[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Rules and Regulations]
[Pages 7374-7377]
[FR Doc No: 2014-02464]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0691; Directorate Identifier 2012-NM-170-AD;
Amendment 39-17678; AD 2013-24-04]
RIN 2120-AA64

Airworthiness Directives; Learjet Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2003-19-11 for
certain Learjet Inc. Model 60 airplanes. AD 2003-19-11 required
determining if a certain fuel crossflow tube is installed; and follow-
on/corrective actions, as applicable. This new AD requires retaining
all actions in AD 2003-19-11, and it also requires determining if a
certain fuel crossflow tube is installed, performing repetitive
measurements of the fuel crossflow tube and surrounding valves and
cables, and doing corrective actions if necessary. In addition, this
new AD expands the applicability of AD 2003-19-11. This AD was prompted
by a report that airplanes produced since 2003 might also be subject to
the unsafe condition; and that the minimum allowable clearance is not
established in the airplane maintenance information. We are issuing
this AD to prevent chafing and consequent failure of the fuel crossflow
tube due to inadequate clearance between the tube and the flight
control cables, which could result in loss of fuel from one fuel tank
during normal operating conditions or loss of fuel from both main fuel
tanks during fuel cross-feeding operations.

DATES: This AD is effective March 14, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 3,
2003 (68 FR 55812, September 29, 2003).

ADDRESSES: For service information identified in this AD, contact
Learjet, Inc., One Learjet Way, Wichita, KS 67209-2942; telephone 316-
946-2000; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FAA-2013-0691; 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, the regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
Docket 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: Jeff Janusz, Aerospace Engineer,
Propulsion Branch, ACE-116W, FAA, Wichita Aircraft Certification Office
(ACO), 1801 Airport Road, Room 100, Wichita, KS 67209; phone: 316-946-
4148; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2003-19-11, Amendment 39-13314 (68 FR 55812,
September 29, 2003). AD 2003-19-11 applied to certain Learjet Inc.
Model 60 airplanes. The NPRM published in the Federal Register on
August 13, 2013 (78 FR 49232). The NPRM was prompted by a report that
airplanes produced since 2003 might also be subject to the unsafe
condition; and that the minimum allowable clearance is not established
in the airplane maintenance information. The NPRM proposed to continue
to require determining if a certain fuel crossflow tube is installed;
and follow-on/corrective actions, as applicable. The NPRM also proposed
to require determining if a certain fuel crossflow tube is installed,
performing repetitive measurements of the fuel crossflow tube and
surrounding valves and cables, and doing corrective actions if
necessary. In addition, the NPRM proposed to expand the applicability
of AD 2003-19-11. We are issuing this AD to prevent chafing and
consequent failure of the fuel crossflow tube due to inadequate
clearance between the tube and the flight control cables, which could
result in loss of fuel from one fuel tank during normal operating
conditions or loss of fuel from both main fuel tanks during fuel cross-
feeding operations.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (78 FR 49232, August 13,
2013) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 49232, August 13, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 49232, August 13, 2013).

Costs of Compliance

    We estimate that this AD affects 264 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost  on
                  Action                            Labor cost           Parts cost     Cost per        U.S.
                                                                                product      operators
----------------------------------------------------------------------------------------------------------------
Inspection [retained actions from AD 2003- 2 work-hours x $85 per hour           $2          $172       $45,408
 19-11, Amendment 39-13314 (68 FR 55812,    = $170.
 September 29, 2003)].
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacement
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need this
replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement..................................  4 work-hours x $85 per hour =               $20             $360
                                                $340.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information
Collection Clearance Officer, AES-200.

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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

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

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2003-19-11, Amendment 39-13314 (68 FR 55812, September 29, 2003), and
adding the following new AD:

2013-24-04 Learjet Inc.: Amendment 39-17678; Docket No. FAA-2013-
0691; Directorate Identifier 2012-NM-170-AD.

(a) Effective Date

    This AD is effective March 14, 2014.

(b) Affected ADs

    This AD supersedes AD 2003-19-11, Amendment 39-13314 (68 FR
55812, September 29, 2003).

(c) Applicability

    This AD applies to Learjet Inc. Model 60 airplanes, certificated
in any category, serial numbers 60-001 through 60-409 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by a report that airplanes produced since
2003 might also be subject to the unsafe condition; and that the
minimum allowable clearance is not established in the airplane
maintenance information. We are issuing this AD to prevent chafing
and consequent failure of the fuel crossflow tube due to inadequate
clearance between the tube and the flight control cables, which
could result in loss of fuel from one fuel tank during normal
operating conditions or loss of fuel from both main fuel tanks
during fuel cross-feeding operations.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Part Identification for Airplanes Having Serial Numbers
60-001 Through 60-145 Inclusive

    This paragraph restates the part identification required by
paragraph (a) of AD 2003-19-11, Amendment 39-13314 (68 FR 55812,
September 29, 2003). For airplanes having serial numbers 60-001
through 60-145 inclusive: Within 25 flight hours after November 3,
2003 (the effective date of AD 2003-19-11), inspect the fuel
crossflow tube to determine whether part number (P/N) 6026020-005 is
installed. Instead of inspecting the tube, a review of airplane
maintenance records is acceptable if the part number of the tube can
be positively determined from that review.

(h) Retained Clearance Measurement and Corrective Action for Airplanes
Having Serial Numbers 60-001 Through 60-145 Inclusive, With Revised
Repair Language

    This paragraph restates the clearance measurement and corrective
action required by paragraph (b) of AD 2003-19-11, Amendment 39-
13314 (68 FR 55812, September 29, 2003), with revised repair
language. For airplanes having serial numbers 60-001 through 60-145
inclusive: If P/N 6026020-005 is found installed during the review
or inspection required by paragraph (g) of this AD, before further
flight, measure the clearance between the fuel crossflow tube and
the flight control cables to determine if it is at least 0.35 inch,
per paragraph 2.B.(8) of the Accomplishment Instructions of
Bombardier Alert Service Bulletin A60-28-3, Revision 2, dated
October 26, 1998.
    (1) If the clearance is 0.35 inch or more, no further action is
required by this paragraph.
    (2) If the clearance is less than 0.35 inch, before further
flight, repair in accordance with a method approved by the Manager,
Wichita Aircraft Certification Office (ACO), FAA. For a repair
method to be approved by the Manager, Wichita ACO, as required by

this paragraph, the Manager's approval letter must specifically
refer to this AD.

    Note 1 to paragraphs (h) and (j) of this AD: Bombardier Alert
Service Bulletin A60-28-3, Revision 2, dated October 26, 1998,
Figure 1, Detail D, incorrectly identifies the fuel crossflow tube
to be installed as P/N 6026020-001. The manufacturer is aware of
this error and stated it plans to correct the part number in the
next revision of the service information.

