[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36101-36105]
[FR Doc No: 2019-15906]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Generic Drug User Fee Rates for Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or
statute), as amended by the Generic Drug User Fee Amendments of 2017
(GDUFA II), authorizes the Food and Drug Administration (FDA, Agency,
or we) to assess and collect fees for abbreviated new drug applications
(ANDAs), drug master files (DMFs), generic drug active pharmaceutical
ingredient (API) facilities, finished dosage form (FDF) facilities,
contract manufacturing organization (CMO) facilities, and generic drug
applicant program user fees. In this document, FDA is announcing fiscal
year (FY) 2020 rates for GDUFA II fees.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42) establish fees associated with human generic drug products. Fees
are assessed on: (1) Certain types of applications for human generic
drug products; (2) certain facilities where APIs and FDFs are produced;
(3) certain DMFs associated with human generic drug products; and (4)
generic drug applicants who have approved ANDAs (the program fee) (see
section 744B(a)(2) to (5) of the FD&C Act).
    GDUFA II stipulates that user fees should total $493,600,000
annually adjusted each year for inflation. For FY 2020, the generic
drug fee rates are: ANDA ($176,237), DMF ($57,795), domestic API
facility ($44,400), foreign API facility ($59,400), domestic FDF
facility ($195,662), foreign FDF facility ($210,662), domestic CMO
facility ($65,221), foreign CMO facility ($80,221), large size
operation generic drug applicant program ($1,661,684), medium size
operation generic drug applicant program ($664,674), and small business
generic drug applicant program ($166,168). These fees are effective on
October 1, 2019, and will remain in effect through September 30, 2020.

II. Fee Revenue Amount for FY 2020

    GDUFA II directs FDA to use the yearly revenue amount determined
under the statute as a starting point to set the fee rates for each fee
type. For more information about GDUFA II, please refer to the FDA
website (https://www.fda.gov/gdufa). The ANDA, DMF, API facility, FDF
facility, CMO facility, and generic drug applicant program fee (GDUFA
program fee) calculations for FY 2020 are described in this document.
    The base revenue amount for FY 2020 is $501,721,201. This is the
amount calculated for the prior fiscal year, FY 2019, pursuant to the
statute (see section 744B(b)(1) of the FD&C Act). GDUFA II specifies
that the $501,721,201 is to be adjusted for inflation increases for FY
2020 using two separate adjustments--one for personnel compensation and
benefits (PC&B) and one for non-PC&B costs (see sections 744B(c)(1)(B)
and (C) of the FD&C Act).
    The component of the inflation adjustment for PC&B costs shall be
one plus the average annual percent change in the cost of all PC&B paid
per full-time equivalent position (FTE) at FDA for the first 3 of the 4
preceding fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs of human generic drug activities for the first 3 of the
preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act).
    Table 1 summarizes the actual cost and total FTEs for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2020. The 3-year average is 3.1175 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
               Fiscal year                      2016              2017              2018         3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..............................    $2,414,728,159    $2,581,551,000     $2,690,678,00  ................
Total FTEs..............................            16,381            17,022            17,023  ................
PC&B per FTE............................          $147,408          $151,660          $158,061  ................
Percent Change from Previous Year.......            2.2474            2.8845            4.2206            3.1175
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 3.1175 percent should be multiplied
by the proportion of PC&B expended for human generic drug activities
for the first 3 of the preceding 4 fiscal years. Table 2 shows the
amount of PC&B and the total amount obligated for human generic drug
activities from FY 2016 through FY 2018.

Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last
                                                     3 Years
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               Fiscal year                      2016              2017              2018         3-Year  average
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PC&B....................................      $242,963,571      $271,748,229      $332,617,643  ................
Non-PC&B................................      $250,987,599      $262,058,852      $276,911,265  ................
Total Costs.............................      $493,951,170      $533,807,081      $609,528,908  ................
PC&B Percent............................           49.1878           50.9076           54.5696           51.5550
Non-PC&B Percent........................           50.8122           49.0924           45.4304           48.4450
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    The payroll adjustment is 3.1175 percent multiplied by 51.5550
percent (or 1.6072 percent).
    The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2020 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first 3 of the preceding 4 years of available
data multiplied by the proportion of all costs other than PC&B costs to
total costs of human generic drug activities (see section 744B(c)(1)(C)
of the FD&C Act). As a result of a geographical revision made by the
Bureau of Labor and Statistics in January 2018,\1\ the ``Washington-
Baltimore, DC-MD-VA-WV'' index was discontinued and replaced with two
separate indices (i.e., ``Washington-Arlington-Alexandria, DC-VA-MD-
WV'' and ``Baltimore-Columbia-Towson, MD''). In order to continue
applying a CPI that best reflects the geographic region in which FDA is
headquartered and provides the most current data available, the
Washington-Arlington-Alexandria index will be used in calculating the
relevant adjustment factors for FY 2020 and subsequent years. Table 3
provides the summary data for the percent change in the specified CPI.
The data are published by the Bureau of Labor Statistics and can be
found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

