[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37304-37311]
[FR Doc No: 2019-16270]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3505]

Medical Device User Fee Rates for Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV),
authorizes FDA to collect user fees for certain medical device
submissions and annual fees both for certain periodic reports and for
establishments subject to registration. This notice establishes the fee
rates for FY 2020, which apply from October 1, 2019, through September
30, 2020. To avoid delay in the review of your application, you should
pay the application fee before or at the time you submit your
application to FDA. The fee you must pay is the fee that is in effect
on the later of the date that your application is received by FDA or
the date your fee payment is recognized by the U.S. Treasury. If you
want to pay a reduced small business fee, you must qualify as a small
business before making your submission to FDA; if you do not qualify as
a small business before making your submission to FDA, you will have to
pay the higher standard fee.

Please note that the establishment registration fee is not eligible for
a reduced small business fee. As a result, if the establishment
registration fee is the only medical device user fee that you will pay
in FY 2020, you should not submit a Small Business Certification
Request. This document provides information on how the fees for FY 2020
were determined, the payment procedures you should follow, and how you
may qualify for reduced small business fees.

FOR FURTHER INFORMATION CONTACT:
    For information on Medical Device User Fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
    For questions relating to the MDUFA Small Business Program, please
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
    For questions relating to this notice: David Haas, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 62041A, Beltsville, MD 20705,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, notices,
and requests (for simplicity, this document refers to these
collectively as ``submissions'' or ``applications''); for periodic
reporting on class III devices; and for the registration of certain
establishments. Under statutorily defined conditions, a qualified
applicant may receive a fee waiver or may pay a lower small business
fee (see 21 U.S.C. 379j(d) and (e)).
    Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2018 through FY 2022; the
base fee for a premarket application received by FDA during FY 2020 is
$310,000. From this starting point, this document establishes FY 2020
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
    The FD&C Act specifies the base fee for establishment registration
for each year from FY 2018 through FY 2022; the base fee for an
establishment registration in FY 2020 is $4,760. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary of Health
and Human Services under section 510 of the FD&C Act (21 U.S.C. 360)
because such establishment is engaged in the manufacture, preparation,
propagation, compounding, or processing of a device is required to pay
the annual fee for establishment registration.

II. Revenue Amount for FY 2020

    The total revenue amount for FY 2020 is $200,132,014, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA directs FDA to use the yearly total revenue amount
as a starting point to set the standard fee rates for each fee type.
The fee calculations for FY 2020 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $200,132,014 is to be adjusted for
inflation increases for FY 2020 using two separate adjustments--one for
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)).
The base inflation adjustment for FY 2020 is the sum of one plus the
two separate adjustments and is compounded as specified in the statute
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
    The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 1 summarizes the actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2020.
The 3-year average is 3.1175 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
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                                                                                3-Year
                Fiscal year                       2016              2017              2018            average
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Total PC&B................................    $2,414,728,159    $2,581,551,000    $2,690,678,000  ..............
Total FTE.................................            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
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    The payroll adjustment is 3.1175 percent multiplied by 60 percent,
or 1.8705 percent. The statute specifies that the component of the
inflation adjustment for non-payroll 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 0.40, or 40 percent (see 21
U.S.C. 379j(c)(2)(C)). 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 that 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.
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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.
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    Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Washington-Arlington-Alexandria
area. These data are published by the Bureau of Labor Statistics and
can be found on their website under series Id CUURS35ASA0 at: https://
data.bls.gov/pdq/SurveyOutputServlet?

data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

          Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
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                                                                                3-Year
                   Fiscal year                         2016            2017            2018           average
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Annual CPI......................................         253.422         256.221         261.445  ..............
Annual Percent Change...........................          1.1003          1.1045          2.0389  ..............
3-Year Average Percent Change in CPI............  ..............  ..............  ..............          1.4146
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    The non-pay adjustment is 1.4146 percent multiplied by 40 percent,
or 0.5658 percent. Next, the payroll adjustment (1.8705 percent or
0.018705) is added to the non-payroll adjustment (0.5658 percent or
.005658), for a total of 2.4363 percent (or 0.024363). To complete the
inflation adjustment, 1 (100 percent or 1.0) is added for a total base
inflation adjustment of 1.024363 for FY 2020.
    MDUFA IV provides for this inflation adjustment to be compounded
for FY 2020 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2020, the FY 2019 compounded adjustment (1.073823) is multiplied by
the FY 2020 base inflation adjustment (1.024363) to reach the
applicable inflation adjustment of 1.099985 (rounded) for FY 2020. We
then multiply the total revenue amount for FY 2020 ($200,132,014) by
1.099985, yielding an inflation adjusted total revenue amount of
$220,142,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2020

    Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)).

A. Inflation Adjustment

    MDUFA specifies that the base fees of $310,000 (premarket
application) and $4,760 (establishment registration) are to be adjusted
for FY 2020 using the same methodology as that for the total revenue
inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)).
Multiplying the base fees by the compounded inflation adjustment of
1.099985 yields inflation adjusted base fees of $340,995 (premarket
application) and $5,236 (establishment registration).

B. Further Adjustments

    After the applicable inflation adjustment to fees is done, FDA may
increase, if necessary to achieve the inflation adjusted total revenue
amount, the base fee amounts on a uniform proportionate basis (see 21
U.S.C. 379j(c)(2)(D)(ii)). If necessary after this adjustment, FDA may
further increase the base establishment registration fees to generate
the inflation adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).

C. Calculation of Fee Rates

    Table 3 provides the last 3 years of fee-paying submission counts
and the 3-year average. These numbers are used to project the fee-
paying submission counts that FDA will receive in FY 2020.

