[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48809-48810]
[FR Doc No: 2017-22835]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP18-28-000.
    Applicants: Northwest Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Entitlement and OFO Filing to
be effective 11/10/2017.
    Filed Date: 10/11/17.
    Accession Number: 20171011-5112.
    Comments Due: 5 p.m. ET 10/23/17.

    Docket Numbers: RP18-29-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Compliance filing 2017 Penalty Revenue Sharing Report.
    Filed Date: 10/12/17.
    Accession Number: 20171012-5077.
    Comments Due: 5 p.m. ET 10/24/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 12, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-22835 Filed 10-19-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32305-32306]
[FR Doc No: 2018-14935]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2180]

Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval
of 29 New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 29 new drug applications (NDAs) from multiple
applicants. The holders of the applications notified the Agency in
writing that the drug products were no longer marketed and requested
that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 13, 2018.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 011287.............  Kayexalate (sodium       Concordia
                          polystyrene sulfonate)   Pharmaceuticals,
                          Powder for Suspension,   Inc., c/o Mapi USA,
                          453.6 gram (g)/bottle.   Inc., 2343 Alexandria
                                                   Dr., Lexington, KY
                                                   40504.
NDA 012249.............  Librium                  Valeant
                          (chlordiazepoxide        Pharmaceuticals North
                          hydrochloride (HCl))     America, LLC, 400
                          Capsules, 5 milligram    Somerset Corporate
                          (mg), 10 mg, and 25 mg.  Blvd., Bridgewater,
                                                   NJ 08807.
NDA 016211.............  Miochol (acetylcholine   Novartis
                          chloride) for            Pharmaceuticals
                          Ophthalmic Solution,     Corp., One Health
                          20 mg/vial.              Pl., East Hanover, NJ
                                                   07936.
NDA 018674.............  Metro I.V.               B. Braun Medical,
                          (metronidazole)          Inc., 901 Marcon
                          Injection, 500 mg/100    Blvd., Allentown, PA
                          milliliter (mL).         18109.
NDA 018852.............  Sulfamethoxazole and     Watson Laboratories,
                          Trimethoprim Tablets     Inc., Subsidiary of
                          USP, 400 mg; 80 mg.      Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
NDA 018854.............  Sulfamethoxazole and     Do.
                          Trimethoprim Tablets
                          USP, 800 mg; 160 mg.
NDA 018988.............  Vasocidin (prednisolone  Novartis
                          sodium phosphate and     Pharmaceuticals Corp.
                          sulfacetamide sodium)
                          Ophthalmic Solution,
                          equivalent to (EQ)
                          0.23% phosphate/10%.
NDA 019844.............  Isolyte H in Dextrose    B. Braun Medical, Inc.
                          5% in Plastic
                          Container Injection.
NDA 019870.............  Isolyte M in Dextrose    Do.
                          5% in Plastic
                          Container Injection.
NDA 019964.............  Terazol 3 (terconazole)  Janssen
                          Vaginal Cream, 0.8%.     Pharmaceuticals,
                                                   Inc., 1125 Trenton-
                                                   Harbourton Rd.,
                                                   Titusville, NJ 08560.
NDA 020000.............  Dextrose 5% in Ringer's  B. Braun Medical, Inc.
                          in Plastic Container
                          Injection.
NDA 020393.............  Atrovent (ipratropium    Boehringer Ingelheim
                          bromide) Nasal Spray,    Pharmaceuticals,
                          0.021 mg/spray.          Inc., 900 Ridgebury
                                                   Rd., P.O. Box 368,
                                                   Ridgefield, CT 06877-
                                                   0368.
NDA 020394.............  Atrovent (ipratropium    Do.
                          bromide) Nasal Spray,
                          0.042 mg/spray.
NDA 021180.............  Ortho Evra (ethinyl      Janssen
                          estradiol;               Pharmaceuticals,
                          norelgestromin)          Inc., 1000 U.S. Route
                          Transdermal Patch,       202, P.O. Box 300,
                          0.035 mg/24 h; 0.15 mg/  Raritan, NJ 08869-
                          24 h.                    0602.
NDA 021633.............  Femtrace (estradiol      Allergan
                          acetate) Tablets, 0.45   Pharmaceuticals
                          mg, 0.9 mg, and 1.8 mg.  International, Ltd.,
                                                   c/o Allergan Sales,
                                                   LLC, 2525 Dupont Dr.,
                                                   Irvine, CA 92612.
NDA 022033.............  Luvox CR (fluvoxamine    Jazz Pharmaceuticals,
                          maleate) Extended-       Inc., 3180 Porter
                          Release Capsules, 100    Dr., Palo Alto, CA
                          mg and 150 mg.           94304.
NDA 022106.............  Doribax (doripenem) for  Shionogi, Inc., 300
                          Injection, 250 mg/vial   Campus Dr., Florham
                          and 500 mg/vial.         Park, NJ 07932.
NDA 022386.............  PrandiMet (metformin     Novo Nordisk, Inc.,
                          HCl; repaglinide)        P.O. Box 846,
                          Tablets, 500mg; 1 mg     Plainsboro, NJ 08536.
                          and 500 mg; 2 mg.
NDA 050201.............  Ophthocort               Parkedale
                          (chloramphenicol,        Pharmaceuticals,
                          hydrocortisone           Subsidiary of Pfizer
                          acetate, polymyxin B     Inc., 235 East 42nd
                          sulfate) Ophthalmic      St., New York, NY
                          Ointment USP, 10 mg/g;   10017.
                          5 mg/g; 10,000 units/g.
NDA 050344.............  Statrol (neomycin        Alcon Laboratories,
                          sulfate; polymyxin B     Inc., 6201 South
                          sulfate) Ophthalmic      Freeway, TC-45, Fort
                          Ointment, EQ 3.5 mg      Worth, TX 76134.
                          base/g; 10,000 units/g.
NDA 050442.............  Vibramycin (doxycycline  Pfizer, Inc., 235 East
                          hyclate) Injection, EQ   42nd St., New York,
                          to 200 mg base/vial      NY 10017.
                          and EQ 100 mg base/
                          vial.
NDA 050497.............  Ticar (ticarcillin       GlaxoSmithKline, 1250
                          disodium) Injection,     Collegeville Rd.,
                          EQ 1 g base/vial, EQ 3   Collegeville, PA
                          g base/vial, EQ 6 g      19426.
                          base/vial, EQ 20 g
                          base/vial, and EQ 30 g
                          base/vial.
NDA 050512.............  Duricef (cefadroxil      Warner Chilcott Co.,
                          monohydrate) USP         LLC, 100 Enterprise
                          Capsules, EQ 500 mg      Dr., Rockaway, NJ
                          base and EQ 250 mg       07866.
                          base.
NDA 050527.............  Duricef (cefadroxil      Do.
                          monohydrate) USP For
                          Oral Suspension, EQ
                          125 mg base/5 mL, EQ
                          250 mg base/5 mL, and
                          EQ 500 mg base/5 mL.
NDA 050593.............  Eryc Sprinkles           Hospira Inc., 275
                          (erythromycin)           North Field Dr., Lake
                          Capsules, 125 mg.        Forest, IL 60045.
NDA 050646.............  Ceptaz (ceftazidime)     GlaxoSmithKline.
                          Injection, 500 mg/
                          vial, 1 g/vial, 2 g/
                          vial, and 10 g/vial.
NDA 050668.............  Lorabid (loracarbef)     King Pharmaceuticals,
                          Capsules USP, 200 mg     Inc., 501 Fifth St.,
                          and 400 mg.              Bristol, TN 37620.
NDA 050792.............  Cefotaxime and Dextrose  B. Braun Medical, Inc.
                          2.4% in Plastic
                          Container, EQ 2 g
                          base, and Cefotaxime
                          and Dextrose 3.9% in
                          Plastic Container, EQ
                          1 g base.