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    \1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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                  Year                          2016              2017              2018         3-Year  average
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Annual CPI..............................           253.422           256.221           261.445  ................
Annual Percent Change...................            1.1003            1.1045            2.0389            1.4146
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    To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (1.4146 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Because 51.5550 percent was
obligated for PC&B as shown in table 2, 48.4450 percent is the portion
of costs other than PC&B. The non-pay adjustment is 1.4146 percent
times 48.4450 percent, or 0.6853 percent.
    To complete the inflation adjustment for FY 2020, we add the PC&B
component (1.6072 percent) to the non-PC&B component (0.6853 percent)
for a total inflation adjustment of 2.2925 percent (rounded), making
1.022925. We then multiply the base revenue amount for FY 2020
($501,721,201) by 1.022925, yielding an inflation-adjusted amount of
$513,223,000 (rounded to the nearest thousand dollars).

III. ANDA Filing Fee

    Under GDUFA II, the FY 2020 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2019. This fee is
due on the submission date of the ANDA. Section 744B(b)(2)(B) of the
FD&C Act specifies that the ANDA fee will make up 33 percent of the
$513,223,000, which is $169,363,590.
    To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2020. The
submissions are broken down into three categories: New originals
(submissions that have not been received by FDA previously);
submissions that have been refused to receive (RTR) for reasons other
than failure to pay fees; and applications that are resubmitted after
having been RTR

for reasons other than failure to pay fees. An ANDA counts as one FAE;
however, 75 percent of the fee paid for an ANDA that has been RTR shall
be refunded according to GDUFA II if (1) the ANDA is refused for a
cause other than failure to pay fees, or (2) the ANDA has been
withdrawn prior to receipt (section 744B(a)(3)(D)(i) of the FD&C Act).
Therefore, an ANDA that is considered not to have been received by FDA
due to reasons other than failure to pay fees or withdrawn prior to
receipt counts as one-fourth of an FAE. After an ANDA has been RTR, the
applicant has the option of resubmitting. For user fee purposes, these
resubmissions are equivalent to new original submissions--ANDA
resubmissions are charged the full amount for an application (one FAE).
    FDA utilized data from ANDAs submitted from October 1, 2017, to
April 30, 2019, to estimate the number of new original ANDAs that will
incur filing fees in FY 2020. For FY 2020, the Agency estimates that
approximately 953 new original ANDAs will be submitted and incur filing
fees. Not all of the new original ANDAs will be received by the Agency
and some of those not received will be resubmitted in the same fiscal
year. Therefore, the Agency expects that the FAE count for ANDAs will
be 961 for FY 2020.
    The FY 2020 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2020 (961) into the fee revenue amount
to be derived from ANDA application fees in FY 2020 ($169,363,590). The
result, rounded to the nearest dollar, is a fee of $176,237 per ANDA.
    The statute provides that those ANDAs that include information
about the production of active pharmaceutical ingredients other than by
reference to a DMF will pay an additional fee that is based on the
number of such active pharmaceutical ingredients and the number of
facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA anticipates that this additional
fee is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs.

IV. DMF Fee

    Under GDUFA II, the DMF fee is owed by each person that owns a type
II active pharmaceutical ingredient DMF that is referenced, on or after
October 1, 2012, in a generic drug submission by an initial letter of
authorization. This is a one-time fee for each DMF. This fee is due on
the earlier of the date on which the first generic drug submission is
submitted that references the associated DMF or the date on which the
drug master file holder requests the initial completeness assessment.
Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has
successfully undergone an initial completeness assessment and the fee
is paid, the DMF will be placed on a publicly available list
documenting DMFs available for reference.
    To calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. The Agency assessed DMFs from October 1, 2017,
to April 30, 2019, and concluded that averaging the number of fee-
paying DMFs provided the most accurate model for predicting fee-paying
DMFs for FY 2020. The monthly average of paid DMF submissions the
Agency received in FY 2018 and FY 2019 is 37. To determine the FY 2020
projected number of fee-paying DMFs, the average of 37 DMF submissions
is multiplied by 12 months, which results in 444 estimated FY 2020 fee-
paying DMFs. FDA is estimating 444 fee-paying DMFs for FY 2020.
    The FY 2020 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2020. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $513,223,000, which is $25,661,150. Dividing the DMF
revenue amount ($25,661,150) by the estimated fee-paying DMFs (444),
and rounding to the nearest dollar, yields a DMF fee of $57,795 for FY
2020.

V. Foreign Facility Fee Differential

    Under GDUFA II, the fee for a facility located outside the United
States and its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United States and
its territories and possessions. The basis for this differential is the
extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.