(i) Retained Part Replacement, Measurement, and Repair for Airplanes
Having Serial Numbers 60-001 Through 60-055 Inclusive, With Revised
Repair Language

    This paragraph restates the part replacement, clearance
measurement, and corrective action required by paragraph (c) of AD
2003-19-11, Amendment 39-13314 (68 FR 55812, September 29, 2003),
with revised repair language. For airplanes having serial numbers
60-001 through 60-055 inclusive: If P/N 6026020-005 is not found
installed during the review or inspection required by paragraph (g)
of this AD, within 90 days after accomplishing the review or
inspection, replace the existing fuel crossflow tube with a new fuel
crossflow tube having P/N 6026020-005, and measure the clearance
between the newly installed fuel crossflow tube and the flight
control cables, per paragraph 2.A. of the Accomplishment
Instructions of Bombardier Service Bulletin 60-28-4, Revision 2,
dated August 22, 2001.
    (1) If the clearance is 0.35 inch or more, no further action is
required by this paragraph.
    (2) If the clearance is less than 0.35 inch, before further
flight, repair in accordance with a method approved by the Manager,
Wichita ACO, FAA. For a repair method to be approved by the Manager,
Wichita ACO, as required by this paragraph, the Manager's approval
letter must specifically refer to this AD.

(j) Retained Part Replacement, Measurement, and Repair for Airplanes
Having Serial Numbers 60-056 Through 60-145 Inclusive, With Revised
Repair Language

    This paragraph restates the part replacement, clearance
measurement, and corrective action required by paragraph (d) of AD
2003-19-11, Amendment 39-13314 (68 FR 55812, September 29, 2003),
with revised repair language. For airplanes having serial numbers
60-056 through 60-145 inclusive: If P/N 6026020-005 is not found
installed during the review or inspection required by paragraph (g)
of this AD, within 90 days after accomplishing the review or
inspection, replace the existing fuel crossflow tube with a new fuel
crossflow tube having P/N 6026020-005, and measure the clearance
between the newly installed fuel crossflow tube and the flight
control cables to determine if the clearance is at least 0.35 inch,
per paragraph 2.B. of the Accomplishment Instructions of Bombardier
Alert Service Bulletin A60-28-3, Revision 2, dated October 26, 1998.
    (1) If the clearance is 0.35 inch or more, no further action is
required by this paragraph.
    (2) If the clearance is less than 0.35 inch, before further
flight, repair in accordance with a method approved by the Manager,
Wichita ACO, FAA. For a repair method to be approved by the Manager,
Wichita ACO, as required by this paragraph, the Manager's approval
letter must specifically refer to this AD.

 (k) New Part Identification

    For airplanes having serial numbers 60-001 through 60-409
inclusive: Within 25 flight hours after the effective date of this
AD, inspect the fuel crossflow tube to determine whether P/N
6026020-005 is installed. In lieu of inspecting the tube, a review
of airplane maintenance records is acceptable if the part number of
the tube can be positively determined from that review.

(l) New Clearance Measurement

    If P/N 6026020-005 is found installed during the inspection
required by paragraph (k) of this AD, before further flight, measure
the clearance between the fuel crossflow tube and both elevator
control cables to determine if it is 0.35 inch or more, in
accordance with paragraph 2.A.(9) of the Accomplishment Instructions
of Bombardier Service Bulletin 60-28-4, Revision 2, dated August 22,
2001.
    (1) If the clearance is 0.35 inch or more, no further action is
required by this paragraph.
    (2) If the clearance is less than 0.35 inch, before further
flight, adjust the fit of the P/N 6026020-005 tube to provide 0.35
inch or more clearance to both elevator control cables, in
accordance with paragraph 2.A.(9) of the Accomplishment Instructions
of Bombardier Service Bulletin 60-28-4, Revision 2, dated August 22,
2001. If the tube shows any indication of chafing from the control
cables, before further flight, replace the fuel crossflow tube with
a new fuel crossflow tube, in accordance with paragraph 2.A.(9) of
the Accomplishment Instructions of Bombardier Service Bulletin 60-
28-4, Revision 2, dated August 22, 2001.

(m) New Repetitive Measurements

    For all airplanes: As of the effective date of this AD and after
accomplishing the inspection required by paragraph (g) or (k) of
this AD, as applicable: Before further flight after removal,
replacement, or adjustment of any crossflow tube, fuel crossflow
drain valve, fuel crossflow valve or related plumbing and fittings,
and elevator control cable, measure the clearance between the fuel
crossflow tube and the flight control cables, in accordance with
paragraph 2.A.(9) of the Accomplishment Instructions of Bombardier
Service Bulletin 60-28-4, Revision 2, dated August 22, 2001.
    (1) If the clearance is 0.35 inch or more, no further action is
required by this paragraph.
    (2) If the clearance is less than 0.35 inch, before further
flight, adjust the fit of the P/N 6026020-005 tube to provide 0.35
inch or more clearance to both elevator control cables, in
accordance with paragraph 2.A.(9) of the Accomplishment Instructions
of Bombardier Service Bulletin 60-28-4, Revision 2, dated August 22,
2001.

(n) Reporting Requirement

    Submit a report of the findings of the initial measurement
required by paragraph (l) of this AD to the Wichita Manufacturing
Inspection District Office, 2204 South Tyler Road, Wichita, KS
67209-3001, at the applicable time specified in paragraph (n)(1) or
(n)(2) of this AD. The report must include the airplane
registration, serial number, the total time in service, and the
measured clearance found between the fuel crossflow tube and the
elevator control cables after the initial inspection.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(o) Part Installation Prohibition

    As of the effective date of AD, only fuel crossflow tubes having
P/N 6026020-005 may be installed on any airplane.

(p) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(q) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita ACO, 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 manager of the
ACO, send it to the attention of the person identified in paragraph
(r) of this AD.
    (2) 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.

(r) Related Information

    For more information about this AD, contact Jeff Janusz,
Aerospace Engineer, Propulsion Branch, ACE-116W, FAA, Wichita ACO,
1801 Airport Road, Room 100, Wichita, KS 67209; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(s) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this

paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
November 3, 2003 (68 FR 55812, September 29, 2003).
    (i) Bombardier Alert Service Bulletin A60-28-3, Revision 2,
dated October 26, 1998.
    (ii) Bombardier Service Bulletin 60-28-4, Revision 2, dated
August 22, 2001.
    (4) For service information identified in this AD, contact
Learjet, Inc., One Learjet Way, Wichita, KS 67209-2942; telephone
316-946-2000; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://www.bombardier.com.
    (5) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 27, 2013.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-02464 Filed 2-6-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 19, 2006 (Volume 71, Number 181)]
[Notices]
[Page 54810-54811]
[DOCID:fr19se06-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-437-000]

