[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61063-61070]
[FR Doc No: 2022-21968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2355]

Prescription Drug User Fee Rates for Fiscal Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2023. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription
Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect
application fees for certain applications for the review of human drug
and biological products and prescription drug program fees for certain
approved products. This notice establishes the fee rates for FY 2023.
These fees apply to the period from October 1, 2022, through September
30, 2023.

FOR FURTHER INFORMATION CONTACT: Robert Marcarelli, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD,<PHONE_NUMBER>; and the User Fees Support Staff at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h)
establish two different kinds of user fees. Fees are assessed as
follows: (1) application fees are assessed on certain types of
applications for the review of human drug and biological products and
(2) prescription drug program fees are assessed on certain approved
products (section 736(a) of the FD&C Act). The statute also includes
conditions under which such fees may be waived or reduced (section
736(d) of the FD&C Act), or under which fee exceptions, refunds, or
exemptions apply (sections 736(a)(1)(C) through (G), 736(a)(2)(B)
through (C), and 736(k) of the FD&C Act).
    For FY 2023 through FY 2027, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA VII. The base
revenue amount for FY 2023 is $1,151,522,958. The FY 2023 base revenue
amount is adjusted for inflation, strategic hiring and retention, and
for the resource capacity needs for the process for the review of human
drug applications (the capacity planning adjustment (CPA)). This amount
is further adjusted to include the additional dollar amount as
specified in the statute (see section 736(b)(1)(F) of the FD&C Act) to
provide for additional full-time equivalent (FTE) positions to support
PDUFA VII initiatives. If applicable, an operating reserve adjustment
is added to provide sufficient operating reserves of carryover user
fees. The amount from the preceding adjustments is then

adjusted to provide for additional direct costs to fund PDUFA VII
initiatives. Fee amounts are to be established each year so that
revenues from application fees provide 20 percent of the total revenue,
and prescription drug program fees provide 80 percent of the total
revenue (see section 736(b)(2) of the FD&C Act).
    This document provides fee rates for FY 2023 for an application
requiring covered clinical data \1\ ($3,242,026), for an application
not requiring covered clinical data ($1,621,013), and for the
prescription drug program fee ($393,933). These fees are effective on
October 1, 2022, and will remain in effect through September 30, 2023.
For applications that are submitted on or after October 1, 2022, the
new fee schedule must be used.
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    \1\ As used herein, ``covered clinical data'' is ``clinical data
(other than bioavailability or bioequivalence studies) with respect
to safety or effectiveness [that] are required for approval'' (see
section 736(a)(1)(A)) of the FD&C Act).
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II. Fee Revenue Amount for FY 2023

    The base revenue amount for FY 2023 is $1,151,522,958 (see section
736(b)(1)(A) and (b)(3) of the FD&C Act). This amount is prior to any
adjustments made for inflation, the strategic hiring and retention
adjustment, CPA, additional dollar amount, operating reserve adjustment
(if applicable), and additional direct costs (see section 736(b)(1) of
the FD&C Act).

A. FY 2023 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VII specifies that the $1,151,522,958 is to be adjusted for
inflation increases for FY 2023 using two separate adjustments: one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 736(c)(1) of the FD&C Act).
    The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all PC&B paid per FTE
positions at FDA for the first 3 of the preceding 4 fiscal years,
multiplied by the proportion of PC&B costs to total FDA costs of the
process for the review of human drug applications for the first 3 of
the preceding 4 fiscal years (see section 736(c)(1)(A) and (B)(i) of
the FD&C Act).
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, provides the percent changes from the previous fiscal
years, and provides the average percent changes over the first 3 of the
4 fiscal years preceding FY 2023. The 3-year average is 1.3918 percent.
[GRAPHIC] [TIFF OMITTED] TN07OC22.033

    The payroll adjustment is 1.3918 percent from table 1 multiplied by
61.8539 percent resulting in 0.8609 percent.
    The statute specifies that this 1.3918 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of human drug applications. Table 2 shows the PC&B and the total
obligations for the process for the review of human drug applications
for the first 3 of the preceding 4 fiscal years.
[GRAPHIC] [TIFF OMITTED] TN07OC22.034

    The payroll adjustment is 1.3918 percent from table 1 multiplied by
61.8539 percent resulting in 0.8609 percent.
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index for urban consumers (Washington-
Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years of
available data multiplied by the proportion of all costs other than
personnel compensation and benefits costs to total costs of the process
for the review of human drug applications (as defined in section
735(6)) for the first 3 years of the preceding 4 fiscal years (see
section 736(c)(1)(A) and (B)(ii)). Table 3 provides the summary data
for the percent changes in the specified CPI for the Washington-
Arlington-Alexandria area.\2\
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    \2\ 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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[GRAPHIC] [TIFF OMITTED] TN07OC22.035

