[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Page 24488]
[FR Doc No: 2014-09894]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fifth Meeting: RTCA Tactical Operations Committee (TOC)

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

ACTION: Fifth meeting notice of RTCA Tactical Operations Committee.

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SUMMARY: The FAA is issuing this notice to advise the public of the
fifth meeting of the RTCA Tactical Operations Committee.

DATES: The meeting will be held May 16, 2014 from 9 a.m.-1 p.m.

ADDRESS: The meeting will be held at RTCA, Inc., 1150 18th Street NW.,
Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or Trin
Mitra, TOC Secretary<EMAIL_ADDRESS>202-330-0655.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the RTCA Tactical Operations Committee.
The agenda will include the following:

May 16

     Opening of Meeting/Introduction of TOC Members.
    [cir] Co-Chairs Mr. Jim Bowman, FedEx Express, and Mr. Dale Wright,
National Air Traffic Controllers Association (NATCA).
     Official Statement of Designated Federal Official.
    [cir] Ms. Elizabeth Ray, FAA Air Traffic Organization, Vice
President Mission Support.
     Approval of February 6, 2014 Meeting Summary.
     FAA Report.
     FAA Response to Previous TOC Recommendations.
    [cir] FAA present response to NOTAM Task 1 and Task 2
Recommendations, VOR MON Task 1 and Task 2 Recommendations and 20:1
Visual Area Surface Recommendations.
     Notice to Airmen (NOTAM) Follow Up to Recommendation 1.
    [cir] NOTAM Task Group present feedback to questions from the FAA
response to Task 1.
     Update from VHF Omni-directional Range (VOR) Minimum
Operating Network Task Group.
    [cir] VOR MON Task Group provide status of taskings and interim
report.
     Report from the NextGen Advisory Committee (NAC): the
NextGen Integration Working Group.
     Update on Regional Task Groups (RTGs).
    [cir] Request approval of new Eastern RTG Co Chair by TOC.
    [cir] Review status of tasking RTGs on Special Activity Airspace.
    [cir] Eastern, Western, Central RTG updates.
     Anticipated Issues for TOC consideration and action at the
next meeting.
     Other business.
     Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, 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 April 23, 2014.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2014-09894 Filed 4-29-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 84034-84039]
[FR Doc No: 2020-28307]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90702; File No. 4-529]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Notice of Filing and Order Approving and Declaring
Effective an Amended Plan for the Allocation of Regulatory
Responsibilities Between the Financial Industry Regulatory Authority,
Inc. and Nasdaq ISE, LLC

December 17, 2020.
    Notice is hereby given that the Securities and Exchange Commission
(``Commission'') has issued an Order, pursuant to Section 17(d) of the
Securities Exchange Act of 1934 (``Act''),\1\ approving and declaring
effective an amendment to the plan for allocating regulatory
responsibility (``Plan'') filed on November 19, 2020, pursuant to Rule
17d-2 of the Act,\2\ by the Financial Industry Regulatory Authority,
Inc. (``FINRA'') and Nasdaq ISE, LLC (``ISE'') (collectively,
``Participating Organizations'' or ``parties''). This agreement amends
and restates the agreement entered into between FINRA and International
Securities Exchange, LLC on December 16, 2006, entitled ``Agreement
Between Financial Industry Regulatory Authority, Inc. and International
Securities Exchange, LLC Pursuant to Rule 17d-2 under the Securities
Exchange Act of 1934,'' and any subsequent amendments thereafter.
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    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
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I. Introduction

    Section 19(g)(1) of the Act,\3\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or national securities association to examine for,
and enforce compliance by, its members and persons associated with its
members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this responsibility
pursuant to Section

17(d) \4\ or Section 19(g)(2) \5\ of the Act. Without this relief, the
statutory obligation of each individual SRO could result in a pattern
of multiple examinations of broker-dealers that maintain memberships in
more than one SRO (``common members''). Such regulatory duplication
would add unnecessary expenses for common members and their SROs.
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    \3\ 15 U.S.C. 78s(g)(1).
    \4\ 15 U.S.C. 78q(d).
    \5\ 15 U.S.C. 78s(g)(2).
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    Section 17(d)(1) of the Act \6\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\7\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
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    \6\ 15 U.S.C. 78q(d)(1).
    \7\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
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    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\8\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\9\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce member compliance with financial
responsibility requirements. Rule 17d-1 does not relieve an SRO from
its obligation to examine a common member for compliance with its own
rules and provisions of the federal securities laws governing matters
other than financial responsibility, including sales practices and
trading activities and practices.
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    \8\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \9\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
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    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\10\ Rule 17d-2 permits
SROs to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for appropriate notice and opportunity for comment, it
determines that the plan is necessary or appropriate in the public
interest and for the protection of investors, to foster cooperation and
coordination among the SROs, to remove impediments to, and foster the
development of, a national market system and a national clearance and
settlement system, and is in conformity with the factors set forth in
Section 17(d) of the Act. Commission approval of a plan filed pursuant
to Rule 17d-2 relieves an SRO of those regulatory responsibilities
allocated by the plan to another SRO.
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    \10\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
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II. The Plan

    On February 27, 2007, the Commission declared effective the Plan
entered into between FINRA and ISE for allocating regulatory
responsibility pursuant to Rule 17d-2.\11\ The Plan is intended to
reduce regulatory duplication for firms that are common members of
FINRA and ISE by allocating regulatory responsibility with respect to
certain applicable laws, rules, and regulations that are common among
them. Included in the Plan is an exhibit that lists every ISE rule for
which FINRA bears responsibility under the Plan for overseeing and
enforcing with respect to ISE members that are also members of FINRA
and the associated persons therewith (``Certification'').
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    \11\ See Securities Exchange Act Release No. 55367 (February 27,
2007), 72 FR 9983 (March 6, 2007).
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III. Proposed Amendment to the Plan

