[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19735-19737]
[FR Doc No: 2017-08582]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1551]

Determination That DEMEROL (Meperidine Hydrochloride) Injectable
and Other Drug Products Were Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements. Through this notice, FDA is hoping to
stimulate the economy and increase the regulatory certainty with
respect to generic versions of these drug products by confirming that
generic versions of the subject drug products may continue to be
marketed.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or

effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
    Application No.         Drug name       ingredient(s)      Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 005010............  DEMEROL.........  Meperidine        50 milligrams     Syrup; Oral.....  U.S.
                                           Hydrochloride.    (mg)/5                              Pharmaceutical
                                                             milliliter (mL).                    Holdings II,
                                                                                LLC.
NDA 006035............  METHERGINE......  Methylergonovine  0.2 mg..........  Tablet; Oral....  Edison
                                           Maleate.                                              Therapeutics
                                                                                LLC.
NDA 007337............  PERCODAN and      Aspirin,          325 mg, 4.5 mg,   Tablet; Oral....  Endo
                         PERCODAN-DEMI.    Oxycodone         0.38 mg; and                        Pharmaceuticals
                                           Hydrochloride,    325 mg, 2.25                        Inc.
                                           Oxycodone         mg, 0.19 mg.
                                           Terephthalate.
NDA 008720............  LEVO-DROMORAN...  Levorphanol       2 mg............  Tablet; Oral....  Valeant
                                           Tartrate.                                             Pharmaceuticals
                                                                                North America
                                                                                LLC.
NDA 008848............  PAMINE and        Methscopolamine   2.5 mg and 5 mg.  Tablet; Oral....  Fougera
                         PAMINE FORTE.     Bromide.                                              Pharmaceuticals
                                                                                Inc.
NDA 009470............  XYLOCAINE         Lidocaine         2%..............  Solution; Oral..  Fresenius Kabi
                         VISCOUS.          Hydrochloride.                                        USA, LLC.
NDA 010485............  ATARAX..........  Hydroxyzine       10 mg/5 mL......  Syrup; Oral.....  Pfizer Inc.
                                           Hydrochloride.
NDA 010742............  COMPAZINE.......  Prochlorperazine  Equivalent to     Injectable;       GlaxoSmithKline.
                                           Edisylate.        (EQ) 5 mg Base/   Injection.
                                                             mL.
NDA 012111............  MYDRIACYL.......  Tropicamide.....  0.5%; 1%........  Solution/Drops;   Alcon
                                                                               Ophthalmic.       Laboratories
                                                                                Inc.
NDA 012248............  PLEGINE.........  Phendimetrazine   35 mg...........  Tablet; Oral....  Wyeth Ayerst
                                           Tartrate.                                             Laboratories.
NDA 012365............  SOMA COMPOUND...  Aspirin;          325 mg; 200 mg..  Tablet; Oral....  Meda
                                           Carisoprodol.                                         Pharmaceuticals
                                                                                Inc.
NDA 012366............  SOMA COMPOUND W/  Aspirin;          325 mg; 200 mg;   Tablet; Oral....  Ditto.
                         CODEINE.          Carisoprodol;     16 mg.
                                           Codeine
                                           Phosphate.
NDA 016012............  VIVACTIL........  Protriptyline     5 mg; 10 mg.....  Tablet; Oral....  Teva Women's
                                           Hydrochloride.                                        Health, Inc.
NDA 017352............  FASTIN..........  Phentermine       30 mg...........  Capsule; Oral...  GlaxoSmithKline.
                                           Hydrochloride.
NDA 017690............  IMODIUM.........  Loperamide        2 mg............  Capsule; Oral...  Johnson &
                                           Hydrochloride.                                        Johnson
                                                                                Consumer Inc.
NDA 017694............  IMODIUM.........  Loperamide        2 mg............  Capsule; Oral...  Ditto.
                                           Hydrochloride.
NDA 017741............  FLORONE.........  Diflorasone       0.05%...........  Cream; Topical..  Pharmacia and
                                           Diacetate.                                            Upjohn Co.
NDA 017802............  LO/OVRAL-28.....  Ethinyl           0.03 mg; 0.3 mg.  Tablet; Oral-28.  Wyeth
                                           Estradiol;                                            Pharmaceuticals
                                           Norgestrel.                                           Inc.
NDA 017857............  STADOL..........  Butorphanol       2 mg/mL.........  Injectable;       Delcor Asset
                                           Tartrate.                           Injection.        Corporation.
