[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60016-60017]
[FR Doc No: 2011-24961]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-545-000]

Tennessee Gas Pipeline Company; Notice of Request Under Blanket
Authorization

    Take notice that on September 9, 2011, Tennessee Gas Pipeline
Company (Tennessee), 1001 Louisiana Street, Houston, Texas 77002 filed
a prior notice request in accordance with sections 157.205, 157.216(b)
of the Federal Energy Regulatory Commission's (Commission) Regulations
under the Natural Gas Act and Tennessee's authorization in Docket No.
CP82-413-000, to abandon in place and by removal an inactive supply
lateral designated as Line No. 524C-900 (Supply Lateral) and associated
meters and appurtenances located in Lafourche Parish, Louisiana and
extending into the state waters of offshore Louisiana in the Bay
Marchand Area, all as more fully set forth in the application, which is
open to the public for inspection. 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 TTY,
(202) 502-8659.
    Any questions regarding the application should be directed to
Thomas G. Joyce, Manager, Certificates & Compliance, Tennessee Gas
Pipeline Company, 1001 Louisiana Street, or telephone<PHONE_NUMBER>,
or fax (713) 420-160 or by e-mail<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.

    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 commentors 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 commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors 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.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link. Persons unable
to file electronically should submit an original and 14 copies of the
protest or intervention to the Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426.

    Dated: September 22, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-24961 Filed 9-27-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56847-56851]
[FR Doc No: 2012-22659]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0921]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submission of Food and Drug Administration
Adverse Event Reports and Other Safety Information Using the Electronic
Submission Gateway and the Safety Reporting Portal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the use of the FDA Electronic
Submission Gateway (ESG) and the Safety Reporting Portal (the SRP) to
collect adverse event reports and other

safety information for FDA-regulated products.

DATES: Submit either electronic or written comments on the collection
of information by November 13, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

II. Electronic Submission of Food and Drug Administration Adverse Event
Reports and Other Safety Information Using the Electronic Submission
Gateway and the Safety Reporting Portal--21 CFR 310.305, 314.80,
314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803 (OMB Control
Number 0910-0645)--Revision

    The SRP (formerly referred to as the MedWatch\Plus\ Portal and
Rational Questionnaire) and the ESG are the Agency's electronic systems
for collecting, submitting, and processing adverse event reports and
other safety information for FDA-regulated products. To ensure the
safety and identify any risks, harms, or other dangers to health for
all FDA-regulated human and animal products, the Agency needs to be
informed whenever an adverse event, product quality problem, or product
use error occurs. This risk identification process is the first
necessary step that allows the Agency to gather the information
necessary to be able to evaluate the risk associated with the product
and take whatever action is necessary to mitigate or eliminate the
public's exposure to the risk.
    Some adverse event reports are required to be submitted to FDA
(mandatory reporting) and some adverse event reports are submitted
voluntarily (voluntary reporting). Requirements regarding mandatory
reporting of adverse events or product problems have been codified in
21 CFR parts 310, 314, 514, 600, 803 and 1271, specifically Sec. Sec.
310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40,
803.50, 803.53, 803.56 and 1271.350(a) (21 CFR 310.305, 314.80, 314.98,
314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56 and
1271.350(a)). Many of the adverse event reports submitted to FDA are
currently filed in paper format using FDA Forms FDA 3500, 3500A, 1932,
and 1932a, approved under OMB control numbers 0910-0284 and 0910-0291.
This notice solicits comments on adverse event reports filed
electronically via the SRP and the ESG, approved under OMB control
number 0910-0645.

III. The FDA Safety Reporting Portal Rational Questionnaires

    FDA currently has OMB approval to receive three types of adverse
event reports electronically via the SRP using rational questionnaires.
In this notice, FDA seeks comments on the extension of OMB approval for
the existing three rational questionnaires, as well as comments on a
proposed fourth rational questionnaire that will be used for a new
safety reporting program being launched by the Center for Tobacco
Products (CTP).

A. Reportable Food Registry Reports

    The Food and Drug Administration Amendments Act of 2007 (Pub. L.
110-085) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by creating a new section 417 (21 U.S.C. 350f), Reportable
Food Registry (RFR or the Registry). Section 417 of the FD&C Act
defines ``reportable food'' as an ``article of food (other than infant
formula or dietary supplements) for which there is a reasonable
probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals.'' (See section 417(a)(2) of the FD&C Act). The Secretary of
Health and Human Services (the Secretary) has delegated to the
Commissioner of FDA the responsibility for administering the FD&C Act,
including section 417. To further the development of the RFR, section
417 of the FD&C Act required FDA to establish an electronic portal by
which instances of reportable food (``RFR reports'') must be submitted
to FDA by responsible parties and may be submitted by public health
officials. A ``responsible party'' is the person who submits the
registration under section 415(a) of the FD&C Act (21 U.S.C. 350d) for
a food facility that is required to register under section 415(a), at
which such article of food is manufactured, processed, packed, or held.
The RFR electronic portal was established in 2009 as part of the
MedWatch\Plus\ Portal, now the SRP, and approved under OMB control
number 0910-0645.
    The Congressionally identified purpose of the RFR is to provide ``a
reliable mechanism to track patterns of adulteration in food [which]
would support efforts by the Food and Drug Administration to target
limited inspection resources to protect the public health'' (121 Stat.
965). The RFR reports are designed to enable FDA to quickly identify,
track, and remove from commerce an article of food (other than infant
formula and dietary supplements) for which there is a reasonable
probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals. FDA uses the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses.
    On January 4, 2011, the President signed into law the FDA Food
Safety Modernization Act (Pub. L. 111-353)