    The statute specifies that this 2.0434 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of human drug applications obligated. Because 61.8539
percent was obligated for PC&B (as shown in table 2), 38.1461 percent
is the portion of costs other than PC&B (100 percent minus 61.8539
percent equals 38.1461 percent). The non-payroll adjustment is 2.0434
percent times 38.1461 percent, or 0.7795 percent.
    Next, we add the payroll adjustment (0.8609 percent) to the non-
payroll adjustment (0.7795 percent), for a total inflation adjustment
of 1.6404 percent (rounded) for FY 2023.
    We then multiply the base revenue amount for FY 2023
($1,151,522,958) by 1.6404 percent which produces an inflation
adjustment amount of 18,889,582. Adding this amount to the base revenue
amount yields an inflation-adjusted base revenue amount of
$1,170,412,541.

B. FY 2023 Strategic Hiring and Retention Adjustment

    For each fiscal year, after the annual base revenue established in
section II is adjusted for inflation in accordance with section II.A
above, the statute directs FDA to further increase the fee revenue and
fees to support strategic hiring and retention. For FY 2023, this
amount is $9,000,000 (see section 736(c)(2)(A) of the FD&C Act).

C. FY 2023 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after the base revenue amount for FY
2023 of $1,151,522,958 has been adjusted as described in sections II.A
and II.B above, this amount shall be further adjusted to reflect
changes in the resource capacity needs for the process of human drug
application reviews (see section 736(c)(3) of the FD&C Act). Following
a process required in statute, FDA established a new CPA methodology
and first applied it in the setting of FY 2021 fees. The establishment
of this methodology is described in the Federal Register of August 3,
2020 (85 FR 46651). This methodology includes a continuous, iterative
improvement approach, under which the Agency intends to refine its data
and estimates for the core review activities to improve their accuracy
over time.
    For FY 2023, updates were made to refine the time reporting
categories included within the CPA. As such, the time reporting data
and baseline capacity have been revised to match the refinements. In
the coming fiscal years, additional updates are anticipated to be made
to account for additional activities that are also directly related to
the direct review of applications and supplements, including additional
formal meeting types and the direct review of postmarketing commitments
and requirements, the direct review of risk evaluation and mitigation
strategies, and the direct review of annual reports for approved
prescription drug products.
    The CPA methodology includes four steps:
    1. Forecast workload volumes: predictive models estimate the volume
of workload for the upcoming FY.
    2. Forecast the resource needs: forecast algorithms are generated
utilizing time reporting data. These algorithms estimate the required
demand in FTEs \3\ for direct review-related effort. This is then
compared to current available resources for the direct review-related
workload.
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    \3\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
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    3. Assess the resource forecast in the context of additional
internal factors: program leadership examines operational, financial,
and resourcing data to assess whether FDA will be able to utilize
additional funds during the FY, and the funds are required to support
additional review capacity. FTE amounts are adjusted, if needed.
    4. Convert the FTE need to dollars: utilizing FDA's fully loaded
FTE cost model, the final feasible FTEs are converted to an equivalent
dollar amount.
    To determine the FY 2023 CPA, FDA calculated a CPA for the Center
for Drug Evaluation and Research (CDER) and the Center for Biologics
Evaluation and Research (CBER) individually. The final Center-level
results were then combined to determine the total FY 2023 PDUFA CPA.
The following section outlines the major components of each Center's FY
2023 PDUFA CPA.
    Table 4 summarizes the forecasted workload volumes for CDER in FY
2023 based on predictive models, as well as historical actuals from FY
2021 for comparison.

[GRAPHIC] [TIFF OMITTED] TN07OC22.036

    Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2023 were then converted into estimated FTE needs for
CDER's PDUFA direct review-related work. The resulting expected FY 2023
FTE need for CDER was compared to current resource capacity for direct
review related work to determine the FY 2023 resource delta, as
summarized in table 5. Refinement of the time reporting categories
included in the CPA resulted in a lowering of both the resource
capacity and resource forecast compared to prior years.
[GRAPHIC] [TIFF OMITTED] TN07OC22.037

