the hose assembly sleeve. The break was located just above and inside the flight deck entry door, and resulted in water spilling into the flight deck ceiling, which affected various radios and the Aircraft Communications Addressing and Reporting System (ACARS) and caused them to become inoperative. These affected parts had to be replaced due to water damage. An analysis of the broken hose assembly showed signs of previous small leaks. It was concluded that an incompletely soldered joint failed and consequently separated. A broken hose assembly in this location, if not corrected, could leak into the flight deck ceiling and result in an electrical short and possible loss of several functions essential to safe flight. Relevant Service Information We have reviewed Boeing Alert Service Bulletin 737-38A1054, dated August 23, 2007. The service bulletin describes procedures for replacing the existing straight-to-90-degree hose assembly for the Lavatory “A” water supply. The replacement is a new straight hose assembly and a separate 90-degree elbow fitting. FAA's Determination and Requirements of This Proposed AD We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other airplanes of the same type design. This proposed AD would require accomplishing the actions specified in the service information described previously. Costs of Compliance We estimate that this proposed AD would affect 779 airplanes of U.S. registry. We also estimate that it would take between 4 and 7 work-hours per airplane to comply with this proposed AD, depending on the airplane configuration. The average labor rate is $80 per work-hour. Required parts would cost about $400 per product. Based on these figures, we estimate the cost of this proposed AD to the U.S. operators to be between $560,880 and $747,840, or between $720 and $960 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. You can find our regulatory evaluation and the estimated costs of compliance 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: **Boeing** : Docket No. FAA-2008-0149; Directorate Identifier 2007-NM-319-AD. Comments Due Date
(a)We must receive comments by March 24, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category; as identified in Boeing Alert Service Bulletin 737-38A1054, dated August 23, 2007. Unsafe Condition
(d)This AD results from a report of a separated hose assembly for the passenger water system. We are issuing this AD to prevent a water leak into the flight deck ceiling, which could result in an electrical short and possible loss of several functions essential to safe flight. Compliance
(e)Comply with this AD within the compliance times specified, unless already done. Replacement
(f)Within 60 months after the effective date of this AD, replace the existing straight-to-90-degree hose assembly for the Lavatory “A” water supply with a new straight hose assembly and a separate 90-degree elbow fitting, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-38A1054, dated August 23, 2007. Parts Installation
(g)As of the effective date of this AD, any hose assembly part having a part number identified in Table 1 of this AD must not be used in any location that is subject to the requirements of this AD. However, those parts may be used in other locations if not otherwise prohibited. Table 1.—Spare Parts Prohibited for This AD Airplane group identified in Boeing Alert Service Bulletin 737-38A1054, dated August 23, 2007 Existing part Nos. 1 and 2 10-61998-430, AS4471-08-0401, or AS4471-08-0404. 3 10-61998-25 or 10-60871-125. 4 10-61998-31 or 10-60871-139. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, ATTN: Marcia Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6484; fax
(425)917-6590; has the authority to approve AMOCs for this AD, if requested using 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. Issued in Renton, Washington, on January 31, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-2353 Filed 2-7-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0151; Directorate Identifier 2007-NM-347-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 727 Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for all Boeing Model 727 airplanes. This proposed AD would require repetitive inspections for any crack in the area of the elevator side fitting/hinge fitting joint and for any crack or elongation inside and outside of the holes in the clevis and in the lug, corrective actions if necessary, and other specified actions. This proposed AD results from reports of elongated holes and cracks found in the lugs of the attachment fittings of the elevator quadrant upper support assembly at the tip of the vertical fin. We are proposing this AD to detect and correct damage to the aft attachment lugs of the elevator quadrant support assembly that could lead to failure of the lugs. This condition could accelerate wear elsewhere in the elevator control system, which could reduce the crew's ability to maintain safe flight. DATES: We must receive comments on this proposed AD by March 24, 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: Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6577; 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-2008-0151; Directorate Identifier 2007-NM-347-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 We have received reports of elongated holes or cracks found in the lugs of the attachment fittings on three Boeing Model 727 airplanes. The attachment fittings are located on the left and right sides of the elevator quadrant upper support assembly at the tip of the vertical fin. In one incident, the lug was cracked completely through. The airplanes had accumulated between 28,385 and 72,448 total flight hours and between 16,387 and 47,485 total flight cycles. Damage to the aft attachment lugs of the elevator quadrant support assembly could lead to failure of the lugs. This condition, if not corrected, could accelerate wear elsewhere in the elevator control system, which could reduce the crew's ability to maintain safe flight. Relevant Service Information We have reviewed Boeing Special Attention Service Bulletin 727-55-0092, dated June 4, 2007. Part 2 of the Accomplishment Instructions of the service bulletin describes procedures for doing repetitive detailed inspections for any crack in the area of the elevator side fitting/hinge fitting joint, repetitive detailed inspections for elongation inside and outside of the holes in the clevis and in the lug, and high frequency eddy current
(HFEC)inspections for any crack inside and outside of the holes in the clevis and in the lug. The service bulletin specifies doing these initial inspections within 18 months of the date on the service bulletin. The service bulletin also specifies repeating the inspections at intervals not to exceed 24 months, 4,000 flight hours, or 3,000 flight cycles, whichever occurs first, until the repair or modification specified in Part 3 of the Accomplishment Instructions is done. The service bulletin also describes procedures for doing corrective actions if necessary. The corrective actions, which the service bulletin specifies doing before further flight, include the following actions: • Repairing the elevator side fittings and hinge fittings as specified in Part 3 of the Accomplishment Instructions if any crack, or any hole diameter elongation over 0.3203 inch, is found during the inspections specified in Part 2 of the service bulletin. The repair includes oversizing the holes, fabricating new bushings, installing and in-line reaming the fabricated bushings through the entire stack-up, and installing the elevator side fittings. • Replacing the bushings with fabricated bushings if any hole diameter elongation over 0.3203 inch is found during the inspections specified in Part 4 of the Accomplishment Instructions of the service bulletin. • Contacting Boeing for repair instructions if any damage is beyond the repair limits or any crack is found in the area of the elevator side fitting/hinge fitting joint, during any inspection specified in Part 2 or Part 4 of the Accomplishment Instructions of the service bulletin. The service bulletin also describes procedures for doing other specified actions, which include the following: • Either installing the elevator side fittings and access panels and restoring the cable tension, or modifying the elevator side fittings and hinge fittings, if all of the holes are found acceptable during the inspections specified in Part 2 of the Accomplishment Instructions. The modification includes oversizing the holes, fabricating and installing new bushings, in-line reaming the fabricated bushings through the entire stack-up, and installing the elevator side fittings. The service bulletin specifies that the modification must be done in conjunction with the Part 2 detailed and HFEC inspections. • After the repair or modification specified in Part 3 of the Accomplishment Instructions has been done, doing repetitive detailed inspections for any crack in the area of the elevator side fitting/hinge fitting joint and repetitive detailed inspections for elongation inside and outside of the holes in the clevis and in the lug as specified in Part 4 of the Accomplishment Instructions. The service bulletin specifies doing the initial inspections within 24,000 flight hours or 16,000 flight cycles, whichever occurs first, after accomplishing the repair or modification specified in Part 3 of the service bulletin. The service bulletin also specifies repeating the inspections at intervals not to exceed 24,000 flight hours or 16,000 flight cycles, whichever occurs first. FAA's Determination and Requirements of This Proposed AD We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the(se) same type design(s). This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Difference between the Proposed AD and Service Bulletin.” Difference Between the Proposed AD and Service Bulletin The service bulletin specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways: • Using a method that we approve; or • Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings. Costs of Compliance We estimate that this proposed AD would affect 401 airplanes of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this proposed AD to the U.S. operators to be $64,160 or $160 per product, per inspection cycle. 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. You can find our regulatory evaluation and the estimated costs of compliance 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: **Boeing** : Docket No. FAA-2008-0151; Directorate Identifier 2007-NM-347-AD. Comments Due Date