    On November 19, 2020, the parties submitted a proposed amendment to
the Plan (``Amended Plan''). The primary purpose of the Amended Plan is
to allocate surveillance, investigation, and enforcement
responsibilities for Rule 14e-4 under the Act and to reflect the name
change of International Securities Exchange, LLC to Nasdaq ISE, LLC.
The text of the proposed Amended Plan is as follows (additions are
italicized; deletions are [bracketed]):
* * * * *
AGREEMENT BETWEEN [NASD]FINANCIAL INDUSTRY REGULATORY AUTHORITY, INC.
AND [INTERNATIONAL SECURITIES EXCHANGE]NASDAQ ISE, LLC PURSUANT TO RULE
17d-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934
    This Agreement, by and between the [National Association of
Securities Dealers, Inc. (``NASD'')]Financial Industry Regulatory
Authority, Inc. (``FINRA'') and the [International Securities
Exchange]Nasdaq ISE, LLC (``ISE''), is made this [20th] 16th day of
[December] November, 20[06]20 (the ``Agreement''), pursuant to Section
17(d) of the Securities Exchange Act of 1934 (the ``Exchange Act'') and
Rule 17d-2 thereunder which permits agreements between self-regulatory
organizations to allocate regulatory responsibility to eliminate
regulatory duplication. [NASD]FINRA and ISE may be referred to
individually as a ``party'' and together as the ``parties.''
    This Agreement amends and restates the agreement entered into
between the parties on April 3, 2000 and amended on April 27, 2000 and
December 20, 2006, entitled ``Agreement Between the National
Association of Securities Dealers, Inc., NASD [Regulation, Inc.] and
the International Securities Exchange LLC Pursuant to Section 17(d) and
Rule 17d-2,'' and any subsequent amendments thereafter.
    Whereas, [NASD]FINRA and ISE desire to reduce duplication in the
examination of their Dual Members (as defined herein) and in the filing
and processing of certain registration and membership records; and
    Whereas, [NASD]FINRA and ISE desire to execute an agreement
covering such subjects pursuant to the provisions of Rule 17d-2 under
the Exchange Act and to file such agreement with the Securities and
Exchange Commission (the ``SEC'' or ``Commission'') for its approval.
    Now, therefore, in consideration of the mutual covenants contained
hereinafter, [NASD]FINRA and ISE hereby agree as follows:
    1. Definitions. Unless otherwise defined in this Agreement or the
context otherwise requires, the terms used in this Agreement shall have
the same meaning as they have under the Exchange Act and the rules and
regulations thereunder. As used in this Agreement, the following terms
shall have the following meanings:

    (a) ``ISE Rules'' or ``[NASD]FINRA Rules'' shall mean the rules
of the ISE or [NASD]FINRA, respectively, as the rules of an exchange
or association are defined in Exchange Act Section 3(a)(27).
    (b) ``Common Rules'' shall mean the ISE Rules that are
substantially similar to the applicable [NASD]FINRA Rules in that
examination for compliance with such rules would not require
[NASD]FINRA to develop one or more new examination standards,
modules, procedures, or criteria in order to analyze the application
of the rule, or a Dual Member's activity, conduct, or output in
relation to such rule. Common Rules shall not include any provisions
regarding (i)

notice, reporting or any other filings made directly to or from ISE,
(ii) incorporation by reference of ISE Rules that are not Common
Rules, (iii) exercise of discretion in a manner that differs from
FINRA's exercise of discretion including, but not limited to
exercise of exemptive authority by ISE, (iv) prior written approval
of ISE and (v) payment of fees or fines to ISE.
    (c) ``Dual Members'' shall mean those ISE members that are also
members of [NASD]FINRA and the associated persons therewith.
    (d) ``Effective Date'' shall have the meaning set forth in
paragraph 14.
    (e) ``Enforcement Responsibilities'' shall mean the conduct of
appropriate proceedings, in accordance with the [NASD]FINRA Code of
Procedure (the Rule 9000 Series) and other applicable [NASD]FINRA
procedural rules, to determine whether violations of pertinent laws,
rules or regulations have occurred, and if such violations are
deemed to have occurred, the imposition of appropriate sanctions as
specified under the [NASD]FINRA's Code of Procedure and sanctions
guidelines.
    (f) ``Regulatory Responsibilities'' shall mean the examination
responsibilities and Enforcement Responsibilities relating to
compliance by the Dual Members with the Common Rules and the
provisions of the Exchange Act and the rules and regulations
thereunder, and other applicable laws, rules and regulations, each
as set forth on Exhibit 1 attached hereto. The term ``Regulatory
Responsibilities'' shall also include the surveillance,
investigation and Enforcement Responsibilities relating to
compliance by Common Members with Rule 14e-4 of the Securities
Exchange Act (``Rule 14e-4''), with a focus on the standardized call
option provision of Rule 14e-4(a)(1)(ii)(D).