    The projected 151 FTE delta was then assessed by FDA in the context
of additional operational and internal factors to ensure that a fee
adjustment is only made for resources that can be utilized in the
fiscal year and for which funds are required to support additional
review capacity. CDER recognizes that FY 2023 presents significant
hiring commitments for the Center, including the hiring goals set forth
for FY 2023 per the PDUFA VII Commitment Letter, as well as hiring
commitments for other user fee programs. In addition, current labor
market conditions may present continuing hiring and retention
challenges. In light of these commitments and challenges, CDER is
opting to take a conservative adjustment for FY 2023.
    CDER emphasizes that the limiting factor on the FY 2023 adjustment
is its ability to net gain additional hires above and beyond the
existing committed hires across its user fee programs. If a significant
resource gap persists in future years and the Agency's ability to net
gain additional hires above existing commitments improves, larger CPA
adjustments should be expected.
    After assessing current hiring capacity and existing funded
vacancies, CDER adjusted the 151 FTE delta to 27 FTEs. The FY 2023
PDUFA CPA for CDER is therefore $8,541,423, as summarized in table 6.
[GRAPHIC] [TIFF OMITTED] TN07OC22.038

    To calculate the FY 2023 PDUFA CPA for CBER, FDA followed the
approach outlined above. Table 7 summarizes the forecasted workload
volumes for CBER in FY 2023 as well as the corresponding historical
actuals from FY 2021 for comparison.
[GRAPHIC] [TIFF OMITTED] TN07OC22.039

    The forecasted CBER PDUFA workload for FY 2023 was then converted
into expected FTE resources and compared to current resource capacity
for PDUFA direct review work, as summarized in table 8.
[GRAPHIC] [TIFF OMITTED] TN07OC22.040

    The projected 10 FTE delta for CBER was also assessed in the
context of other operational and financial factors that may impact the
need and/or feasibility of obtaining the additional resources. After
considering subject matter expert input on industry trends and ongoing
workload impacts stemming from the COVID-19 pandemic, accounting for
historical net FTE gains within CBER and the hiring necessary to meet
the hiring commitments set forth for FY 2023 in the PDUFA VII
commitment letter, subtracting previously funded PDUFA vacancies
aligned with CPA-covered activities, CBER determined that an adjustment
of 10 additional FTEs for FY 2023 is needed. The FY 2023 CPA for CBER
is therefore $3,116,730, as summarized in table 9.
[GRAPHIC] [TIFF OMITTED] TN07OC22.041

    The CDER and CBER CPA amounts were then added together to determine
the PDUFA CPA for FY 2023 of $11,658,153, as outlined in table 10. FDA
will track the utilization of the CPA funds to ensure they are
supporting the organizational components engaged in PDUFA direct review
work to enhance resources and expand staff capacity and capability.
Should FDA be unable to utilize any amounts of the CPA funds during the
fiscal year, it will not spend those funds and the unspent funds will
be transferred to the carryover balance at the end of the fiscal year.
[GRAPHIC] [TIFF OMITTED] TN07OC22.042

D. FY 2023 Statutory Fee Revenue Adjustments for Additional Dollar
Amounts

    PDUFA VII provides an additional dollar amount for each of the 5
fiscal years covered by PDUFA VII for additional FTE to support
enhancements outlined in the PDUFA VII commitment letter. The
additional dollar amount for FY 2023 as outlined in statute is
$65,773,693 (see section 736(b)(1)(F) of the FD&C Act). This amount
will be added to the total FY 2023 PDUFA VII revenue amount.
[GRAPHIC] [TIFF OMITTED] TN07OC22.043

E. FY 2023 Statutory Fee Revenue Adjustments for Operating Reserve

    PDUFA VII provides for an operating reserve that may result in an
increase or decrease in fee revenue and fees for a given FY (see
section 736(c)(4) of the FD&C Act). For FY 2023, FDA is required to
further increase fee revenue and fees if an adjustment is necessary to
provide for at least 8 weeks of operating reserves of carryover user
fees (see section 736(c)(4)(A)(i) of the FD&C Act). If FDA has
carryover balances of user fees in excess of 14 weeks of operating
reserves, FDA is required to decrease fee revenue and fees to provide
for not more than 14 weeks of operating reserves of

