Rules and Regulations. Final rule

7,561 words·~34 min read·/register/2007/03/12/07-1131

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

BILLING CODE 4910-13-C DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-20850; Directorate Identifier 2005-NE-05-AD; Amendment 39-14976; AD 2007-05-15] RIN 2120-AA64 Airworthiness Directives; Teledyne Continental Motors GTSIO-520 Series Reciprocating Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is superseding an existing airworthiness directive

(AD)for Teledyne Continental Motors

(TCM)GTSIO-520 series reciprocating engines. That AD currently requires initial and repetitive visual inspections of the starter adapter assembly and crankshaft gear and unscheduled visual inspections of the starter adapter assembly and crankshaft gear due to a rough-running engine. That AD also requires replacement of the starter adapter shaft gear needle bearing with a certain bushing and installation of a certain TCM service kit at the next engine overhaul, or at the next starter adapter replacement, whichever occurs first. This AD requires performing the inspection ordered in paragraph

(h)of this AD every 100 hours time-in-service (TIS), or annually. This proposed AD results from an error discovered in AD 2005-20-04. We are issuing this AD to failure of the starter adapter assembly and or crankshaft gear, resulting in failure of the engine and possible forced landing. DATES: This AD becomes effective April 16, 2007. The Director of the **Federal Register** approved the incorporation by reference of certain publications listed in the regulations as of April 16, 2007. ADDRESSES: You can get the service information identified in this AD from Teledyne Continental Motors, Inc., PO Box 90, Mobile, AL 36601; telephone

(251)438-3411. You may examine the AD docket on the Internet at *http://dms.dot.gov* or in Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC. FOR FURTHER INFORMATION CONTACT: Jerry Robinette, Senior Engineer, Propulsion, Atlanta Aircraft Certification Office, FAA, Small Airplane Directorate, One Crown Center, 1895 Phoenix Blvd., Suite 450, Atlanta, GA 30349; telephone:

(770)703-6096, fax:

(770)703-6097. SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39 with a proposed AD. The proposed AD applies to TCM GTSIO-520 series reciprocating engines. We published the proposed AD in the **Federal Register** on October 26, 2006, (71 FR 62570). That action proposed to require performing the inspection ordered in paragraph

(h)of AD 2005-20-04 every 100 hours time-in-service (TIS), or annually to correct an error that required the inspection at every 100-hour inspection. Examining the AD Docket You may examine the docket that contains the AD, any comments received, and any final disposition in person at the Docket Management Facility Docket Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone

(800)647-5227) is located on the plaza level of the Department of Transportation Nassif Building at the street address stated in ADDRESSES . Comments will be available in the AD docket shortly after the DMS receives them. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comment[s] received. Remove the Requirement for a Placard Two commenters propose dropping the placard from the requirements of the proposed AD. The commenters do not believe the placard is necessary. We agree. It appears the commenters are basing their comment on the original notice of proposed rulemaking

(NPRM)that we issued on April 6, 2005, not the current NPRM. We received comments to the original NPRM similar to these comments and removed the requirement to add a placard before we issued AD 2005-20-05. We didn't change this AD. Request to Change the Required Inspection The same two commenters request we mandate a more detailed inspection for the components. The commenters state that a visual inspection might not be sufficient. We don't agree. The commenters didn't specify any additional inspections. We consider a visual inspection the best method to detect abnormal surface wear. We don't have any requirement for nondestructive testing because we have no indication of subsurface deterioration. We didn't change the AD. Request To Perform Additional Economic Assessment One commenter asks us to perform additional economic assessment. The commenter states we didn't consider the economic effects on other small entities. We don't agree. We used our current procedures to consider the economic effects of this action. We didn't change the AD. Editorial Changes To Improve Clarity and Correct an Omission We changed paragraph

(f)of this AD from “If, during an inspection * * * crankcase, replace it with a serviceable bushing before reassembling components” to “(f) If, during an inspection required by paragraph (g), (h), (i), or

