[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Notices]
[Pages 17011-17012]
[FR Doc No: 2017-06901]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1813]

Antimicrobial Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Antimicrobial Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on April 13, 2017, from 8:30 a.m. to 5
p.m. The docket number is FDA-2017-N-1813. The docket will close on
April 12, 2017. Comments received on or before April 10, 2017, will be
provided to the committee. Comments received after that date will be
taken into consideration by the Agency.

ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New
Hampshire Ave., Silver Spring, MD 20903. The conference center's
telephone number is<PHONE_NUMBER>. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets

Management, FDA will post your comment, as well as any attachments,
except for information submitted, marked and identified, as
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-1813 for ``Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION
    Agenda: The committee will discuss the development of antibacterial
drugs that treat a single species of bacteria when the target species
infrequently causes infections; examples of such drugs include those
that are only active against Pseudomonas aeruginosa or Acinetobacter
baumannii.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before April 10, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 7, 2017. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by April 10, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren D. Tesh at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 3, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-06901 Filed 4-6-17; 8:45 am]
 BILLING CODE 4164-01-P


MEMORANDUM

TO:  Portland Cement MACT Docket

FROM:  Steven Silverman, Attorney, OGC

RE:  Telephone call with Portland Cement Ass’n (PCA) Nov. 16, 2006

On Nov. 16, Keith Barnett, Steve Fruh, and I spoke with Andy O’Hare of
PCA, and Fran Streitman of Ashgrove Cement and Tim Matz of Lehigh Cement
regarding potential developments in the Portland Cement MACT rule.  Each
HAP was discussed separately.

THC

PCA asked for a reaction to their suggestion of using a 112 (d) (4)
approach for hydrocarbons, and the risk assessment information they had
furnished to us.  We noted that section 112 (d) (4) is limited to
threshold pollutants, and that organic HAP emitted by cement kilns
include nonthreshold pollutants.  PCA also inquired whether the
risk-based subcategory approach used in plywood MACT might be an option.
 We explained that that rule had considered all HAP emitted by the
source category, and that PCA had supplied information only on
non-dioxin organic HAP.  To fit the plywood MACT template, information
would be needed on dioxin, and all metal HAP.

They also inquired about potential new source standards.  We discussed
use of a Thermal Oxidizer on one existing kiln, as well as the level of
performance EPA had considered in other rules that such a device
typically achieved.  PCA inquired about the possibility of a midport
sampling option, which we had thought not feasible based on earlier
conversations with PCA.  We also noted that midport sampling would only
reflect hydrocarbon destruction for fuel-related organics, not those in
the feed (which predominate).  Feed-related organics would be controlled
by a thermal oxidizer.  PCA noted the adverse energy implications of use
of a thermal oxidizer.

Mercury

PCA explained that cement kiln dust is not recycled back to the kiln for
reasons other than alkali levels.

There was some discussion of wet scrubber performance for mercury.  We
indicated we had obtained some outlet data for mercury but had no inlet
data.  PCA observed that outlet emission levels could reflect low
mercury concentrations in raw materials.

PCA inquired about our reaction to their suggestion of importing the
mercury standard for hazardous waste cement kilns, but we stated that
that limit reflects feed control of mercury in hazardous waste fuels,
and so is not related to performance of a non-hazardous waste kiln.

PCA confirmed that new sources will be equipped with in-line raw mills.
They estimated that these mills would be off for 10-20% of the time the
cement kiln operates both because they require more maintenance and
because mill capacity exceeds kiln capacity.

PCA inquired about a potential standard greenfield standard reflecting
choice (through siting) of lower mercury feedstock, but did not offer
any basis for quantifying what ‘lower mercury feedstock’ would be.

PCA also indicated that it is hard to determine which areas have high or
low-pyrite limestone (which influences SO2 emissions).  There can even
be substantial variability of pyrite levels within a quarry.


[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 53995-53996]
[FR Doc No: 2021-21109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93107; File Nos. SR-NYSE-2021-15, SR-NYSEAMER-2021-13,
SR-NYSEArca-2021-15, SR-NYSENAT-2021-05, SR-NYSECHX-2021-04]

Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE
American LLC; NYSE Arca, Inc.; NYSE National, Inc.; NYSE Chicago, Inc.;
Notice of Designation of a Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To Amend Each of the Exchange's Fee Schedules Related to
Co-Location

September 23, 2021.
    On March 10, 2021, New York Stock Exchange LLC, NYSE American LLC,
NYSE Arca, Inc., NYSE National, Inc., and NYSE Chicago, Inc. each filed
with the Securities and Exchange Commission (``Commission''), pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'')
\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to provide
Users with access to the systems and connectivity to the data feeds of
several third parties and establish associated fees.\3\ Each proposed
rule change was immediately effective upon filing with the Commission
pursuant to Section 19(b)(3)(A) of the Act.\4\ The proposed rule
changes were published for comment in the Federal Register on March 29,
2021.\5\ On May 7, 2021, the Commission, pursuant to Section
19(b)(3)(C) of the Act \6\ temporarily suspended File Nos. SR-NYSE-
2021-15, SR-NYSEAMER-2021-13, SR-NYSEArca-2021-15, SR-NYSENAT-2021-05,
and SR-NYSECHX-2021-04; and (2) instituted proceedings to determine
whether to approve or disapprove File Nos. SR-NYSE-2021-15, SR-
NYSEAMER-2021-13, SR-NYSEArca-2021-15, SR-NYSENAT-2021-05, and SR-
NYSECHX-2021-04.\7\

