[Federal Register Volume 76, Number 247 (Friday, December 23, 2011)]
[Notices]
[Pages 80420-80421]
[FR Doc No: 2011-32919]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 19d-2, OMB Control No. 3235-0205, SEC File No. 270-204.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.) the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the existing collection
of information of Rule 19d-2 (17 CFR 240.19d-2) under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act'').
    Rule 19d-2 prescribes the form and content of applications to the
Commission by persons desiring stays of final disciplinary sanctions
and summary action of self-regulatory organizations (``SROs'') for
which the Commission is the appropriate regulatory agency.
    It is estimated that approximately fifteen respondents will utilize
this application procedure annually, with a total burden of 45 hours,
based upon past submissions. The staff estimates that the average
number of hours necessary to comply with the requirements of Rule 19d-2
is 3 hours.
    Based on the most recent available information, the Commission
staff estimates that the cost to respondents of complying with the
requirements of Rule 19d-2 is $876 per response. Therefore, the
Commission staff estimates that the total annual reporting cost per
respondent is $876 (1 response/respondent/year x $876 cost/response),
for a total annual related cost to all respondents of $13,140 ($876
cost/respondent x 15 respondents).
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid Office of Management and Budget control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory

Affairs, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or by sending an email to:
<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312 or send an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: December 19, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-32919 Filed 12-22-11; 8:45 a.m.]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64238-64239]
[FR Doc No: 2022-23018]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1862]

In Vitro Permeation Test Studies for Topical Products Submitted
in Abbreviated New Drug Applications; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``In Vitro
Permeation Test Studies for Topical Products Submitted in ANDAs.'' This
draft guidance document provides recommendations for in vitro
permeation test (IVPT) studies for locally acting liquid-based and/or
other semisolid topical products. This draft guidance is intended to
assist applicants who are submitting abbreviated new drug applications
(ANDAs) for such products by providing recommendations for IVPT
studies, which can be used to support a demonstration that two topical
products are bioequivalent.

DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2022 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-2022-D-1862 for ``In Vitro Permeation Test Studies for Topical
Products Submitted in ANDAs.'' 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, 240-
402-7500.
     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.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>.
    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 the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Levine, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``In Vitro Permeation Test Studies for Topical Products Submitted in
ANDAs.'' This draft guidance document provides recommendations on IVPT
studies for locally acting liquid-based and/or other semisolid topical
products. This draft guidance is intended to assist applicants who are
submitting ANDAs for such products by providing recommendations for
IVPT studies, which can support a demonstration that two topical
products are bioequivalent.
    Once validated, an IVPT study may be used to assess the rate and
extent to which an active ingredient from a topical product becomes
available at or near a site of action in the skin and may be used to
characterize and compare the rate and extent of bioavailability for a
drug from a test topical product and the reference standard. This draft
guidance focuses on general considerations and recommendations for the
method development, method validation, and conduct of IVPT studies that
are submitted in ANDAs and intended to support a demonstration of
bioequivalence.

    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 ``In Vitro
Permeation Test Studies for Topical Products Submitted in ANDAs.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for the submission of ANDAs have been approved under OMB
control number 0910-0001. Applicant submission of controlled
correspondence related to generic drug development and FDA approval is
approved under OMB control number 0910-0797. The collections of
information that support Good Laboratory Practice for Non-Clinical
Laboratory Studies have been approved under OMB control number 0910-
0119. The collections of information in part 320 for ``Investigational
New Drug Safety Reporting Requirements for Human Drug and Biological
Products and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans'' have been approved under OMB control
number 0910-0014. The recordkeeping requirement for CGMP sample
retention in 21 CFR 211.170 has been approved under OMB control number
0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23018 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 172 (Thursday, September 7, 2017)]
[Notices]
[Pages 42407-42410]
[FR Doc No: 2017-18937]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81512; File No. SR-BX-2017-039]

Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Address the
Application of Exchange Rule 11140 (Transactions in Securities ``Ex-
Dividend,'' ``Ex-Rights'' or ``Ex-Warrants'') as it Relates to
Establishing Ex-Dividend Dates in connection With the Implementation of
the T+2 Settlement Cycle on September 5, 2017

August 31, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 29, 2017, NASDAQ BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to address the application of Exchange Rule
11140 (Transactions in Securities ``Ex-Dividend,'' ``Ex-Rights'' or
``Ex-Warrants'') as it relates to establishing ex-dividend dates in
connection with the implementation of the T+2 settlement cycle on
September 5, 2017. No change to the text of Rule 11140(b)(1) is
required by this proposal.