(j)of this AD, you find needle bearing, part number (P/N) 537721, installed in the crankcase, replace it with a serviceable bushing, P/N 654472 or equivalent FAA approved bearing, before reassembling components” to clarify the intent of that requirement. We also added paragraph (h)(3) to make the compliance times in that requirement consistent with paragraph (i)(3). Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD. Costs of Compliance We estimate that this AD will affect 4,240 engines installed on airplanes of U.S. registry. We also estimate that it will take about one work-hour per engine to perform the inspection, about one work-hour per engine to perform the proposed bushing installation and about six work-hours per engine to install the TCM service kit. The average labor rate is $80 per work-hour. We estimate that about 25 percent of the engines will require an unscheduled (rough-running engine) inspection and about half of the engines will require the bushing and TCM service kit. Required bushings would cost about $16 per engine and service kits about $800 per engine. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $6,393,432. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:

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

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

(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES . 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 Federal Aviation Administration 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 removing Amendment 39-14297 (70 FR 56355, September 27, 2005) and by adding a new airworthiness directive, Amendment 39-14976, to read as follows: **2007-05-15 Teledyne Continental Motors:** Amendment 39-14976. Docket No. FAA-2005-20850; Directorate Identifier 2005-NE-05-AD. Effective Date

(a)This airworthiness directive

(AD)becomes effective April 16, 2007. Affected ADs

(b)This AD supersedes AD 2005-20-04, Amendment 39-14297. Applicability

(c)This AD applies to Teledyne Continental Motors

(TCM)GTSIO-520 series reciprocating engines. These engines are installed on, but not limited to, Twin Commander (formerly Aero Commander) model 685, Cessna model 404, 411 series, and 421 series, British Aerospace, Aircraft Group, Scottish Division model B.206 series 2 and Aeronautica Macchi model AM-3 airplanes. Unsafe Condition

(d)This AD results from an error discovered in AD 2005-20-04. We are issuing this AD to prevent failure of the starter adapter assembly and or crankshaft gear, resulting in failure of the engine and possible forced landing. 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. Starter Adapter Shaft Gear Needle Bearing Replacement

(f)If, during an inspection required by paragraph (g), (h), (i), or

(MSB)No. MSB94-4G, dated October 31, 2005. Unscheduled Inspections for Rough-Running Engines

(g)For any engine that experiences rough running conditions regardless of time-in-service (TIS), do the following:

(1)Before further flight, perform the inspection procedures specified in Part 1 and Part 3 of TCM MSB No. MSB94-4G, dated October 31, 2005, and replace components as necessary.

(2)An engine is considered rough-running if there is a sudden increase in the perceived vibration levels that cannot be cleared by adjustment of the engine controls; particularly the fuel mixture setting. Information on rough running engines can be found in the aircraft manufacturer's Airplane Flight Manual, Pilot's Operating Handbook, or Aircraft Owners Manual. 100-Hour and Annual Inspections

(h)For any engine that has been inspected using paragraph

(h)of AD 2005-20-04 and the 100-hour inspection procedures or 100 hour TIS intervals or annual inspection procedures, continue the inspections as follows:

(1)Perform the inspection procedures specified in Part 2 of TCM MSB No. MSB94-4G, dated October 31, 2005 and replace components as necessary at each 100 hour TIS interval (plus or minus 10 hours TIS) or annual inspection, whichever occurs first.

(2)Thereafter, at each 100 hour TIS interval (plus or minus 10 hours TIS) perform repetitive inspections and component replacements as specified in paragraph (h)(1) of this AD.

(3)If the inspection is performed at more than 100 hour intervals, subtract the additional hours from the next scheduled 100 hour inspection.

(i)For any engine that has not been inspected using paragraph

(h)of AD 2005-20-04, within 25 hours TIS or at the annual inspection, whichever occurs first, do the following:

(1)Perform the inspection procedures specified in Part 2 of TCM MSB No. MSB94-4G, dated October 31, 2005 and replace components as necessary.

(2)Thereafter, at each 100-hour TIS interval (plus or minus 10 hours TIS) perform repetitive inspections and component replacements as specified in paragraph (i)(1) of this AD.

(3)If the inspection is performed at more than 100 hour intervals, subtract the additional hours from the next scheduled 100 hour inspection. Starter Adapters With 400 Hours or More Time-In-Service

(TIS)or Unknown TIS

(j)For any starter adapter with 400 hours or more TIS or unknown TIS on the effective date of this AD, do the following:

(1)Within 25 hours TIS, perform the inspection procedures specified in Part 3 of TCM MSB No. MSB94-4G, dated October 31, 2005, and replace components as necessary.