The Commission received two comment letters on the proposal from the
Exchanges.\8\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The New York Stock Exchange LLC, NYSE American LLC, NYSE
Arca, Inc., NYSE National, Inc, and NYSE Chicago, Inc. are
collectively referred to herein as ``NYSE'' or the ``Exchanges.''
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ See Securities Exchange Act Release Nos. 91386 (March 23,
2021), 86 FR 16410 (March 29, 2021); 91387 (March 23, 2021), 86 FR
16417 (March 29, 2021); 91388 (March 23, 2021), 86 FR 16433 (March
29, 2021); 91389 (March 23, 2021), 86 FR 16403 (March 29, 2021);
91390 (March 23, 2021), 86 FR 16424 (March 29, 2021) (collectively,
the ``Notices'').
    \6\ 15 U.S.C. 78s(b)(3)(C).
    \7\ See Securities Exchange Act Release No. 91790 (May 7, 2021),
86 FR 26242 (May 13, 2021) (SR-NYSE-2021-15, NYSEAMER-2021-13, SR-
NYSEArca-2021-15, SR-NYSENAT-2021-05, SR-NYSECHX-2021-04).
    \8\ See, respectively, letter dated June 21, 2021 from Elizabeth
K. King, Chief Regulatory Officer, ICE, General Counsel and
Corporate Secretary, NYSE to Vanessa Countryman, Secretary,
Commission; and letter dated September 7, 2021 from Elizabeth K.
King, Chief Regulatory Office, ICE, General Counsel and Corporate
Secretary, NYSE to Vanessa Countryman, Secretary, Commission. All
comments received by the Commission on the proposed rule change are
available on the Commission's website at: https://www.sec.gov/comments/sr-nyse-2021-15/srnyse202115.htm. NYSE filed comment
letters on behalf of all of the Exchanges.
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    Section 19(b)(2) of the Act \9\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of the filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule changes were published for comment in the Federal
Register on March 29, 2021.\10\ The 180th day after publication of the
Notices is September 25, 2021. The Commission is extending the time
period for approving or disapproving the proposal for an additional 60
days.
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    \9\ 15 U.S.C. 78s(b)(2).
    \10\ See supra note 5.
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    The Commission finds that it is appropriate to designate a longer
period within which to issue an order approving or disapproving the
proposed rule change so that it has sufficient time to consider the
proposed rule changes along with the comments received. Accordingly,
the Commission, pursuant to Section 19(b)(2) of the Act,\11\ designates
November 24, 2021 as the date by which the Commission should either
approve or disapprove the proposed rule changes (File Nos. SR-NYSE-
2021-15, SR-NYSEAMER-2021-13, SR-NYSEArca-2021-15, SR-NYSENAT-2021-05,
NYSECHX-2021-04).
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    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21109 Filed 9-28-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 15, 2009 (Volume 74, Number 113)]
[Notices]
[Page 28255-28256]
[DOCID:fr15jn09-66]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0254]

Determination That THORAZINE (Chlorpromazine Hydrochloride)
Injection and 18 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) has determined that the
19 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.

FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors 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. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the 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 withdrawn 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 reasons
of safety or effectiveness, 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. (As requested by the
applicants, FDA withdrew approval of NDA 20-225 for IMDUR (isosorbide
mononitrate) Extended-Release Tablets in the Federal Register of
February 11, 2009 (74 FR 6896) and NDA 11-556 for ANTURANE
(sulfinpyrazone) Tablets and Capsules, NDA 15-500 for TOLINASE
(tolazamide) Tablets, NDA 18-285 for VISKEN (pindolol) Tablets, NDA 20-
137 for DEMADEX (torsemide) Injection, and NDA 20-154 for VIDEX
(didanosine) Chewable Tablets in the Federal Register of May 19, 2009
(74 FR 23407)).

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 9-149                THORAZINE                GlaxoSmithKline, 2301
                          (chlorpromazine          Renaissance Blvd.,
                          hydrochloride (HCI))     King of Prussia, PA
                          Injection, 25            19406
                          milligrams (mg)/
                          milliliter (mL)
------------------------------------------------------------------------
NDA 9-149                THORAZINE                Do.
                          (chlorpromazine HCl)
                          Oral Concentrate, 30
                          mg/mL and 100 mg/mL
------------------------------------------------------------------------
NDA 9-149                THORAZINE                Do.
                          (chlorpromazine HCl)
                          Oral Syrup, 10 mg/5 mL
------------------------------------------------------------------------
NDA 9-149                THORAZINE                Do.
                          (chlorpromazine)
                          Suppositories, 25 mg
                          and 100 mg
------------------------------------------------------------------------
NDA 11-552               STELAZINE                Do.
                          (trifluoperazine HCl)
                          Tablets, Equivalent to
                          (EQ) 1 mg base, EQ 2
                          mg base, EQ 5 mg base,
                          and EQ 10 mg base
------------------------------------------------------------------------
NDA 11-556               ANTURANE                 Novartis
                          (sulfinpyrazone)         Pharmaceuticals
                          Tablet, 100 mg           Corp., One Health
                                                   Plaza, East Hanover,
                                                   NJ 07963
------------------------------------------------------------------------
NDA 11-556               ANTURANE                 Do.
                          (sulfinpyrazone)
                          Capsule, 200 mg
------------------------------------------------------------------------
NDA 12-940               ISORDIL (isosorbide      Biovail
                          dinitrate) Sublingual    Pharmaceuticals,
                          Tablets, 2.5 mg, 5 mg,   Inc., 700 Route 202-
                          and 10 mg                206 North,
                                                   Bridgewater, NJ 08807-
                                                   0980
------------------------------------------------------------------------
NDA 15-500               TOLINASE (tolazamide)    Pfifzer, Inc., 235
                          Tablets, 100 mg, 250     East 42d St., New
                          mg, and 500 mg           York, NY 10017
------------------------------------------------------------------------