    2. Regulatory and Enforcement Responsibilities. [NASD]FINRA shall
assume Regulatory Responsibilities and Enforcement Responsibilities for
Dual Members. Attached as Exhibit 1 to this Agreement and made part
hereof, ISE furnished [NASD]FINRA with a current list of Common Rules
and certified to [NASD]FINRA that such rules are substantially similar
to the corresponding [NASD]FINRA rule (the ``Certification'').
[NASD]FINRA hereby agrees that the rules listed in the Certification
are Common Rules as defined in this Agreement. Each year following the
Effective Date of this Agreement, or more frequently if required by
changes in either the rules of ISE or [NASD]FINRA, ISE shall submit an
updated list of Common Rules to [NASD]FINRA for review which shall add
ISE rules not included in the current list of Common Rules that qualify
as Common Rules as defined in this Agreement; delete ISE rules included
in the current list of Common Rules that no longer qualify as Common
Rules as defined in this Agreement; and confirm that the remaining
rules on the current list of Common Rules continue to be ISE rules that
qualify as Common Rules as defined in this Agreement. Within 30 days of
receipt of such updated list, [NASD]FINRA shall confirm in writing
whether the rules listed in any updated list are Common Rules as
defined in this Agreement. Notwithstanding anything herein to the
contrary, it is explicitly understood that the term ``Regulatory
Responsibilities'' does not include, and ISE shall retain full
responsibility for (unless otherwise addressed by separate agreement or
rule) the following:
    (a) Surveillance and enforcement with respect to trading activities
or practices involving ISE's own marketplace, including without
limitation ISE's rules relating to the rights and obligations of market
makers;
    (b) registration pursuant to its applicable rules of associated
persons (i.e., registration rules that are not Common Rules);
    (c) discharge of its duties and obligations as a Designated
Examining Authority pursuant to Rule 17d-1 under the Exchange Act; and
    (d) any ISE Rules that are not Common Rules, except for ISE Rules
for any ISE member that operates as a facility (as defined in Section
3(a)(2) of the Exchange Act), acts as an outbound router for the ISE
and is a member of [NASD]FINRA (``Router Member'') as provided in
paragraph 6. As of the date of this Agreement, ISE Route LLC is the
only Router Member.
    3. Dual Members. Prior to the Effective Date, ISE shall furnish
[NASD]FINRA with a current list of Dual Members, which shall be updated
no less frequently than once each quarter.
    4. No Charge. There shall be no charge to ISE by [NASD]FINRA for
performing the Regulatory Responsibilities and Enforcement
Responsibilities under this Agreement except as hereinafter provided.
[NASD]FINRA shall provide ISE with ninety (90) days advance written
notice in the event [NASD]FINRA decides to impose any charges to ISE
for performing the Regulatory Responsibilities under this Agreement. If
[NASD]FINRA determines to impose a charge, ISE shall have the right at
the time of the imposition of such charge to terminate this Agreement;
provided, however, that [NASD]FINRA's Regulatory Responsibilities under
this Agreement shall continue until the Commission approves the
termination of this Agreement.
    5. Reassignment of Regulatory Responsibilities. Notwithstanding any
provision hereof, this Agreement shall be subject to any statute, or
any rule or order of the Commission, or industry agreement,
restructuring the regulatory framework of the securities industry or
reassigning Regulatory Responsibilities between self-regulatory
organizations. To the extent such action is inconsistent with this
Agreement, such action shall supersede the provisions hereof to the
extent necessary for them to be properly effectuated and the provisions
hereof in that respect shall be null and void.
    6. Notification of Violations. In the event that [NASD]FINRA
becomes aware of apparent violations of any ISE Rules, which are not
listed as Common Rules, discovered pursuant to the performance of the
Regulatory Responsibilities assumed hereunder, [NASD]FINRA shall notify
ISE of those apparent violations for such response as ISE deems
appropriate. Apparent violations of all other applicable rules,
including violations of the Common Rules, various securities acts, and
rules and regulations thereunder, shall be processed by, and
enforcement proceedings in respect thereto shall be conducted by
[NASD]FINRA as provided hereinbefore; provided, however, that in the
event a Dual Member is the subject of an investigation relating to a
transaction on the ISE, ISE may in its discretion assume concurrent
jurisdiction and responsibility. With respect to apparent violations of
any ISE Rules by any Router Member, [NASD]FINRA shall not make
referrals to ISE pursuant to this paragraph 6. Such apparent violations
shall be processed by, and enforcement proceedings in respect thereto
will be conducted by, [NASD]FINRA as provided in this Agreement. Each
party agrees to make available promptly all files, records and
witnesses necessary to assist the other in its investigation or
proceedings.
    7. Continued Assistance. [NASD]FINRA shall make available to ISE
all information obtained by [NASD]FINRA in the performance by it of the
Regulatory Responsibilities hereunder in respect to the Dual Members
subject to this Agreement. In particular, and not in limitation of the
foregoing, [NASD]FINRA shall furnish ISE any information it obtains
about Dual Members which reflects adversely on their financial
condition. It is understood that such information is of an extremely
sensitive nature and, accordingly, ISE acknowledges and agrees to take
all reasonable steps to maintain its confidentiality. ISE shall make
available to [NASD]FINRA any information coming to its attention that
reflects adversely on the financial condition of Dual Members or
indicates