carryover user fees (see section 736(c)(4)(B) of the FD&C Act).
    To determine the dollar amounts for the 8-week and 14-week
operating reserve thresholds, the adjustments (inflation, strategic
hiring and retention, capacity planning, and additional dollar amount)
discussed in sections II.A, II.B, II.C, and II.D are applied to the FY
2023 base revenue (see section 736(c)(4)(A) of the FD&C Act), resulting
in $1,256,844,387. This amount is then divided by 52 to generate the 1-
week operating amount of $24,170,084. The one-week operating amount is
then multiplied by 8 and 14. This results in an 8-week threshold amount
of $193,360,675 and a 14-week threshold amount of $338,381,181.
    To determine the FY 2022 end-of-year operating reserves of
carryover user fees, the Agency assessed the operating reserve of
carryover fees at the end of July 2022 and forecast collections and
obligations in the fourth quarter of FY 2022 combined. This provides an
estimated end-of-year FY 2022 operating reserve of carryover user fees,
or $184,271,732, which equates to 7.6 weeks of operations.\5\
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    \5\ For purposes of the operating reserve adjustment under PDUFA
VII, the operating reserve of carryover user fees includes only user
fee funds that are available for obligation. FDA does not consider
part of the operating reserve of carryover user fees certain user
fee funds that were collected prior to 2010 and that are held by
FDA, but which are considered unavailable for obligation due to lack
of an appropriation ($78,850,995).
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    Because the estimated FY 2022 end-of-year operating reserves of
carryover user fees does not exceed the 14-week threshold amount, FDA
will not reduce the FY 2023 fees or fee revenue. However, because the
estimated FY 2022 end-of-year operating reserves of carryover user fees
of $184,271,732 is below the 8-week threshold amount of $193,360,675 by
$9,088,943, FDA will apply an operating reserve adjustment of
$9,088,943 to increase the fee revenue and fees for FY 2023.
    With respect to target revenue for FY 2023, adding the operating
reserve adjustment amount of $9,088,943 to the inflation, strategic
hiring and retention, CPA, and additional dollar amount of
$1,256,844,387 results in the cumulative revenue amount of
$1,265,933,330.
[GRAPHIC] [TIFF OMITTED] TN07OC22.044

F. FY 2023 Statutory Fee Revenue Adjustments for Additional Direct Cost

    PDUFA VII specifies that an additional direct cost of $44,386,150
is to be added to the total FY 2023 PDUFA revenue amount (see section
736(c)(5) of the FD&C Act). With respect to target revenue for FY 2023,
adding the additional direct cost amount of $44,386,150 to the
inflation, strategic hiring and retention, CPA, additional dollar
amount, and operating reserve adjustment of $1,265,933,330 results in
the total revenue amount of $1,310,319,000 (rounded to the nearest
thousand dollars).
[GRAPHIC] [TIFF OMITTED] TN07OC22.045

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate 20 percent of the total
revenue amount, amounting to $262,063,800 in FY 2023.

B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees

    Historically, FDA has estimated the total number of fee-paying full
application equivalents (FAEs) it expects to receive during the next
fiscal year by averaging the number of fee-paying FAEs received in the
three most recently completed fiscal years. For FY 2023 fee setting,
the three relevant fiscal years are FYs 2019, 2020,\6\ and 2021. Prior
year FAE totals are updated annually to reflect refunds and waivers
processed after the close of the fiscal year.
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    \6\ FY 2020 data was omitted in FY 2022 methodology as FDA took
into account the global COVID-19 pandemic situation at the time.
However, after reviewing the data trend, FY 2020 data is included in
this year's methodology given the higher FAE count for FY 2021. See
table 13.
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    In estimating the number of fee-paying FAEs, an application
requiring covered clinical data \7\ counts as one FAE. An application
not requiring covered clinical data counts as one-half of an FAE. An
application that is withdrawn before filing, or refused for filing,
counts as one-fourth of an FAE if the applicant initially paid a full
application fee, or one-eighth of an FAE if the applicant initially
paid one-half of the full application fee amount.
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    \7\ As defined in section 736(a)(1)(A)(i) of the FD&C Act.
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    As table 14 shows, the average number of fee-paying FAEs received
annually in FY 2019 through FY 2021 is 80.8333. FDA will set fees for
FY 2023 based on this estimate as the number of full application
equivalents that will be subject to fees.
[GRAPHIC] [TIFF OMITTED] TN07OC22.046

    The FY 2023 application fee is estimated by dividing the average
number of full applications that paid fees from FY 2019 through FY
2021, 80.8333, into the fee revenue amount to be derived from
application fees in FY 2023, $262,063,800. The result is a fee of
$3,242,026 per full application requiring clinical data, and $1,621,013
per application not requiring clinical data.