NDA 18-154               LONITEN (minoxidil)      Pharmacia & Upjohn
                          Tablets, 2.5 mg and 10   Co., c/o Pfizer, Inc.
                          mg
------------------------------------------------------------------------
NDA 18-285               VISKEN (pindolol)        Novartis
                          Tablets, 5 mg and 10     Pharmaceuticals Corp.
                          mg
------------------------------------------------------------------------
NDA 18-445               DOLOBID (diflunisal)     Merck & Co., Inc.,
                          Tablets, 250 mg and      Sunneytown Pike, P.O.
                          500 mg                   Box 4, BLA-20, West
                                                   Point, PA 19486
------------------------------------------------------------------------
NDA 19-661               CYTOVENE IV              Roche Laboratories,
                          (ganciclovir sodium)     Inc., 340 Kingsland
                          Injection, EQ 500 mg     St., Nutley, NJ 07110-
                          base/vial                1199
------------------------------------------------------------------------
NDA 20-027               CARDIZEM (diltiazem      Biovail
                          HCl) Injection, 5 mg/    Pharmaecuticals, Inc.
                          mL and 25 mg/vial
------------------------------------------------------------------------
NDA 20-137               DEMADEX (torsemide)      Roche Laboratories,
                          Injection, 20 mg/2 mL    Inc.
                          (10 mg/mL) and 50 mg/5
                          mL (10 mg/mL)
------------------------------------------------------------------------
NDA 20-154               VIDEX (didanosine)       Bristol-Myers Squibb
                          Chewable Tablets, 25     Co., P.O. Box 5100,
                          mg, 50 mg, 100 mg, 150   Wallingford, CT 06492-
                          mg, and 200 mg           7660
------------------------------------------------------------------------
NDA 20-225               IMDUR (isosorbide        Schering Corp., 2000
                          mononitrate) Extended-   Galloping Hill Rd.,
                          Release Tablets, 30      Kenilworth, NJ 07033
                          mg, 60 mg, and 120 mg
------------------------------------------------------------------------
NDA 21-238               KYTRIL (granisetron      Roche Laboratories,
                          HCl) Oral Solution, EQ   Inc.
                          2 mg base/10 mL
------------------------------------------------------------------------
NDA 21-301               LEVOXYL (levothyroxine   King Pharmaceuticals,
                          sodium) Tablet, 0.3 mg   Inc., 501 Fifth St.,
                                                   Bristol, TN 37620
------------------------------------------------------------------------

    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 listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. 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.

    Dated: June 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14000 Filed 6-12-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 130 (Thursday, July 7, 2016)]
[Notices]
[Pages 44373-44377]
[FR Doc No: 2016-16026]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78199; File No. SR-BX-2016-035]

Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change to the Professional
Designation

June 30, 2016.

    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 17, 2016, NASDAQ BX, Inc. (Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I and II, 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 Exchange Rules at Chapter I, Section
1, entitled ``Definitions'' to add specificity to the definition of a
Professional with respect to the manner in which the volume threshold
will be calculated by the Exchange.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.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 Exchange 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.
The Exchange 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
    The Exchange proposes to amend the definition of ``Professional''
at Chapter I, Section 1(49) to specify the manner in which the Exchange
calculates orders to determine if an order should be treated as
Professional.
Background
    The definition of the term Professional at Chapter I, Section 1(49)
currently states, ``any person or entity that (i) is not a broker or
dealer in securities, and (ii) places more than 390 orders in listed
options per day on average during a calendar month for its own
beneficial account(s).'' In order to properly represent orders entered
on the Exchange Participants are required to indicate whether Public
Customer \3\ orders are ``Professional'' orders.'' \4\ To comply with
this requirement, Participants are required to review their Public
Customers' activity on at least a quarterly basis to determine whether
orders that are not for the account of a broker-dealer should be
represented as Public Customer orders or Professional orders.\5\
---------------------------------------------------------------------------

    \3\ The term ``Public Customer'' means a person that is not a
broker or dealer in securities. See Chapter I, Section 1(50).
    \4\ The Exchange utilizes a special order origin code for
Professional orders.
    \5\ Orders for any Public Customer that had an average of more
than 390 orders per day during any month of a calendar quarter must
be represented as Professional orders for the next calendar quarter.
Members are required to conduct a quarterly review and make any
appropriate changes to the way in which they are representing orders
within five days after the end of each calendar quarter. While
members are only required to review their accounts on a quarterly
basis, if during a quarter the Exchange identifies a Public Customer
for which orders are being represented as Public Customer orders but
that has averaged more than 390 orders per day during a month, the
Exchange will notify the member and the member will be required to
change the manner in which it is representing the Public Customer's
orders within five days.
---------------------------------------------------------------------------

    The Exchange accepts orders routed from other markets that are
marked Professional. The designation of Professional or Professional
order does not result in any different treatment of such orders for
purposes of Exchange rules concerning away market protection. That is,
all non-broker or dealer orders, including those that meet the
definition of Professional orders, are treated equally for purposes of
Exchange away market protection rules.\6\ The Exchange continues to
believe that identifying Professional accounts based upon the average
number of orders entered in qualified accounts is an appropriately
objective approach to reasonably distinguish such persons and entities
from retail investors or market participants.
---------------------------------------------------------------------------