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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
Background
    On March 22, 2017, the SEC adopted amendments to SEA Rule 15c6-1(a)
to shorten the standard settlement cycle for U.S. secondary market
transactions in equities, corporate and municipal bonds, unit
investment trusts and financial instruments composed of these products,
from three business days after the trade date (``T+3'') to two business
days after the trade date (``T+2'').\3\ The industry-wide initiative is
designed to reduce a number of risks, including credit risk, market
risk, and liquidity risk and, as a result, reduce systemic risk for
U.S. market participants.\4\ The compliance date for the rule
amendments is September 5, 2017.
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    \3\ See Securities Exchange Act Release No. 80295 (March 22,
2017), 82 FR 15564 (March 29, 2017) (Securities Transaction
Settlement Cycle) (File No. S7-22-16) (stating that, as amended, SEA
Rule 15c6-1(a) will prohibit broker-dealers from effecting or
entering into a contract for the purchase or sale of a security
(other than an exempted security, government security, municipal
security, commercial paper, bankers' acceptances or commercial
bills) that provides for payment of funds and delivery of securities
later than the second business day after the date of the contract,
unless otherwise expressly agreed to by the parties at the time of
the transaction).
    \4\ See id.
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    In support of this initiative, the Exchange proposed changes to its
rules pertaining to securities settlement by, among other things,
amending the definition of ``regular way'' settlement as occurring on
T+2.\5\ On May 10, 2017, the SEC approved the Exchange's amendments to
the applicable rules, including Rule 11140(b), that establish or
reference T+3 to conform to T+2, and these amendments will become
effective on September 5, 2017.\6\
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    \5\ See Securities Exchange Act Release No. 34-80282 (March 21,
2017), 82 FR 15258 (March 27, 2017) (Notice of Filing of File No.
SR-BX-2017-13).
    \6\ See Securities Exchange Act Release No. 34-80640 (May 10,
2017), 82 FR 22598 (May 16, 2017) (Order Approving File No. SR-BX-
2017-13).
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    During the transition period the industry and self-regulatory
organizations (``SROs''), including The Depository Trust Company
(``DTC'') which processes corporate action events, have raised concern
that the September 5, 2017 industry-wide transition date from T+3 to
T+2 will result in September 7, 2017 being a ``double'' settlement date
for trades that occur on September 1, 2017 (under T+3 and reflecting
the Labor Day holiday on September 4, 2017) and trades that occur on
September 5, 2017 (under T+2), which generally will result in investors
who trade on either date being deemed a record holder of September 7,
2017.\7\ In order to avoid confusion about the proper settlement date
and to coordinate with other SROs, the Exchange is proposing not to
establish September 5, 2017 as an ex-dividend date for applicable
securities.
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    \7\ See, e.g., Nasdaq Issuer Alert 2017-001, Changes to Ex-
dividend Procedures Effective September 5, 2017 to Accommodate T+2
Settlement, http://nasdaq.cchwallstreet.com/nasdaq/pdf/nasdaq-issalerts/2017/2017-001.pdf; NYSE, NYSE MKT, NYSE ARCA: Changes
Related to the Shortened Settlement Cycle (T+2) (July 11, 2017),
https://www.nyse.com/trader-update/history#110000069618.
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Proposal
    The Exchange is proposing to address the application of Rule
11140(b) as it relates to the ex-dividend date in connection with the
implementation of the T+2 settlement cycle on September 5, 2017. As
amended to address T+2, the timeframes in Rule 11140 to establish an
ex-dividend date were generally reduced by one business day.
    The ex-dividend date (or ex-date) is the date on or after which a
security is traded without a specific dividend or distribution. Rule
11140(b) provides for the determination of normal ex-dividend and ex-
warrant dates for certain types of dividends and distributions. As
amended to address T+2, Rule 11140(b)(1) provides that with respect to
cash dividends or distributions, or stock dividends, and the issuance
or distribution of warrants, which are less than 25% of the value of
the subject security (i.e., ``regular'' distributions), if the
definitive information is received sufficiently in advance of the
record date, the date designated as the ``ex-dividend date'' is the
first business day preceding the record date if the record date falls
on a business day, or the second business day preceding the record date
if the record date falls on a day designated by the Exchange's Uniform
Practice Code (``UPC'') Committee as a non-delivery date.\8\ Rule
11140(b)(2), which did not require amendment in connection with T+2,
establishes the ex-dividend date as the first business day following
the payable date with respect to cash dividends or distributions, stock
dividends and/or splits, and the distribution of warrants, which are
25% or greater of the value of the subject security (i.e., ``large''
distributions).\9\
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    \8\ The record date is the date fixed by an issuer for the
purpose of determining the holder of the security who is eligible to
receive the dividend, interest or principal payment, or any other
distribution relating to the security.
    \9\ The payable date is the date that the dividend is sent to
the record owner of the security.
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    Consistent with the compliance date of the amendments to SEA Rule
15c6-1(a), the industry and the Exchange have adopted Tuesday,
September 5, 2017 as the transition date to the T+2 settlement
cycle.\10\ To mitigate the potential confusion that may result
concerning proper settlement during the transition period, the
Exchange, in coordination with other SROs, supports the proposal that
Tuesday, September 5, 2017 should not be designated as an ex-dividend
date.\11\
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    \10\ See Nasdaq Equity Trader Alert 2017-174 (July 28, 2017).
    \11\ See, e.g., Nasdaq Issuer Alert 2017-001, Changes to Ex-
dividend Procedures Effective September 5, 2017 to Accommodate T+2
Settlement, http://nasdaq.cchwallstreet.com/nasdaq/pdf/nasdaq-issalerts/2017/2017-001.pdf; NYSE, NYSE MKT, NYSE ARCA: Changes
Related to the Shortened Settlement Cycle (T+2) (July 11, 2017),
https://www.nyse.com/trader-update/history#110000069618.
---------------------------------------------------------------------------