NDA 017857............  STADOL            Butorphanol       1 mg/mL; 2 mg/mL  Injectable;       Ditto.
                         PRESERVATIVE      Tartrate.                           Injection.
                         FREE.
NDA 018342............  WELLCOVORIN.....  Leucovorin        EQ 5 mg Base; EQ  Tablet; Oral....  GlaxoSmithKline.
                                           Calcium.          25 mg Base.
NDA 018353............  FLAGYL I.V......  Metronidazole     EQ 500 mg Base/   Injectable;       G.D. Searle LLC,
                                           Hydrochloride.    Vial.             Injection.        a subsidiary of
                                                                                Pfizer Inc.
NDA 018733............  TALWIN NX.......  Naloxone          EQ 0.5 mg Base;   Tablet; Oral....  Sanofi-Aventis
                                           Hydrochloride;    EQ 50 mg Base.                      U.S. LLC.
                                           Pentazocine
                                           Hydrochloride.
NDA 019488............  CARDENE.........  Nicardipine       20 mg; 30 mg....  Capsule; Oral...  Chiesi USA, Inc.
                                           Hydrochloride.
NDA 019578............  MEFLOQUINE        Mefloquine        250 mg..........  Tablet; Oral....  U.S. Army Walter
                         HYDROCHLORIDE.    Hydrochloride.                                        Reed Army
                                                                                Institute
                                                                                Research.
NDA 019591............  LARIAM..........  Mefloquine        250 mg..........  Tablet; Oral....  Hoffmann-La
                                           Hydrochloride.                                        Roche Inc.
NDA 019735............  FLOXIN..........  Ofloxacin.......  200 mg; 300 mg;   Tablet; Oral....  Janssen
                                                             400 mg.                             Pharmaceuticals
                                                                                , Inc.
NDA 019890............  STADOL..........  Butorphanol       1 mg/Spray......  Spray, Metered;   Bristol-Myers
                                           Tartrate.                           Nasal.            Squibb Co.
NDA 020142............  CATAFLAM........  Diclofenac        50 mg...........  Tablet; Oral....  Novartis
                                           Potassium.                                            Pharmaceuticals
                                                                                Corp.
NDA 020254............  VOLTAREN-XR.....  Diclofenac        100 mg..........  Extended-Release  Ditto.
                                           Sodium.                             Tablet; Oral.
NDA 020312............  UNIVASC.........  Moexipril         7.5 mg; 15 mg...  Tablet; Oral....  UCB, Inc.
                                           Hydrochloride.
NDA 020346............  ZYRTEC..........  Cetirizine        5 mg/5 mL.......  Syrup; Oral.....  Johnson &
                                           Hydrochloride.                                        Johnson
                                                                                Consumer Inc.
NDA 020584............  LODINE XL.......  Etodolac........  400 mg; 500 mg;   Extended-Release  Wyeth
                                                             600 mg.           Tablet; Oral.     Pharmaceuticals
                                                                                Inc.
NDA 020625............  ALLEGRA.........  Fexofenadine      60 mg...........  Capsule; Oral...  Sanofi-Aventis
                                           Hydrochloride.                                        U.S. LLC.
NDA 020729............  UNIRETIC........  Hydro             12.5 mg/7.5 mg;   Tablet; Oral....  UCB, Inc.
                                           chlorothiazide;   12.5 mg/15 mg;
                                           Moexipril         25 mg/15 mg.
                                           Hydrochloride.
NDA 021066............  ZADITOR.........  Ketotifen         EQ 0.025% Base..  Solution/Drops;   Alcon
                                           Fumarate.                           Ophthalmic.       Pharmaceuticals
                                                                                , Ltd.
NDA 021224............  RAZADYNE........  Galantamine       4 mg/mL.........  Solution; Oral..  Janssen
                                           Hydrobromide.                                         Pharmaceuticals
                                                                                , Inc.
NDA 021378............  COMBUNOX........  Ibuprofen;        400 mg; 5 mg....  Tablet; Oral....  Forest
                                           Oxycodone                                             Laboratories,
                                           Hydrochloride.                                        Inc.
NDA 021473............  CIPRO XR........  Ciprofloxacin;    212.6 mg; EQ      Extended-Release  Bayer HealthCare
                                           Ciprofloxacin     287.5 mg Base;    Tablet; Oral.     Pharmaceuticals
                                           Hydrochloride.    425.2 mg; EQ                        , Inc.
                                                             574.9 mg Base.
NDA 021606............  ZEMPLAR.........  Paricalcitol....  4 micrograms      Capsule; Oral...  AbbVie Inc.
                                                             (mcg).
NDA 021729............  ABILIFY.........  Aripiprazole....  10 mg and 15 mg.  Tablet, Orally    Otsuka
                                                                               Disintegrating;   Pharmaceutical
                                                                               Oral.             Co., Ltd.