(a)We must receive comments by March 24, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to all Boeing Model 727, 727C, 727-100, 727-100C, 727-200, and 727-200F series airplanes, certificated in any category. Unsafe Condition
(d)This AD results from reports of elongated holes and cracks found in the lugs of the attachment fittings of the elevator quadrant upper support assembly at the tip of the vertical fin. We are issuing this AD to detect and correct damage to the aft attachment lugs of the elevator quadrant support assembly that could lead to failure of the lugs. This condition could accelerate wear elsewhere in the elevator control system, which could reduce the crew's ability to maintain safe flight. Compliance
(e)Comply with this AD within the compliance times specified, unless already done. Repetitive Inspections and Corrective/Other Specified Actions
(f)At the applicable compliance times specified in paragraph 1.E. of Boeing Special Attention Service Bulletin 727-55-0092, dated June 4, 2007, except as provided by paragraph
(g)of this AD: Do the detailed inspection for any crack in the area of the elevator side fitting/hinge fitting joint, detailed inspections for elongation inside and outside of the holes in the clevis and in the lug, and high frequency eddy current
(HFEC)inspections for any crack inside and outside of the holes in the clevis and in the lug, and do all the applicable corrective actions and other specified actions, by accomplishing all of the applicable actions specified in the Accomplishment Instructions of the service bulletin, except as provided by paragraph
(h)of this AD. Repeat the inspections thereafter at the applicable intervals specified in paragraph 1.E. of the service bulletin. Accomplishing the repair or modification specified in Part 3 of the service bulletin only terminates the repetitive inspections specified in Part 2 of the service bulletin. Exception to Compliance Times
(g)Where Boeing Special Attention Service Bulletin 727-55-0092, dated June 4, 2007, specifies counting the compliance time from “* * * the date on this service bulletin,” this AD requires counting the compliance time from the effective date of this AD. Exception to Corrective Actions
(h)If any damage beyond the repair limits or any crack is found in the area of the elevator side fitting/hinge fitting joint during any inspection required by this AD, and Boeing Special Attention Service Bulletin 727-55-0092, dated June 4, 2007, specifies to contact Boeing for appropriate action: Before further flight, repair the crack using a method approved in accordance with the procedures specified in paragraph
(i)of this AD. Alternative Methods of Compliance (AMOCs) (i)(1) The Manager, Seattle Aircraft Certification Office, FAA, ATTN: Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-120S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6577; fax
(425)917-6590; has the authority to approve AMOCs for this AD, if requested using 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)An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. Issued in Renton, Washington, on January 31, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-2354 Filed 2-7-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0152; Directorate Identifier 2007-NM-348-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 737-400, -500, -600, -700, -700C, -800, and -900 Series Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for certain Boeing Model 737-400, -500, -600, -700, -700C, -800, and -900 series airplanes. This proposed AD would require an inspection to determine the part and serial numbers of the windshield wiper motors for the pilot's and first officer's windshields, and the applicable corrective action. This proposed AD results from two reports that the left and right windshield wipers stopped working in flight. We are proposing this AD to prevent failure of the windshield wipers in wet weather, which could result in decreased visibility for the flightcrew. DATES: We must receive comments on this proposed AD by March 24, 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: Nick Wilson, 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)917-6476; 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-2008-0152; Directorate Identifier 2007-NM-348-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 We have received two reports that the left and right windshield wipers stopped working in flight. In one incident, the left and right windshield wiper motors stopped at the same time during a landing approach in wet weather. Investigation revealed that the power converter module for the windshield wipers was not properly soldered. Failure of the windshield wipers in wet weather, if not corrected, could result in decreased visibility for the flightcrew. Other Related Rulemaking On October 2, 2003, we issued AD 2003-20-13, amendment 39-13331 (68 FR 58268, October 9, 2003), applicable to certain Boeing Model 737-400, -500, -600, -700, and -800 series airplanes. That AD requires either modification of the wiring to the windshield wiper motors in the flight compartment or replacement of those windshield wiper motor/converters with new motor/converters. That AD resulted from reports of the windshield motors stalling during flight. We issued that AD to prevent a reduction in flightcrew visibility due to stalled wiper motors during heavy precipitation and a period of substantial crew workload, which could result in damage to the airplane structure and injury to flightcrew, passengers, or ground personnel during final approach for landing. For certain airplanes, accomplishing the modification required by paragraph
(b)of AD 2003-20-13 is acceptable for compliance with certain requirements of this proposed AD. Relevant Service Information We have reviewed Boeing Service Bulletin 737-30A1057, Revision 1, dated October 31, 2007, for Model 737-600, -700, -700C, -800, and -900 series airplanes; and Boeing Alert Service Bulletin 737-30A1059, dated September 10, 2007, for Model 737-400 and -500 series airplanes. The service bulletins describe procedures for looking at the windshield wiper motors for the pilot's and first officer's windshields to determine the part number and serial number of the windshield wiper motors, and doing the applicable corrective action. The corrective actions include the following: • Replacing the windshield wiper motor with an improved windshield wiper motor if the part and serial numbers cannot be read, or if the part and serial numbers are listed in Appendix A of Rosemount Aerospace Service Bulletin 2313M-347/2313M-348-30-01, dated June 30, 2006, and the “Module Replacement Completed (Yes/No)” column is marked “No.” (The part number is identified as the model number in Appendix A of the Rosemount Aerospace service bulletin.) • Changing the part number if the part and serial numbers are not listed in Appendix A of Rosemount Aerospace service bulletin, or if the part and serial numbers are listed in Appendix A of Rosemount Aerospace service bulletin and the “Module Replacement Completed (Yes/No)” column is marked “Yes.” The Boeing service bulletins refer to the Rosemount Aerospace service bulletin as an additional source of service information for determining whether the windshield wiper motor has been previously replaced and for changing the part number. FAA's Determination and Requirements of This Proposed AD We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the(se) same type design(s). This proposed AD would require accomplishing the actions specified in the service information described previously. Costs of Compliance We estimate that this proposed AD would affect 767 airplanes of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the proposed inspection. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this proposed AD to the U.S. operators to be $61,360 or $80 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. You can find our regulatory evaluation and the estimated costs of compliance 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: **Boeing** : Docket No. FAA-2008-0152; Directorate Identifier 2007-NM-348-AD. Comments Due Date
(a)We must receive comments by March 24, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to the Boeing airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certificated in any category.
(1)Model 737-400 and -500 series airplanes as identified in Boeing Alert Service Bulletin 737-30A1059, dated September 10, 2007.