NDA 050807.............  Epirubicin HCl for       Hospira, Inc.
                          Injection, 50 mg/vial,
                          200 mg/vial.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 13, 2018. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the
table that are in inventory on August 13, 2018 may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.

    Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14935 Filed 7-11-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39638-39639]
[FR Doc No: 2016-14309]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP16-1020-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendments to NC Agmts
(Oglethorpe 8481, 8482) to be effective 6/7/2016.
    Filed Date: 6/8/16.
    Accession Number: 20160608-5047.
    Comments Due: 5 p.m. ET 6/20/16.

    Docket Numbers: RP16-1021-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Delphi Energy to Chinook
Energy to be effective 6/1/2016.
    Filed Date: 6/8/16.
    Accession Number: 20160608-5061.
    Comments Due: 5 p.m. ET 6/20/16.

    Docket Numbers: RP16-1022-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Compliance filing Pre-Filing Rate Case Settlement
Associated with Docket No. RP11-2107 to be effective 12/31/9998.
    Filed Date: 6/8/16.
    Accession Number: 20160608-5179.
    Comments Due: 5 p.m. ET 6/20/16.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP16-748-001.
    Applicants: Gulf Shore Energy Partners, LP.
    Description: Compliance filing Gulf Shore Energy Filing--Compliance
Filing Amendment to be effective 4/1/2016.
    Filed Date: 6/8/16.

    Accession Number: 20160608-5077.
    Comments Due: 5 p.m. ET 6/20/16.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 9, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-14309 Filed 6-16-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Proposed Rules]
[Pages 5430-5432]
[FR Doc No: 2022-01999]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2021-0774]
RIN 1625-AA08

Special Local Regulation; Montlake Cut, Union Bay Reach, Seattle,
Washington

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a special local
regulation for a recurring marine event on Lake Washington the first
Satruday of May each year. This action is necessary to provide for the
safety of life on the navigable waters during the marine event. This
proposed rulemaking would restrict vessel traffic in the designated
area during the event unless authorized by the Captain of the Port
Sector Puget Sound or a designated representative. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before March 3, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0774 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Chief Warrant Officer William
Martinez, Sector Puget Sound Waterways Management Division, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Puget Sound
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Coast Guard proposes to establish a special local regulation
for the Windermere Cup marine event held annually on the first Saturday
of May each year from 8 a.m. to noon. This event is held on the
navigable waters of the Montlake Cut and Union Bay Reach between
Portage Bay and Webster Point on Lake Washington in Seattle, WA.
    Under 46 U.S.C. 70041, Coast Guard Thirteenth District Commander
has authority to promulgate certain special local regulations deemed
necessary to ensure the safety of life on the navigable waters
immediately before, during, and immediately after an approved marine
event. The District Commander has determined that potential hazards
associated with the marine event would pose a safety concern for anyone
within the race area.
    In order to protect the safety of all waterway users, including
event participants and spectators, this proposed rule would establish a
special local regulation for the time and location of the marine event.
Participant means all persons and vessels registered with the event
sponsor as a participants in the race. Spectator means any vessel in
the vicinity of the marine event with the primary purpose of witnessing
the marine event. Spectator vessels can observe the marine event from
one of the designated spectator areas. One area is located north of
Union Bay Reach in Union Bay. The other is located in the area between
the state route 520 bridge and south of Union Bay Reach. Vessels would
not be permitted to enter the regulated areas unless authorized by the
COTP or a designated representative.

III. Discussion of Proposed Rule

    The Coast Guard proposes to add a new annually recurring special
local regulation on the first Saturday of May each year from 8 a.m. to
12 p.m. The regulated area would cover the all navigable waters from
Montlake Cut and Union Bay Reach between Portage Bay and Webster Point
on Lake Washington in Seattle, from the southern corner of University
of Washington Oceanography pier at 47[deg]38'57'' N, 122[deg]18'45'' W
thence south to 47[deg]38'46'' N, 122[deg]18'45'' W, thence eastward to
Webster Point Light 21 at 47[deg]38'51'' N, 122[deg]16'33'' W, thence
south to the SR520 bridge at 47[deg]38'37'' N, 122[deg]16'34'' W. These
coodinates are based on Nort American Datum 83 (NAD 83).
    The duration of the regulated area is intended to ensure the safety
of the public and participants during the rowing race. Non-participant
vessels are not permitted to enter, transit through, anchor in, or
remain within the regulated area without obtaining permission from the
COTP or a designated representative. A designated representative means
a Coast Guard