IV. Fee Calculation for Prescription Drug Fees

    PDUFA VII assesses prescription drug program fees for certain
prescription drug products. Program fees will be set to generate 80
percent of the total target revenue amount amounting to $1,048,255,200
in FY 2023.
    An applicant will not be assessed more than five program fees for a
FY for prescription drug products identified in a single approved NDA
or BLA (see section 736(a)(2)(C) of the FD&C Act). Applicants are
assessed a program fee for a fiscal year for user fee eligible
prescription drug products identified in a human drug application
approved as of October 1 of such fiscal year. Additionally, applicants
are assessed a program fee for a product that is not a prescription
drug product on October 1 because it is included in the discontinued
section of the Orange Book or the CDER/CBER Biologics List on that
date, if the product becomes a fee-eligible prescription drug product
during the fiscal year.
    FDA estimates 2,876 program fees will be invoiced in FY 2023 before
factoring in waivers, refunds, and exemptions. FDA approximates that
there will be 70 waivers and refunds granted. In addition, FDA
approximates that another 43 program fees will be exempted in FY 2023
based on the orphan drug exemption in section 736(k) of the FD&C Act.
    PDUFA VII changes the definition of the same product exception for
program fees. FDA determined that 93 products may be eligible for the
pharmaceutical equivalence same product exception. An additional
exception for program fees for skin-test diagnostic products is
included in the PDUFA VII. FDA has determined that there are nine skin-
test diagnostic application products that may be eligible for the
exception for skin diagnostic tests. FDA estimates 2,661 program fees
in FY 2023, after allowing for an estimated 215 waivers and reductions,
including the orphan drug exemptions, excepted and exempted fee-liable
products. The FY 2023 prescription drug program fee rate is calculated
by dividing the adjusted total revenue from program fees
($1,048,255,200) by the estimated 2,661 program fees resulting in a FY
2023 program fee of $393,933 (rounded to the nearest dollar).

V. Fee Schedule for FY 2023

    The fee rates for FY 2023 are displayed in table 15.
    [GRAPHIC] [TIFF OMITTED] TN07OC22.047

VI. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application subject to fees under PDUFA VII that
is submitted on or after October 1, 2022. Payment must be made in U.S.
currency by electronic check, check, bank draft, wire transfer, or U.S.
postal money order payable to the order of the Food and Drug
Administration. 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 use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the Prescription 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 that are
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.
    If a check, bank draft, or postal money order is submitted, make it
payable to the order of the Food and Drug Administration and include
the user fee ID number to ensure that the payment is applied to the
correct fee(s). Payments can be mailed to: Food and Drug
Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If a check,
bank draft, or money order is to be sent by a courier that requests a
street address, the courier should deliver your payment to: U.S. Bank,
Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis,
MO 63101. (Note: This U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery, contact the U.S.
Bank at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery). Please make sure that the FDA post office box number
(P.O. Box 979107) is written on the check, bank draft, or postal money
order.
    For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied,
which could result in FDA not filing an application and other
penalties.

    Note: The originating financial institution may charge a wire
transfer fee, especially for international wire transfers.
Applicable wire transfer fees must be included with payment to
ensure fees are paid in full. Questions about wire transfer fees
should be addressed to the financial institution. The account
information for wire transfers is as follows: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If needed, FDA's
tax identification number is 53-0196965.

B. Prescription Drug Program Fees

    FDA will issue invoices and payment instructions for FY 2023
program fees under the new fee schedule in October 2022. Under section
736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are
generally due on October 3, 2022. However, given the late date of the
PDUFA reauthorization, invoices should be paid within 30 days of
invoice.
    FDA will issue invoices in December 2023 for products that qualify
for FY 2023 program fee assessments after the October 2022 billing.

C. Fee Waivers and Refunds

    To qualify for consideration for a waiver or reduction under
section 736(d) of the FD&C Act, an exemption under section 736(k) of
the FD&C Act, or the return of an application or program fee paid under
section 736 of the FD&C Act, including if the fee is claimed to have
been paid in error, a person must submit to FDA a written request
justifying such waiver, reduction, exemption or return not later than
180 days after such fee is due (section 736(i) of the FD&C Act). A
request submitted under this paragraph must include any legal
authorities under which the request is made.

    Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21968 Filed 10-5-22; 11:15 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Rules and Regulations]
[Pages 7536-7537]
[FR Doc No: 2012-3172]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0761; FRL-9501-6]

Revisions to the California State Implementation Plan, Joaquin
Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing approval of revisions to the San Joaquin
Valley Unified Air Pollution Control District (SJVUAPCD) portions of
the California State Implementation Plan (SIP). These revisions were
proposed in the Federal Register on October 6, 2011 and concern
volatile organic compound (VOC) emissions from Motor Vehicle and Motor
Equipment Coating Operations and Adhesives and Sealants. We are
approving local rules that regulate these emission sources under the
Clean Air Act as amended in 1990 (CAA or the Act).

