[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Proposed Rules]
[Pages 37158-37160]
[FR Doc No: 2013-14693]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0526; Directorate Identifier 2008-SW-14-AD]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada (Bell)
Model Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Bell Model 206L-4 and 407 helicopters. This proposed AD would require
replacing or reworking certain aft bearing caps. This proposed AD is
prompted by the manufacture of certain freewheel aft bearing caps
without a lubrication channel to allow oil flow into the aft bearing
support assembly. The proposed actions are intended to prevent failure
of the freewheel unit and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by August 19, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to the ``Mail'' address 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 or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
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 service information identified in this proposed AD, contact
Bell Helicopter Textron, Inc., P.O. Box 482, Fort Worth, Texas 76101,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

FOR FURTHER INFORMATION CONTACT: Eric Haight, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Regulations and Policy Group, Fort Worth,
Texas 76137, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a

report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    Transport Canada Civil Aviation (TCAA), which is the aviation
authority for Canada, has issued TCAA AD No. CF-2004-17R1, dated
February 11, 2005 (AD No. CF-2004-17R1), which requires replacing or
reworking freewheel assemblies on the Bell Model 206L-4 and 407
helicopters. TCAA advises of a manufacturing oversight where a
lubrication channel was not machined into the aft bearing cap of some
freewheel units to allow oil flow into the aft bearing support
assembly. TCAA states that lack of lubrication may adversely affect the
durability and potentially the function of the freewheel unit.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, TCAA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other helicopters of the same type design.

Related Service Information

    Bell has issued Alert Service Bulletin (ASB) No. 206L-04-129 for
the Model 206L-4 and No. 407-04-66 for the Model 407, both Revision A,
and both dated December 1, 2004. The ASBs specify identifying the
affected freewheel aft bearing caps. The ASBs also provide separate
procedures, depending on whether helicopters are ``not exclusively used
for training'' or ``exclusively used for training,'' for replacing or
reworking the freewheel cap assembly and replacing the output shaft,
part number (P/N) 406-040-517-101, and sprag and retainer, P/N 406-040-
580-103. TCCA classified these ASBs as mandatory and issued AD No. CF-
2004-17R to ensure the continued airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would require for each affected freewheel
assembly, within 50 hours time-in-service (TIS), removing and
disassembling the freewheel assembly, replacing the sprag, retainer,
and the aft seal and visually inspecting the remaining freewheel part
details for a missing channel. Also, the proposed AD would require, if
the channel is missing, before further flight, replacing the cap
assembly with an airworthy cap or reworking and reidentifying the
existing cap by using a vibrating stylus to add the letter ``R'' to the
serial number of the reworked cap. Reworking or replacing the affected
cap assembly is terminating action for the requirements of this AD.

Differences Between This Proposed AD and the TCAA AD

    This proposed AD differs from the TCAA AD as follows:
     We would not use a calendar time, which has already
passed.
     We would require all affected helicopters to comply within
50 hours TIS; the TCAA AD has different compliance times as stipulated
by the calculated average engine start cycle count identified in the
applicable ASB, and a 300-hour TIS terminating action for modifying all
affected helicopters.
     We would not require referencing compliance with the ASBs
as does the TCAA AD, and we would not require you to provide an
affected cap for rework to Bell Tennessee nor require the original cap
to be reworked by Bell Tennessee.
     We would not require any action on ``spare'' parts before
installation on a helicopter but would require before installing any
replacement bearing support assembly, ensuring that the rework has been
done.

Costs of Compliance

    We estimate that this proposed AD would affect 212 Model 206L-4
helicopters and 540 Model 407 helicopters of U.S. registry; however, we
estimate that only 80 helicopters are affected. We estimate that
operators may incur the following costs in order to comply with this
AD: It would take about 16 work hours to replace the freewheel unit for
all the affected parts at an average labor rate of $85 per work hour.
Required parts would cost about $21,600 per helicopter. Based on these
figures, we estimate the total cost per helicopter would be $22,900 and
the total cost of the proposed AD on U.S. operators would be
$1,836,800.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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):

Bell Helicopter Textron Canada: Docket No. FAA-2013-0526;
Directorate Identifier 2008-SW-14-AD.

(a) Applicability

    This AD applies to Model 206L-4 and 407 helicopters, with a
freewheel aft bearing cap (cap), part number (P/N) 406-040-509-101,
with a serial number with a prefix of ``A-'' and Nos. 1833 through
1912, installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as certain caps being
manufactured without a lubrication channel to allow oil flow into
the aft bearing support assembly, which could result in failure of
the freewheel unit and subsequent loss of control of the helicopter.

