[Federal Register Volume 83, Number 89 (Tuesday, May 8, 2018)]
[Rules and Regulations]
[Pages 20731-20733]
[FR Doc No: 2018-09725]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]

Menu Labeling: Supplemental Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Menu Labeling:
Supplemental Guidance for Industry.'' The guidance addresses
stakeholder concerns regarding the implementation of nutrition labeling
required for foods sold in covered establishments, includes expanded
and new examples of alternatives to aid in compliance, identifies
places where we intend to be more flexible in our approach, and advises
of our intent to exercise enforcement discretion regarding nutrient
declaration for ``calories from fat'' as part of the additional written
nutrition information. The guidance also includes many graphical
depictions to convey our thinking on various topics and to provide
examples of options for implementation, and addresses calorie
disclosure signage for self-service foods, including buffets and grab-
and-go foods; reasonable basis, and the criteria for considering the
natural variation of foods, when determining nutrition labeling for
such foods; various methods for providing calorie disclosure
information, including those for pizza; compliance and enforcement; and
criteria for distinguishing between menus and other information
presented to the consumer.

DATES: The announcement of the guidance is published in the Federal
Register on May 8, 2018.

ADDRESSES: You may submit either electronic or written comments on FDA
guidances 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-2011-F-0172 for ``Menu Labeling: Supplemental Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Menu Labeling: Supplemental Guidance for Industry.'' We are
issuing this guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The guidance represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
    In the Federal Register of December 1, 2014 (79 FR 71156), we
published a final rule on nutrition labeling of standard menu items in
restaurants and similar retail food establishments to implement the
menu labeling provisions of section 403(q)(5)(H) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)). The menu labeling
requirements are codified at Title 21 of the Code of Federal
Regulations, Sec.  101.11 (21 CFR 101.11).
    In the Federal Register of May 4, 2017 (82 FR 20825), we published
an interim final rule extending the compliance date to May 7, 2018. Our
goals are to ensure that consumers are provided with consistent
nutrition information they can use to make informed choices for
themselves and their families, and to guide industry in clearly
understanding the flexible ways in which the requirements can be
implemented.
    In the Federal Register of November 9, 2017 (82 FR 52036), we made
available a draft guidance for industry entitled ``Menu Labeling:
Supplemental Guidance for Industry'' and gave interested parties an
opportunity to submit comments by January 8, 2018, for us to consider
before beginning work on the final version of the guidance. The draft
guidance addressed concerns raised by stakeholders regarding the
implementation of nutrition labeling required for foods sold in covered
establishments. It included expanded and new examples of alternatives
to aid in compliance and identified places where we intend to be more
flexible in our approach. The draft guidance also included many
graphical depictions to convey our thinking on various topics and to
provide examples of options for implementation. It addressed calorie
disclosure signage for self-service foods, including buffets and grab-
and-go foods; reasonable basis, and the criteria for considering the
natural variation of foods; various methods for providing calorie
disclosure information, including those for pizza; compliance and
enforcement; and criteria for distinguishing between menus and other
information presented to the consumer.
    We received numerous comments on the draft guidance and have
modified the final guidance where appropriate. Changes to the guidance
include adding new questions and answers 3.4, 3.5, and 8.3 and Figures
12, 13, 16, 17, and 18. In addition, we made editorial changes to
improve clarity in questions and answers 4.1, 5.4, 6.2, 7.1, 8.1, 10.1,
and 10.2 and clarified the headings for the graphics in Figures 3 and
14.
    In addition, the final guidance announces our intent to exercise
enforcement discretion regarding the ``calories from fat'' nutrient
declaration requirement as part of the additional written nutrition
information required in Sec.  101.11(b)(2)(ii)(A). As discussed in the
final guidance, we are taking this position because the current science
supports a view that the type of fat is more relevant with respect to
the risk of chronic disease than the overall caloric fat intake, and to
align with the final rule, ``Food Labeling: Revision of the Nutrition
and Supplement Facts Labels'' (81 FR 33742, May 27, 2016). (Our current
thinking on this issue is discussed in the preamble to the final rule
titled, ``Food Labeling: Revision of the Nutrition and Supplement Facts
Labels'' (81 FR 33742 at 33780 through

33781) now codified primarily at 21 CFR 101.9 and 101.36). With respect
to our enforcement discretion policy pertaining to ``calories from
fat'' declarations, this part of the guidance is immediately effective
because we have determined that prior public participation is not
feasible or appropriate (21 CFR 10.115(g)(2)). The guidance announced
in this notice finalizes the draft guidance dated November 2017.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec.  101.11(b)(2), (c)(3), and (d) have
been approved under OMB control number 0910-0783.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: May 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09725 Filed 5-7-18; 8:45 am]
 BILLING CODE 4164-01-P


Issues for Discussion

Plan moving forward/ working groups

Revision to work plan document

Meeting Locations

Meeting agenda structure

Preparatory Materials

Other issues Options for Organizing Next Phase of Subcommittee Work

Objectives   Continue information collection, but focus more on analysis needed to support development of recommendations   link to key questions/ priorities   Provide logical progression through issues   Lay groundwork for formulation of recommendations   build options and alternatives for analysis   Get information in a form to work with and on which to base recommendations   Provide opportunity for smaller working groups Options for Work Groups

Focus # 1 ( work group):

Driving Question: What is relationship between Superfund and other clean up programs?

What is the link/ relationship to Superfund and the Subcommittee's charge? If there is then assess:

Categorization and Analysis of Clean up Programs: Why?

What can they clean up?

Lessons learned about what has worked and what has not

Continuity between programs

Incentives   how p ro g rams interact ( + &  ) Assess:

  Other federal programs ° RCRA ° Brownfields   State Programs   Others ( need to be far reaching and creative in the exploration of alternatives)

Elizabeth do analysis tied to the policy questions Criteria to be Analyzed With Respect to Clean up Programs

What is the link/ relationship to Superfund and the Subcommittee's charge? If there is then assess:

  Scope ( nature of sites being addressed)

  Funding ( scale and sources)

  Public participation   Cleanup standards   Track record ( what has been accomplished)

  Future projections ( what is anticipated in coming years, what sites are not yet in the pipeline)

Focus # 2: Site Types ( work group)

  Characteristics/ numbers ° Size ° Complexity ( various indices)

° Cost ° origin ° Explore " megasite" definitional issues ° What is coming through the " pipeline?"

  Tie to Key Questions in the charge/ work plan relating to Megasites and NPL ° What kind of sites belong on the NPL?

° Criteria for listing sites Focus # 3: How does it work now?

Develop a Briefing Paper ( no work group):

What is the decision making process for NPL eligible sites?