Northern Indiana Fuel and Light Company, Inc.; Notice of
Application

September 13, 2006.
    Take notice that on August 29, 2006, Northern Indiana Fuel and
Light Company, Inc. (NIFL) 501 Technology Drive, Canonsburg,
Pennsylvania 15317, filed in Docket No. CP06-437-000, an application
pursuant to section 7(c) of the Natural Gas Act (NGA) requesting a
blanket transportation certificate pursuant to Part 284.224 of the
Commission's regulations which would authorize NIFL to transport
natural gas in interstate commerce to the same extent and in the same
manner that intrastate pipelines are authorized to engage in such
activities under Subparts C and D of Part 284 of the Commission's
regulations, all as more fully set forth in the application, which is
on file with the Commission and open to public inspection. NIFL states
that it has also submitted a copy of its application to the Indiana
Utility Regulatory Commission. The filing may also be viewed on the web
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,

(202) 502-8659.
    Any questions regarding this application should be directed to
Kenneth W. Christman, 501 Technology Drive, Canonsburg, Pennsylvania
15317, or at<PHONE_NUMBER> (telephone); (724)

416-6384 (fax<EMAIL_ADDRESS>(e-mail).
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a) (1) (iii)
and the instructions on the Commission's Web site under the ``e-
Filing'' link.
    Comment Date: September 25, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-15518 Filed 9-18-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 4, 2010 (Volume 75, Number 107)]
[Notices]
[Page 31790-31791]
[DOCID:fr04jn10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0278]

Determination That Cysteine Hydrochloride Injection, USP, 7.25%,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that Cysteine Hydrochloride Injection, USP, 7.25%
(Cysteine HCl), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for Cysteine HCl if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 6358, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved.

Sponsors of ANDAs do not have to repeat the extensive clinical testing
otherwise necessary to gain approval of a new drug application (NDA).
The only clinical data required in an ANDA are data to show that the
drug that is the subject of the ANDA is bioequivalent to the listed
drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness
(Sec.  314.162 (21 CFR 314.162)). Under Sec.  314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug.
    Cysteine HCl is the subject of NDA 19-523, most recently held by
Hospira, Inc. (Hospira), and initially approved on October 22, 1986.
Cysteine HCl is indicated for use as an additive to amino acid
solutions to meet the nutritional requirements of newborn infants
requiring total parenteral nutrition (TPN) and of adult and pediatric
patients with severe liver disease who may have impaired enzymatic
processes and require TPN. It can also be added to amino acid solutions
to provide a more complete profile of amino acids for protein
synthesis. Hospira notified FDA in a letter dated May 26, 2005, that it
had not commercially manufactured and marketed Cysteine HCl, and
voluntarily asked that the NDA be withdrawn. The drug product was moved
to the ``Discontinued Drug Product List'' section of the Orange Book,
and FDA withdrew approval of NDA 19-523 effective June 16, 2006 (71 FR
34940). In previous instances (see, e.g., 74 FR 63404, December 3,
2009; 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the agency
has determined that, for purposes of Sec. Sec.  314.161 and 314.162,
never marketing an approved drug product is equivalent to withdrawing
the drug from sale. Regulus Pharmaceutical Consulting, Inc., submitted
a citizen petition, dated April 30, 2008 (Docket No. FDA-2008-P-0278),
under 21 CFR 10.30, requesting that the agency determine whether
Cysteine HCl was withdrawn from sale for reasons of safety or
effectiveness.
    FDA has reviewed its records and, under Sec.  314.161, has
determined that Cysteine Hydrochloride Injection, USP, 7.25%, was not
withdrawn for reasons of safety or effectiveness. We have also
independently evaluated relevant literature and have found no
information that would indicate that this product was withheld from
sale for reasons of safety or effectiveness. Accordingly, the agency
will continue to list Cysteine Hydrochloride Injection, USP, 7.25%, in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to Cysteine
Hydrochloride Injection, USP, 7.25% may be approved by the agency if
all other legal and regulatory requirements for the approval of ANDAs
are met. If FDA determines that the labeling for this drug product
should be revised to meet current standards, the agency will advise
ANDA applicants to submit such labeling.

    Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13463 Filed 6-3-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40587-40588]
[FR Doc No: 2021-16050]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0649]

Determination That CECLOR CD (Cefaclor Extended-Release Tablets)
375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness, Except the Indication of Secondary
Bacterial Infections of Acute Bronchitis, Which Was Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that CECLOR CD (cefaclor extended-release tablets) 375
milligrams (mg) and 500 mg were not withdrawn from sale for reasons of
safety or effectiveness, except with respect to the indication of
secondary bacterial infections of acute bronchitis (SBIAB) that was
withdrawn for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to suspend approval of any
abbreviated new drug application (ANDA) that refers to this drug
product and has removed the indication for SBIAB. This determination
also will allow FDA to continue to approve ANDAs that refer to these
drug products as long as they meet relevant legal and regulatory
requirements. However, the Agency will not accept or approve ANDAs for
CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg that
include SBIAB as an indication.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and, with certain exceptions, labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale but
must be made prior to approving an ANDA that refers to the listed drug
(Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does
not refer to a listed drug.
    Under Sec.  314.161(a)(2), the Agency must also determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness if ANDAs that referred to the listed drug have already
been approved prior to its market withdrawal. If the Agency determines
that a listed drug was withdrawn from sale for reasons of safety or
effectiveness, and there are approved ANDAs that reference that listed
drug, FDA will initiate a proceeding to determine whether the
suspension of the ANDAs is also required (21 CFR 314.161(d)).
    CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg are
the subject of NDA 050673 held by Eli Lilly and Co., and initially
approved on June 28, 1996. CECLOR CD (cefaclor extended-release
tablets) is indicated for the treatment of patients with the following
mild to moderate infections when caused by susceptible strains of the
designated microorganisms:
     Acute bacterial exacerbations of chronic bronchitis due to
Haemophilus influenzae (non-[beta]-lactamase-producing strains only),
Moraxella catarrhalis (including [beta]-lactamase-producing strains) or
Streptococcus pneumoniae.
     Secondary bacterial infections of acute bronchitis due to
H. influenzae (non-[beta]-lactamase-producing strains only), M.
catarrhalis (including [beta]-lactamase-producing strains), or S.
pneumoniae.
     Pharyngitis and tonsillitis due to Streptococcus pyogenes.
     Uncomplicated skin and skin structure infections due to
Staphylococcus aureus (methicillin-susceptible).
    On June 13, 2005, Eli Lilly and Co. submitted a request to the
Agency to withdraw approval of NDA 050673, CECLOR CD (cefaclor
extended-release tablets), 375 mg and 500 mg, under 21 CFR 314.150(c).
The Agency published a Federal Register notice on April 22, 2014,
withdrawing approval of NDA 050673, effective May 22, 2014.\1\
---------------------------------------------------------------------------

    \1\ See 79 FR 22501 (April 22, 2014).
---------------------------------------------------------------------------