DATES: Effective Date: This rule is effective on March 14, 2012.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2011-0761 for
this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps, multi-volume
reports), and some may not be available in either location (e.g.,
confidential business information (CBI)). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Adrianne Borgia, EPA Region IX, (415)
972-3576<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On October 6, 2011 (76 FR 62002), EPA proposed to approve the
following rules into the California SIP.

----------------------------------------------------------------------------------------------------------------
           Local agency                Rule No.              Rule title               Amended        Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD..........................            4612  Motor Vehicle and Mobile            10/21/10          4/5/11
                                                     Equipment Coating
                                                     Operations.
SJVUAPCD..........................            4653  Adhesives and Sealants......        09/16/10          4/5/11
----------------------------------------------------------------------------------------------------------------

    We proposed to approve these rules because we determined that they
complied with the relevant CAA requirements. Our proposed action
contains more information on the rules and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted that change our assessment that the
submitted rules comply with the relevant CAA requirements. Therefore,
as authorized in section 110(k)(3) of the

Act, EPA is fully approving these rules into the California SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: November 18, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220, is amended by adding paragraphs (c)(388)
(i)(B)(2)and(3) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (388) * * *
    (i) * * *
    (B) * * *
    (2) Rule 4612, ``Motor Vehicle and Mobile Equipment Coating,''
amended on October 21, 2010.
    (3) Rule 4653, ``Adhesives and Sealants,'' amended on September 16,
2010.
* * * * *
[FR Doc. 2012-3172 Filed 2-10-12; 8:45 am]
BILLING CODE 6560-50-P


County Designation Recommendation Adams Attainment Allen Nonattainment Bartholomew Attainment Benton Attainment: Factor 1 Blackford Attainment Boone Nonattainment Brown Attainment Carroll Attainment: Factor 1 Cass Attainment Clark Nonattainment Clay Attainment: Factor 1 Clinton Attainment Crawford Attainment Daviess Attainment Dearborn Attainment Decatur Attainment DeKalb Attainment Delaware Attainment: Factor 1 Dubois Attainment Elkhart Nonattainment Fayette Attainment Floyd Nonattainment Fountain Attainment Franklin Attainment Fulton Attainment Gibson Recommendation Deferred*: Factors 1 & 2 Grant Attainment Greene County Affected by Overwhelming Transport Hamilton Nonattainment Hancock Nonattainment Harrison Attainment Hendricks Nonattainment Henry Attainment Howard Attainment Huntington County Affected by Overwhelming Transport Jackson County Affected by Overwhelming Transport Jasper Attainment Jay Attainment Jefferson Attainment Jennings Attainment Johnson Nonattainment Knox Attainment Kosciusko Attainment LaGrange Attainment Lake Nonattainment LaPorte Nonattainment ATTACHMENT I Indiana July 15, 2003 Eight Hour Ozone Designation Recommendations By County ATTACHMENT I ( page 2)

County Designation Recommendation Lawrence Attainment Madison Nonattainment Marion Nonattainment Marshall Attainment Martin Attainment Miami Attainment Monroe Attainment Montgomery Attainment Morgan Nonattainment Newton Attainment Noble Attainment Ohio Attainment Orange Attainment Owen Attainment Parke Attainment Perry Attainment Pike Attainment Porter Nonattainment Posey Recommendation Deferred*: Factors 1 & 2 Pulaski Attainment Putnam Attainment Randolph Attainment Ripley Attainment Rush Attainment St. Joseph Nonattainment Scott Attainment Shelby Nonattainment Spencer Attainment Starke Attainment Steuben Attainment Sullivan Attainment: Factor 1 Switzerland Attainment Tippecanoe Attainment: Factor 1 Tipton Attainment Union Attainment Vanderburgh Recommendation Deferred*: Factors 1 & 2 Vermillion Attainment: Factor 1 Vigo Attainment: Factor 1 Wabash Attainment Warren Attainment Warrick Recommendation Deferred*: Factors 1 & 2 Washington Attainment Wayne Attainment Wells Attainment White Attainment Whitley Attainment * Recommendation will be made upon close of 2003 ozone season.

Note: Factor 1 ( Ozone readings in summer of 2003) and Factor 2 ( EPA guidance and mandatory controls for nonattainment areas) are outlined in detail on pages 2 3 of the cover letter attached hereto.