A bit more elaboration on what Dave and Paul presented yesterday

How listing and funding allocation decisions get made? January Agenda

Discussion of analysis of Program and Site analysis and policy exploration   goal to present key findings that link to policy questions/ focus of subcommittee charge

Tribal presentation/ discussion

Measuring program performance

Work group time


[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Notices]
[Page 68467-68471]
[DOCID:fr18no08-125]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58909; File No. SR-FINRA-2008-046]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Granting Approval of a Proposed Rule Change, as
Modified by Amendment No. 1 Thereto, To Realign the Representation of
Industry Members on the National Adjudicatory Council To Follow More
Closely the Categories of Industry Representation on the FINRA Board

November 6, 2008.
    On September 8, 2008, Financial Industry Regulatory Authority, Inc.
(``FINRA,'' f/k/a National Association of Securities Dealers, Inc. and
NASD) filed with the Securities and Exchange Commission
(``Commission'') pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'')\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend the By-Laws of FINRA's regulatory
subsidiary, FINRA Regulation, Inc. (``FINRA Regulation,'' f/k/a NASD
Regulation, Inc.). On September 17, 2008, FINRA filed Amendment No. 1
to the proposed rule change. The proposed rule change was published in
the Federal Register on September 30, 2008.\3\ The Commission received
one comment on the proposal.\4\ This order approves the proposed rule
change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 58626 (September 23,
2008), 73 FR 56872 (``Notice'').
    \4\ The commenter stated that FINRA's proposal seemed reasonable
and that he generally favored it. However, he expressed concern
about the elimination of the regional representation on the National
Adjudicatory Council (``NAC''). See letter from Neal E. Nakagiri,
Esq., NPB Financial Group, LLC, to Florence E. Harmon, Acting
Secretary, Commission, dated October 20, 2008.
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I. Background and Description of the Proposal

A. Background

    On July 30, 2007, NASD and the New York Stock Exchange, Inc.
consolidated their member firm regulation operations into a combined
organization, FINRA. As part of the consolidation, the Commission
approved amendments to the NASD By-Laws to implement governance and
related changes.\5\ The approved changes included a FINRA Board
governance structure that balanced public and industry representation
and designated seven governor seats to represent member firms of
various sizes based on the criteria of firm size.\6\
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    \5\ See Securities Exchange Act Release No. 56145 (July 26,
2007), 72 FR 42169 (August 1, 2007), as amended by Securities
Exchange Act Release No. 56145A (May 30, 2008), 73 FR 32377 (June 6,
2008) (File No. SR-NASD-2007-023).
    \6\ The FINRA Board consists of eleven Public Governors (who are
appointed), ten Industry Governors (seven of whom are elected by
industry members), the current Chief Executive Officer (``CEO'') of
NYSE Regulation, and the current CEO of FINRA. The ten Industry
Governors include: (a) Three elected Governors who are registered
with member firms that employ 500 or more registered persons (Large
Firm Governors); (b) one elected Governor who is registered with a
member firm that employs at least 151 and no more than 499
registered persons (Mid-Size Firm Governor); (c) three elected
Governors who are registered with member firms that employ at least
one and no more than 150 registered persons (Small Firm Governors);
(d) one appointed Governor who is associated with a floor member of
the New York Stock Exchange; (e) one appointed Governor who is
associated with an independent contractor financial planning member
firm or an insurance company affiliate; and (f) one appointed
Governor who is associated with an affiliate of an investment
company. See FINRA By-Laws, Article VII (Board of Governors).
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    FINRA Regulation is a subsidiary of FINRA that operates according
to the Plan of Allocation and Delegation of Functions by NASD to
Subsidiaries, as amended, which NASD adopted first in 1996 when it
formed NASD Regulation. FINRA Regulation's By-Laws were not amended at
the time of the

consolidation, other than in a few sections where those By-Laws
conflicted with the new FINRA By-Laws.

B. Description of the Proposal

    The proposed rule change would amend the FINRA Regulation By-Laws
(``By-Laws'') to: (1) Restructure the industry representation on the
NAC to parallel the firm-size criteria for industry representation on
the FINRA Board; (2) modify the nomination process for certain industry
member seats on the NAC by using the FINRA Nominating Committee
(``Nominating Committee'') and by discontinuing the Regional Nominating
Committees; and (3) adopt conforming changes to reflect the corporate
name change and similar matters.\7\
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    \7\ The proposed rule change would revise, delete, and/or
renumber various provisions of the FINRA Regulation By-Laws.
Renumbered sections are referred to herein as ``proposed FINRA
Regulation By-Laws.'' All other sections (that is, sections for
which new numbering did not result from the proposed revisions) are
referred to as ``current FINRA Regulation By-Laws.''
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1. Changes to the NAC
    The NAC reviews all disciplinary decisions issued by Hearing Panels
and presides over disciplinary matters that have been appealed to or
called for review by the NAC. The NAC also reviews statutory
disqualification matters and considers appeals of membership
proceedings and exemption requests.\8\
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    \8\ See current FINRA Regulation By-Laws, Article V, Section 5.1
(Appointment and Authority).
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a. Composition
    Under the current By-Laws, the NAC must consist of no fewer than 12
and no more than 14 members, and the number of non-industry members,
including at least three public members, must equal or exceed the
number of industry members.\9\ Since 1999, each of five geographic
regions, which had been established by the NASD Board of Governors, has
been represented on the NAC. Consistent with Article V of the FINRA
Regulation By-Laws, the current NAC consists of 14 members \10\ and
includes seven industry and seven non-industry members.\11\ Five of the
industry NAC members represent the five geographic regions, and the
remaining two industry seats are ``at-large'' seats, which NASD
historically used (and FINRA currently uses) to add balance to the
types of firms being represented on the NAC.\12\
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    \9\ See current FINRA Regulation By-Laws, Article V, Section 5.2
(Number of Members and Qualifications).
    \10\ See Notice, supra note 3, 73 FR 56872, 56873, n.6.
    \11\ See Notice, supra note 3, 73 FR at 56873.
    \12\ Id.
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    FINRA proposes to eliminate the size range of the NAC (12-14
members) prescribed by the current By-Laws and instead provide that the
NAC consist of 14 members. Additionally, FINRA proposes that the NAC be
divided equally between industry and non-industry members, and thereby
eliminate the possibility that the number of non-industry members
exceed the number of industry members.
    The proposed rule change also would eliminate regional
representation on the NAC and instead provide for representation of the
various firm sizes. Specifically, FINRA would replace the five region-
based industry members of the NAC with two small firm, one mid-size
firm, and two large firm industry representatives.
    In summary, the restructured NAC would consist of 14 members,
including seven industry members, two of whom would be ``at large,''
and five of whom would be designated specifically as representatives of
large firms, mid-size firms, and small firms, and seven non-industry
members, three of whom are public.\13\ The tenure of NAC members
generally is three years and the terms of the members are staggered.
The proposal would not disrupt the process of approximately one-third
of the NAC members completing their service in a particular year and
being replaced with newly appointed NAC members. The proposal would
result in a Small Firm and a Large Firm NAC Member joining the NAC near
the beginning of 2009; a Mid-Size Firm NAC Member joining in 2010; and
a Small Firm and Large Firm NAC Member joining in 2011.\14\
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    \13\ A public member of the NAC has no material business
relationship with a broker or dealer or a self-regulatory
organization registered under the Act.
    \14\ A Large Firm is any broker or dealer admitted to membership
in FINRA which, at the time of determination, has 500 or more
registered persons. A Mid-Size Firm is any broker or dealer admitted
to membership in FINRA which, at the time of determination, has at
least 151 and no more than 499 registered persons. A Small Firm is
any broker or dealer admitted to membership in FINRA which, at the
time of determination, has at least 1 and no more than 150
registered persons. See proposed FINRA Regulation By-Laws, Article I
(Definitions) (defining Small Firm, Small Firm NAC Member, Large
Firm, Large Firm NAC Member, Mid-Size Firm, and Mid-Size Firm NAC
Member, respectively).
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b. Nomination and Election Process
    Currently, non-industry members of the NAC and two ``at-large''
industry members are nominated to serve on the NAC by the Nominating
Committee and then appointed by the FINRA Regulation Board.\15\ The
five industry members of the NAC who are drawn from the five geographic
regions are selected through Regional Nominating Committees (through
either an uncontested or a contested nomination process), then
nominated by the Nominating Committee, and finally appointed by the
FINRA Regulation Board.
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    \15\ See supra note 13.
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    In conjunction with its proposed transition to representation on
the NAC based on firm size, FINRA would simplify the NAC appointment
process for industry representatives and follow more closely the
procedures for electing industry members of the FINRA Board. FINRA
proposes to eliminate the five Regional Nominating Committees and have
the Nominating Committee perform their function. Instead of relying on
Regional Nominating Committees to identify possible industry candidates
and submit candidates to the Nominating Committee and the FINRA
Regulation Board, FINRA proposes that the Nominating Committee would
identify and solicit candidates for all NAC seats, including the five
industry-member positions that are to be based on firm size.\16\ FINRA
states that the Nominating Committee would be free to consult with or
receive recommendations for industry NAC members from other FINRA
committees, such as the District Nominating Committees, before
communicating its nominations to the FINRA Board.
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    \16\ See proposed FINRA Regulation By-Laws, Article V, Section
5.3 (Appointments).
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    Individuals who seek to serve on the NAC but who were not nominated
(``Additional Candidates'') would still be allowed to gather petitions
in support of their candidacy and potentially compete in a contested
election. The proposed rule change permits Additional Candidates to
petition for consideration as Small, Mid-Size, or Large Firm NAC
Members, based on the size of the firm with which they are registered.
Additional Candidates would be able to qualify for a contested election
by gathering petitions from three percent (or ten percent in the case
of petitions in support of more than one person) of the firms in their
size category.\17\ In the event of a contested election, FINRA members
would have an opportunity to vote for a NAC candidate based on firm
size.\18\