Patrol Commander, including a Coast Guard coxswain, petty officer, or
other officer operating a Coast Guard vessel and a Federal, State, and
local officer designated by or assisting the Captain of the Port Puget
Sound (COTP) in the enforcement of the regulations in this section. To
seek permission to enter, contact the COTP or the COTP's representative
by calling the Sector Puget Sound Command Center at<PHONE_NUMBER>. Those
in the regulated area must comply with all lawful orders or directions
given to them by the COTP or the designated representative. The Coast
Guard will provide notice of the regulated area by Broadcast Notice to
Mariners, announcement in the Local Notice to Mariners and on-scene
designated representatives. The regulatory text we are proposing
appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the special local regulation. Vessel traffic
would be able to safely transit around this special local regulation
area which would impact a small-designated area of the Montlake Cut and
Union Bay Reach. Moreover, the Coast Guard would issue a Broadcast
Notice to Mariners via VHF-FM marine channel 16 about the areas, and
the proposed rule would allow vessels to seek permission to enter the
areas.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this proposed rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves regulated
area lasting 4 hours that would prohibit persons or vessels from
transiting the regulated area during the rowing event. Normally such
actions are categorically excluded from further review under paragraph
L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 1. A preliminary Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without

jeopardizing the safety or security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG- 2021-0774 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.1311 to read as follows:

Sec.  100.1311  Special Local Regulation; Montlake Cut, Lake
Washington, Seattle, Washington.

    (a) Regulated area. The regulations in this section apply to the
following area: The navigable waters from Montlake Cut and Union Bay
Reach between Portage Bay and Webster Point on Lake Washington in
Seattle, from the southern corner of University of Washington
Oceanography pier at 47[deg]38'57'' N, 122[deg]18'45'' W thence south
to 47[deg]38'46'' N, 122[deg]18'45''W, thence eastward to Webster Point
Light 21 at 47[deg]38'51'' N, 122[deg]16'33'' W, thence south to the
SR520 bridge at 47[deg]38'37'' N, 122[deg]16'34'' W. These coodinates
are based on Nort American Datum 83 (NAD 83).
    (b) Definitions. As used in this section--
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Sector Puget Sound
(COTP) in the enforcement of the regulations in this section.
    Participant means all persons and vessels registered with the event
sponsor as a participants in the race. Spectator means any vessel in
the vicinity of a marine event with the primary purpose of witnessing
the event. Spectator vessels can observe the marine event from one of
the designated spectator areas. One area is located north of Union Bay
Reach in Union Bay. The other is located in the area between the state
route 520 bridge and south of Union Bay Reach.
    (c) Regulations. (1) All non-participants are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area described in paragraph (a) of this section unless
authorized by the COTP or their designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling the Sector Puget Sound Command Center at 206-
217-6002. Those in the regulated area must comply with all lawful
orders or directions given to them by the COTP or the designated
representative.
    (3) The COTP will provide notice of the regulated area through
advanced notice via broadcast notice to mariners, announcement in the
local notice to mariners, and by on-scene designated representatives.
    (d) Enforcement period. This section will be enforced annually from
8 a.m. to 12 a.m. on first Saturday of May.

    Dated: October 26, 2021.
M.W. Bouboulis,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.

    Editorial note: This document was received for publication by
the Office of the Federal Register on January 27, 2022.

[FR Doc. 2022-01999 Filed 1-31-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Notices]
[Pages 35833-35838]
[FR Doc No: 2014-14693]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72418; File No. SR-MIAX-2014-23]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 515A

June 18, 2014.
    Pursuant to the provisions of 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 5, 2014, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange is filing a proposal to amend Exchange Rule 515A.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, 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 adopted Rule 515A to establish a price improvement
auction (``PRIME Auction'') and a solicited order mechanism
(``Solicitation Auction'').\3\ The Exchange has identified several
additional enhancements to the functionality that the Exchange believes
should be included in the Rules prior to deployment of the new PRIME
Auction and Solicitation Auction functionality. The Exchange proposes
to amend Exchange Rules 515A accordingly.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release Nos. 71640 (March 4,
2014), 79 FR 13334 (March 10, 2014) (SR-MIAX-2014-09) (``Notice'');
72009 (April 23, 2014), 79 FR 24032 (April 29, 2014) (SR-MIAX-2014-
09).
---------------------------------------------------------------------------

    The Exchange proposes to amend Rule 515A(a)(2)(ii)(B) and Rule
515A(b)(2)(ii)(B) in order to provide that the PRIME Auction and
Solicitation Auction will conclude upon the receipt by the System of an
unrelated order (in the same option as the Agency Order) on the
opposite side of the market from the RFR responses, that is marketable
against either the NBBO, the initiating price,\4\ or the RFR responses.
In addition, the Exchange proposes to separately provide in amended
Rule 515A(a)(2)(ii)(C) and Rule 515A(b)(2)(ii)(C) that the PRIME
Auction and Solicitation Auction will conclude upon the receipt by the
System of an unrelated order (in the same option as the Agency Order)
on the same side of the market as the RFR responses, that is marketable
against the NBBO. Currently, the Rules state that the PRIME Auction and
a Solicitation Auction will conclude upon the receipt by the System of
an unrelated order on the same side or opposite side of the market from
the RFR responses, that is marketable against either the MBBO (when
such quote is the NBBO) or the RFR responses.\5\ The proposed change
will add the initiating price of the Auction as an additional trigger
to cause the early termination of an Auction upon the receipt of an
unrelated order on the opposite side of the market from the RFR
responses. The proposed change will also use the NBBO as a trigger to
cause the early termination of an Auction in lieu of the MBBO when such
quote is the NBBO. In addition, the proposed change will restructure
the Rules so that the treatment of same side and opposite side
unrelated orders are described in separate provisions in order to
provide additional clarity and reduce the potential for confusion on
behalf of market participants. The Exchange proposes to make these
enhancements to further ensure that the PRIME Auction and Solicitation
Auction will work seamlessly with the

Exchange's Book in a manner that would ensure a fair and orderly market
by maintaining priority of orders and quotes while still affording the
opportunity for price improvement on each Auction commenced on the
Exchange. The Exchange believes that by using such additional reasons
for terminating an Auction early will improve the interaction between
the Auction and the Exchange's Book and the national market system.
---------------------------------------------------------------------------

    \4\ The ``initiating price'' is the stopped price specified by
the Initiating Member on the Agency Order. See Rule
515A(a)(2)(i)(A).
    \5\ See Rules 515A(a)(2)(ii)(B) and 515A(b)(2)(ii)(B). See also
CBOE Rules 6.74A(b)(2) and 6.74B(b)(2).
---------------------------------------------------------------------------

    The following examples show how the proposed amendments described
above would affect the outcome of the PRIME Auction.