[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Rules and Regulations]
[Pages 76413-76416]
[FR Doc No: 2022-27020]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0799; Project Identifier AD-2022-00611-T;
Amendment 39-22251; AD 2022-24-11]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
The Boeing Company Model 787-8, 787-9, and 787-10 airplanes. This AD
was prompted by a report indicating that foreign object debris (FOD)
could have been introduced during rework of certain engine fire shutoff
switches (EFSSs). This AD requires determining the serial number of the
left and right EFSS and replacing affected parts. This AD also limits
the installation of affected parts under certain conditions. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective January 18, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 18,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0799; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-0799.

FOR FURTHER INFORMATION CONTACT: Tak Kobayashi, Aerospace Engineer,
Propulsion Section, FAA Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone:<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all The Boeing Company
Model 787-8, 787-9, and 787-10 airplanes. The NPRM published in the
Federal Register on July 8, 2022 (87 FR 40747). The NPRM was prompted
by a report indicating that FOD could have been introduced during
rework of certain EFSSs. In the NPRM, the FAA proposed to require
determining the serial number of the left and right EFSSs and replacing
affected parts. The FAA also proposed to limit the installation of
affected parts under certain conditions. The FAA is issuing this AD to
address FOD in an EFSS, which, if not addressed, could result in a
latent failure and loss of intended functions, including the inability
to pull the engine fire handle and uncommanded activation of the engine
fuel shutoff function. The inability to pull the engine fire handle
when an engine fire is detected could lead to an uncontrolled engine
fire and subsequent wing failure, and uncommanded activation of the
fuel shutoff function for an engine, combined with in-flight shutdown
of the remaining engine, could lead to total loss of engine thrust.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from The Airline Pilots Association,
International (ALPA) and United Airlines who both supported the NPRM
without change.
    The FAA received additional comments from Qatar Airways and Boeing.
The following presents the comments received on the NPRM and the FAA's
response.

Request for Guidance if an EFSS Has Two Labels

    Qatar Airways requested the FAA's guidance regarding how to handle
an EFSS having two identification labels. The commenter explained that
it has done ``spot checks'' of EFSS spares and discovered parts with
both ``pre-modification'' and ``post-modification'' nameplates/labels.
The commenter stated that having two identification labels on the EFSS
could create confusion and lead to erroneous updating of airplane
records, leading to a possible non-compliance with the final AD. The
commenter indicated that the EFSS manufacturer should be able to
provide the list of EFSS parts that have both ``pre-modification'' and
``post-modification'' labels.
    The FAA acknowledges that some EFSSs could have both ``pre-
modification'' and ``post-modification'' labels, which could be
confusing. However, having both labels on a part would not affect an
operator's ability to comply with the requirements of this AD. This AD
requires determining the serial number of the left EFSS having P/N
417000-104 and the right EFSS having P/N 417000-105, and replacing any
EFSS that has an affected serial number with an EFSS that does not have
an affected serial number, or with an EFSS that has an affected serial
number but is marked with ``Inspection Record SB D533-1X-003.'' The
``post-modification'' label on an EFSS specifies the part number,
either P/N 417000-104 or PN 417000-105. The serial number remains the
same regardless of modification.
    The modification referred to on the EFSS labels addresses the
requirements of AD 2021-02-06, Amendment 39-21389 (86 FR 10790,
February 23, 2021), which required replacement of EFSSs having P/Ns
417000-101 and 417000-102 with EFSSs having P/Ns 417000-104 and 417000-
105, respectively. This modification was made to EFSSs having P/Ns
417000-101 and 417000-102, followed by re-identification of those part
numbers as P/Ns 417000-104 and 417000-105. It addresses a design issue
that caused a latent failure of the EFSS and is not the subject of this
AD. When this modification was accomplished at a sub-tier supplier,
however, FOD could have been introduced inside the EFSS, and this FOD
issue is the subject of this AD. The FAA has not changed this AD in
response to this comment.