(2)Thereafter, at 400-hour TIS intervals, (plus or minus 10 hours TIS), perform repetitive inspections and component replacements specified in Part 3 of TCM MSB No. MSB94-4G, dated October 31, 2005, and replace components as necessary. Starter Adapters With Fewer Than 400 Hours TIS

(k)For any starter adapter with fewer than 400 hours TIS on the effective date of this AD, do the following:

(1)Upon accumulation of 400 hours TIS, (plus or minus 10 hours TIS), perform the inspection procedures specified in Part 3 of TCM MSB No. MSB94-4G, dated October 31, 2005, and replace components as necessary.

(2)Thereafter, at 400-hour TIS intervals, (plus or minus 10 hours TIS), perform repetitive inspections and component replacements, as specified in Part 3 of TCM MSB No. MSB94-4G, dated October 31, 2005, and replace components as necessary. Installation of TCM Service Kit, EQ6642 or EQ6642R

(l)At the next engine overhaul or starter adapter replacement after the effective date of this AD, whichever occurs first, do the following:

(1)Install TCM service kit, P/N EQ6642

(new)or EQ6642R (rebuilt). Use the service kit installation procedures specified in Part 5 of TCM MSB No. MSB94-4G, dated October 31, 2005.

(2)Continue performing the inspections and component replacements specified in paragraphs (g), (h), (i),

(j)and

(k)of this AD. Prohibition of Special Flight Permits for Rough-Running Engines

(m)Special flight permits are prohibited for rough-running engines described in paragraph (g)(2) of this AD. Alternative Methods of Compliance (AMOCs)

(n)The Manager, Atlanta Aircraft Certification Office, FAA, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information

(o)None. Material Incorporated by Reference

(p)You must use TCM MSB No. MSB94-4G, dated October 31, 2005, to perform the actions required by this AD. The Director of the Federal Register approved the incorporation by reference of this service bulletin in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Teledyne Continental Motors, Inc., PO Box 90, Mobile, AL 36601; telephone

(251)438-3411 for a copy of this service information. For the Teledyne Continental Motors Web site: Go to *http://www.TCMLINK.com.* You may review copies at the FAA, New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA; 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 Burlington, Massachusetts, on February 26, 2007. Peter A. White, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E7-3832 Filed 3-9-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-24846; Directorate Identifier 2006-NE-21-AD; Amendment 39-14981; AD 2007-05-20] RIN 2120-AA64 Airworthiness Directives; Microturbo Saphir 20 Models 095 Auxiliary Power Units

(APU)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: It has been reported that with the existing configuration, a certain failure could cause overspeed of the gas generator rotor resulting in uncontained burst of the turbine liberating high-energy fragments. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective April 16, 2007. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of April 16, 2007. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. FOR FURTHER INFORMATION CONTACT: Tracy Murphy, Aerospace Engineer, Boston Aircraft Certification Office, FAA, Engine and Propeller Directorate; 12 New England Executive Park, Burlington, MA 01803; telephone 781-238-7172; fax 781-238-7170. SUPPLEMENTARY INFORMATION: Streamlined Issuance of AD The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. This streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and **Federal Register** requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products. This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles. 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 December 18, 2006 (71 FR 75684). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that: It has been reported that with the existing configuration, a certain failure could cause overspeed of the gas generator rotor resulting in uncontained burst of the turbine liberating high-energy fragments. The occurrence that the high-energy fragments would be uncontained is considered a potentially dangerous situation which requires imperative corrective action. The purpose of the modification, which has been made mandatory, is to limit gas generator speed during an acceleration towards overspeed by installation of a modified Electronic Control Unit

(ECU)and Drain Valve. In addition, the modification also renders the exhaust gas temperature

