File name: CPI. xls Date updated: 12/ 27/ 2005 Worksheet CPI Description Contains consumer price index data from the U. S. Bureau of Labor Statistics. Consumer Price Index  All Urban Consumers Source: http:// data. bls. gov/ cgi bin/ surveymost? cu updated 12/ 27/ 05 Series Id: CUUR0000AA0 Not Seasonally Adjusted Area: U. S. city average Item: All items  old base Base Period: 1967= 100 Year Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 1960 87.9 88 88 88.5 88.5 88.7 88.7 88.7 88.8 89.2 89.3 89.3 1961 89.3 89.3 89.3 89.3 89.3 89.4 89.8 89.7 89.9 89.9 89.9 89.9 1962 89.9 90.1 90.3 90.5 90.5 90.5 90.7 90.7 91.2 91.1 91.1 91 1963 91.1 91.2 91.3 91.3 91.3 91.7 92.1 92.1 92.1 92.2 92.3 92.5 1964 92.6 92.5 92.6 92.7 92.7 92.9 93.1 93 93.2 93.3 93.5 93.6 1965 93.6 93.6 93.7 94 94.2 94.7 94.8 94.6 94.8 94.9 95.1 95.4 1966 95.4 96 96.3 96.7 96.8 97.1 97.4 97.9 98.1 98.5 98.5 98.6 1967 98.6 98.7 98.9 99.1 99.4 99.7 100.2 100.5 100.7 101 101.3 101.6 1968 102 102.3 102.8 103.1 103.4 104 104.5 104.8 105.1 105.7 106.1 106.4 1969 106.7 107.1 108 108.7 109 109.7 110.2 110.7 111.2 111.6 112.2 112.9 1970 113.3 113.9 114.5 115.2 115.7 116.3 116.7 116.9 117.5 118.1 118.5 119.1 1971 119.2 119.4 119.8 120.2 120.8 121.5 121.8 122.1 122.2 122.4 122.6 123.1 1972 123.2 123.8 124 124.3 124.7 125 125.5 125.7 126.2 126.6 126.9 127.3 1973 127.7 128.6 129.8 130.7 131.5 132.4 132.7 135.1 135.5 136.6 137.6 138.5 1974 139.7 141.5 143.1 143.9 145.5 146.9 148 149.9 151.7 153 154.3 155.4 1975 156.1 157.2 157.8 158.6 159.3 160.6 162.3 162.8 163.6 164.6 165.6 166.3 1976 166.7 167.1 167.5 168.2 169.2 170.1 171.1 171.9 172.6 173.3 173.8 174.3 1977 175.3 177.1 178.2 179.6 180.6 181.8 182.6 183.3 184 184.5 185.4 186.1 1978 187.2 188.4 189.8 191.5 193.3 195.3 196.7 197.8 199.3 200.9 202 202.9 1979 204.7 207.1 209.1 211.5 214.1 216.6 218.9 221.1 223.4 225.4 227.5 229.9 1980 233.2 236.4 239.8 242.5 244.9 247.6 247.8 249.4 251.7 253.9 256.2 258.4 1981 260.5 263.2 265.1 266.8 269 271.3 274.4 276.5 279.3 279.9 280.7 281.5 1982 282.5 283.4 283.1 284.3 287.1 290.6 292.2 292.8 293.3 294.1 293.6 292.4 1983 293.1 293.2 293.4 295.5 297.1 298.1 299.3 300.3 301.8 302.6 303.1 303.5 1984 305.2 306.6 307.3 308.8 309.7 310.7 311.7 313 314.5 315.3 315.3 315.5 1985 316.1 317.4 318.8 320.1 321.3 322.3 322.8 323.5 324.5 325.5 326.6 327.4 1986 328.4 327.5 326 325.3 326.3 327.9 328 328.6 330.2 330.5 330.8 331.1 1987 333.1 334.4 335.9 337.7 338.7 340.1 340.8 342.7 344.4 345.3 345.8 345.7 1988 346.7 347.4 349 350.8 352 353.5 354.9 356.6 358.9 360.1 360.5 360.9 1989 362.7 364.1 366.2 368.8 370.8 371.7 372.7 373.1 374.6 376.2 377 377.6 1990 381.5 383.3 385.5 386.2 386.9 389.1 390.7 394.1 397.5 400 400.7 400.9 1991 403.1 403.8 404.3 405.1 406.3 407.3 408 409.2 411.1 411.5 412.7 413 1992 413.8 415.2 417.2 417.9 418.6 419.9 420.8 422 423.2 424.7 425.3 425.2 1993 427 428.7 430.1 431.2 432 432.4 432.6 433.9 434.7 436.4 436.9 436.8 1994 437.8 439.3 441.1 441.4 441.9 443.3 444.4 446.4 447.5 448 448.6 448.4 1995 450.3 452 453.5 455 455.8 456.7 457 458 459 460.3 460.1 459.9 1996 462.5 464.2 466.5 468.2 469 469.5 470.4 471.1 472.7 474.1 475 475 1997 476.7 478.2 479.3 479.7 479.6 480.2 480.7 481.6 483 484.1 483.9 483.2 1998 484.2 484.9 485.8 486.8 487.7 488.2 488.8 489.6 490.1 491.3 491.3 491 1999 492.3 492.9 494.4 497.8 497.7 497.9 499.2 500.7 502.9 503.9 504.1 504.1 2000 505.8 508.7 512.8 513.2 513.6 516.5 517.5 517.6 520.3 521.2 521.5 521.1 2001 524.5 526.7 528 529.9 532.2 533.3 531.6 531.8 534 532.2 531.3 529.2 2002 530.6 532.7 535.5 538.6 538.5 538.9 539.5 541.2 542.1 543.2 543.1 541.9 2003 544.2 548.5 551.8 550.5 549.7 550.4 550.9 553 554.7 554.3 552.7 552.1 2004 554.9 557.9 561.5 563.2 566.4 568.2 567.5 567.6 568.7 571.9 572.2 570.1 2005 571.2 574.5 579 582.9 582.4 582.6 585.2 588.2 595.4 596.7 592 To convert June 2003$ to 2004$ To convert nominal $$ into 2004 $$, multiply by this factor:

Annual HALF 1 HALF 2 Conversion Factor 88.7 6.38 89.6 6.31 90.6 6.25 91.7 6.17 92.9 6.09 94.5 5.99 97.2 5.82 100 5.66 104.2 5.43 109.8 5.15 116.3 4.87 121.3 4.66 125.3 4.52 133.1 4.25 147.7 3.83 161.2 3.51 170.5 3.32 181.5 3.12 195.4 2.90 217.4 2.60 246.8 2.29 272.4 2.08 289.1 1.96 298.4 1.90 311.1 308.1 314.2 1.82 322.2 319.3 325.1 1.76 328.4 326.9 329.9 1.72 340.4 336.7 344.1 1.66 354.3 349.9 358.7 1.60 371.3 367.4 375.2 1.52 391.4 385.4 397.3 1.45 408 405 410.9 1.39 420.3 417.1 423.5 1.35 432.7 430.2 435.2 1.31 444 440.8 447.2 1.27 456.5 453.9 459.1 1.24 469.9 466.7 473.1 1.20 480.8 479 482.8 1.18 488.3 486.3 490.4 1.16 499 495.5 502.5 1.13 515.8 511.8 519.9 1.10 530.4 529.1 531.7 1.07 538.8 535.8 541.8 1.05011 551.1 549.2 553 1.02667 565.8 562 569.7 1.00 578.8 # DIV/ 0!

4$, multiply by this factor: 1.027980 106.5232 353828.7


[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Rules and Regulations]
[Pages 3739-3740]
[FR Doc No: 2014-01216]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2013-N-1662]

Medical Devices; Immunology and Microbiology Devices;
Classification of John Cunningham Virus Serological Reagents

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying John
Cunningham Virus (JCV) serological reagents into class II (special
controls). The Agency is classifying the device into class II (special
controls) in order to provide a reasonable assurance of safety and
effectiveness of the device.

DATES: This order is effective February 24, 2014. The classification
was effective January 20, 2012.

