36950 Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Proposed Rules 

TABLE 1—AFFECTED PARTS

Part name Part No. 

Upper Pin ........................ 600–92384–5 

Upper Pin ........................ 600–92384–7 

Upper Pin ........................ 601R92310–1 

Lower Pin ........................ 600–92383–5 

Lower Pin ........................ 600–92383–7 

Lower Pin ........................ 601R92309–1 

Trunnion .......................... 601R92386–1 

(h) Replacement 

If, during any inspection required by 

paragraph (g) of this AD, any gouges, 

scratches, or corrosion are found: Before 

further flight, replace the affected part with 

a part other than one identified in table 1 of 

this AD, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 601R–27–160, dated 

September 29, 2011. 

(i) Re-Identification 

If, during any inspection required by 

paragraph (g) of this AD, no gouges, scratches 

or corrosion are found: Before further flight, 

add serial numbers and new part numbers to 

the trunnions, upper pins, and lower pins, in 

accordance with the Accomplishment 

Instructions of Bombardier Service Bulletin 

601R–27–160, dated September 29, 2011. 

(j) Revise Maintenance Program 

Within 30 days after the effective date of 

this AD, revise the maintenance program to 

incorporate the information specified in 

Bombardier Temporary Revisions 2B–2180, 

dated August 8, 2011; and 2B–2186, dated 

August 8, 2011; to Appendix B— 

Airworthiness Limitations, of Part 2, 

Airworthiness Requirements, of the 

Bombardier CL–600–2B19 Maintenance 

Requirements Manual (MRM). The 

compliance time for doing the initial 

replacement for the HSTA trunnion support 

and attaching hardware is before the 

accumulation of 80,000 landings or within 60 

days after the effective date of this AD, 

whichever occurs later. The compliance time 

for doing the initial inspection of the upper 

and lower installation pins of the horizontal 

stabilizer pitch trim actuator is before the 

accumulation of 40,000 landings or within 60 

days after the effective date of this AD, 

whichever occurs later. 

(k) No Alternative Actions or Intervals 

After accomplishing the revision required 

by paragraph (j) of this AD, no alternative 

actions (e.g., inspections) or intervals may be 

used unless the actions or intervals are 

approved as an alternative method of 

compliance (AMOC) in accordance with the 

procedures specified in paragraph (l)(1) of 

this AD. 

(l) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York Aircraft 

Certification Office, ANE–170, FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the ACO, send it to ATTN: Program 

Manager, Continuing Operational Safety, 

FAA, New York ACO, 1600 Stewart Avenue, 

Suite 410, Westbury, New York 11590; 

telephone 516–228–7300; fax 516–794–5531. 

Before using any approved AMOC, notify 

your appropriate principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office/ 

certificate holding district office. The AMOC 

approval letter must specifically reference 

this AD. 

(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. 

(m) Related Information 

(1) Refer to MCAI Canadian Airworthiness 

Directive CF–2011–45, dated December 19, 

2011, and the service information specified 

in paragraphs (m)(1)(i), (m)(1)(ii), and 

(m)(1)(iii) of this AD, for related information. 

(i) Bombardier Service Bulletin 601R–27– 

160, dated September 29, 2011. 

(ii) Bombardier Temporary Revision 2B– 

2180, dated August 8, 2011, to Appendix B— 

Airworthiness Limitations, of Part 2, 

Airworthiness Requirements, of the 

Bombardier CL–600–2B19 Maintenance 

Requirements Manual. 

(iii) Bombardier Temporary Revision 2B– 

2186, dated August 8, 2011, to Appendix B— 

Airworthiness Limitations, of Part 2, 

Airworthiness Requirements, of the 

Bombardier CL–600–2B19 Maintenance 

Requirements Manual. 

(2) For service information identified in 

this AD, contact Bombardier, Inc., 400 CoˆteVertu Road West, Dorval, Que ́bec H4S 1Y9, 

Canada; telephone 514–855–5000; fax 514– 

855–7401; email 

thd.crj@aero.bombardier.com; Internet http:// 

www.bombardier.com. You may review 

copies of the referenced service information 

at the FAA, Transport Airplane Directorate, 

1601 Lind Avenue SW., Renton, Washington. 

For information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on June 11, 

2012. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–15063 Filed 6–19–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2011–0222; Directorate 

Identifier 2010–NM–056–AD] 

RIN 2120–AA64 

Airworthiness Directives; Dassault 

Aviation Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Proposed rule; withdrawal. 

SUMMARY: The FAA withdraws a notice 

of proposed rulemaking (NPRM) that 

proposed a new airworthiness directive 

(AD) for certain Dassault Aviation 

Model FALCON 7X airplanes. The 

proposed AD would have required 

revising the maintenance program to 

incorporate a limitation that reduced 

time between overhauls, and required 

an initial overhaul, of the direct current 

(DC) generator (bearings). Since the 

proposed AD was issued, we have 

received new data that confirm the 

identified unsafe condition is not 

sufficient to warrant issuance of an AD. 