Example 1--Early Conclusion of Auction, limit order on the same
side of the market as RFR Responses that is marketable against NBBO
at the time of arrival

NBBO = $1.20-$1.24 200 x 100
BBO = $1.20-$1.24 100 x 100
Agency Order to buy 50 contracts with a limit of $1.24
Initiating Member's Contra Order selling 50 contracts with a stop
price of $1.24
RFR sent identifying the option, side and size, initiating price of
$1.24 (Auction Starts)
 @ 200 milliseconds MM3 response received, AOC eQuote to
Sell 50 at $1.22
 @ 210 milliseconds MM1 response received, AOC eQuote to
Sell 50 at $1.22
 @ 230 milliseconds MM4 response received, AOC eQuote to
Sell 50 at $1.23
 @ 400 milliseconds BD1 Unrelated Order received Sell 10 at
$1.20 (Opposite-side order marketable against the NBB causes an
early conclusion to the Auction)

    Under this scenario, the Agency Order would be executed as
follows:

1. 10 contracts trade with the unrelated order for BD1 @
$1.21(midpoint of the best RFR response of $1.22 and the opposite
side of the market from the RFR response of $1.20)
2. 20 contracts trade with MM3 @ $1.22
3. 20 contracts trade with MM1 @ $1.22 (This fills the entire Agency
Order)
4. MM4 does not trade any contracts
5. Contra Order does not trade any contracts

Example 2--Early Conclusion of Auction, limit order on the same
side of the market as RFR Responses that is marketable against NBBO
at the time of arrival

NBBO = $1.20-$1.24 200 x 100
BBO = $1.18-$1.26 100 x 100
Agency Order to buy 50 contracts with a limit of $1.24
Initiating Member's Contra Order selling 50 contracts with a stop
price of $1.24
RFR sent identifying the option, side and size, initiating price of
$1.24
(Auction Starts)
 @ 200 milliseconds MM3 response received, AOC eQuote to
Sell 50 at $1.22
 @ 210 milliseconds MM1 response received, AOC eQuote to
Sell 50 at $1.22
 @ 230 milliseconds MM4 response received, AOC eQuote to
Sell 50 at $1.23
 @ 400 milliseconds BD1 Unrelated Order received Sell 10 at
$1.20 (Opposite-side order marketable against the NBB causes an
early conclusion to the Auction)

    Under this scenario, the Agency Order would be executed as
follows:

1. 10 contracts trade with the unrelated order for BD1 @
$1.21(midpoint of the best RFR response of $1.22 and the opposite
side of the market from the RFR response of $1.20)
2. 20 contracts trade with MM3 @ $1.22
3. 20 contracts trade with MM1 @ $1.22 (This fills the entire Agency
Order)
4. MM4 does not trade any contracts
5. Contra Order does not trade any contracts

    In Example 1, since the MBBO is the same as the NBBO, the outcome
of the PRIME Auction will be identical under the proposal as the
current approved Rule.\6\ However, in Example 2, under the proposal,
the PRIME Auction terminates early upon the receipt of the unrelated
order that is marketable against the NBBO, but not the MBBO. In
contrast, in Example 2 under the current approved Rule, the PRIME
Auction would not have terminated early upon the receipt of the
unrelated order that is marketable against the NBBO and could have
continued another 100 milliseconds.\7\
---------------------------------------------------------------------------

    \6\ See Notice, supra note 3, Example 17. See Rule
515A(a)(2)(ii)(B).
    \7\ See Rule 515A(a)(2)(ii)(B).
---------------------------------------------------------------------------

Example 3--Early Conclusion of Auction, IOC marketable against
either side of NBBO at time of arrival

NBBO = $1.20-$1.24 200 x 200
BBO = $1.20-$1.24 100 x 100
Agency Order to buy with a limit price of $1.22 for 20 contracts
Initiating Member's Contra Order selling 20 contracts at $1.22
RFR sent identifying the option, side and size, with initiating
price of $1.22
(Auction Starts)
 @ 100 milliseconds MM3 response received, AOC eQuote to
Sell 20 at $1.22
 @ 210 milliseconds MM1 response received, AOC eQuote to
Sell 20 at $1.22
 @ 330 milliseconds MM4 response received, AOC eQuote to
Sell 20 at $1.22
 @ 400 milliseconds C1 Unrelated IOC Order received Buy 100
at $1.24 (Same side IOC order to buy marketable against the NBO
causes the Auction to conclude early)

    Under this scenario, the Agency Order would be executed as
follows:

1. 8 contracts trade with the Contra Order @ $1.22 (This satisfies
their 40% participation guarantee)
2. 4 contracts trades with MM3 @ $1.22
3. 4 contracts trades with MM1 @ $1.22
4. 4 contracts trade with MM4 @ $1.22 (This fills the entire Agency
Order)
5. C1 unrelated IOC order then executes as follows:

    a. 16 contracts trade with MM3 @ $1.22
    b. 16 contracts trade with MM1 @ $1.22
    c. 16 contracts trade with MM4 @ $1.22
    d. Remaining 52 contracts then executes with the posted market
at the Exchange's $1.24 BO

Example 4--Early Conclusion of Auction, IOC marketable against
either side of NBBO at time of arrival

NBBO = $1.20-$1.24 200 x 200
BBO = $1.18-$1.26 100 xx 100
Agency Order to buy with a limit price of $1.22 for 20 contracts
Initiating Member's Contra Order selling 20 contracts at $1.22
RFR sent identifying the option, side and size, with initiating
price of $1.22
(Auction Starts)
 @ 100 milliseconds MM3 response received, AOC eQuote to
Sell 20 at $1.22
 @ 210 milliseconds MM1 response received, AOC eQuote to
Sell 20 at $1.22
 @ 330 milliseconds MM4 response received, AOC eQuote to
Sell 20 at $1.22
 @ 400 milliseconds C1 Unrelated IOC Order received Buy 100
at $1.24 (Same side IOC order to buy marketable against the NBO
causes the Auction to conclude early)

    Under this scenario, the Agency Order would be executed as
follows:

1. 8 contracts trade with the Contra Order @ $1.22 (This satisfies
their 40% participation guarantee)
2. 4 contracts trades with MM3 @ $1.22
3. 4 contracts trades with MM1 @ $1.22
4. 4 contracts trade with MM4 @ $1.22 (This fills the entire Agency
Order)
5. C1 unrelated IOC order then executes as follows:

    a. 16 contracts trade with MM3 @ $1.22
    b. 16 contracts trade with MM1 @ $1.22
    c. 16 contracts trade with MM4 @ $1.22
    d. Remaining 52 contracts are then canceled