FOR FURTHER INFORMATION CONTACT: Haja Sittana El Mubarak, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 5519, Silver Spring, MD 20993-0002,
301-796-6193.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act provided a procedure by which a
person may request that FDA classify a device under the criteria set
forth in section 513(a)(1). The person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
In response to a request to classify a device under the procedure
provided by section 513(f)(2) of the FD&C Act, FDA will classify the
device by written order within 60 days. This classification will be the
initial classification of the device. Within 30 days after the issuance
of an order classifying the device, FDA must publish a notice in the
Federal Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on December 22, 2011, classifying the STRATIFY JCVTM
antibody enzyme-linked immunosorbent assay (ELISA) into class III
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On January 5, 2012,
Focus Diagnostics, Inc., submitted a request for de novo classification
of the STRATIFY JCVTM antibody ELISA under section 513(f)(2)
of the FD&C Act. The manufacturer recommended that the device be
classified into class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request for de novo classification in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act. FDA classifies devices into class II if general controls
by themselves are insufficient to provide reasonable assurance of
safety and effectiveness, but there is sufficient information to
establish special controls to provide reasonable assurance of the
safety and effectiveness of the device for its intended use. After
review of the information submitted in the request, FDA determined that
the device can be classified into class II with the establishment of
special controls. FDA believes these special controls will provide
reasonable assurance of the safety and effectiveness of the device.
    The device is assigned the generic name John Cunningham Virus
serological reagents, which are devices that consist of antigens and
antisera used in serological assays to identify antibodies to JCV in
serum and plasma. The identification aids in the risk stratification
for the development of progressive multifocal leukoencephalopathy in
multiple sclerosis and Crohn's disease patients undergoing natalizumab
therapy. These devices are for adjunctive use, in the context of other
clinical risk factors for the development of progressive multifocal
leukoencephalopathy.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

       Table 1--Identified Risks to Health and Mitigation Measures
------------------------------------------------------------------------
        Identified risks to health               Mitigation measures
------------------------------------------------------------------------
False positive results....................  Device Description
                                            Performance.
False negative results....................  Device Description
                                            Performance.

Failure to perform as indicated or an       Labeling.
 error in the interpretation of the
 results.
------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline: John
Cunningham Virus Serological Reagents'' are necessary, in addition to
general controls, to mitigate the risks to health described in table 1.
    Therefore, on January 20, 2012, FDA issued an order to the
petitioner classifying JCV serological reagents into class II. FDA is
codifying this device type by adding 21 CFR 866.3336.

II. 510(k) Premarket Notification

    Following the effective date of this final classification order,
any firm submitting a 510(k) premarket notification for this device
type will need to comply with the special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this type of device is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the JCV serological
reagents they intend to market.

III. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 801 and 21 CFR 809.10
have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 866.3336 is added to subpart D to read as follows:

Sec.  866.3336  John Cunningham Virus serological reagents.

    (a) Identification. John Cunningham Virus serological reagents are
devices that consist of antigens and antisera used in serological
assays to identify antibodies to John Cunningham Virus in serum and
plasma. The identification aids in the risk stratification for the
development of progressive multifocal leukoencephalopathy in multiple
sclerosis and Crohn's disease patients undergoing natalizumab therapy.
These devices are for adjunctive use, in the context of other clinical
risk factors for the development of progressive multifocal
leukoencephalopathy.
    (b) Classification. Class II (special controls). The special
control for this device is the FDA guideline document entitled ``Class
II Special Controls Guideline: John Cunningham Virus Serological
Reagents.'' For availability of the guideline document, see Sec.
866.1(e).

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01216 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Notices]
[Pages 42807-42809]
[FR Doc No: 2013-17097]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69974; File No. SR-NYSEMKT-2013-55]

 Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Its Price
List To Change the Monthly Fees for the Use of Certain Ports

July 11, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on June 28, 2013, NYSE MKT LLC (the ``Exchange'' or ``NYSE MKT'')
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 by the Exchange. 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).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its Price List to change the monthly
fees for the use of certain ports. The Exchange proposes to implement
the fee changes on July 1, 2013. The text of the proposed rule change
is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend its Price List to change the monthly
fees for the use of certain ports.\3\ The Exchange proposes to
implement the fee changes on July 1, 2013.\4\
---------------------------------------------------------------------------