(the legislation or FSMA). Section 211 of the legislation amended
section 417 of the FD&C Act to require FDA to collect additional
information in the Agency's RFR reports:
    (1) A description of the article of food;
    (2) Affected product identification codes, such as Universal
Product Code, Stock Keeping Unit, or lot or batch numbers sufficient
for the consumer to identify the article of food;
    (3) Contact information for the responsible party; and
    (4) Any other information the Secretary determines is necessary to
enable a consumer to accurately identify whether such consumer is in
possession of the reportable food.
    Section 211 of FSMA also amended section 417 of the FD&C Act to
require FDA to generate one-page notices from RFR reports to post on
www.fda.gov for grocery stores to display to consumers when a
reportable food has been sold. The amendment made by section 211 of
FSMA took effect June 4, 2012, 18 months after the date of enactment.
To comply with this statutory deadline, FDA initially obtained OMB
approval of the additional collection of information requirements under
the emergency processing provisions of the PRA under OMB control number
0910-0709. The new data improves the RFR's effectiveness in carrying
out its purpose of tracking patterns of adulteration in food and
supporting FDA's efforts to target limited inspection resources to
protect the public health.
    Table 1 of this document, entitled ``New Data Elements for RFR
Reports,'' presents the new data elements aded by FDA to RFR Reports on
June 4, 2012.

               Table 1--New Data Elements for RFR Reports
------------------------------------------------------------------------
                                   Mandatory or         Authority if
          Field text              optional input         mandatory
------------------------------------------------------------------------
Reason this food is reportable  Mandatory........  Section 417(e)(4) of
 (agent).                                           the FD&C Act.
What did your investigation     Mandatory........  Section 417(e)(5) of
 identify as the root cause of                      the FD&C Act.
 the problem (if you were
 required to conduct an
 investigation under section
 417(d)(1)(B) of the FD&C
 Act)?
How did you determine which     Mandatory........  Section 417(e)(4) and
 products/lots/batches were                         (5) of the FD&C Act.
 affected?
To the best of your knowledge,  Mandatory........  Section 417(e)(6) of
 has all of the reportable                          the FD&C Act.
 food been removed from
 commerce?
What corrective actions have    Optional.........  .....................
 been taken to prevent future
 occurrences?
Product Commodity Type........  Mandatory........  Section 417(e)(3) of
                                                    the FD&C Act.
Manufacturing/Production        Mandatory........  Section 417(e)(3) and
 Date(s).                                           (4) of the FD&C Act.
Use-by dates, if any, or        Mandatory........  Section 417(e)(7) of
 approximate Shelf Life.                            the FD&C Act.
Was product treated to reduce   Mandatory (but     Section 417(e)(3) and
 microorganisms.                 conditional).      (4) of the FD&C Act.
Microbial Reduction Treatment   Mandatory (but     Section 417(e)(3) and
 Details.                        conditional).      (4) of the FD&C Act
                                                    (Conditional for
                                                    microbial hazards
                                                    only and only after
                                                    ``yes'' answer to
                                                    ``was product
                                                    treated to reduce
                                                    microorganisms?'')
Is a Bacterial Isolate          Mandatory (but     Section 417(e)(4) of
 Available for collection?       conditional).      the FD&C Act
                                                    (Conditional for
                                                    microbial hazards
                                                    only.)
Animal Species Intended for...  Mandatory........  Section 417(e)(3) and
                                                    (4) of the FD&C Act.
Life Stage of Animal Intended   Mandatory........  Section 417(e)(3) and
 for.                                               (4) of the FD&C Act.
Have you notified all           Optional.........  .....................
 immediate previous sources of
 this reportable food?
Have you notified all           Mandatory........  Section 417(e)(6) of
 immediate subsequent                               the FD&C Act.
 recipients of this reportable
 food?
------------------------------------------------------------------------

    In this request for extension of OMB approval, FDA is combining the
burden hours associated with OMB control number 0910-0709 with the
burden hours approved under this OMB control number (0910-0645).

B. Reports Concerning Experience With Approved New Animal Drugs

    Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and Sec.
514.80(b) of FDA's regulations (21 CFR 514.80) require applicants of
approved new animal drug applications (NADAs) and approved abbreviated
new animal drug applications (ANADAs) to report adverse drug
experiences and product/manufacturing defects.
    This continuous monitoring of approved NADAs and ANADAs affords the
primary means by which FDA obtains information regarding potential
problems with the safety and efficacy of marketed approved new animal
drugs as well as potential product/manufacturing problems. Post-
approval marketing surveillance is important because data previously
submitted to FDA may no longer be adequate, as animal drug effects can
change over time and less apparent effects may take years to manifest.
    If an applicant must report adverse drug experiences and product/
manufacturing defects and chooses to do so using the Agency's paper
forms, the applicant is required to use Form FDA 1932, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.''
Periodic drug experience reports and special drug experience reports
must be accompanied by a completed Form FDA 2301, ``Transmittal of
Periodic Reports and Promotional Material for New Animal Drugs'' (see
Sec.  514.80(d)). Form FDA 1932a, ``Veterinary Adverse Drug Reaction,
Lack of Effectiveness or Product Defect Report'' allows for voluntary
reporting of adverse drug experiences or product/manufacturing defects.
Collection of information using existing paper forms FDA 2301, 1932,
and 1932a is approved under OMB control number 0910-0284.
Alternatively, an applicant may choose to report adverse drug
experiences and product/manufacturing defects electronically.
Collection of this information electronically was approved in 2010
under OMB control number 0910-0645. The electronic submission data
elements to report adverse drug experiences and product/manufacturing
defects electronically remain unchanged in this request for extension
of OMB approval.