possible violations of applicable laws, rules or regulations by such
firms.
    8. Dual Member Applications.
    (a) Dual Members subject to this Agreement shall be required to
submit, and [NASD]FINRA shall be responsible for processing and acting
upon all applications submitted on behalf of allied persons, partners,
officers, registered personnel and any other person required to be
approved by the rules of both ISE and [NASD]FINRA or associated with
Dual Members thereof. Upon request, [NASD]FINRA shall advise ISE of any
changes of allied members, partners, officers, registered personnel and
other persons required to be approved by the rules of both ISE and
[NASD]FINRA.
    (b) Dual Members shall be required to send to [NASD]FINRA all
letters, termination notices or other material respecting the
individuals listed in paragraph 8(a).
    (c) When as a result of processing such submissions [NASD]FINRA
becomes aware of a statutory disqualification as defined in the
Exchange Act with respect to a Dual Member, [NASD]FINRA shall determine
pursuant to Sections 15A(g) and/or Section 6(c) of the Exchange Act the
acceptability or continued applicability of the person to whom such
disqualification applies and keep ISE advised of its actions in this
regard for such subsequent proceedings as ISE may initiate.
    (d) Notwithstanding the foregoing, [NASD]FINRA shall not review the
membership application, reports, filings, fingerprint cards, notices,
or other writings filed to determine if such documentation submitted by
a broker or dealer, or a person associated therewith or other persons
required to register or qualify by examination: (i) Meets the ISE
requirements for general membership or for specified categories of
membership or participation in the ISE, such as (A) Primary Market
Maker Membership (``PMM''); (B) Competitive Market Maker Membership
(``CMM''); (C) Electronic Access Membership (``EAM'') (or any similar
type of ISE membership or participation that is created after this
Agreement is executed); or (ii) meets the ISE requirements to be
associated with, or employed by, an ISE member or participant in any
capacity, such a Designated Trading Representative (``DTR'') (or any
similar type of participation, employment category or title, or
associate-person category or class that is created after this Agreement
is executed). [NASD]FINRA shall not review applications or other
documentation filed to request a change in the rights or status
described in this paragraph 8(d), including termination or limitation
on activities, of a member or a participant of the ISE, or a person
associated with, or requesting association with, a member or
participant of the ISE.
    9. Branch Office Information. [NASD]FINRA shall also be responsible
for processing and, if required, acting upon all requests for the
opening, address changes, and terminations of branch offices by Dual
Members and any other applications required of Dual Members with
respect to the Common Rules as they may be amended from time to time.
[NASD]FINRA shall advise ISE monthly of the opening, address change and
termination of branch and main offices of Dual Members and the names of
such branch office managers.
    10. Customer Complaints. ISE shall forward to [NASD]FINRA copies of
all customer complaints involving Dual Members received by ISE relating
to [NASD]FINRA's Regulatory Responsibilities under this Agreement. It
shall be [NASD]FINRA's responsibility to review and take appropriate
action in respect to such complaints.
    11. Advertising. [NASD]FINRA shall assume responsibility to review
the advertising of Dual Members subject to the Agreement, provided that
such material is filed with [NASD]FINRA in accordance with
[NASD]FINRA's filing procedures and is accompanied with any applicable
filing fees set forth in [NASD]FINRA Rules. Such review shall be made
in accordance with then applicable [NASD]FINRA rules and
interpretations. The advertising of Dual Members shall be subject only
to compliance with appropriate [NASD]FINRA rules and interpretations.
    12. No Restrictions on Regulatory Action. Nothing contained in this
Agreement shall restrict or in any way encumber the right of either
party to conduct its own independent or concurrent investigation,
examination or enforcement proceeding of or against Dual Members, as
either party, in its sole discretion, shall deem appropriate or
necessary.
    13. Termination. This Agreement may be terminated by ISE or
[NASD]FINRA at any time upon the approval of the Commission after one
(1) year's written notice to the other party, except as provided in
paragraph 4.
    14. Effective Date. This Agreement shall be effective upon approval
of the Commission.
    15. Arbitration. In the event of a dispute between the parties as
to the operation of this Agreement, ISE and [NASD]FINRA hereby agree
that any such dispute shall be settled by arbitration in Washington, DC
in accordance with the rules of the American Arbitration Association
then in effect, or such other procedures as the parties may mutually
agree upon. Judgment on the award rendered by the arbitrator(s) may be
entered in any court having jurisdiction.
    16. Separate Agreement. This Agreement is wholly separate from (1)
the multiparty Agreement made pursuant to Rule 17d-2 of the Exchange
Act between the [American Stock Exchange LLC, the Boston Stock
Exchange, Inc., the Chicago Board Options Exchange, Inc., the
International Securities Exchange LLC, the National Association of
Securities Dealers, Inc., the New York Stock Exchange, Inc., the
Pacific Exchange, Inc., and the Philadelphia Stock Exchange, Inc.] NYSE
American LLC, Cboe BZX Exchange, Inc., the Cboe EDGX Exchange, Inc.,
Cboe C2 Exchange, Inc., Cboe Exchange, Inc., Nasdaq ISE, LLC, Financial
Industry Regulatory Authority, Inc., NYSE Arca, Inc., The NASDAQ Stock
Market LLC, BOX Exchange LLC, NASDAQ BX, Inc., NASDAQ PHLX LLC, Miami
International Securities Exchange, LLC, Nasdaq GEMX, LLC, Nasdaq MRX,
LLC, MIAX PEARL, LLC, and MIAX Emerald, LLC involving the allocation of
regulatory responsibilities with respect to common members for
compliance with common rules relating to the conduct by broker-dealers
of accounts for listed options or index warrants entered into on
[January 14, 2004]February 12, 2019, and as may be amended from time to
time or (2) the multiparty Agreement made pursuant to Rule 17d-2 of the
Exchange Act among NYSE American LLC, Cboe BZX Exchange, Inc., the Cboe
EDGX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe Exchange, Inc.,
Nasdaq ISE, LLC, Financial Industry Regulatory Authority, Inc., NYSE
Arca, Inc., The NASDAQ Stock Market LLC, BOX Exchange LLC, NASDAQ BX,
Inc., NASDAQ PHLX LLC, Miami International Securities Exchange, LLC,
Nasdaq GEMX, LLC, Nasdaq MRX, LLC, MIAX PEARL, LLC, and MIAX Emerald,
LLC approved by the Commission on February 11, 2019 involving options-
related market surveillance matters and such agreements as may be
amended from time to time.
    17. Notification of Members. ISE and [NASD]FINRA shall notify Dual
Members of this Agreement after the Effective Date by means of a
uniform joint notice.
    18. Amendment. This Agreement may be amended in writing duly
approved

by each party. All such amendments must be filed with and approved by
the Commission before they become effective.
    19. Limitation of Liability. Neither [NASD]FINRA nor ISE nor any of
their respective directors, governors, officers or employees shall be
liable to the other party to this Agreement for any liability, loss or
damage resulting from or claimed to have resulted from any delays,
inaccuracies, errors or omissions with respect to the provision of
Regulatory Responsibilities as provided hereby or for the failure to
provide any such responsibility, except with respect to such liability,
loss or damages as shall have been suffered by one or the other of
[NASD]FINRA or ISE and caused by the willful misconduct of the other
party or their respective directors, governors, officers or employees.
No warranties, express or implied, are made by [NASD]FINRA or ISE with
respect to any of the responsibilities to be performed by each of them
hereunder.
    20. Relief from Responsibility. Pursuant to Sections 17(d)(1)(A)
and 19(g) of the Exchange Act and Rule 17d-2 thereunder, [NASD]FINRA
and ISE join in requesting the Commission, upon its approval of this
Agreement or any part thereof, to relieve ISE of any and all
responsibilities with respect to matters allocated to [NASD]FINRA
pursuant to this Agreement; provided, however, that this Agreement
shall not be effective until the Effective Date.
    In witness whereof, each party has executed or caused this
Agreement to be executed on its behalf by a duly authorized officer as
of the date first written above.

[NATIONAL ASSOCIATION OF SECURITIES DEALERS]FINANCIAL INDUSTRY
REGULATORY AUTHORITY, INC.

By---------------------------------------------------------------------
Name:
Title:

[INTERNATIONAL SECURITIES EXCHANGE]NASDAQ ISE, LLC

By---------------------------------------------------------------------
Name:
Title:

    Note: The entire existing table of rules should be deleted and
replaced with the table below.