    After reviewing Agency records and based on the information we have
at this time, FDA has determined under Sec.  314.161 that CECLOR CD
(cefaclor extended-release tablets), 375 mg and 500 mg, were not
withdrawn from sale for reasons of safety or effectiveness, except with
respect to the indication for SBIAB.
    Based on a review of relevant information, FDA has concluded that
the SBIAB indication is not appropriate because most cases of SBIAB are
considered to be viral or noninfectious. As an antibacterial drug,
CECLOR CD (cefaclor extended-release tablets) is not considered to be
effective to treat SBIAB. Such use of CECLOR CD (cefaclor extended-
release tablets) would likely result in inappropriate antibacterial
drug use. Accordingly, for the treatment of SBIAB, the benefit-risk
profile of CECLOR CD (cefaclor extended-release tablets) is unfavorable
and does not support approval of these products (or ANDAs referencing
them) for this indication. For the remaining indications, the Agency
has determined that CECLOR CD (cefaclor extended-release tablets)
continues to have a favorable benefit-risk profile.
    Accordingly, the Agency will continue to list CECLOR CD (cefaclor
extended-release tablets), 375 mg and 500 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The approved ANDA has

removed the SBIAB indication from its labeling, consistent with this
decision. In addition, FDA will continue to accept and, where
appropriate, approve ANDAs that refer to CECLOR CD (cefaclor extended-
release tablets) as long as they meet relevant legal and regulatory
requirements, but FDA will not accept or approve ANDAs that refer to
this drug product and propose to include the SBIAB indication. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16050 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]
[Page 69683]
[DOCID:fr19no08-120]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold its second Roundtable on Mark-to-
Market Accounting on Friday, November 21, 2008 beginning at 9:30 a.m.
    The Roundtable will take place in the Auditorium of the
Commission's headquarters at 100 F Street, NE., Washington DC. The
Roundtable will be open to the public with seating on a first-come,
first-served basis. Doors will open at 9 a.m. Visitors will be subject
to security checks.
    The roundtable will consist of an open discussion on potential
improvements to the current accounting model and implications of
possible changes. The roundtable will be organized as a panel
consisting of investors, issuers, auditors and other parties with
experience in mark-to-market accounting.
    For further information, please contact the Office of the Secretary
at<PHONE_NUMBER>.

     Dated: November 14, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-27557 Filed 11-18-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40317-40319]
[FR Doc No: 2016-14640]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1376]

Leveraging Existing Clinical Data for Extrapolation to Pediatric
Uses of Medical Devices; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the final guidance entitled ``Leveraging Existing

Clinical Data for Extrapolation to Pediatric Uses of Medical Devices;
Guidance for Industry and Food and Drug Administration Staff.'' This
guidance explains the circumstances in which it may be appropriate to
extrapolate existing medical device data to support pediatric device
indications in premarket approval applications (PMAs), humanitarian
device exemptions (HDEs) and de novo requests. This guidance also
describes FDA's approach for determining whether extrapolation may be
appropriate and the factors that should be considered within a
statistical model for extrapolation. Extrapolation may be appropriate
when there are few differences in safety or effectiveness of the
proposed device when used in adult as compared to the intended
pediatric populations and the adult data are of high quality for
borrowing.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-1376 for ``Leveraging Existing Clinical Data for
Extrapolation to Pediatric Uses of Medical Devices; Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses
of Medical Devices; Guidance for Industry and Food and Drug
Administration Staff'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002; or the Office of Communication,
Outreach, and Development, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jacqueline Francis, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G426, Silver Spring, MD 20993-0002, 301-
796-6405; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The objectives of this final guidance are: (1) To increase the
availability of safe and effective pediatric devices by providing a
roadmap for leveraging relevant existing clinical data for use in
demonstrating a reasonable assurance of safety and effectiveness in
PMAs and de novo requests, as well as for use in supporting approvals
of HDEs; (2) to explain the circumstances in which it may be
appropriate to leverage existing clinical data to support pediatric
device indications and labeling; (3) to outline the approach FDA uses
to determine whether extrapolation is appropriate, and, to what extent
the data can be leveraged; and (4) to describe statistical methodology
that can be used to leverage the data in a way that increases precision
for pediatric inferences. This approach will potentially streamline the
process for establishing a pediatric

intended use claim, and enhance and encourage pediatric device
development programs.
    This guidance does not change the regulatory threshold for valid
scientific evidence. Instead, the document seeks to provide clarity and
predictability for device sponsors and to ensure consistency within FDA
regarding the specific criteria that should be considered when deciding
whether leveraging existing clinical data to support pediatric claims
is appropriate, and if so, to what extent. When considering
extrapolation, sponsors are encouraged to engage FDA early in product
development planning.
    For the purposes of this document, ``extrapolation'' refers to the
leveraging process whereby an indication for use of a device in a new
pediatric patient population can be supported by existing clinical data
from a studied patient population. That is, when existing data are
relevant to a pediatric indication and determined to be valid
scientific evidence, it may be scientifically appropriate to attempt to
extrapolate such data to a pediatric use in support of demonstrating a
reasonable assurance of effectiveness or probable benefit and,
occasionally, safety.
    FDA published in the Federal Register of May 6, 2015 (80 FR 26061),
the document entitled ``Leveraging Existing Clinical Data for
Extrapolation to Pediatric Uses of Medical Devices; Guidance for
Industry and Food and Drug Administration Staff'' and the comment
period closed on August 4, 2015. FDA has considered all of the comments
received in finalizing this guidance. The comments from the docket
sought further clarification of the scope of the document, the extent
of extrapolation that may be feasible across various pediatric
subpopulations, and the concept of ``borrowing strength'' from existing
adult data. Accordingly, this guidance document has been updated to
include de novo requests within the scope and to provide additional
explanation on the concepts of extrapolation of data across pediatric
subpopulations and ``borrowing strength.''
    This guidance should be used in conjunction with other device-
specific guidances to help ensure that medical devices intended for use
in pediatric population provide reasonable assurance of safety and
effectiveness.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the extrapolation of data for pediatric uses
of medical devices. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download
an electronic copy of ``Leveraging Existing Clinical Data for
Extrapolation to Pediatric Uses of Medical Devices; Guidance for
Industry and Food and Drug Administration Staff'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1827 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485 (medical device labeling);
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078 (investigational device exemptions);
the collections of information in 21 CFR part 814 have been approved
under OMB control number 0910-0231 (subparts A through E, premarket
approval).

V. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA guidance entitled ``Premarket Assessment of Pediatric Medical
Devices,'' March 24, 2014, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.

    Dated: June 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14640 Filed 6-20-16; 8:45 am]
 BILLING CODE 4164-01-P


     Review Report for Trisodium Citrate (CASRN 68-04-2) Partial Exemption

                                 October 2014

                      The Corn Refiners Association (CRA)
                   Docket Identifier:  EPA-HQ-OPPT-2014-0347
Note: Supporting petition information for citric acid (CASRN 77-92-9) and tripotassium citrate (CASRN 866-84-2) are addressed in separate supporting review reports.