C. Pet Food Early Warning System

    Section 1002(b) of FDAAA directed the Secretary to establish an
early warning and surveillance system to identify adulteration of the
pet food supply and outbreaks of illness associated with pet food. As
part of the effort to fulfill that directive, the Secretary tasked FDA
with developing the instrument that would allow consumers to report
voluntarily adverse events associated with pet food.
    FDA developed the Pet Food Early Warning System rational
questionnaire as a user-friendly data collection tool, to make it easy
for the public to report a safety problem with pet food. The Pet Food
Early Warning System is designed to identify adulteration of the pet
food supply and outbreaks of illness associated with pet food to enable
FDA to quickly identify, track, and remove from commerce such articles
of food. FDA uses the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses. In 2010, OMB approved the Pet Food Early Warning
System component of the SRP under OMB control number 0910-0645, and FDA
launched the rational questionnaire by which consumers may
electronically report adverse events associated with pet food. The
electronic submission data elements to report adverse events associated
with pet food remain unchanged in this request for extension of OMB
approval.

D. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    As noted, this notice seeks comments on a proposed fourth rational
questionnaire that will be used for a new safety reporting program
being launched by the FDA Center for Tobacco Products (CTP) to collect
voluntary tobacco product adverse event and product problem reports.
    FDA has broad legal authority under the FD&C Act to protect the
public health. CTP's mission is to protect Americans from tobacco-
related death and disease by regulating the manufacture, distribution,
and marketing of tobacco products and by educating the public,
especially young people, about tobacco products and the dangers their
use poses to themselves and others. The Family Smoking Prevention and
Tobacco Control Act of 2009 (Pub. L. 111-31) (Tobacco Control Act)
amended the FD&C Act by creating a new section 909 (21 U.S.C. 387i,
Records and Reports on Tobacco Products). Section 909(a) of the FD&C
Act (21 U.S.C. 387i(a)) authorizes FDA to establish regulations with
respect to mandatory adverse event reports associated with the use of a
tobacco product. At this time, FDA is proposing to collect voluntary
adverse event reports associated with the use of tobacco products from
interested parties such as health care providers, researchers,
consumers, and other users of tobacco products. Information collected
in voluntary adverse event reports will contribute to CTP's ability to
be informed of, and assess the real consequences of, tobacco product
use. The need for this collection of information derives from our
objective to obtain current, timely, and policy-relevant information to
carry out our statutory functions. The FDA Commissioner is authorized
to undertake this collection as specified in section 1003(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2)).
    CTP currently receives adverse event and product problem reports
primarily via paper MedWatch forms, approved under OMB control number
0910-0291. MedWatch forms, although recently updated with field labels
and descriptions to better clarify for reporters the range of
reportable products, including tobacco products, do not specifically
include questions relevant for the analysis of adverse events or
product problems related to tobacco products. The proposed voluntary
tobacco product adverse event and product problem rational
questionnaire will include these specific questions. The questionnaire
evolved with input from a National Institutes of Health team of human-
factors experts, from other regulatory Agencies, and with extensive
input from consumer advocacy groups and the general public. FDA is also
working with the FDA Internet team to follow the HHS Internet
guidelines for Web design. FDA has and will continue to reach out to
professional organizations and community interest groups to collect
feedback during the user acceptance testing. The rational questionnaire
will provide the user with detailed navigation instructions to include
drop-down menus, lists of values, controlled vocabularies, and mouse
over help where possible. In addition, CTP will issue guidance for the
rational questionnaire. Finally, we note that users who are unable to
submit reports using the electronic system will still be able to
provide their information by paper form (by mail or fax) or telephone.
    The rational questionnaire will capture tobacco-specific adverse
event and product problem information from voluntary reporting entities
such as health care providers, researchers, consumers, and other users
of tobacco products. To carry out its responsibilities, FDA needs to be
informed when an adverse event, product problem, or error with use is
suspected or identified. When FDA receives tobacco-specific adverse
event and product problem information, it will use the information to
assess and evaluate the risk associated with the product, and then FDA
will take whatever action is necessary to reduce, mitigate, or
eliminate the public's exposure to the risk through regulatory and
public health interventions.

IV. Information Collection Burden Estimate

    Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
adverse event reports electronically to FDA via the ESG or the SRP.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Number of
                Activity                  FDA Form No.      Number of     responses per   Total annual     Average burden per response      Total hours
                                                           respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Adverse Event Report via the             3800           1,513               1           1,513  0.6 (36 minutes)...............             908
 SRP (Other than RFR Reports).
Mandatory Adverse Event Report via the             3800             636               1             636  1.0............................             636
 SRP (Other than RFR Reports).
Mandatory Adverse Event Report via the             3800       1,491,228               1       1,491,228  0.6 (36 minutes)...............         894,737
 ESG (Gateway-to-Gateway transmission).