(2)Model 737-600, -700, -700C, -800, and -900 series airplanes as identified in Boeing Service Bulletin 737-30A1057, Revision 1, dated October 31, 2007. Unsafe Condition
(d)This AD results from two reports that the left and right windshield wipers stopped working in flight. We are issuing this AD to prevent failure of the windshield wipers in wet weather, which could result in decreased visibility for the flightcrew. Compliance
(e)Comply with this AD within the compliance times specified, unless already done. Inspection and Corrective Actions if Necessary
(f)Within 60 months after the effective date of this AD, inspect to determine the part number and serial number of the windshield wiper motors for the pilot's and first officer's windshields, and do all the applicable corrective actions, by accomplishing all of the applicable actions specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-30A1059, dated September 10, 2007 (for Model 737-400 and -500 series airplanes); or Boeing Service Bulletin 737-30A1057, Revision 1, dated October 31, 2007 (for Model 737-600, -700, -700C, -800, and -900 series airplanes); as applicable. A review of airplane maintenance records is acceptable in lieu of the inspection if the part number and serial number of the windshield wiper motors can be conclusively determined from that review. Note 1: The Boeing service bulletins refer to Rosemount Aerospace Service Bulletin 2313M-347/2313M-348-30-01, dated June 30, 2006, as an additional source of service information for determining whether the windshield wiper motor has been previously replaced and for changing the part number. Credit for Modification Done According to AD 2003-20-13
(g)For Model 737-400, -500, -600, -700, and -800 series airplanes: Accomplishing the modification required by paragraph
(b)of AD 2003-20-13, amendment 39-13331, is acceptable for compliance with the requirements of paragraph
(f)of this AD, provided that no Rosemount Aerospace windshield wiper motor having part number (P/N) 2313M-347-3 or P/N 2313M-348-3 has been installed. Credit for Actions Done According to Previous Issue of Service Bulletin
(h)For Model 737-600, -700, -700C, -800, and -900 series airplanes: Actions done before the effective date of this AD in accordance with Boeing Alert Service Bulletin 737-30A1057, dated October 6, 2006, are acceptable for compliance with the requirements of paragraph
(f)of this AD. Parts Installation
(i)As of the effective date of this AD, no person may install Rosemount Aerospace windshield wiper motors having P/N 2313M-347-3 or P/N 2313M-348-3 on any airplane. Alternative Methods of Compliance (AMOCs) (j)(1) The Manager, Seattle Aircraft Certification Office, FAA, ATTN: Nick Wilson, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6476; fax
(425)917-6590; has the authority to approve AMOCs for this AD, if requested using 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. Issued in Renton, Washington, on January 31, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-2355 Filed 2-7-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. 2003-NM-33-AD] RIN 2120-AA64 Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-120, -120ER, -120FC, -120QC, and -120RT Airplanes AGENCY: Federal Aviation Administration, DOT. ACTION: Supplemental notice of proposed rulemaking; reopening of comment period. SUMMARY: This document revises an earlier proposed airworthiness directive (AD), applicable to all EMBRAER Model EMB-120 series airplanes, that would have required revising the airplane flight manual to include operational limitations for use of the autopilot, and installing two placards that advise the flight crew to check the pitch trim before descent. This new action would retain the original requirements, but with revised placard language. This new action would also require modifying the elevator trim system, which would terminate the requirements of the AD. The actions specified by this new proposed AD are intended to prevent pitch trim upsets if the pitch trim actuators jam or freeze, which could result in reduced controllability of the airplane. This action is intended to address the identified unsafe condition. DATES: Comments must be received by March 4, 2008. ADDRESSES: Submit comments in triplicate to the Federal Aviation Administration (FAA), Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2003-NM-33-AD, 1601 Lind Avenue, SW., Renton, Washington 98057-3356. Comments may be inspected at this location between 9 a.m. and 3 p.m., Monday through Friday, except Federal holidays. Comments may be submitted via fax to
(425)227-1232. Comments may also be sent via the Internet using the following address: *9-anm-nprmcomment@faa.gov.* Comments sent via fax or the Internet must contain “Docket No. 2003-NM-33-AD” in the subject line and need not be submitted in triplicate. Comments sent via the Internet as attached electronic files must be formatted in Microsoft Word 97 or 2000 or ASCII text. The service information referenced in the proposed rule may be obtained from Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Jose dos Campos—SP, Brazil. This information may be examined at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2125; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received. Submit comments using the following format: • Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues. • For each issue, state what specific change to the proposed AD is being requested. • Include justification (e.g., reasons or data) for each request. Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2003-NM-33-AD.” The postcard will be date stamped and returned to the commenter. Availability of NPRMs Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2003-NM-33-AD, 1601 Lind Avenue SW., Renton, Washington 98057-3356. Discussion A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to add an airworthiness directive (AD), applicable to all EMBRAER Model EMB-120 series airplanes, was published as a notice of proposed rulemaking
(NPRM)in the **Federal Register** on April 1, 2003 (68 FR 15684). That NPRM would have required revising the airplane flight manual to include operational limitations for use of the autopilot, and installing two placards that advise the flight crew to check the pitch trim before descent. That NPRM was prompted by pitch trim upsets during the autopilot-coupled descent phase of flight, which have been attributed to jammed or frozen pitch trim actuators. That condition, if not corrected, could result in reduced controllability of the airplane. New Relevant Service Information The original NPRM cited EMBRAER Service Bulletin 120-25-0262, dated October 15, 2001, and Change 01, dated September 3, 2002, as the appropriate sources of service information for installing the placards. Since we issued the original NPRM, EMBRAER revised the service bulletin. Change 02, dated October 30, 2003, recommends revised placard language that clarifies that the pitch trim system is to be checked only before the initial descent. EMBRAER has issued Service Bulletins 120-27-0095 and 120-27-0096, both dated February 16, 2007, which describe procedures for modifying the elevator trim system. Service Bulletin 120-27-0095 describes procedures for replacing the elevator trim tab actuators with new ones that have been developed using corrosion-resistant internal materials and other improvements, including a damper coupled to one of the two actuators. Service Bulletin 120-27-0096 describes procedures for replacing some segments of the elevator trim tab control cables. The replacement segments have a different diameter, and have been developed to contribute to the new actuator dampening function specified in Service Bulletin 120-27-0095. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The Agência Nacional de Aviaço Civil (ANAC), which is the airworthiness authority for Brazil, mandated the service information and issued Brazilian airworthiness directive 2001-06-01R4, effective August 23, 2007, to ensure the continued airworthiness of these airplanes in Brazil. Comments Due consideration has been given to the comments received in response to the original NPRM. Support for Original NPRM SkyWest Airlines concurs with the proposed requirement to revise the Limitations section of the Collins APS-65B Autopilot AFM Supplement. The Air Line Pilots Association
(ALPA)concurs (conditionally, based on its comments as discussed below) with the proposed actions. Request for Appropriate Solution for Mechanical Problem ALPA asserts that the original NPRM would implement an operational fix to address a mechanical problem, and requests that we revise the original NPRM to adequately correct the unsafe condition. ALPA notes that the original NPRM addresses pitch trim actuators that freeze in position when moisture accumulates at colder temperatures. ALPA requests that the FAA and EMBRAER identify the extent of water intrusion in this area and look into a mechanical means to preclude the actuators from jamming. ALPA also notes that the original NPRM does not identify the cause of the jammed pitch trim actuators. ALPA explains that pitch trim actuators have become mechanically jammed on other EMBRAER aircraft due to insufficient power available from the actuator. If the cause of the jamming can be mechanical, ALPA requests that the FAA and the manufacturer identify a means to preclude such a failure. We agree. In this supplemental NPRM, we consider the AFM revisions and placards to be interim solutions, and propose to also mandate the modifications described in Service Bulletins 120-27-0095 and 120-27-0096, which would terminate the proposed requirements to revise the AFM and install the placards. Assertion Regarding Jamming Conditions The commenter, Thomas Kuhlman, states that the original NPRM apparently assumes that all or most of the jamming occurs during cruise flight. Mr. Kuhlman instead asserts, based on the supportive data that accompany his comment, that the pitch trim actuator jamming can and does occur when moisture is present in freezing conditions. Although Mr. Kuhlman makes no specific request regarding the original NPRM's proposed requirements, we agree with his rationale. When actuator internal frictions are within their normal specified ranges, the system can manage normal envelope load increases attributed to events such as speed variations and cold soak environment icing, so a jam attributable solely to a cold soak environment is unlikely. If contamination is gradually occurring inside the actuators, the proposed manual checks of the pitch trim systems on initial descent on every flight will inform the flight crew of degraded system performance, and affected actuators would then be removed before they reach a condition that could lead to a complete jam. In any event, as stated previously, we have revised this supplemental NPRM to require modifications that will adequately address the commenter's concerns. Request To Allow Autopilot Re-Engagement Under Certain Conditions SkyWest concurs with the proposed requirement in the original NPRM to revise the elevator trim jamming procedure specified in the flight controls failure paragraph of the AFM abnormal procedures section, but requests that we allow the flight crew to re-engage the autopilot once pitch trim is recovered. The commenter asserts that SkyWest's experience suggests that, once normal elevator trim operation was restored, continued use of the autopilot did not result in any abnormal operation. We disagree. When free pitch trim is restored after jamming, the appropriate approach is to continue the flight manually without the autopilot and report the issue to maintenance, rather than re-engaging the autopilot, so the cause of the jam can be evaluated and corrected before further use of the autopilot. We have not changed the supplemental NPRM regarding this issue. Request To Revise AFM Normal Procedures SkyWest reports that its EMB-120 SOP already includes an advisory to check the pitch trim before initiating a descent if trim jamming is suspected. The commenter requests that we revise the original NPRM to include these revised procedures in the descent checklist in the AFM's normal procedures section. We acknowledge that conducting such checks whenever a trim system jam is suspected is a reasonable practice. But conducting such manual checks of the pitch trim system at every flight before initial descent on autopilot is a more effective approach because it will detect jamming before it is suspected. We have not changed the supplemental NPRM regarding this issue. Request To Revise Placard Language SkyWest asserts that the placard language proposed in the original NPRM, which specifies a check before any