Accordingly, the proposed AD is 

withdrawn. 

ADDRESSES: You may examine the AD 

docket on the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Management Facility between 

9 a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The AD 

docket contains this AD action, the 

regulatory evaluation, any comments 

received, and other information. The 

address for the Docket Office (telephone 

800–647–5527) is the 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: Tom 

Rodriguez, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue SW., Renton, 

Washington 98057–3356; telephone 

(425) 227–1137; fax (425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We proposed to amend part 39 of the 

Federal Aviation Regulations (14 CFR 

part 39) with a notice of proposed 

rulemaking (NPRM) for a new AD for 

certain Dassault Aviation Model 

FALCON 7X airplanes. That NPRM was 

published in the Federal Register on 

March 15, 2011 (76 FR 13924). That 


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Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Proposed Rules 36951 

NPRM would have required revising the 

maintenance program to incorporate a 

limitation that reduced time between 

overhauls, and required an initial 

overhaul, of the DC generator (bearings). 

That NPRM resulted from mandatory 

continuing airworthiness information 

(MCAI) originated by an aviation 

authority of another country to identify 

and correct an unsafe condition on an 

aviation product. The MCAI described 

the unsafe condition as: 

Time between overhaul (TBO) of DC [direct 

current] generator bearings is set at 1,000 

flight hours (FH) in the airworthiness 

limitations section of the Falcon 7X Aircraft 

Maintenance Manual Chapter 5.40. 

In service report has shown that the 

bearing current design cannot sustain the 

current TBO. * * * 

* * * * * 

Failure to comply with those revised 

maintenance tasks could constitute an unsafe 

condition. 

The proposed actions were intended to 

prevent failure of the DC generator 

bearings, which could lead to loss of the 

generator and potential loss of electrical 

power to the fly-by-wire system and 

subsequent loss of control of the 

airplane. 

Actions Since NPRM (76 FR 13924, 

March 15, 2011) Was Issued 

Since we issued the NPRM (76 FR 

13924, March 15, 2011), the airplane 

manufacturer provided further 

information on the redundancy of the 

electrical system that supplies power to 

the fly-by-wire system. There are three 

DC generators that can supply electrical 

power to the fly-by-wire system. 

Electrical power can also be supplied by 

two independent permanent magnet 

alternator converters that are dedicated 

to that system. Failure of all three DC 

generators to supply electrical power 

automatically triggers a command to 

deploy the ram air turbine, which will 

supply the airplane systems (including 

fly-by-wire) with sufficient electrical 

power for continued safe flight and 

landing. 

FAA’s Conclusions 

Upon further consideration, we have 

determined that, based on the airplane 

design, and the multiple electrical 

power generation sources, the potential 

loss of one DC generator due to an unreduced maintenance interval would 

not result in loss of electrical power to 

the airplane. Therefore, the potential 

loss of one DC generator does not 

constitute an unsafe condition. 

Accordingly, the NPRM (76 FR 13924, 

March 15, 2011) is withdrawn. 

Withdrawal of the NPRM (76 FR 

13924, March 15, 2011) does not 

preclude the FAA from issuing another 

related action or commit the FAA to any 

course of action in the future. 

Regulatory Impact 

Since this action only withdraws an 

NPRM (76 FR 13924, March 15, 2011), 

it is neither a proposed nor a final rule 

and therefore is not covered under 

Executive Order 12866, the Regulatory 

Flexibility Act, or DOT Regulatory 

Policies and Procedures (44 FR 11034, 

February 26, 1979). 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Withdrawal 

Accordingly, we withdraw the NPRM, 

Docket No. FAA–2011–0222, Directorate 

Identifier 2010–NM–056–AD, which 

was published in the Federal Register 

on March 15, 2011 (76 FR 13924). 

Issued in Renton, Washington, on June 12, 

2012. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–15097 Filed 6–19–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2012–N–0303] 

Gastroenterology-Urology Devices; 

Reclassification of Implanted Blood 

Access Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify the implanted blood access 

device preamendments class III device 

into class II (special controls). FDA is 

proposing this reclassification on its 

own initiative based on new 

information. FDA is taking this action 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments), the Safe Medical Devices 

Act of 1990 (SMDA), the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA), and the Medical Device 

User Fee and Modernization Act of 2002 

(MDUFMA). 

DATES: Submit either electronic or 

written comments on the proposed rule 

by September 18, 2012. Please see 

section XIII of this document for the 

effective date of any final rule that may 

publish based on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0303 by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http://www.

regulations.gov, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://www.

regulations.gov and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Cooper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. G228, Silver Spring, 

MD 20993, 301–796–6517. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The FD&C Act, as amended by the 

1976 amendments (Pub. L. 94–295), the 

SMDA (Pub. L. 101–629), the FDAMA 


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