Mandatory and Voluntary RFR Reports via            3800           1,413               1           1,413  0.6 (36 minutes)...............             848
 the SRP.
                                        ----------------------------------------------------------------------------------------------------------------
    Total..............................  ..............  ..............  ..............  ..............  ...............................         897,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The Agency's estimate of the number of respondents and the total
annual responses in table 2, Estimated Annual Reporting Burden, is
based primarily on mandatory and voluntary adverse event reports
electronically submitted to the Agency. The estimated total annual
responses are based on initial reports. Follow-up reports, if any, are
not counted as new reports. Based on its experience with adverse event
reporting, FDA estimates that it will take a respondent 0.6 hour to
submit a voluntary adverse event report via the SRP, 1.0 hour to submit
a mandatory adverse event report via the SRP, and 0.6 hour to submit a
mandatory adverse event report via the ESG (gateway-to-gateway
transmission). Both mandatory and voluntary RFR reports must be
submitted via the SRP. FDA estimates that it will take a respondent 0.6
hour to submit a RFR report, whether the submission is mandatory or
voluntary.
    Voluntary adverse event reports submitted via the SRP (other than
RFR Reports) include reports associated with pet food (the Pet Food
Early Warning System) and the new tobacco product adverse event and
product problem reports. CVM received 845 pet food adverse event
reports in 2010; 1,293 reports in 2011; and 471 reports in the first 4
months of 2012; and estimates that for the full 12 months of 2012 it
will receive 1,413 reports. Based on this experience, CVM estimates
that it will receive, on average, 1,413 pet food reports annually over
the next 3 years. CTP estimates that it will receive approximately 100
voluntary tobacco product adverse event and product problem reports
annually, after implementation of electronic reporting. CTP received 27
reports in 2010, 30 reports in 2011, and 22 reports in the first half
of 2012, and estimates that for the full 12 months of 2012 it will
receive over 40 reports. Based on this experience and an expectation
that reporting will increase once electronic reporting is launched, CTP
estimates that it will receive, on average, 100 voluntary adverse event
and product problem reports annually over the next 3 years. Thus, FDA
estimates that over the next 3 years it will receive annually 1,513
voluntary adverse event reports submitted via the SRP, with a burden of
907.8 hours, rounded to 908 hours, as reported in table 2, row 1 (1,413
+ 100 = 1,513).
    Mandatory adverse event reports submitted via the SRP (other than
RFR Reports) include reports of adverse animal drug experiences and
product/manufacturing defects associated with approved NADAs and
ANADAs. CVM received 144 such adverse event reports in 2010, 537
reports in 2011, and 212 reports in the first 4 months of 2012, and
estimates that for the full 12 months of 2012 it will receive 636
reports. Based on this experience, CVM estimates that it will receive,
on average, 636 reports of adverse drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs
annually over the next 3 years. Thus, FDA estimates that over the next
3 years it will receive annually 636 mandatory adverse event reports
submitted via the SRP, with a burden of 636 hours, as reported in table
2, row 2.
    Adverse event reports submitted via the ESG include reports of
adverse experiences related to drugs, biological products, and medical
devices, as well as, adverse animal drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs. FDA
received 586,229 such adverse event reports in 2010; 850,161 reports in
2011; and 497,076 reports in the first 4 months of 2012; and estimates
that for the full 12 months of 2012 it will receive 1,491,228 reports.
Based on this experience, FDA estimates that it will receive, on
average, 1,491,228 adverse event reports submitted via the ESG, with a
burden of 894,736.8 hours, rounded to 894,737 hours, as reported in
table 2, row 3.
    FDA estimates that over the next 3 years it will receive annually
1,413 mandatory and voluntary RFR Reports submitted via the SRP, as
reported in table 2, row 4. CFSAN received 845 such adverse event
reports in 2010; 1,293 reports in 2011; and 471 reports in the first 4
months of 2012; and estimates that for the full 12 months of 2012 it
will receive 1,413 reports. Based on this experience, CFSAN estimates
that it will receive, on average, 1,413 mandatory and voluntary RFR
Reports submitted via the SRP annually over the next 3 years, with a
burden of 847.8 hours, rounded to 848 hours, as reported in table 2,
row 4.
    The burden hours required to complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control
numbers 0910-0284 and 0910-0291.
    While FDA does not charge for the use of the ESG, FDA requires
respondents to obtain a public key infrastructure certificate in order
to set up the account. This can be obtained in-house or outsourced by
purchasing a public key certificate that is valid for 1 year to 3
years. The certificate typically costs from $20 to $30.

    Dated: August 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22659 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: September 26, 2008 (Volume 73, Number 188)]
[Proposed Rules]
[Page 55781-55786]
[DOCID:fr26se08-20]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0018; Directorate Identifier 2007-NM-145-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310 Series Airplanes and
Model A300-600 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

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

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SUMMARY: The FAA is revising an earlier NPRM for an airworthiness
directive (AD) that applies to all Airbus Model A310 series airplanes
and Model A300-600 series airplanes. The original NPRM would have
required superseding two existing ADs. One existing AD applies to
certain Airbus Model A310 series airplanes and currently requires

repetitive inspections for cracking of the flap transmission shafts,
and replacement of the transmission shafts if necessary. That existing
AD also provides an optional terminating action for the repetitive
inspections. The other existing AD applies to all Airbus Model A310 and
A300-600 series airplanes and currently requires a one-time inspection
of the trimmable horizontal stabilizer actuator, corrective actions if
necessary, and follow-on repetitive tasks. The original NPRM would have
added revising the Airworthiness Limitations Section of the
Instructions for Continued Airworthiness to incorporate new limitations
and maintenance tasks for aging systems maintenance. The original NPRM
resulted from the manufacturer's determination that life limitations
and maintenance tasks are necessary in order to ensure continued
operational safety of the affected airplanes. This new action revises
the original NPRM by reducing the initial compliance times. We are
proposing this supplemental NPRM to prevent reduced structural
integrity of these airplanes due to the failure of system components.

DATES: We must receive comments on this supplemental NPRM by October
21, 2008.

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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Airbus, 1
Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.

Examining the AD Docket

    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 proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Stafford, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1622; 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-2008-0018;
Directorate Identifier 2007-NM-145-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 because of 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

    The FAA issued a notice of proposed rulemaking (NPRM) (the
``original NPRM'') to amend 14 CFR part 39 to include an AD that
supersedes two existing ADs: AD 2006-10-11, amendment 39-14595 (71 FR
28254, May 16, 2006), which applies to certain Airbus Model A310 series
airplanes; and AD 2006-15-10, amendment 39-14690 (71 FR 42021, July 25,
2006), which applies to all Airbus Model A310 and A300-600 series
airplanes. The original NPRM was published in the Federal Register on
January 14, 2008 (73 FR 2197). The original NPRM applies to all Airbus
Model A310 series airplanes and Model A300-600 series airplanes. The
original NPRM proposed to retain the requirements of the existing ADs.
The original NPRM also proposed to add revising the Airworthiness
Limitations Section (ALS) of the Instructions for Continued
Airworthiness (ICA) to incorporate new limitations and maintenance
tasks for aging systems maintenance.