                              Table 3--Three-Year Average of Fee-Paying Submissions
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                                                      FY 2016         FY 2017         FY 2018         3-Year
                Application type                      actual          actual          actual          average
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Full Fee Applications...........................              37              37              38              37
    Small Business..............................              10               6               7               8
Panel-Track Supplement..........................              17              22              23              21
    Small Business..............................               1               2               5               3
De Novo Classification Request \1\..............  ..............  ..............              27              27
    Small Business \1\..........................  ..............  ..............              29              29
180-Day Supplements.............................             115             167             133             138
    Small Business..............................              16              33              27              25
Real-Time Supplements...........................             179             187             169             178
    Small Business..............................              27              19              34              27
510(k)s.........................................           2,583           2,969           2,122           2,558
    Small Business..............................           1,002           1,072           1,385           1,153
30-Day Notice...................................             926             998           1,058             994
    Small Business..............................              76              78              98              84
513(g) (21 U.S.C. 360c(g)) Request for                        68              93              84              82
 Classification Information.....................
    Small Business..............................              46              41              33              40
Annual Fee for Periodic Reporting \2\...........             586             618             624             609
    Small Business \2\..........................              75              57              74              69
Establishment Registration......................          26,043          27,115          27,544          26,901
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\1\ Three-year average for De Novo is based on estimate for FY 2020.
\2\ Includes collection of quarter 4 billing for FY 2018 during FY 2019.

    The information in table 3 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 4
displays the FY 2020 base fees set in statute (column one) and the
inflation adjusted base fees (per calculations in section III.A.)
(column two). Using the inflation adjusted fees and the 3-year averages
of fee-paying submissions, collections are projected to total
$221,603,174, which is $1,461,174 higher than the inflation adjusted
total revenue amount (in section II). The fees in column two are

those we are establishing in FY 2020, which are the standard fees.

                           Table 4--Fees Needed To Achieve New FY 2020 Revenue Target
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                                                                    FY 2020
                                                                   inflation         3-Year
                                                   FY 2020         adjusted        average of        FY 2020
               Application type                statutory fees   statutory  base    fee-paying      revenue from
                                                 (base fees)    fees  (standard    submissions    adjusted fees
                                                                     fees)
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Full Fee Applications........................        $310,000          $340,995              37      $12,616,815
    Small Business...........................          77,500            85,249               8          681,992
Panel-Track Supplement.......................         232,500           255,747              21        5,370,687
    Small Business...........................          58,125            63,937               3          191,811
De Novo Classification Request...............          93,000           102,299              27        2,762,073
    Small Business...........................          23,250            25,575              29          741,675
180-Day Supplements..........................          46,500            51,149             138        7,058,562
    Small Business...........................          11,625            12,787              25          319,675
Real-Time Supplements........................          21,700            23,870             178        4,248,860
    Small Business...........................           5,425             5,968              27          161,136
510(k)s......................................          10,540            11,594           2,558       29,657,452
    Small Business...........................           2,635             2,899           1,153        3,342,547
30-Day Notice................................           4,960             5,456             994        5,423,264
    Small Business...........................           2,480             2,728              84          229,152
513(g) Request for Classification Information           4,185             4,603              82          377,446
    Small Business...........................           2,093             2,302              40           92,080
Annual Fee for Periodic Reporting............          10,850            11,935             609        7,268,415
    Small Business...........................           2,713             2,984              69          205,896
Establishment Registration...................           4,760             5,236          26,901      140,853,636
                                              ------------------------------------------------------------------
    Total....................................  ..............  ................  ..............      221,603,174
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    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $340,995 for FY 2020. The fees set by reference
to the standard fee for a premarket application are:
     For a panel-track supplement, 75 percent of the standard
fee;
     For a de novo classification request, 30 percent of the
standard fee;
     For a 180-day supplement, 15 percent of the standard fee;
     For a real-time supplement, 7 percent of the standard fee;
     For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee;
     For a 510(k) premarket notification, 3.4 percent of the
standard fee;
     For a 30-day notice, 1.6 percent of the standard fee; and
     For a 513(g) request for classification information, 1.35
percent of the standard fee.
    For all submissions other than a 30-day notice and a 513(g) request
for classification information, the small business fee is 25 percent of
the standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C)). For a 30-day notice and a 513(g) request for
classification information, the small business fee is 50 percent of the
standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)).
    The annual fee for establishment registration, after adjustment, is
set at $5,236 for FY 2020. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
    Table 5 summarizes the FY 2020 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2020
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                                            Standard fee  (as a percent of the
          Application fee type                standard fee for a  premarket           FY 2020     FY 2020  small
                                                       application)                standard fee     business fee
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Premarket application (a PMA submitted   Base fee specified in statute..........        $340,995         $85,249
 under section 515(c)(1) of the FD&C
 Act (21 U.S.C. 360e(c)(1)), a PDP
 submitted under section 515(f) of the
 FD&C Act, or a BLA submitted under
 section 351 of the Public Health
 Service Act (the PHS Act) (42 U.S.C.
 262)).
Premarket report (submitted under        100....................................         340,995          85,249
 section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA  100....................................         340,995          85,249
 under section 351 of the PHS Act).
Panel-track supplement.................  75.....................................         255,747          63,937
De novo classification request.........  30.....................................         102,299          25,575
180-day supplement.....................  15.....................................          51,149          12,787
Real-time supplement...................  7......................................          23,870           5,968
510(k) premarket notification            3.40...................................          11,594           2,899
 submission.
30-day notice..........................  1.60...................................           5,456           2,728
513(g) request for classification        1.35...................................           4,603           2,302
 information.
Annual Fee Type
Annual fee for periodic reporting on a   3.50...................................          11,935           2,984
 class III device.