(EGT)control function compliant with the certificated specifications. In operation, if EGT exceeds the certificated limit value, turbine blade shedding could occur. 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. Conclusion We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. 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 our FAA policies. Any such differences are described in a separate paragraph of the AD, and take precedence over the actions copied from the MCAI. Costs of Compliance Based on the service information, we estimate that this AD will affect about 3 products of U.S. registry. We also estimate that it will take about 10 work-hours per product to comply with this AD. The average labor rate is $80 per work-hour. Required parts will cost about $1,000 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the AD on U.S. operators to be $5,400 or $1,800 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 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 AD and placed it in the AD docket. Examining the AD Docket You may examine the AD docket on the Internet at *http://dms.dot.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)647-5227) 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: **2007-05-20 Microturbo:** Amendment 39-14981. Docket No. FAA-2006-24846; Directorate Identifier 2006-NE-21-AD. Effective Date

(a)This airworthiness directive

(AD)becomes effective April 16, 2007. Affected ADs

(b)None. Applicability

(c)This AD applies to Microturbo Saphir 20 Models 095 Auxiliary Power Units

(APU)installed on, but not limited to, Eurocopter AS 332C, AS 332L, AS 332L1, and AS 332L2 helicopters. Reason

(d)Direction Generale De l'Aviation Civile Airworthiness Directive F-2005-146, dated August 17, 2005, states: It has been reported that with the existing configuration, a certain failure could cause overspeed of the gas generator rotor resulting in uncontained burst of the turbine liberating high-energy fragments. The occurrence that the high-energy fragments would be uncontained is considered a potentially dangerous situation which requires imperative corrective action. The purpose of the modification, which has been made mandatory, is to limit gas generator speed during an acceleration towards overspeed by installation of a modified Electronic Control Unit

(ECU)and Drain Valve. In addition, the modification also renders the exhaust gas temperature

(EGT)control function compliant with the certificated specifications. In operation, if EGT exceeds the certificated limit value, turbine blade shedding could occur. Actions and Compliance

(e)Unless already done, do the following actions except as stated in paragraph

(f)below.

(1)Within 60 days after the effective date of this AD, replace the existing ECU and drain valve.

(2)Follow paragraph 2. of Accomplishment Instructions of Microturbo Alert Service Bulletin

(ASB)No. 095-49A11, Edition 2, dated October 7, 2005, to do these actions. FAA AD Differences

(f)This AD differs from the mandatory continuing airworthiness information

(MCAI)and/ or service information as follows:

(1)The MCAI issued by an airworthiness authority of another country refers to Microturbo ASB No. 095-49A11, dated July 27, 2005.

(2)This AD refers to Edition 2 of that ASB, dated October 7, 2005, which contains revised torque values. Other FAA AD Provisions

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

(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Boston Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.

(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:* None. Related Information

(h)France AD No. F-2005-146, dated August 17, 2005, also pertains to the subject of this AD.

(i)Contact Tracy Murphy, Aerospace Engineer, Boston Aircraft Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; telephone

(781)238-7172; fax

(781)238-7170, for more information about this AD. Material Incorporated by Reference

(j)You must use Microturbo Alert Service Bulletin No. 095-49A11, Edition 2, dated October 7, 2005 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 Microturbo SA; Technical Publications Department; 8 Chemin du pont de Rupe, BP 62089; 31019 Toulouse Cedex 2, France; telephone 33 0 5 61 37 55 00; fax 33 0 5 61 70 74 45.

(3)You may review copies at the FAA, New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA; 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 Burlington, Massachusetts, on March 2, 2007. Robert J. Ganley, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E7-4140 Filed 3-9-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. 2006N-0051] RIN 0910-AF65 Health Resources and Services Administration 42 CFR Part 121 Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation AGENCIES: Food and Drug Administration, Health Resources and Services Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)and the Health Resources and Services Administration

(HRSA)are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue-based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). DATES: This rule is effective on April 11, 2007. FOR FURTHER INFORMATION CONTACT: *For information regarding FDA's rule* : Denise Sánchez, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. *For information regarding HRSA's rule* : Jim Burdick, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, rm. 12C-06, Rockville, MD 20857, 301-443-7577. SUPPLEMENTARY INFORMATION: I. Introduction HRSA oversees transplantation of organs through the Organ Procurement and Transplantation Network (OPTN), which sets policies related to the procurement, transplantation, and allocation of human organs (see 42 CFR part 121). FDA currently regulates blood vessels. However, FDA does not regulate vascularized human organs (see 21 CFR 1270.3(j)(4) and 1271.3(d)(1)). FDA's jurisdiction over blood vessels intended for use in organ transplantation overlaps with HRSA's oversight of the OPTN. There is a routine practice of recovering blood vessels intended for use in organ transplantation during organ procurement and using such blood vessels to connect donor organ and recipient vessels. Blood vessels intended for use in organ transplantation are recovered with human organs by Organ Procurement Organizations