Request To Clarify Affected Airplanes

    Boeing requested a revision to the FAA's Determination section in
the NPRM, which stated that the unsafe condition is ``likely to exist
or develop on other products of the same type design.'' Boeing
recommends that the NPRM instead clarify that the unsafe condition is
``contained to only 787-8, 787-9, and 787-10 airplanes having certain
line numbers identified to be impacted by the unsafe condition.''
Boeing asserted that the nonconformance applies only to a specific
group of EFSS serial numbers that were affected at the rework site, and
is not endemic to the type design.
    The FAA acknowledges that FOD inside the EFSS is not endemic to the
type design since it was introduced during rework at a sub-tier
supplier. However, because the Determination section in the preamble of
the NPRM is not repeated in this AD, the FAA cannot provide the
clarification requested by the commenter. Furthermore, the affected
EFSS serial numbers can be installed on any Model 787 airplane,
therefore the unsafe condition is not limited to certain Model 787-8,
787-9, and 787-10 airplane line numbers. The FAA has not changed this
AD in response to this comment.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-
SB260010-00 RB, Issue 001, dated May 2, 2022. This service information
specifies procedures for determining the serial number of the left EFSS
having P/N 417000-104 and the right EFSS having P/N 417000-105, and
replacing any EFSS having an affected serial number with an EFSS that
does not have an affected serial number, or with an EFSS that has an
affected serial number but is marked with ``Inspection Record SB D533-
1X-003.'' This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 132 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Determination of EFSS serial number...  1 work-hour x $85 per                 $0             $85         $11,220
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
inspection. The agency has no way of determining the number of aircraft
that might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                 Action                           Labor cost            Parts cost         Cost per product
----------------------------------------------------------------------------------------------------------------
Replacement of EFSS.....................  2 work-hours x $85 per              $9,685  $9,855
                                           hour = $170.                               (for one EFSS).
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

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:

2022-24-11 The Boeing Company: Amendment 39-22251; Docket No. FAA-
2022-0799; Project Identifier AD-2022-00611-T.

(a) Effective Date

    This airworthiness directive (AD) is effective January 18, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 787-8, 787-9,
and 787-10 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Unsafe Condition

    This AD was prompted by a report indicating that foreign object
debris (FOD) could have been introduced during rework of certain
engine fire shutoff switches (EFSSs). The FAA is issuing this AD to
address FOD in an EFSS, which if not addressed, could result in a
latent failure and loss of intended functions, including the
inability to pull the engine fire handle and uncommanded activation
of the engine fuel shutoff function. The inability to pull the
engine fire handle when an engine fire is detected could lead to an
uncontrolled engine fire and subsequent wing failure, and
uncommanded activation of the fuel shutoff function for an engine,
combined with in-flight shutdown of the remaining engine, could lead
to total loss of engine thrust.

(f) Compliance

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

(g) Required Actions

    For airplanes with an original airworthiness certificate or
original export certificate of airworthiness issued on or before the
effective date of this AD: Except as specified by paragraph (h) of
this AD, at the applicable time specified in the ``Compliance''
paragraph of Boeing Alert Requirements Bulletin B787-81205-SB260010-
00 RB, Issue 001, dated May 2, 2022, do all applicable actions
identified in, and in accordance with, the Accomplishment
Instructions of Boeing Alert Requirements Bulletin B787-81205-
SB260010-00 RB, Issue 001, dated May 2, 2022.

    Note 1 to paragraph (g):
    Guidance for accomplishing the actions required by this AD can
be found in Boeing Alert Service Bulletin B787-81205-SB260010-00,
Issue 001, dated May 2, 2022, which is referred to in Boeing Alert
Requirements Bulletin B787-81205-SB260010-00 RB, Issue 001, dated
May 2, 2022.

(h) Exceptions to Service Information Specifications

    Where the Compliance Time column of the table in the
``Compliance'' paragraph of Boeing Alert Requirements Bulletin B787-
81205-SB260010-00 RB, Issue 001, dated May 2, 2022, uses the phrase
``the Issue 001 date of Requirements Bulletin B787-81205-SB260010-00
RB,'' this AD requires using ``the effective date of this AD.''

(i) Parts Installation Limitation

    For airplanes with an original airworthiness certificate or
original export certificate of airworthiness issued after the
effective date of this AD: As of the effective date of this AD, no
person may install a left EFSS P/N 417000-104 or a right EFSS P/N
417000-105, having a serial number specified in Boeing Alert
Requirements Bulletin B787-81205-SB260010-00 RB, Issue 001, dated
May 2, 2022, unless that EFSS is marked with ``Inspection Record SB
D533-1X-003.''

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, 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 responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (k) of this AD. Information may be emailed
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    For more information about this AD, contact Tak Kobayashi,
Aerospace Engineer, Propulsion Section, FAA Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone:<PHONE_NUMBER>; email
[email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin B787-81205-SB260010-00
RB, Issue 001, dated May 2, 2022.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.

    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 16, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-27020 Filed 12-13-22; 8:45 am]
BILLING CODE 4910-13-P