EXHIBIT 1

ISE CERTIFICATION OF COMMON RULES
    ISE hereby certifies that the requirements contained in the rules
listed below for ISE are identical to, or substantially similar to, the
comparable [NASD]FINRA rules identified.
    # Common Rules shall not include provisions regarding (i) notice,
reporting or any other filings made directly to or from ISE, (ii)
incorporations by reference to other ISE Rules that are not Common
Rules, (iii) exercise of discretion in a manner that differs from
FINRA's exercise of discretion including, but not limited to exercise
of exemptive authority, by ISE, (iv) prior written approval of ISE, and
(v) payment of fees or fines to ISE.

------------------------------------------------------------------------
              ISE RULE(S)                         FINRA RULE(S)
------------------------------------------------------------------------
General 3, Section 3(b)--Persons         FINRA Rule 1010 Electronic
 Associated with Members; General 4--     Filing Requirements for
 Nasdaq Stock Market General 4, Rule      Uniform Forms; FINRA By-Laws
 1.1250 Electronic Filing Requirements    Article IV, Sec. 1(c)
 for Uniform Forms incorporated by        Application for Membership;
 reference .                             FINRA By-Laws, Article V,
                                          Section 1 Qualification
                                          Requirements; FINRA By-Laws,
                                          Article V, Sec. 2 Application
                                          for Registration; and FINRA By-
                                          Laws Article V, Section 3
                                          Notification by Member to the
                                          Corporation and Associated
                                          Person of Termination;
                                          Amendments to Notification.
General 4--Nasdaq Stock Market General   FINRA Rule 1240 Continuing
 4, Section 1.1240 Continuing Education   Education Requirements.
 Requirements incorporated by reference
 .
Options 9, Section 1 Just and Equitable  FINRA Rule 2010 Standards of
 Principles of Trade \1\.                 Commercial Honor and
                                          Principles of Trade; FINRA
                                          Rule 0140(a) Applicability.
Options 9, Section 9(a)(1) Prevention    Section 15(g) of the Securities
 of the Misuse of Material, Nonpublic     Exchange Act of 1934, and
 Information .                           FINRA Rule 3110(b)(1), (d)
                                          Supervision.
Options 9, Section 10 Disciplinary       FINRA Rule 4530(a)(1)(A) and
 Action by Other Organizations .         (2) Reporting Requirements;
                                          FINRA By-Laws, Article V,
                                          Section 2(c); and FINRA By-
                                          Laws, Article V, Section 3.
Options 9, Section 21 Anti-Money         FINRA Rule 3310 Anti-Money
 Laundering Compliance Program .         Laundering Compliance Program.
Options 10, Section 12 Statements of     Rule 17a-5 of the Securities
 Financial Condition to Customers.        Exchange Act of 1934.
Options 10, Section 19 Transfer of       FINRA Rule 11870 Customer
 Accounts .                              Account Transfer Contracts.
Options 10, Section 23 Telemarketing...  FINRA Rule 3230 Telemarketing.
Options 6E, Section 1 Maintenance,       FINRA Rule 4511(a) Books and
 Retention, and Furnishing of Books,      Records--Requirements.
 Records and Other Information .
------------------------------------------------------------------------
\1\ FINRA shall not have Regulatory Responsibilities with respect to the
  Supplementary Material to ISE Options 9, Section 1. Responsibility for
  such shall remain with ISE.

    In addition, the following provisions shall be part of this 17d-2
Agreement:
    SEA Rule 14e-4--Prohibited Transactions in Connection with Partial
Tender Offers [supcaret]
    [supcaret] FINRA shall perform surveillance, investigation, and
Enforcement Responsibilities for SEA Rule 14e-4(a)1)(ii)(D).

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing. 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 4-529 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 4-529. 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

plan that are filed with the Commission, and all written communications
relating to the proposed plan 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 plan also will be
available for inspection and copying at the principal offices of FINRA
and ISE. 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 4-529 and should be submitted
on or before January 13, 2021.

V. Discussion

    The Commission finds that the proposed Amended Plan is consistent
with the factors set forth in Section 17(d) of the Act \12\ and Rule
17d-2(c) thereunder \13\ in that the proposed Amended Plan is necessary
or appropriate in the public interest and for the protection of
investors, fosters cooperation and coordination among SROs, and removes
impediments to and fosters the development of the national market
system. In particular, the Commission believes that the proposed
Amended Plan should reduce unnecessary regulatory duplication by
allocating to FINRA certain examination and enforcement
responsibilities for Common Members that would otherwise be performed
by both FINRA and ISE. Accordingly, the proposed Amended Plan promotes
efficiency by reducing costs to Common Members. Furthermore, because
ISE and FINRA will coordinate their regulatory functions in accordance
with the Amended Plan, the Amended Plan should promote investor
protection.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q(d).
    \13\ 17 CFR 240.17d-2(c).
---------------------------------------------------------------------------

    The Commission notes that, under the Amended Plan, ISE and FINRA
have allocated regulatory responsibility for those ISE rules, set forth
in the Certification, that are substantially similar to the applicable
FINRA rules in that examination for compliance with such provisions and
rules would not require FINRA to develop one or more new examination
standards, modules, procedures, or criteria in order to analyze the
application of the rule, or a Common Member's activity, conduct, or
output in relation to such rule. In addition, under the Amended Plan,
FINRA would assume regulatory responsibility for certain provisions of
the federal securities laws and the rules and regulations thereunder
that are set forth in the Certification. The Common Rules covered by
the Amended Plan are specifically listed in the Certification, as may
be amended by the Parties from time to time.
    According to the Amended Plan, ISE will review the Certification at
least annually, or more frequently if required by changes in either the
rules of ISE or FINRA, and, if necessary, submit to FINRA an updated
list of Common Rules to add ISE rules not included on the then-current
list of Common Rules that are substantially similar to FINRA rules;
delete ISE rules included in the then-current list of Common Rules that
no longer qualify as common rules; and confirm that the remaining rules
on the list of Common Rules continue to be ISE rules that qualify as
common rules.\14\ FINRA will then confirm in writing whether the rules
listed in any updated list are Common Rules as defined in the Amended
Plan. Under the Amended Plan, ISE also will provide FINRA with a
current list of Common Members and will update the list no less
frequently than once each quarter.\15\ The Commission believes that
these provisions are designed to provide for continuing communication
between the Parties to ensure the continued accuracy of the scope of
the proposed allocation of regulatory responsibility.
---------------------------------------------------------------------------