Annual establishment registration fee    Base fee specified in statute..........           5,236           5,236
 (to be paid by the establishment
 engaged in the manufacture,
 preparation, propagation, compounding,
 or processing of a device, as defined
 by 21 U.S.C. 379i(14)).
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IV. How To Qualify as a Small Business for Purposes of Medical Device
Fees

    If your business, including your affiliates, has gross receipts or
sales of no more than $100 million for the most recent tax year, you
may qualify for reduced small business fees. If your business,
including your affiliates, has gross sales or receipts of no more than
$30 million, you may also qualify for a waiver of the fee for your
first premarket application (i.e., PMA, PDP, or BLA) or premarket
report. If you want to pay the small business fee rate for a submission
or you want to receive a waiver of the fee for your first premarket
application or premarket report, you should submit the materials
showing you qualify as a small business at least 60 days before you
send your submission to FDA. FDA will review your information and
determine whether you qualify as a small business eligible for the
reduced fee and/or fee waiver. If you make a submission before FDA
finds that you qualify as a small business, you must pay the standard
(full) fee for that submission.
    If your business qualified as a small business for FY 2019, your
status as a small business will expire at the close of business on
September 30, 2019. You must re-qualify for FY 2020 in order to pay
small business fees during FY 2020.
    If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2020, you must submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the U.S. (Form FDA 3602). Form FDA 3602 is
provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
    2. A signed certified copy of your Federal (U.S.) Income Tax Return
for the most recent tax year. The most recent tax year will be 2019,
except:
    If you submit your MDUFA Small Business Certification Request for
FY 2020 before April 15, 2020, and you have not yet filed your return
for 2019, you may use tax year 2018.
    If you submit your MDUFA Small Business Certification Request for
FY 2020 on or after April 15, 2020, and have not yet filed your 2019
return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year, or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The business must also submit a
statement signed by the head of the business's firm or by its chief
financial officer that the business has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the business has no affiliates.
    If you are a foreign business, and wish to qualify as a small
business for FY 2020, you must submit the following:
    1. A completed MDUFA Foreign Small Business Certification Request
For a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.
    2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2019 or later), or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The business must also
submit a statement signed by the head of the business's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the business has no affiliates.

V. Procedures for Paying Application Fees

    If your application or submission is subject to a fee and your
payment is received by FDA between October 1, 2019, and September 30,
2020, you must pay the fee in effect for FY 2020. The later of the date
that the application is received in the reviewing center's document
room or the date the U.S. Treasury recognizes the payment determines
whether the fee rates for FY 2019 or FY 2020 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
    FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: Do not send your user fee
check to FDA with the application.)

A. Secure a Payment Identification Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before Submitting Either the Application or
the Payment

    Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application submission date range. (Two
choices will be offered until October 1, 2019. One choice is for
applications and fees that will be received on or before September 30,
2019, which are subject to FY 2019 fee rates. A second choice is for
applications and fees received on or after October 1, 2019, which are
subject to FY 2020 fee rates.) After completing data entry, print a
copy of the Medical Device User Fee cover sheet and note the unique PIN
located in the upper right-hand corner of the printed cover sheet.

B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN

    When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.

C. Submit Payment for the Completed Medical Device User Fee Cover Sheet

    1. 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 system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
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 you search for
your invoice, select ``Pay Now'' 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.
    2. If paying with a paper check:
     All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. If needed, FDA's
tax identification number is 53-0196965.
     Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
     Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
    If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 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 U.S. Bank at<PHONE_NUMBER>. This telephone number is
only for questions about courier delivery).
    3. If paying with a wire transfer:
     Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
     The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee
it is required that you add that amount to the payment to ensure that
the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
    FDA records the official application receipt date as the later of
the following: (1) The date the application was received by the FDA
Document Control Center for the reviewing Center or (2) the date the
U.S. Treasury recognizes the payment. It is helpful if the fee arrives
at the bank at least 1 day before the application arrives at FDA.

D. Submit Your Application to FDA With a Copy of the Completed Medical
Device User Fee Cover Sheet

    Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

    You will be invoiced at the end of the quarter in which your PMA
Periodic Report is due. Invoices will be sent based on the details
included on your PMA file. You are responsible for ensuring FDA has
your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the pending PMA
or a supplement to the approved PMA.
    1. The preferred payment method is online using electronic check
(ACH also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). 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 you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that 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.
    2. If paying with a paper check:
    The check must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. If needed, FDA's tax
identification number is 53-0196965.
     Please write your invoice number on the check.
     Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
(Please note that this address is for payments of application and
annual report fees only and is not to be used for payment of annual
establishment registration fees.)
    To send a check by a courier, the courier must deliver the check
and printed copy of the cover sheet to: U.S. Bank, Attn: Government
Lockbox 979033, 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 U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery).
    3. When paying by a wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. If the payment amount is not applied, the invoice amount would
be referred to collections. The originating financial

institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required that you add
that amount to the payment to ensure that the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

VII. Procedures for Paying Annual Establishment Registration Fees

    To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website address after this document publishes in the Federal Register.)
Create a DFUF order and you will be issued a PIN when you place your
order. After payment has been processed, you will be issued a payment
confirmation number (PCN). You will not be able to register your
establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2020 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(g)(2)).
    Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.

A. Submit a DFUF Order With a PIN From FDA Before Registering or
Submitting Payment

    To submit a DFUF Order, you must create or have previously created
a user account and password for the user fee website listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2020 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is accurate, electronically transmit that data to FDA according
to instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.

B. Pay For Your DFUF Order

    Unless paying by credit card, all payments must be in U.S. currency
and drawn on a U.S. bank.
    1. If paying by credit card or electronic check (ACH or eCheck):
    The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
    2. If paying with a paper check:
    The check must be in U.S. currency and drawn on a U.S. bank, and
mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO
63197-9000. (Note: This address is different from the address for
payments of application and annual report fees and is to be used only
for payment of annual establishment registration fees.)
    If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 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 U.S. Bank at<PHONE_NUMBER>. This
telephone number is only for questions about courier delivery.)
    Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. Include a copy of your printed order
when you mail your check.
    3. If paying with a wire transfer:
    Wire transfers may also be used to pay annual establishment
registration fees. To send a wire transfer, please read and comply with
the following information:
    Include your order's unique PIN (in the upper right-hand corner of
your completed DFUF order) in your wire transfer. Without the PIN, your
payment may not be applied to your facility and your registration may
be delayed.
    The originating financial institution may charge a wire transfer
fee. If the financial institution charges a wire transfer fee, it is
required that you add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept. 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.