    Accordingly, the Exchange proposes to interpret Rule 11140(b)(1) so
that the first record date to which the new ex-dividend date
determination will be applied will be Thursday, September 7, 2017. The
ex-dividend dates for ``regular'' distributions during the transition
to T+2 will be as follows:
---------------------------------------------------------------------------

    \12\ The last day of the T+3 settlement cycle.
    \13\ The first day of the T+2 settlement cycle.
    \14\ Monday, September 4, 2017 is Labor Day, a Federal holiday.
    \15\ See id.
    \16\ The date on which previous trades settling on a T+3
settlement cycle and current trades on the T+2 settlement cycle will
be processed.

----------------------------------------------------------------------------------------------------------------
                 Record date                                                Ex-date
----------------------------------------------------------------------------------------------------------------
Friday, September 1, 2017 \12\..............  Wednesday, August 30, 2017.
Tuesday, September 5, 2017 \13\.............  Thursday, August 31, 2017.\14\
Wednesday, September 6, 2017................  Friday, September 1, 2017.\15\
Thursday, September 7, 2017 \16\............  Wednesday, September 6, 2017.
----------------------------------------------------------------------------------------------------------------

    As described above, the ex-date for ``large'' distributions under
Rule 11140(b)(2) is the first business day following the payable date.
This provision was not amended in connection with T+2. In order to
ensure that September 5, 2017 will not be designated as an ex-dividend
date for ``large'' distributions, the Exchange will advise issuers to
not set September 1, 2017 as the payable date for any ``large''
distribution under Rule 11140(b)(2) and proposes to interpret Rule
11140(b)(2) so that, if an issuer sets September 1, 2017 as the payable
date for a ``large'' distribution, the ex-dividend date will be
September 6, 2017, not September 5, 2017.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\17\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\18\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest. Specifically, the Exchange believes that the proposal to
address the application of Rule 11140(b) to exclude September 5, 2017
as an ex-dividend date for ``regular'' or ``large'' distributions
supports the collective effort among the industry and SROs to mitigate
the potential confusion concerning proper settlement during the
transition from the T+3 settlement cycle to the T+2 settlement cycle.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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. As noted above, the SROs
support that no securities will be subject to an ex-date ruling on
September 5, 2017. The primary benefit of this proposal is to minimize
potential confusion about proper settlement that may arise during the
transition to the T+2 settlement cycle.\19\ The Exchange believes that
the proposal would not impose any additional costs on the industry. As
noted above, the proposal does not change the text to Rule 11140(b).
Instead, the proposal interprets the application of the rule solely to
refrain from designating September 5, 2017 as an ex-dividend date for
``regular'' or ``large'' distributions.
---------------------------------------------------------------------------