(c) Comments Due Date

    We must receive comments by August 19, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 50 hours time-in-service (TIS):
    (1) Remove and disassemble each freewheel assembly.
    (2) Replace the sprag and retainer (item 7), the output shaft
(item 10), and the aft seal (item 3), as depicted in Figure 2 of
Bell Alert Service Bulletin (ASB) No. 206L-04-129 for the Model
206L-4 and ASB No. 407-04-66 for the Model 407, both Revision A, and
both dated December 1, 2004.
    (3) Visually inspect the remaining freewheel part details for a
missing channel.
    (4) If the channel is missing, replace or rework the cap
assembly by following the instructions depicted in Figure 3 of ASB
206L-04-129 or ASB 407 04-66, as applicable for your model
helicopter. Using a vibrating stylus, mark the letter ``R'' at the
end of the serial number on the cap assembly.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Eric Haight, Aviation Safety
Engineer, FAA, Rotorcraft Directorate, Regulations and Policy Group,
Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in Transport Canada Civil
Aviation AD No. CF-2004-17R1, dated February 11, 2005.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6300: Main Rotor
Drive System.

    Issued in Fort Worth, Texas, on June 13, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-14693 Filed 6-19-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36598-36604]
[FR Doc No: 2018-16178]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Medical Device User Fee Rates for Fiscal Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2019. 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 2019, which apply from October 1, 2018, through September
30, 2019. 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 2019, you should not submit a
Small Business Certification Request. This document provides
information on how the fees for FY 2019 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: Visit FDA's website
at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
    For questions relating to the MDUFA Small Business Program, please
visit CDRH's website: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/ucm577696.htm.
    For questions relating to this notice: David Haas, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202I), Silver Spring, MD 20993-0002,<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 2019 is
$300,000. From this starting point, this document establishes FY 2019
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 2019 is $4,548. 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 2019

    The total revenue amount for FY 2019 is $190,654,875, 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 2019 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $190,654,875 is to be adjusted for
inflation increases for FY 2019 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 2019 is the sum of one plus these
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 2019.
The 3-year average is 2.4152 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                 Fiscal year                        2015             2016             2017        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..................................   $2,232,304,000   $2,414,728,159   $2,581,551,000  ...............

Total FTE...................................           15,484           16,381           17,022  ...............
PC&B per FTE................................         $144,168         $147,408         $151,660  ...............
Percent change from previous year...........           2.1136           2.2474           2.8845           2.4152
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.4152 percent multiplied by 60 percent,
or 1.4491 percent.
    The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2019 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)).
    Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Baltimore-Washington area. These
data are published by the Bureau of Labor Statistics and can be found
on their website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.

               Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
                 Fiscal year                        2015             2016             2017        3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..................................          155.353          157.180          159.202  ...............
Annual Percent Change.......................           0.3268           1.1760           1.2864  ...............
3-Year Average Percent Change in CPI........  ...............  ...............  ...............           0.9297
----------------------------------------------------------------------------------------------------------------

    The non-pay adjustment is 0.9297 percent multiplied by 40 percent,
or 0.3719 percent.
    Next, the payroll adjustment (1.4491 percent or 0.014491) is added
to the non-payroll adjustment (0.3719 percent or 0.003719), for a total
of 1.8210 percent (or 0.018210). To complete the inflation adjustment,
1 (100 percent or 1.0) is added for a total base inflation adjustment
of 1.018210 for FY 2019.
    MDUFA IV provides for this inflation adjustment to be compounded
for FY 2019 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2019
(1.018210) is compounded by multiplying it by the compounded applicable
inflation factor from FY 2018 (1.054618). To complete the compounded
inflation adjustment for FY 2019, the FY 2018 compounded adjustment
(1.054618) is multiplied by the FY 2019 base inflation adjustment
(1.018210) to reach the applicable inflation adjustment of 1.073823
(rounded) for FY 2019. We then multiply the total revenue amount for FY
2019 ($190,654,875) by 1.073823, yielding an inflation adjusted total
revenue amount of $204,730,000 (rounded to the nearest thousand
dollars).

III. Fees for FY 2019

    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 $300,000 (premarket
application) and $4,548 (establishment registration) are to be adjusted
for FY 2019 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
1.073823 yields inflation adjusted base fees of $322,147 (premarket
application) and $4,884 (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 2019. Most of the
fee-paying submission counts are published in the MDUFA Financial
Report to Congress each year.

