Rules and Regulations. Final rule; request for comments

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BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-0378; Directorate Identifier 2007-SW-04-AD; Amendment 39-15314; AD 2007-26-12] RIN 2120-AA64 Airworthiness Directives; Robinson Helicopter Company Models R22, R22 Alpha, R22 Beta, R22 Mariner, R44 and R44 II Helicopters AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule; request for comments. SUMMARY: This amendment adopts a new airworthiness directive

(AD)for the specified Robinson Helicopter Company (Robinson) helicopters. This action requires a one-time visual inspection for skin separation along the leading edge of blade skin aft of the skin-to-spar bond line on the lower surface of each blade and in the tip cap area. This action also requires a “tap test” for detecting a separation or void in both bonded areas. This action also requires repainting any exposed area of the blades. If any separation or void is detected, replacing the blade before further flight is required. Thereafter, before each flight, this AD also requires checking for any exposed (bare metal) along the skin-to-spar bond line on the lower surface of each blade near the tip. If any bare metal is found, a mechanic must inspect the area. This amendment is prompted by 11 reports of blade debond, some occurring in flight causing the pilot to feel excessive vibrations and land, and some found during routine maintenance. The actions specified in this AD are intended to detect blade skin debond and to prevent blade failure and subsequent loss of control of the helicopter. DATES: Effective January 18, 2008. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of January 18, 2008. Comments for inclusion in the Rules Docket must be received on or before March 3, 2008. ADDRESSES: Use one of the following addresses to submit comments on this AD: • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically; • *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:* Deliver to the “Mail” address between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays; or • *Fax:*

(202)493-2251. You may get the service information identified in this AD from Robinson Helicopter Company, 2901 Airport Drive, Torrance, CA 90505, telephone

(310)539-0508, fax

(310)539-5198. Examining the Docket You may examine the docket that contains the AD, any comments, and other information on the Internet at *http://regulations.gov* , or in person at the Docket Management System

(DMS)Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Operations office (telephone

(800)647-5527) is located in Room W12-140 on the ground floor of the West Building at the street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the DMS receives them. FOR FURTHER INFORMATION CONTACT: For information relating to the Robinson R22 helicopter, contact Eric Schrieber, Aviation Safety Engineer, FAA, Los Angeles Aircraft Certification Office, Airframe Branch, 3960 Paramount Blvd., Lakewood, California 90712, telephone

(562)627-5348, fax

(562)627-5210. For information relating to the Robinson R44 helicopter, contact Fred Guerin, Aviation Safety Engineer, FAA, Los Angeles Aircraft Certification Office, Airframe Branch, 3960 Paramount Blvd., Lakewood, California 90712, telephone