Actions Since Original NPRM Was Issued

    Since the original NPRM was issued, we have determined that the
initial compliance times for the revision specified in paragraph (o) of
the original NPRM need to be reduced. In paragraph (o) of the original
NPRM, we specified that for all tasks ``* * * the initial compliance
times start from the effective date of this AD * * *.'' However, the
thresholds specified in Airbus A310 ALS Part 4--Aging Systems
Maintenance, Revision 01, dated December 21, 2006; and Airbus A300-600
ALS Part 4--Aging Systems Maintenance, Revision 01, dated December 21,
2006; (which are referred to as the appropriate sources of service
information for accomplishing the required actions in paragraph (o) of
the original NPRM); start from ``* * * the initial entry into service
of a specific maintenance task.''
    In order to ensure timely action to address the identified unsafe
condition, we have reduced the initial compliance times in order to
match the service information. We have revised paragraph (o) of the
supplemental NPRM accordingly.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments that have been
received on the original NPRM.

Request To Refer to Latest Revisions of Service Bulletins

    Federal Express (FedEx) requests that we refer to the latest
revision of Airbus Service Bulletin A300-27-6044, Revision 04, dated
September 10, 2001; and Airbus Service Bulletin A310-27-2089, Revision
02, dated June 28, 2001 (which are referred to in Table 1 of paragraph
(k) of the original NPRM as the appropriate sources of service
information for doing the actions specified in paragraphs (l), (m), and
(n) of the original NPRM). FedEx states that Airbus Service Bulletin
A300-27-6044, Revision 05, dated August 29, 2006; and Airbus Service
Bulletin A310-27-2089, Revision 03, dated August 29, 2006; do not
specify any additional work and were primarily issued to adjust the
service bulletin effectivity as well as to provide additional reference
data.
    We agree with the commenter to refer to Airbus Service Bulletin
A300-27-6044, Revision 05, dated August 29, 2006; and Airbus Service
Bulletin A310-27-2089, Revision 03, dated August 29, 2006. We have
reviewed the service bulletins and determined no additional work is
required. We have revised Table 1 of this supplemental NPRM
accordingly.

Request To Clarify Definition of ``New''

    FedEx requests that we clarify the word ``new'' specified in
paragraph (m) of the original NPRM. FedEx states that the word ``new''
pertains to the replacement of the trimmable horizontal stabilizer
actuator (THSA), and the replacement could be with a new or used
(serviceable) THSA provided that the THSA has not been operated more
than 65,000 flight hours or 40,000 flight cycles or been in service
more than 25 years since new, whichever occurs first. FedEx also states
that if an THSA that was operated more than 47,000 flight hours has
been installed, it must be inspected in accordance with Airbus Service
Bulletins A300-27-6044 or A310-27-2089 (as specified in paragraph (n)
of the original NPRM). FedEx further states that Airbus is in
concurrence with FedEx's comment.
    We agree with the commenter that the replacement specified in
paragraph (m) of this supplemental NPRM could be with a new or
serviceable THSA. Sub-part 4-2 of the Airbus A300-600 and A310 ALS Part
4 lists the life limits for the operational life of the listed
components. When a component (e.g., the THSA) reaches the earliest of
any of the life limits in flight hours, flight cycles, or calendar
time, that component has reached the end of its given operational life
and must be removed from the airplane and replaced by another unit. It
is not necessary that the replacement unit/component be ``new.'' The
rules of application for the ALS Part 4 are given in sub-part 4-0 of
the ALS.
    It is a requirement that a life-limited component not be operated
beyond the limitation stated in the ALS Part 4-2. Thus, for the THSA,
as long as none of the limits (65,000 flight hours, 40,000 flight
cycles, or 25 years of operation) have been exceeded and the component
is classified ``serviceable,'' then the component can be installed and
operated on the airplane. Airbus Operators Information Telex (OIT) SE
999.0074/05/BB, dated August 3, 2005, provides clarification on these
limits. We have revised paragraph (m) of this supplemental NPRM to
clarify that the installed part may be ``new'' or ``serviceable,'' and
we have added Note 6 and Note 7 to this supplemental NPRM to refer to
the OIT for clarification of these limits.

Request To Clarify Starting Point of 25-Year Life Limit

    FedEx requests that we clarify the starting point for the 25-year
life limit specified in the Airbus A300-600 and A310 ALS Part 4 for
THSAs built as spare parts and not originally installed on airplanes.
FedEx suggests that operators be required to use the date of
manufacture of the THSA as documented by Goodrich, the original
equipment manufacturer (OEM) of the THSA. FedEx states that it would be
difficult to determine when the component, produced as a spare by
Goodrich, was first installed on an airplane.
    We agree to clarify the starting point for the 25-year life limit.
The ALS Part 4 does not provide the calendar limit guidance that is
provided in Airbus Service Information Letter (SIL) 05-008, dated July
7, 2006. Airbus issued SIL 05-008 to give guidance (i.e., a calculation
method) for life limitations in calendar parameters for components
whose history is partially or completely unknown. This calculation
method could be used by operators when they comply with the ALS Parts
4-2 and 4-3(a).
    The SIL is intended for use when operators cannot retrieve their
parts history (in flight hours/flight cycles). This method provides an
estimated parts life (flight hours/flight cycles) and is very
conservative. As suggested in the FedEx request, one method employed in
the life calculation (starting point) is the date of manufacture (DOM).
The DOM is shown in one of the tables and examples within the SIL.
    The SIL is not currently referenced in the ALS Part 4. However,
Airbus has issued OIT SE 999.0008/07/LB, dated January 16, 2007.
Section 4 of the OIT advises users of the availability of SIL 05-008.
We have added Note 8 to this supplemental NPRM to refer to the OIT and
SIL for clarification.

