[Federal Register: February 26, 2010 (Volume 75, Number 38)]
[Notices]
[Page 9016]
[DOCID:fr26fe10-144]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fifty-Fifth Meeting, RTCA Special Committee 135: Environmental
Conditions and Test Procedures for Airborne Equipment

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 135: Environmental Conditions
and Test Procedures for Airborne Equipment meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 135: Environmental Conditions and
Test Procedures for Airborne Equipment.

DATES: The meeting will be held March 17-19, 2010, starting at 9 a.m.

ADDRESSES: The meeting will be held at Honeywell International Inc.,
Deer Valley Facilities, 21111 N. 19th Ave., Phoenix, AZ.

FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat, 1828 L Street,
NW., Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 135: Environmental Conditions
and Test Procedures for Airborne Equipment meeting. The agenda will
include:

October 28-30

 Opening Session (Welcome, Chairman's Opening Remarks,
Introductions)
 Approval of Summary from the Fifty-Fourth Meeting.
 RTCA Paper No. 006-10/SC135-676
 Status and Review of Revision of AC
 Report from Section 16, 20, 21, & 26 Working Groups
 Review List of Change Proposals for DO-160G/ED-14G
 Status of User Guide Material
 Review Schedule for DO-160G
 New/Unfinished Business
 Establish Date for Next SC-135 Meeting
 Closing

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the ``FOR FURTHER INFORMATION CONTACT'' section. Members of the public
may present a written statement to the committee at any time.

    Issued in Washington, DC, on February 19, 2010.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 2010-3939 Filed 2-25-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66009-66010]
[FR Doc No: 2023-20920]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2925]

Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals; 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 (GFI) #273 entitled
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' This draft
guidance document, when finalized, will provide recommendations on how
sponsors may voluntarily establish defined durations of use for certain
antimicrobial new animal drugs used in or on the medicated feed of
food-producing animals that are currently approved with one or more
indications that lack a defined duration of use. Establishing defined
durations of use within the approved new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs) is
intended to mitigate development of antimicrobial resistance for these
antimicrobial drugs, which are important to human medicine. It also,
when finalized, will propose timelines for stakeholders wishing to
voluntarily align their affected applications with this guidance.

DATES: Submit either electronic or written comments on the draft
guidance by December 26, 2023, 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-2023-D-2925 for ``Defining Durations of Use for Approved Medically
Important Antimicrobial Drugs Fed to Food-Producing Animals.'' 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,<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.'' 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 guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
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: John Mussman, Center for Veterinary
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #273 entitled
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' This draft
guidance, when finalized, will provide information to sponsors of
certain antimicrobial animal drug products who are interested in
establishing appropriately defined durations of therapeutic
administration to food-producing animals where none currently exist.
The draft guidance, when finalized, will also propose timelines for
stakeholders wishing to comply voluntarily with this guidance.

    In response to recommendations made by FDA in GFI #213,\1\ as part
of a strategy to address antimicrobial resistance associated with the
use of antimicrobial drugs in animal agriculture, sponsors of all NADAs
and ANADAs for antimicrobial drugs important to human medicine
(medically important antimicrobial drugs) approved for use in or on the
feed or in the drinking water of food-producing animals worked with FDA
over a 3-year period from 2013 to 2016 to voluntarily withdraw approval
of indications that were not considered necessary for ensuring animal
health (production indications). In response to FDA recommendations
made in GFI #263,\2\ sponsors also voluntarily worked with FDA to
change the marketing status of all remaining approved uses of such new
animal drugs from over-the-counter (OTC) to either by veterinary
prescription (Rx) or by veterinary feed directive, as applicable.
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    \1\ See GFI #213, ``New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or
Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209,'' December 2013. (https://www.fda.gov/media/83488/download)
    \2\ See GFI #263, ``Recommendations for Sponsors of Medically
Important Antimicrobial Drugs Approved for Use in Animals to
Voluntarily Bring Under Veterinary Oversight All Products That
Continue to be Available Over-the-Counter,'' June 2021. (https://www.fda.gov/media/130610/download)
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    In September 2016, FDA announced that it intended to enter the next
phase of its efforts to mitigate antimicrobial resistance by focusing
on medically important antimicrobials used in animal feed or water that
have at least one therapeutic indication without a defined duration of
use. In a notice published in the Federal Register of September 14,
2016 (81 FR 63187), the Agency requested comments from the public about
how to establish appropriately targeted durations of use for
therapeutic products within the scope of GFI #213 with no currently
defined duration of use. Public feedback received in response to that
request for information was taken into consideration during subsequent
development of a concept paper released in 2021.
    On September 14, 2018, FDA released a 5-year action plan for
supporting antimicrobial stewardship in veterinary settings.\3\ This
plan includes an action item intended ``to ensure that all medically
important antimicrobial drugs used in the feed or drinking water of
food-producing animals have an appropriately targeted duration of
use.'' \4\
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    \3\ See FDA's 5-year action plan entitled ``Supporting
Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal
Years 2019-2023.'' (https://www.fda.gov/media/115776/download)
    \4\ See Action item 1.1.2 of the 5-year plan.
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    In a notice published in the Federal Register of January 11, 2021
(86 FR 1979), FDA requested comments from the public on a concept paper
that outlined a potential framework for how sponsors of NADAs and
ANADAs for products containing medically important antimicrobial drugs
approved for use in or on the feed of food-producing animals could
voluntarily work with FDA to change the approved conditions of use of
these drugs to establish appropriately defined durations of use for
those indications that currently have an undefined duration of use. The
concept paper generated invaluable public comment; FDA considered all
information and feedback received on the concept paper as it developed
this draft guidance.
    This level 1 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
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669. The collections of information in 21 CFR part 514 have been
approved under OMB control number 0910-0032.