(562)627-5232, fax

(562)627-5210. SUPPLEMENTARY INFORMATION: This amendment adopts a new AD for the specified Robinson helicopters. This action also requires a one-time visual inspection for skin separation along the leading edge of the blade skin aft of the skin-to-spar bond line on the lower surface of each blade and in the tip cap area. This action also requires a “tap test” for detecting a separation or void in both bonded areas. This AD also requires repainting any exposed area of the blades. If any separation or void is detected, replacing the blade before further flight is required. Thereafter, this action requires, before each flight, checking for any exposed (bare metal) along the skin-to-spar bond line on the lower surface of each blade near the tip. If any bare metal is found, a mechanic must visually inspect the area, perform a “tap test,” and remove both blade tip covers and inspect. This amendment is prompted by 11 reports of blade debond, some occurring in flight, causing the pilot to feel excessive vibrations and land, and some found during routine maintenance. In one of the reported incidents, the debond was caused by corrosion from the lower surface of the aluminum tip cap, which is bonded to the inside of the blade tip. The corrosion bubbles caused lifting of the skin and eventual separation. This condition was found during inspection and not in flight. *We have reviewed the following:* • Robinson R22 and R44 Safety Alert, issued on January 4, 2007, revised on March 16, 2007, and March 22, 2007 (Safety Alert); • Robinson R22 and R44 Service Letter SL-56 and SL-32, dated March 16, 2007, and Revision A, dated March 29, 2007 (Service Letter); • Robinson R22 and R44 Service Bulletin SB-96 and SB-61, both dated March 29, 2007 (Service Bulletin); • Robinson letter titled “Additional Information Regarding Main Rotor Blade Skin Debonding,” dated May 25, 2007; and • The Robinson Model R22 and R44 Rotorcraft Flight Manuals changes to the Normal Procedures Section 4, and Systems Description Section 7, revised April 20, 2007. The latest Safety Alert states in part, “During each daily preflight, visually check blade finish along lower surface bond line. If any bare metal is exposed at or beyond bond line, have blade refinished per R22 Service Letter SL-56 or Service Letter SL-32 by a qualified mechanic before further flight.” The Service Letter, Revision A, dated March 29, 2007, specifies using 10x magnification to visually inspect the leading edge of any exposed (bare metal) blade skin at skin-to-spar bond line. The Service Letter also specifies tap testing all bare metal skin-to-spar bonded areas. If any tap test indication of separation or any void is detected, the blade is unairworthy. The March 16, 2007, Service Letter to R22/R44 owners/operators, and Service Centers, specifies using a 5x to 10x magnification for the visual inspection and makes certain changes to the painting process. Revision A, dated March 29, 2007, to the Service Letter includes a more accurate drawing of the exposed skin-to-spar joint area. That Service Letter also includes an inspection for corrosion around the internal aluminum tip cap area and specifies painting any bare metal. Bond failures have occurred on blades where the protective coatings have eroded away leaving the skin aft of the bond line at the skin-to-spar bond line exposed on the lower surface near the tip. Further erosion of the leading edge of the unprotected skin has caused voids and skin separation. Bond failures have also occurred due to corrosion around the tip cap where corrosion residue has disrupted and eventually separated the bond. To attempt to prevent debonding on new blades, the manufacturer has changed the production process. However, it has not been proven that these changes will prevent a debond. Therefore, at this time, the FAA does not consider these newly manufactured blades to provide terminating action for the requirements of this AD. This unsafe condition is likely to exist or develop on other helicopters of these same type designs. Therefore, this AD is being issued to detect blade skin debond to prevent blade failure and subsequent loss of control of the helicopter. *This AD requires the following:* • Within 10 hours TIS, unless accomplished previously, • Using a 10x or higher magnification, visually inspect for skin separation along the leading edge of any exposed (bare metal) blade skin aft of the skin-to-spar bond line on the lower surface of each blade. If there is skin separation, the blade is unairworthy. • Perform a “tap test” to detect any separation or void on skin-to-spar bonded areas on the lower blade skin aft of the skin-to-spar bond line of each blade using a 1965 or later U.S. quarter-dollar coin. If there is any separation or any void, the blade is unairworthy. • Remove both main rotor blade tip covers. Using a 10x or higher magnification, visually inspect the blade tip area exposed when the blade tip covers are removed. “Tap test” the skin to cap bond joints on both upper and lower surfaces of each blade. If any corrosion, separation, or void is detected, the blade is unairworthy. • Repaint any exposed area of the blade. • Before further flight, replace any unairworthy blade with an airworthy blade. • Thereafter, if the rotor blade is found airworthy by the initial inspection, before each flight, visually check for any exposed (bare metal) skin-to-spar bonded area on the lower surface of each blade within the outboard 24 inches paying particular attention to the last 10 inches before the tip. An owner/operator (pilot) holding at least a private pilot certificate may perform this visual check and must enter compliance into the aircraft maintenance records in accordance with 14 CFR 43.11 and 91.417(a)(2)(V). A pilot may perform this check because it involves only a visual check for any bare metal in the skin-to-spar bonded area and can be performed equally well by a pilot or a mechanic. If a pilot finds any area of skin bare metal in the outboard 24 inches of either blade, before further flight, a qualified mechanic must comply with the requirements of this AD. The repainting must be done by following the specified portions of the Service Letter described previously. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the structural integrity and controllability of the helicopter. Therefore, the actions described are required before each flight and initially within 10 hours TIS, both very short time intervals, and this AD must be issued immediately. Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days. We estimate that this AD will affect 2290 helicopters. A check before each flight of each blade will take a minimal amount of time. It will take about: • 3 work hours to inspect 2 blades; and • 10 work hours to remove and replace a blade for an estimated 10 blades based on reports of 10 affected blades in the past 2 years. • The average labor rate is $80 per work hour. • Required parts will cost about $16,432 for a Model R22 blade, and about $23,060 for a Model R44 blade. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $755,060; $549,600 to inspect all the blades; plus $86,160, to remove and replace 5 of the Model R22 helicopter blades plus $119,300 to remove and replace 5 of the Model R44 helicopter blades. Comments Invited This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any written data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2007-0378; Directorate Identifier 2007-SW-04-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD. We will consider all comments received by the closing date and may amend the AD in light of those comments. We will post all comments we receive, without change, to *http://regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of our docket web site, you can find and read the comments to any of our dockets, including the name of the individual who sent the comment. You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78). Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the 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 an economic evaluation of the estimated costs to comply with this AD. See the DMS to examine the economic evaluation. 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. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends 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 a new airworthiness directive to read as follows: **2007-26-12 Robinson Helicopter Company:** Amendment 39-15314. Docket No. FAA-2007-0378; Directorate Identifier 2007-SW-04-AD. Applicability Model R22, R22 Alpha, R22 Beta, R22 Mariner helicopters, serial numbers 0002 through 4100; R44 helicopters, serial numbers 0001 through 1670; and R44 II helicopters, serial numbers 10001 through 11570, certificated in any category. Compliance Required as indicated. To detect main rotor blade (blade) skin debond and prevent blade failure and subsequent loss of control of the helicopter, do the following:

(a)Within 10 hours time-in-service (TIS), unless accomplished previously:

(1)Using a 10x or higher magnification, visually inspect for skin separation along the leading edge of any exposed (bare metal) blade skin aft of the skin-to-spar bond line on the lower surface of each blade. If there is any skin separation, the blade is unairworthy.

(2)Perform a “tap test” to detect any separation or void on the skin-to-spar bonded areas on the lower blade skin aft of the skin-to-spar bond line of each blade using a 1965 or later U.S. quarter-dollar coin. If there is any separation or any void, the blade is unairworthy.

(3)Remove both blade tip covers. Using a 10x or higher magnification, visually inspect the blade tip area exposed when the blade tip covers were removed. “Tap test” the skin to cap bond joints on both upper and lower surfaces. If corrosion, separation, or any void is detected, the blade is unairworthy.

(4)Repaint any exposed area of the blade according to the Compliance Procedure, paragraphs 3 through 7, of R22 Service Letter SL-56 and R44 Service Letter SL-32, Revision A, dated March 29, 2007.

(b)Before further flight, replace any unairworthy blade with an airworthy blade.

(c)Thereafter, if the rotor blade has been found airworthy by the inspections in paragraph (a), before each flight, visually check for any exposed (bare metal) skin-to-spar bonded area on the lower surface of each blade within the outboard 24 inches paying particular attention to the last 10 inches before the tip. An owner/operator (pilot) holding at least a private pilot certificate may perform this visual check and must enter compliance into the aircraft maintenance records in accordance with 14 CFR 43.11 and 91.417(a)(2)(V). If a pilot finds any area of skin bare metal in the outboard 24 inches of either blade, before further flight, a qualified mechanic must comply with the requirements of paragraph

(a)of this AD.

(d)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Contact the Manager, Los Angeles Aircraft Certification Office, FAA, *ATTN:* (For R22) Eric Schrieber, Aviation Safety Engineer, Aircraft Certification Office, Airframe Branch, 3960 Paramount Blvd., Lakewood, California 90712, telephone

(562)627-5348, fax

(562)627-5210, or (for R44) Fred Guerin, Aviation Safety Engineer, Airframe Branch, 3960 Paramount Blvd., Lakewood, California 90712, telephone

(562)627-5232, fax

(562)627-5210, for information about previously approved alternative methods of compliance.

(e)Repaint the exposed area of a blade by following Robinson R22 Service Letter SL-56 and R44 Service Letter SL-32, Revision A, dated March 29, 2007. The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Robinson Helicopter Company, 2901 Airport Drive. Torrance, CA 90505, telephone

(310)539-0508, fax

(310)539-5198. Copies may be inspected at the FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* .

(f)This amendment becomes effective on January 18, 2008. Issued in Fort Worth, Texas, on December 17, 2007. David A. Downey, Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. E7-25395 Filed 1-2-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-28843 Directorate Identifier 2007-CE-065-AD; Amendment 39-15317; AD 2007-26-25] RIN 2120-AA64 Airworthiness Directives; DG Flugzeugbau GmbH Model DG-500MB Gliders AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive

(AD)for the products listed above. This AD results from mandatory continuing airworthiness information

(MCAI)issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: In some cases the electric motor of the spindle drive detached itself from the spindle drive, causing the powerplant to retract itself after engine shutdown. In another case the attachment fork on the spindle drive failed with the same consequences. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective February 7, 2008. On February 7, 2008, the Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD. ADDRESSES: You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Greg Davison, Glider Program Manager, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; *telephone:*

(816)329-4130; *fax:*

(816)329-4090. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the **Federal Register** on August 20, 2007 (72 FR 46411). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: In some cases the electric motor of the spindle drive detached itself from the spindle drive, causing the powerplant to retract itself after engine shutdown. In another case the attachment fork on the spindle drive failed with the same consequences. The MCAI requires you to modify the affected parts and exchange pages in the flight, maintenance, and repair manuals. Comments We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public. The FAA reviewed the proposed requirement of the NPRM to exchange pages in the flight, maintenance, and repair manuals. We have determined that the exchange of certain pages in the flight, maintenance, and repair manuals is outside the scope of what is needed to correct the unsafe condition for aircraft of U.S. registry. Conclusion We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed, except for eliminating the need to exchange manual pages. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance We estimate that this AD will affect 5 products of U.S. registry. We also estimate that it will take about 5 work-hours per product to comply with basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $422 per product. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $4,110 or $822 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 AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this AD:

(1)Is not a “significant regulatory action” under Executive Order 12866;

(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket. 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 the NPRM, 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. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **2007-26-25 DG Flugzeugbau GmbH:** Amendment 39-15317; Docket No. FAA-2007-28843; Directorate Identifier 2007-CE-065-AD. Effective Date

(a)This airworthiness directive

(AD)becomes effective February 7, 2008. Affected ADs

(b)None. Applicability

(c)This AD applies to Model DG-500MB gliders, all serial numbers, certificated in any category. Subject

(d)Air Transport Association of America

(ATA)Code 24: Electric Power. Reason

(e)The mandatory continuing airworthiness information

(MCAI)states: In some cases the electric motor of the spindle drive detached itself from the spindle drive, causing the powerplant to retract itself after engine shutdown. In another case the attachment fork on the spindle drive failed with the same consequences. The MCAI requires you to modify the affected parts and exchange pages in the flight, maintenance, and repair manuals. Actions and Compliance

(f)Unless already done, within 90 days after February 7, 2008 (the effective date of this AD):

(1)Secure the connection between the spindle drive “Stross BSA10” and the spindle drive motor following DG Flugzeugbau GmbH Working instruction No. 1, dated January 23, 2006, as referenced in DG Flugzeugbau GmbH Technical Note No. 843-24, dated January 31, 2006.

(2)Replace the fork 8M233/1 from the spindle drive with the strengthened fork 8M233“f”; replace the bearing support with the modified support 8M229“e”; and secure the spindle drive fork between the spindle drive “Stross BSA10” and the spindle drive motor following DG Flugzeugbau GmbH Working instruction No. 2, dated January 30, 2006, as referenced in DG Flugzeugbau GmbH Technical Note No. 843-24, dated January 31, 2006; DG Flugzeugbau GmbH Drawing 5M210, Spindle drive Stross BSA 10 assembly, issued: January 22, 2003, revised: May 19, 2006; and DG Flugzeugbau GmbH Drawing 5M211, Spindle drive Stross BSA 10 assembly with strengthened fork 8M233“f”, issued: January 23, 2006. Note 1: We recommend that you insert and update the new Flight Manual pages 0.1, 0.3, 0.4, 2.8, 3.7, 3.8, 4.1, 4.25, 4.26; the new Maintenance Manual pages 1, 2, 3, 4, 5, 42, 49, 68, 89, 89a, 93, and Enclosure 1; and the new Repair Manual pages 1, 2, 7, and 8 following DG Flugzeugbau GmbH Technical Note No. 843-24, dated January 31, 2006. FAA AD Differences Note 2: This AD differs from the MCAI and/or service information as follows:

(1)The service information specifies a one-time inspection of the fork and requires replacement if cracks are found. This AD requires mandatory replacement of these parts with redesigned parts. The FAA believes mandatory replacement rather than inspection will prevent failure of these parts in the future.

(2)The MCAI requires, for gliders certificated for operation in Germany, to have the pages in the flight, maintenance, and repair manuals exchanged.We have determined that the exchange of these pages is outside the scope of what is needed to correct the unsafe condition for gliders certificated for operation in the United States. Other FAA AD Provisions

(g)The following provisions also apply to this AD:

(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Greg Davison, Glider Program Manager, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; *telephone:*

(816)329-4130; *fax:*

(816)329-4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector

(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ), the Office of Management and Budget

(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information

(h)Refer to MCAI Federal Republic of Germany Luftfahrt-Bundesamt AD D-2006-060, dated March 6, 2006; and DG Flugzeugbau GmbH Technical Note No. 843-24, dated January 31, 2006. Material Incorporated by Reference

(i)You must use DG Flugzeugbau GmbH Technical Note No. 843-24, dated January 31, 2006; DG Flugzeugbau GmbH Working instruction No. 1, dated January 23, 2006; DG Flugzeugbau GmbH Working instruction No. 2, dated January 30, 2006; DG Flugzeugbau GmbH Drawing 5M210, Spindle drive Stross BSA 10 assembly, revised May 19, 2006; and DG Flugzeugbau GmbH Drawing 5M211, Spindle drive Stross BSA 10 assembly with strengthened fork 8M233“f”, dated January 23, 2006, to do the actions required by this AD, unless the AD specifies otherwise.