    \19\ As a result of the September 5, 2017 transition date for
regular-way settlement from T+3 to T+2, September 7, 2017 will be a
``double'' settlement date for trades that occur on September 1,
2017 (under T+3 and reflecting the Labor Day holiday on September 4,
2017) and trades that occur on September 5, 2017 (under T+2).
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \20\ and Rule 19b-4(f)(6)
thereunder.\21\
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of 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.
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    A proposed rule change filed under Rule 19b-4(f)(6) \22\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\23\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative upon filing. The Exchange has stated that the
purpose of the proposed rule change is to minimize confusion about
proper settlement that may arise during the transition to the T+2
settlement cycle on September 5, 2017. The Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest to avoid the confusion that could
arise in connection with the transition to the T+2 settlement cycle on
September 5, 2017, if normal or large distributions were to be ex-
dividend on that date. Accordingly, the Commission hereby waives the
30-day operative delay requirement and designates the proposed rule
change as operative upon filing.\24\
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    \22\ 17 CFR 240.19b-4(f)(6).
    \23\ 17 CFR 240.19b-4(f)(6)(iii).
    \24\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of 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-BX-2017-039 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-BX-2017-039. 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-BX-2017-039, and should be
submitted on or before September 28, 2017.
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-18937 Filed 9-6-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 17, 2005 (Volume 70, Number 221)]
[Notices]
[Page 69793-69795]
[DOCID:fr17no05-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52758; File No. SR-NASD-2005-126]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Order Granting Accelerated Approval
of Proposed Rule Change To Modify the Pricing for Non-Members Using
Nasdaq's Brut Facility

November 9, 2005.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 26, 2005, the National Association of Securities Dealers,
Inc. (``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons, and at

the same time is granting accelerated approval of the proposed rule
change.
---------------------------------------------------------------------------

    \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

    Nasdaq proposes to modify the pricing for non-members using
Nasdaq's Brut Facility (``Brut''). Nasdaq requests approval to
implement the proposed rule change retroactively as of November 1,
2005. The text of the proposed rule change is below. Proposed new
language is in italics. Proposed deletions are in [brackets].
* * * * *

7010. System Services

    (a)-(h) No change.
    (i) Nasdaq Market Center and Brut Facility Order Execution
    (1)-(5) No change.
    (6) The fees applicable to non-members using Nasdaq's Brut Facility
shall be the fees established for members under Rule 7010(i), as
amended by SR-NASD-2005-019, SR-NASD-2005-035, SR-NASD-2005-048, [and
]SR-NASD-2005-071, and SR-NASD-2005-125, and as applied to non-members
by SR-NASD-2005-020, SR-NASD-2005-038, SR-NASD-2005-049, [and ]SR-NASD-
2005-072, and SR-NASD-2005-126.
    (j)-(v) No change.
* * * * *

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

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

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

1.Purpose
    In SR-NASD-2005-125, which applies to NASD members, Nasdaq has
modified the fee schedule applicable to execution and routing of orders
in exchange-traded funds (``ETFs'') listed on exchanges other than the
American Stock Exchange (``Amex''). In this filing, Nasdaq is proposing
to apply the same modification to non-NASD members that use Nasdaq's
Brut Facility.
    Nasdaq states that, prior to NASD-2005-125, execution and routing
of Nasdaq-listed stocks and Amex-listed ETFs has been subject to the
fee schedule in NASD Rule 7010(i)(1), whereas execution and routing of
other exchange-listed securities, including other exchange-listed ETFs,
had generally not been subject to per order routing and execution
charges. Because an increasing number of ETFs are being listed on
exchanges other than the Amex, however, Nasdaq states that it has
concluded that it is necessary to apply the same fee schedule to all
ETFs, to ensure that its fees are commensurate with the volumes of
shares being routed and executed through its systems.
2.Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 15A of the Act,\3\ in general, and with
Section 15A(b)(5) of the Act,\4\ in particular, in that the proposed
rule change provides for the equitable allocation of reasonable dues,
fees, and other charges among members and issuers and other persons
using any facility or system which the NASD operates or controls. The
proposed rule change applies to non-members that use Nasdaq's Brut
Facility a fee change that is being implemented for NASD members that
use the Nasdaq Market Center and/or Nasdaq's Brut Facility.
Accordingly, Nasdaq believes that the proposed rule change promotes an
equitable allocation of fees between members and non-members using
Nasdaq's order execution facilities. Nasdaq states that the proposed
change reflects the increased extent to which ETFs are being listed on
exchanges other than the Amex and would result in the application of
the same fee schedule to all ETFs, regardless of where they are listed.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78o-3.
    \4\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

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

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

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

    Nasdaq states that written comments were neither solicited nor
received.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2005-126 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-NASD-2005-126. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at Nasdaq's
Office of the Secretary. 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-NASD-2005-126 and should be submitted on or before December 8, 2005.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a self-regulatory

organization.\5\ Specifically, the Commission believes that the
proposed rule change is consistent with Section 15A(b)(5) of the
Act,\6\ which requires that the rules of the self-regulatory
organization provide for the equitable allocation of reasonable dues,
fees, and other charges among members and issuers and other persons
using any facilities or system which it operates or controls.
---------------------------------------------------------------------------

    \5\ The Commission has considered the proposed rule's impact on
efficiency, competition and capital formation. 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