Specifically, small, mid-size, or large firms would vote for NAC
candidates only if the contested election was for a NAC seat designated
for a firm of corresponding size.
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    \17\ See proposed FINRA Regulation By-Laws, Article V, Section
6.2 (Designation of Additional Candidates).
    \18\ See proposed FINRA Regulation By-Laws, Article VI, Section
6.3 (List of FINRA Members Eligible to Vote) and Article VI, Section
6.7 (Ballots).
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    The proposed rule change authorizes the FINRA Secretary to collect
information from candidates to determine that the nominee or Additional
Candidate, as applicable, satisfies the definition of an Industry,
Small Firm, Mid-Sized Firm, Large Firm, Non-Industry, or Public Member
of the NAC.\19\
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    \19\ See proposed FINRA Regulation By-Laws, Article V, Section
5.4 (Nomination Process).
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    The proposed rule change also ensures that the winner of a
contested election serves on the NAC. While all NAC members would
continue to be recommended initially by the Nominating Committee and
appointed by the FINRA Board,\20\ the candidate who receives the most
votes in any contested election for a Small, Mid-Size, or Large Firm
NAC Member seat would be required under the FINRA Regulation By-Laws to
be appointed to the NAC.\21\ FINRA does not propose to change the NAC
selection process if no Additional Candidates reach the threshold to
qualify for a contested election; when there are no Additional
Candidates, the industry NAC members selected by the Nominating
Committee would not have a contested election and would be recommended
for appointment to the NAC.\22\
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    \20\ The Exchange states that the seven non-industry members and
two at-large industry members would continue to follow the
nomination and Board appointment process currently employed for non-
industry and at-large industry NAC members. See Notice, supra note
3, 73 FR at 56874, n. 14.
    \21\ See proposed FINRA Regulation By-Laws, Article V, Section
5.3 (Appointments) and 5.5 (Rejection of Nominating Committee
Nominee).
    \22\ The proposed FINRA Regulation By-Laws would continue to
allow the Nominating Committee to propose two or more candidates for
a single open small, mid-size, or large firm NAC seat. See proposed
FINRA Regulation By-Laws, Article VI, Section 6.5 (Notice of
Contested Nomination). In such a case, there would be a contested
election. The proposed rule change would clarify that only when the
Nominating Committee nominates two or more candidates for the same
open seat would the Nominating Committee trigger a contested
election.
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    Additionally, FINRA proposes to modify the provision that restricts
NAC members and certain committees from communicating in an official
capacity in support of a candidate in a contested election. The current
provisions that permit individuals who are Directors or NAC or other
committee members to communicate their views regarding a candidate in
an individual capacity would remain the same. The modification would
specify the narrow circumstances under which the Nominating Committee
may support its candidate by sending a maximum of two mailings in
support of its nominee.\23\ The proposal clarifies that this limited
support is available during contested NAC elections by referring to
support allowed ``under these By-Laws,'' which includes the support
allowed under Article IV, Section 4.16.\24\
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    \23\ See proposed FINRA Regulation By-Laws, Article IV, Section
4.16(b) (Communication of Views Regarding Contested Election or
Nomination). Section 4.16(b) would also mirror the language of the
FINRA By-Law provision that allows, in contested elections, the
appropriate FINRA committee to communicate a responsive message in
reply to an additional candidate's communication. See FINRA By-Laws,
Article VII, Section 11(b) (Communication of Views).
    \24\ See proposed FINRA Regulation By-Laws, Article VI, Section
6.6 (Administrative Support).
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    The proposed rule change would designate the Secretary of FINRA,
instead of the FINRA Regulation Secretary, as the person who would:
send notice to FINRA members announcing a contested NAC election;
assist in preparing ballots; prepare a list of FINRA members eligible
to vote; arrange for the location for counting of ballots by an
independent agent; resolve ballots that were set aside, if necessary;
extend a time period regarding elections for good cause; and perform
similar duties.\25\
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    \25\ See proposed FINRA Regulation By-Laws, Article VI, Sections
6.5, 6.7, 6.8, 6.10, 6.11, 6.13, and 6.14.
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2. Other Changes
    FINRA proposes to allow the NAC to continue to function while a
vacancy is being filled. More specifically, the By-Laws would be
changed to provide that a vacancy on the NAC lasting six months or less
does not result in a violation of the compositional requirements of the
NAC.
    FINRA proposes to amend provisions of the By-Laws governing
resignation, removal, appointment, and disqualification of NAC members
and the NAC's authority to act on FINRA's behalf to designate the FINRA
Board as the body authorized to oversee the NAC.\26\ Under the
proposal, the FINRA Board would have authority to remove all NAC
members (for refusal, failure, neglect, or inability to discharge
duties), accept their resignations, appoint them, and declare them
disqualified.
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    \26\ See current FINRA Regulation By-Laws, Article V, Sections
5.1 (Appointment and Authority), and proposed Sections 5.7-5.9.
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    The proposed rule change would eliminate the By-Laws provision that
requires the Chair of the NAC to serve as a Director of the FINRA
Regulation Board for a one-year term.
    The proposed rule change would modify the By-Laws' definition of
``Industry Member'' by limiting the look-back test that measures
whether a NAC or committee member is considered ``industry.''
Currently, a person who has served as an officer, director, or employee
of a broker or dealer, within the past three years is considered to be
``industry.'' The proposal would shorten that period to one year.
    The proposal also would add the term ``independent director'' to
the portion of the definition of ``Industry Member'' that excludes
outside directors of a broker or dealer. According to FINRA,
``independent director'' is synonymous with outside director, but would
be added to the exclusionary clause of the definition to harmonize the
FINRA Regulation By-Laws with the FINRA By-Laws' use of the term
``independent director'' when defining an Industry Governor. In
addition, the definitions of ``Public Director'' and ``Public Member,''
which refer to NAC or committee members, would be modified to clarify
that, for example, a Public Director's service on FINRA Regulation's
Board or a Public Member's service on the NAC does not disqualify that
person from satisfying the definition of Public Director or Public
Member.\27\
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    \27\ See proposed FINRA Regulation By-Laws, Article I(hh) and
(ii).
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    Finally, the proposed rule change would make certain non-
substantive changes to several articles of the FINRA Regulation By-Laws
as follows:
     ``The NASD'' or ``NASD'' is to be replaced with ``FINRA''
or ``the Corporation;''
     ``NASD Regulation'' is to be changed to ``FINRA
Regulation;''
     ``The Rules of the Association'' is to be replaced with
``the Rules of the Corporation;'' and
     ``National Nominating Committee'' is to be replaced with
``Nominating Committee.''