VI. FDF and CMO Facility Fees

    Under GDUFA II, the annual FDF facility fee is owed by each person
who owns an FDF facility that is identified in at least one approved
generic drug submission owned by that person or its affiliates. The CMO
facility fee is owed by each person who owns an FDF facility that is
identified in at least one approved ANDA but is not identified in an
approved ANDA held by the owner of that facility or its affiliates.
These fees are due no later than the first business day on or after
October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act
specifies that the FDF and CMO facility fee revenue will make up 20
percent of the $513,223,000, which is $102,644,600.
    To calculate the fees, data from FDA's Integrity Services (IS) were
utilized as the primary source of facility information for determining
the denominators of each facility fee type. IS is the master data
steward for all facility information provided in generic drug
submissions received by FDA. A facility's reference status in an
approved generic drug submission is extracted directly from submission
data rather than relying on data from self-identification. This
information provided the number of facilities referenced as FDF
manufacturers in at least one approved generic drug submission. Based
on FDA's IS data, the FDF and CMO facility denominators are 192 FDF
domestic, 248 FDF foreign, 75 CMO domestic, and 99 CMO foreign
facilities for FY 2020.
    GDUFA II specifies that the CMO facility fee is to be equal to one-
third the amount of the FDF facility fee. Therefore, to generate the
target collection revenue amount from FDF and CMO facility fees
($102,644,600), FDA must weight a CMO facility as one-third of an FDF
facility. FDA set fees based on the estimate of 192 FDF domestic, 248
FDF foreign, 25 CMO domestic (75 multiplied by one-third), and 33 CMO
foreign facilities (99 multiplied by one-third), which equals 498 total
weighted FDF and CMO facilities for FY 2020.
    To calculate the fee for domestic facilities, FDA first determines
the total fee revenue that will result from the foreign facility
differential by subtracting the fee revenue resulting from the foreign
facility fee differential from the target collection revenue amount
($102,644,600) as follows. The foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (248) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (99), totaling $5,205,000. This results in
foreign fee differential revenue of $5,205,000 from the total FDF and
CMO facility fee target collection revenue. Subtracting the foreign
facility differential fee revenue ($5,205,000) from the total FDF and
CMO facility target collection revenue ($102,644,600) results in a
remaining facility fee revenue balance of $97,439,600. To determine the
domestic FDF facility fee, FDA divides the $97,439,600 by the total
weighted number of FDF and CMO facilities (498), which results in a
domestic FDF facility fee of $195,662. The foreign FDF

facility fee is $15,000 more than the domestic FDF facility fee, or
$210,662.
    According to GDUFA II, the domestic CMO fee is calculated as one-
third the amount of the domestic FDF facility fee. Therefore, the
domestic CMO fee is $65,221, rounded to the nearest dollar. The foreign
CMO fee is calculated as the domestic CMO fee plus the foreign fee
differential of $15,000. Therefore, the foreign CMO fee is $80,221.

VII. API Facility Fee

    Under GDUFA II, the annual API facility fee is owed by each person
who owns a facility that is identified in (1) at least one approved
generic drug submission or (2) in a Type II API DMF referenced in at
least one approved generic drug submission. These fees are due no later
than the first business day on or after October 1 of each such year.
Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee
will make up 7 percent of $513,223,000 in fee revenue, which is
$35,925,610.
    To calculate the API facility fee, data from FDA's IS were utilized
as the primary source of facility information for determining the
denominator. As stated above, IS is the master data steward for all
facility information provided in generic drug submissions received by
FDA. A facility's reference status in an approved generic drug
submission is extracted directly from submission data rather than
relying on data from self-identification. This information provided the
number of facilities referenced as API manufacturers in at least one
approved generic drug submission.
    The total number of API facilities identified was 624; of that
number, 76 were domestic and 548 were foreign facilities. The foreign
facility differential is $15,000. To calculate the fee for domestic
facilities, FDA must first subtract the fee revenue that will result
from the foreign facility fee differential. FDA takes the foreign
facility differential ($15,000) and multiplies it by the number of
foreign facilities (548) to determine the total fee revenue that will
result from the foreign facility differential. As a result of that
calculation, the foreign fee differential revenue will make up
$8,220,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($8,220,000) from the total API
facility target revenue ($35,925,610) results in a remaining balance of
$27,705,610. To determine the domestic API facility fee, we divide the
$27,705,610 by the total number of facilities (624), which gives us a
domestic API facility fee of $44,400. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $59,400.