Summary of Decision:  The U.S. Environmental Protection Agency (hereinafter "EPA" or the "Agency") has determined that there is a low current interest in the processing and use information collected under the Chemical Data Reporting (CDR) rule (see 40 CFR Part 711) for 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, sodium salt (1:3) (hereafter referred to as trisodium citrate, CASRN 68-04-2).  This determination is based on the totality of information on the chemical substance, including an evaluation of the considerations listed in 40 CFR 7l1.6(b)(2)(ii): 1) Consideration A: Current CDR information suggests that at least one site would have a production volume sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 pound threshold); 2) Consideration B: The prior evaluation of trisodium citrate by EPA's High Production Volume (HPV) Challenge Program in conjunction with the Organisation of Economic and Co-operation Development's (OECD) Swiss-sponsored Screening Information Data Set (SIDS) Initial Assessment Report (SIAR) and the U.S. Food and Drug Administration's (FDA) affirmation of trisodium citrate as Generally Recognized As Safe (GRAS, 21 CFR 182.1 and 184) for use as a direct human food ingredient indicates a low concern for human health.  Based on the available ecotoxicity information from the HPV Challenge Program hazard assessment, the Swiss OECD SIAR, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) minimal risk tolerance exemption (40 CFR 180.950(e)),  and the U.S. EPA's Office of Pesticide Program's (OPP's) final Registration Review Decision, trisodium citrate appears to be of low toxicity to aquatic organisms.  Concerning environmental fate, EPA determined that trisodium citrate has the potential to biodegrade, will not persist in the environment, and has a low potential for bioconcentration or bioaccumulation; 3) Consideration C: EPA is not aware of any currently existing unmet information needs for CDR processing and use information for this chemical substance; 4) Consideration D: The availability of complementary risk screening information was not sufficiently characterized in the petition; however, EPA recognizes that the data reviewed for the OECD SIAR, EPA's HPV Challenge Program Risk Based Prioritization (RBP) and supporting Hazard Characterization (HC), OPP's final Registration Review Decision, and the EPA FIFRA 40 CFR 180.950(e) minimal risk tolerance exemption provide evidence of complementary risk screening information for trisodium citrate; 5) Consideration E: Comparable processing and use information is available in the European Chemical Agency's (ECHA's) database, and although it is for use of products in Europe and not the United States, it provides an indication of uses that may occur in the United States; and 6) Consideration F: EPA is unaware of any specific actions that have already been taken by other agencies or authorities to manage risks relating to this substance.

A direct final rule to add trisodium citrate, using its Toxic Substances Control Act (TSCA) Inventory name, 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, sodium salt (1:3) to the list of chemical substances partially exempt from reporting CDR processing and use information in 40 CFR 711.6(2)(b)(iv) will be published in the Federal Register. The final listing is pending, based on possible adverse responses to the Federal Register notice. If the level of interest in the CDR processing and use information for this chemical substance were to change after final listing, EPA may reevaluate the listing and pursue amendment of the listing as appropriate.

Persons submitting information in accordance with the CDR rule can still report processing and use information even if a chemical substance is partially exempt, so that their chemical substances may be considered for safer substitute analyses.

Background:  EPA received a petition from the Corn Refiners Association (CRA) (hereinafter the "petitioner"), requesting that trisodium citrate be added to the 40 CFR 711.6(b)(2)(iv) list of specific chemical substances that are exempt from the reporting requirements of 40 CFR 711.15(b)(4) (i.e., exempt from requirements to report industrial processing and use and commercial/consumer use information).  The chemical substances already included on this "partial exemption" list are substances for which EPA has previously determined that there is a low current interest in the CDR processing and use information.  However, as stated in the preamble to the Inventory Update Reporting Amendments (IURA) rule promulgated on January 7, 2003, "...the need for processing and use information under IURA changes over time.  The inclusion of a chemical substance under this partial exemption is not based on the potential risks of a chemical.  This partial exemption is solely intended to provide a tool to assist the Agency in better managing the collection of processing and use information..." and is also "...based on the Agency's current assessment of the need for collecting IURA processing and use information."   Additionally, the preamble states, "[i]n determining whether there is low current interest in IUR processing and use information related to a specific chemical substance, EPA will look to the specific circumstances surrounding the chemical in question, and may use one or more of the considerations identified below, and/or considerations not identified below, to make an informed decision." The considerations used by EPA in reviewing this petition and an analysis of how those considerations relate to trisodium citrate are set forth below.

Discussion:  EPA considered information submitted with the petition, as well as other information including, but not limited to:  whether the petitioned chemical substance is listed on the Emergency Planning and Community Right to Know Act (EPCRA), Section 313 list of Toxic Chemicals and thus is reportable to the Toxics Release Inventory (TRI); 2012 CDR submissions for the chemical substance; evaluations available through the EPA's Integrated Risk Information System (IRIS), the International Agency for Research on Cancer (IARC), the OECD's HPV SIDS program, or the EPA's HPV Challenge Program; whether the substance is subject to other regulatory programs administered by EPA or other federal agencies; and other information researched by EPA to supplement the petition.

The petitioner provided information concerning trisodium citrate from a variety of sources and linked it to specific considerations cited in 40 CFR 711.6(b)(2)(ii).

Consideration A:  Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in 40 CFR 711.15(b)(4).

The petitioner indicated that trisodium citrate was reported for the 2006 IUR and 2012 CDR.  EPA reviewed the 2012 CDR data for trisodium citrate and found that 11 sites reported domestically manufacturing and/or importing trisodium citrate with a nationally aggregated production volume of 14,333,759 pounds in 2011.

EPA has concluded that at least one manufacturing site would likely have a production volume sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 lb threshold). Thus, EPA concludes that the other considerations are ripe for evaluation.

Consideration B:  The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together).

The petitioner submitted summary information from EPA's HPV Challenge Program for carboxylic acids and salts category that was submitted by the American Chemistry Council's Acetic Acid and Salts Panel on April 16, 2003. EPA published an Initial RBP document with a supporting HC in August 2008.  The petitioner noted that FDA affirms the use of trisodium citrate (CASRN 68-04-2) as Generally Recognized As Safe (GRAS, 21 CFR 184.1751) for use as direct human food ingredients.  The safety of these ingredients have been evaluated under the comprehensive safety review conducted by FDA (as specified in 21 CFR parts 182 and 184).