    Similarly, in Example 3, since the MBBO is the same as the NBBO,
the outcome of the PRIME Auction will be identical under the proposal
as the current approved Rule.\8\ However, in Example 4, under the
proposal, the PRIME Auction terminates early upon the receipt of the
unrelated order that is marketable against the NBBO, not the MBBO. In
contrast, in Example 4 under the current approved Rule, the PRIME
Auction would not have terminated early upon the receipt of the
unrelated order that is marketable against the NBBO and could have
continued another 100 milliseconds.\9\
---------------------------------------------------------------------------

    \8\ See Notice, supra note 3, Example 24.
    \9\ See Rule 515A(a)(2)(ii)(D).
---------------------------------------------------------------------------

    As mentioned above, in Examples 2 and 4, the PRIME Auctions could
have continued for another 100 milliseconds under the current approved
rule, with the potential for additional price improvement beyond the
NBBO to the MBBO. However, there is no guarantee that the market would
not move to the detriment of the Agency Order, providing no additional
price improvement. In other words, if market prices moved away from the
Agency Order's price and better prices for the

Member's trading interest exist outside the PRIME Auction, Members
might be unwilling to continue to provide additional price improvement
even if the PRIME Auction continued. Further, the marketable unrelated
order could have also executed prior to the end of the Auction Period,
thus reducing the potential price improvement for the Agency Order
which would be left to execute against any remaining RFR Responses or
the initiating member's stop price. Under the proposal, the unrelated
order benefits from receiving an execution sooner than anticipated
against liquidity that they may not have known was there at the time.
The Exchange believes that the benefits of terminating the PRIME
Auction early for both the Agency Order and the marketable unrelated
order outweigh any marginal loss of opportunity from terminating at the
NBBO versus the MBBO.
    The following examples show how the proposed amendments to
terminate the PRIME Auction and Solicitation Auction early upon the
receipt of an unrelated order on the opposite side of the market from
the RFR Responses that is marketable against the initiating price would
affect the outcome of the PRIME Auction and Solicitation Auction.

Example 5--Early Conclusion of Auction, limit order on the opposite
side of the market from RFR Responses improves initiating price

NBBO = $1.20-$1.24 200 x 200
BBO = $1.20-$1.24 100 x 100
Agency Order to buy 20 contracts with a limit price of $1.22
Initiating Member's Contra Order selling 20 contracts at $1.22
RFR sent identifying the option, side and size, with an initiating
price of $1.22
(Auction Starts)
 @ 300 milliseconds MM3 response received, AOC eQuote to
Sell 20 at $1.22
 @ 310 milliseconds MM1 response received, AOC eQuote to
Sell 20 at $1.22
 @ 430 milliseconds MM4 response received, AOC eQuote to
Sell 20 at $1.22
 @ 450 milliseconds C1 Unrelated Order received Buy 100 at
$1.23 (limit order to buy on the opposite side of the market from
RFR Responses that improves (i.e., is priced higher than) the Agency
Order's initiating price causes the Auction to conclude early)

    Under this scenario, the Agency Order would be executed as
follows:

1. 8 contracts trade with the Contra Order @ $1.22 (This satisfies
their 40% participation guarantee)
2. 4 contracts trades with MM3 @ $1.22
3. 4 contracts trades with MM1 @ $1.22
4. 4 contracts trade with MM4 @ $1.22 (This fills the entire Agency
Order)
5. C1 unrelated order then executes as follows:

    a. 16 contracts trade with MM3 @ $1.22
    b. 16 contracts trade with MM1 @ $1.22
    c. 16 contracts trade with MM4 @ $1.22
    d. Remaining contracts post to the Book as new BB paying $1.23
for 52 contracts

Example 6--Early Conclusion of Auction, limit order on the opposite
side of the market from RFR Responses matches the initiating price

NBBO = $1.20-$1.24 200 x200
BBO = $1.20-$1.24 100 x 100
Agency Order to buy 20 contracts with a limit price of $1.22
Initiating Member's Contra Order selling 20 contracts at $1.22
RFR sent identifying the option, side and size, with an initiating
price of $1.22
(Auction Starts)
 @ 300 milliseconds MM3 response received, AOC eQuote to
Sell 20 at $1.22
 @ 310 milliseconds MM1 response received, AOC eQuote to
Sell 20 at $1.22
 @ 430 milliseconds MM4 response received, AOC eQuote to
Sell 20 at $1.22
 @ 450 milliseconds C1 Unrelated Order received Buy 100 at
$1.22 (limit order to buy on the opposite side of the market from
RFR Responses that matches the Agency Order's initiating price
causes the Auction to conclude early)

    Under this scenario, the Agency Order would be executed as
follows:

1. 8 contracts trade with the Contra Order @ $1.22 (This satisfies
their 40% participation guarantee)
2. 4 contracts trades with MM3 @ $1.22
3. 4 contracts trades with MM1 @ $1.22
4. 4 contracts trade with MM4 @ $1.22 (This fills the entire Agency
Order)
5. C1 unrelated order then executes as follows:

    a. 16 contracts trade with MM3 @ $1.22
    b. 16 contracts trade with MM1 @ $1.22
    c. 16 contracts trade with MM4 @ $1.22
    d. Remaining contracts post to the Book as new BB paying $1.22
for 52 contracts

Example 7--Solicitation Auction--Customer gets price improved for
AON size, unrelated order on the opposite side of the market from
RFR Responses ends auction and trades vs. responses

XYZ Jan 50 Calls
NBBO--1.10-1.25
BBO--1.10-1.30
Paired order to execute 2000 contracts AON (customer selling) @ 1.10
A RFR is broadcast to all subscribers showing option, size, side,
and price; timer is started
System starts the auction at the Initiating Customer price to sell @
1.10
 @ 100 milliseconds Response 1 to buy @ 1.10 2000 AOC order
arrives
 @ 200 milliseconds Response 2 to buy @ 1.10 2000 AOC order
arrives
 @ 220 milliseconds Response 3 to buy @ 1.10 5000 AOC order
arrives
 @ 332 milliseconds Response 4 to buy @ 1.20 1000 AOC order
arrives
 @ 400 milliseconds Response 5 to buy @ 1.15 2000 AOC order
arrives
 @ 450 milliseconds, unrelated same side order arrives
selling 100 @ 1.10--(limit order to sell on the opposite side of the
market from RFR Responses that is marketable against Initiating
Price or RFR responses causes the Auction to conclude early)