VIII. Generic Drug Applicant Program Fee

    Under GDUFA II, if a person and its affiliates own at least one but
not more than five approved ANDAs on October 1, 2019, the person and
its affiliates shall owe a small business GDUFA program fee. If a
person and its affiliates own at least 6 but not more than 19 approved
ANDAs, the person and its affiliates shall owe a medium size operation
GDUFA program fee. If a person and its affiliates own at least 20
approved ANDAs, the person and its affiliates shall owe a large size
operation GDUFA program fee. These fees are due no later than the first
business day on or after October 1 of each such year. Section
744B(b)(2)(E) of the FD&C Act specifies the GDUFA program fee will make
up 35 percent of $513,223,000 in fee revenue, which is $179,628,050.
    To determine the appropriate number of parent companies for each
tier, the Agency asked companies to claim their ANDAs and affiliates in
the Center for Drug Evaluation and Research (CDER) NextGen Portal. The
companies were able to confirm relationships currently present in the
Agency's records, while also reporting newly approved ANDAs, newly
acquired ANDAs, and new affiliations.
    In determining the appropriate number of approved ANDAs, the Agency
has factored in a number of variables that could affect the collection
of the target revenue: (1) Inactive ANDAs--applicants who have not
submitted an annual report for one or more of their approved
applications within the past 2 years; (2) FY 2018 Program Fee Arrears
List--applicants who failed to satisfy the FY 2018 program fee and were
unresponsive to attempts to collect; (3) Center for Biologics
Evaluation and Research (CBER) approved ANDAs--applicants and their
affiliates with CBER-approved ANDAs in addition to CDER's approved
ANDAs; (4) withdrawals of approved ANDAs by April 1st--applicants who
have submitted a written request for withdrawal of approval by April
1st of the previous fiscal year; (5) Abbreviated Antibiotic
Applications (AADA) conversions--ANDAs (previously AADAs) for bulk
antibiotic drug substance converted and refiled as DMFs; and (6) ANDAs
with Conditional Approval status--a small number of pre-1984 ANDAs that
are considered approved for marketing, but as to which additional
information has been requested. The list of original approved ANDAs
from the Generic Drug Review Platform as of April 30, 2019, shows 265
applicants in the small business tier, 71 applicants in the medium size
tier, and 64 applicants in the large size tier. Factoring in all the
variables for the third year of GDUFA II, the Agency estimates there
will be 199 applicants in the small business tier, 63 applicants in the
medium size tier, and 63 applicants in the large size tier for FY 2020.
    To calculate the GDUFA program fee, GDUFA II provides that large
size operation generic drug applicants pay the full fee, medium size
operation applicants pay two-fifths of the full fee, and small business
applicants pay one-tenth of the full fee. To generate the target
collection revenue amount from GDUFA program fees ($179,628,050), we
must weigh medium and small tiered applicants as a subset of a large
size operation generic drug applicant. FDA will set fees based on the
weighted estimate of 19.90 applicants in the small business tier (199
multiplied by 10 percent), 25.20 applicants in the medium size tier (63
multiplied by 40 percent), and 63 applicants in the large size tier,
arriving at 108.10 total weighted applicants for FY 2020.
    To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $179,628,050 by 108.10, which equals
$1,661,684. The medium size operation GDUFA program fee is 40 percent
of the full fee ($664,674), and the small business operation GDUFA
program fee is 10 percent of the full fee ($166,168).

IX. Fee Schedule for FY 2020

    The fee rates for FY 2020 are set out in table 4.

                    Table 4--Fee Schedule for FY 2020
------------------------------------------------------------------------
                                                          Fees rates for
                      Fee category                            FY 2020
------------------------------------------------------------------------
Applications:
    Abbreviated New Drug Application (ANDA).............        $176,237
    Drug Master File (DMF)..............................          57,795

Facilities:
    Active Pharmaceutical Ingredient (API) Domestic.....          44,400
    API--Foreign........................................          59,400
    Finished Dosage Form (FDF)--Domestic................         195,662
    FDF--Foreign........................................         210,662
    Contract Manufacturing Organization (CMO)--Domestic.          65,221
    CMO--Foreign........................................          80,221
GDUFA Program:
    Large size operation generic drug applicant.........       1,661,684
    Medium size operation generic drug applicant........         664,674
    Small business operation generic drug applicant.....         166,168
------------------------------------------------------------------------

X. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2019. To pay the ANDA,
DMF, API facility, FDF facility, CMO facility, and GDUFA program fees,
a Generic Drug User Fee Cover Sheet must be completed, available at
https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee identification (ID) number must be
generated. Payment must be made in U.S. currency drawn on a U.S. bank
by electronic check, check, bank draft, U.S. postal money order, credit
card, or wire transfer. The preferred payment method is online using
electronic check (Automated Clearing House (ACH), also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). FDA has
partnered with the U.S. Department of the Treasury to utilize Pay.gov,
a web-based payment application, for online electronic payment. The
Pay.gov feature is available on the FDA website after completing the
Generic Drug User Fee Cover Sheet and generating the user fee ID
number.
    Secure electronic payments can be submitted using the User Fees
Payment Portal at https://userfees.fda.gov/pay. (Note: Only full
payments are accepted; no partial payments can be made online.) Once an
invoice is located, ``Pay Now'' should be selected to be redirected to
Pay.gov. Electronic payment options are based on the balance due.
Payment by credit card is available for balances less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S bank accounts as well as U.S. credit
cards.
    The user fee ID number must be included on the check, bank draft,
or postal money order and must be made payable to the order of the Food
and Drug Administration. Payments can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. For questions concerning courier
delivery, U.S. Bank can be contacted at<PHONE_NUMBER>. This telephone
number is only for questions about courier delivery.) The FDA post
office box number (P.O. Box 979108) must be written on the check, bank
draft, or postal money order.
    For payments made by wire transfer, the unique user fee ID number
must be referenced. Without the unique user fee ID number, the payment
may not be applied. If the payment amount is not applied, the invoice
amount will be referred to collections. The originating financial
institution may charge a wire transfer fee. Applicable wire transfer
fees must be included with payment to ensure fees are fully paid.
Questions about wire transfer fees should be addressed to the financial
institution. The following account information should be used to send
payments by wire transfer: U.S. Department of the Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, account number: 75060099, routing
number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is
53-0196965.

    Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15906 Filed 7-25-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Rules and Regulations]
[Pages 31483-31486]
[FR Doc No: 2012-13034]

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

The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0494; Directorate Identifier 2012-NM-088-AD;
Amendment 39-17069; AD 2012-11-06]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Gulfstream Aerospace Corporation Model G-1159, G-1159A, and G-1159B
airplanes. This AD requires, for certain airplanes, a measurement to
determine the clearance (gap) of the exposed rounded portion of the
doubler and clothespin fitting at the wing-to-fuselage attachment, and
repair if necessary. This AD also requires, for certain other
airplanes, determining if a certain aircraft service change has been
incorporated, and for affected airplanes, a measurement to determine
the clearance (gap) of the exposed rounded portion of the doubler and
clothespin fitting at the wing-to-fuselage attachment, and repair if
necessary. This AD was prompted by a report of an improper structural
modification that had excessive gaps in the wing-to-fuselage attachment
fittings. We are issuing this AD to detect and correct excessive gaps
in the wing-to-fuselage attachment fittings, which could result in
reduced structural integrity at the wing-to-fuselage attachment and
consequent separation of the wing from the airplane.

DATES: This AD is effective May 29, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of May 29, 2012.
    We must receive comments on this AD by July 13, 2012.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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 Gulfstream
Aerospace Corporation, Technical Publications Dept., P.O. Box 2206,
Savannah, Georgia 31402-2206; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm.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 Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Michael Cann, Senior Aerospace
Engineer, Airframe Branch, ACE-117A, Atlanta Aircraft Certification
Office, FAA, 1701 Columbia Avenue, College Park, GA 30337; phone: (404)
474-5548; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We received a report of an improper structural modification that
resulted in excessive gaps in the wing-to-fuselage attachment fittings
on a number of airplanes. The modification specified in Gulfstream
Model G-1159A (also known as (aka) G-III) and G-1159B (aka G-IIB)
Aircraft Service Change (ASC) 229 and G-1159 (aka G-II) ASC 426
installs a new three-piece box fitting on the left and right side wing-
to-fuselage installations, including new part number 1159SB30175-11/-12
doublers.
    During a routine corrosion inspection on a Model G-1159A (G-III)
airplane, it was observed that the aft wing-to-fuselage attach fitting
had an assembly gap exceeding the gap allowed by type design. This
condition results in a transfer of wing loads through a different load
path resulting in negative margins of safety in the upper bolt and
lower bolt in bearing.
    A records review revealed that this condition was the result of an
improper structural modification. This records search also revealed
that six other Model G-1159 (G-II) and G-1159A (G-III) airplanes
incorporated the modification. All seven airplanes have been inspected,
and four airplanes were found not to be in conformity with the type
design, two are in conformity to the type design, and no data are
available on the other. A further search has revealed that a similar
nonconforming condition was found on a total of six airplanes. Of
those, one airplane does not conform to type design, and no further
information is available for the other five airplanes. Based on this
information, it is possible that other Model G-1159 (G-II), G-1159B (G-
IIB), and G-1159A (G-III) airplanes could potentially exhibit the same
condition.
    The excessive clearance between the structural members results in a
change in load path and reduced structural strength of the assembly
below certified limits. This condition, if not corrected, could result
in reduced structural integrity at the wing-to-fuselage attachment and
consequent separation of the wing from the airplane.

Relevant Service Information

    We reviewed Gulfstream III Alert Customer Bulletin 21, including
Service Reply Card, dated May 18, 2012 (for Model G-1159A airplanes);
and Gulfstream II/IIB Alert Customer Bulletin 36, including Service
Reply Card, dated May 18, 2012 (for Model G-1159 and G-1159B
airplanes). This service information describes procedures for a
measurement to determine the clearance (gap) of the exposed rounded
portion of the doubler and clothespin fitting at the wing-to-fuselage
attachment, and contacting Gulfstream if necessary.
    We have also reviewed Gulfstream III Alert Customer Bulletin 22,
including Service Reply Card, dated May 18, 2012 (for Model G-1159A
airplanes); and Gulfstream II/IIB Alert Customer Bulletin 37, including
Service Reply Card, dated May 18, 2012 (for Model G-1159 and G-1159B
airplanes). This service information describes procedures for
determining if a certain airplane service change has been incorporated,
and, for affected airplanes, a measurement to determine the clearance
(gap) of the exposed rounded portion of the doubler and clothespin
fitting at the wing-to-fuselage attachment, and contacting Gulfstream
if necessary.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information described previously, except as discussed under
``Differences Between the AD and the Service Information.'' The AD also
requires sending the measurement results to Gulfstream.

Differences Between the AD and the Service Information

    Although the service information specifies that operators may
contact the manufacturer for disposition of certain repair conditions,
this AD requires operators to repair those conditions in accordance
with a method approved by the FAA.