EPA assessed trisodium citrate along with citric acid and tripotassium citrate as a subcategory of the carboxylic food acids and salts category based on structural, functional and toxicological properties and published a Risk-Based Prioritization (RBP) document in August 2008[cite].  Additionally, trisodium citrate is also listed under 40 CFR 180.950(e) as having a tolerance exemption as a minimal risk active or inert ingredient in pesticides.  In a 2002 Decision Memo, reassessing the tolerance exemption, EPA's hazard characterization concluded that there is no available information indicative of a hazard, significant adverse effects to the general public or any population for trisodium citrate (cite).  EPA reviewed hazard information during the development of the RBP and pesticide determinations.  EPA's conclusions are summarized in the sections below.

EPA also considered other sources of information to  confirm its decisions on human health, environmental toxicity, and environmental fate, including the 2001 Swiss-sponsored OECD SIAR for citric acid  and FDA's affirmation that trisodium citrate (CASRN 68-04-2) as Generally Recognized As Safe (GRAS, 21 CFR 184.1751) for use as direct human food ingredients.

Human Health Effects. EPA's Hazard Characterization (HC) supporting the RBP concluded that the acute oral toxicity for the supporting chemical citric acid is low.  The supporting chemical citric acid is irritating to rabbit skin and severely irritating to the rabbit eye.  At high doses, trisodium citrate showed no adverse effects in oral reproductive and developmental toxicity studies (species and sex not identified).  The supporting chemical citric acid did not show potential to induce genetic mutations; no data are available for chromosomal aberrations.

Environmental Effects. Trisodium citrate has a low potential hazard to aquatic organisms.  Based on the available ecotoxicity data for trisodium citrate and citric acid from the HPV Challenge Program HC, the Swiss OECD SIAR, and the OPP decision memo, trisodium citrate appears to be of low toxicity to aquatic organisms.

Environmental Fate. Trisodium citrate is expected to have high mobility in soil, and is expected to partition primarily to water and soil if released to the environment. Based on experimental data for trisodium citrate and citric acid, trisodium citrate is expected to be readily biodegradable. EPA ran the Estimation Programs Interface Suite (v. 3.20) modeling software to support the HPV Program Risk-based prioritization screening assessment and determined that trisodium citrate has a low potential to bioaccumulate.
EPA believes that the EPA's HPV Challenge Program's HC, FIFRA tolerance exemptions, and the OPP decision memo are supported by the OECD SIAR and provide sufficient evidence to address human health and environmental toxicity concerns for trisodium citrate. Taken together, this information is sufficient to weigh in favor of partially exempting trisodium citrate from CDR reporting based on human health and environmental concerns covered under consideration B.

Consideration C:  The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

The petitioner stated that it was unaware of any unmet information needs of EPA, other federal agencies, tribes, states, local governments, or members of the public in light of FDA regulatory clearances available for trisodium citrate in food applications and the extensive data published on the ECHA website.  The petitioner also noted that trisodium citrate has not been the subject of information collection requirement by EPA under the Toxic Substances Control Act (TSCA) (other than CDR), the Interagency Testing Committee (ITC), or the Agency for Toxic Substances and Disease Registry (ATSDR). The petitioner asserts that there is sufficient information available, and there have been no previous information requests.

In 2006, EPA denied an earlier petition for partial exemption for trisodium citrate, indicating that because trisodium citrate was part of EPA's HPV Challenge Program, the Agency needed IUR processing and use information to put the hazard data received under the HPV Program in context in a risk screening assessment.  In 2009, EPA completed a RBP document for trisodium citrate as part of the carboxylic food acids and salts category, using processing and use information from the 2006 IUR.

EPA is not aware of any currently existing unmet information needs respecting the processing and use of trisodium citrate and agrees that recent processing and use information for this chemicals is otherwise available to government agencies and the public on the ECHA website. Although the uses in Europe noted in ECHA information may not be exactly the same as the uses in the United States, EPA believes they can provide an indication of potential uses on which to base further analysis, should the chemical substance be of interest (for a detailed summary of specific uses see Consideration E). Overall, EPA regards Consideration C as weighing in favor of establishing a partial exemption for this chemical substance.

Consideration D:  The availability of other complementary risk screening information.

The petitioner included a table which provided the status of the petitioned substances on the European Commission Annex II list of low risk substances, exemption determinations by the European Union for the REACH program, status under the voluntary EPA HPV Challenge Program and safety determinations for low toxicity pesticide inerts.  However, no discussion was provided linking the status to the availability of risk screening information.  Therefore, it is unclear how this table relates to Consideration D, the availability of other complementary risk screening information.  EPA notes that the fact that the petitioned substances were not present on most of these lists provided no evidence of the availability of risk screening information nor were explanations given of the significance of the chemicals not being listed on the two European lists.  The significance of the chemical not being listed on the two European lists was not explained.  Also, the fact that trisodium citrate could be sponsored under the HPV program does not mean that risk screening data is necessarily available and that entry is outdated.
In this case, the petitioner should have noted the availability of an OECD SIAR for citric acid (which is a suitable analog for trisodium citrate) and an EPA RBP document (which included trisodium citrate, which had been sponsored in the HPV program), both of which conclude that citric acid and its salts present a low concern.  The identification of trisodium citrate as a 4A pesticide inert does not provide information about risk screening.  It is more useful to note that Trisodium citrate is listed under 40 CFR 180.950(e) as having a tolerance exemption as a minimal risk active or inert ingredient in pesticides.  Additionally, upon review of all available information, EPA issued a Decision Memo in March 2008 reassessing the tolerance exemption and concluding that there are not likely to be any unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, or to non-target organisms or the environment from the use of the tolerance exemption

EPA determined that although the petitioner did not provide evidence that complementary risk screening information is available for trisodium citrate under Consideration D, the data reviewed for the OECD SIAR, EPA's RBP and supporting HC, EPA's FIFRA 40 CFR 180.950(e) minimal risk tolerance exemption and the decision memo affirming it provide evidence of complementary risk screening information for trisodium citrate. Overall, EPA concluded that the availability of information relevant to Consideration D weighs in favor of partially exempting trisodium citrate from CDR reporting.

Consideration E:  The availability of comparable processing and use information.

While the petitioner indicated that trisodium citrate is predominantly used in food (which is not a use subject to TSCA), the information they provided from the ECHA database indicated a broader range of uses. The petitioner asserted that TSCA-regulated exposures are comparable to, or less significant than, the food-use exposures associated with these substances, which have already been shown to be "safe." The petitioner included a list of uses obtained from ECHA's database.

The uses in the ECHA database are for the European Union and indicate that trisodium citrate may have broader use in Europe than in the United States.  Data from the non-confidential 2012 CDR database identified the following industrial uses: fillers, processing aids, and surface active agents.  The following consumer and commercial uses were also identified: ink, toner and colorant products, laundry and dishwashing products and personal care products.