    \14\ See paragraph 2 of the Amended Plan.
    \15\ See paragraph 3 of the Amended Plan.
---------------------------------------------------------------------------

    The Commission is hereby declaring effective an Amended Plan that,
among other things, allocates regulatory responsibility to FINRA for
the oversight and enforcement of all ISE rules that are substantially
similar to the rules of FINRA for Common Members of ISE and FINRA.
Therefore, modifications to the Certification need not be filed with
the Commission as an amendment to the Amended Plan, provided that the
Parties are only adding to, deleting from, or confirming changes to ISE
rules in the Certification in conformance with the definition of Common
Rules provided in the Amended Plan. However, should the Parties decide
to add a ISE rule to the Certification that is not substantially
similar to a FINRA rule; delete a ISE rule from the Certification that
is substantially similar to a FINRA rule; or leave on the Certification
a ISE rule that is no longer substantially similar to a FINRA rule,
then such a change would constitute an amendment to the Amended Plan,
which must be filed with the Commission pursuant to Rule 17d-2 under
the Act.\16\
---------------------------------------------------------------------------

    \16\ The addition to or deletion from the Certification of any
federal securities laws, rules, and regulations for which FINRA
would bear responsibility under the Amended Plan for examining, and
enforcing compliance by, Common Members, also would constitute an
amendment to the Amended Plan.
---------------------------------------------------------------------------

    Under paragraph (c) of Rule 17d-2, the Commission may, after
appropriate notice and comment, declare a plan, or any part of a plan,
effective. In this instance, the Commission believes that appropriate
notice and comment can take place after the proposed amendment is
effective. The primary purpose of the amendment is to allocate
surveillance, investigation, and enforcement responsibilities for Rule
14e-4 under the Act, to reflect the name change of International
Securities Exchange, LLC to Nasdaq ISE, LLC. By declaring it effective
today, the Amended Plan can become effective and be implemented without
undue delay. The Commission notes that the prior version of this plan
immediately prior to this proposed amendment was published for comment
and the Commission did not receive any comments thereon.\17\
Furthermore, the Commission does not believe that the amendment to the
plan raises any new regulatory issues that the Commission has not
previously considered.
---------------------------------------------------------------------------

    \17\ See supra note 11 (citing to Securities Exchange Act
Release No. 55367).
---------------------------------------------------------------------------

VI. Conclusion

    This order gives effect to the Amended Plan filed with the
Commission in File No. 4-529. The Parties shall notify all members
affected by the Amended Plan of their rights and obligations under the
Amended Plan.
    It is therefore ordered, pursuant to Section 17(d) of the Act, that
the Amended Plan in File No. 4-529, between the FINRA and ISE, filed
pursuant to Rule 17d-2 under the Act, hereby is approved and declared
effective.
    It is further ordered that ISE is relieved of those
responsibilities allocated to FINRA under the Amended Plan in File No.
4-529.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-28307 Filed 12-22-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18904-18905]
[FR Doc No: 2014-07532]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD14-8-000]

Winter 2013-2014 Operations and Market Performance in Regional
Transmission Organizations and Independent System Operators;
Supplemental Notice of Technical Conference

    As announced in the Notice issued on February 21, 2014, and the
Supplemental Notice issued on March 19, 2014 (March 19 Notice), the
Federal Energy Regulatory Commission (Commission) will hold a
Commissioner-led technical conference on Tuesday, April 1, 2014, from
9:00 a.m. to approximately 5:15 p.m. to discuss the impacts of recent
cold weather events on the Regional Transmission Organizations/
Independent System Operators (RTOs/ISOs), and discuss actions taken to
respond during those occurrences. The conference will be held at the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426. This conference is free of charge and open to the public.
Commission members will participate in the conference. Following the
conference, the Commission will take written public comments until May
15, 2014.
    While this conference is not for the purpose of discussing specific
cases, the March 19 Notice noted that discussions at the technical
conference may address matters at issue in a number of Commission
proceedings that are either pending or within their rehearing period
and included a list of those proceedings. The following additional
Commission proceedings may also involve issues that could be addressed
at the technical conference: Posting of Offers to Purchase Capacity,
Docket No. RP14-442; California Independent System Operator
Corporation, Docket No. EL14-22; ISO New England Inc., Docket No. EL14-
23; PJM Interconnection, LLC, Docket No. EL14-24; Midcontinent
Independent System Operator, Inc., Docket No. EL14-25; New York
Independent System Operator, Inc.,

Docket No. EL14-26; Southwest Power Pool, Inc., Docket No. EL14-27; ISO
New England Inc., Docket No. ER13-2266; and ISO New England Inc. and
New England Power Pool, Docket Nos. ER13-1877 and ER14-1050.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the requested accommodations.
    For more information about the technical conference, please
contact:
    Jordan Kwok (Technical Information), Office of Energy Policy and
Innovation, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>    Sarah McKinley (Logistical Information), Office of External
Affairs, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: March 31, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-07532 Filed 4-3-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3722-3723]
[DOCID:fr22ja08-59]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-0270; FRL-8518-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Asbestos-Containing Materials in
Schools Rule and Revised Asbestos Model Accreditation Plan Rule; EPA
ICR No. 1365.08, OMB No. 2070-0091

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before February 21,
2008.

ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2007-0270 to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to:

Document Control Office (DCO), Office of Pollution Prevention and
Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Director,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Mailcode: 7408-M, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 9, 2007 (72 FR 26355), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any comments
related to this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPPT-2007-0270, which is available for online viewing at
http://www.regulations.gov, or in person inspection at the OPPT Docket

in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Reading Room is
202-566-1744, and the telephone number for the Pollution Prevention and
Toxics Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA

receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov
.