    Trade is allocated against Initiating Customer:

1. 1000 trade vs. Response 4 @ 1.20
2. 1000 trade vs. Response 5 @ 1.15
3. Solicited contra does not participate because entire size was
price improved
4. Unrelated same side order trades 100 vs. Response 5 @ 1.15;
balance of response size is cancelled

    In Examples 5, 6,\10\ and 7, the outcome of both the PRIME Auction
and Solicitation Auction will be identical under the proposal as the
current approved Rule.\11\ The Exchange notes that there will be no
impact on the allocation or priority.
---------------------------------------------------------------------------

    \10\ The Commission notes that with respect to Examples 5 and 6,
while the outcome of the PRIME auction is the same under the
proposal as under the current Rule, the cause of early termination
under the proposal differs from the current Rule. Under the current
Rule, the PRIME auctions in Examples 5 and 6 would end early due to
the receipt of an unrelated order on the same side of the market as
the Agency Order that is marketable against an RFR response. See
Rule 515A(a)(2)(ii)(B). However, under the amended Rule, the PRIME
auctions would end early due to the receipt of an unrelated order on
the same side as the Agency Order that is marketable against either
the RFR responses or the initiating price. See amended Rule
515A(a)(2)(ii)(B). In both examples, the best RFR response matches
the initiating price.
    \11\ See Notice, supra note 3, Examples 23 and 28.
---------------------------------------------------------------------------

    The Exchange proposes to amend Rule 515A(a)(2)(ii) and Rule
515A(b)(2)(ii) to provide that the PRIME Auction and Solicitation
Auction will conclude any time an RFR response matches the NBBO on the
opposite side of the market from RFR responses. Currently, the Rules
state that the PRIME Auction will conclude any time an RFR response
matches the MBBO on the opposite side of the market from the RFR
responses.\12\ The proposed change will use the NBBO as a trigger to
cause the early termination of an Auction in lieu of the MBBO. The
Exchange proposes to make this enhancement to further ensure that the
PRIME Auction and Solicitation Auction will work seamlessly with the
national market system in a manner that would ensure a fair and orderly
market by maintaining priority of orders and quotes while still
affording the opportunity for price improvement on each Auction
commenced on the Exchange. The Exchange believes that by using the NBBO
instead of the MBBO as a reason for terminating an Auction early will
improve the interaction between the Auction and the national market
system.
---------------------------------------------------------------------------

    \12\ See Rules 515A(a)(2)(ii) and 515A(b)(2)(ii). See also CBOE
Rules 6.74A(b)(2) and 6.74B(b)(2).
---------------------------------------------------------------------------

    The following examples show how the proposed amendments to use the
NBBO as a trigger to cause the early termination of an Auction in lieu
of the

MBBO would affect the outcome of the PRIME Auction.

Example 8--Single Price Submission, priority customer order on the
Book on the same side locks the final Auction Price

NBBO = $1.15-$1.25 200 x 200
BBO = $1.15-$1.25 100 x 100
Agency Order to buy 50 contracts with a limit price of $1.20
Initiating Member's Contra Order selling 50 contracts with a single
stop price of $1.20
RFR sent identifying the option, side and size, with initiating
price of $1.20
(Auction Starts)
 @ 110 milliseconds MM1 response received, AOC eQuote to
Sell 10 at $1.22
 @ 230 milliseconds MM4 response received, AOC eQuote to
Sell 50 at $1.15 (response matches the opposite side NBB causes the
Auction to conclude early)

    Under this scenario the Agency Order would be executed as
follows:

1. 50 contracts trade with MM4 @ $1.15 (This fills the entire Agency
Order and Contra Order does not receive an execution)

Example 9--Single Price Submission, priority customer order on the
Book on the same side

NBBO = $1.15-$1.25 200 x 200
BBO = $1.14-$1.25 100 x 100
Agency Order to buy 50 contracts with a limit price of $1.20
Initiating Member's Contra Order selling 50 contracts with a single
stop price of $1.20
RFR sent identifying the option, side and size, with initiating
price of $1.20
(Auction Starts)
 @ 110 milliseconds MM1 response received, AOC eQuote to
Sell 10 at $1.22
 @ 230 milliseconds MM4 response received, AOC eQuote to
Sell 50 at $1.15 (response matches the opposite side NBB causes the
Auction to conclude early)
    Under this scenario the Agency Order would be executed as
follows:

1. 50 contracts trade with MM4 @ $1.15 (This fills the entire Agency
Order and Contra Order does not receive an execution)

    In Example 8, since the MBBO is the same as the NBBO, the outcome
of the PRIME Auction will be identical under the proposal as the
current approved Rule.\13\ However, in Example 9, under the proposal,
the PRIME Auction terminates early anytime an RFR Response matches the
NBBO on the opposite side of the market from the RFR Response, but not
the MBBO. In contrast, in Example 9 under the current approved Rule,
the PRIME Auction would not have terminated early upon the receipt of
the unrelated order that is marketable against the NBBO and could have
continued another 270 milliseconds.\14\
---------------------------------------------------------------------------

    \13\ See Notice, supra note 3; Rule 515A(a)(2)(ii)(D).
    \14\ See Rule 515A(a)(2)(ii)(D).
---------------------------------------------------------------------------