    \3\ The Exchange has a Common Customer Gateway (``CCG'') that
accesses the equity trading systems that it shares with its
affiliates, New York Stock Exchange LLC (``NYSE'') and NYSE Arca,
Inc. (``NYSE Arca''), and all ports connect to the CCG. See, e.g.,
Securities Exchange Act Release No. 64543 (May 25, 2011), 76 FR
31667 (June 1, 2011) (SR-NYSEAmex-2011-20). All NYSE MKT member
organizations are also NYSE member organizations and, accordingly, a
member organization utilizes its ports for activity on both NYSE
and/or NYSE MKT and is charged port fees based on the total number
of ports connected to the CCG, whether the ports are used to quote
and trade on NYSE, NYSE MKT, and/or both, because those trading
systems are integrated. The NYSE Arca trading platform is not
integrated in the same manner. Therefore, it does not share its
ports with NYSE or NYSE MKT.
    \4\ The Exchange notes that billing for ports is based on the
number of ports on the third business day prior to the end of the
month. In addition, the level of activity with respect to a
particular port does not affect the assessment of monthly fees, such
that, except for ports that are not charged, even if a particular
port is not used, a port fee still applies.
---------------------------------------------------------------------------

    The Exchange currently makes ports available that provide
connectivity to the Exchange's trading systems (i.e., ports for entry
of orders and/or quotes (``order/quote entry ports'')) and charges $200
per port per month.\5\ The Exchange proposes that the $200 fee per port
per month would apply to users with five or fewer order/quote entry
ports and that the fee for users with more than five order/quote entry
ports would be $500 per port per month, including for the

first five ports.\6\ The Exchange is proposing this change in order to
permit the Exchange to offset, in part, its infrastructure costs
associated with making such ports available. The proposed change would
also encourage users to become more efficient with, and reduce the
number of, their order/quote ports, thereby resulting in a
corresponding increase in the efficiency that the Exchange would be
able to realize with respect to managing its own infrastructure. In
this regard, as users decrease the number of order/quote ports that
they utilize, the Exchange would similarly be able to decrease the
amount of its hardware that it is required to support to interface
[sic] with such ports.
---------------------------------------------------------------------------

    \5\ The Price List provides that (i) users of the Exchange's
Risk Management Gateway service (``RMG'') are not charged for order/
quote entry ports if such ports are designated as being used for RMG
purposes, and (ii) Designated Market Makers (``DMMs'') are not
charged for order/quote entry ports that connect to the Exchange via
the DMM Gateway. See Securities Exchange Act Release No. 68261
(November 19, 2012), 77 FR 70522 (November 26, 2012) (SR-NYSEMKT-
2012-64). Two methods are available to DMMs to connect to the
Exchange: DMM Gateway and CCG. The two methods are quite distinct,
however. Only DMMs may utilize the DMM Gateway, and they may only
use DMM Gateway when acting in their capacity as a DMM. DMMs are
required to use the DMM Gateway for certain DMM-specific functions
that relate to the DMM's role on the Exchange and the obligations
attendant therewith, which are not applicable to other market
participants on the Exchange. By contrast, non-DMMs as well as DMMs
may use the CCG, use of the CCG by a DMM is optional, and a DMM that
connects to the Exchange via CCG can use the relevant order/quote
entry port for orders and quotes both in its capacity as a DMM and
for orders and quotes in other securities. Accordingly, because DMMs
are required to utilize DMM Gateway, but not CCG, to be able to
fulfill their functions as DMMs, DMMs are not charged for order/
quote entry ports that connect to the Exchange via the DMM Gateway,
but DMMs, like other market participants, are charged for order/
entry ports that connect to the Exchange via the CCG. DMMs can elect
to use the DMM Gateway, the CCG, or both for their connectivity to
the Exchange. However, the DMM Gateway must be used for certain DMM-
specific functions that relate to the DMM's role on the Exchange and
the obligations attendant therewith.
    \6\ For example, a user with five ports would be charged $200
per port per month for a total of $1,000 per month for all five
ports. A user with six ports would be charged $500 per port per
month, including for the first five ports, for a total of $3,000 per
month for all six ports.
---------------------------------------------------------------------------