    Title: Asbestos-Containing Materials in Schools Rule and Revised
Asbestos Model Accreditation Plan Rule.
    ICR Numbers: EPA ICR No. 1365.08, OMB Control No. 2070-0091.
    ICR Status: This ICR is currently scheduled to expire on January
31, 2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The Asbestos Hazard Emergency Response Act (AHERA)
requires Local Education Agencies (LEAs) to conduct inspections,
develop management plans, and design or conduct response actions with
respect to the presence of asbestos-containing materials in school
buildings. AHERA also requires states to develop model accreditation
plans for persons who perform asbestos inspections, develop management
control plans, and design or conduct response actions. This information
collection addresses the burden associated with reporting and
recordkeeping requirements imposed on LEAs by the asbestos in schools
rule, and reporting and recordkeeping requirements imposed on state
agencies and training providers related to the model accreditation plan
rule.
    Responses to the collection of information are mandatory (see 40
CFR part 763, Subpart E). Respondents may claim all or part of a notice
as CBI. EPA will disclose information that is covered by a CBI claim
only to the extent permitted by, and in accordance with, the procedures
in 40 CFR part 2.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9 and included on the related
collection instrument or form, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to range between
5.5 hours and 140 hours per response, depending on the category of the
respondent. Burden means the total time, effort or financial resources
expended by persons to generate, maintain, retain or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install and utilize
technology and systems for the purposes of collecting, validating and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    Respondents/Affected Entities: Entities potentially affected by
this action are local education agencies

(LEAs, e.g., elementary or secondary public school districts or a
private school or school system); asbestos training providers to
schools and educational systems; and state education departments or
commissions or state public health departments or commissions.
    Frequency of Response: On occasion.
    Estimated No. of Respondents: 125,691.
    Estimated Total Annual Hour Burden: 2,530,600 hours.
    Estimated Total Annual Labor Costs: $76,352,159.
    Changes in Burden Estimates: There is a net increase of 45,160
hours (from 2,485,440 hours to 2,530,600 hours) in the total estimated
respondent burden compared with that currently in the OMB inventory.
This increase reflects changes in the estimated numbers of Local
Education Agencies and training providers. The increase is an
adjustment.

    Dated: January 15, 2008.
Sara Hisel-McCoy,
 Director, Collection Strategies Division.
[FR Doc. E8-1000 Filed 1-18-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Page 34770]
[FR Doc No: 2021-13967]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0424]

Medical Devices; Exemption From Premarket Notification: Powered
Patient Transport, All Other Powered Patient Transport

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
announcing receipt of a petition requesting exemption from the
premarket notification requirements. The document was published with an
incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 15, 2021 (86
FR 31722), in FR Doc. 2021-12505, on page 31722, the following
correction is made:
    On page 31722, in the second column, in the header of the document,
and, also on page 31723, in the first column under ``Instructions,''
``Docket No. FDA-2021-N-0493'' is corrected to read ``Docket No. FDA-
2021-P-0424''.

    Dated: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13967 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48826-48829]
[FR Doc No: 2018-21033]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0007]

Fee for Using a Rare Pediatric Disease Priority Review Voucher in
Fiscal Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a rare

pediatric disease priority review voucher for fiscal year (FY) 2019.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA),
authorizes FDA to determine and collect rare pediatric disease priority
review user fees for certain applications for review of human drug or
biological products when those applications use a rare pediatric
disease priority review voucher. These vouchers are awarded to the
applicants of rare pediatric disease product applications that meet all
of the requirements of this program and that are submitted 90 days or
more after July 9, 2012, upon FDA approval of such applications. The
amount of the fee for using a rare pediatric disease priority review
voucher is determined each FY, based on the difference between the
average cost incurred by FDA to review of a human drug application
designated as priority review in the previous FY and the average cost
incurred in the review of an application that is not subject to
priority review in the previous FY. This notice establishes the rare
pediatric disease priority review fee rate for FY 2019 and outlines the
payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14541B, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the
FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress
encouraged development of new human drugs and biological products for
prevention and treatment of certain rare pediatric diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 529 of the FD&C Act, the applicant of an eligible human
drug application submitted 90 days or more after July 9, 2012, for a
rare pediatric disease (as defined in section 529(a)(3)) shall receive
a priority review voucher upon approval of the rare pediatric disease
product application. The recipient of a rare pediatric disease priority
review voucher may either use the voucher for a future human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to
another party. The voucher may be transferred (including by sale)
repeatedly until it ultimately is used for a human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act or section
351(a) of the Public Health Service Act. A priority review is a review
conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6
months after the receipt or filing date, depending on the type of
application. Information regarding PDUFA goals is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The applicant that uses a rare pediatric disease priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a rare pediatric disease priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the rare pediatric disease priority
review voucher program is available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
    This notice establishes the rare pediatric disease priority review
fee rate for FY 2019 at $2,457,140 and outlines FDA's procedures for
payment of rare pediatric disease priority review user fees. This rate
is effective on October 1, 2018, and will remain in effect through
September 30, 2019.

II. Rare Pediatric Priority Review User Fee for FY 2019

    Under section 529(c)(2) of the FD&C Act, the amount of the rare
pediatric disease priority review user fee is determined each fiscal
year based on the difference between the average cost incurred by FDA
in the review of a human drug application subject to priority review in
the previous fiscal year, and the average cost incurred by FDA in the
review of a human drug application that is not subject to priority
review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug or biological product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. Under the PDUFA goals letter,
FDA has committed to reviewing and acting on 90 percent of standard
applications within 10 months of the receipt or filing date depending
on the type of application. A priority review involves a more intensive
level of effort and a higher level of resources than a standard review.
    FDA is setting a fee for FY 2019, which is to be based on standard
cost data from the previous fiscal year, FY 2018. However, the FY 2018
submission cohort has not been closed out yet, thus the cost data for
FY 2018 are not complete. The latest year for which FDA has complete
cost data is FY 2017. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. FDA uses data that the Agency estimates and
publishes on its website each year--standard costs for review. FDA does
not publish a standard cost for ``the review of a human drug
application subject to priority review in the previous fiscal year.''
However, we expect all such applications would contain clinical data.
The standard cost application categories with clinical data that FDA
publishes each year are: (1) New drug applications (NDAs) for a new
molecular entity (NME) with clinical data and (2) biologics license
applications (BLAs).
    The standard cost worksheets for FY 2017 show standard costs of
$5,340,560 for an NME NDA, and $4,596,936 for a BLA. Based on these
standard costs, the total cost to review the 57 applications in these
two categories in FY 2017 (31 NME NDAs with clinical data and 26 BLAs)
was $285,077,688. (Note: These numbers exclude the President's
Emergency Plan for AIDS Relief NDAs; no investigational new drug (IND)
review costs are included in this amount.) Thirty-three of these
applications (20 NDAs and 13 BLAs) received priority review, which
would mean that the remaining 24 received standard reviews. Because a
priority review compresses a review schedule that ordinarily takes 10
months into 6 months, FDA estimates that a multiplier of 1.67 (10
months / 6 months) should be applied to non-priority review costs in
estimating the effort and cost of a priority review as compared to a
standard review. This multiplier is consistent with published research
on this subject which supports a priority review multiplier in the
range of 1.48 to 2.35 (Ref. 1). Using FY 2017 figures, the costs of a
priority and standard review