    The Commission notes that this proposal would retroactively modify
pricing for non-NASD members using the Nasdaq's Brut Facility to be
implemented as of November 1, 2005. This proposal would permit the
schedule for non-NASD members to mirror the schedule applicable to NASD
members that became effective October 26, 2005, pursuant to SR-NASD-
2005-125 and that Nasdaq stated it would implement on November 1, 2005.
    The Commission finds good cause for approving the proposed rule
change prior to the 30th day of the date of publication of the notice
thereof in the Federal Register. The Commission notes that the proposed
fees for non-NASD members are identical to those in SR-NASD-2005-125,
which implemented those fees for NASD members and which became
effective as of October 26, 2005. The Commission notes that this change
will promote consistency in Nasdaq's fee schedule by applying the same
pricing schedule with the same date of effectiveness for both NASD
members and non-NASD members. Therefore, the Commission finds that
there is good cause, consistent with Section 19(b)(2) of the Act,\7\ to
approve the proposed change on an accelerated basis.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (File No. SR-NASD-2005-126), is
approved on an accelerated basis.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
[FR Doc. E5-6356 Filed 11-16-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27061-27062]
[FR Doc No: 2011-11359]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0631]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Updating Labeling for Susceptibility Test Information in Systemic
Antibacterial Drug Products and Antimicrobial Susceptibility Testing
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 9,
2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0638.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Updating Labeling for Susceptibility Test
Information in Systemic Antibacterial Drug Products and Antimicrobial
Susceptibility Testing Devices--(OMB Control Number 0910-0638)--
Extension

    The Food and Drug Administration Amendments Act of 2007 (FDAAA)
includes a requirement that FDA identify and periodically update
susceptibility test interpretive criteria for antibacterial drug
products and make those findings publicly available. As a result of
this provision, the guidance explains the importance of making
available to health care providers the most current information
regarding susceptibility test interpretive criteria for antibacterial
drug products. To address concerns about antibacterial drug product
labeling with out-of-date information on susceptibility test
interpretive criteria, quality control parameters, and susceptibility
test methods, the guidance describes procedures for FDA, applications
holders, and antimicrobial susceptibility testing device manufacturers
to ensure that updated susceptibility test information is available to
health care providers. Where appropriate, FDA will identify
susceptibility test interpretive criteria, quality control parameters,
and susceptibility test methods by recognizing annually, in a Federal
Register notice, standards developed by one or more nationally or
internationally recognized standard development organizations. The FDA
recognized standards will be available to application holders of
approved antibacterial drug products for updating their product
labeling.
    Application holders can use one of the following approaches to meet
their responsibilities to update their product labeling under the
guidance and FDA regulations: Submit a labeling supplement that relies
upon a standard recognized by FDA in a Federal Register notice or
submit a labeling supplement that includes data supporting a proposed
change to the microbiology information in the labeling. In addition,
application holders should include in their annual report an assessment
of whether the information in the ``Microbiology'' subsection of their
product labeling is current or whether changes are needed. This
information collection is already approved by OMB under control number
0910-0572 (the requirement in 21 CFR 201.56(a)(2) to update labeling
when new information becomes available that causes the labeling to
become inaccurate, false, or misleading) and control number 0910-0001
(the requirement in 21 CFR

314.70(b)(2)(v) to submit labeling supplements for certain changes in
the product's labeling and the requirement in 21 CFR 314.81(b)(2)(i) to
include in the annual report a brief summary of significant new
information from the previous year that might affect the labeling of
the drug product).
    In addition, under the guidance, if the information in the
applicant's product labeling differs from the standards recognized by
FDA in the Federal Register notice, and the applicant believes that
changes to the labeling are not needed, the applicant should provide
written justification to FDA why the recognized standard does not apply
to its drug product and why changes are not needed to the
``Microbiology'' subsection of the product's labeling. This
justification should be submitted as general correspondence to the
product's application, and a statement indicating that no change is
currently needed and the supporting justification should be included in
the annual report. Based on our knowledge of the need to update
information on susceptibility test interpretive criteria,
susceptibility test methods, and quality control parameters in the
labeling for systemic antibacterial drug products for human use, and
our experience with the FDAAA requirement and the guidance
recommendations during the past 16 months, we estimate that, annually,
approximately two applicants will submit the written justification
described previously and in the guidance, and that each justification
will take approximately 16 hours to prepare and submit to FDA as
general correspondence and as part of the annual report.
    In the Federal Register of December 23, 2010 (75 FR 80823), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
                                    respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Justification Submitted as                     2               1               2              16              32
 General Correspondence and in
 the Annual Report..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11359 Filed 5-9-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Rules and Regulations]
[Pages 16185-16188]
[FR Doc No: 2023-04928]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket Number USCG-2019-0952]
RIN 1625-AA01