Request To Include New THSA Part

    FedEx requests that we include the new configuration of THSA, part
number (P/N) 47142-323, and its life limitation. FedEx states that P/N
47142-323 does not have the 25-year life limit due to the application
of enhanced materials and processes used during manufacture to
reinforce their resistance to corrosion. FedEx notes that Airbus issued
Service Bulletins A300-27-6058 and A310-27-2100, both dated August 30,
2007, to introduce this new THSA configuration, which does not carry a
calendar life limit. FedEx further states that ALS Part 4 does not
address this THSA configuration.
    We do not agree to include the new THSA part number. We acknowledge
that Airbus Service Bulletins A300-27-6058 (for Model A300-600
airplanes) and A310-27-2100 (for Model A310 airplanes) specify
procedures to install THSA P/N 47142-323. However, Airbus has not
published a revised inspection task that will apply to P/N 47142-323 to
address the corrosion issue. After this task has been published,
operators may request an alternative method of compliance (AMOC)
according to the provisions of paragraph (r) of this supplemental NPRM.
We have not revised this supplemental NPRM in this regard.

Request To Allow Additional Compliance Time

    FedEx requests that we add a grace period of 1,200 flight hours for
Task Number 274411-12-1. FedEx states that the task is contained within
Airbus A310 ALS Part 4--Aging Systems Maintenance, Revision 01, dated
December 21, 2006; and Airbus A300-600 ALS Part 4--Aging Systems
Maintenance, Revision 01, dated December 21, 2006; which were referred
to in paragraph (o) of the original NPRM for the incorporation of new
limitations and maintenance tasks for aging systems maintenance. FedEx
states that the task establishes a threshold for accomplishment at
47,000 flight hours or 20 years, whichever occurs first, but does not
provide a grace period for the inspection on actuators that have
exceeded 20 years in service but not yet reached 25 years in service
(the established life limit of the THSA). FedEx suggests a grace period
of 1,200 flight hours to provide sufficient time to sequence airplanes
through maintenance for accomplishment of this THSA inspection at the
new established threshold.
    We agree that a grace period is necessary. In accordance with
paragraph (o) of this supplemental NPRM, operators have three months to
revise the ALS of the ICA to incorporate the tasks specified in Airbus
A310 ALS Part 4--Aging Systems Maintenance, Revision 01, dated December
21, 2006; and A300-600 ALS Part 4--Aging Systems Maintenance, Revision
01, dated December 21, 2006; as applicable. For the initial compliance
times for the tasks identified in the ALS, we have added paragraph
(o)(2) of this supplemental NPRM to provide a grace period of within 3
months after revising the ALS of the ICA.

FAA's Determination and Proposed Requirements of the Supplemental NPRM

    The changes discussed above expand the scope of the original NPRM;
therefore, we have determined that it is necessary to reopen the
comment period to provide additional opportunity for public comment on
this supplemental NPRM.

Costs of Compliance

    The following table provides the estimated costs for U.S. operators
to comply with this supplemental NPRM.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
            Action               Work hours     Average labor      Cost per        registered       Fleet cost
                                                rate per hour      airplane         airplanes
----------------------------------------------------------------------------------------------------------------
Inspection (required by AD                  1             $80  $80, per                      59  $4,720, per
 2006-10-11).                                                   inspection                        inspection
                                                                cycle.                            cycle.
Inspection (required by AD                  3              80  $240............             213  $51,120.
 2006-15-10).
Repetitive follow-on tasks                 12              80  $960, per                    213  $204,480, per
 (required by AD 2006-15-10).                                   inspection                        inspection
                                                                cycle.                            cycle.
ALS revision (new action)....               1              80  $80.............             213  $17,040.
----------------------------------------------------------------------------------------------------------------

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 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 that the 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this supplemental NPRM and placed it in the AD docket. See
the ADDRESSES section for a location to examine the regulatory
evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-14595 (71 FR 28254, May 16, 2006) and amendment
39-14690 (71 FR 42021, July 25, 2006) and adding the following new
airworthiness directive (AD):

Airbus: Docket No. FAA-2008-0018; Directorate Identifier 2007-NM-
145-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by October
21, 2008.

Affected ADs

    (b) This AD supersedes AD 2006-10-11 and AD 2006-15-10.

Applicability

    (c) This AD applies to all Airbus Model A310 series airplanes;
and Model A300-600 series airplanes; certificated in any category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (r) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Unsafe Condition

    (d) This AD results from the manufacturer's determination that
life limitations and maintenance tasks are necessary in order to
ensure continued operational safety of the affected airplanes. We
are issuing this AD to prevent reduced structural integrity of these
airplanes due to the failure of system components.