                              Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
        Application type            FY 2015 actual      FY 2016 actual      FY 2017 actual      3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........                  42                  37                  40                  40
    Small Business..............                   7                  10                   7                   8
Panel-Track Supplement..........                  22                  17                  27                  22
    Small Business..............                   3                   1                   2                   2
De Novo Classification Request    ..................  ..................                  24                  24
 \1\............................
    Small Business \1\..........  ..................  ..................                  31                  31
180-Day Supplements.............                 143                 116                 184                 148
    Small Business..............                  15                  16                  36                  22
Real-Time Supplements...........                 204                 179                 195                 193
    Small Business..............                  28                  27                  20                  25
510(k)s.........................               2,768               2,599               3,141               2,836
    Small Business..............               1,037               1,005               1,125               1,056

30-Day Notice...................                 920                 929               1,080                 976
    Small Business..............                  71                  76                  82                  76
513(g) (21 U.S.C. 360c(g))                        75                  68                  98                  80
 Request for Classification
 Information....................
    Small Business..............                  33                  46                  41                  40
Annual Fee for Periodic                          554                 582                 429                 522
 Reporting \2\..................
    Small Business \2\..........                  73                  75                  37                  62
Establishment Registration......              25,363              26,046              27,268              26,226
----------------------------------------------------------------------------------------------------------------
\1\ Three-year average for De Novo is based on estimate for FY 2019.
\2\ Includes collection of quarter 4 billing for FY 2017 during FY 2018.

    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 2019 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
$207,708,611, which is $2,978,611 higher than the inflation adjusted
total revenue amount. The fees in column two are those we are
establishing in FY 2019, which are the standard fees.

                           Table 4--Fees Needed to Achieve New FY 2019 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                                           FY 2019 inflation
                                                       FY 2019 statutory  adjusted statutory    FY 2019 revenue
                  Application type                     fees (base fees)        base fees      from adjusted fees
                                                                            (standard fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...............................            $300,000            $322,147         $12,885,880
    Small Business..................................              75,000              80,537             644,296
Panel-Track Supplement..............................             225,000             241,610           5,315,420
    Small Business..................................              56,250              60,403             120,806
De Novo Classification Request......................              90,000              96,644           2,319,456
    Small Business..................................              22,500              24,161             748,991
180-Day Supplements.................................              45,000              48,322           7,151,656
    Small Business..................................              11,250              12,081             265,782
Real-Time Supplements...............................              21,000              22,550           4,352,150
    Small Business..................................               5,250               5,638             140,950
510(k)s.............................................              10,200              10,953          31,062,708
    Small Business..................................               2,550               2,738           2,891,328
30-Day Notice.......................................               4,800               5,154           5,030,304
    Small Business..................................               2,400               2,577             195,852
513(g) Request for Classification Information.......               4,050               4,349             347,920
    Small Business..................................               2,025               2,175              87,000
Annual Fee for Periodic Reporting...................              10,500              11,275           5,885,550
    Small Business..................................               2,625               2,819             174,778
Establishment Registration..........................               4,548               4,884         128,087,784
                                                     -----------------------------------------------------------
    Total...........................................  ..................  ..................         207,708,611
----------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $322,147 for FY 2019. 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 $4,884 for FY 2019. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
    Table 5 summarizes the FY 2019 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2019
----------------------------------------------------------------------------------------------------------------
                                       Standard fee (as a percent of the
         Application fee type             standard fee for a premarket     FY 2019 standard      FY 2019 small
                                                  application)                    fee            business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA           Base fee specified in statute....            $322,147             $80,537
 submitted 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 (21 U.S.C. 360e(f),
 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..............................             322,147              80,537
 section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved    100..............................             322,147              80,537
 BLA under section 351 of the PHS
 Act).
Panel-track supplement...............  75...............................             241,610              60,403
De novo classification request.......  30...............................              96,644              24,161
180-day supplement...................  15...............................              48,322              12,081
Real-time supplement.................  7................................              22,550               5,638
510(k) premarket notification          3.40.............................              10,953               2,738
 submission.
30-day notice........................  1.60.............................               5,154               2,577
513(g) request for classification      1.35.............................               4,349               2,175
 information.
Annual Fee Type......................  .................................  ..................  ..................
Annual fee for periodic reporting on   3.50.............................              11,275               2,819
 a class III device.
Annual establishment registration fee  Base fee specified in statute....               4,884               4,884
 (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(13)).
----------------------------------------------------------------------------------------------------------------