    The Exchange notes that the proposed changes detailed above will
likely result in both the shortening of the Auction Period and an
increase in the frequency of early conclusions of the Auction for both
the PRIME Auction and Solicitation Auction and the Agency Order
potentially receiving less opportunity for price improvement. However,
the Exchange believes that the benefits to market participants
(including those participating in the Auctions and outside of the
Auctions) as a result of the new proposed enhancements to make both the
PRIME Auction and Solicitation Auction more integrated with the
Exchange's Book and the national market system, exceed any potential
loss of opportunity for price improvement caused by the proposed
changes.
    The Exchange proposes to amend Interpretations and Policies .06 and
.07 of Rule 515A to provide that same treatment for interest subject to
a route timer as the Rules currently provide for managed interest.
Specifically, the Exchange proposes to amend Interpretation and Policy
.06 to provide that if trading interest exists on the Exchange's Book
that is subject to the managed interest process pursuant to Rule 515(c)
or a route timer pursuant to Rule 529 for the option on the opposite of
side of the market as the Agency Order and when the MBBO is equal to
the NBBO, the Agency Order will be automatically executed against the
managed interest or route timer interest if the execution would be at a
price equal to or better than the initiating price of the Agency Order.
If the Agency Order is not fully executed after the managed interest or
route timer interest is fully exhausted and is no longer at a price
equal to the initiating price of the Agency Order, the Auction will be
initiated for the balance of the order as provided in this rule. With
respect to any portion of an Agency Order that is automatically
executed against managed interest or route timer interest pursuant to
this paragraph .06, the exposure requirements contained in Rule 520(b)
and (c) will not be satisfied just because the member utilized the
PRIME. Trading interest subject to a route timer on the opposite side
of the market as the Agency Order pursuant to Rule 515(c) is posted at
one minimum trading increment away from the NBBO, but is available for
execution at the NBBO. In order to preserve the priority of trading
interest subject to a route timer against incoming RFR responses to the
Auction of the Agency Order, the System will execute the Agency Order
to the extent possible. The Exchange believes that this provision is
necessary to ensure that PRIME works seamlessly with the Exchange's
Book in a manner that would ensure a fair and orderly market by
maintaining priority of orders and quotes while still affording the
opportunity for price improvement on each Auction commenced on the
Exchange.
    In addition, the Exchange proposes to amend Interpretation and
Policy .07 to provide that if trading interest exists on the Exchange's
Book that is subject to the managed interest process pursuant to Rule
515(c) or a route timer pursuant to Rule 529 for the option on the same
side of the market as the Agency Order, the Agency Order will be
rejected by the System prior to initiating an Auction or a Solicitation
Auction. The Exchange also proposes to provide that if trading interest
exists on the MIAX Book that is subject to the liquidity refresh pause
pursuant to Rule 515(c) for the option on the same side or opposite
side of the market as the Agency Order, the Agency Order will be
rejected by the System prior to initiating an Auction or a Solicitation
Auction. Trading interest subject to a liquidity refresh pause or a
route timer is posted at one minimum trading increment away from the
NBBO, but is available for execution at the NBBO. In order to preserve
the priority of trading interest subject to a liquidity refresh pause
or a route timer against incoming RFR responses to the Auction of the
Agency Order, the System will reject the Agency Order. The Exchange
believes that this provision is necessary to ensure that PRIME works
seamlessly with the Exchange's Book in a manner that would ensure a
fair and orderly market by maintaining priority of orders and quotes
while still affording the opportunity for price improvement on each
Auction commenced on the Exchange.
    Finally, the Exchange proposes new Interpretation and Policy .09 to
provide that if the market is locked or crossed as defined in Rule 1402
for the option, the Agency Order will be rejected by the System prior
to initiating a PRIME Auction or a Solicitation Auction. The Exchange
believes that this provision is necessary to ensure that PRIME works
seamlessly with the national market system in a manner that would
ensure a fair and orderly market by maintaining priority of orders and
quotes while still affording the opportunity for price improvement on
each Auction commenced on the Exchange.
    The Exchange also proposes a couple minor technical changes to the
Rules. The Exchange also proposes an updated comprehensive list of the
data that the Exchange represents that it will collect in order to aid
the Commission in its

evaluation of the PRIME that incorporates the changes proposed.\15\
---------------------------------------------------------------------------

    \15\ See Rule 515A, Interpretations and Policies .08; Exhibit 3.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) \16\ of the Act in general, and furthers the
objectives of Section 6(b)(5) \17\ of the Act 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 facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposal to add the initiating price of the Auction and to use
the NBBO as a trigger to cause the early termination of an Auction is
designed to facilitate transactions, to remove impediments to and
perfect the mechanism of a free and open market by freeing up interest
in the Auction when conditions have changed that renders the initiating
order no longer marketable to the benefit of market participants. The
proposed enhancements to the Rules are designed to further ensure that
the Auctions will work seamlessly with the national market system in a
manner that would ensure a fair and orderly market by maintaining
priority of orders and quotes while still affording the opportunity for
price improvement on each Auction commenced on the Exchange. The
Exchange believes that by using the NBBO instead of the MBBO as a
reason for terminating an Auction early will improve the interaction
between the Auction and the national market system.
    The proposal to provide similar treatment for interest subject to a
liquidity refresh pause and a route timer as the Rules currently
provide for managed interest is also designed to ensure that PRIME
works seamlessly with the Exchange's Book in a manner that would ensure
a fair and orderly market by maintaining priority of orders and quotes
while still affording the opportunity for price improvement on each
Auction commenced on the Exchange in a manner that also protects
investors and the public interest.
    Finally, the proposal to reject Agency Orders if the market is
locked or crossed is designed to ensure that PRIME works seamlessly
with the national market system in a manner that would ensure a fair
and orderly market by maintaining priority of orders and quotes while
still affording the opportunity for price improvement on each Auction
commenced on the Exchange.

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. The PRIME Auction and
Solicitation Auction are designed to increase competition for order
flow on the Exchange in a manner intended to be beneficial to investors
seeking to effect option orders with an opportunity to access
additional liquidity and receive price improvement. The Exchange notes
that it operates in a highly competitive market in which market
participants can readily direct order flow to competing venues who
offer similar functionality. The Exchange believes that the proposed
changes to the Auctions are pro-competitive by providing market
participants with functionality that is similar to that of other
options exchanges. The Exchange notes that not having the PRIME Auction
and Solicitation Auction places the Exchange at a competitive
disadvantage versus other exchanges that offer similar price
improvement functionality.

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

    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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \18\ and Rule 19b-4(f)(6) \19\
thereunder.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 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.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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 to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2014-23 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 Number SR-MIAX-2014-23. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only

information that you wish to make available publicly. All submissions
should refer to File Number SR-MIAX-2014-23 and should be submitted on
or before July 15, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14693 Filed 6-23-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Page 80959]
[FR Doc No: 2011-33038]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4048-DR; Docket ID FEMA-2011-0001]

New Jersey; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New Jersey (FEMA-4048-DR), dated November 30, 2011,
and related determinations.

DATES: Effective Date: December 12, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New Jersey is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of November 30, 2011.