NDA 050072............  PENBRITIN-S.....  Ampicillin        EQ 125 mg Base/   Injectable;       Wyeth Ayerst
                                           Sodium.           Vial; EQ 250 mg   Injection.        Laboratories.
                                                             Base/Vial; EQ
                                                             500 mg Base/
                                                             Vial; EQ 1 gram
                                                             (g) Base/Vial;
                                                             EQ 2 g Base/
                                                             Vial; EQ 4 g
                                                             Base/Vial.
NDA 050309............  POLYCILLIN-N....  Ampicillin        EQ 125 mg Base/   Injectable;       Bristol
                                           Sodium.           Vial; EQ 250 mg   Injection.        Laboratories
                                                             Base/Vial; EQ                       Inc.
                                                             500 mg Base/
                                                             Vial; EQ 1 g
                                                             Base/Vial; EQ 2
                                                             g Base/Vial.
NDA 050674............  VANTIN..........  Cefpodoxime       EQ 100 mg Base;   Tablet; Oral....  Pharmacia and
                                           Proxetil.         EQ 200 mg Base.                     Upjohn Co.
ANDA 064170...........  CEFAZOLIN SODIUM  Cefazolin Sodium  EQ 10 g Base/     Injectable;       Fresenius Kabi
                                                             Vial; EQ 20 g     Injection.        USA, LLC.
                                                             Base/Vial.
ANDA 075406...........  OGESTREL 0.5/50-  Ethinyl           0.05 mg; 0.5 mg.  Tablet; Oral-21.  Watson
                         21.               Estradiol;                                            Laboratories,
                                           Norgestrel.                                           Inc.
ANDA 085106...........  PERCOCET........  Acetaminophen;    325 mg; 5 mg....  Tablet; Oral....  Vintage
                                           Oxycodone                                             Pharmaceuticals
                                           Hydrochloride.                                        LLC.
ANDA 089351...........  ROXICET.........  Acetaminophen;    325 mg/5 mL; 5    Solution; Oral..  West-Ward
                                           Oxycodone         mg/5 mL.                            Pharmaceuticals
                                           Hydrochloride.                                        International
                                                                                Ltd.
ANDA 089456...........  PERPHENAZINE....  Perphenazine....  8 mg............  Tablet; Oral....  ANI
                                                                                Pharmaceuticals
                                                                                , Inc.
ANDA 089457...........  PERPHENAZINE....  Perphenazine....  16 mg...........  Tablet; Oral....  Teva
                                                                                Pharmaceuticals
                                                                                USA.
ANDA 089707...........  PERPHENAZINE....  Perphenazine....  2 mg............  Tablet; Oral....  Ditto.
ANDA 089708...........  PERPHENAZINE....  Perphenazine....  4 mg............  Tablet; Oral....  Do.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
    This is not a significant regulatory action subject to Executive
Order 12866, and does not impose any additional burden on regulated
entities.

    Dated: April 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:A 75 day time period to review the proposed regulations is insufficient. We request that the time period be extended to 180 days.


[Federal Register Volume 77, Number 3 (Thursday, January 5, 2012)]
[Notices]
[Pages 546-547]
[FR Doc No: 2011-33782]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-1999-6439, Notice No. 23]

Adjustment of Nationwide Significant Risk Threshold

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of adjustment of nationwide significant risk threshold.

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SUMMARY: In accordance with Appendix D to Title 49 Code of Federal
Regulations (CFR) Part 222, Use of Locomotive Horns at Highway-Rail
Grade Crossings, FRA is updating the Nationwide Significant Risk
Threshold (NSRT). This action is needed to ensure that the public has
the proper threshold of permissible risk for calculating quiet zones
established in relationship to the NSRT. This is the fifth update to
the NSRT, which has fallen from 14,007 to 13,722.