Compliance

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

Restatement of Requirements of AD 2006-10-11

Inspection and Corrective Action

    (f) For Airbus Model A310-203, -204, -221, -222, -304, -322, -
324, and -325 airplanes, except for airplanes on which Airbus
Modification 12247 has been embodied in production: At the earlier
of the compliance times specified in paragraph (f)(1) or (f)(2) of
this AD, perform a detailed inspection for stress corrosion cracking
of the flight transmission shafts located between the power control
unit (PCU) and the torque limiters in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A310-27-2092,
Revision 02, dated April 11, 2005. Thereafter, repeat the
inspections as required by paragraph (g) of this AD. Before further
flight, replace any cracked transmission shaft discovered during any
inspection required by this AD with a new or reconditioned shaft, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A310-27-2095, dated March 29, 2000. Doing an inspection in
accordance with paragraph (o) or (p) of this AD terminates the
requirements of this paragraph.
    (1) Within 2,000 flight hours after the last flap asymmetry
protection test performed in accordance with Airbus A310 Maintenance

Planning Document (MPD) Task 275600-01-1.
    (2) Within 8,000 flight cycles after the last flap asymmetry
protection test performed in accordance with Airbus A310 MPD Task
275600-02-1 or 800 flight cycles after June 20, 2006 (the effective
date of AD 2006-10-11), whichever comes later.

    Note 2: Airbus Service Bulletin A310-27-2092, Revision 02, dated
April 11, 2005, refers to Lucas Liebherr Service Bulletin 551A-27-
624, Revision 1, dated August 18, 2000, as an additional source of
service information for accomplishing the inspections.

    Note 3: Airbus Service Bulletin A310-27-2092, Revision 02,
refers to Airbus Service Bulletin A310-27-2095, dated March 29,
2000, as a source of service information for replacing the flap
transmission shafts.

    Note 4: Airbus Service Bulletin A310-27-2095 refers to Lucas
Liebherr Service Bulletin 551A-27-M551-05, dated January 12, 2000,
as an additional source of service information for replacing the
flap transmission shafts.

Repetitive Inspections

    (g) Repeat the inspection required by paragraph (f) of this AD
at the applicable times specified in paragraphs (g)(1), (g)(2), and
(g)(3) of this AD. Doing an inspection in accordance with paragraph
(o) or (p) of this AD terminates the requirements of this paragraph.
    (1) Before further flight after any occurrence of jamming of the
flap transmission system.
    (2) At intervals not to exceed 2,000 flight hours after each
flap asymmetry protection test performed in accordance with Airbus
A310 MPD Task 275600-01-1.
    (3) At intervals not to exceed 8,000 flight cycles after each
flap asymmetry protection test performed in accordance with Airbus
A310 MPD Task 275600-02-1.

Optional Terminating Action

    (h) Replacing any flap transmission shaft with a new or
reconditioned transmission shaft in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A310-27-2095,
dated March 29, 2000, ends the inspections required by paragraphs
(f) and (g) of this AD for that transmission shaft only.

Actions Performed Using Previously Issued Service Information

    (i) Actions performed in accordance with Airbus Service Bulletin
A310-27-2092, dated April 9, 1999; or Revision 01, dated December
11, 2001; are considered acceptable for compliance with the
corresponding requirements of paragraphs (f) and (g) of this AD.

No Reporting

    (j) Although Airbus Service Bulletin A310-27-2092, Revision 02,
dated April 11, 2005, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

Restatement of Requirements of AD 2006-15-10

Service Bulletin References

    (k) Unless otherwise specified in this AD, the term ``service
bulletin,'' as used in paragraphs (l), (m), and (n) of this AD,
means the applicable required service bulletin identified in Table 1
of this AD. The service bulletins refer to Goodrich Actuation
Systems Service Bulletin 47142-27-11, Revision 3, dated April 25,
2005, as an additional source of service information for the
required actions.

                       Table 1--Service Bulletins
------------------------------------------------------------------------
                                    Approved Airbus
                                   Service Bulletin
                                      version for
Required Airbus Service Bulletin     actions done       Airbus airplane
                                      before the             model
                                   effective date of
                                        this AD
------------------------------------------------------------------------
A300-27-6044, Revision 04, dated  A300-27-6044,       A300 B4-601, B4-
 September 10, 2001; or A300-27-   Revision 02,        603, B4-620, and
 6044, Revision 05, dated August   dated August 26,    B4-622.
 29, 2006.                         2000; or Revision  A300 B4-605R and
                                   03, dated June      B4-622R.
                                   28, 2001.          A300 F4-605R and
                                                       F4-622R.
                                                      A300 C4-605R
                                                       Variant F.
A310-27-2089, Revision 02, dated  A310-27-2089,       A310-203, -204, -
 June 28, 2001; or A310-27-2089,   Revision 01,        221, and -222
 Revision 03, dated August 29,     dated August 25,   A310-304, -322, -
 2006.                             2000.               324, and -325.
------------------------------------------------------------------------

Inspection

    (l) At the applicable time specified in paragraph (l)(1) or
(l)(2) of this AD, do a detailed inspection of specified components
of the trimmable horizontal stabilizer actuator (THSA) in accordance
with paragraph 1.E.(2)(a) and the Accomplishment Instructions of the
applicable service bulletin. Repair any discrepancy before further
flight in accordance with a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA) (or its delegated
agent). TRW Aeronautical Systems/Lucas Aerospace Component
Maintenance Manual 27-44-13, dated September 14, 2001, is one
acceptable method for the repair. Doing an inspection in accordance
with paragraph (o) or (p) of this AD terminates the requirements of
this paragraph.
    (1) If the flight hours accumulated on the THSA can be
positively determined: Inspect at the earlier of:
    (i) Before the accumulation of 47,000 total flight hours on the
THSA, or within 600 flight hours after August 29, 2006 (the
effective date of AD 2006-15-10), whichever occurs later.
    (ii) Within 25 years since the THSA was new or within 600 flight
hours after August 29, 2006, whichever occurs later.
    (2) If the flight hours accumulated on the THSA cannot be
positively determined: Inspect before the accumulation of 47,000
total flight hours on the airplane, or within 600 flight hours after
August 29, 2006, whichever occurs later.