(OPOs)and stored for use at transplant centers. Both OPOs and transplant centers are already subject to HRSA oversight because of their organ procurement and transplantation activities. The application of both HRSA and FDA regulatory requirements to these facilities in relation to organs and blood vessels procured for use in organ transplantation is not supported by a need for such dual oversight. In order to avoid the duplication of efforts and reduce the burden on affected facilities, this final rule transfers from FDA to HRSA jurisdiction over blood vessels intended and labeled for use in organ transplantation. This final rule does not affect the regulation of blood vessels intended for transplantation that do not involve organ transplantation. Jurisdiction over such blood vessels remains with FDA. Under this final rule, blood vessels labeled and intended solely for use in organ transplantation will be subject to HRSA requirements in 42 CFR part 121 and any enforceable OPTN policies established under 42 CFR part 121. To be regulated under HRSA requirements, such blood vessels intended for use in organ transplantation must be labeled “For use in organ transplantation only.” However, they are not required to be attached to the organ(s), transplanted simultaneously with such organ(s) to the same recipient, or transplanted with the organ(s) from the same donor. For example, occasionally blood vessels not used immediately for the transplantation of a donated organ are stored for a number of days and subsequently used to modify the organ transplant in the same recipient or to accomplish transplantation in the recipient of an organ from a different donor. Such blood vessels intended and labeled for use in organ transplantation may be used in these ways when the use is consistent with HRSA requirements. II. Background In the **Federal Register** of May 12, 2006, we published a direct final rule and a companion proposed rule (71 FR 27606 and 27649, respectively) to revise HRSA's definition of “organ” to include blood vessels recovered from an organ donor during the same recovery procedure of such organ(s) and intended and labeled for use in organ transplantation; and to exclude such blood vessels from FDA's definition of human cells, tissues, or cellular or tissue-based products (HCT/Ps) (21 CFR 1271.3(d)). The direct final rule amended the regulations so that blood vessels intended and labeled for use in organ transplantation were under the same regulatory scheme as organs, thereby making blood vessels intended and labeled for use in organ transplantation readily available to meet organ transplant needs. Such direct final rule would become effective unless we received significant adverse comment. We published a companion proposed rule to provide a procedural framework within which the rule could be finalized in the event we received any significant adverse comments regarding the direct final rule, and the direct final rule had to be withdrawn. We received comments from health care professionals and a nonprofit organization. Among the comments received, one comment fully supported the rulemaking. Another comment concerned the use and tracking of blood vessels recovered from a deceased organ donor but not transplanted with the recovered organ, and questioned the transfer of regulatory responsibility for such blood vessels from FDA to HRSA. Another comment suggested that the rulemaking distinguish between organ transplant recipients based on the type of their organ donor (living, nonrelated; living, related; or deceased) and use these distinctions to define who may receive the blood vessels addressed in the rulemaking. The comments received and our responses to the comments are discussed in section IV of this document. Because we received significant adverse comment in response to the rulemaking, we published a notice in the **Federal Register** of September 14, 2006 (71 FR 54198), withdrawing the direct final rule. III. Highlights of the Final Rule To transfer from FDA to HRSA jurisdiction over blood vessels intended for use in organ transplantation, the final rule amends 21 CFR 1271.3(d), 42 CFR 121.2, and 42 CFR 121.7 as follows: A. 21 CFR 1271.3(d) 21 CFR 1271.3(d) defines HCT/Ps as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” In the definition, we also exclude certain articles from the definition of HCT/Ps. This final rule adds § 1271.3(d)(8), excluding from the definition of HCT/Ps blood vessels intended for use in organ transplantation. The rule excludes such blood vessels intended for use in organ transplantation only when they are labeled as “For use in organ transplantation only,” to distinguish such vessels from blood vessels not intended for use in organ transplantation. By labeling such blood vessels “For use in organ transplantation only,” we expect that they will not be used for other purposes. Under the final rule, blood vessels intended for other uses remain subject to 21 CFR part 1271. B. 42 CFR 121.2 Under 42 CFR 121.2, “Organ” means a human kidney, liver, heart, lung, or pancreas. This final rule adds to that definition “Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this Part if the vessels are intended for use in organ transplantation and labeled ‘For use in organ transplantation only’.” Blood vessels intended for use in organ transplantation are required to be in compliance with HRSA provisions for donor screening and testing. The labeling provision is required in order for such blood vessels to fall under this regulatory program. Any OPTN labeling policies, whether voluntary or enforceable, supplement this requirement. C. 42 CFR 121.7 In 42 CFR 121.7, we are redesignating paragraph