    Bergen, Middlesex, and Passaic Counties for Public Assistance.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-33038 Filed 12-23-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9512-9513]
[FR Doc No: 2021-03068]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0134]

Joint Meeting of the Arthritis Advisory Committee and the Drug
Safety and Risk Management Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Arthritis Advisory Committee
and the Drug Safety and Risk Management Advisory Committee. The general
function of the committees is to provide advice and recommendations to
FDA on 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 March 24, 2021, from 9 a.m. to 4:30
p.m. Eastern Time and March 25, 2021, from 10 a.m. to 1 p.m. Eastern
Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0134. The docket will close on March
23, 2021. Submit either electronic or written comments on this public
meeting by March 23, 2021. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before March 23, 2021. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of March 23, 2021. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before March 10, 2021, will be provided to
the committees. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2021-N-0134 for ``Joint Meeting of the Arthritis Advisory Committee
and the Drug Safety and Risk Management Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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.'' FDA 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 Dockets Management Staff. If you do not wish your name
and contact information 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 the 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.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug

Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,
email<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 FDA's website at https://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 meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The
committees will discuss biologics license application (BLA) 761130,
tanezumab subcutaneous injection, submitted by Pfizer Inc., for the
proposed indication of relief of signs and symptoms of moderate to
severe osteoarthritis in adult patients for whom use of other
analgesics is ineffective or not appropriate.
    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 website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before March 10, 2021, will be provided to the
committees. Oral presentations from the public will be scheduled
between approximately 3:30 p.m. and 4:30 p.m. Eastern Time on March 24,
2021. 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
March 2, 2021. 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 March 3, 2021.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    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 Moon Hee V. Choi (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://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: February 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03068 Filed 2-12-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60019-60021]
[FR Doc No: 2017-27133]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0759]

Drug Products, Including Biological Products, That Contain
Nanomaterials; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Drug
Products, Including Biological Products, that Contain Nanomaterials.''
This draft guidance has been developed to provide industry with the
Agency's current thinking for the development of human drug products,
including those that are biological products, that contain
nanomaterials. The draft guidance also includes recommendations for
applicants and sponsors of investigational, premarket, and postmarket
submissions for these products.

DATES: Submit either electronic or written comments on the draft
guidance by March 19, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-D-0759 for ``Drug Products, Including Biological Products,
that Contain Nanomaterials.'' 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 Dockets
Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Tyner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4146, Silver Spring, MD 20993-0002, 301-
796-0085; or Stephen Ripley, Center for Biologics Evaluation and
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Drug Products, Including Biological Products, That Contain
Nanomaterials.'' This guidance applies to human drug products,
including those that are biological products, in which a nanomaterial
is present in the finished dosage form. This draft guidance discusses
both general principles and specific considerations for the development
of drug products containing nanomaterials, including considerations for
establishing the equivalence of such products with other drugs.
Considerations for quality, nonclinical, and clinical studies are
discussed as they relate to drug products containing nanomaterials
throughout product development and production.
    This draft guidance does not limit or classify the types of
nanomaterials that can be used in drug products. Rather, it is focused
on the deliberate and purposeful manipulation and control of dimensions
to produce specific physicochemical properties which may warrant
further evaluation with regards to safety, effectiveness, performance,
and quality. This guidance does not address, or presuppose, what
ultimate regulatory outcome, if any, will result for a particular drug
product that contains nanomaterials. Issues such as the safety,
effectiveness, public health impact, or the regulatory status of drug
products that contains nanomaterials are currently addressed on a case-
by-case basis using FDA's existing review processes. Current CDER and
CBER guidance documents and requirements for the evaluation and
maintenance of quality, safety, and efficacy, apply to drug product
containing nanomaterials that otherwise fall within their scopes. In
addition, the Agency may continue to develop guidance addressing
certain specific commonly-used types of nanomaterials, e.g., some
liposomes, to better address the challenges in evaluating and
characterizing the quality and performance of drug products that
incorporate them.
    This draft guidance is one of several FDA guidance documents
related to FDA-regulated products that may involve the use of
nanotechnology. FDA has not established regulatory definitions of
``nanotechnology,'' ``nanomaterial,'' ``nanoscale,'' or other related
terms. In Guidance for Industry,'' Considering Whether an FDA-Regulated
Product Involves the Application of Nanotechnology,'' issued in 2014,
FDA described certain considerations for determining whether FDA-
regulated products involve the application of nanotechnology. FDA will
apply these considerations broadly to all FDA-regulated products,
including drug products within the scope of this draft guidance. The
use of the term ``nanomaterial'' in this draft guidance, as in other
FDA guidance documents, does not constitute the establishment of a
regulatory definition. Rather, we use this term for ease of reference
only. See section II of the draft guidance for additional information.
    FDA requests comment on the draft guidance. We also seek comment on
the terminology, including the term ``nanomaterial'', as used in the
draft guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on Drug Products,
Including Biological Products, That Contain Nanomaterials. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes recommendations related to collections
of information that are subject to review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44
U.S.C. 3501-3520). The collections of information that are related to
the burden of submitting investigational new drug applications are
covered under 21 CFR part 312 and have been approved under OMB control
number 0910-0014. The collections of information related to the burden
of submitting new drug applications, including supplemental
applications, are covered under 21 CFR part 314 and have been approved
under OMB control number 0910-0001. The collections of information
related to the burden of submitting section 351(k) biosimilar
applications have been approved under OMB control number 0910-0719. The
collections of information related to the burden of complying with the
current good manufacturing process recordkeeping requirements under 21
CFR part 211 have been approved under OMB control number 0910-0139. The
collections of information related to the burden of complying with the
environmental impact requirements under 21 CFR part 25 have been
approved under OMB control number 0910-0322. The design and testing of
prescription drug labeling required under 21 CFR 201.56 and 201.57 is
approved under OMB control number

0910-0572. Concerning the immediate container label and outer container
or package, in the Federal Register of December 18, 2014 (79 FR 75506),
we published a proposed rule on the electronic distribution of
prescribing information for human prescription drugs, including
biological products. In Section VII, Paperwork Reduction Act of 1995,
we estimated the burden to design (including revisions), test, and
produce the label for a drug's immediate container and outer container
or package, as set forth in 21 CFR part 201 and other sections in
subpart A and subpart B.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
https;www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27133 Filed 12-15-17; 8:45 am]
 BILLING CODE 4164-01-P