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 2018, your
status as a small business will expire at the close of business on
September 30, 2018. You must re-qualify for FY 2019 in order to pay
small business fees during FY 2019.
    If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2019, 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 2018,
except:
    If you submit your MDUFA Small Business Certification Request for
FY 2019 before April 15, 2019, and you have not yet filed your return
for 2018, you may use tax year 2017.
    If you submit your MDUFA Small Business Certification Request for
FY 2019 on or after April 15, 2019, and have not yet filed your 2018
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 2019, 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 (2018 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, 2018, and September 30,
2019, you must pay the fee in effect for FY 2019. 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 2018 or FY 2019 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, 2018. One choice is for
applications and fees that will be received on or before September 30,
2018, which are subject to FY 2018 fee rates. A second choice is for
applications and fees received on or after October 1, 2018, which are
subject to FY 2019 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 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 2019 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 2019 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 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 2019, or To Register a New Establishment for
FY 2019

    Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm 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 2018.
Manufacturers of licensed biologics should register in the BER system
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
    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 protected] or call 301-
796-7400 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 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16178 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 4, 2008 (Volume 73, Number 43)]
[Rules and Regulations]
[Page 11544-11545]
[DOCID:fr04mr08-11]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0369; Directorate Identifier 2007-NM-258-AD;
Amendment 39-15402; AD 2008-05-08]
RIN 2120-AA64

Airworthiness Directives; Dassault Model Mystere-Falcon 50
Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Some occurrences have been reported where life rafts were
difficult to remove from inside divan compartment. Investigations
revealed that:

--Life raft was incorrectly stowed, with deployment straps inboard;
--Life raft had not been repacked to specified dimensions
* * * * *

    We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective April 8, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 8,
2008.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on December 20, 2007
(72 FR 72273). That NPRM proposed to correct an unsafe condition for
the specified products. The MCAI states:

    Some occurrences have been reported where life rafts were
difficult to remove from inside divan compartment. Investigations
revealed that:

--Life raft was incorrectly stowed, with deployment straps inboard;
--Life raft had not been repacked to specified dimensions

    The purpose of this Airworthiness Directive (AD) is to verify
that all life rafts are stowed correctly with deployment straps
outboard, and are repacked to specified dimensions.

    Corrective actions include correctly reinstalling an incorrectly
stowed life raft, installing a properly repacked life raft, and
installing placards. You may obtain further information by examining
the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect about 25 products of U.S.
registry. We also estimate that it will take about 1 work-hour per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Required parts will cost about $68 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $3,700, or $148 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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 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); and

    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 AD:

2008-05-08 Dassault Aviation: Amendment 39-15402. Docket No. FAA-
2007-0369; Directorate Identifier 2007-NM-258-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective April 8,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Dassault Model Mystere-Falcon 50
airplanes, certificated in any category, serial numbers 294, 299,
301 through 304, 306, 307, 310, 313, 314, 316 through 320, 322
through 331, 334 through 337 and 339.

Subject

    (d) Air Transport Association (ATA) of America Code 25:
Equipment/Furnishings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Some occurrences have been reported where life rafts were
difficult to remove from inside divan compartment. Investigations
revealed that:

--Life raft was incorrectly stowed, with deployment straps inboard;
--Life raft had not been repacked to specified dimensions.

    The purpose of this Airworthiness Directive (AD) is to verify
that all life rafts are stowed correctly with deployment straps
outboard, and are repacked to specified dimensions.
    Corrective actions include correctly reinstalling an incorrectly
stowed life raft, installing a properly repacked life raft, and
installing placards.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 10 flight cycles after the effective date of this AD:
Verify that the life rafts are stowed correctly, with deployment
straps outboard, in accordance with the instructions specified in
Dassault Service Bulletin F50-480, dated December 5, 2006, and
verify that the overall dimensions of the life raft hard pack do not
exceed nominal values, as indicated in Part F50-480-1 of the service
bulletin.
    (i) If a life raft is found incorrectly stowed, before next
flight, reinstall it in accordance with the instructions specified
in Part F50-480-1 of the service bulletin.
    (ii) If nominal values of the overall dimensions of the life
raft hard pack are exceeded, within 3 months after the effective
date of this AD, install a properly repacked life raft as instructed
in Part F50-480-2 of the service bulletin.

    Note 1: Notice that with no life raft aboard, local national
operating regulations may not allow some extended overwater flights.

    (2) Within 3 months after the effective date of this AD: Install
placards on the sofa in accordance with the instructions specified
in Part F50-480-2 of Dassault Service Bulletin F50-480, dated
December 5, 2006.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI EASA Airworthiness Directive 2006-0366, dated
December 11, 2006, and Dassault Service Bulletin F50-480, dated
December 5, 2006, for related information.