(all)descents, will compromise the safe operation of Model EMB-120 airplanes. The commenter reports that it is not unusual to level off at intermediate altitudes four to eight times during descent from cruise altitude and approach, depending on cruise altitude, terminal area requirements, and type of approach. As a result, the proposed limitation would require the pilot to disconnect the autopilot during flight an equal number of times, including just before ILS glide slope intercept. The commenter requests that we change the proposed placard language to the following: “Perform pitch trim system check prior to initial descent and anytime elevator trim jamming is suspected.” According to the commenter, limiting the checks in this way would ensure that the check is completed at least once per flight (consistent with EMBRAER's recommendations from the 2002 World Wide Operators Conference), but mandating a check before every descent would create a distraction, unnecessarily increase pilot workload, and compromise safety. We partially agree. EMBRAER has revised the placard language to require trim system checks only before initial descent. Manually checking the system when jamming is suspected would be a natural reaction, so it is not necessary to add the extra requested words to the placard. We have revised paragraph
(c)in this supplemental NPRM to mandate Change 02 of the service bulletin. Request To Remove Placard Requirement: Potential Pilot Distraction The commenter, Thomas Kuhlman, feels that the proposed requirement to test the trim system before every descent could result in little effect, or even decreased safety due to pilot distraction, during arrival procedures with multiple descents. He also notes that most precision approaches have a level flight segment just before glide slope intercept. The AD as proposed would require an elevator trim test at the critical glide slope intercept. We infer the commenter wants us to remove the proposed requirement to install the placards. We partially agree. We agree with the manufacturer's recommendation to check the system manually before initial descent only. As we stated previously, the placard language has been revised in Change 02 of Service Bulletin 120-25-0262, and in corresponding paragraph
(c)of this supplemental NPRM, to clarify that such checks are necessary only before the initial descent of every flight. Limiting the number of checks in this way would maintain the safety of the fleet and still address the commenter's concern about potential pilot distraction during critical phases of flight. Request To Remove Placard Requirement: Inadequate Solution The commenter, SkyWest Airlines, states that merely installing the placards as proposed in the original NPRM would not adequately address the problem of elevator trim jamming. The commenter notes that this procedure would be inconsistent with its findings: In the 18 months before the original NPRM was issued, there were ten incidents involving elevator trim jamming; of these, four occurred in the descent phase of flight, four occurred in the cruise phase of flight, and two occurred during climb to cruise altitude. The commenter concludes that advising the flight crew to perform a pitch trim check only during descent will not prevent problems associated with pitch upset. We infer that the commenter wants us to require revised procedures during other phases of flight. We partially agree. We agree that the pitch trim can jam during any phase of flight. But while the data provided by SkyWest might reflect results for SkyWest, the fleet data suggest that most of the reported events occurred during the descent phase or during transition from cruise to descent. The possibility that a pitch trim jam can occur during any flight phase does not render the proposed approach ineffective. The multiple system checks will assist in reducing the possibility of a pitch oscillation event due to actuator performance degradation. Since the comment was submitted, we revised this supplemental NPRM to add the modifications of the elevator trim system, which will address the identified unsafe condition and eliminate the need for the placards. Explanation of Additional Changes to Original NPRM We have revised the applicability identified in the original NPRM to identify model designations as published in the most recent type certificate data sheet for the affected models. To correspond with the ANAC AD, we have revised paragraph
(b)of this supplemental NPRM to specify that the revised AFM language in that paragraph also be included in the Normal Procedures section (in addition to the Limitations section) of the autopilot system supplement. Conclusion Since certain changes described above expand the scope of the originally proposed rule, the FAA has determined that it is necessary to reopen the comment period to provide additional opportunity for public comment. Cost Impact The following table provides the estimated costs for U.S. operators to comply with this supplemental NPRM. Estimated Costs Action Work hours Average labor rate per hour Parts Cost per product Number of U.S.- registered airplanes Fleet cost AFM revisions 1 $80 $0 $80 103 $8,240 Placard installation 2 80 182 342 103 35,226 Actuator replacement 7 80 16,670 17,230 103 1,774,690 Cable replacement 14 80 1,050 2,170 103 223,510 The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. 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 Impact The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132. For the reasons discussed above, I certify that 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)if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (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. Section 39.13 is amended by adding the following new airworthiness directive: **Empresa Brasileira De Aeronautica S.A. (Embraer):** Docket 2003-NM-33-AD. *Applicability:* All Model EMB-120, -120ER, -120FC, -120QC, and -120RT airplanes, certificated in any category. *Compliance:* Required as indicated, unless accomplished previously. To prevent pitch trim upsets if the pitch trim actuators jam or freeze, which could result in reduced controllability of the airplane, accomplish the following: Revision of Airplane Flight Manual (AFM): AFM-120/794
(a)Within 100 flight hours after the effective date of this AD, revise the FAA-approved AFM, EMBRAER AFM-120/794, as specified in paragraphs (a)(1) and (a)(2) of this AD. These actions may be accomplished by inserting a copy of this AD into the AFM.
(1)Revise the FLIGHT CONTROLS FAILURES paragraph of the Abnormal Procedures section by replacing the existing ELEVATOR TRIM JAMMING procedure with the following: **“ELEVATOR TRIM JAMMING** Control Wheel Hold Firmly. Autopilot Disengage. Airspeed Reduce. **NOTE:** Minimum airspeed with flap 0 °—160 KIAS Pitch trim command Check all switches and elevator trim wheel. If pitch trim is recovered: Re-trim the airplane and continue the flight with the autopilot disengaged, not exceeding the airspeed when the trim was recovered. If pitch trim is not recovered: Land at the nearest suitable airport. Approach and landing configuration: Landing gear Down. Flaps 25. Airspeed Vref25. *CAUTION:* DO NOT TRY TO RE-ENGAGE THE AUTOPILOT.”
(2)Revise the Normal Procedures section of the AFM, after the current checklist item for activating the FASTEN BELTS switch, by inserting the following: **“PITCH TRIM SYSTEM CHECK** Control Wheel Hold firmly. Autopilot Disengage. Power Levers As required. Elevator Trim Wheels As required. *CAUTION:* MANUALLY SET THE ELEVATOR TRIM WHEELS TO THE REQUIRED DESCENT ATTITUDE. If any trim system binding (if trim wheel rotates more than one trim wheel index mark after being released), or abnormal trim operation is observed: Elevator Trim Jamming Procedure Perform. *CAUTION:* DO NOT TRY TO RE-ENGAGE THE AUTOPILOT. If no abnormal trim operation is observed: Flight Director Vertical Mode As required. Autopilot Reengage.” AFM Revision: Collins APS-65B Autopilot AFM Supplement
(b)Concurrently with the AFM revisions required by paragraph
(a)of this AD, revise the Limitations section of the Collins APS-65B Autopilot System Supplement to include the following (this may be accomplished by inserting a copy of this AD into the AFM Supplement): “(1) The autopilot must not be used during descent unless a trim check has been performed successfully prior to descent, as follows: PITCH TRIM SYSTEM CHECK Control Wheel Hold firmly. Autopilot Disengage. Power Levers As required. Elevator Trim Wheels As required. *CAUTION:* MANUALLY SET THE ELEVATOR TRIM WHEELS TO THE REQUIRED DESCENT ATTITUDE. If any trim system binding (if trim wheel rotates more than one trim wheel index mark after being released), or abnormal trim operation is observed: Elevator Trim Jamming Procedure Perform. *CAUTION:* DO NOT TRY TO RE-ENGAGE THE AUTOPILOT. If no abnormal trim operation is observed: Flight Director Vertical Mode As required. Autopilot Reengage. “(2) If an elevator trim jamming is detected during flight and the pitch trim system resumes normal operation on ground, only a ferry flight using a special permit may be performed to return the aircraft to a maintenance base for replacement of the actuators. In this case, the use of autopilot is prohibited.” Placard Installation
(c)Within 300 flight hours after the effective date of this AD, install two placards on the glareshield, advising the flight crew to check the pitch trim before initial descent, in accordance with Part II of the Accomplishment Instructions of EMBRAER Service Bulletin 120-25-0262, Change 02, dated October 30, 2003. Elevator Trim System Modification
(d)Within 36 months after the effective date of this AD, modify the elevator trim system, in accordance with the Accomplishment Instructions of EMBRAER Service Bulletin 120-27-0095 and 120-27-0096, both dated February 16, 2007. Accomplishment of the modification terminates the requirements of paragraphs (a), (b), and
(c)of this AD, and the corresponding AFM revisions and placards may be removed. Parts Installation
(e)As of 36 months after the effective date of this AD, no person may install, on any airplane, an elevator trim tab actuator or control cable having a part number identified in Table 1 of this AD. Table 1.—Prohibited Parts Part Part No. Elevator trim tab actuator 120-19685-001 120-19685-003 120-19685-007 120-38650-001 120-39205-001 5299 5299-1 Control cable 120-27729-095 120-27729-097 120-31370-095 120-31370-097 Alternative Methods of Compliance (f)(1) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)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. Note 1: The subject of this AD is addressed in Brazilian airworthiness directive 2001-06-01R4, effective August 23, 2007. Issued in Renton, Washington, on February 1, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-2356 Filed 2-7-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 [Docket No. 2007N-0484] Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration
(FDA)is proposing to reclassify, on its own initiative, the Medical Device Data System
(MDDS)from class III (premarket approval) to class I (general controls). This action does not include medical device data systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be exempt from the premarket notification requirements when it is indicated for use only by a healthcare professional and does not perform irreversible data compression. DATES: Submit written or electronic comments on the proposed rule by May 8, 2008. Submit comments regarding information collection by March 10, 2008, to the Office of Management and Budget