    \6\ See Exchange Rules at Chapter VI, Section 11, Chapter XII,
Sections 2 and 3.
---------------------------------------------------------------------------

Proposal
    The Exchange proposes to count each order entered by a Professional
toward the number of orders, regardless of the options exchange to
which the order was routed in determining Professional orders.\7\
---------------------------------------------------------------------------

    \7\ All order types count toward the 390 orders on average per
day.
---------------------------------------------------------------------------

Cancel and Replace
    A cancel and replace order is a type of order that replaces a prior
order. The Exchange believes that the second order (the replacement
order) should be counted as a new order. With respect to ``single-
strike algorithms,'' which are a series of cancel and replace orders in
an individual strike which track the NBBO, these orders shall be
counted as new orders.\8\ The Exchange believes that because [sic] the
Public Customer is specifically instructing the executing broker in the
``single-strike algorithm'' scenario to cancel and replace these
orders. This type of activity is akin to market making in a Public
Customer account and should be counted, as a new order.
---------------------------------------------------------------------------

    \8\ Cancel messages do not count as an order.
---------------------------------------------------------------------------

Parent/Child Orders
    An order that converts into multiple subordinate orders to achieve
an execution strategy shall be counted as one order per side and
series, even if the order is routed away.\9\ An order that cancels and
replaces a resulting subordinate order and results in multiple sides/
series shall be counted as a new order on each side and series. For
purposes of counting Public Customer orders, the manner in which the
Public Customer submitted the order and whether the order was on the
same side and series will determine if the order will count as one
order. If one Public Customer order on the same side and series is
subsequently broken-up by a broker into multiple orders for purposes of
execution or routed away, this order will count as one order. The
Exchange believes that the proposed amendment will provide more
certainty to market participants in determining the manner in which the
Exchange will compute the number of orders in listed options per day on
average during a calendar month for its own beneficial account(s) to
determine the Professional designation.
---------------------------------------------------------------------------

    \9\ An order which is placed for the beneficial account(s) of a
person or entity that is not a broker or dealer in securities that
is broken into multiple parts by a broker or dealer or by an
algorithm housed at a broker or dealer or by an algorithm licensed
from a broker or dealer. Strategies include volatility orders, for
example.
---------------------------------------------------------------------------

    In order to make clear when orders will count as new orders, the
Exchange offers the following scenarios as examples.
     The Exchange proposes to count multiple orders that were
submitted by the member as separate orders as multiple orders.
     The Exchange proposes to count a single order submitted by
a member, which was automatically executed in multiple parts by the
trading system, as one order, because the member did not intervene to
create multiple orders. Another example is where an order was entered
in the trading system and only partially filled, the order would count
as one order. The subsequent fills, which could be multiple executions,
would not count as additional orders in determining the 390 limit. The
manner in which the order is ultimately executed, as one order or
multiple orders, should not itself determine whether the activity is
that of a Professional; also the member did not intervene in that
circumstance.
     The Exchange proposes to not count an order which
reprices, for example because of a locked and crossed market, as a new
order because the member did not intervene.
     The Exchange proposes to count orders, which result in
multiple orders due to cancel and replacement orders, as new orders.
This is because in this situation the member did intervene to create
the subsequent orders.
     The Exchange proposes to count an order submitted by the
Public Customer as a single order, on the same side and series, as a
single order despite the fact that a broker broke-up the order into
multiple orders for purposes of execution.
    The Exchange notes that other options exchanges have issued notices
which describe the manner in which those Exchanges believe thresholds
should be computed for determining if an order qualifies as a
Professional order.\10\ The

Exchange believes that there is industry confusion as to which orders
count toward the 390 contract threshold. The Exchange's proposal is
intended to provide clarity and to continue to promote consistency in
the treatment of orders as Professional orders.
---------------------------------------------------------------------------

    \10\ See NYSE Arca, Inc.'s and NYSE MKT LLC's Joint Regulatory
Bulletin (RBO-15-03 and RBO-15-06, respectively) dated September 9,
2015; CBOE's Regulatory Circulator (RG10-126) dated December 1,
2010; and the International Securities Exchange LLC's Regulatory
Information Circular (2009-179) dated June 23, 2009.
---------------------------------------------------------------------------

    Below are some examples of the calculation of Professional orders.
Example #1
    A Public Customer has an order to buy 100 calls at a volatility
level of 35. The order then generates a child order resulting in a 1.00
bid for 100 options which is sent to exchange A. After the underlying
stock price ticks up 2 cents the child order is then adjusted to
reflect a 35 level volatility which in this case (50 delta) results in
a 1.01 bid sent to Exchange A replacing the current 1.00 bid.
    In determining the number of orders that attribute to the 390 order
count, in this case, because the child order is being canceled and
replaced in the ``same series'' this would only count as one (1) order
for purposes of Professional designation calculation.
Example #2
    A Public Customer has an order to buy 20k Vega at a 35 volatility
level in symbol XYZ. The order then generates 50 child orders across
different strikes. Throughout the day those 50 orders are adjusted as
the stock moves resulting in the replacement of child orders to the
tune of 5 times per order (50 x 5 cancels) resulting in 250 total
orders generated to Exchange A.
    In determining the number of orders that attribute to the 390 order
count, in this case, because the child orders generated are across
multiple series it would be necessary to count all 250 orders.
    In addition to the above examples, the Exchange provides the below
chart to demonstrate the manner in which it will count orders.