(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.

(2)For service information identified in this AD, contact DG Flugzeugbau GmbH, Im Schollengarten 20, D-76646 Bruchsal 4, Federal Republic of Germany.

(3)You may review copies at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html* . Issued in Kansas City, Missouri, on December 20, 2007. John R. Colomy, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-25212 Filed 1-2-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 208, and 209 [Docket No. 2003N-0342] RIN 0910-AC35 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule. SUMMARY: The Food and Drug Administration

(FDA)is issuing an interim final rule to codify the provisions of the proposed rule entitled “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products” (69 FR 21778, April 22, 2004) (the toll-free number proposed rule or proposed rule) that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act (the act). The added statement includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints. DATES: *Effective Date* : This rule is effective January 1, 2008. *Compliance Date* : The agency anticipates that affected entities, including manufacturers, authorized dispensers, and pharmacies, will need time to update labeling and systems to comply with the new requirements. Therefore, FDA intends to exercise its enforcement discretion and not take enforcement actions with regard to these regulations until January 1, 2009. FOR FURTHER INFORMATION CONTACT: Carol Drew, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: I. Background On September 27, 2007, the President signed into law FDAAA (Public Law 110-85). Among other things, FDAAA reauthorized the Best Pharmaceuticals for Children Act (BPCA). When enacted in 2001, the BPCA (Public Law 107-109) directed FDA to issue a final rule requiring the labeling of each human drug product for which an application is approved under section 505 of the act (21 U.S.C. 355) to include:

(1)A toll-free number maintained by FDA for the purpose of receiving reports of adverse events regarding drugs and

(2)a statement that the number is to be used for reporting purposes only, not to receive medical advice. Collectively, we refer to the toll-free number and reporting statement as the “side effects statement.” The BPCA stated that the final rule must reach the broadest consumer audience and minimize the cost to the pharmacy profession. As required, FDA issued a proposed rule entitled “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products” (69 FR 21778, April 22, 2004). FDA received 22 comments on this proposed rule and was in the process of analyzing the comments and conducting research on consumer comprehension of the side effects statement when FDAAA was enacted (see section IV of this document). II. FDAAA Requirements Section 502(f) of FDAAA states that “the proposed rule * * * ‘Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products’ * * * shall take effect on January 1, 2008,” unless FDA issues a final rule before that date. FDAAA mandates one change to the proposed rule. As described in section III of this document, section 502(f)(2) of FDAAA states that the toll-free number proposed rule shall not apply to over-the-counter

(OTC)drugs marketed with an application approved under section 505 of the act (application OTC drug products) if these application OTC drug products meet certain labeling requirements. (Neither the BPCA, the proposed rule, nor this interim final rule addresses OTC drugs marketed *without* approved applications.) Because the agency's rulemaking process is ongoing, for the reasons explained in section IV of this document, this interim rule codifies the provisions of the proposed rule as modified by FDAAA. As mandated by FDAAA, these provisions came into effect on January 1, 2008. The agency is publishing this interim final rule to codify the modified toll-free number proposed rule that has now come into effect. III. Description of the Interim Final Rule Consistent with the mandates of the BPCA, FDA proposed to require that the side effects statement be included in FDA-approved Medication Guides for drug products approved under section 505 of the act. We also proposed that the side effects statement be distributed with each prescription drug product approved under section 505 of the act and dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting. In addition, as described in the toll-free number proposed rule, FDA interpreted the BPCA to apply to application OTC drug products. Accordingly, FDA also proposed to require the side effects statement in the labeling for application OTC drug products. Section 502(f)(2) of FDAAA states that the proposed rule shall not apply to a drug:

(1)For which an application is approved under section 505 of the act;

(2)that is not described under section 503(b)(1) of the act (21 U.S.C. 353(b)(1)); and

(3)the packaging of which includes a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug. This provision means that the proposed rule as it has come into effect by operation of law in accordance with FDAAA does not apply to an application OTC drug product if the product's packaging includes a manufacturer's or distributor's toll-free number for reporting complaints. Accordingly, this interim final rule includes a modified § 201.66(c)(5)(vii) reflecting the change to the proposed rule mandated by FDAAA. IV. Ongoing Research on the Side Effects Statement FDA is in the process of conducting research on the wording of the side effects statement published in the toll-free number proposed rule. FDA initiated this research after reviewing the comments on the proposed rule. Among the reasons cited in these comments for testing the statement were:

(1)To determine the best and most precise wording for the statement;