Material Incorporated by Reference

    (i) You must use Dassault Service Bulletin F50-480, dated
December 5, 2006, to do the actions required by this AD, unless the
AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, New Jersey
07606.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on February 20, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-3818 Filed 3-3-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 79 (Wednesday, April 26, 2017)]
[Rules and Regulations]
[Pages 19190-19191]
[FR Doc No: 2017-08375]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-8475]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Patricia Suber, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 400 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of

Executive Order 12866 of September 30, 1993, Regulatory Planning and
Review, 58 FR 51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
            Region V

Minnesota:
    Badger, City of, Roseau            270412  April 22, 1975,    April 19, 2017........  April 19, 2017.
     County.                                    Emerg; June 8,
                                                1984, Reg; April
                                                19, 2017, Susp..
    Chatfield, City of,                270125  April 15, 1982,    ......do..............   Do.
     Fillmore and Olmsted                       Emerg; August 2,
     Counties.                                  1982, Reg; April
                                                19, 2017, Susp..
    Dover, City of, Olmsted            270566  March 15, 1982,    ......do..............   Do.
     County.                                    Emerg; April 15,
                                                1982, Reg; April
                                                19, 2017, Susp..
    Eyota, City of, Olmsted            270329  December 3, 1981,  ......do..............   Do.
     County.                                    Emerg; December
                                                15, 1981, Reg;
                                                April 19, 2017,
                                                Susp..
    Olmsted County,                    270626  April 17, 1984,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; May 19,
                                                1981, Reg; April
                                                19, 2017, Susp..
    Oronoco, City of, Olmsted          270330  July 3, 1974,      ......do..............   Do.
     County.                                    Emerg; November
                                                4, 1981, Reg;
                                                April 19, 2017,
                                                Susp..
    Pine Island, City of,              270145  September 4,       ......do..............   Do.
     Goodhue and Olmsted                        1974, Emerg;
     Counties.                                  March 2, 1981,
                                                Reg; April 19,
                                                2017, Susp..
    Rochester, City of, Olmsted        275246  April 3, 1970,     ......do..............   Do.
     County.                                    Emerg; March 26,
                                                1971, Reg; April
                                                19, 2017, Susp..
    Roseau, City of, Roseau            270414  April 26, 1974,    ......do..............   Do.
     County.                                    Emerg; September
                                                29, 1978, Reg;
                                                April 19, 2017,
                                                Susp..
    Roseau County,                     270633  April 26, 1974,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; January
                                                2, 1980, Reg;
                                                April 19, 2017,
                                                Susp..
    Stewartville, City of,             270332  May 7, 1975,       ......do..............   Do.
     Olmsted County.                            Emerg; September
                                                2, 1982, Reg;
                                                April 19, 2017,
                                                Susp..
    Warroad, City of, Lake Of          270415  July 3, 1974,      ......do..............   Do.
     The Woods and Roseau                       Emerg; December
     Counties.                                  4, 1979, Reg;
                                                April 19, 2017,
                                                Susp..

           Region VI

Louisiana:
    Baldwin, Town of, St. Mary         220193  April 23, 1973,    ......do..............   Do.
     Parish.                                    Emerg; December
                                                15, 1978, Reg;
                                                April 19, 2017,
                                                Susp..
    St. Mary Parish,                   220192  April 6, 1973,     ......do..............   Do.
     Unincorporated Areas.                      Emerg; September
                                                3, 1980, Reg;
                                                April 19, 2017,
                                                Susp..
----------------------------------------------------------------------------------------------------------------
-do- =Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: April 13, 2017.
Michael M. Grimm,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration, Department of Homeland Security, Federal
Emergency Management Agency.
[FR Doc. 2017-08375 Filed 4-25-17; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: June 20, 2008 (Volume 73, Number 120)]
[Notices]
[Page 35147-35148]
[DOCID:fr20jn08-71]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1766-DR]

Indiana; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-1766-DR), dated June 8, 2008, and
related determinations.

DATES: Effective Date: June 11, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of June 8, 2008.

    Bartholomew, Johnson, Monroe, Morgan, Vermillion, and Vigo
Counties for Individual Assistance (already designated for emergency
protective measures [Category B], limited to direct Federal
assistance, under the Public Assistance program.)

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-13942 Filed 6-19-08; 8:45 am]

BILLING CODE 9110-10-P