Anchorage Regulations; Special Anchorages Areas Within the First
Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The First Coast Guard District is removing notes from its
special anchorage area regulations and removing language from the text
of four of these regulations because those provisions are inconsistent
with simply designating the location of a special anchorage area. These
existing notes and regulatory text provisions, which contain obsolete
and duplicative language, will be replaced with a note in a new section
we are adding that will apply to all special anchorage area regulations
in the First Coast Guard District. The note will advise interested
persons that state and local regulations may apply and that they should
contact other authorities, such as the local harbormaster, to ensure
compliance with any such applicable regulations. These changes are
primarily editorial in nature and are intended to clarify and update
First Coast Guard District special anchorage area regulations. This
rule will not create, remove, or change any previously established
special anchorage areas in the First Coast Guard District.

DATES: This rule is effective April 17, 2023

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0952 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, contact Mr. Craig Lapiejko, Waterways Management
at First Coast Guard District, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
SAA Special Anchorage Area
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On July 17, 2019, the First Coast Guard District received a request
to remove the note in 33 CFR 110.32--Hingham Harbor, Hingham,
Massachusetts. This regulation, note included, was added to 33 CFR part
110 soon after the Coast Guard was authorized Federal anchorage
regulations more than 50 years ago. In response, on April 8, 2021, the
Coast Guard published a notice of proposed rulemaking (NPRM) titled
``Anchorage Regulations; Special Anchorages Areas within the First
Coast Guard District'' (86 FR 18224). There we stated why we issued the
NPRM, and invited comments on our proposed regulatory action related to
the revision of the notes. During the comment period that ended on June
7, 2021, we received one comment.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
2071; 33 CFR 1.05-1; Department of Homeland Security Delegation No.
00170.1. The First Coast Guard District Commander has determined that
revising the notes for its special anchorage area (SAA) regulations and
to remove language from the text of four of these regulations because
those provisions are inconsistent with simply designating the location
of a special anchorage area.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received one comment on our NPRM published April
8, 2021.
    The commenter disagreed that the changes were primarily editorial
in nature and that they were intended to clarify and update the notes.
The commenter further provided that the town had relied on the notes to
enforce a prohibition on fixed piles or stakes for the past 50 years.
The commenter requested that any proposed change to the notes currently
cited in the CFR for Hingham Harbor SAAs be exempted from those
changes. As we stated in our April 8, 2021, NPRM, in general, there is
a misunderstanding of the Coast Guard's authority with regard to
special anchorage grounds. The Coast Guard does not regulate vessel
activities within SAAs as it does in anchorage grounds. The only effect
of designating a SAA under the authority of 33 U.S.C. 2071 is that
vessels under 20 meters in length (65 feet) anchored in these areas do
not have to exhibit the lights, shapes or sounds signals required by
Rule 30 and 35 of the Inland Navigation Rules. Other vessels active
within these SAA may be regulated by local authorities as long as local
regulations do not conflict with Federal regulations which may be
promulgated under other statutory authority. The Town of Hingham,
similar to other State and/or local governments, promulgated ordinances
and those ordinances were often cited as notes within some SAA
regulations, but those notes were incorrectly interpreted as federal
regulations. In a rule published August 3, 1968 (33FR 11079), the Coast
Guard added Sec.  110.32 to 33 CFR part 110 which created five separate
SAAs in Hingham Harbor, MA. That regulation was issued in response to a
request from the Chairman of the Board of Selectmen of Hingham, MA. The
note in that regulation said that:
     These areas will be principally used by yachts and other
recreational craft.
     Temporary floats or buoys for marking anchors will be
allowed in the areas but fixed piles or stakes may not be placed.
     The anchoring of vessels and the placing of moorings in
these areas will be under the jurisdiction of the local Harbor Master.
    The inclusion of these references to ordinances in Part 110 is not
desirable as it appears that the Coast Guard has adopted similar
provisions into the federal regulations. As such, the Coast Guard is
removing the note from the regulation. The Coast Guard interprets the
note as indicating that the rule itself