(e)as paragraph (f), and adding a new paragraph (e). Under 42 CFR 121.7(e), a blood vessel intended for use in organ transplantation is subject to the allocation requirements under 42 CFR part 121 and enforceable OPTN policies pertaining to the organ with which the blood vessel is procured. These provisions apply until the transplant center receiving the organ determines that the blood vessel is not needed for the transplantation of that organ. This allocation priority assures that vessels that may be necessary for the immediate transplantation of the organs with which they are recovered are made available for that use prior to being diverted to other organ transplant uses. IV. Comments on the Proposed Rule and HRSA and FDA Responses (Comment 1) One comment supported the proposed rule. The comment stated that the Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) Board of Directors has approved a policy to provide guidance for the recovery, use, and storage of deceased donor vascular allografts. The comment also stated that the OPTN/UNOS policy does not result in undue burden to the transplant community and is consistent with the provisions of the proposed rule. (Response) We appreciate the supportive comment. One of our reasons for the proposed rule is to eliminate the burden of dual oversight, by FDA and HRSA, of those blood vessels used in organ transplantation. The policy discussed in the comment is OPTN/UNOS Policy 5.7. 1 OPTN/UNOS Policy 5.7 addresses practices for blood vessel recovery, storage, and transplant by transplant centers and OPOs. The policy will only be implemented once this final rule goes into effect. 1 See *http://www.optn.org/PoliciesandBylaws2/policies/pdfs/policy_17.pdf* . (FDA and HRSA have verified the Web site address, but the agencies are not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** ). (Comment 2) One comment stated that patients would be better protected under the existing regulatory scheme. The comment questioned the safety of transplanting blood vessels recovered from a deceased organ donor into third party recipients who received organs from other donors. The comment explained that use of blood vessels in these recipients poses disease transmission and human leukocyte antigen

(HLA)sensitization risks that jeopardize patient safety. The comment also stated that the OPTN and organ transplant programs lack adequate tracking and traceability mechanisms for such blood vessels. (Response) We acknowledge that the use of blood vessels poses disease transmission and HLA sensitization risks in third party recipients. The intent of this rule is to facilitate the successful completion of life-saving organ transplants in medical procedures where the vasculature of the donated organ is inadequate, or to salvage a graft that would otherwise be lost. It is up to the organ transplant surgeon to assess the risks and benefits of, and alternatives to, using a particular vessel to accomplish or modify an organ transplant. Moreover, the risks of disease transmission and HLA sensitization would apply even if FDA retained jurisdiction over these blood vessels as HCT/Ps. FDA regulations, like HRSA policies, reduce, but cannot entirely eliminate, the risk of disease transmission, and FDA tissue regulations do not address HLA sensitization. In addition, the OPTN has long-established mechanisms for tracking of organs from the donor to the recipient, which require the reporting of transplant outcomes. HRSA intends to monitor the use and outcomes of these vessels used in organ transplantation, and to work with the OPTN to modify policies governing their use as needed. (Comment 3) One comment suggested that the rulemaking should distinguish between organ recipients based on the type of their organ donor (living, nonrelated; living, related; or deceased) and use these distinctions to define the types of transplant recipients who may receive these vessels for organ transplant use. The comment asked whether a surgeon may use vessels from a deceased donor to repair a thrombosed renal artery in the recipient of a living donor kidney. (Response) We decline to make these suggested changes to the rulemaking. The language in 42 CFR 121.7(e) establishes a priority allocation for use of vessels with organs from the same donor. If vessels are not needed for this use, the rule does not preclude vessels recovered from deceased donors and labeled “For use in organ transplantation only” from being transplanted into recipients of organs from living donors, either to perform the initial transplant of the organ or to later modify the organ transplant. The situation described in the comment would be an example of the use of such vessels to modify a transplant. V. Legal Authority We are issuing these regulations under the authority of the National Organ Transplant Act as amended

