[Federal Register Volume 77, Number 133 (Wednesday, July 11, 2012)]
[Proposed Rules]
[Pages 40823-40826]
[FR Doc No: 2012-16970]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0150; Directorate Identifier 2011-NM-234-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for all Airbus Model A318 series airplanes, Airbus Model A319
series airplanes, Airbus Model A320 series airplanes, and Airbus Model
A321 series airplanes. That NPRM proposed an inspection to determine if
certain angle of attack (AOA) probes are installed, and replacing the
affected AOA probe if necessary. That NPRM was prompted by reports of
oil residue between the stator and the rotor parts of the position
resolvers of the AOA vane, which was a result of incorrect removal of
the machining oil during the manufacturing process of the AOA
resolvers. This action revises that NPRM by including an inspection to
determine if certain other AOA probes are installed, and replacing the
affected probes. We are proposing this AD to prevent erroneous AOA
information and consequent delayed or non-activation of the AOA
protection systems which, during flight at a high angle of attack,
could result in reduced control of the airplane. Since these actions
impose an additional burden over that proposed in the NPRM, we are
reopening the comment period to allow the public the chance to comment
on these proposed changes.

DATES: We must receive comments on this proposed AD by August 27, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. For Thales Avionics service information identified in
this proposed AD, contact Thales Avionics, Retrofit Manager, 105,
Avenue du G[eacute]n[eacute]ral Eisenhower, BP 63647, 31036 Toulouse
Cedex 1, France; telephone +33 5 61 19 76 95; fax +33 5 61 19 68 20;
email<EMAIL_ADDRESS>Internet http://www.thalesgroup.com/aerospace. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1405; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0150;
Directorate Identifier 2011-NM-234-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We proposed to amend 14 CFR part 39 with an earlier NPRM for the
specified products, which was published in the Federal Register on
February 23, 2012 (77 FR 10693). That earlier NPRM proposed to require
actions intended to address the unsafe condition for the products
listed above.
    Since that NPRM (77 FR 10693, February 23, 2012) was issued, we
have determined that certain other AOA probes need to be inspected in
order to address the identified unsafe condition.

Comments

    We gave the public the opportunity to comment on the previous NPRM
(77 FR 10693, February 23, 2012). The following presents the comments
received on the previous NPRM and the FAA's response to each comment.

Request To Include Other AOA Probes

    Airbus stated that certain Thales AOA probes, part number (P/N)
C16291AB, have been modified in accordance with Thales Avionics Service
Bulletin C16291A-34-007, August 27, 2009, without incorporating Thales
Avionics Service Bulletin C16291A-34-007, Revision 01, dated December
3, 2009. We infer that Airbus is requesting that we change the previous
NPRM (77 FR 10693, February 23, 2012) to include an inspection of those
AOA probes.
    We agree with Airbus' request. The AOA probes may have the same
unsafe condition found in AOA probe P/N C16291AA. We have determined
that those discrepant AOA probes, P/N C16291AB, must also be replaced.
We have added new paragraph (g)(2) of this supplemental NPRM to address
the identified unsafe condition on those AOA probes.

Request To Refer to the Latest Service Information

    Airbus and United Airlines requested that the previous NPRM (77 FR
10693, February 23, 2012) reference Thales Avionics Service Bulletin
C16291A-34-007, Revision 02, dated December 16, 2011, as a means of
compliance.
    We agree to refer to the latest revision of this service
information. Thales Avionics has issued Service Bulletin C16291A-34-
007, Revision 03, dated April 10, 2012. We have revised this
supplemental NPRM accordingly.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    Certain changes described above expand the scope of the earlier
NPRM (77 FR 10693, February 23, 2012). As a result, we have determined
that it is necessary to reopen the comment period to provide additional
opportunity for the public to comment on this proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 755 products of U.S. registry. We also estimate that
it would take about 2 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $128,350, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 3 work-hours and require parts costing $0, for a cost of
$255 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.