    The Exchange notes that the proposed change is not otherwise
intended to address any other issues, and the Exchange is not aware of
any problems that member organizations would have in complying with the
proposed change.
    The Exchange believes that it is subject to significant competitive
forces, as described below in the Exchange's statement regarding the
burden on competition.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Sections 6(b)(4) and 6(b)(5) of the Act,\8\ in
particular, because it provides for the equitable allocation of
reasonable dues, fees, and other charges among its members, issuers and
other persons using its facilities and does not unfairly discriminate
between customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed change to the monthly rates
is reasonable because the fees charged for order/quote entry ports are
expected to permit the Exchange to offset, in part, its infrastructure
costs associated with making such ports available, including costs
based on gateway software and hardware enhancements and resources
dedicated to gateway development, quality assurance, and support. In
this regard, the Exchange believes that the proposed fees are
competitive with those charged by other exchanges.\9\ The proposed
change is also reasonable because the proposed per port rates would
encourage users to become more efficient with, and reduce the number
of, ports used for order/quote entry, thereby resulting in a
corresponding increase in the efficiency that the Exchange would be
able to realize with respect to managing its own infrastructure.
---------------------------------------------------------------------------

    \9\ For example, the charge on the NASDAQ Stock Market LLC
(``NASDAQ'') for a FIX Trading Port is $500 per port per month. See
Nasdaq Rule 7015. A separate charge for Pre-Trade Risk Management
ports also is applicable, which ranges from $400 to $600 and is
capped at $25,000 per firm per month. See Nasdaq Rule 7016. EDGA
Exchange, Inc. (``EDGA'') and EDGX Exchange, Inc. (``EDGX'') also
each charge $500 per port per month.
---------------------------------------------------------------------------

    The Exchange also believes that these changes to the fees are
equitable and not unfairly discriminatory because they would apply to
all users of order/quote entry ports on the Exchange, subject to the
exceptions noted above.\10\ The Exchange also believes that it is
equitable and not unfairly discriminatory to charge a higher fee to
users with more than five order/quote entry ports, as compared to users
with five or fewer order/quote entry ports, because the Exchange
believes that users with more than five order/quote entry ports would
be incentivized to become more efficient with their utilization of
ports.\11\
---------------------------------------------------------------------------

    \10\ See supra note 4.
    \11\ The Exchange also notes that at least one of its
competitors charges different rates depending on the number of ports
utilized. Specifically, EDGA and EDGX each provide the first five
ports for free.
---------------------------------------------------------------------------

    The Exchange has considered multiple factors in proposing the
tiered approach to order/quote entry port pricing, including that the
fee increase would occur once a user has more than five order/quote
entry ports. The Exchange believes that this approach to pricing is
equitable and not unfairly discriminatory, including for the following
reasons. Specifically, the Exchange believes that there is a
correlation between the number of order/quote entry ports utilized by
users and the level of trading volume sent to the Exchange by such
users, such that a user with significant trading activity sent to the
Exchange likely utilizes a greater number of order/quote entry ports
than a user with minimal trading activity sent to the Exchange.
However, despite this correlation, and regardless of the amount of
activity a user sends to the Exchange via its order/quote entry ports,
or the size of the firm, every user that connects its systems to the
Exchange's trading systems requires at least one port for order/quote
entry. Many users also maintain a certain number of additional order/
quote entry ports for redundancy and/or hardware configuration
purposes. These users have a limited opportunity to become more
efficient with their use of ports. Accordingly, the Exchange believes
that five is a reasonable number of ports that would permit a user that
sends a lesser amount of trading activity to the Exchange to manage its
ports in such a way that it could sufficiently address these redundancy
and configuration concerns without crossing the threshold for which
higher fees apply.
    In this regard, the Exchange anticipates that, as a result of the
proposed increase of the order/quote entry port fee under the tiered
structure, users would become more efficient with their utilization of
order/quote entry ports and would decrease the number of order/quote
entry ports so as to qualify for the $200 rate per port. Such a
decrease in order/quote entry port use would result in a corresponding
decrease in the infrastructure that the Exchange is required to support
for connectivity to its trading systems and a decrease in the costs
related thereto.
    For the reasons above, the Exchange believes that the proposal is
consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\12\ the Exchange
does not believe that the proposed rule change will impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. Instead, the Exchange believes that the
proposed change will permit the Exchange to set fees for ports that are
competitive with those charged by other exchanges.\13\ Moreover, the
Exchange believes that charging different rates for users with five or
fewer order/quote entry ports as compared to users with more than five
ports would not impose any burden on competition that is not necessary
or appropriate in furtherance of the purposes of the Act because the
Exchange believes that a reduction in the number of order/quote entry
ports would result in a decrease in the infrastructure that the
Exchange is required to support for connectivity to its trading
systems. This would also provide incentive for users to become more
efficient with their use of ports and could therefore result in such
users becoming more competitive due to decreased costs. In this regard,
the Exchange notes that at least one of the Exchange's competitors
charges different rates depending on the number of ports utilized.\14\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(8).
    \13\ See supra note 8.
    \14\ See supra note 10.