II. Discussion and Commission's Findings

    After careful review, including consideration of the comment letter
received \28\ and FINRA's response thereto,\29\ 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
national securities

association.\30\ In particular, the Commission finds that the proposed
rule change is consistent with Section 15A(b)(4) of the Act,\31\ which
requires that FINRA rules are designed to assure a fair representation
of FINRA's members in the administration of its affairs. Additionally,
the Commission finds that the proposed rule change is consistent with
Section 15A(b)(6) of the Act,\32\ which requires, among other things,
that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \28\ See supra note 4.
    \29\ See letter from Carla Carloni, Associate Vice President,
FINRA, to Florence E. Harmon, Acting Secretary, Commission, dated
October 22, 2008, at 1 (``FINRA Response Letter'').
    \30\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \31\ 15 U.S.C. 78o-3(b)(4).
    \32\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

A. Changes to the NAC

1. Composition
    FINRA proposes that the restructured NAC consist of 14 members,
including seven industry members, two of whom will be ``at large'' and
five of whom will be designated specifically as representatives of
large firms, mid-size firms, and small firms, and seven non-industry
members, three of whom are public.\33\ As noted above, the Commission
received one letter regarding this proposal.\34\ The commenter
expressed support for the proposal, although he noted a concern that
NAC members no longer would be required to come from different
geographic regions of the country. In response, FINRA stated that it
will ``remain sensitive'' to the commenter's concern.\35\ FINRA also
pointed out that, under the proposed nomination process, which is
discussed further below, the District Nominating Committees, which
currently select the five industry members on the NAC that come from
the five geographic regions, are permitted to recommend candidates to
the Nominating Committee.
---------------------------------------------------------------------------

    \33\ A public member of the NAC has no material business
relationship with a broker or dealer or a self-regulatory
organization registered under the Act.
    \34\ See supra note 4.
    \35\ See FINRA Response Letter, supra note 29.
---------------------------------------------------------------------------

    The Commission finds that the proposed composition of the NAC
satisfies the fair representation requirement of Section 15A(b)(4) of
the Act because five of the 14 NAC members will be industry members,
elected by member firms of similar size.\36\ The proposed rule change
aligns the representation of industry members on the NAC to follow more
closely the industry representation of the FINRA Board. Previously, the
Commission found that the composition of the FINRA Board satisfies the
fair representation requirement of Section 15A(b)(4) of the Act.\37\
---------------------------------------------------------------------------

    \36\ See infra note 43 and accompanying text.
    \37\ See Securities Exchange Act Release No. 56145, supra note
5, 72 FR at 42182.
---------------------------------------------------------------------------

2. Nomination and Election
    FINRA proposes that the Nominating Committee identify and solicit
candidates for all NAC seats, including the five industry-member
positions that are based on firm size. The Nominating Committee would
be free to consult with and receive recommendations for industry NAC
members from other FINRA committees, including the District Nominating
Committees, before submitting nominees to the FINRA Board.
    Under the proposed rule change, Additional Candidates would be: (a)
Permitted to petition for consideration as Small, Mid-Size, or Large
Firm NAC Members, based on the size of the firm with which they are
registered; and (b) able to qualify for a contested election by
gathering petitions from three percent of the firms in their size
category. In the event of a contested election, FINRA members would
have an opportunity to vote for a NAC candidate based on firm size.\38\
Specifically, small, mid-size, or large firms would vote for NAC
candidates only if the contested election was for a NAC seat designated
for a firm of corresponding size.
---------------------------------------------------------------------------

    \38\ See proposed FINRA Regulation By-Laws, Article VI, Section
6.3 (List of FINRA Members Eligible to Vote) and Article VI, Section
6.7 (Ballots).
---------------------------------------------------------------------------

    The proposed rule change authorizes the FINRA Secretary to collect
information from candidates to determine that the nominee or Additional
Candidate, as applicable, satisfies the definition of an Industry,
Small Firm, Mid-Sized Firm, Large Firm, Non-Industry, or Public Member
of the NAC.\39\ The proposed rule change also ensures that the winner
of a contested election would serve on the NAC. While all NAC members
would continue to be recommended initially by the Nominating Committee
and appointed by the FINRA Board,\40\ the candidate who receives the
most votes in any contested election for a Small, Mid-Size, or Large
Firm NAC Member seat would be required under the FINRA Regulation By-
Laws to be appointed to the NAC.\41\ FINRA does not propose to change
the NAC selection process if no Additional Candidates reach the
threshold to qualify for a contested election. When there are no
additional candidates, the industry NAC members selected by the
Nominating Committee would not have a contested election and would be
recommended for appointment to the NAC.\42\
---------------------------------------------------------------------------