(2)to evaluate consumer comprehension of the proposed statement; and

(3)to address concerns that consumers who read the statement will mistakenly call FDA in search of medical advice. FDA designed a two-part study in response to these comments. Part one consisted of focus groups held to narrow the field of potential statement alternatives. This research was completed in 2006 (OMB Control No. 0910-0497). The second part of this research is a labeling comprehension experiment to be conducted over the Internet (OMB Control No. 0910-0603). FDA plans to complete this research. Then, based on the results of the data collected from the research and the comments received on the proposed rule, the agency will determine whether to finalize this interim final rule as published or to publish a final rule that amends this interim final rule. The effective date and implementation schedule for the final rule will be designed to minimize the burden of any additional regulatory changes for affected entities who must comply with this interim final rule. V. Legal Authority Section 502(f) of FDAAA states that the toll-free number proposed rule shall take effect on January 1, 2008, unless the agency publishes a final rule prior to that date. FDA determined that the research being undertaken to inform the proposed side effects statement could not be completed in time for FDA to publish a final rule prior to January 1, 2008, and that this research needed to be completed for the agency to respond fully to the comments received on the toll-free number proposed rule. Therefore, FDA did not publish a final rule before January 1, 2008, and the toll-free number proposed rule, as modified by FDAAA, came into effect by operation of law on that date. FDA has received comments on the proposed rule addressing issues including the scope of the rule, the content and presentation of the side effects statement, the reporting provisions, the costs and benefits of the rule, implementation of the rule, and compliance with it. As part of the final rulemaking that the agency will undertake after completing the research on the side effects statement (see section IV in this document), FDA will consider and address all comments submitted to the docket for the toll-free number proposed rule. VI. Effective Date/Compliance Date As mandated by FDAAA, the effective date of the interim final rule is January 1, 2008. In the preamble to the toll-free number proposed rule, the agency proposed that all manufacturers, dispensers and pharmacies subject to the rule be in compliance not more than 1 year after the effective date of the final rule. FDA explained that the agency anticipated these entities would require time to update labeling and systems to comply with the new requirements. FDAAA does not address timing needs for affected entities to come into compliance with the rule. The only change FDAAA makes to the agency's proposal is to limit the scope of the proposed rule to make the rule inapplicable to certain application OTC drug products. Accordingly, FDA concludes that FDAAA was not intended to make any other changes to the agency's proposal, including with regard to addressing the anticipated needs of affected entities for time to come into compliance with the rule. FDA continues to anticipate that affected entities, including manufacturers of drug products, authorized dispensers, and pharmacies, will need time to update labeling and systems to comply with the new requirements. Therefore, consistent with the agency's proposal, the agency intends to exercise its enforcement discretion with regard to these regulations until January 1, 2009. That is, the agency does not intend to take enforcement action with regard to this interim final rule before that date. List of Subjects 21 CFR Part 201 Drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 208 Labeling, Prescription drugs, Reporting and recordkeeping requirements. 21 CFR Part 209 Authorized dispensers, Drugs, Pharmacies, Prescription drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR Chapter I is amended as follows: PART 201—LABELING 1. The authority citation for 21 CFR part 201 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264. 2. Amend § 201.66 by adding two sentences at the end of paragraph (c)(5)(vii) to read as follows: § 201.66 Format and content requirements for over-the-counter

(OTC)drug product labeling.

(c)* * *

(5)* * *

(vii)* * * For all OTC drug products under an approved drug application whose packaging does not include a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug product, the following text shall immediately follow the subheading: “[Bullet] side effects occur. You may report side effects to FDA at 1-800-FDA-1088.” The telephone number must appear in a minimum 6-point bold letter height or type size. PART 208—MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS 3. The authority citation for 21 CFR part 208 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 360, 371, 374; 42 U.S.C. 262. 4. Amend § 208.20 by adding paragraph (b)(7)(iii) to read as follows: § 208.20 Content and format of a Medication Guide.

(b)* * *

(7)* * *

(iii)For drug products approved under section 505 of the act, the following verbatim statement: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” 5. Add part 209 to read as follows: PART 209—REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT Subpart A—General Provisions Sec. 209.1 Scope and purpose. 209.2 Definitions. Subpart B—Requirements 209.10 Content and format of the side effects statement. 209.11 Dispensing and distributing the side effects statement. Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371; 42 U.S.C. 241. Subpart A—General Provisions § 209.1 Scope and purpose.

(a)This part sets forth requirements for human prescription drug products approved under section 505 of the Federal Food, Drug, and Cosmetic Act and dispensed by authorized dispensers and pharmacies to consumers. This part requires distribution of a side effects statement and applies to new and refill prescriptions. This part is not intended to apply to authorized dispensers dispensing or administering prescription drug products to inpatients in a hospital or health care facility under an order of a licensed practitioner, or as part of supervised home health care.