    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2012-0150; Directorate Identifier 2011-NM-
234-AD.

(a) Comments Due Date

    We must receive comments by August 27, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Model A318-111, -112, -121, and -
122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes; Model A320-111, -211, -212, -214, -231, -232,
and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -
213, -231, and -232 airplanes; certificated in any category; all
manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 34: Navigation.

(e) Reason

    This AD was prompted by reports of oil residue between the
stator and the rotor parts of the position resolvers of the angle of
attack (AOA) vane, which was a result of incorrect removal of the
machining oil during the manufacturing process of the AOA resolvers.
We are issuing this AD to prevent erroneous AOA information and
consequent delayed or non-activation of the AOA protection systems
which, during flight at a high angle of attack, could result in
reduced control of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Within 12 months after the effective date of this AD, except as
provided by paragraph (h) of this AD: Do the inspections in
paragraphs (g)(1) and (g)(2) of this AD.
    (1) Inspect to determine the part number (P/N) and serial number
of each Thales Avionics AOA probe, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-34-1452,
excluding Appendix 01, dated January 29, 2010. If any probe is found
having P/N C16291AA and having a serial number listed in Thales
Avionics Service Bulletin C16291A-34-007, Revision 03, dated April
10, 2012: Within 12 months after the effective date of this AD,
replace the AOA probe, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-34-1452, excluding
Appendix 01, dated January 29, 2010. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
part number and serial number of the installed AOA probes can be
conclusively determined from that review.
    (2) Inspect to determine the part number and serial number of
each Thales Avionics AOA probe, in accordance with paragraph
3.C.1.a. of the Accomplishment Instructions of Airbus Service
Bulletin A320-34-1452, excluding Appendix 01, dated January 29,
2010. If any probe is found having P/N C16291AB, on which Thales
Avionics Service Bulletin C16291A-34-009, Revision 1, dated January
7, 2010, has been incorporated, and on which Thales Avionics Service
Bulletin C16291A-34-007, Revision 01, dated December 3, 2009, has
not been incorporated: Within 12 months after the effective date of
this AD, replace the AOA probe, in accordance with a method approved
by the Manager, International Branch, ANM-116, FAA, or EASA (or its
delegated agent). A review of airplane maintenance records is
acceptable in lieu of this inspection if the part number of the
installed AOA probes can be conclusively determined from that
review.

(h) Exception

    For any airplane on which Airbus modification 150006
(installation of Thales Avionics AOA probes P/N C16291AB) or
modification 26934 (installation of Goodrich AOA probes P/N 0861ED)
has been embodied in production, and on which no AOA probe
replacement has been made since first flight: The actions specified
in paragraph (g) of this AD are not required.

(i) Parts Installation Limitations

    (1) As of the effective date of this AD, no person may install a
Thales Avionics AOA probe, P/N C16291AA, having a serial number
listed in Thales Avionics Service Bulletin C16291A-34-007, Revision
03, dated April 10, 2012, on any airplane, unless that Thales
Avionics probe has been inspected, re-identified and tested, in
accordance with the Accomplishment Instructions of Thales Avionics
Service Bulletin C16291A-34-007, Revision 03, dated April 10, 2012.
    (2) As of the effective date of this AD, no person may install a
Thales Avionics AOA probe, P/N C16291AB, on which Thales Avionics
Service Bulletin C16291A-34-009, dated September 10, 2009, has been
incorporated, and on which Thales Avionics Service Bulletin C16291A-
34-007, Revision 01, dated December 3, 2009, has not been
incorporated.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.