C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2020, or To Register a New Establishment for
FY 2020

    Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the ``Access Electronic
Registration'' link on the left side of the page. This opens up a new
page with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
``Access Electronic Registration'' link in the middle of the page. This
link takes you to an FDA Industry Systems page with tutorials that
demonstrate how to create a new FURLS user account, if your
establishment did not create an account in FY 2019. Manufacturers of
licensed biologics should register in the Biologics Establishment
Registration (BER) system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
    Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. When you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
<EMAIL_ADDRESS>or call<PHONE_NUMBER> for assistance. (Note: This
email address and this telephone number are for assistance with
establishment registration only; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
the BER system should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call<PHONE_NUMBER>.

D. Enter Your DFUF Order PIN and PCN

    After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.

    Dated: July 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16270 Filed 7-30-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 4, 2007 (Volume 72, Number 170)]
[Proposed Rules]
[Page 50650-50652]
[DOCID:fr04se07-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R02-OAR-2006-0920, FRL-8462-7]

Approval and Promulgation of Implementation Plans; New Jersey;
Zero Emission Vehicle Component of the Low Emission Vehicle Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency is proposing to approve,
through model year 2011, New Jersey's low emission vehicle program
related to the manufacture and sale of zero-emission vehicles,
consistent with California's current low emission vehicle regulations.
EPA previously approved New Jersey's low emission vehicle program, but
did not take action on the zero-emission vehicle provisions. The
intended effect of this action is to approve, as consistent with
section 110(a)(2) of the Clean Air Act, a control strategy that will
help New Jersey achieve attainment of the National Ambient Air Quality
Standard for ozone.

DATES: Comments must be received on or before October 4, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R02-
OAR-2006-0920, by one of the following methods: http://www.regulations.gov:
 Follow the on-line instructions for submitting

comments.
    E-mail<EMAIL_ADDRESS>    Fax:<PHONE_NUMBER>.
    Mail: Raymond Werner, Chief, Air Programs Branch, Environmental
Protection Agency, Region 2 Office, 290 Broadway, 25th Floor, New York,
New York 10007-1866.
    Hand Delivery: Raymond Werner, Chief, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866. Such deliveries are only accepted
during the Regional Office's normal hours of operation. The Regional
Office's official hours of business are Monday through Friday, 8:30
a.m. to 4:30 p.m. excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R02-OAR-
2006-0920. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

FOR FURTHER INFORMATION CONTACT: Matthew Laurita,
<EMAIL_ADDRESS>at the Environmental Protection Agency, Region

2 Office, Air Programs Branch, 290 Broadway, 25th Floor, New York, NY
10007-1866, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>.
    Copies of the State submittals are available at the following
addresses for inspection during normal business hours:

    Environmental Protection Agency, Region 2 Office, Air Programs
Branch, 290 Broadway, 25th Floor, New York, New York 10007-1866.
    New Jersey Department of Environmental Protection, Public Access
Center, 401 East State Street 1st Floor, Trenton, New Jersey 08625.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. History of New Jersey's Low Emission Vehicle Program
II. California's Zero-Emission Vehicle Regulations
III. Status of New Jersey's Zero-Emission Vehicle Regulations
IV. Proposed EPA Action
V. Statutory and Executive Order Reviews

I. History of New Jersey's Low Emission Vehicle Program

    In January 2004, the New Jersey Legislature passed legislation
requiring the New Jersey Department of Environmental Protection (NJDEP)
to adopt the California Low Emission Vehicle (LEV) program, known as
the LEV II program. Pursuant to this legislation, New Jersey
promulgated regulations to adopt a LEV program identical to
California's LEV II program. New Jersey's regulations were adopted on
November 28, 2005 and published in the New Jersey Register on January
17, 2006. On June 2, 2006, New Jersey submitted a state implementation
plan (SIP) revision to EPA, seeking federal approval of the
regulations.
    On August 27, 2007, EPA approved New Jersey's LEV program into the
New Jersey SIP, with the exception of two provisions (72 FR 48936). EPA
took no action on the portions of New Jersey's LEV program related to
the manufacture and sale of Zero-Emission Vehicles (ZEV), commonly
referred to as the ``ZEV mandate,'' and portions of the rule related to
emission standards for greenhouse gases. Today EPA is proposing to
approve the ZEV portion of New Jersey's LEV program into the SIP,
through model year 2011.
    Section 209(a) of the CAA prohibits states from adopting or
enforcing standards relating to the control of emissions from new motor
vehicles or new motor vehicle engines. However, under section 209(b) of
the CAA, EPA may grant a waiver of the section 209(a) prohibition to
the State of California, thereby allowing California to adopt its own
motor vehicle emissions standards. Before EPA may grant such a waiver,
section 209(b) requires California to show that its standards will be
``* * * in the aggregate, at least as protective of public health and
welfare as applicable Federal standards* * * .'' Section 209(b) further
provides that EPA will grant a waiver unless it finds that: (1) The
State's determination is ``arbitrary and capricious,'' (2) the State
``does not need such State standards to meet compelling and
extraordinary conditions,'' or (3) the State's standards and
accompanying enforcement procedures are ``not consistent'' with CAA
section 202(a).
    Section 177 of the CAA allows other states to adopt and enforce
California's standards relating to the control of emissions from new
motor vehicles, provided that, among other things, such state standards
are identical to the California standards for which a waiver has been
granted under CAA section 209(b). In addition to the identicality
requirement, the state must adopt such standards at least two years
prior to the commencement of the model year to which the standards will
apply. All SIP revisions submitted to EPA for approval must also meet
the requirements of CAA section 110. In our August 27, 2007, Final Rule
(72 FR 48936), we found that New Jersey had met the requirements of CAA
sections 177 and 110.