Interim Action

    We consider this AD interim action. The manufacturer is currently
developing a modification intended to address the unsafe condition
identified in this AD. Once this modification is developed, approved,
and available, we might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
the discovery of an improper structural modification that had excessive
gaps in the wing-to-fuselage attachment fittings. We are issuing this
AD to detect and correct excessive gaps in the wing-to-fuselage
attachment fittings, which could result in reduced structural integrity
at the wing-to-fuselage attachment. Therefore, we find that notice and
opportunity for prior public comment are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2012-0494 and
Directorate Identifier 2012-NM-088-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
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 AD.

Costs of Compliance

    We estimate that this AD affects 223 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Number of  U.S.    Cost on U.S.
                Action                                 Labor cost                    Parts cost          product          operators         operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records Review........................  1 work-hour x $85 per hour = $85........                $0               $85               210           $17,850
Measurement...........................  4 work-hours x $85 per hour = $340......                 0               340                13             4,420
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary measurements
and repairs that would be required based on the results of the
measurement. We have no way of determining the number of aircraft that
might need these actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Measurement...................................  4 work-hours....................              $0            $340
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition repair specified in this AD.

Authority for This Rulemaking

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

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2012-11-06 Gulfstream Aerospace Corporation: Amendment 39-17069;
Docket No. FAA-2012-0494; Directorate Identifier 2012-NM-088-AD.

(a) Effective Date

    This AD is effective May 29, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Gulfstream Aerospace Corporation Model G-
1159, G-1159A, and G-1159B airplanes; certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings; and 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by a report of an improper structural
modification that had excessive gaps in the wing-to-fuselage
attachment fittings. We are issuing this AD to detect and correct
excessive gaps in the wing-to-fuselage attachment fittings, which
could result in reduced structural integrity at the wing-to-fuselage
attachment and consequent separation of the wing from the airplane.

(f) Compliance

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

(g) Measurement and Repair

    For airplanes identified in paragraphs (g)(1) and (g)(2) of this
AD: Before further flight, measure to determine the clearance (gap)
of the exposed rounded portion of the doubler and clothespin fitting
at the wing-to-fuselage attachment, in accordance with Gulfstream
III Alert Customer Bulletin 21, including Service Reply Card, dated
May 18, 2012 (for Model G-1159A airplanes); or Gulfstream II/IIB
Alert Customer Bulletin 36, including Service Reply Card, dated May
18, 2012 (for Model G-1159 and G-1159B airplanes). If the clearance
exceeds the limit specified in Gulfstream III Alert Customer
Bulletin 21, including Service Reply Card, dated May 18, 2012 (for
Model G-1159A airplanes); or Gulfstream II/IIB Alert Customer
Bulletin 36, including Service Reply Card, dated May 18, 2012 (for
Model G-1159 and G-1159B airplanes); before further flight, repair
in accordance with a method approved by the Manager, Atlanta
Aircraft Certification Office (ACO), FAA. For a repair method to be
approved by the Manager, Atlanta ACO, as required by this paragraph,
the Manager's approval letter must specifically refer to this AD.
    (1) Model G-1159, and G-1159B airplanes, having serial numbers
(S/N) 083, 084, 096, 130, 176, 202, 238, 239, and 240.
    (2) Model G-1159A airplanes, having S/N 346, 355, 385, and 486.

(h) Records Review, Measurement, and Repair

    For all airplanes except those identified in paragraph (g) of
this AD: Within 10 flight hours or 60 days after the effective date
of this AD, whichever occurs first, do a review of airplane
maintenance records to determine if the aircraft service change
specified in Gulfstream III Alert Customer Bulletin 22, including
Service Reply Card, dated May 18, 2012 (for Model G-1159A
airplanes); or Gulfstream II/IIB Alert Customer Bulletin 37,
including Service Reply Card, dated May 18, 2012 (for Model G-1159
and G-1159B airplanes); has been incorporated.
    (1) For airplanes on which the aircraft service change specified
in Gulfstream III Alert Customer Bulletin 22, including Service
Reply Card, dated May 18, 2012 (for Model G-1159A airplanes); or
Gulfstream II/IIB Alert Customer Bulletin 37, including Service
Reply Card, dated May 18, 2012 (for Model G-1159 and G-1159B
airplanes); has not been incorporated: No more work is required by
this AD.
    (2) For airplanes on which the aircraft service change specified
in Gulfstream III Alert Customer Bulletin 22, including Service
Reply Card, dated May 18, 2012 (for Model G-1159A airplanes); or
Gulfstream II/IIB Alert Customer Bulletin 37, including Service
Reply Card, dated May 18, 2012 (for Model G-1159 and G-1159B
airplanes); has been incorporated: Within 10 flight hours or 60 days
after the effective date of this AD, whichever occurs first, measure
to determine the clearance (gap) of the exposed rounded portion of
the doubler and clothespin fitting at the wing-to-fuselage
attachment, in accordance with Gulfstream III Alert Customer
Bulletin 22, including Service Reply Card, dated May 18, 2012 (for
Model G-1159A airplanes); or Gulfstream II/IIB Alert Customer
Bulletin 37, including Service Reply Card, dated May 18, 2012 (for
Model G-1159 and G-1159B airplanes). If the clearance exceeds the
limit specified in Gulfstream III Alert Customer Bulletin 22,
including Service Reply Card, dated May 18, 2012 (for Model G-1159A
airplanes); or Gulfstream II/IIB Alert Customer Bulletin 37,
including Service Reply Card, dated May 18, 2012 (for Model G-1159
and G-1159B airplanes); before further flight, repair in accordance
with a method approved by the Manager, Atlanta ACO, FAA. For a
repair method to be approved by the Manager, Atlanta, ACO, as
required by this paragraph, the Manager's approval letter must
specifically refer to this AD.