DATES: The effective date is January 5, 2012.

FOR FURTHER INFORMATION CONTACT: Mr. Ronald Ries, Office of Railroad
Safety, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, (202)
493-6299, or<EMAIL_ADDRESS>or Kathryn Shelton, Office of Chief
Counsel, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, (202)
493-6038, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The NSRT is an average of the risk indexes for gated public
crossings nationwide where train horns are routinely sounded. FRA
developed this risk index to serve as one threshold of permissible risk
for quiet zones established under this rule across the nation. Thus, a
community that is trying to establish and/or maintain its quiet zone,
pursuant to 49 CFR Part 222, can compare the Quiet Zone Risk Index
calculated for its specific crossing corridor to the NSRT to determine
whether sufficient measures have been taken to compensate for the
excess risk that results from prohibiting routine sounding of the
locomotive horn. (In the alternative, a community can establish its
quiet zone in comparison to the Risk Index With Horns, which is a
corridor-specific measure of risk to the motoring public when
locomotive horns are routinely sounded at every public highway-rail
grade crossing within the quiet zone.)
    In 2006, when the final rule titled, ``Use of Locomotive Horns at
Highway-Rail Grade Crossings,'' was amended, the NSRT was 17,030 (71 FR
47614, August 17, 2006). In 2007, FRA recalculated the NSRT to be
19,047 (72 FR 14850, March 29, 2007). In 2008, FRA recalculated the
NSRT to be 17,610 (73 FR 30661, May 28, 2008). In 2009, FRA
recalculated the NSRT to be 18,775 (74 FR 45270, September 1, 2009). In
2010, FRA recalculated the NSRT to be 14,007 (75 FR 82136, December 29,
2010).

New NSRT

    Using collision data from 2006 to 2010, FRA has recalculated the
NSRT based on formulas identified in Appendix D to 49 CFR part 222. In
making this recalculation, FRA noted that the total number of gated,
non-whistle-ban crossings was 42,150.

[GRAPHIC] [TIFF OMITTED] TN05JA12.011

    Applying the fatality rate and injury rate to the probable number
of fatalities and casualties predicted to occur at each of the 42,150
identified crossings and the predicted cost of the associated injuries
and fatalities, FRA calculates the NSRT to be 13,722.

    Issued in Washington, DC, on December 29, 2011.
Robert C. Lauby,
Acting Associate Administrator for Railroad Safety/Chief Safety
Officer.
[FR Doc. 2011-33782 Filed 1-4-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Notices]
[Page 13172-13174]
[DOCID:fr18mr10-110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61700; File No. SR-NASDAQ-2010-034]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Establish an Optional Non-Display Usage Cap for Internal
Distributors of TotalView and OpenView

March 12, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on March 5, 2010, The NASDAQ Stock Market LLC (``Nasdaq'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by Nasdaq. 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 create an optional non-display usage cap
of $30,000 per month for internal distributors of TotalView and
OpenView.
    The text of the proposed rule change is below. Proposed new
language is in italics.\3\
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    \3\ Changes are marked to the rules of The NASDAQ Stock Market
LLC found at http://nasdaqomx.cchwallstreet.com.
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* * * * *

7023. Nasdaq TotalView

    (a) No change.
    (a)(1)(A)-(C) No change.
    (D) As an alternative to (a)(1)(A), (B) and (C), a market
participant may purchase an enterprise license at a rate of $30,000 per
month for internal use of non-display data. The enterprise license
entitles a distributor to provide

TotalView and OpenView to an unlimited number of non-display devices
within its firm. The enterprise license shall not apply to relevant
Level 1 fees.
    (a)(2) No change.
    (b)-(d) No change.
* * * * *