------------------------------------------------------------------------
        Single strike activity              Singular         Multiple
------------------------------------------------------------------------
Public Customer order posted to 1 SRO                X   ...............
 Order Book...........................
Public Customer order posted to                      X   ...............
 Multiple SRO Order Books
 simultaneously.......................
Cancel/Replace Activity...............               X   ...............
Cancel/Replace Activity tracking NBBO.  ...............               X
------------------------------------------------------------------------

Singular--counts as a single order towards the 390 count.
Multiple--each order applies towards the 390 count.

    The Exchange proposes to implement this rule on July 1, 2016 to
provide market participants with advance notice for their quarterly
calculations. The Exchange will issue an Options Trader Alert in
advance to inform market participants of such date.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \11\ in general, and furthers the objectives of Section
6(b)(5) of the Act \12\ in particular, in that it is designed to
promote just and equitable principles of trade, 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, by promoting the consistent application of its rules by
further defining the manner in which the Exchange will compute the
number of orders in listed options per day on average during a calendar
month for its own beneficial account(s) for purposes of determining the
Professional designation. Furthermore, the Exchange believes that
specifying the manner in which the 390 threshold will be calculated
within its Rules will provide members with certainty and provide them
with insight as they conduct their own quarterly reviews for purposes
of designating orders.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that counting all orders toward the number of
orders, regardless of the options exchange to which the order was
routed, will promote the consistent application of its rules by making
clear that all order types shall be counted as well as all orders for
the purpose of determining whether the definition of Professional has
been met.
Cancel and Replace
    With respect to determining the Professional designation, a cancel
and replace order that replaces a prior order shall be counted as a
second order. An order that is filled partially or in its entirety or
is a replacement order that is automatically canceled or reduced by the
number of contracts that were executed will not count as second order
because it was not replaced.\13\ The Exchange believes that counting
the replacement order as a second order is consistent with Exchange
Rules because the replacement order is viewed as a new order with its
own unique identifier.
---------------------------------------------------------------------------

    \13\ See Exchange Rules at Chapter VI, Section 1(e)(1). Cancel-
replacement order shall mean a single message for the immediate
cancellation of a previously received order and the replacement of
that order with a new order with new terms and conditions. If the
previously placed order is already filled partially or in its
entirety, the replacement order is automatically canceled or reduced
by the number of contracts that were executed. The replacement order
will not retain the priority of the cancelled order except when the
replacement order reduces the size of the order and all other terms
and conditions are retained.
---------------------------------------------------------------------------

    The Exchange believes that counting cancel and replace orders with
``single-strike algorithms,'' which are a series of cancel and replace
orders in an individual strike which track the NBBO, as new orders is
consistent with the Act because the Public Customer is specifically
instructing the executing broker in the ``single-strike algorithm''
scenario to cancel and replace these orders. Tracking the NBBO \14\ is
akin to market making on the Exchange in a Public Customer account and
should be counted as new orders. The Exchange believes that the Public
Customers order designation should be reserved for retail Public
Customers.
---------------------------------------------------------------------------

    \14\ Tracking the NBBO shall mean any parent order that consumes
any self-regulatory organization order book data feed, or the OPRA
feed, to generate automated child orders, and move with, or follow
the Bid or Offer of the series in question.
---------------------------------------------------------------------------

Parent/Child Orders
    The Exchange's adoption of the Professional order was to treat
orders in listed options per day on average during a calendar month in
his or her own beneficial account differently from Public Customer
orders for purposes of priority within the order Book and pricing.\15\
For this reason, the Exchange is adopting rules concerning the
computation of orders which convert into multiple subordinate orders
for the purpose of determining the Professional designation. The
Exchange's proposal to count multiple subordinate orders that achieve
an execution strategy as one

order per side and series and count an order that cancels and replaces
a resulting subordinate order and results in multiple sides/series as a
new order is consistent with the Act, because the Exchange is
distinguishing where the member is actively entering orders that result
in multiple orders and canceling and replacing orders that result in
multiple orders versus where the member had no control of the resulting
executions. Allowing orders on the same side of the market to be
counted as a single order is consistent with the original intent of the
Professional order designation. The same side of market distinction
protects retail Public Customers. This practice is typically the type
of transaction Public Customers execute versus a Professional trader.
Multiple related orders resulting from a large order filled in part, or
an order which is cancelled and replaced several times are considered
part of a related order. The Exchange does not desire to count large
orders filled in part as multiple orders because the member did not
intervene in the outcome of the execution. An order that results in
several separate and unrelated orders would be counted as multiple
orders because the member intervened in this circumstance.
---------------------------------------------------------------------------

    \15\ See BX Rules at Chapter VI, Section 10 and Chapter XV,
Section 2.
---------------------------------------------------------------------------

    The Exchange believes that the proposed amendment will provide more
certainty to market participants in determining the computation of the
number of orders in listed options per day on average during a calendar
month for its own beneficial account(s) to determine the Professional
designation. The Exchange notes that other options exchanges have
issued notices describing the manner in which they believe that
Professional order should be counted when determining if an order
qualifies as a Professional order.\16\ The Exchange believes that there
is confusion as to which orders count toward the 390 contract
threshold. The Exchange proposes to provide clarity to its Rules with
specific guidance as to the computation of Professional orders, which
it believes will promote consistency in the treatment of orders as
Professional orders. The Exchange believes that this proposed guidance
will promote consistency and permit the proper calculation of options
orders to prevent members with high volume from receiving benefits
reserved for Public Customer orders. The Professional designation
focuses specifically on the number of orders generated.
---------------------------------------------------------------------------