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

    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive. In such an environment, the Exchange must continually
review, and consider adjusting, its fees and credits to remain
competitive with other exchanges. For the reasons described above, the
Exchange believes that the proposed rule change reflects this
competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \15\ of the Act and subparagraph (f)(2) of Rule
19b-4 \16\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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 email to<EMAIL_ADDRESS>Please
include File Number SR-NYSEMKT-2013-55 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2013-55. This
file number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. 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-NYSEMKT-2013-55 and should
be submitted on or before August 7, 2013.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-17097 Filed 7-16-13; 8:45 am]
BILLING CODE 8011-01-P


% Gender neutral or male specific values, except for female BTW and fat available
% Set sex=1 to access female parameters

SPECIES=1;
SEX=0;
PREG=0;
GDSTART=1;
PAFC=1;

%BWT and Volume fat specific to women
% Gompertz BWT Parameters (Luecke 2007)
% set Female BWT Parameters
B1=3.4;B2=2.07402;B3=1.504154;B5=34.8806;B6=0.2120837;B7=0.443786;
B4=2.672665;B8=0.31127;
AGE1=2.949004;AGE2=11;AGE3=21.86533;
BWSW=1; %Switch for age (set =0) or set (set =1) determination of BW
BWST=68; %Set value of BW (kg) Np=68, 1ST TRIMESTER=74, 3RD TRIMESTER=77
% set Female VFCb
VF6=-1.273e-30;VF5=7.249e-25;VF4=-1.558e-19;VF3=1.540e-14;VF2=-6.787e-10;
VF1=1.401e-05;VF0=9.217e-02;

% Constant organ volumes
VBMC=0.021;	% Brown 1997 (red only, yellow is in adipose)
VDC=0.0003;
VPC=0.00148; 	% Young 2009, Brown 1997
VINTC=0.0091;	% Just small intestine (Brown 1997)

% HCT
HCTN=0.40; 	% 0.43 women, 0.47 men (Bresarb 1998); 40 from Abdjljalil et al

% Partitioning Coef. (Lowe 2009)
% CPF
PPLA=83; %PLACENTA =1/3 fat - placenta/fetus could include some bound CPF?
PAFC=19;
% CPF-oxon
PPLAO=11.2; %PLACENTA =2xrapid
VVOL=0.075;  %ml/hr urine production in women

start @nocallback


[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45463-45465]
[DOCID:fr05au08-69]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0396]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex on
Microbiological Examination of Non-Sterile Products: Microbial
Enumeration Tests General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 4A: Microbiological Examination of Non-Sterile Products:
Microbial Enumeration Tests General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results