(i) Reporting

    Submit a report of the findings of any measurement required by
paragraph (g) or (h) of this AD to Gulfstream, at the applicable
time specified in paragraph (i)(1) or (i)(2) of this AD, using the
Service Reply Card of the applicable customer bulletin specified in
paragraph (g) or (h) of this AD. The report must include the
measurement results, a description of any discrepancies found, the
airplane serial number, and the number of landings and flight hours
on the airplane. Under the provisions of the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.), the Office of Management and Budget (OMB)
has approved the information collection requirements contained in
this AD and has assigned OMB Control Number 2120-0056.
    (1) If the measurement was done on or after the effective date
of this AD: Submit the report within 10 days after the measurement.
    (2) If the measurement was done before the effective date of
this AD: Submit the report within 10 days after the effective date
of this AD.

(j) Special Flight Permit

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the

Federal Aviation Regulations (14 CFR 21.197 and 21.199), are not
allowed.

(k) Paperwork Reduction Act Burden Statement

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

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ACO, send it to the attention of the person identified in the
Related Information section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    For more information about this AD, contact Michael Cann, Senior
Aerospace Engineer, Airframe Branch, ACE-117A, Atlanta Aircraft
Certification Office, FAA, 1701 Columbia Avenue, College Park, GA
30337; phone:<PHONE_NUMBER>; fax<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(n) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (2) The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (i) Gulfstream III Alert Customer Bulletin 21, including Service
Reply Card, dated May 18, 2012.
    (ii) Gulfstream III Alert Customer Bulletin 22, including
Service Reply Card, dated May 18, 2012.
    (iii) Gulfstream II/IIB Alert Customer Bulletin 36, including
Service Reply Card, dated May 18, 2012.
    (iv) Gulfstream II/IIB Alert Customer Bulletin 37, including
Service Reply Card, dated May 18, 2012.
    (3) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, Georgia 31402-2206; telephone<PHONE_NUMBER>; fax
912-965-3520; email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm.
    (4) You may review copies of the 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>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr_locations.html.

    Issued in Renton, Washington, on May 22, 2012.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-13034 Filed 5-25-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Proposed Rules]
[Pages 51946-51948]
[FR Doc No: 2012-21102]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0861; Directorate Identifier 2012-NM-074-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model DHC-8-102, -103, -106, -201, -202, -301,
-311, and -315 airplanes. This proposed AD was prompted by reports of
the loss of the fixed frequency system, leading to the loss of power to
the left and right buses and all systems serviced by these buses. This
proposed AD would require modification of the wiring and changes to
existing airworthiness limitations. We are proposing this AD to prevent
loss of the fixed frequency system, which could lead to loss of a
number of the pilot's and co-pilot's flight instruments, in addition to
other avionics systems.

DATES: We must receive comments on this proposed AD by October 12,
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
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<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: Assata Dessaline, Aerospace Engineer,
Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; 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-2012-0861;
Directorate Identifier 2012-NM-074-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

    The Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2012-09, dated February 15, 2012 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    There have been several reported occurrences of the loss of the
400Hz [hertz] Fixed Frequency System, leading to the loss of power
to the Left 115VAC [alternating current] bus, the Right 115VAC bus,
the Left 26VAC bus, the Right 26VAC bus and all systems serviced by
these four electrical buses. The loss of the 400Hz Fixed Frequency
System has been attributed to a failure of one or two static
inverters, which resulted in the loss of the remaining inverters.
The loss of systems serviced by the four fixed frequency electrical
buses creates an unsafe condition due to the loss of a number of the
pilot's and co-pilot's flight instruments, in addition to the other
avionics systems.
    This [Canadian] Airworthiness Directive (AD) mandates the wiring
modification to untie the 400Hz inverters and additional
Airworthiness Limitation tasks introduced as a result of this
modification.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier has issued the following service information:
     Bombardier Service Bulletin 8-24-87, Revision B, dated
April 3, 2012;
     de Havilland Dash 8 Series 100 Temporary Revision AWL-117,
dated April 8, 2011, to Section AWL--Systems Maintenance, of Part 2,
Airworthiness Limitations, of the Bombardier Dash 8 Series 100
Maintenance Program Manual, PSM 1-8-7.
     de Havilland Dash 8 Series 200 Temporary Revision AWL 2-
48, dated April 8, 2011, to Section AWL--Systems Maintenance, of Part
2, Airworthiness Limitations, of the Bombardier Dash 8 Series 200
Maintenance Program Manual, PSM 1-82-7; and
     de Havilland Dash 8 Series 300 Temporary Revision AWL 3-
118, dated April 8, 2011, to Section AWL--Systems Maintenance, of Part
2, Airworthiness Limitations, of the Bombardier Dash 8 Series 300
Maintenance Program Manual, PSM 1-83-7.
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

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.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 94 products of U.S. registry. We also estimate that
it would take about 9 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 $71,910, or $765 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this 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:

Bombardier, Inc.: Docket No. FAA-2012-0861; Directorate Identifier
2012-NM-074-AD.