    \39\ See proposed FINRA Regulation By-Laws, Article V, Section
5.4 (Nomination Process).
    \40\ The seven non-industry members and two at-large industry
members would continue to follow the nomination and Board
appointment process currently employed for non-industry and at-large
industry NAC members.
    \41\ See proposed FINRA Regulation By-Laws, Article V, Section
5.3 (Appointments) and 5.5 (Rejection of Nominating Committee
Nominee).
    \42\ The proposed FINRA Regulation By-Laws would continue to
allow the Nominating Committee to propose two or more candidates for
a single open small, mid-size, or large firm NAC seat. See proposed
FINRA Regulation By-Laws, Article VI, Section 6.5 (Notice of
Contested Nomination). In such a case, there would be a contested
election. The proposed rule change would clarify that only when the
Nominating Committee nominates two or more candidates for the same
open seat would the Nominating Committee trigger a contested
election.
---------------------------------------------------------------------------

    The Commission finds that the proposed petition process, coupled
with the proposed By-Law provisions on the NAC's composition, also are
consistent with the fair representation requirement of Section
15A(b)(4) of the Act. As noted above, the Commission previously
approved a proposed rule change relating to the composition of the
FINRA Board that similarly provided firms with the right to petition
for and vote on FINRA Board candidates industry members, according to
firm size.\43\ The Commission also notes that FINRA's proposal to
permit Additional Candidates to qualify for a contested election by
gathering petitions from three percent of the firms in their size
category (or ten percent in the case of petitions in support of more
than one person) is lower than the ten percent threshold that has been
in place under the By-Laws to qualify a FINRA member as an Additional
Candidate for a regional NAC seat.\44\
---------------------------------------------------------------------------

    \43\ See supra note 37.
    \44\ Compare current FINRA Regulation By-Laws, Article VI,
Section 6.15 (Requirement for Petition Supporting Additional
Candidate) with proposed FINRA Regulation By-Laws, Article VI,
Section 6.2 (Designation of Additional Candidates).
---------------------------------------------------------------------------

    In addition, FINRA proposes to: (a) The narrow circumstances under
which the Nominating Committee may support its candidate by sending a
maximum of two mailings in support of its nominee; and (b) assign to
the Secretary of FINRA the duties of sending notice to FINRA members
announcing a contested NAC election, assisting in preparing ballots;
preparing a list of FINRA members eligible to vote, arranging for the
location for counting of ballots by an independent agent; resolving
ballots that were set aside, as necessary,

extending a time period regarding elections for good cause, and similar
duties. The Commission finds that these proposals are consistent with
Section 15A(b)(6) of the Act,\45\ which requires, among other things,
that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \45\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

3. Other Changes
    FINRA proposes to allow NAC to continue to function for a period of
6 months or less while a vacancy is being filled.
    FINRA proposes to broaden the FINRA Board's oversight authority
over the NAC.\46\ The proposed rule change grants the FINRA Board
authority to remove all NAC members (for refusal, failure, neglect, or
inability to discharge duties), accept their resignations, appoint
them, and declare them disqualified. FINRA believes that this change
will benefit the appellate portion of the disciplinary process.\47\
---------------------------------------------------------------------------

    \46\ The authority of the FINRA Board to establish disciplinary
procedures, impose sanctions, and review disciplinary decisions of
the NAC are discussed in the Notice. See Notice, supra note 3, 73 FR
at 56875.
    \47\ See id.
---------------------------------------------------------------------------

    The proposed rule change eliminates the reference to the Chair of
the NAC serving as a Director of the FINRA Regulation Board for a one-
year term. FINRA explains that this provision is obsolete because the
NAC Chair is no longer an automatic member of the FINRA Regulation
Board.
    FINRA proposes to narrow the pool of people qualified to be an
``Industry Member,'' requiring that a person who has served as an
officer, director, or employee of a broker or dealer, within the past
year (instead of three years) is considered to be ``industry.'' The
proposed change is consistent with the definitions of ``Industry
Governor'' and ``Industry committee member'' in the FINRA By-Laws.\48\
---------------------------------------------------------------------------

    \48\ See FINRA By-Laws, Article I(t).
---------------------------------------------------------------------------

    The proposal also adds the term ``independent director'' to the
portion of the definition of ``Industry Member'' that excludes outside
directors of a broker or dealer. FINRA states that the goal of this
proposal is to harmonize use of the term ``independent director'' when
defining an Industry Governor in the FINRA Regulation By-Laws and the
FINRA By-Laws.
    In addition, FINRA would modify the qualifications for ``Public
Director'' and ``Public Member.'' Currently, only someone with no
material business relationship with a broker, dealer, or the NASD, NASD
Regulation, or a market for which NASD provides regulation is eligible
for those positions. Alternatively, FINRA proposes to require that
Public Directors and Public Members have no material business
relationship with a broker, dealer, or a self regulatory organization
registered under the Act (``SRO''), provided that service as a public
director of an SRO or as a public member on an SRO committee is not
disqualifying.
    Finally, FINRA proposes to make the following non-substantive
replacements in the FINRA Regulation By-Laws:
     Substitute ``the NASD'' or ``NASD'' with ``FINRA'' or
``the Corporation;''
     Substitute ``NASD Regulation'' with ``FINRA Regulation;''
     Substitute ``the Rules of the Association'' with ``the
Rules of the Corporation;'' and
     Substitute ``National Nominating Committee'' with
``Nominating Committee.''
    The Commission finds that these proposed changes are consistent
with Section 15A(b)(6) of the Act,\49\ which requires, among other
things, that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \49\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

III. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\50\ that the proposed rule change (SR-FINRA-2008-046) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \50\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\51\
---------------------------------------------------------------------------

    \51\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-27249 Filed 11-17-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: March 6, 2006 (Volume 71, Number 43)]
[Notices]
[Page 11250-11251]
[DOCID:fr06mr06-77]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53377; File No. SR-CBOE-2005-112]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change Seeking
Permanent Approval of a Pilot Program Relating to Market-Maker Access
to the Exchange's Hybrid Automatic Execution System

February 27, 2006.
    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 December 30, 2005, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to make permanent its pilot program in CBOE
Rule 6.13 relating to market-maker (``MM'') access to the Exchange's
automatic execution system. The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.com), at the

Exchange's Office of the Secretary, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those 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 parts of such
statements.