II. California's Zero-Emission Vehicle Regulations

    The California Air Resources Board (CARB) adopted the first
generation LEV regulations in 1990, which were effective through the
2003 model year. CARB adopted California's second generation LEV
regulations (LEV II) following a November 1998 hearing. Subsequent to
the adoption of the LEV II program in February 2000, the U.S. EPA
adopted separate Federal standards known as the Tier 2 regulations (65
FR 6698). In December 2000, CARB modified the LEV II program to take
advantage of some elements of the Federal Tier 2 regulations to ensure
that only the cleanest vehicle models would continue to be sold in
California.
    In addition to LEV II emission requirements, minimum percentages of
passenger cars and the lightest light-duty trucks, marketed in
California by large or intermediate volume manufacturers, must be ZEVs.
This is referred to as the ZEV mandate. California has modified the ZEV
mandate several times since it took effect. In a December 19, 2003
revision to the ZEV regulation, CARB put in place an alternative
compliance program (ACP) to provide auto manufacturers with several
options to meet the ZEV mandate. The ACP established ZEV credit
multipliers to allow auto manufacturers to take credit for meeting the
ZEV mandate by selling more Partial Zero-Emission Vehicles (PZEVs) and
Advanced-Technology Partial Zero-Emission Vehicles (ATPZEVs) than they
are otherwise required to sell.
    EPA granted California a section 209(b) waiver for its LEV II
program on April 22, 2003 (68 FR 19811), but did not consider the ZEV
regulations in its decision. In a September 23, 2004 letter to EPA,
CARB requested that EPA find the 1999, 2001, and 2003 amendments to the
ZEV regulations within the scope of previous waivers issued to
California for model year 2003 through 2006 vehicles. In addition, CARB
requested that EPA grant a section 209(b) waiver to enforce the ZEV
regulations for 2007 and subsequent model year vehicles. In a December
28, 2006, notice (71 FR 78190), EPA found the 1999 through 2003 ZEV
amendments to be within the scope of previous waivers as they pertain
to 2003 through 2006 model year vehicles. In addition, EPA granted
California's request for a section 209(b) waiver to enforce provisions
of the ZEV regulations for model years 2007 through 2011. This waiver
allows for other states to adopt and enforce ZEV regulations that are
identical to California's, effective through model year 2011.

III. Status of New Jersey's Zero-Emission Vehicle Regulations

    In New Jersey's November 28, 2005 adoption of the California LEV II
program, the State adopted the entirety of California's regulations by
reference, including the ZEV regulations. At that time, EPA had not
issued a section 209(b) waiver of Federal pre-emption that would allow
California to enforce the provisions of its ZEV regulations. Therefore,
at that time New Jersey was also unable to enforce those provisions.
When EPA issued its December 28, 2006 waiver to California, New Jersey
became eligible to enforce its identical ZEV regulations for model
years 2009 through 2011.
    New Jersey requested that EPA approve the ZEV regulations into the
SIP in a comment on EPA's March 21, 2007 Notice of Proposed Rulemaking
(72 FR 13227), where EPA proposed approval of New Jersey's LEV program
without the ZEV and greenhouse gas provisions. EPA has found that New
Jersey's ZEV regulations meet the requirements of CAA Section 177 for
model years 2009 through 2011, and is therefore proposing to approve
the ZEV regulations into the New Jersey SIP for only those model years.

IV. Proposed EPA Action

    EPA is proposing to approve the ZEV portion of New Jersey's low
emission vehicle program that is identical to the California standards
for which a waiver has been granted. Because the waiver granted for the
ZEV portion of the program is limited to model year 2011 and earlier
vehicles, EPA is only proposing approval of the ZEV provisions of New
Jersey's LEV program for model years 2009 through 2011.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a ``significant regulatory action'' and
therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations

That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001). This proposed action merely proposes to approve
State law as meeting Federal requirements and imposes no additional
requirements beyond those imposed by State law. Accordingly, the
Administrator certifies that this proposed rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule proposes to approve pre-existing requirements under State law
and does not impose any additional enforceable duty beyond that
required by State law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
    This proposed rule also does not have tribal implications because
it will not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000). This action also does not
have Federalism implications because it does not have substantial
direct effects 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, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999). This action
merely proposes to approve a State rule implementing a Federal
standard, and does not alter the relationship or the distribution of
power and responsibilities established in the CAA. This proposed rule
also is not subject to Executive Order 13045, ``Protection of Children
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April
23, 1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the State
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the CAA. Thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply. This proposed rule does not impose
an information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

    Dated: August 17, 2007.
Alan J. Steinberg,
Regional Administrator, Region 2.
 [FR Doc. E7-17411 Filed 8-31-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Rules and Regulations]
[Pages 55939-55941]
[FR Doc No: 2017-25382]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1095; Product Identifier 2012-NM-215-AD; Amendment
39-19108; AD 2017-24-04]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Fokker Services B.V. Model F.27 airplanes. This AD requires contacting
the FAA to obtain instructions for addressing the unsafe condition on
these products, and doing the actions specified in those instructions.
This AD was prompted by reports indicating that certain exit signs have
a hydrogen isotope that decays over time, causing the signs to lose
their brightness. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD becomes effective December 12, 2017.
    We must receive comments on this AD by January 11, 2018.

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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1095; 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 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: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 1601 Lind
Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>; fax 425-227-
1149.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2012-0238, dated November 9, 2012 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Fokker Services B.V. Model F.27
airplanes. The MCAI states:

    A number of Fokker F.27 aeroplanes have exit signs installed to
locate the emergency exits. A number of these signs are not
electrically powered, but are self-illuminated by means of a
hydrogen isotope known as Tritium. As this isotope decays over time,
these signs will lose their brightness.
    To remain compliant with regulations, Tritium exit signs should
be replaced when their brightness has deteriorated below accepted
levels. The established service life for the Tritium powered exit
signs is 7 years. Currently, the F.27 maintenance program does not
include a replacement task for exit signs containing Tritium.
    This condition, if not corrected, could result in insufficiently
bright exit signs, possibly preventing safe evacuation during an
emergency, which could result in injury to occupants.
    For the reasons described above, this [EASA] AD requires the
replacement of the affected Tritium powered exit signs. Depending on
the aeroplane configuration, the replacement exit signs must be
either photo-luminescent or Tritium powered. In addition, this
[EASA] AD introduces a life limit for the Tritium signs and requires
repetitive maintenance tasks for the photo-luminescent signs. [The
EASA AD provides an option to revise the airplane maintenance
program.]

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1095.