(b)The purpose of providing the side effects statement is to enable consumers to report side effects of prescription drug products to FDA. § 209.2 Definitions. For the purposes of this part, the following definitions apply: *Act* means the Federal Food, Drug, and Cosmetic Act (sections 201-907 (21 U.S.C. 301-397)). *Authorized dispenser* means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice. *Consumer medication information* means written information voluntarily provided to consumers by dispensing pharmacists as part of patient medication counseling activities. *Medication Guide* means FDA-approved patient labeling conforming to the specifications set forth in part 208 of this chapter and other applicable regulations. *Pharmacy* includes, but is not limited to, a retail, mail order, Internet, hospital, university, or clinic pharmacy, or a public health agency, regularly and lawfully engaged in dispensing prescription drugs. *Side effects statement* means the following verbatim statement: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” Subpart B—Requirements § 209.10 Content and format of the side effects statement.

(a)*Content* . The side effects statement provided with each prescription drug product approved under section 505 of the act must read: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.”

(b)*Format* . The side effects statement must be in a single, clear, easy-to-read type style. The letter height or type size used for the side effects statement in accordance with paragraphs (b)(1) and (b)(2) of § 209.11 must be no smaller than 6 points (1 point = 0.0138 inch). The letter height or type size for the side effects statement under paragraphs (b)(3), (b)(4), and (b)(5) of § 209.11 must be no smaller than 10 points. § 209.11 Dispensing and distributing the side effects statement.

(a)Each authorized dispenser or pharmacy must distribute the side effects statement with each prescription drug product approved under section 505 of the act and dispensed. The side effects statement must be distributed with new and refill prescriptions.

(b)An authorized dispenser or pharmacy must choose one or more of the following options to distribute the side effects statement:

(1)Distribute the side effects statement on a sticker attached to the unit package, vial, or container of the drug product;

(2)Distribute the side effects statement on a preprinted pharmacy prescription vial cap;

(3)Distribute the side effects statement on a separate sheet of paper;

(4)Distribute the side effects statement in consumer medication information; or

(5)Distribute the appropriate FDA-approved Medication Guide that contains the side effects statement. Dated: December 21, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-25426 Filed 1-2-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 414 [CMS-1385-F2] RIN 0938-AO65 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Delay of the Date of Applicability of the Revised Anti-Markup Provisions for Certain Services Furnished in Certain Locations (§ 414.50) AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule delays until January 1, 2009 the applicability of the anti-markup provisions in § 414.50, as revised at 72 FR 66222, except with respect to the technical component of a purchased diagnostic test and with respect to any anatomic pathology diagnostic testing services furnished in space that: Is utilized by a physician group practice as a “centralized building” (as defined at § 411.351 of this chapter) for purposes of complying with the physician self-referral rules; and does not qualify as a “same building” under § 411.355(b)(2)(i) of this chapter. DATES: The provisions of this final rule are effective January 1, 2008. However, the date of applicability of the provisions of § 414.50, as revised at 72 FR 66222, with respect to certain services furnished in certain locations, as described herein, are delayed until January 1, 2009. FOR FURTHER INFORMATION CONTACT: Donald Romano,

