10920 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 

(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/ibrlocations.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 


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Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 10921 

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 workhours 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. 


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10922 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Rules and Regulations 

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 Sa ́nchez, 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 


hsrobinson on PROD1PC76 with RULES