(OMB)(see ADDRESSES ). FDA proposes that any final regulation based on this proposal become effective 60 days after its date of publication in the **Federal Register** . See section VIII of the SUPPLEMENTARY INFORMATION section of the preamble for further information about the effective date. ADDRESSES: You may submit comments, identified by Docket No. 2007N-0484, 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 followings 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, 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: Anthony D. Watson, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700. SUPPLEMENTARY INFORMATION: I. Background (Regulatory Authorities) The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 *et seq.* ), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA)(Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513(a)(1) of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are: • Class I (general controls), • Class II (special controls), and • Class III (premarket approval). FDA refers to devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), as “preamendment devices.” FDA classifies these devices after it: 1. Receives a recommendation from a device classification panel (an FDA advisory committee); 2. Publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and 3. Publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). Reclassification of postamendment devices is governed by section 513(f)(3) of the act, formerly section 513(f)(2) of the act. This section provides that FDA may initiate the reclassification of a device classified into class III under section 513(f)(1) of the act, or the manufacturer or importer of a device may petition the Secretary of Health and Human Services for the issuance of an order classifying the device in class I or class II. FDA's regulations in 21 CFR 860.134 set forth the procedures for the filing and review of a petition for reclassification of such class III devices. In order to change the classification of the device, it is necessary that the proposed new classification have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. FDAMA added section 510(l) to the act. Section 510(l) of the act provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. FDA refers to the criteria that designate a class I device as not exempt from premarket notification as “reserved criteria.” An exemption permits manufacturers to introduce into commercial distribution generic types of devices without first submitting a premarket notification to FDA. II. Regulatory History of the Device Computer-based and software-based products are subject to regulation as devices when they meet the definition of a device contained in section 201(h) of the act (21 U.S.C. 321(h)). In 1989, FDA prepared a general policy statement on how it planned to determine whether a computer-based product and/or software based product is a device and, if so, how FDA intended to regulate it. This document became known as the “Draft Software Policy.” The scope and intention of the 1989 policy were based on the existing state of computer and software technology at that time. That policy included the principle that the level of FDA oversight of software should depend primarily on the risk to the patient should the software fail to perform in accordance with its specifications. Since 1989, the use of computer-based products and software-based products as medical devices has grown exponentially. In addition, device interconnectivity and complexity have grown in ways that could not have been predicted in 1989. This growth and expansion have created new considerations for elements of risk that did not previously exist. FDA realized that the Draft Software Policy was not adequate to address all of the issues related to the regulation of computer-based and software-based medical devices. Based on this history and the complexity and diversity of computer software, FDA decided it would be impractical to prepare one “software” or “computer” policy that would be able to address all the issues related to the regulation of computer- and software-based medical devices. Nonetheless, the principle that the level of FDA oversight of software should depend primarily on the risk to the patient should the software fail to perform in accordance with its specifications remains important. Many software classifications reflect this principle, including: • FDA has classified software used in computer aided detection of cancerous lesions in the breast in class III; • FDA has classified software used in computer tomography
(CT)and X-ray systems to provide images to assist in clinical decisionmaking in class II; and • FDA has classified laboratory information systems in class I. This principle also informs this proposed reclassification, in which FDA is focusing on a category of post amendment computer- and software-based devices that present a low risk and should not be subject to premarket review that have not been classified elsewhere. An examination of modern medical device networks and computer infrastructure helped FDA to identify a category of computer based and software products that meet the definition of a device, which the FDA would consider to pose minimal risks, and that should not be Class III and should not require premarket submission. This medical device has been named a “Medical Device Data System.” III. Device Description A medical device data system
(MDDS)is a device intended to provide one or more of the following uses: • The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices. For example, this would include software that interrogates a ventilator every 15 minutes and transfers information about patient CO 2 levels to a central patient data repository; • The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices. For example, this would include software that stores historical blood pressure information for later review by a healthcare provider; • The electronic display of medical device data, without altering the function or parameters of connected devices. For example, this would include software that displays the previously stored electrocardiogram for a particular patient; • The electronic conversion of medical device data from one format to another format in accordance with a preset specification. For example, this would include software that converts digital data generated by a pulse oximeter into a digital format that can be printed. • Examples of medical device data systems that would be used in the home are systems that periodically collect data from glucose meters or blood pressure devices for later review by a healthcare provider. Medical device data consist of numerical or other information available from a medical device in a form suitable for processing by computer. Medical device data can represent many types of information (e.g., clinical values, alarm conditions, error messages). MDDS are not intended or designed to provide any real time, active, or online patient monitoring functions. Medical device data systems can deliver and store alarm data but do not have the capability to display, create, or detect alarm conditions, or to actually sound an alarm. In particular, a MDDS can record the fact that an alarm sounded, but cannot by itself sound an alarm in response to patient information. Medical device data systems cannot create alarms that are not already present from the connected medical devices. By themselves, MDDS do not provide any diagnostic or clinical decision making functions. Medical device data systems can transmit, exchange, store, or retrieve data in its original format or can be used to convert the medical device data from one format to another so that the arrangement or organization of the medical device data is in accordance with preset specifications. In developing its current regulatory strategy for MDDS, FDA considered how the risks presented by an MDDS compare to existing manual processes for managing these data. Hospitals, clinics, and other healthcare facilities are well-aware of the shortcomings of manual functions and have introduced other manual oversight to reduce their effects, such as audits of records and multiple-person checks of paperwork prior to treatments. These facilities have also introduced electronic systems to help reduce the human element in these errors. However, when data are being stored, retrieved, transferred, exchanged, or displayed electronically, an additional element of risk is introduced. This element of risk would not be present for a manual transfer of files or information because the information is readily apparent to the healthcare provider. When manual data is converted to electronic form, data can be altered in such a way as to not be transparent to the user and pose a risk to the patient. In effect, even though manual functions have their risks (e.g., illegible handwriting, wrong charts, etc.), when these functions are automated, users tend to rely entirely on the technology because the technology is assumed to alleviate those risks. This is especially true when software systems are designed to interface with a number of unspecified medical devices. Thus, regulatory oversight of MDDS is critical to ensuring that there is an adequate expectation of performance. It is FDA's long-standing practice to not regulate those manual office functions that are simply automated for the ease of the user (e.g., office automation) and that do not include MDDS as described previously. For example, the report-writing functions of a computer system that allow for the manual (typewriter like) input of data by practitioners would not be considered as a MDDS, because these systems are not directly connected to a medical device. In addition, software that merely performs library functions, such as storing, indexing, and retrieving information not specific to an individual patient, is not considered to be a medical device. Examples include medical texts or the Physician's Desk Reference on CD-ROM that are indexed and cross-referenced for ease of use. This proposed regulation does not address software that allows a doctor to enter or store a patient's health history in a computer file. IV. Proposed Reclassification Because MDDS that are subject to the rulemaking are new post amendment devices, they are deemed to be class III by operation of the statute (section 513(f) of the act (21 U.S.C. 360c(f)). FDA believes that classification in class I, with appropriate application of the Quality System Regulation (part 820 (21 CFR part 820)), will provide reasonable assurance of the safety and effectiveness of this device. FDA is proposing that the Medical Device Data System be reclassified from class III to class I. In addition, FDA is proposing that when the device is indicated for use only by a healthcare professional and does not perform irreversible data compression, in accordance with section 510(l) of the act (21 U.S.C. 360(l)), it would be exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in § 880.9 (21 CFR 880.9). For purposes of this regulation, “healthcare professional” is any practitioner licensed by the law of the State in which he or she practices to use or order the use of the device. When the device is indicated for use by a lay user, or performs irreversible data compression, FDA believes that the device presents a potential for unreasonable risk of illness or injury. FDA is proposing that MDDS devices indicated for lay use or that perform irreversible data compression not be exempt from premarket notification requirements. V. Risks to Health FDA believes that general controls, including the Quality System regulation and the requirements for Design Controls as per § 820.30, will provide a reasonable assurance of safety and effectiveness for a MDDS. Risks to health from this device would be caused by inadequate software quality. Specifically, the risk to health would be that incorrect medical device data is stored, retrieved, transferred, exchanged, or displayed, resulting in incorrect treatment or diagnosis of the patient. As explained below, FDA believes the risk related to inadequate software quality can be mitigated through application of the Quality System Regulation. VI. Summary of Reasons for Reclassification FDA believes that the MDDS should be reclassified into class I because general controls would provide reasonable assurance of safety and effectiveness and special controls and premarket approval are not necessary to provide such assurance. FDA believes that the application of the Quality System Regulation (part 820), particularly the design control provisions, would significantly reduce the risk of errors from these devices that might cause incorrect treatment or diagnosis of the