    \16\ See NYSE Arca, Inc.'s and NYSE MKT LLC's Joint Regulatory
Bulletin (RBO-15-03 and RBO-15-06, respectively) dated September 9,
2015; The Chicago Board Options Exchange, Incorporated's Regulatory
Circulator (RG10-126) dated December 1, 2010; and the International
Securities Exchange LLC's Regulatory Information Circular (2009-179)
dated June 23, 2009.
---------------------------------------------------------------------------

    Customer priority is one of the marketplace advantages provided to
Public Customer orders on the Exchange. Customer priority means that
Customer orders are given execution priority over non-Customer orders
and quotations of specialists and BX Options Market Makers \17\ at the
same price. Another marketplace advantage afforded to Public Customer
orders on the Exchange is that members are generally not assessed
transaction fees for the execution of Public Customer orders. The
purpose of these marketplace advantages is to attract retail order flow
to the Exchange by leveling the playing field for retail investors over
market Professionals.\18\ The Exchange believes that permitting certain
types of orders to be counted as a single order and other types of
orders to be counted as multiple orders is consistent with the original
intent of the Professional designation, which was to continue to
provide Public Customer accounts with marketplace advantages and
distinguish those accounts non-Professional retail investors from the
Professionals accounts some non-broker-dealer individuals and entities
have access to information and technology that enables them to
Professionally trade listed options in the same manner as a broker or
dealer in securities.\19\
---------------------------------------------------------------------------

    \17\ A BX Options Market Maker means an Options Participant
registered with the Exchange for the purpose of making markets in
options contracts traded on the Exchange and that is vested with the
rights and responsibilities specified in Chapter VII of these Rules.
See BX Rules at Chapter I, Section 1(a)(9).
    \18\ Market Professionals have access to sophisticated trading
systems that contain functionality not available to Public
Customers, including things such as continuously updated pricing
models based upon real-time streaming data, access to multiple
markets simultaneously and order and risk management tools.
    \19\ For example, some broker-dealers provided their
Professional customers with multi-screened trading stations equipped
with trading technology that allows the trader to monitor and place
orders on all six options exchanges simultaneously. These trading
stations also provide compliance filters, order managements tools,
the ability to place orders in the underlying securities, and market
data feeds.
---------------------------------------------------------------------------

    Finally, the proposed guidance is being issued to stem confusion as
to the manner in which options exchanges compute the Professional order
volume. The Exchange's Rules may be similar to notices issued by NYSE
Arca, Inc, NYSE MKT LLC (``NYSE MKT'') and International Securities
Exchange LLC (``ISE'').

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act because the Exchange will
uniformly apply the rules to calculate volume on all members in
determining Professional orders. The designation of Professional orders
would not result in any different treatment of such orders for purposes
of the Exchange's Rules concerning order protection or routing to away
exchanges. Also, SIFMA supports the guidance issued by NYSE Arca and
NYSE MKT. The guidance is being issued to stem confusion as to the
manner in which options exchanges compute the Professional order
volume.
    The Exchange is adopting similar counting methods the Exchange
believes is currently being utilized by NYSE MKT, NYSE ARCA and ISE
related to designation of Professional orders.
Counting All Orders
    The Exchange believes that counting all orders entered by a
Professional toward the number of orders, regardless of the options
exchange to which the order was routed, does not create an undue burden
on intra-market competition because this proposed rule change will be
consistently applied to all members in determining Professional orders.
Cancel and Replace
    The Exchange believes that its application of cancel and replace
orders does not create an undue burden on intra-market competition
because this application is consistent with Exchange Rules, where the
replacement order is viewed as a new order. This treatment is
consistent with the manner in which this order type is applied today
within the Order Book.
Parent/Child Orders
    The Exchange's treatment of subordinate orders does not create an
undue burden on intra-market competition because allowing orders on the
same side of the market to be counted as a single order is consistent
with the original intent of the Professional order designation which is
to count distinct orders and focus on the number of orders generated.
    The Exchange does not believe that the proposed rule change will
impose an undue burden on inter-market competition because other
exchanges have announced the intent to adopt

similar guidance.\20\ The Exchange believes that disparate rules
regarding Professional order designation, and a lack of uniform
application of such rules, does not promote the best regulation and
may, in fact, encourage regulatory arbitrage. The Exchange believes
that it is therefore prudent and necessary to conform its rules to that
of other options exchanges for purposes of calculating the threshold
volume of orders to be designated as a Professional. This is
particularly true where the Exchange's third-party routing broker-
dealers are members of several exchanges that have rules requiring
Professional order designations.
---------------------------------------------------------------------------

    \20\ See supra note 16.
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    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, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \21\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\22\ A proposed rule
change filed under Rule 19b-4(f)(6) normally does not become operative
prior to 30 days after the date of filing.\23\ Rule 19b-4(f)(6)(iii),
however, permits the Commission to designate a shorter time if such
action is consistent with the protection of investors and the public
interest.\24\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \22\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
    \23\ 17 CFR 240.19b-4(f)(6)(iii).
    \24\ Id.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission notes that it has considered a
substantially similar proposed rule change filed by CBOE and PHLX which
it approved after a notice and comment period.\25\ This proposed rule
change does not raise any new or novel issues from those considered in
the CBOE and PHLX proposals. Based on the foregoing, the Commission
believes that it is consistent with the protection of investors and the
public interest to waive the 30-day operative date so that the proposal
may take effect upon filing.\26\
---------------------------------------------------------------------------