EPA agrees that other recent processing and use information, available from ECHA is sufficiently comparable to CDR processing and use information to favor granting a partial reporting exemption for this chemical substance.  While the ECHA information may not be completely representative of use in the United States, EPA concluded in this case (in view of all relevant considerations) that the ECHA information is a reasonable surrogate indicator of possible United States processing and use.  EPA also recognizes that the ECHA database does not specify the amounts of trisodium citrate to each use.  But when considered in combination with the other substance-specific factors that weigh in favor of granting a partial reporting exemption (e.g., the evidence that the potential human health effects and/or environmental effects would be low) EPA does not regard the lack of use-by-use volume information as sufficient to affect the decision.

Consideration F: Whether the potential risks of the chemical substance are adequately managed by EPA or another agency or authority.

The petitioner generally indicated that the manufacturing and use of trisodium citrate primarily falls within the jurisdiction and authority of the FDA.  The petitioner also stated that EPA, the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC) regulate the manufacture and use of trisodium citrate. However, the petitioner did not specifically identify which uses of trisodium citrate are regulated by the foregoing governmental bodies or regulations, except for the FDA regulations covering the use of trisodium citrate as a food additive in a variety of products and as part of resinous and polymeric coatings and packaging materials.

Overall, although the petition included the general claim that this substance is already "controlled adequately under other regulatory regimes," it did not identify how any particular agency or authority was managing any particular risk relating to this substance, let alone how such risk management actions should bear on EPA's level of current interest in processing and use information.

As noted above, trisodium citrate is approved for use as a minimal risk active or inert ingredient in pesticides.  EPA is unaware of any specific actions that have already taken by other agencies or authorities to manage risks relating to this substance.  However, given the evidence that the potential human health effects and/or environmental effects would be low, EPA does not therefore assume that this substance would likely be the subject of risk management actions in the future.  Thus, in this case, EPA believes this consideration weighs neither in favor of nor against adding the substance to the CDR partial exemption list.


[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Rules and Regulations]
[Pages 52213-52215]
[FR Doc No: 2011-21312]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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Federal Register / Vol. 76, No. 162 / Monday, August 22, 2011 / Rules
and Regulations

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0998; Directorate Identifier 2010-NE-29-AD;
Amendment 39-16783; AD 2011-18-01]
RIN 2120-AA64

Airworthiness Directives; General Electric Company (GE) CF6-45
Series and CF6-50 Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD requires performing a fluorescent
penetrant inspection (FPI) of the low-pressure turbine (LPT) rotor
stage 3 disk at every shop visit at which the LPT module is separated
from the engine. This AD was prompted by seven reports of uncontained
failures of LPT rotor stage 3 disks and eight reports of cracked LPT
rotor stage 3 disks found during shop visit inspections. We are issuing
this AD to prevent LPT rotor separation, which could result in an
uncontained engine failure and damage to the airplane.

DATES: This AD is effective September 26, 2011.

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, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is 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: Tomasz Rakowski, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone: (781) 238-
7735; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
the specified products. That NPRM published in the Federal Register on
October 20, 2010, (75 FR 64681). That NPRM proposed to require
performing a fluorescent penetrant inspection at every shop visit when
the LPT module assembly is separated from the engine.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Support for the NPRM as Written

    Two commenters, the National Transportation Safety Board and The
Boeing Company support the NPRM as written.

Request To Define LPT Module

    Two commenters, GE and MTU Maintenance Canada, asked us to define
``LPT module.'' The commenters feel the term LPT module could be
confused with the LPT rotor assembly.
    We agree. We changed paragraph (e) of the proposed AD to clarify
that the intent of this AD is to inspect the LPT rotor stage 3 disk
when the LPT module assembly separates from the engine for maintenance,
and added new paragraphs (i) and (i)(1) that define the LPT module
assembly.

Request To Require Only Conditional Inspection

    One commenter, MTU Maintenance Canada, asked us to change the
compliance time for the inspection. MTU stated the proposed AD requires
stage 3 disk FPI at piece-part level regardless of the part utilization
(cycles-since-last inspection) or operational history since the last
inspection. MTU asked us to change the inspection to the next time the
LPT module assembly is disassembled to piece-part level for certain
engine conditions only.
    We don't agree with the request for conditional inspections only.
The intent of this AD is to require an FPI of the LPT rotor stage 3
disk forward spacer arm at each shop visit where the LPT module
assembly is separated in a cyclic manner, regardless of the reason for
the separation. The requirements for conditional piece-part FPI are
already mandated by AD 2011-02-07. We didn't change the AD.

Request To Add Conditional Inspection

    One commenter, Evergreen International Airlines, asked us to
additionally require the inspection if the engine encountered excessive
core vibration, or HPT blade separation or excessive material loss, or
unserviceable LPT blade interlock wear, in addition to the repetitive
inspections proposed in the NPRM.
    We don't agree. The requirements for conditional piece-part FPI are
already mandated by AD 2011-02-07. We didn't change the AD.

Request To Change the Compliance Time for the Inspection

    One commenter, Evergreen International Airlines, asked us to
require inspections if the LPT rotor stage 3 disk hasn't been FPI
inspected within the last 2,000 cycles or at all. Evergreen stated the
separation of the LPT module is required when the maintenance of
certain HPC, combustor, and HPT assemblies and parts need to be
performed. Engines removed for maintenance of those components would
require LPT rotor stage 3 disk cleaning and FPI regardless of the time
interval since the last FPI per the proposed AD, which would be an
unnecessary burden on the operators.
    We partially agree. We agree with the request for a certain number
of cycles since the last FPI to exclude the part from mandatory
inspection. However, we do not find the number of 2,000 cycles since
last inspection (CSLI) appropriate to ensure a desired level of safety.
We find that an acceptable level of safety will be retained when the
disk FPI inspection is skipped during the shop visit if the disk was
inspected within the last 1,000 cycles. We changed paragraphs (f) and
(g) to ``(f) At the next shop visit after the effective date of this
AD, clean and fluorescent

penetrant inspect the LPT rotor stage 3 disk forward spacer arm,
including the use of a wet abrasive blast to eliminate residual or
background fluorescence before inspecting. You can find guidance on
cleaning the disk and performing the FPI in the CF6-50 Engine Manual,
GEK 50481 72-57-02.'' and ``(g) Thereafter, clean and inspect the LPT
rotor stage 3 disk forward spacer arm, as specified in paragraph (f),
at each engine shop visit that occurs after 1,000 cycles since the last
FPI of the LPT rotor stage 3 disk forward spacer arm.'' We also added
paragraphs (i) and (i)(2) that define an engine shop visit as follows:
``An engine shop visit is the induction of an engine into the shop for
maintenance involving the separation of the turbine mid-frame forward
flange from the compressor rear frame aft flange, except that the
separation of these engine flanges solely for the purposes of
transportation without subsequent engine maintenance does not
constitute an engine shop visit.''