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

1. Purpose
    In July 2004, the Exchange implemented on a pilot basis CBOE Rule
6.13(b)(i)(C)(iii), which relates to the frequency with which certain
market participants may submit orders for automatic execution through
the Exchange's Hybrid Trading System (``Hybrid'').\3\ The Exchange has
subsequently extended the pilot program, which expires on October 12,
2006, on two occasions.\4\ CBOE Rule 6.13(b)(i)(C)(iii) currently
provides in relevant part:
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 50005 (July 12,
2004), 69 FR 43032 (July 19, 2004) (SR-CBOE-2004-33) (approving the
pilot program).
    \4\ See Securities Exchange Act Release Nos. 51030 (January 12,
2005), 70 FR 3404 (January 24, 2005) (SR-CBOE-2004-91) (extending
the pilot program until October 12, 2005); and 52494 (September 22,
2005), 70 FR 56943 (September 29, 2005) (SR-CBOE-2005-70) (extending
the pilot program until October 12, 2006).
---------------------------------------------------------------------------

    (iii) 15-Second Limitation: With respect to orders eligible for
submission pursuant to paragraph (b)(i)(C)(ii), members shall neither
enter nor permit the entry of multiple orders on the same side of the
market in an option class within any 15-second period for an account or
accounts of the same beneficial owner. The appropriate FPC may shorten
the duration of this 15-second period by providing notice to the
membership via a Regulatory Circular that is issued at least one day
prior to implementation. The effectiveness of this rule shall terminate
on October 12, 2006.
    Upon approval of the pilot program, the Exchange began allowing
orders from options exchange MMs to be eligible for automatic
execution, subject to the 15-second limitation described above.\5\ The
Exchange believes that the

pilot program has been successful and has helped to contribute to the
maintenance of efficient markets and to attract MM volume to the
Exchange. Given this success, the Exchange is requesting permanent
approval of the pilot program.
---------------------------------------------------------------------------

    \5\ CBOE Rule 6.13(b)(i)(C)(ii) governs the submission of orders
from MMs (paragraph (C)(ii)(A)) and stock exchange specialists
(paragraph (C)(ii)(B)). It should be noted that, pursuant CBOE Rule
6.13(b)(i)(C)(iii), the floor procedures committees (``FPCs'')
determined to shorten to 5 seconds (from 15 seconds) the period
required between entry of multiple market-maker orders (including
non-CBOE MM orders) on the same side of the market in an option
class for an account or accounts of the same beneficial owner using
Hybrid. This change went into effect on July 18, 2005 and was
announced to the membership via Regulatory Circular RG05-61.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act \6\ and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\7\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \8\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and practices \9\ and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78a et seq.
    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ At the request of the Exchange, the Commission staff has
added ``and practices,'' which was inadvertently omitted from the
proposed rule change. Telephone conversation between Jennifer M.
Lamie, Managing Senior Attorney, CBOE, and Kim M. Allen, Special
Counsel, Division of Market Regulation, Commission, on February 23,
2006.
---------------------------------------------------------------------------

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.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2005-112 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2005-112. 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. Copies of such 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-CBOE-2005-112 and should be submitted on or before March 27, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-3092 Filed 3-3-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Notices]
[Page 2179]
[FR Doc No: 2015-00555]

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

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0097]

Acceptance of Applications for Mexican-Domiciled Long-Haul
Operations

AGENCY: Federal Motor Carrier Safety Administration, DOT.

ACTION: Notice.

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

SUMMARY: The United States-Mexico Cross-Border Long-Haul Trucking Pilot
Program (Pilot Program) concluded on October 10, 2014. The Pilot
Program was part of FMCSA's implementation of the North American Free
Trade Agreement (NAFTA) cross-border long-haul trucking provisions.
Congress required the Pilot Program to test the safety of granting
long-haul authority to Mexico-domiciled motor carriers. This notice
announces that the U.S. Department of Transportation (DOT) has
submitted the required report to Congress and is accepting applications
from Mexico-domiciled motor carriers interested in conducting long-haul
operations.

DATES: This decision is effective January 15, 2015.

ADDRESSES: Docket: For access to the docket to read background
documents or comments submitted to previous notices concerning the
Pilot Program, go to www.regulations.gov at any time or visit Room W12-
140 on the ground level of the West Building, 1200 New Jersey Avenue
SE., Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through
Friday, except Federal holidays. The on-line Federal document
management system is available 24 hours each day, 365 days each year.
The docket number is FMCSA-2011-0097.

FOR FURTHER INFORMATION CONTACT: Bryan Price, Chief, North American
Borders Division, Federal Motor Carrier Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. Telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: From October 14, 2011, to October 10, 2014,
FMCSA conducted a Pilot Program to test and demonstrate the ability of
Mexico-based motor carriers to operate safely in the United States
beyond the municipalities and commercial zones along the United States-
Mexico border. The Pilot Program was part of FMCSA's implementation of
the North American Free Trade Agreement (NAFTA) cross-border long-haul
trucking provisions.
    As of October 10, 2014, 13 Mexico-domiciled motor carriers with
authority to operate in the United States beyond the commercial zones
and municipalities at the U.S.-Mexico border had successfully
participated in the Pilot Program and established a record of safety.
    On October 10, 2014, FMCSA issued new certificates of operating
authority registration to the 13 Pilot Program participants pursuant to
49 U.S.C. 13902(a) and (c),\1\ the November 27, 2002 Memorandum of the
President of the United States to the Secretary of Transportation [67
FR 71795 (December 2, 2002)] and the motor carriers' successful
performance in the Pilot Program.\2\
---------------------------------------------------------------------------

    \1\ Including compliance with Section 350 of the Fiscal Year
2002 DOT Appropriations Act, (Pub. L. 104-87), which has been
incorporated in successive appropriations legislation.
    \2\ Pursuant to the procedures noted in 76 FR 40420 (July 8,
2011).
---------------------------------------------------------------------------

    On October 10, 2014, the Department verbally advised Congress of
the completion of the Pilot Program. On January 9, 2015, DOT submitted
its report titled, ``United States-Mexico Cross-Border Long-Haul
Trucking Pilot Program Report to Congress'' to the House and Senate
Committees on Appropriations as well as the Senate Committee on
Commerce, Science and Transportation and the House of Representatives'
Committee on Transportation and Infrastructure. A copy of the report is
posted in the docket for this program (FMCSA-2011-0097) and the Agency
posted a link to the docket on the Pilot Program's Web site at: http://www.fmcsa.dot.gov/international-programs/mexico-cross-border-trucking-pilot-program.
    As a result of the successful completion of the Pilot Program,
FMCSA will again accept applications from Mexico-domiciled motor
carriers seeking authority to operate in long-haul transportation
beyond the U.S. commercial zones. Information regarding the application
and review processes is available at http://www.fmcsa.dot.gov/registration/form-op-1mx.