(410)786-1401. SUPPLEMENTARY INFORMATION: I. Background The final rule with comment period, entitled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions,” that appeared in the November 27, 2007 **Federal Register** (72 FR 66222), amended the anti-markup provisions for certain diagnostic tests in § 414.50. II. Provisions of the Final Regulations As amended, the anti-markup provisions in § 414.50 will apply to the technical and professional components of diagnostic tests covered under section 1861(s)(3) of the Social Security Act (the Act) and paid for under part 414 (other than clinical diagnostic laboratory tests paid under section 1833(a)(2)(D) of the Act, which are subject to the special billing rules set forth in section 1833(h)(5)(A) of the Act). If a physician or other supplier bills for the technical component or professional component of a diagnostic test that was ordered by the physician or other supplier (or ordered by a party related to such physician or other supplier through common ownership or control) and the diagnostic test is either purchased from an outside supplier or performed at a site other than the office of the billing physician or other supplier, the payment to the billing physician or other supplier (less the applicable deductibles and coinsurance paid by the beneficiary or on behalf of the beneficiary) for the technical component or professional component of the diagnostic test may not exceed the lowest of the following amounts: • The performing supplier's net charge to the billing physician or other supplier. • The billing physician or other supplier's actual charge. • The fee schedule amount for the test that would be allowed if the performing supplier billed directly. In revised § 414.50(a)(2)(iii), we define the “office of the billing physician or other supplier” as medical office space where the physician or other supplier regularly furnishes patient care. With respect to a billing physician or other supplier that is a physician organization (as defined at § 411.351 of this chapter), the “office of the billing physician or other supplier” is space in which the physician organization provides substantially the full range of patient care services that the physician organization provides generally. Subsequent to the publication of the final rule with comment period, we received informal comments from various stakeholders who allege that the application of the rule is unclear with respect to whether certain types of space arrangements meet the definition of the “office of the billing physician or other supplier.” Further, some of these stakeholders assert that patient access may be significantly disrupted due to the alleged inability of physician groups to render services in a cost-effective manner if medical office space that satisfies the “same building” test in § 411.355(b)(2)(i) of this chapter for purposes of the physician self-referral rules in Part 411, Subpart J of this chapter and other medical office space in which patients are seen and that complies with the physician self-referral rules are subject to the anti-markup provisions in revised § 414.50. That is, physician groups allege that, in situations in which they are subject to the anti-markup provisions and are limited to billing Medicare for the amount of the net charge imposed by the performing supplier, because they will not be able to realize a profit and will not be able to recoup their overhead costs, they will not be able to continue to provide diagnostic testing services to the same extent that they are currently providing such services. We are concerned that the definition of “office of the billing physician or other supplier” may not be entirely clear and could have unintended consequences. Accordingly, in order for us to study the issues further, we are delaying until January 1, 2009, the applicability of the revised anti-markup provisions in § 414.50, except for anatomic pathology diagnostic testing services furnished in space that:

(1)Is utilized by a physician group practice as a “centralized building” (as defined at § 411.351 of this chapter) for purposes of complying with the physician self-referral rules; and

(2)does not qualify as a “same building” under § 411.355(b)(2)(i) of this chapter. During the next 12 months, we plan to issue clarifying guidance as to what constitutes the “office of the billing physician or other supplier” or propose additional rulemaking, or both. Because anatomic pathology diagnostic testing arrangements precipitated our proposal for revision of the anti-markup provisions and remain our core concern, we are not delaying the date of applicability with respect to anatomic pathology diagnostic testing services furnished in space that:

(1)Is utilized by a physician group practice as a “centralized building” (as defined at § 411.351 of this chapter) for purposes of complying with the physician self-referral rules; and

(2)does not qualify as a “same building” under § 411.355(b)(2)(i) of this chapter. In addition, we are not delaying the applicability of the revised anti-markup rule with respect to the technical component of any purchased diagnostic test. The anti-markup prohibition with respect to the technical component of purchased diagnostic tests is longstanding and was incorporated into the expanded and revised provision of § 414.50. Accordingly, it will remain applicable to the technical component of any purchased diagnostic test. III. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking and invite public comment on the proposed rule. The notice and comment rulemaking procedure is not required, however, if the rule is interpretive or procedural in nature, and it may be waived if there is good cause that it is impracticable, unnecessary, or contrary to the public interest and we incorporate in the rule a statement of such a finding and the reasons supporting that finding. Likewise, we ordinarily provide for a delayed effective date of a final rule, but we are not required to do so if the rule is procedural or interpretive. Where a delayed effective date is required, this requirement may be waived for good cause. We set forth below our finding of good cause for the waiver of notice and comment rulemaking and the waiver of a delayed effective date. Our implementation of this action without opportunity for public comment and without a delayed effective date is based on the good cause exceptions in 5 U.S.C. 553(b)(3)(B) and (d), respectively. We find that seeking public comment on this action is impracticable and contrary to the public interest. We are implementing this delay of effective date as a result of our review of the informal comments on the final rule with comment period from various stakeholders. As discussed above, we understand from those comments that patient access for common diagnostic tests may be significantly disrupted unless we delay the effective date of revised § 414.50 with respect to anatomic pathology diagnostic testing services furnished in space that:

(1)Is utilized by a physician group practice as a “centralized building” (as defined at § 411.351 of this chapter) for purposes of complying with the physician self-referral rules; and

(2)does not qualify as a “same building” under § 411.355(b)(2)(i) of this chapter. Likewise, if we do not make this final rule effective upon publication, patient care may be significantly disrupted during the interim period between the issuance of the rule and a delayed effective date. IV. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). V. Regulatory Impact Statement We do not believe that this delay in the date of applicability will result in any significant economic impact on any small entity. Until January 1, 2009, the majority of billing suppliers affected by the revised § 414.50 do not have to comply with the revised requirements in § 414.50. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: December 18, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: December 27, 2007. Michael O. Leavitt, Secretary. [FR Doc. 07-6280 Filed 12-28-07; 1:17 pm]

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