FAA's Determination and Requirements of This 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. We are issuing this AD because we evaluated all pertinent
information and determined the unsafe condition exists and is likely to
exist or develop on other products of the same type design.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product, we
find good cause that notice and opportunity for prior public comment
are unnecessary. In addition, for the reason(s) stated above, we find
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 we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2017-1095; Product
Identifier 2012-NM-215-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 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 AD.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. This AD
requires contacting the FAA to obtain instructions for addressing the
unsafe condition, and doing the actions specified in those
instructions. Based on the actions specified in the MCAI, we are
providing the following cost estimates for an affected airplane that is
placed on the U.S. Register in the future:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                Action                          Labor cost                   Parts cost               product
----------------------------------------------------------------------------------------------------------------
Replacement...........................  1 work-hour x $85 per      Unavailable..................             $85
                                         hour = $85.
Inspection............................  1 work-hour x $85 per      $0...........................              85
                                         hour = $85.
Maintenance or inspection program       1 work-hour x $85 per      $0...........................              85
 revision.                               hour = $85.
----------------------------------------------------------------------------------------------------------------

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under 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.

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):

2017-24-04 Fokker Services B.V.: Amendment 39-19108; Docket No. FAA-
2017-1095; Product Identifier 2012-NM-215-AD.

(a) Effective Date

    This AD becomes effective December 12, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.27 airplanes,
certificated in any category, serial numbers 10425 through 10692
inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 11, Placards and
markings.

(e) Reason

    This AD was prompted by reports indicating that certain exit
signs have a hydrogen isotope that decays over time, causing the
signs to lose their brightness. We are issuing this AD to prevent
insufficiently illuminated exit signs, which could possibly prevent
safe evacuation during an emergency and cause injury to occupants.

(f) Compliance

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

(g) Required Actions

    Within 30 days after the effective date of this AD, request
instructions from the Manager, International Section, Transport
Standards Branch, FAA, to address the unsafe condition specified in
paragraph (e) of this AD; and accomplish the actions at the times
specified in, and in accordance with, those instructions. Guidance
can be found in Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency (EASA) AD 2012-0238, dated
November 9, 2012.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, International Section, Transport Standards 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 local
Flight Standards District Office, as appropriate. If sending
information directly to the International Section, send it to the
attention of the person identified in paragraph (i)(2) of this AD.
Information may be emailed to: [email protected].
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.

(i) Related Information

    (1) Refer to MCAI EASA AD 2012-0238, dated November 9, 2012, for
related information. You may examine the MCAI on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2017-1095.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone
425-227-1137; fax<PHONE_NUMBER>.

(j) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on November 14, 2017.
Chris Spangenberg,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2017-25382 Filed 11-24-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 5, 2008 (Volume 73, Number 87)]
[Notices]
[Page 24599]
[DOCID:fr05my08-484]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0257]

Draft Prescription Drug User Fee Act IV Drug Safety Five-Year
Plan; Availability for Comment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability for public comment of the draft drug safety 5-year plan
entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-
Year Plan.'' This plan is intended to communicate FDA's strategy for
meeting the commitments for enhancing and modernizing the drug safety
system within the context of the PDUFA IV program.

DATES:  Submit written or electronic comments on the draft drug safety
5-year plan by June 19, 2008.

ADDRESSES:  Submit written requests for single copies of the draft plan
to the Office of Executive Programs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6100, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the draft drug safety 5-year plan to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the document.

FOR FURTHER INFORMATION CONTACT:  Jayne C. Ware, Food and Drug
Administration, Center for Drug Evaluation and Research, Office of
Executive Programs, 10903 New Hampshire Ave., Bldg. 51, rm. 6100,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, President Bush signed into law the Food and
Drug Administration Amendments Act of 2007, which includes the
reauthorization and expansion of PDUFA. The reauthorization of PDUFA
will significantly broaden and modernize the agency's drug safety
program and facilitate more efficient development of safe and effective
new medications for the American public. During the user fee
negotiation process leading up to the renewal of PDUFA, FDA and the
relevant regulated industries mutually agreed to certain commitments
that the FDA will carry out during fiscal years 2008 through 2012.
Congress signaled its agreement with the commitments by authorizing
PDUFA funds for them. Among those commitments is the responsibility of
the FDA to develop and periodically update a 5-year plan describing
activities that will lead to enhancing and modernizing FDA's drug
safety system.
    FDA is announcing for public comment the availability of the draft
drug safety 5-year plan entitled ``Prescription Drug User Fee Act
(PDUFA) IV Drug Safety Five-Year Plan.'' This plan is intended to
communicate FDA's strategy for meeting the commitments for enhancing
and modernizing the drug safety system within the context of the PDUFA
IV program. The plan describes the agency's strategy for achieving the
commitments defined in section VIII, Enhancement and Modernization of
the FDA Drug Safety System, and section IX, Review of Proprietary Names
to Reduce Medication Errors, of the PDUFA IV Performance Goals (http://
www.fda.gov/oc/pdufa4/pdufa4goals.html). At the end of the comment
period, FDA will review the comments, update the ``PDUFA IV Drug Safety
Five-Year Plan,'' and publish the final version.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf.

    Dated: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9726 Filed 5-2-08; 8:45 am]

BILLING CODE 4160-01-S


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on January 24, 2005

                     NOTICE OF ACTION TAKEN -- DOCKET OST-04-17680

_____________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Motion of   American Airlines, Inc.    filed   1/3/2005  for:

XX  Waiver of dormancy condition:

The Department granted exemption authority to American to provide
scheduled transportation of persons, property, and mail between
Honolulu, Hawaii, and Tokyo, Japan and allocated it seven weekly
frequencies to operate this service.  The frequencies are subject to the
condition that they will expire automatically and revert to the
Department for reallocation if they are not used for a period of 90 days
after American’s proposed start-up date of November 1, 2004.
Therefore, the frequencies would expire January 30, 2005.  American
seeks a waiver of the 90-day dormancy condition until November 1, 2005.
It states that it has been unable to secure the needed slots at Tokyo
Narita Airport to operate this Honolulu-Tokyo service.

No objections to American's application were filed.