of the ICH Q4B evaluation of the Microbiological Examination of Non-
Sterile Products: Microbial Enumeration Tests General Chapter
harmonized text from each of the three pharmacopoeias (United States,
European, and Japanese) represented by the Pharmacopoeial Discussion
Group (PDG). The draft guidance conveys recognition of the three
pharmacopoeial methods by the three ICH regulatory regions and provides
specific information regarding the recognition. The draft guidance is
intended to recognize the interchangeability between the local regional
pharmacopoeias, thus avoiding redundant testing in favor of a common
testing strategy in each regulatory region. This draft guidance is part
A of the fourth annex to the core Q4B guidance, which was made
available in the Federal Register of February 21, 2008 (73 FR 9575).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 6, 2008.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or<PHONE_NUMBER>. Send two self-addressed adhesive labels to assist the
office in processing your requests. Submit written comments on the
draft guidance 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
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
    Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-1), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In June 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination
of Non-Sterile Products: Microbial Enumeration Tests General Chapter''
should be made available for public comment. The draft guidance is the
product of the Q4B Expert Working Group of the ICH. Comments about this
draft will be considered by FDA and the Q4B Expert Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Microbiological Examination of Non-Sterile
Products: Microbial Enumeration Tests General Chapter harmonization
proposal originating from the three-party PDG. This draft guidance is
in the form of an annex to the core ICH Q4B guidance. Once finalized,
the annex will provide guidance to assist industry and regulators in
the implementation of the specific topic evaluated by the ICH Q4B
process.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
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.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,

or http://www.fda.gov/cber/guidelines.htm.

    Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17862 Filed 8-4-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Proposed Rules]
[Pages 33916-33918]
[FR Doc No: 2021-13636]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0214; Project Identifier 2018-CE-064-AD]
RIN 2120-AA64

Airworthiness Directives; Viking Aircraft Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Viking Air Limited Model DHC-3 airplanes. This proposed AD was
prompted by 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 identifies
the unsafe condition as fatigue damage of the wing strut lug fitting
components and the fuselage to wing strut attachment (tie-bar). This
proposed AD would require determining service life limits for the wing
strut fitting on the main spar and for the tie-bar and following
instructions for removal and replacement of affected parts. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 12,
2021.

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 https://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 Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Viking Air
Limited Technical Support, 1959 De Havilland Way, Sidney, British
Columbia, Canada, V8L 5V5; phone: (North America)<PHONE_NUMBER>; fax:
(250) 656-0673; email<EMAIL_ADDRESS>website:
https://www.vikingair.com/support/service-bulletins. You may view this
service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0214; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Aziz Ahmed, Aviation Safety Engineer,
New York ACO Branch, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0214; Project Identifier
2018-CE-064-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Aziz
Ahmed, Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    Transport Canada, which is the aviation authority for Canada, has
issued AD Number CF-2017-29, dated August 24, 2017 (referred to after
this as ``the MCAI''), to correct an unsafe condition for Viking Air
Limited Model DHC-3 airplanes. The MCAI states:

    It has been determined that the current maintenance program does
not adequately address potential fatigue damage of the wing strut
lug fitting components or the fuselage to wing strut attachment (Tie
Bar). Affected parts must be replaced before specified air time
limits are reached to avoid fatigue cracking of the affected parts.
Cracking which is not detected may compromise the structural
integrity of the wing or the Tie-Bar.
    Fatigue damage occurs more rapidly on aeroplanes that are
operated at higher gross weights. For that reason, the corrective
actions of this [Transport Canada] AD must be accomplished sooner
for aeroplanes that have been certified for operation at higher
gross weights.
    Fatigue damage also occurs more rapidly on aeroplanes that are
operated below 2000 feet above ground level (AGL) over land due to
higher and more frequent gust and maneuvering loads. Low level
flights over water are not known to produce increased fatigue damage
on the DHC-3. For that reason, the corrective actions of this
[Transport Canada] AD must be accomplished sooner for aeroplanes
that have been operated at low altitudes over land.

    This condition, if not addressed, could result in cracking and
failure of the structural integrity of the wing or the tie-bar.
    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0214.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Viking Air Limited DHC-3 Otter Service Bulletin
Number V3/0008, Revision NC, dated February 9, 2017. The service
information specifies determining service life limits for the wing
strut fitting on the main spar and for the tie-bar, and contains
instructions for removal and replacement. De Havilland Aircraft of
Canada has issued DHC-3 Otter Service Bulletin Number 3/37, Revision B,
dated October 8, 1982. The service information specifies instructions
for removal and replacement of the Fuselage to Wing Strut Attachment
Tie-Bar. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

FAA's Determination

    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 this State of Design Authority, it has
notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is issuing this NPRM
after determining the unsafe condition described previously is likely
to exist or develop on other products of the same type design.