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

(k) Related Information

    (1) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0203, dated October 13, 2011, and the service
information specified in paragraphs (k)(1)(i) and (k)(1)(ii) of this
AD, for related information.
    (i) Airbus Service Bulletin A320-34-1452, excluding Appendix 01,
dated January 29, 2010.
    (ii) Thales Avionics Service Bulletin C16291A-34-007, Revision
03, dated April 10, 2012.
    (2) For Airbus service information identified in this AD,
contact Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. For Thales Avionics service
information identified in this AD, contact Thales Avionics, Retrofit
Manager, 105, Avenue du G[eacute]n[eacute]ral Eisenhower, BP 63647,
31036 Toulouse Cedex 1, France; telephone +33 5 61 19 76 95; fax +33
5 61 19 68 20; email<EMAIL_ADDRESS>Internet
http://www.thalesgroup.com/aerospace. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on July 5, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-16970 Filed 7-10-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58259-58260]
[FR Doc No: 2018-25128]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the Agency's annual report entitled ``Report on the
Performance of Drug and Biologics Firms in Conducting Postmarketing
Requirements and Commitments.'' Under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), FDA is required to report annually on the
status of postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) required of, or agreed upon by, application holders
of approved drug and biological products. The report on the status of
the studies and clinical trials that applicants have agreed to, or are
required to, conduct is on the FDA's ``Postmarketing Requirements and
Commitments: Reports'' web page (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm).

FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to
publish an annual report on the status of postmarketing study
commitments that applicants have committed to, or are required to
conduct, and for which annual status reports have been submitted.
    Under Sec. Sec.  314.81(b)(2)(vii) and 601.70 (21 CFR
314.81(b)(2)(vii) and 601.70), applicants of approved drugs and
licensed biologics are required to submit annually a report on the
status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study or clinical trial either
required by FDA (PMRs) or that they have committed to conduct (PMCs),
either at the time of approval or after approval of their new drug
application, abbreviated new drug application, or biologics license
application. The status of PMCs concerning chemistry, manufacturing,
and production controls and the status of other studies or clinical
trials conducted on an applicant's own initiative are not required to
be reported under Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not
addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C
Act (21 U.S.C. 355(o)(3)(E)) requires that applicants report
periodically on the status of each required study or clinical trial and
each study or clinical trial ``otherwise undertaken . . . to
investigate a safety issue . . .''
    An applicant must report on the progress of the PMR/PMC on the
anniversary of the drug product's approval\1\ until the PMR/PMC is
completed or terminated and FDA determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either no longer feasible or would no
longer provide useful information.
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    \1\ An applicant must submit an annual status report on the
progress of each open PMR/PMC within 60 days of the anniversary date
of U.S. approval of the original application or on an alternate
reporting date that was granted by FDA in writing. Some applicants
have requested and been granted by FDA alternate annual reporting
dates to facilitate harmonized reporting across multiple
applications.
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II. Fiscal Year 2017 Report

    With this notice, FDA is announcing the availability of the
Agency's annual report entitled ``Report on the Performance of Drug and
Biologics Firms in Conducting Postmarketing Requirements and
Commitments.'' Information in this report covers any PMR/PMC that was
established, in writing, at the time of approval or after approval of
an application or a supplement to an application, and summarizes the
status of PMRs/PMCs in fiscal year (FY) 2017 (i.e., as of September 30,
2017). Information summarized in the report reflects combined data from
the Center for Drug Evaluation and Research and the Center for
Biologics Evaluation and Research and includes the following: (1) The
number of applicants with open PMRs/PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant submission of the annual status
reports

(ASRs); (4) FDA-verified status of open PMRs/PMCs reported in Sec.
314.81(b)(2)(vii) or Sec.  601.70 ASRs; (5) the status of closed PMRs/
PMCs; and (6) the distribution of the status by fiscal year of
establishment \2\ (FY2011 to FY2017) for PMRs and PMCs open at the end
of FY2017, or those closed within FY2017. Additional information about
PMRs/PMCs is provided on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
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    \2\ The establishment date is the date of the formal FDA
communication to the applicant that included the final FDA-required
(PMR) or -requested (PMC) postmarketing study or clinical trial.

    Dated: November 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25128 Filed 11-16-18; 8:45 am]
 BILLING CODE 4164-01-P