patient. The design controls section (§ 820.30) of the QS regulation (§ 820.30) applies to the design of devices including class I devices with software. FDA does not intend to apply design controls retroactively to currently legally marketed MDDS devices. However, changes to existing designs or to currently marketed devices must be made in accordance with design control requirements, even if the original design was not subject to these requirements, § 820.30. This approach to implementing design controls for MDDS is consistent with the way FDA implemented design controls after the issuance of the Quality System Regulation in 1996. VII. Summary of Data Upon Which the Reclassification is Based FDA is basing this proposed rule upon the history of use of this type of device in clinical practice as well as the substantial knowledge of FDA staff about this device type. These types of systems provide no new or unique clinical algorithms or clinical functions that have not already been reviewed and cleared in existing medical devices; therefore, no new pre-market review or evaluation should be required. Further, FDA believes that the proper application of a Quality System approach to the design and development of MDDS devices will ensure their quality. FDA believes that this is the least burdensome approach to the regulation of these medical devices. VIII. Effective Date FDA intends that this rule, if finalized, will become effective 60 days after the date of publication of the final rule. However, FDA intends to continue to exercise enforcement discretion after publication of any final rule so that manufacturers who are already on the market with MDDS devices may have sufficient time to come into compliance as follows: FDA expects manufacturers who are already marketing a MDDS device before publication of a final rule and who meet the criteria for exemption from premarket notification to register and list under part 807 within 60 days after publication of the final rule. If a premarket notification is required, FDA expects manufacturers who are marketing an MDDS device without FDA clearance to submit a premarket notification within 90 days of the effective date of a final rule and to obtain final clearance of a premarket notification within 180 days after publication of a final rule. FDA expects manufacturers who are required to obtain clearance of a premarket notification to register and list within 30 days after receiving a substantial equivalence order for their device. Manufacturers who are not already marketing an MDDS device will be required to comply with any final rule as of the effective date. IX. Environmental Impact The agency has determined under 21 CFR 25.34(b) that this proposed reclassification 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. X. Analysis of Impact 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 of 1995 (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; 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 this action is deregulatory and imposes no new burdens, the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. 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 exceed this amount. Background An MDDS is a device that electronically stores, transfers, displays, or reformats patient medical data. It does not provide any diagnostic or clinical decision making functions. A MDDS could, for example, store alarm data being generated by a connected medical device, but would not be able to generate alarms on its own. The MDDS device is currently classified into class III, the highest level of regulatory oversight. The MDDS was initially placed in this classification by default. MDDS manufacturers, as makers of class III devices, bear all costs associated with premarket approval, including the cost of submitting the premarket approval application
(PMA)and payment of user fees. The costs associated with the submission of the PMA are substantial, potentially reaching $1,000.000. Although we can identify several MDDS devices and device manufacturers, we nevertheless do not know the size of the affected industry because FDA has not been enforcing registration and listing requirements for manufacturers of MDDS devices. We welcome comment on the size and other characteristics of the affected industry. FDA is proposing to reclassify MDDS devices from class III to class I. Based on the history of use of this type of device in clinical practice and on the experience of FDA reviewers, the agency concludes that in the hands of a healthcare professional, a MDDS is safe and effective under general controls. The application of general controls, including the software design controls in part 820, would be consistent with the principle of applying the least degree of regulatory control necessary to provide reasonable assurance of safety and effectiveness. The application of this lowest level of regulatory oversight would be consistent with the treatment of other devices with similar risk profiles. Software used to store, transmit, and communicate patient medical data, such as Laboratory Information Systems and Medical Image Communication Systems, is typically classified into class I. FDA has already recognized that the class III requirements are not necessary for ensuring the safety and effectiveness of MDDS devices and has been exercising enforcement discretion with MDDS device manufacturers. These firms have not been required to submit PMAs or meet other requirements typically required of manufacturers of class III devices, but the agency believes that all or nearly all firms in this industry have in place good business practices, including quality systems. If FDA were to discontinue enforcement discretion, most firms would continue to comply with the class I provisions. Cost of the Proposed Regulation This proposed regulation is deregulatory. Device manufacturers currently subject to class III requirements would be subject to the less burdensome requirements for makers of class I devices. Of course, changing the device classification may not have an impact on the practices of MDDS device manufacturers as long as FDA continues its practice of enforcement discretion. For the purpose of this analysis, however, we assume that enforcement discretion would not be permanent. The regulatory alternatives are therefore class III, II, or I controls, enforced by the agency. This proposed rule would re-classify MDDS devices as class I, which would reduce the applicable regulatory requirements. Manufacturers of class I devices are required to:
(1)Register and list their MDDS devices with the agency,
(2)conform to applicable medical device current good manufacturing practice requirements (part 820),
(3)comply with Medical Device Reporting
(MDR)requirements (21 CFR part 803), and
(4)submit a premarket notification for the device unless it is exempt. This proposed rule proposes to exempt MDDS devices unless they are indicated for use by someone other than a healthcare professional, perform irreversible data compression, or exceed the limitations in § 880.9. MDDS devices indicated for use solely by a healthcare professional, are exempt from the premarket notification requirements. *Registration and listing* . The majority of manufacturers of MDDS devices would incur a cost to register and list their devices with the agency. We estimate this burden to be less than 1 hour per year for manufacturers familiar with this requirement, and up to 2 hours of time for manufacturers not currently producing any FDA-regulated devices. Manufacturers would also face user fees of $1,708 in fiscal year
(FY)2008 to register and list their devices with the agency. These fees would rise to $2,364 in 2012. *Current Good Manufacturing Practices (CGMP)/Quality System Regulation
(QSR)compliance/Medical Device Reporting* . Based on experience with this and similar devices, FDA believes that most manufacturers of these devices already have quality systems in place as part of good business practices. Good quality systems would include complaint-handling procedures. FDA's QSR (part 820) requirements are very flexible and FDA believes that these manufacturers will be able to conform their systems to FDA requirements with little difficulty or cost. Manufacturers are already required to report to FDA whenever they learn that their device may have caused or contributed to a death or serious injury to a patient. The cost of complying with these requirements would be small, but would vary depending on the number and nature of the devices manufactured and the nature of the firm's current quality system. Firms with existing quality systems should be able to adapt their complaint procedures to incorporate MDR reporting with little difficulty. Based on our understanding of the industry and that it has in place measures to ensure quality, we believe most firms would be able to adapt their systems to meet FDA's QSR and MDR regulations for no more than $20,000. Again, this would not be a cost imposed by this proposed rule, but the cost of an existing burden manufacturers may not have incurred because FDA's practice of enforcement discretion with manufacturers of MDDS devices. *Premarket notification* . If FDA finalizes the classification of MDDS devices into class I, a manufacturer of a MDDS device that is indicated for use solely in a health care facility would not need to comply with the PMA requirement that applies to class III devices or submit a premarket notification. FDA is unaware of any MDDS devices that are not intended for use solely by healthcare professionals, so we believe all or nearly all MDDS devices will be exempt from premarket review. A manufacturer of a MDDS device that is indicated for use by anyone other than a healthcare professional or that performs irreversible data compression would need to submit a premarket notification, but the burden of submitting a premarket notification is substantially less than that of submitting a PMA. A premarket notification for a MDDS device would be far less complex than a PMA. The cost of preparing and submitting such a notification would be several thousand dollars. The user fees for a premarket notification would be $3,404 for FY 2008, increasing to $4,717 in 2012. In contrast, the cost of submitting a PMA can reach $1,000,000, plus user fees of an additional $185,000 in FY 2008, increasing to $256,384 in 2012. In summary, this device reclassification would substantially reduce an existing burden on the manufacturers of MDDS devices. The regulatory burden of compliance with the general controls provisions applicable to the manufacturers of all class I devices is attributable to statutory requirements that already apply but have not been enforced. Assuming that continued enforcement discretion is not a viable long-term regulatory alternative, the proposed rule would reduce the regulatory burden for manufacturers of MDDS devices. Considering the cost of submitting a PMA plus the relevant user fees, the reduction could be $1,000,000 per device. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of the affected devices from class III to class I would relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), 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. XI. Paperwork Reduction Act of 1995 This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information addressed in the proposed rule have been approved by OMB in accordance with the PRA under the QSR (part 820, OMB Control No. 0910-0073) and the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB Control No. 0910-0120). XII. 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, if finalized, would not contain policies that would 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 tentatively concludes 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 has not been prepared. XIII. Submission of 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 Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. List of Subjects in 21 CFR Part 880 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, FDA proposes to amend 21 CFR part 880 as follows: PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES 1. The authority citation for 21 CFR part 880 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Part 880 is amended in subpart G by adding § 880.6310 to read as follows: § 880.6310 Medical Device Data System.