(a) Comments Due Date

    We must receive comments by October 12, 2012.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Bombardier, Inc. Model DHC-8-102, -103, -
106, -201, -202, -301, -311, and -315 airplanes, certificated in any
category, serial numbers 002 through 672 inclusive.
    (2) This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., 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 actions, the operator may not be
able to accomplish the actions 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 (k)(1) 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.

(d) Subject

    Air Transport Association (ATA) of America Code 24; Electrical
Power.

(e) Reason

    This AD was prompted by reports of the loss of the fixed
frequency system, leading to the loss of power to the left and right
buses and all systems serviced by these buses. We are issuing this
AD to prevent loss of the fixed frequency system, which could lead
to loss of a number of the pilot's and co-pilot's flight
instruments, in addition to other avionics systems.

(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) Wiring Modifications

    Within 6,000 flight hours or 36 months after the effective date
of this AD, whichever occurs first: Incorporate the wiring
modifications specified in and in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 8-24-87, Revision B,
dated April 3, 2012.

(h) Airplane Maintenance Program Revision

    Within 30 days after the effective date of this AD: Revise the
airplane maintenance program by incorporating Task 2420/13,
Operational Check of Relays K4, K5, K6, and K7 (Post Modsum
8Q101917), in the applicable temporary revision specified in
paragraph (h)(1), (h)(2), or (h)(3) of this AD. The initial
compliance time for Task 2420/13 is within 18,000 flight hours after
accomplishing the actions specified in paragraph (g) of this AD, or
30 days after the effective date of this AD, whichever occurs later.
    (1) For Model DHC-8-102, -103, and -106 airplanes: de Havilland
Dash 8 Series 100 Temporary Revision AWL-117, dated April 8, 2011,
to Section AWL--Systems Maintenance, of Part 2, Airworthiness
Limitations, of the Bombardier Dash 8 Series 100 Maintenance Program
Manual, PSM 1-8-7.
    (2) For Model DHC-8-201 and -202 airplanes: de Havilland Dash 8
Series 200 Temporary Revision AWL 2-48, dated April 8, 2011, to
Section AWL--Systems Maintenance, of Part 2, Airworthiness
Limitations, of the Bombardier Dash 8 Series 200 Maintenance Program
Manual, PSM 1-82-7.
    (3) For Model DHC-8-301, -311, and -315 airplanes: de Havilland
Dash 8 Series 300 Temporary Revision AWL 3-118, dated April 8, 2011,
to Section AWL--Systems Maintenance, of Part 2, Airworthiness
Limitations, of the Bombardier Dash 8 Series 300 Maintenance Program
Manual, PSM 1-83-7.

(i) No Alternative Actions or Intervals

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used, unless the actions and intervals are approved as an AMOC in
accordance with the procedures specified in paragraph (k)(1) of this
AD.

(j) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Bombardier Service Bulletin 8-24-87,
dated May 26, 2011; or Bombardier Service Bulletin 8-24-87, Revision
A, dated October 5, 2011.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(l) Related Information

    (1) Refer to MCAI Canadian Airworthiness Directive CF-2012-09,
dated February 15, 2012, and the service information specified in
paragraphs (l)(1)(i) through (l)(1)(iv) of this AD, for related
information.
    (i) Bombardier Service Bulletin 8-24-87, Revision B, dated April
3, 2012.
    (ii) de Havilland Dash 8 Series 100 Temporary Revision AWL-117,
dated April 8, 2011, to Section AWL--Systems Maintenance, of Part 2,
Airworthiness Limitations, of the Bombardier Dash 8 Series 100
Maintenance Program Manual, PSM 1-8-7.
    (iii) de Havilland Dash 8 Series 200 Temporary Revision AWL 2-
48, dated April 8, 2011, to Section AWL--Systems Maintenance, of
Part 2, Airworthiness Limitations, of the Bombardier Dash 8 Series
200 Maintenance Program Manual, PSM 1-82-7.
    (iv) de Havilland Dash 8 Series 300 Temporary Revision AWL 3-
118, dated April 8, 2011, to Section AWL--Systems Maintenance, of
Part 2, Airworthiness Limitations, of the Bombardier Dash 8 Series
300 Maintenance Program Manual, PSM 1-83-7.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 22, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-21102 Filed 8-27-12; 8:45 am]
BILLING CODE 4910-13-P