Request To Change the Type of Inspection

    One commenter, GE, asked us to consider changing the type of
inspection from FPI to ultrasonic inspection (USI). GE stated that they
have developed a USI technique and tooling which allow inspecting the
LPT rotor stage 3 disk forward spacer arm without piece part
disassembly of the LPT. Implementing the USI will detect cracks in the
forward spacer arm, which might propagate during operation and would be
a suitable alternative to the piece-part disassembly, cleaning, and FPI
of the forward spacer arm in many situations.
    We don't agree. We don't believe USI technique specified in GE SB
CF6-50 S/B 72-1309 is a sufficient means of detecting flaws or
microcracks on the inner surface of the LPT rotor stage 3 disk forward
spacer arm. Paragraph E.(5) of SB CF6-50 S/B 72-1309 states ``The new
USI probe was specifically designed to detect flaws 0.030 inch (0.76
mm) deep or greater in the forward spacer arm of the stage 3 LPTR
disk.'' We find that a 0.030-inch deep surface crack size is
unacceptable in that location, as it would have already propagated in a
high-cycle fatigue mode. The intent of this AD is to detect cracks
before they propagate. We made no change to the proposed AD.

Request To Change the Costs of Compliance

    Two commenters, MTU Canada and FedEx, asked us to re-evaluate the
Costs of Compliance for the actions required by the proposed AD. The
commenters state that cleaning the stage 3 disk and performing an FPI
are done at the piece-part level, and that the costs of disassembling
and reassembling the LPT module assembly, and of the inspections
required by the engine manual for reinstalling the stage 3 blades must
be added to the cost of cleaning and inspecting the disk.
    We don't agree. Our estimated cost is the direct cost to comply
with the AD, and doesn't include preparatory disassembly or
reinstallation. We didn't change the AD.

Request To Change Paragraph (f) of the Proposed AD

    One commenter, GE, asked us to change paragraph (f) of the proposed
AD to use the words ``including the use of'' in place of the word
``using'', where cleaning the LPT rotor stage 3 disk with wet-abrasive
blast to eliminate residual or background fluorescence is required. GE
doesn't consider a wet-abrasive blast alone sufficient to clean the LPT
rotor stage 3 disk to allow performance of the FPI of the inner
diameter of the forward cone body of the LPT rotor stage 3 disk.
    We agree. We changed paragraph (f) of the proposed AD from ``Clean
the LPT rotor stage 3 disk, using a wet abrasive blast to eliminate
residual or background fluorescence. You can find guidance on cleaning
the disk in the cleaning procedure of CF6-50 Engine Manual, GEK 50481
72-57-02.'' to ``At the next engine shop visit after the effective date
of this AD, clean and fluorescent-penetrant inspect the LPT rotor stage
3 disk forward spacer arm, including the use of a wet-abrasive blast to
eliminate residual or background fluorescence before inspecting. You
can find guidance on cleaning the disk and performing the FPI in the
CF6-50 Engine Manual, GEK 50481 72-57-02.''

Request To Include Definitions for Cleaning and FPI of the LPT Rotor
Stage 3 Disk

    One commenter, Evergreen International Airlines, asked us to add
definitions of ``cleaning the LPT rotor stage 3 disk'' and ``FPI of the
LPT rotor stage 3 disk,'' with specific engine manual subtask
references, to the proposed AD. The commenter states that the
definitions will clarify the actions required by the proposed AD.
    We don't agree. The reference provided in the proposed AD is
sufficient to define the required actions. We made no changes to the
proposed AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 387 engines installed on
airplanes of U.S. registry. We also estimate that it will take about 7
work-hours per engine to clean and FPI the disk 387 engines. The
average labor rate is $85 per work-hour. No parts will be required.
Based on these figures, we estimate the total cost of the AD to U.S.
operators to be $230,265.

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

    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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

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

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2011-18-01 General Electric Company: Amendment 39-16783; Docket No.
FAA-2010-0998; Directorate Identifier 2010-NE-29-AD.

Effective Date

    (a) This AD is effective September 26, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF6-45A,
CF6-45A2, CF6-50A, CF6-50C, CF6-50CA, CF6-50C1, CF6-50C2, CF6-50C2B,
CF6-50C2D, CF6-50E, CF6-50E1, and CF6-50E2 series turbofan engines,
including engines marked on the engine data plate as CF6-50C2-F and
CF6-50C2-R, with a low-pressure turbine (LPT) rotor stage 3 disk
that has a part number (P/N) listed in Table 1 of this AD installed.

                  Table 1--LPT Rotor Stage 3 Disk P/Ns
------------------------------------------------------------------------

------------------------------------------------------------------------
     1473M90P01         1473M90P02         1473M90P03        1473M90P04
     1479M75P01         1479M75P02         1479M75P03        1479M75P04
     1479M75P05         1479M75P06         1479M75P07        1479M75P08
     1479M75P09         1479M75P11         1479M75P13        1479M75P14
     9061M23P06         9061M23P07         9061M23P08        9061M23P09
     9061M23P10         9061M23P12         9061M23P14        9061M23P15
     9061M23P16         9224M75P01    ................  ................
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from seven reports of uncontained failures
of LPT rotor stage 3 disks and eight reports of cracked LPT rotor
stage 3 disks found during shop visit inspections. We are issuing
this AD to prevent LPT rotor separation, which could result in an
uncontained engine failure and damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed at each shop visit after the effective date of this AD,
at which the LPT module assembly is separated from the engine.

Initial Inspection

    (f) At the next shop visit after the effective date of this AD,
clean and fluorescent-penetrant inspect the LPT rotor stage 3 disk
forward spacer arm, including the use of a wet-abrasive blast to
eliminate residual or background fluorescence before inspecting. You
can find guidance on cleaning the disk and performing the FPI in the
CF6-50 Engine Manual, GEK 50481 72-57-02.

Repetitive Inspection

    (g) Thereafter, clean and inspect the LPT rotor stage 3 disk
forward spacer arm, as specified in paragraph (f) of this AD, at
each engine shop visit that occurs after 1,000 cycles since the last
FPI of the LPT rotor stage 3 disk forward spacer arm.
    (h) If a crack or a band of fluorescence is present, remove the
disk from service.

Definitions

    (i) For the purpose of this AD:
    (1) The LPT module assembly is defined as consisting of turbine
mid-frame, LPT stage 1 nozzle, LPT stator cases and vanes, LPT
rotor, and turbine rear frame.
    (2) An engine shop visit is the induction of an engine into the
shop for maintenance involving the separation of the turbine mid-
frame forward flange from the compressor rear frame aft flange,
except that the separation of these engine flanges solely for the
purposes of transportation without subsequent engine maintenance
does not constitute an engine shop visit.

Alternative Methods of Compliance

    (j) The Manager, Engine Certification Office, 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

    (k) For more information about this AD, contact Tomasz Rakowski,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
Material Incorporated by Reference

    (l) None.

    Issued in Burlington, Massachusetts on August 15, 2011.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2011-21312 Filed 8-19-11; 8:45 am]
BILLING CODE 4910-13-P