(a)*Identification* .
(1)A medical device data system
(MDDS)is a device intended to provide one or more of the following uses:
(i)The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.
(ii)The electronic storage and retrieval of medical device data from a medical device, without altering the function or parameters of connected devices.
(iii)The electronic display of medical device data from a medical device, without altering the function or parameters of connected devices.
(iv)The electronic conversion of medical device data from one format to another format in accordance with a preset specification.
(2)Medical device data consists of numerical or other information available from a medical device in a form suitable for processing by computer. Medical device data can represent any type of information or knowledge, e.g., clinical values, alarm conditions, error messages. This identification does not include a device that creates diagnostic, decision support, or alarm functions. It also does not include the report-writing functions of a data system that allows for the manual input of data by practitioners. This identification does not include devices with any real time, active, or online patient monitoring.
(b)*Classification* . Class I (general controls). When the device is indicated for use only by a healthcare professional and does not perform irreversible data compression, it is exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in § 880.9. When the device is indicated to be prescribed by a healthcare professional for use by a lay user, or performs irreversible data compression, or for over-the-counter use by a lay user, the device requires the submission and clearance of a premarket notification. Dated: January 25, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8-2325 Filed 2-7-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-153589-06] RIN 1545-BG34 Time and Manner for Electing Capital Asset Treatment for Certain Self-Created Musical Works AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking by cross-reference to temporary regulation. SUMMARY: In the Rules and Regulations section of this issue of the **Federal Register** , the IRS is issuing a temporary regulation that provides the time and manner for making an election to treat the sale or exchange of musical compositions or copyrights in musical works created by the taxpayer (or received by the taxpayer from the works' creator in a transferred basis transaction) as the sale or exchange of a capital asset. The temporary regulation reflects changes to the law made by the Tax Increase Prevention and Reconciliation Act of 2005 and the Tax Relief and Health Care Act of 2006. The temporary regulation affects taxpayers making the election under section 1221(b)(3) of the Internal Revenue Code
(Code)to treat gain or loss from such a sale or exchange as capital gain or loss. The text of the temporary regulation also serves as the text of this proposed regulation. DATES: Written or electronic comments and requests for a public hearing must be received by May 8, 2008. ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-153589-06), 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-153589-06), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC, or sent electronically via the Federal eRulemaking Portal at www.regulations.gov (IRS REG-153589-06). FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulation, Jamie Kim,
(202)622-4950; concerning submission of comments or requesting a hearing, *Richard.A.Hurst@irscounsel. treas.gov,*
(202)622-7180 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Background and Explanation of Provisions Temporary regulation in the Rules and Regulations section of this issue of the **Federal Register** amends the Income Tax Regulations (26 CFR part 1) relating to section 1221(b)(3) of the Internal Revenue Code (Code). The temporary regulation provides rules regarding the time and manner for making an election under section 1221(b)(3) to treat the sale or exchange of certain musical compositions or copyrights in musical works as the sale or exchange of a capital asset. The text of the temporary regulation also serves as the text of this proposed regulation. The preamble to the temporary regulation explains the amendments. 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 also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, this regulation 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 this proposed regulation is adopted as a final regulation, consideration will be given to any written comments (a signed original and eight
(8)copies) or electronic comments that are submitted timely to the IRS. The IRS and Treasury Department request comments on the clarity of the proposed rules and how they can 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 that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the **Federal Register** . Drafting Information The principal author of these regulations is Jamie Kim of the Office of Associate Chief Counsel (Income Tax & Accounting). However, other personnel from the IRS and Treasury Department participated in their development. List of Subjects in 26 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 1.1221-3 is added to read as follows: § 1.1221-3 Time and manner for electing capital asset treatment for certain self-created musical works. [The text of proposed § 1.1221-3 is the same as the text of § 1.1221-3T(a) through (d)(1) published elsewhere in this issue of the **Federal Register** .] Linda E. Stiff, Deputy Commissioner for Services and Enforcement. [FR Doc. E8-2307 Filed 2-7-08; 8:45 am] BILLING CODE 4830-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2007-1054; A-1-FRL-8524-8] Approval and Promulgation of Air Quality Implementation Plans; Maine; Transportation Conformity AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: The EPA is proposing to approve a State Implementation Plan
(SIP)revision submitted by the State of Maine. This revision establishes transportation conformity criteria and procedures related to interagency consultation and enforceability of certain transportation-related control measures and mitigation measures. The intended effect of this action is to approve State criteria and procedures to govern transportation conformity determinations. This action is being taken in accordance with the Clean Air Act. DATES: Written comments must be received on or before March 10, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-OAR-2007-1054 by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail: arnold.anne@epa.gov.* 3. *Fax:*
(617)918-0047. 4. *Mail:* “EPA-R01-OAR-2007-1054”, Anne Arnold, U.S. Environmental Protection Agency, EPA New England Regional Office, One Congress Street, Suite 1100 (mail code CAQ), Boston, MA 02114-2023. 5. *Hand Delivery or Courier. Deliver your comments to:* Anne Arnold, Manager, Air Quality Planning Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding legal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023, telephone number
(617)918-1668, fax number
(617)918-0668, e-mail *cooke.donald@epa.gov.* SUPPLEMENTARY INFORMATION: In the Final Rules section of this **Federal Register** , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this **Federal Register** . Dated: January 24, 2008. Ira W. Leighton, Acting Regional Administrator, EPA New England. [FR Doc. E8-2248 Filed 2-7-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 70 [EPA-R07-OAR-2007-0829; FRL-8526-1] Approval and Promulgation of Implementation Plans and Operating Permits Program; State of Kansas AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a revision to the Kansas State Implementation Plan
(SIP)for the purpose of revoking the Sulfur Compound Emissions rule and for the purpose of approving revisions to a Class I major source operating permit annual emissions inventory rule and several Class II minor source operating permits rules. EPA is also proposing to approve additional amendments adopted by KDHE on February 20, 1998 which pertain to the Class II operating permit rules. The rules were primarily revised to align the annual emission inventory reporting date deadline with the June 1 payment of applicable emissions fees. EPA's proposed approval of these amendments would ensure consistency between the state and the Federally-approved rules. DATES: Comments on this proposed action must be received in writing by March 10, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-OAR-2007-0829 by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail: grier.gina@epa.gov.* 3. *Mail:* Gina Grier, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. 4. *Hand Delivery or Courier. Deliver your comments to:* Gina Grier, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8 to 4:30, excluding legal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Gina Grier at