    \25\ See Securities Exchange Act Release Nos. 77450 (March 25,
2016) (Order Approving SR-CBOE-2016-005); 77449 (March 25, 2016), 81
FR 18665, (March 31, 2016) (Order Approving SR-Phlx-2016-10).
    \26\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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) of the Act \27\ to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \27\ 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 No. SR-BX-2016-035 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-BX-2016-035. 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 such filing will also 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 No. SR-BX-2016-035 and should be
submitted on or before July 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-16026 Filed 7-6-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20104-20106]
[FR Doc No: 2013-07644]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0142; FRL-9382-1]

Notice of Receipt of Requests for Amendments To Delete Uses in
Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of request
for amendments by registrants to delete uses in certain pesticide
registrations. FIFRA provides that a registrant of a pesticide product
may at any time request that any of its pesticide registrations be
amended to delete one or more uses. FIFRA further provides that, before
acting on the request, EPA must publish a notice of receipt of any
request in the Federal Register.

DATES: The deletions in Table 1 of Unit II., are effective May 3, 2013,
because the registrants requested a waiver of the 180-day comment
period, unless the Agency receives a written withdrawal request on or
before May 3, 2013. The Agency will consider a withdrawal request
postmarked no later than May 3, 2013. The deletion in Table 2 of Unit
II., is effective September 30, 2013, unless the Agency receives a
written withdrawal request on or before September 30, 2013. The Agency
will consider a withdrawal request postmarked no later than September
30, 2013.
    Users of these products who desire continued use on crops or sites
being deleted should contact the applicable registrant in Table 1 of
Unit II., before May 3, 2013, for the registrants that requested a
waiver of the 180-day comment period. Users of these products who
desire continued use on crops or sites being deleted should contact the
applicable registrant in Table 2 of Unit II., before September 30,
2013.

ADDRESSES: Submit your withdrawal request, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0142, by one of the
following methods:
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on visiting the docket, along with more information about
dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Christopher Green, Information
Technology and Resources Management Division (7502P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to persons who produce or use
pesticides, the Agency has not attempted to describe all the specific
entities that may be affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2013-0142, is available either electronically
through http://www.regulations.gov or in hard copy at the OPP Docket in
the Environmental Protection Agency Docket Center (EPA/DC), located in
EPA West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-
0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional

information about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    This notice announces receipt by the Agency of applications from
registrants to delete uses in certain pesticide registrations. These
registrations are listed in Table 1 and Table 2 of this unit by
registration number, product name, active ingredient, and specific uses
deleted.

               Table 1--Requests for Amendments To Delete Uses in Certain Pesticide Registrations
----------------------------------------------------------------------------------------------------------------
       EPA Registration No.              Product name           Active ingredient          Delete from label
----------------------------------------------------------------------------------------------------------------
100-769...........................  Medallion Fungicide..  Fludioxonil...............  Post-harvest uses on
                                                                                Citrus, Kiwi, Pome
                                                                                fruit, Pomegranates,
                                                                                Stone fruit & Yams.
9198-227..........................  The Andersons 3-Way    Chlorothalonil,             Golf course roughs, Sod
                                     Snow Mold Fungicide.   Pentachloronitrobenzene &   farms, & other Turf
                                                            Propiconazole.              grown areas (athletic
                                                                                fields, cemeteries,
                                                                                parks & commercial
                                                                                turf).
11603-52..........................  Agan Imazethapyr       Imazethapyr...............  Field corn (Clearfield
                                     Technical.                                         corn hybrids only) &
                                                                                Clearfield rice.
11678-71..........................  Pyriproxyfen           Pyriproxyfen..............  Greenhouse non-food,
                                     Technical.                                         Terrestrial non-food
                                                                                crop, Terrestrial food
                                                                                uses.
----------------------------------------------------------------------------------------------------------------

    Users of these products in Table 1 of this unit, who desire
continued use on crops or sites being deleted should contact the
applicable registrant before May 3, 2013, because the registrants
requested a waiver of the 180-day comment period, to discuss withdrawal
of the application for amendment.
    This 30-day period will also permit interested members of the
public to intercede with registrants prior to the Agency's approval of
the deletion.

               Table 2--Requests for Amendments To Delete Uses in Certain Pesticide Registrations
----------------------------------------------------------------------------------------------------------------
       EPA Registration No.              Product name           Active ingredient          Delete from label
----------------------------------------------------------------------------------------------------------------
87284-3...........................  Willowood              Propiconazole.............  Wood preservative uses
                                     Propiconazole
                                     Technical II.
----------------------------------------------------------------------------------------------------------------

    Users of this product in Table 2 of this unit who desire continued
use on crops or sites being deleted should contact the applicable
registrant before September 30, 2013 to discuss withdrawal of the
application for amendment. This 180-day period will also permit
interested members of the public to intercede with registrants prior to
the Agency's approval of the deletion.
    Table 3 of this unit includes the names and addresses of record for
all registrants of the products listed in Tables 1 and 2 of this unit,
in sequence by EPA company number.