would not forbid the installation of piles or stakes in Hingham Harbor.
    In the regulatory text, we did amend the instruction for Sec.
110.30, to correct the reference to where the three notes to be removed
in that section were located. Also, we updated the authority citation
for Part 110 to reflect that Section 8501 the William M. (Mac)
Thornberry National Defense Authorization Act, Public Law 116-283,
transferred Section 7 Rivers and Harbors Appropriations Act of 1915
authority for anchorage grounds to 46 U.S.C. 70006, and the reference
to the edition of the Department of Homeland Security delegation.
    This rule will remove existing notes in regulations for SAAs in the
First Coast Guard District and removes the regulatory provisions in
Sec. Sec.  110.25, 110.29, 110.50d, and 110.60 that do not designate
the location of SAAs. Additionally, we are adding Sec.  110.3,
entitled, ``First Coast Guard District Special Anchorage Areas.'' Its
text identifies SAA regulations for the First Coast Guard District
(Sec.  110.4 through Sec.  110.60) and its note advises those planning
to use a SAA in the First District that state ordinances, local
ordinances, or both, may apply to those anchoring there and that the
local harbormaster is often the best source of information about any
such ordinances. These ordinances may involve, for example, compliance
with direction from the local harbormaster when placing or using
moorings within the anchorage.
    These changes are primarily editorial in nature and are intended to
clarify and update the notes in this part. This rule does not create,
remove, or change any SAA. Vessels less than 65 feet in length, when at
anchor in these SAAs, are not required to sound signals or display
anchorage lights or shapes when at anchor.
    This rule will remove notes from the following sections in 33 CFR
part 110 that designate SAAs in the First Coast Guard District:

    Section 110.4, Penobscot Bay, Maine.
    Section 110.5, Casco Bay, Maine.
    Section 110.6, Portland Harbor, Portland, Maine (between Little
Diamond Island and Great Diamond Island).
    Section 110.8, Lake Champlain, New York and Vermont.
    Section 110.26, Marblehead Harbor, Marblehead, Massachusetts.
    Section 110.29, Boston Inner Harbor, Massachusetts.
    Section 110.30, Boston Harbor, Massachusetts.
    Section 110.31, Hull Bay and Allerton Harbor at Hull,
Massachusetts.
    Section 110.32, Hingham Harbor, Hingham, Massachusetts.
    Section 110.37, Sesuit Harbor, Dennis, Massachusetts.
    Section 110.38, Edgartown Harbor, Massachusetts.
    Section 110.45a, Mattapoisett Harbor, Mattapoisett,
Massachusetts.
    Section 110.50, Stonington Harbor, Connecticut.
    Section 110.50a, Fishers Island Sound, Stonington, Connecticut.
    Section 110.50b, Mystic Harbor, Groton and Stonington,
Connecticut.
    Section 110.50c, Mumford Cove, Groton, Connecticut.
    Section 110.51, Groton, Connecticut.
    Section 110.52, Thames River, New London, Connecticut.
    Section 110.53, Niantic, Connecticut.
    Section 110.55, Connecticut River, Connecticut.
    Section 110.55a, Five Mile River, Norwalk and Darien,
Connecticut.
    Section 110.55b, Connecticut River, Old Saybrook, Connecticut.
    Section 110.56, Noroton Harbor, Darien, Connecticut.
    Section 110.58, Cos Cob Harbor, Greenwich, Connecticut.
    Section 110.59, Eastern Long Island, New York.
    Section 110.60, Captain of the Port, New York.

    For a specific listing of the notes being removed, please review
the regulatory text at the end of this rule.
    Additionally, this rule removes regulatory text from four CFR
sections because that text is inconsistent with simply designating the
location of a SAA. In Sec.  110.25, Salem Sound, Massachusetts, we are
removing the last two sentences of paragraph (c). In Sec.  110.29,
Boston Inner Harbor, Massachusetts, we are removing paragraph (d)(2).
In Sec.  110.50d, Mystic Harbor, Noank, Connecticut, we are removing
paragraph (b). Finally, in Sec.  110.60, Captain of the Port, New York;
we are removing paragraphs (c)(13)(i), (d)(7)(i), and (d)(9)(i).

V. Regulatory Analyses

    We developed this 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.

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 rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    These changes are primarily editorial in nature and are intended to
clarify and update notes for First Coast Guard District SAA regulations
and to remove regulatory text in four CFR sections that is not needed
to designate the location of SAAs. This rule will not create, remove,
or change any previously established SAAs in the First Coast Guard
District

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 received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities. We reach this
conclusion based on the reasons stated in section IV.A above.
    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 rule. If the rule will 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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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.