III. Electronic Access

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

    Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20920 Filed 9-25-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 172 (Thursday, September 3, 2020)]
[Notices]
[Pages 55052-55054]
[FR Doc No: 2020-19454]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89710; File No. SR-LTSE-2020-14]

Self-Regulatory Organizations; Long-Term Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
to Temporarily Suspend the Application of Order Price Collars in Rule
11.190(f)(1) Until September 8, 2020

August 28, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 28, 2020, Long-Term Stock Exchange, Inc. (``LTSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \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

    LTSE proposes to temporarily suspend until September 8, 2020, the
provisions of Rule 11.190(f)(1) pending further systems development
work.
    The text of the proposed rule change is available at the Exchange's
website at https://longtermstockexchange.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 on the Purpose of, and the
Statutory Basis for, the Proposed Rule Change 3
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    \3\ Unless otherwise defined, capitalized terms are used herein
as defined in the LTSE Rulebook.
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1. Purpose
    LTSE Rule 11.190(f)(1) prevents an incoming order or order resting
on the Order Book, including those marked ISO, from executing at a
price outside the Order Collar price range (i.e., prevents buy orders
from trading at prices above the collar and prevents sell orders from
trading at prices below the collar). The Order Collar price range is
calculated using the numerical guidelines for clearly erroneous
executions (``CEE'').\4\ Under Rule 11.190(f)(1), executions are
permitted at prices within the Order Collar price range, inclusive of
the boundaries. Thus, Rule 11.190(f)(1) seeks to prevent an execution
that would otherwise be handled under the CEE procedures.
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    \4\ See LTSE Rule 11.270(f)(1)(D).
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    The Exchange is set to become operational on August 28, 2020.\5\
However, the automated processes to set the Order Collar price range
pursuant to Rule 11.190(f)(1) are not yet fully operational and it is
anticipated that they will not be fully operational when the Exchange
launches. Therefore, to ensure the Exchange operates in conformity with
its Rule Book, the Exchange proposes to temporarily suspend Rule
11.190(f)(1) until September 8, 2020, pending further systems
development work. The Exchange will continue to work diligently to
finalize the implementation of the Order Collar price range as
described in Rule 11.190(f)(1). Additionally, the Exchange will inform
its Members of the proposed rule change in a Regulatory Information
Circular.
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    \5\ See LTSE Production Securities Phase-In Set for Friday,
August 28, LTSE (August 24, 2010), available at https://assets.ctfassets.net/cchj2z2dcfyd/4Ul3ygPsrihSz4lpQnBThu/56a54c087891a5aa20152398bdb51cea/MA-2020-022__Reminder_Production_Securities_Launching_August_28_-_Google_Docs.pdf.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\6\ in general, and
furthers the objectives of Section 6(b)(5) of the Act,\7\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, 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 mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
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    The Order Collar provisions of Rule 11.190(f)(1) are a prophylactic
measure to prevent trade executions outside of certain price bands. The
Exchange has in effect other provisions to address trade executions at
prices outside of these price bands, such as Rule 11.270 (Clearly
Erroneous Executions). Additionally, Rule 11.281 (Limit-Up Limit-Down)
prevents trades in NMS Stocks from occurring outside specified price
bands.\8\ The Exchange further notes that other national securities
exchanges operate without order price collars during their regular,
continuous market trading sessions.\9\ Moreover, the proposed rule
change would only suspend the application of Rule 11.190(f) for a short
period of time during which the Exchange will only be offering trading
in a limited number of securities.\10\ After that time, the Exchange
expects to implement Rule 11.190(f)(1).
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    \8\ Rule 11.281 was adopted under the LULD Plan, see Securities
Exchange Act Release No. 85623 (April 11, 2019), 84 FR 16086 (April
17, 2019), and is designed to prevent trades in NMS Stocks from
occurring outside specified price bands, which are set at a
percentage level above and below the average reference price of a
security over the preceding five-minute period.
    \9\ See, e.g., MEMX Rulebook (8.17.20), available at https://info.memxtrading.com/wp-content/uploads/2020/08/MEMX-Rulebook-8.17.20.pdf; Rulebook--The Nasdaq Stock Market, available at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules (last accessed
August 27, 2020).
    \10\ See supra note 5.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange 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. The proposed
change is not designed to address any competitive issue, but rather
would provide the public and market participants with clarity and
certainty regarding the operations of the Exchange. Additionally, the
proposed rule change would not be an inappropriate burden on
intramarket competition as it would be applied equally to all Members.
It also is not a burden on intermarket competition as other exchange
similarly operate without order price collars.

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 from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, 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 Commission has waived the five business day notification
requirement for this proposed rule change.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \13\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \14\ permits the
Commission to 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 proposed rule change may become operative immediately. According to
the Exchange, waiver of the 30-day operative delay provisions will
avoid the disruption associated with delaying the commencement of
trading on the Exchange, which is anticipated to occur on August 28,
2020. The Exchange believes that the proposed rule change does not
significantly affect the protection of investors or the public interest
or impose a significant burden on competition because it is designed to
temporarily suspend application of a prophylactic rule and that the
proposed rule change does not impose any burden on Members or market
participants. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest, as doing so will ensure that the rule change becomes
operative on the day that LTSE commences trading on the Exchange.
Accordingly, the Commission hereby waives the

operative delay and designates the proposed rule change operative upon
filing.\15\
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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 change 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-LTSE-2020-14 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-LTSE-2020-14. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-LTSE-2020-14 and should be submitted on
or before September 24, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\

Jill M. Peterson,
Assistant Secretary.

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    \16\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2020-19454 Filed 9-2-20; 8:45 am]
BILLING CODE 8011-01-P