Applicant rep.:  Carl B. Nelson, Jr.,<PHONE_NUMBER>   DOT analyst:
Gerald Caolo,<PHONE_NUMBER>

DISPOSITION

XX Granted (See remarks below)

The above action with respect to the frequencies was effective when
taken: January 24, 2005,     through    November 1, 2005

XX  Action taken by:	Paul L. Gretch, Director

			Office of International Aviation

XX  The authority granted is consistent with the Air Transport Services
Agreement between the United States and Japan.

________________________________________________________________________
_____________

Remarks:

We find that grant of American's request, in the particular
circumstances presented, is in the public interest.  However, we are
putting American on notice that there should be no expectation that an
additional request will similarly be granted.  As is our policy in
considering dormancy waiver requests, we reserve the right to reexamine
whether grant of this waiver continues to be in the public interest.
Any further request to extend the dormancy waiver for the frequencies at
issue here will have to be considered in light of the specific arguments
offered and responses thereto, and in the context of the circumstances
present at that time, including whether another carrier seeks to use the
frequencies at issue.

________________________________________________________________________
___________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; and (2) grant of
the waiver was consistent with the public interest. To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp.

 See Notice of Action Taken dated May 10, 2004, Docket OST-2004-17680.

 American’s waiver from the dormancy condition is effective through
November 1, 2005.  As to any frequency with which American does not
begin service by that date, its allocation with respect to that
frequency will expire automatically.

 PAGE   2

 PAGE   2


[Federal Register: October 26, 2005 (Volume 70, Number 206)]
[Notices]
[Page 61859-61861]
[DOCID:fr26oc05-138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52631; File No. SR-FICC-2005-14]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of a Proposed Rule Change Relating to the Federal
Reserve's National Settlement System

October 18, 2005.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on September 9, 2005, Fixed
Income Clearing Corporation (``FICC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I, II, and III below, which items have been prepared
primarily by FICC. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change would amend the rules of FICC's Government
Securities Division (``GSD'') to have funds-only settlement obligation
payment processing occur through the Federal Reserve's National
Settlement System (``NSS'').

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FICC has prepared summaries, set forth in Sections (A),
(B), and (C) below, of the most significant aspects of such
statements.\2\
---------------------------------------------------------------------------

    \2\ The Commission has modified parts of these statements.
---------------------------------------------------------------------------

(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of the proposed rule change is to amend the rules of
GSD to require netting members to satisfy their funds-only settlement
amounts ultimately through the Federal Reserve's NSS.\3\ GSD's funds-
only settlement process is set forth in GSD Rule 13. On a daily basis,
FICC reports a funds-only settlement amount, which is either a debit
amount or a credit amount, to each netting member. Each netting member
that has a debit is required to satisfy its obligation by the
applicable deadline. Netting members with credits are subsequently paid
by FICC by the applicable deadline. All payments of funds-only
settlement amounts by a netting member to FICC and all collections of
funds-only settlement amounts by a netting member from FICC are done
through depository institutions that are designated by such netting
member and FICC to act on their behalves with regard to such payments
and collections. All payments are made by fund wires from one
depository institution to the other.
---------------------------------------------------------------------------

    \3\ This is consistent with the manner in which FICC's
affiliates, The Depository Trust Company (``DTC'') and the National
Securities Clearing Corporation (``NSCC''), handle their funds
settlement process. DTC and NSCC do not currently use NSS for the
processing of funds credits, whereas FICC is proposing to have the
GSD process both the debits and credits of its funds-only settlement
process through NSS.
---------------------------------------------------------------------------

    In 1997, the Commission approved an enhancement to GSCC's \4\
funds-only settlement payment processing (``1997 Filing'').\5\ This
enhancement gave members the option to participate in an auto-debit
arrangement that was to eliminate the need to send fund wires for the
satisfaction of funds-only settlement payments. Under the auto-deposit
arrangement, GSCC, the netting member, and the netting member's
depository institution would enter into a ``funds-only settlement
procedures agreement'' whereby the depository institution would pay or
collect funds-only settlement amounts on behalf of the netting member
and GSCC through accounts of the member at the depository institution.
As a result, the

need for fund wire payments would be eliminated.\6\
---------------------------------------------------------------------------

    \4\ The Government Securities Clearing Corporation (``GSCC'')
was the predecessor to GSD. GSCC became the GSD division of FICC
when GSCC and the Mortgage Backed Securities Clearing Corporation
were merged to create FICC in 2002.
    \5\ Securities Exchange Act Release No. 39309 (November 7,
1997), 62 FR 61158 (November 14, 1997) [File No. SR-GSCC-97-06].
    \6\ This was a voluntary arrangement that was never implemented
because until recently GSCC and then GSD continued to make manual
adjustments to the final funds-only settlement amounts of netting
members. These manual adjustments have recently largely been
eliminated.
---------------------------------------------------------------------------

    The proposed rule change will replace the auto-debit process of the
1997 Filing and will provide even further enhancements to the current
approach to payment processing than was envisioned by the 1997 Filing.
Under the proposed rule change, the required payment mechanism for the
satisfaction of funds-only settlement amounts will be the NSS. FICC
will appoint The Depository Trust Company (``DTC'') as its settlement
agent for purposes of interfacing with the NSS.\7\
---------------------------------------------------------------------------

    \7\ DTC currently performs this service for NSCC.
---------------------------------------------------------------------------

    In order to satisfy their funds-only settlement obligations through
the NSS process, netting members must appoint banks or trust companies
to act as their ``funds-only settling banks.'' A netting member that
qualifies may act as its own funds-only settling bank.
    The GSD will establish a limited membership category for the funds-
only settling banks. Banks or trust companies that are DTC settling
banks, as defined in DTC's rules and procedures, or that are GSD
netting members with direct access to the Federal Reserve and the NSS
will be eligible to become GSD funds-only settling bank members by
executing the requisite membership agreement for this purpose. Other
banks or trust companies that desire to become funds-only settling bank
members must apply to FICC. They must also have direct access to a
Federal Reserve Bank and the NSS as well as satisfy the financial
responsibility standards imposed by FICC from time to time. Initially,
these applicants must meet and maintain a Tier 1 capital ratio of 6
percent.\8\
---------------------------------------------------------------------------