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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this 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 determined 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 rule will remove
existing notes in regulations for SAAs in the First Coast Guard
District and remove regulatory text in four CFR sections that is not
needed to designate the location of SAAs. These existing notes and
provisions in regulatory text, will be replaced with a note in a newly
added section that will apply to all SAA regulations in the First Coast
Guard District. The note will advise those planning to use a SAA in the
First Coast Guard District that state ordinances, local ordinances, or
both, may apply to those anchoring there and that the local
harbormaster is often the best source of information about any such
ordinances. It is categorically excluded from further review under
paragraph A3 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 110 as follows:

PART 110--ANCHORAGE REGULATIONS

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1. The authority citation for part 110 is revised to read as follows:

    Authority:  33 U.S.C. 2071; 46 U.S.C. 70006, 70034; 33 CFR 1.05-
1; Department of Homeland Security Delegation No. 00170.1, Revision
No. 01.3.

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2. Add Sec.  110.3 to read as follows:

Sec.  110.3  First Coast Guard District Special Anchorage Areas.

    Regulations designating special anchorage areas in the First Coast
Guard District appear in Sec. Sec.  110.4 through 110.60.

    Note 1 to Sec.  110.3:  Those planning to use these special
anchorage areas are advised that state ordinances, local ordinances,
or both, may apply. The local harbormaster is often the best source
of information about any such ordinances.

Sec.  110.4  [Amended]

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3. In Sec.  110.4, remove the notes to paragraph (a), (b), (c) and (d).

Sec.  110.5  [Amended]

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4. In Sec.  110.5, remove the notes following paragraphs (a-1), (d),
(e) and (f).

Sec.  110.6  [Amended]

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5. In Sec.  110.6, remove the note at the end of the section.

Sec.  110.8  [Amended]

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6. In Sec.  110.8, remove the notes following paragraphs (c-2) and (i).

Sec.  110.25  [Amended]

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7. In Sec.  110.25, remove the last two sentences in paragraph (c).

Sec.  110.26  [Amended]

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8. In Sec.  110.26, remove the note at the end of the section.

Sec.  110.29  [Amended]

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9. In Sec.  110.29(d), remove the designation ``(1)'', remove paragraph
(d)(2), and remove the note to paragraph (d).

Sec.  110.30  [Amended]

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10. In Sec.  110.30, remove the note to paragraph (h), the note to
paragraphs (j), (k), and (l) and the note to paragraphs (m), (n), (o),
(p) and (q).

Sec.  110.31  [Amended]

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11. In Sec.  110.31, remove the note at the end of the section.

Sec.  110.32  [Amended]

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12. In Sec.  110.32, remove the note at the end of the section.

Sec.  110.37  [Amended]

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13. In Sec.  110.37, remove the note at the end of the section.

Sec.  110.38  [Amended]

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14. In Sec.  110.38, remove the note at the end of the section.

Sec.  110.45a  [Amended]

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15. In Sec.  110.45a, remove the note at the end of the section.

Sec.  110.50  [Amended]

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16. In Sec.  110.50, remove the note at the end the section.

Sec.  110.50a  [Amended]

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17. In Sec.  110.50a, remove the note at the end of the section.

Sec.  110.50b  [Amended]

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18. In Sec.  110.50b, remove the note at the end of the section.

Sec.  110.50c  [Amended]

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19. In Sec.  110.50c, remove the note at the end of the section.

Sec.  110.50d  [Amended]

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20. In Sec.  110.50d, redesignate paragraph (a) as an undesignated
paragraph and remove paragraph (b).

Sec.  110.51  [Amended]

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21. In Sec.  110.51, remove the note at the end of the section.

Sec.  110.52  [Amended]

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22. In Sec.  110.52, remove the note at the end of the section.

Sec.  110.53  [Amended]

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23. In Sec.  110.53, remove the note at the end of the section.

Sec.  110.55  [Amended]

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24. In Sec.  110.55, remove the notes following paragraphs (b), (c),
(e), (e-1), (e-2) and (g).

Sec.  110.55a  [Amended]

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25. In Sec.  110.55a, remove the note at the end of the section.

Sec.  110.55b  [Amended]

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26. In Sec.  110.55b, remove the note at the end of the section.

Sec.  110.56  [Amended]

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27. In Sec.  110.56, remove the note at the end of the section.

Sec.  110.58  [Amended]

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28. In Sec.  110.58, remove the note at the end of the section.

Sec.  110.59  [Amended]

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29. In Sec.  110.59, remove the note following paragraph (g).

Sec.  110.60  [Amended]

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30. In Sec.  110.60, remove the notes to paragraphs (a)(2) and (13);
(b)(5) and (6); (c)(3); (5) and (6); (d)(2), and (5), and remove
paragraphs (c)(13)(i) and (ii), (d)(7)(i) and (ii), and (d)(9)(i) and
(ii).

    Dated: March 3, 2023.
J.W. Mauger,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2023-04928 Filed 3-15-23; 8:45 am]
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