  Table 3--Registrants Requesting Amendments To Delete Uses in Certain
                         Pesticide Registrations
------------------------------------------------------------------------
        EPA company Number                Company name and address
------------------------------------------------------------------------
100...............................  Syngenta Crop Protection, LLC, P.O.
                                     Box 18300, Greensboro, NC 27419-
                                     8300.
9198..............................  The Andersons Lawn Fertilizer
                                     Division, Inc., P.O. Box 119,
                                     Maumee, OH 43537.
11603.............................  Agan Chemical Manufacturing, Ltd.,
                                     3120 Highwoods Blvd., Suite 100,
                                     Raleigh, NC 27604.
11678.............................  Makhteshim Agan of North America,
                                     Inc., 3120 Highwoods Blvd., Suite
                                     100, Raleigh, NC 27604.
87284.............................  Willowood Propiconazole, LLC, 1600
                                     NW., Garden Valley Blvd., Suite
                                     120, Roseburg, OR 97471.
------------------------------------------------------------------------

III. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be amended to delete one or more uses. The FIFRA further provides that,
before acting on the request, EPA must publish a notice of receipt of
any such request in the Federal Register. Thereafter, the EPA
Administrator may approve such a request.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for use deletion must
submit the withdrawal in writing to Christopher Green using the methods
in ADDRESSES. The Agency will consider written withdrawal requests
postmarked no later than May 3, 2013, for the requests that the
registrants requested to waive the 180-day comment period and no later
than September 30, 2013, for the requests with a 180-day comment
period.

V. Provisions for Disposition of Existing Stocks

    The Agency has authorized the registrants to sell or distribute
product under the previously approved labeling for a period of 18
months after approval of the revision, unless other restrictions have
been imposed, as in special review actions.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 18, 2013.
Oscar Morales,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2013-07644 Filed 4-2-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Proposed Rules]
[Page 11841-11842]
[DOCID:fr05mr08-11]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0249; Directorate Identifier 2008-CE-012-AD]
RIN 2120-AA64

Airworthiness Directives; DORNIER LUFTFAHRT GmbH Models 228-200,
228-201, 228-202, and 228-212 Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

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

    During production testing of a batch of control cables, cracks
inside the cable terminal were detected. Despite the specified
strength at the date of delivery was achieved, it can not be
excluded that the mechanical properties of the cable will degrade.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by April 4, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0249;
Directorate Identifier 2008-CE-012-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environment, and energy aspects of this proposed AD. We will
consider all comments received by the closing date and may amend this
proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Luftfahrt-Bundesamt (LBA), which is the aviation authority for
Germany, has issued AD No. D-2007-353, dated December 28, 2007
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    During production testing of a batch of control cables, cracks
inside the cable terminal were detected. Despite the specified
strength at the date of delivery was achieved, it can not be
excluded that the mechanical properties of the cable will degrade.

    This proposed AD would require you to replace rudder control
cables, part number (P/N) B-422420A00F delivered with European Aviation
Safety Agency (EASA) Form One tracking number RS52074/05 after January
1, 2006 (also identified by production batch number 1141044, which is
printed on the fork end next to the P/N), with FAA-approved serviceable
rudder control cables.
    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    RUAG Aerospace Defence Technology has issued Dornier 228 Alert
Service Bulletin No. ASB-228-269, dated March 23, 2007. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist to develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

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

Costs of Compliance

    We estimate that this proposed AD would affect about 17 products of
U.S. registry. We also estimate that it would take about 15 work-hours
per product to comply with the basic requirements of this proposed AD.
The average labor rate is $80 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $20,400 or $1,200 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

DORNIER LUFTFAHRT GmbH: Docket No. FAA-2008-0249; Directorate
Identifier 2008-CE-012-AD.

Comments Due Date

    (a) We must receive comments by April 4, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Models 228-200, 228-201, 228-202, and
228-212, all serial numbers that are:
    (1) Equipped with rudder control cables, part number (P/N) B-
422420A00F delivered with European Aviation Safety Agency (EASA)
Form One tracking number RS52074/05 after January 1, 2006 (also
identified by production batch number 1141044, which is printed on
the fork end next to the P/N); and
    (2) certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    During production testing of a batch of control cables, cracks
inside the cable terminal were detected. Despite the specified
strength oat the date of delivery was achieved, it can not be
excluded that the mechanical properties of the cable will degrade.
    This AD requires you to replace rudder control cables, P/N B-
422420A00F delivered with EASA Form One tracking number RS52074/05
after January 1, 2006 (also identified by production batch number
1141044, which is printed on the fork end next to the P/N), with
FAA-approved serviceable rudder control cables.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Replace the rudder control cables identified in paragraph
(c)(1) of this AD with FAA-approved serviceable rudder control
cables following RUAG Aerospace Defence Technology Dornier 228 Alert
Service Bulletin No. ASB-228-269, dated March 23, 2007, at whichever
of the follow occurs first:
    (i) Upon reaching 1,200 total hours time-in-service (TIS) on the
rudder control cables identified in paragraph (c)(1) of this AD or
within 30 days after the effective date of this AD, whichever occurs
later; or
    (ii) Within the next 3 months after the effective date of this
AD.
    (2) As of the effective date of this AD, do not install any
rudder control cables, P/N B-422420A00F delivered with EASA Form One
tracking number RS52074/05 after January 1, 2006 (also identified by
production batch number 1141044, which is printed on the fork end
next to the P/N).
    (3) Within 30 days after doing the replacement required in
paragraph (f)(1) of this AD, return the removed rudder control
cables and any held as spares to the manufacturer at the address on
RUAG Aerospace Defense Technology Dornier 228 Alert Service Bulletin
No. ASB-228-269, dated March 23, 2007.

FAA AD Differences

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

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Staff, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
sections if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the STate of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI Luftfahrt-Bundesamt (LBA) AD No. D-2007-353,
dated December 28, 2007, and RUAG Aerospace Defence Technology
Dornier 228 Alert Service Bulletin No. ASB-228-269, dated March 23,
2007, for related information.

    Issued in Kansas City, Missouri, on February 26, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 08-929 Filed 3-4-08; 8:45 am]

BILLING CODE 4910-13-M