(NOTA)and section 361 of the Public Health Service Act (the PHS Act). NOTA authorizes HRSA, by delegation from the Secretary, to issue regulations governing the operation of the OPTN. NOTA, as amended, also authorizes the Secretary to define human organs to be covered by the OPTN. Section 374 of the PHS Act specifically states, “[t]he term ‘organ’ means the human kidney, liver, heart, lung, pancreas, *and any other human organ (other than corneas and eyes) specified by the Secretary by regulation* .* * *.” (42 U.S.C. § 274b(d)(2)) (emphasis supplied). Accordingly, HRSA is issuing this regulation to modify the definition of “organ,” and to make blood vessels labeled and intended for use in the transplantation of organs subject to regulations governing the operation of the OPTN. Extending the definition of organs governed by HRSA in 42 CFR 121.2 to add blood vessels recovered with organs that are intended for use in organ transplantation, and labeled as such, furthers the Secretary's charge under NOTA. Under the authority of section 361 of the PHS Act delegated to the Commissioner of FDA, the Department of Health and Human Services may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or from foreign countries into the States. This modification of FDA's existing regulation reflects FDA's re-evaluation of the level of regulation that is necessary to prevent disease transmission involving blood vessels intended for use in organ transplantation. VI. Analysis of Impacts FDA and HRSA have examined the impacts of the final 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 agencies believe that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the agencies do not expect that the transfer from FDA to HRSA of jurisdiction over the blood vessels described in the rule will result in substantial changes in the way transplant hospitals and OPOs procure, store, and transplant such blood vessels, FDA and HRSA certify that the final 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 $122 million, using the most current

(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. VII. The Paperwork Reduction Act of 1995 This final rule contains no collections of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required. VIII. Environmental Impact FDA and HRSA have determined under 21 CFR 25.30(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IX. Federalism FDA and HRSA have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA and HRSA have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, FDA and HRSA have concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. X. Effective Date This final rule is effective on April 11, 2007. List of Subjects 21 CFR Part 1271 Biologics, Communicable diseases, Drugs, HIV/AIDS, Human cells, tissues, and cellular and tissue-based products, Medical devices, Reporting and recordkeeping requirements. 42 CFR Part 121 Healthcare, Hospitals, Reporting and recordkeeping requirements. Therefore, under the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs and to the Administrator, Health Resources and Services Administration, 21 CFR part 1271 and 42 CFR part 121 are amended as follows: 21 CFR Chapter I PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1. The authority citation for 21 CFR part 1271 continues to read as follows: Authority: 42 U.S.C. 216, 243, 263a, 264, 271. 2. Section 1271.3 is amended by adding paragraph (d)(8) to read as follows: § 1271.3 How does FDA define important terms in this part?

(d)* * *

(8)Blood vessels recovered with an organ, as defined in 42 CFR 121.2, that are intended for use in organ transplantation and labeled “For use in organ transplantation only.” 42 CFR Chapter I PART 121—ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK 3. The authority citation for 42 CFR part 121 continues to read as follows: Authority: Sections 215, 371-376 of the Public Health Service Act (42 U.S.C. 216, 273-274d); and sections 1102, 1106, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh). 4. Section 121.2 is amended by adding a sentence at the end of the definition of “Organ” to read as follows: § 121.2 Definitions *Organ* * * * Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled “For use in organ transplantation only.” 5. Section 121.7 is amended by redesignating paragraph

(e)as paragraph

(f)and by adding paragraph

(e)to read as follows: § 121.7 Identification of organ recipient.

(e)*Blood vessels considered part of an organ* . A blood vessel that is considered part of an organ under this part shall be subject to the allocation requirements and policies pertaining to the organ with which the blood vessel is procured until and unless the transplant center receiving the organ determines that the blood vessel is not needed for the transplantation of that organ. Dated: December 8, 2006. Elizabeth M. Duke, Administrator, Health Resources and Services Administration. Dated: February 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy, Food and Drug Administration. [FR Doc. 07-1131 Filed 3-9-07; 8:45 am]

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