    Issued on: January 9, 2015.
T.F. Scott Darling, III,
Acting Administrator.
[FR Doc. 2015-00555 Filed 1-14-15; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Notices]
[Page 28670-28672]
[DOCID:fr21my10-148]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62102; File No. SR-BATS-2010-011]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
BATS Rule 11.9, Entitled ``Orders and Modifiers''

May 13, 2010.
    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 May 4, 2010, BATS Exchange, Inc. (the ``Exchange'' or ``BATS'')
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 the Exchange. The Exchange has designated this
proposal as a ``non-controversial'' proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)(iii)
thereunder,\4\ which renders it effective upon filing with the
Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to make a modification to the existing
technology that it provides to a User that wishes to avoid trading
against orders from that same User (currently referred to as ``Member
Match Trade Prevention'' or ``MMTP'').
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to make a minor change to its Member Match
Trade Prevention, or MMTP, functionality, described in BATS Rules
11.9(f) and 21.1(g) and to rename the functionality as Match Trade
Prevention (``MTP'').
    MMTP modifiers are designed to prevent two orders with the same
Unique Identifier (as defined below) from executing against each other.
The Exchange currently offers four MMTP modifiers that can be set at
the market participant identifier (``MPID''), the Exchange Member
identifier or the Exchange Sponsored Participant identifier level (any
such identifier, a ``Unique Identifier'').\5\ BATS is proposing a
change to the MMTP Decrement and Cancel identifier (``MDC''); none of
the other MMTP identifiers are affected by this proposal, other than to
change the references throughout the rule text to MTP.
---------------------------------------------------------------------------

    \5\ Any Exchange Member that has an MPID issued by FINRA is
identified in the Exchange's internal systems by that MPID. Each
Exchange Member that does not already have an MPID and each
Sponsored Participant is issued an identifier that is specific to
the Exchange and allows the Exchange to determine the User for each
order and trade.
---------------------------------------------------------------------------

    Under the existing rules, an incoming order marked with the MDC
modifier will not execute against opposite side resting interest marked
with any MMTP modifier originating from the same Unique Identifier. If
both orders are equivalent in size, both orders will be cancelled back
to the originating User. If the orders are not equivalent in size, the
equivalent size will be cancelled back to the originating User and the
larger order will be decremented by the size of the smaller order, with
the balance remaining on the BATS Book; provided, however, that if the
resting order is marked with any MMTP modifier other than MDC, and the
incoming order is smaller in size than the resting order, then both
orders will be cancelled back to the originating User (the ``MDC
Exception''). Thus, as shown in the example below, rather than
decrementing either order, pursuant to the MDC Exception both orders
are cancelled in their entirety when the resting order contains an MMTP
modifier other than MDC and is larger than the incoming order.
    Current MDC Exception--Example: An order to buy 500 shares @ $22.00
is

marked with any MMTP modifier other than MDC and becomes a resting
order in the BATS Book. Subsequently, an order to sell 400 shares @
$22.00 is entered with the same Unique Identifier and marked with the
MDC modifier.
    Current MDC Exception--Result: The resting buy order for 500 shares
at $22.00 marked with a MMTP modifier other than MDC is cancelled back
to the originating User. The incoming sell order for 400 shares @
$22.00 marked with the MDC modifier is cancelled back to the
originating User.
    The Exchange proposes to allow Users to opt-out of the default
behavior of the MDC Exception to allow an incoming MDC order to result
in a decremented order even when it is smaller than the resting order
and the resting order contains an MMTP modifier other than MDC.
    Proposed Opt-Out of MDC--Example: An order to buy 500 shares @
$22.00 is marked with any MMTP modifier and becomes a resting order in
the BATS Book. Subsequently, an order to sell 400 shares @ $22.00 is
entered with the same Unique Identifier and marked with the MDC
modifier.
    Proposed Opt-Out of MDC--Result: 400 of the 500 shares on the
resting buy order at $22.00 marked with any MMTP modifier are cancelled
back to the originating User. The outstanding 100 shares remain on the
BATS Book. The incoming sell order for 400 shares @ $22.00 marked with
the MDC modifier is cancelled back to the originating User.
    Although the Exchange intentionally created the MDC Exception based
on conversations with its Users regarding the best way to implement the
MDC modifier, other Users have requested that the Exchange allow them
to have the incoming order control the result in all situations, and
thus, have requested to be able to opt-out of the MDC Exception. The
Exchange notes that NYSE Arca Equities (``NYSE Arca'') has implemented
its version of match trade prevention without the MDC Exception, and
thus, allowing Users to opt-out of the exception is consistent with
NYSE Arca's STP Decrement and Cancel option.\6\ The Exchange will allow
a User to opt-out of the MDC Exception by changing the settings of its
order entry ports. The Exchange may also permit Users to opt-out of the
MDC Exception on an order-by-order basis through use of a specific tag
attached to each order.
---------------------------------------------------------------------------

    \6\ See NYSE Arca Rule 7.31(qq)(3).
---------------------------------------------------------------------------

Additional Discussion

    In addition to the modification to the MDC modifier described
above, the Exchange proposes to change the references throughout its
rules from ``Member Match Trade Prevention'' to ``Match Trade
Prevention'' and from ``MMTP'' to ``MTP''.
    The Exchange believes that its Match Trade Prevention functionality
allows certain firms to better internalize their agency order flow,
which in turn may decrease costs to customers of such firms. The
Exchange notes that MTP modifiers do not alleviate, or otherwise
exempt, broker-dealers from their best execution obligations. As such,
broker-dealers using MTP modifiers are obligated to internally cross
agency orders at the same price, or a better price than they would have
received had the orders been executed on the Exchange. Additionally,
MTP modifiers assist market participants in complying with certain
rules and regulations of the Employee Retirement Income Security Act
(``ERISA'') that preclude and/or limit managing broker-dealers of such
accounts from trading as principal with orders generated for those
accounts. Finally, the Exchange notes that offering the MTP modifiers
may streamline certain regulatory functions by reducing false positive
results that may occur on Exchange generated wash trading surveillance
reports when orders are executed under the same Unique Identifier. For
these reasons, the Exchange believes the MTP modifiers offer users
enhanced order processing functionality that may prevent potentially
undesirable executions without negatively impacting broker-dealer best
execution obligations.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\7\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\8\
because it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to, and perfect
the mechanism of, a free and open market and a national market system.
Specifically, Match Trade Prevention functionality allows firms to
better manage order flow and prevent undesirable executions against
themselves, and the proposed change described herein enhances the
choices available to such firms in how they do so.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 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 imposes
any burden on competition.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\11\
However, Rule 19b-4(f)(6)(iii)\12\ 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 requested that the
Commission waive the 30-day operative delay so that the Exchange may
immediately offer Exchange Users another choice with respect to MTP
modifiers. The Commission notes that the proposal is consistent with
the rules of another national securities exchange.\13\ Based on the
foregoing, the Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest and hereby designates the proposal operative upon filing.\14\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
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 Exchange has satisfied this requirement.
    \12\ Id.
    \13\ See supra note 6.
    \14\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).

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

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-BATS-2010-011 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-BATS-2010-011. 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,\15\ 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 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of BATS.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File No. SR-BATS-2010-011 and
should be submitted on or before June 11, 2010.
---------------------------------------------------------------------------

    \15\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov/rules/sro.shtml.