    Note 5: For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

Follow-on Repetitive Tasks

    (m) After the inspection required by paragraph (l) of this AD:
Do the repetitive tasks in accordance with the Accomplishment
Instructions and at the times specified in paragraph 1.E.(2)(b) of
the service bulletin, as applicable, except as provided by paragraph
(n) of this AD. The repetitive tasks are valid only until the THSA
operational life exceeds 65,000 flight hours, 40,000 flight cycles,
or 25 years, whichever occurs first. Before the THSA is operated
beyond these extended life goals, it must be replaced with a new or
serviceable THSA, except as required by paragraph (n) of this AD.
Doing an inspection in accordance with paragraph (o) or (p) of this
AD terminates the requirements of this paragraph.

    Note 6: Refer to Airbus Operators Information Telex (OIT) SE
999.0074/05/BB, dated August 3, 2005, for additional information on
the THSA life limits.

THSA Replacement

    (n) For any THSA, whether discrepant or not, that is replaced
with a new or serviceable THSA: Within 47,000 flight hours or 25
years, whichever occurs first, after the THSA is replaced, do the
applicable tasks specified in paragraph 1.E.(2)(a) and the
Accomplishment Instructions of the applicable service bulletin.
Thereafter repeat the tasks within the repetitive intervals
specified in paragraph 1.E.(2)(b) of the applicable service
bulletin. Doing the corresponding tasks in accordance with

paragraph (o) or (p) of this AD terminates the requirements of this
paragraph.

New Requirements of This AD

Revise Airworthiness Limitations Section (ALS) To Incorporate
Limitations and Maintenance Tasks for Aging Systems Maintenance

    (o) Within 3 months after the effective date of this AD, revise
the ALS of the Instructions for Continued Airworthiness (ICA) to
incorporate Airbus A310 ALS Part 4--Aging Systems Maintenance,
Revision 01, dated December 21, 2006; or Airbus A300-600 ALS Part
4--Aging Systems Maintenance, Revision 01, dated December 21, 2006;
as applicable. For all tasks identified in Airbus A310 ALS Part 4--
Aging Systems Maintenance, Revision 01; and Airbus A300-600 ALS Part
4--Aging Systems Maintenance, Revision 01; do the tasks at the later
of the times specified in paragraphs (o)(1) and (o)(2) of this AD,
except as provided by paragraph (p) of this AD. The repetitive
inspections must be accomplished thereafter at the interval
specified in Airbus A310 ALS Part 4--Aging Systems Maintenance,
Revision 01; and Airbus A300-600 ALS Part 4--Aging Systems
Maintenance, Revision 01. Doing an inspection required by this
paragraph terminates the corresponding inspection required by
paragraph (f), (g), (l), (m), or (n) of this AD.
    (1) At the initial compliance times (thresholds) specified in
the applicable ALS Part 4--Aging Systems Maintenance, with the
compliance times starting from the later of the times specified in
paragraphs (o)(1)(i) and (o)(1)(ii) of this AD.
    (i) Since first flight of the airplane.
    (ii) Since the applicable part was new or refurbished if the
part's life (in flight hours, flight cycles, landings, or calendar
time, as applicable) can be conclusively determined.
    (2) Within 3 months after doing the revision of the ALS of the
ICA required by paragraph (o) of this AD.

    Note 7: Refer to Airbus OIT SE 999.0074/05/BB, dated August 3,
2005, for additional information on the THSA life limits.

    Note 8: Refer to Airbus OIT SE 999.0008/07/LB, dated January 16,
2007; and Airbus Service Information Letter (SIL) 05-008, Revision
1, dated February 21, 2007; for additional information on the THSA
life limits and calculation method for unknown history of parts.

    (p) For airplanes on which any life limitation/maintenance task
has been complied with in accordance with the requirements of
paragraph (f), (g), (l), (m), or (n) of this AD (e.g., AD 2006-10-11
or AD 2006-15-10), the last accomplishment of each limitation/task
must be retained as a starting point for the accomplishment of each
corresponding limitation/task interval now introduced in Airbus A310
ALS Part 4--Aging Systems Maintenance, Revision 01, dated December
21, 2006; and A300-600 ALS Part 4--Aging Systems Maintenance,
Revision 01, dated December 21, 2006; as applicable. Doing an
inspection required by this paragraph terminates the corresponding
inspection required by paragraph (f), (g), (l), (m), or (n) of this
AD.
    (q) Except as provided by paragraph (r) of this AD: After
accomplishing the actions specified in paragraphs (o) and (p) of
this AD, no alternative inspection, inspection intervals, or
limitations may be used.

Alternative Methods of Compliance (AMOCs)

    (r)(1) 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.
Send information to ATTN: Tom Stafford, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1622; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) AMOCs approved previously in accordance with AD 2006-10-11
are not approved as AMOCs with this AD.
    (3) AMOCs approved previously in accordance with AD 2006-15-10
are not approved as AMOCs with this AD.

Related Information

    (s) EASA airworthiness directive 2007-0092, dated April 10,
2007, also addresses the subject of this AD.

    Issued in Renton, Washington, on September 18, 2008.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-22632 Filed 9-25-08; 8:45 am]

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[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Page 45715]
[FR Doc No: 2012-18887]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

TIME AND DATE: August 2, 2012, 12 noon to 3 p.m., Eastern Daylight
Time.

PLACE: This meeting will take place telephonically. Any interested
person may call<PHONE_NUMBER>, passcode, 908048 to participate in this
meeting.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED:  The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: July 27, 2012.
Larry W. Minor,
Associate Administrator for Policy .
[FR Doc. 2012-18887 Filed 7-30-12; 4:15 pm]
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