(913)551-7078, or by e-mail at *grier.gina@epa.gov.* SUPPLEMENTARY INFORMATION: In the final rules section of the **Federal Register** , EPA is approving the state's SIP revision and Title V revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the rules section of this **Federal Register** . Dated: January 28, 2008. John B. Askew, Regional Administrator, Region 7. [FR Doc. E8-2188 Filed 2-7-08; 8:45 am] BILLING CODE 6560-50-P 73 27 Friday, February 8, 2008 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request February 4, 2008. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Animal Plant and Health Inspection Service *Title:* Importation of Hass Avocado from Mexico *OMB Control Number:* 0579-0129 *Summary of Collection:* The Animal and Plant Health Inspection Service (APHIS) of the Department of Agriculture is responsible for preventing plant diseases or insect pests from entering the United States, preventing the spread of pests not widely distributed in the United States, and eradicating those imported when eradication is feasible. The Plant Protection Act (7 U.S.C. 7701-7772) authorizes APHIS to carry out this mission. APHIS will collect information from a variety of individuals, both within and outside of the United States, who are involved in growing, packing, handling, transporting, and importing foreign logs, trees, shrubs, and other articles. APHIS regulations allow fresh Hass Avocado fruit grown in approved orchards in Michoacan, Mexico to be imported into the United States under certain conditions. *Need and Use of the Information:* APHIS will collect information using form PPQ 587 “Application for Permit to Import Plants or Plant Products,” to ensure that fresh Hass Avocados from Mexico do not harbor insect pests (including Avocado stem weevils, seed weevils, and seed moths). The information collected will ensure that fresh Hass Avocados from Mexico do not harbor exotic insect pests. *Description of Respondents:* Business or other for profit; Federal Government. *Number of Respondents:* 2,205. *Frequency of Responses:* Recordkeeping; Reporting: On occasion. *Total Burden Hours:* 107,061. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E8-2306 Filed 2-7-08; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2008-0006] Notice of Request for Extension of Approval of an Information Collection; Importation of Poultry Meat and Other Poultry Products From Sinaloa and Sonora, Mexico AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Extension of approval of an information collection; comment request. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the importation of poultry meat and other poultry products from Sinaloa and Sonora, Mexico. DATES: We will consider all comments that we receive on or before April 8, 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-2008-0006* 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. APHIS-2008-0006, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2008-0006. *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: For information on the importation of poultry meat and other poultry products from Sinaloa and Sonora, Mexico, contact Dr. Christopher Robinson, Assistant Director, Technical Trade Services—Products, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737;
(301)734-3277. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS* Information Collection Coordinator, at
(301)734-7477. SUPPLEMENTARY INFORMATION: *Title:* Importation of Poultry Meat and Other Poultry Products from Sinaloa and Sonora, Mexico. *OMB Number:* 0579-0144. *Type of Request:* Extension of approval of an information collection. *Abstract:* Under the Animal Health Protection Act (7 U.S.C. 8301 *et seq.* ), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture is authorized, among other things, to prohibit the importation and interstate movement of animals and animal products to prevent the introduction into and dissemination within the United States of animal diseases and pests. To fulfill this mission, APHIS regulates the importation of animals and animal products into the United States. The regulations are contained in title 9, chapter 1, subchapter D, parts 91 through 99, of the Code of Federal Regulations. The regulations in part 94, among other things, restrict the importation of poultry meat and other poultry products from Mexico and other regions of the world where exotic Newcastle disease
(END)has been determined to exist. The regulations allow the importation of poultry meat and poultry products from the Mexican States of Sinaloa and Sonora under conditions that protect against the introduction of END into the United States. To ensure that these items are safe for importation, we require that certain data appear on the foreign meat inspection certificate that accompanies the poultry meat or other poultry products from Sinaloa and Sonora. We also require that serially numbered seals be applied to containers carrying the poultry meat or other poultry products. We are asking the Office of Management and Budget
(OMB)to approve our use of these information collection activities for an additional 3 years. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the information collection on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies, e.g., permitting electronic submission of responses. *Estimate of burden:* The public reporting burden for this collection of information is estimated to average 1 hour per response. *Respondents:* Federal animal health authorities in Mexico and operators of slaughtering and processing plants in Sinaloa and Sonora, Mexico, who engage in the export of poultry meat and other poultry products to the United States. *Estimated annual number of respondents:* 20. *Estimated annual number of responses per respondent:* 2. *Estimated annual number of responses:* 40. *Estimated total annual burden on respondents:* 40 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Done in Washington, DC, this 4th day of February 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8-2369 Filed 2-7-08; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Forest Service Notice of Proposed New Fee Sites; Federal Lands Recreation Enhancement Act (Title VIII, Pub. L. 108-447) AGENCY: Umatilla National Forest, USDA Forest Service. ACTION: Notice of Proposed New Fee Sites. SUMMARY: The Umatilla National Forest is proposing to charge fees at 39 recreation sites. Fees are assessed based on the leval of amenities and services provided, cost of operation and maintenance, market assessment, and public comment. The fees listed below are only proposed. The final fees will be determined upon further analysis and public comment. Funds from fees would be retained locally and used for the continued operation and maintenance of these recreation sites. The public has been notified of proposed fees in several ways. In July of 2007, signs were posted at all potentially affected campgrounds, rental cabins, and trail heads requesting public feedback on the proposed fees. Press releases regarding the Umatilla National Forest's recreation facility master plan and fee proposals were issued to area newspapers on September 11 of 2007. The release was followed by 7 open houses held in communities across the Forest during September and October. The fee proposal continues to be advertised on the Umatilla National Forest's Web site. *Rental Cabins:* Fremont Caretaker's Cabin on the North Fork John Day Ranger District and Tucannon Guard Station on the Pomeroy Ranger District will be available for overnight rental. A financial analysis is being completed to determine the rental fees; the range being considered is from $70 to $100 per night. Cabin rentals offer a unique experience and are a popular offering in National Forests. Both cabins were recently restored to maintain their eligibility to the National Register of Historic Places. Fees would continue to help protect and maintain cabins and their historic integrity. *Campgrounds:* The Umatilla National Forest is proposing to begin charging fees at 20 campgrounds. These sites provide similar amenities as sites that currently require fees. They are as follows: Big Creek, Divide Wells, Driftwood, Drift Fence, Gold Dredge, Oriental, and Winom campgrounds in the North Fork John Day Ranger District; Coalmine Hill, Fairview, and Penland campgrounds in the Heppner Ranger District; Alder thicket, Big Springs, Forest boundary, Godman, Ladybug, Midway, Misery Springs, Panjab, Pataha, and Wickiup campgrounds on the Pomeroy Ranger District. A financial analysis is being completed to determine fee rates.The fees proposed to help maintain these sites would range between $5 and $14 for single sites, $10-$16 for double sites, $20-$40 for group sites. There would be an extra $5.00 charge per additional vehicle per campsite at all the listed campgrounds. *Trailheads:* The Umatilla National Forest proposes charging fees at the following 17 trailheads: North Fork John Day, Frazier, Winom, and Big Creek trailheads on the North Fork John Day Ranger District; Elk Flats, Meadow Creek, Panjab, Teepee, Three Forks, Timothy Springs, Tucannon, and Twin Buttes on Pomeroy Ranger District; and Burnt Cabin, Deduct Pond, Middle Point, North Fork Umatilla, and Rough Fork on the Walla Walla Ranger District. These sites would be established as fee sites since amenities such as toilets, garbage service, and interpretive signing have been or will be added. Recreation Passes such as the Northwest Forest Pass would cover day use fees for these trailheads. Northwest Forest Passes are $5 for a daily pass and $30 for an annual pass. DATES: Proposed fees would begin after June 2008 and are contingent upon completion of certain improvements. The cabin rentals would be available once a final decision is made and are offered through the National Recreation Reservation Service. ADDRESSES: Kevin Martin, Forest Supervisor, Umatilla National Forest, 2517 SW. Hailey Avenue, Pendleton, Oregon 97801. FOR FURTHER INFORMATION CONTACT: Larry Randall, Umatilla Recreation Fee Coordinator, 509-522-6276. Information about proposed fee changes can also be found on the Umatilla National Forest Web site: *http://www.fs.fed.us/r6/uma/recreation/rfa/fee_changes. shtml.* SUPPLEMENTARY INFORMATION: The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the **Federal Register** whenever new recreation fee areas are established. Once public involvement is complete, these new fees will be reviewed by a Recreation Resource Advisory Committee prior to a final decision and implementation. People wanting to rent Fremont Caretaker's Cabin or Tucannon Guard Station would need to do so through the National Recreation Reservation Service, at *http://www.recreation.gov* or by calling 1-877-444-6777 when it becomes available. Dated: January 30, 2008. Kevin Martin, Forest Supervisor. [FR Doc. 08-566 Filed 2-7-08; 8:45 am]
Connectionstraces to 22
21 references not yet in our index
  • 9 CFR 201
  • 7 CFR 1.27(b)
  • Pub. L. 107-171
  • 7 CFR 2.22
  • 14 CFR 39
  • 14 CFR 91.410
  • 21 CFR 880
  • Pub. L. 94-295
  • Pub. L. 101-629
  • Pub. L. 105-115
  • 21 CFR 807
  • 21 CFR 820
  • 5 USC 601-612
  • Pub. L. 104-4
  • 21 CFR 803
  • 44 USC 3501-3520
  • 26 CFR 1
  • 40 CFR 52
  • Pub. L. 104-13
  • 7 USC 7701-7772
  • Pub. L. 108-447
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