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

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-12226 Filed 5-20-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42907]
[FR Doc No: 2021-16672]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92528; File No. SR-CBOE-2020-106]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change, as Modified by Amendment No. 1,
To Amend Its Rules Regarding the Minimum Increments for Electronic Bids
and Offers and Exercise Prices of Certain FLEX Options and Clarify in
the Rules How the System Ranks FLEX Option Bids and Offers for
Allocation Purposes

July 30, 2021.
    On November 16, 2020, Cboe Exchange, Inc. filed with the Securities
and Exchange Commission (``Commission''), pursuant to Section 19(b)(1)
of the Securities Exchange Act of 1934 (``Exchange Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to amend its rules
regarding the minimum increments for electronic bids and offers and
exercise prices of certain FLEX options and clarify how the system
ranks FLEX option bids and offers for allocation purposes. On November
30, 2020, the Exchange filed Amendment No. 1 to the proposed rule
change, which amended and replaced the proposed rule change in its
entirety. The Commission published notice of the proposed rule change,
as modified by Amendment No. 1, in the Federal Register on December 4,
2020.\3\ On January 14, 2021, pursuant to Section 19(b)(2) of the
Exchange Act,\4\ the Commission designated a longer period within which
to approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether to disapprove the
proposed rule change.\5\ On March 4, 2021, the Commission instituted
proceedings under Section 19(b)(2)(B) of the Exchange Act \6\ to
determine whether to approve or disapprove the proposed rule change.\7\
On May 27, 2021, the Commission designated a longer period for
Commission action on proceedings to determine whether to approve or
disapprove the proposed rule change, as modified by Amendment No. 1.\8\
On July 8, 2021, the Exchange withdrew the proposed rule change (SR-
CBOE-2020-106).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 90536 (November 30,
2020), 85 FR 78381.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 90926, 86 FR 6710
(January 22, 2021).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 91257, 86 FR 13769
(March 10, 2021). The Commission received one comment letter, which
was from the Exchange, in response to the order instituting
proceedings. The comment letter is available at the Commission's
website at: https://www.sec.gov/comments/sr-cboe-2020-106/srcboe2020106-8744076-237183.pdf.
    \8\ See Securities Exchange Act Release No. 92040, 85 FR 29817
(June 3, 2021).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16672 Filed 8-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62799-62800]
[FR Doc No: 2023-19796]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-0558]

Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams
and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and
10 mg, were withdrawn from sale for reasons of safety or effectiveness.
The Agency will not accept or approve abbreviated new drug applications
(ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-
796-3600, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    The anabolic steroid Oxandrin (oxandrolone) tablets, 2.5 mg and 10
mg, is the subject of NDA 013718, held by Gemini Laboratories LLC
(Gemini), and initially approved on July 21, 1964 (for the 2.5 mg
strength) and November 5, 2001 (for the 10 mg strength). Oxandrin is
indicated as follows: ``as adjunctive therapy to promote weight gain
after weight loss following extensive surgery, chronic infections, or
severe trauma, and in some patients who without definite
pathophysiologic reasons fail to gain or to maintain normal weight, to
offset the protein catabolism associated with prolonged administration
of corticosteroids, and for the relief of the bone pain frequently
accompanying osteoporosis.'' \1\
---------------------------------------------------------------------------

    \1\ See Oxandrin (oxandrolone) tablets product labeling (NDA
013718, supplement 023), approved on June 20, 2005, available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf.
---------------------------------------------------------------------------

    In a letter dated March 26, 2019, Gemini requested that FDA
withdraw approval of NDA 013718 for Oxandrin (oxandrolone) tablets, 2.5
mg and 10 mg, under Sec.  314.150(c) (21 CFR 314.150(c)), stating that
the product was no longer being marketed. Subsequently, on December 16,
2022, FDA notified Gemini that the Agency believes a potential problem
associated with oxandrolone tablets is sufficiently serious that the
drug product should be removed from the market, and to enable
withdrawal of approval of its application under Sec.  314.150(d). After
FDA notified Gemini that it believes the potential problems associated
with the drug are sufficiently serious that the drug should be removed
from the market pursuant to Sec.  314.150(d), Gemini requested in a
letter dated December 19, 2022, that FDA withdraw approval of NDA
013718 for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg under Sec.
314.150(d). In the Federal Register of June 28, 2023 (88 FR 41970), FDA
announced that it was withdrawing approval of NDA 013718, effective
June 28, 2023.
    Novitium Pharma LLC submitted a citizen petition dated April 6,
2022 (Docket No. FDA-2022-P-0558), under 21 CFR 10.30, requesting that
the Agency determine whether Oxandrin (oxandrolone) tablets, 2.5 mg and
10 mg, were withdrawn from sale for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg,

were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10
mg, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events.
    Our records show that FDA's Endocrinologic and Metabolic Drugs
Advisory Committee met and discussed anabolic steroids in January 1984.
The advisory committee unanimously concluded that there was no evidence
of efficacy for oxandrolone.\2\
---------------------------------------------------------------------------

    \2\ See minutes from the January 24 to 25, 1984, advisory
committee meeting discussing anabolic steroids, at pg. 7.
---------------------------------------------------------------------------

    As communicated in the product labeling for Oxandrin (oxandrolone)
tablets, 2.5 mg and 10 mg, multiple safety warnings and precautions are
associated with the use of this product including peliosis hepatis,
sometimes associated with liver failure and intra-abdominal hemorrhage;
liver cell tumors, sometimes fatal; and blood lipid changes that are
known to be associated with increased risk of atherosclerosis.\3\ Per
the product labeling, additional warnings with using this product
include the risks associated with cholestatic hepatitis, hypercalcemia
in patients with breast cancer, and increased risk for the development
of prostatic hypertrophy and prostatic carcinoma in geriatric
patients.\4\ Considering the safety concerns associated with the use of
oxandrolone noted in the labeling, the Agency concluded that the
benefit-risk profile of the drug product is unfavorable without
substantial evidence to support effectiveness.
---------------------------------------------------------------------------

    \3\ See footnote 1.
    \4\ See footnote 1.
---------------------------------------------------------------------------

    Based on a thorough evaluation of the information we have available
to us and an evaluation of the latest version of the drug products'
approved labeling, we have determined that the drug products would not
be considered safe and effective if they were reintroduced to the
market today. New clinical studies would first need to be conducted to
address the concerns described above. Thus, after considering the
citizen petition and reviewing Agency records and based on the
information we have at this time, FDA has determined under Sec.
314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were
withdrawn for reasons of safety or effectiveness. Accordingly, the
Agency will remove Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg,
from the list of drug products published in the Orange Book per Sec.
314.162. FDA will not accept or approve ANDAs that refer to this drug
product.

    Dated: September 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19796 Filed 9-12-23; 8:45 am]
BILLING CODE 4164-01-P