    \8\ This is the same financial requirement for NSCC settling
bank-only members. Under FICC's proposal, FICC would retain the
discretion to change this financial criterion by providing advanced
notice to the fund-only settling banks and the netting members
through important notice.
---------------------------------------------------------------------------

    In addition to the membership agreement, the funds-only settling
bank and the netting member must execute an agreement whereby the
member will appoint the bank to act on its behalf for funds-only
settlement purposes. The bank must also execute any agreements required
by the Federal Reserve Bank for participation in the NSS for FICC's
funds-only settlement process.
    The funds-only settling banks will be required to follow the
procedures for funds-only settlement payment processing set forth in
FICC's proposed new rules. This will include, for example, providing
FICC or its settlement agent with the requisite acknowledgement of the
bank's intention to settle the funds-only settlement amounts of the
netting members it represents on a timely basis and participating in
the NSS process. Funds-only settling banks will have the right to
refuse to settle for a particular netting member and will also be able
to opt out of NSS for one business day if they are experiencing
extenuating circumstances.\9\ Under FICC's proposal, the netting member
shall be responsible for ensuring that its funds-only debit is wired to
the depository institution designated by FICC for this purpose by the
payment deadline. The proposed rule change makes clear that the
obligation of a netting member to fulfill its funds-only settlement
amount remains at all times with the netting member.
---------------------------------------------------------------------------

    \9\ These procedures are consistent with the NSCC and DTC
procedures in this respect.
---------------------------------------------------------------------------

    As FICC's settlement agent, DTC will submit instructions to have
the Federal Reserve Bank accounts of the funds-only settlement banks
charged for the debit amounts and credited for the credit amounts.
Utilization of NSS will eliminate the need for the initiation of wire
transfers in satisfaction of funds-only settlement amounts, and FICC
believes that it will therefore reduce the risk that the netting member
that designated the bank may incur a late payment fine due to delay in
wiring funds. The proposal will also reduce operational burden for the
operations staff of FICC.
    The NSS is governed by the Federal Reserve's Operating Circular No.
12 (``Circular''). Under the Circular, DTC, as FICC's settlement agent,
has certain responsibilities with respect to an indemnity claim made by
a relevant Federal Reserve Bank as a result of the NSS process. FICC
will apportion the entirety of any such liability to the netting
members for whom the funds-only settling bank to which the indemnity
claim relates was acting. This allocation will be done in proportion to
the amount of such members' funds-only settlement amounts on the
business day in question. If for any reason such allocation is not
sufficient to fully satisfy the Federal Reserve Bank's indemnity claim,
the remaining loss shall be treated as an ``Other Loss'' as defined by
the GSD's Rule 4 and allocated accordingly.
    The proposed rule change will not change the current GSD deadlines
regarding the payment and receipt of funds-only settlement amounts,
which are set forth in the GSD's rules.
    FICC believes the proposed rule change is consistent with the
requirements of Section 17A of the Act, and the rules and regulations
thereunder because it will enhance the current operation of the GSD's
funds-only settlement payment process by promoting the timely
processing of funds payments and credits. As such, the proposed rule
change should support the prompt and accurate clearance and settlement
of securities transactions.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change would have any
impact or impose any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been
solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within thirty-five days of the date of publication of this notice
in the Federal Register or within such longer period (i) as the
Commission may designate up to ninety days of such date if it finds
such longer period to be appropriate and publishes its reasons for so
finding or (ii) as to which the self-regulatory organization consents,
the Commission will:
    (a) By order approve the proposed rule change or
    (b) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/
 rules/sro.shtml) or     Send an e-mail to rule-comments@ sec.gov. Please include

File Number SR-FICC-2005-14 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary,

Securities and Exchange Commission, 100 F Street, NE., Washington, DC
20549-9303.
    All submissions should refer to File Number SR-FICC-2005-14. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/

rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of FICC and on
FICC's Web site at http://www.ficc.com. All comments received will be

posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FICC-2005-14 and should be submitted on
or before November 16, 2005.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5943 Filed 10-25-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 209 (Tuesday, October 31, 2017)]
[Notices]
[Pages 50479-50480]
[FR Doc No: 2017-23611]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary With EUROCAE WG-
98

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

ACTION: Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary with EUROCAE
WG-98.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary with
EUROCAE WG-98.

DATES: The meeting will be held December 12-15, 2017 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at: RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Rebecca Morrison at [email protected]
or<PHONE_NUMBER>, or The RTCA Secretariat, 1150 18th Street NW., Suite
910, Washington, DC, 20036, or by telephone at<PHONE_NUMBER>, fax at
(202) 833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Thirteenth RTCA SC-229 406 MHz ELT
Joint Plenary with EUROCAE WG-98. The agenda will include the
following:

Tuesday, December 12, 2017 9:00 a.m.-5:00 p.m.

1. Welcome/Introductions/Administrative Remarks/DFO FACA Statement
2. Agenda overview and approval
3. Minutes Paris meeting review and approval
4. Review Action Items from Paris meeting
5. Review work plan for the week, timeline and Terms of Reference
6. Working group of the whole meeting to resolve the comments on the
draft document

Wednesday, December 13, 2017 9:00 a.m.-5:00 p.m.

7. Working group of the whole meeting to resolve the comments on the
draft document

Thursday, December 14, 2017 9:00 a.m.-5:00 p.m.

8. Working group of the whole meeting to resolve the comments on the
draft document

Friday, December 15, 2017 9:00 a.m.-5:00 p.m.

9. Working group of the whole meeting to resolve the comments on the
draft document
10. Action item review
11. Consider a motion to open Final Review and Comment/Open
Consultation on the revision to RTCA/DO-204B, EUROCAE ED-62B
12. Future meeting plans and dates for formal FRAC/Open Consultation
resolution
13. Other business
14. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on October 26, 2017.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-23611 Filed 10-30-17; 8:45 am]
BILLING CODE 4910-13-P