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

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

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

1. Purpose
    Nasdaq is proposing to amend Nasdaq Rule 7023 and establish an
optional $30,000 per month non-display TotalView and OpenView fee cap
for internal distributors. The TotalView and OpenView fee cap would not
include distributor fees. By providing this non-display usage cap,
firms will have more administrative flexibility in their consumption of
TotalView and OpenView information.
    Currently, Nasdaq requires that internal distributors count and
report each server and display device that processes TotalView-ITCH
data as a professional TotalView and OpenView user. Some firms report
upwards of 500 devices, while other firms report as few as one non-
display device using TotalView-ITCH data.
    Nasdaq proposes to permit a market participant to purchase an
enterprise license at a rate of $30,000 per month for non-display usage
in a firm. As the number of devices increase, so does the
administrative burden on the end customer of counting these devices.
For firms that feel they are near the capped amount, this new
enterprise license helps relieve this administrative burden.
Additionally, firms would purchase this optional enterprise license to
reduce fees so no firms would experience a fee increase as a result of
this filing. Nasdaq has offered similar enterprise licenses for
professional and non-professional usage of TotalView-ITCH data in the
past and is expanding this service to non-display devices as well.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\4\ in general and with Sections
6(b)(5) of the Act,\5\ in particular in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Nasdaq believes that this
proposal is in keeping with those principles by offering firms an
option to increase their administrative flexibility in their
consumption of TotalView and OpenView information.
---------------------------------------------------------------------------

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

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    The Exchange believes that the foregoing proposed rule change may
take effect upon filing with the Commission pursuant to Section
19(b)(3)(A) \6\ of the Act and Rule 19b-4(f)(6)(iii) thereunder \7\
because the foregoing proposed rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest. In addition, at least five days
prior to the instant filing, the Exchange provided the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-034 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-NASDAQ-2010-034. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for web site viewing and printing in
the Commission's Public Reference Room. 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-NASDAQ-2010-034 and should be submitted
on or before April 8, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 C.F.R. 200.30-3(a)(12). [sic]
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5918 Filed 3-17-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)]
[Notices]
[Pages 12191-12192]
[FR Doc No: 2016-05081]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of the ARAC.

DATES: The meeting will be held on March 23, 2016, starting at 1:00
p.m. Eastern Daylight Savings Time. Arrange oral presentations by March
16, 2016.

ADDRESSES: The meeting will take place at the Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591, 10th
floor, MacCracken Conference Room.

FOR FURTHER INFORMATION CONTACT: Giles Strickler, Federal Aviation
Administration, 490 L'Enfant Plaza SW., Washington, DC 20024, telephone
(202) 267- 5883; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a
meeting of the ARAC taking place on March 23, 2016, at the Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591.
    The Agenda includes:

1. Recommendation Report
    a. Rotorcraft Occupant Protection Working Group Interim Report
    b. Airman Certification Systems Working Group Interim Report
2. Status Reports From Active Working Groups
    a. Aircraft Systems Information Security/Protection Working Group
    b. Air Traffic Controller Training Working Group
    c. Transport Airplane and Engine Subcommittee
    i. Airworthiness Assurance Working Group
    ii. Engine Harmonization Working Group- Engine Endurance Testing
Requirements
    iii. Flight Test Harmonization Working Group--Phase 2 Tasking
    iv. Transport Airplane Metallic and Composite Structures Working
Group--Transport Airplane Damage-Tolerance and Fatigue Evaluation
    v. Transport Airplane Crashworthiness and Ditching Evaluation
Working Group
3. New Tasks
    a. Rotorcraft Bird Strike Working Group
    b. Special Cargo
    i. Special Cargo Report
    ii. Load Master Certification Working Group
4. Status Report from the FAA

    Attendance is open to the interested public but limited to the
space available. Please confirm your attendance with the person listed
in the FOR FURTHER INFORMATION CONTACT section no later than March 16,
2016. Please provide the following information: full legal name,
country of citizenship, and name of your industry association, or
applicable affiliation. If you are attending as a public citizen,
please indicate so.
    For persons participating by telephone, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section by email or phone
for the teleconference call-in number and passcode. Callers are
responsible for paying long-distance charges.
    The public must arrange by March 16, 2016 to present oral
statements at the meeting. The public may present written statements to
the Aviation Rulemaking Advisory Committee by providing 25 copies to
the Designated Federal Officer, or by bringing the copies to the
meeting.
    If you are in need of assistance or require a reasonable
accommodation for this meeting, please contact the person listed under
the heading FOR FURTHER INFORMATION CONTACT. Sign and oral
interpretation, as well as a listening device, can be made available if
requested 10 calendar days before the meeting.

    Issued in Washington, DC, on March 2, 2016.
James Crotty,
Designated Federal Officer, Aviation Rulemaking Advisory Committee.
[FR Doc. 2016-05081 Filed 3-7-16; 8:45 am]
 BILLING CODE 4910-13-P