Proposed AD Requirements in This NPRM

    This AD requires accomplishing the actions specified in the service
information already described.

Differences Between This Proposed AD and the MCAI

    The MCAI requires calculating the compliance time by using a
formula and estimating the altitudes at which an airplane has operated.
The MCAI also instructs operators to assume operations below 2,000 feet
AGL when the operating altitude of the airplane is unknown. Because the
FAA has no regulatory requirement for owners or operators to record or
maintain the operating altitude history of an aircraft, this proposed
AD would require calculating the compliance time by assuming all
operations occurred below 2,000 feel AGL.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 41 airplanes of U.S. registry.
    The FAA also estimates that it would take about 300 work-hours per
airplane to replace both the wing strut fitting and the tie-bar. The
average labor rate is $85 per work-hour. Required parts would cost
about $5,599 per airplane.
    Based on these figures, the FAA estimates the cost of the proposed
AD on U.S. operators to be $1,275,059 or $31,099 per airplane.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The 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:

Viking Air Limited: Docket No. FAA-2021-0214; Project Identifier
2018-CE-064-AD.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 12, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Viking Air Limited Model DHC-3 airplanes, all
serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 5700, Wings.

(e) Unsafe Condition

    This AD was prompted by 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 fatigue damage
of the wing strut lug fitting components or the fuselage to wing
strut attachment (tie-bar). The FAA is issuing this AD to identify
and correct potential fatigue damage of the wing strut lug fitting
components of the fuselage to wing strut attachment. The unsafe
condition, if not addressed, could result in cracking and failure of
the structural integrity of the wing or the tie-bar.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (3):
    (1) For all airplanes: Within 3 months after the effective date
of this AD, determine and record the number of equivalent air time
hours on each wing and tie-bar by doubling the total hours time-in-
service (TIS) accumulated on each part. If the total hours TIS of a
tie-bar is unknown or cannot be determined, use the total hours TIS
of the wing strut lug fitting on the main spar.
    (2) For airplanes with a maximum certificated gross weight that
has never exceeded 8,000 pounds: Remove from service each left and
right hand wing strut fitting and tie-bar by following the
Accomplishment Instructions in Viking Air Limited SB V3/0008,
Revision NC, dated February 9, 2017, and the Replacement section of
the Accomplishment instructions in De Havilland Aircraft of Canada
DHC-3 Otter Service Bulletin Number 3/37, Revision B, dated October
8, 1982, at whichever of the following compliance time that occurs
later:

    (i) Before the part accumulates 40,000 equivalent air time
hours, or
    (ii) Within 12 months after the effective date of this AD.
    (3) For airplanes with a maximum certificated gross weight that
has ever exceeded 8,000 pounds: Remove from service each left and
right hand wing strut fitting and tie-bar by following the
Accomplishment Instructions in Viking Air Limited SB V3/0008,
Revision NC, dated February 9, 2017, and the Replacement section of
the Accomplishment instructions in De Havilland Aircraft of Canada
DHC-3 Otter Service Bulletin Number 3/37, Revision B, dated October
8, 1982, at whichever of the following compliance time that occurs
later:
    (i) Before the part accumulates 32,200 equivalent air time
hours, or
    (ii) Within 12 months after the effective date of this AD.

(g) Alternative Methods of Compliance (AMOCs)

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

(h) Related Information

    (1) For more information about this AD, contact Aziz Ahmed,
Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; phone:<PHONE_NUMBER>; fax:
(516) 794-5531; email<EMAIL_ADDRESS>    (2) Refer to Transport Canada AD Number CF-2017-29, dated August
24, 2017, for more information. You may examine the Transport Canada
AD in the AD docket at https://www.regulations.gov by searching for
and locating it in Docket No. FAA-2021-0214.
    (3) For service information identified in this AD, contact
Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney,
British Columbia, Canada, V8L 5V5; phone: (North America) (800) 663-
8444; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
website: https://www.vikingair.com/support/service-bulletins. You
may view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust, Kansas City, MO
64106. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued on June 21, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-13636 Filed 6-25-21; 8:45 am]
BILLING CODE 4910-13-P