are estimated using the following formula:

(33 [alpha] x 1.67) + (24[alpha]) = $285,077,688

where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$3,603,561 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $6,017,946
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,414,386, represents the incremental cost of conducting
a priority review rather than a standard review.
    For the FY 2019 fee, FDA will need to adjust the FY 2017
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2018, to adjust the FY 2017 amount
for cost increases in FY 2018. That adjustment, published in the
Federal Register on August 1, 2018 (83 FR 37504), setting the FY 2019
PDUFA fee, is 1.7708 percent for the most recent year, not compounded.
Increasing the FY 2017 incremental priority review cost of 2,414,386 by
1.7708 percent (or 0.017708) results in an estimated cost of $2,457,140
(rounded to the nearest dollar). This is the rare pediatric disease
priority review user fee amount for FY 2019 that must be submitted with
a priority review voucher for a human drug application in FY 2019, in
addition to any PDUFA fee that is required for such an application.

III. Fee Schedule for FY 2019

    The fee rate for FY 2019 is set out in table 1:

  Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2019
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2019
------------------------------------------------------------------------
Application submitted with a rare pediatric disease          $2,457,140
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Rare Pediatric Disease Priority Review User Fee

    Under section 529(c)(4)(A) of the FD&C Act, the priority review
user fee is due (i.e., the obligation to pay the fee is incurred) when
a sponsor notifies FDA of its intent to use the voucher. Section
529(c)(4)(B) of the FD&C Act specifies that the application will be
considered incomplete if the priority review user fee and all other
applicable user fees are not paid in accordance with FDA payment
procedures. In addition, section 529(c)(4)(C) specifies that FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act.
    The rare pediatric disease priority review fee established in the
new fee schedule must be paid for any application that is received on
or after October 1, 2018. In order to comply with this requirement, the
sponsor must notify FDA 90 days prior to submission of the human drug
application that is the subject of a priority review voucher of an
intent to submit the human drug application, including the date on
which the sponsor intends to submit the application.
    Upon receipt of this notification, FDA will issue an invoice to the
sponsor who has incurred a rare pediatric disease priority review
voucher fee. The invoice will include instructions on how to pay the
fee via wire transfer or check.
    As noted in section II, if a sponsor uses a rare pediatric disease
priority review voucher for a human drug application, the sponsor would
incur the rare pediatric disease priority review voucher fee in
addition to any PDUFA fee that is required for the application. The
sponsor would need to follow FDA's normal procedures for timely payment
of the PDUFA fee for the human drug application.
    Payment must be made in U.S. currency by electronic check, check,
bank draft, wire transfer, credit card, or U.S. postal money order
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: only full payments are accepted. No
partial payments can be made online.) Once you search for your invoice,
select ``Pay Now'' to be redirected to Pay.gov. Note that electronic
payment options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S bank accounts as well as U.S. credit cards.
    If paying with a paper check the invoice number should be included
on the check, followed by the words ``Rare Pediatric Disease Priority
Review.'' All paper checks must be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery.) The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your invoice number
when completing your transfer. The originating financial institution
may charge a wire transfer fee. If the financial institution charges a
wire transfer fee it is required to add that amount to the payment to
ensure that the invoice is paid in full. The account information is as
follows: U.S. Dept. of Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Account Number: 75060099, Routing Number: 021030004, SWIFT:
FRNYUS33.

V. Reference

    The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected. FDA has verified the website address,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://faculty.fuqua.duke.edu/~willm/
HSM_RA/Documents/HA2006_Ridley_Vouchers.pdf.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21033 Filed 9-26-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Proposed Rules]
[Pages 45253-45255]
[FR Doc No: 2017-20838]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2017-0213; FRL-9968-67-OAR]
RIN 2060-AT43

Protection of Stratospheric Ozone: Refrigerant Management
Regulations for Small Cans of Motor Vehicle Refrigerant

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing this action to correct an editing oversight
that lead to a potential conflict in a prior rulemaking as to whether
or not containers holding two pounds or less of non-exempt substitute
refrigerants for use in motor vehicle air conditioning that are not
equipped with a self-sealing valve can be sold to persons that are not
certified technicians, provided those small cans were manufactured or
imported prior to January 1, 2018. This action clarifies that those
small cans may continue to be sold to persons that are not certified as
technicians under sections 608 or 609 of the Clean Air Act. In the
``Rules and Regulations'' section of this Federal Register, EPA is
publishing this action as a direct final

rule without a prior proposed rule. If we receive no adverse comment,
we will not take further action on this proposed rule.

DATES: Written comments must be received by October 30, 2017. Any party
requesting a public hearing must notify the contact listed below under
FOR FURTHER INFORMATION CONTACT by 5 p.m. Eastern Daylight Time on
October 5, 2017. If a public hearing is requested, the hearing will be
held on or around October 13, 2017. If a hearing is held, it will take
place at EPA headquarters in Washington, DC. EPA will post a notice on
our Web site, www.epa.gov/section608, announcing further information
should a hearing take place.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2017-0213, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Sara Kemme by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205T), 1200 Pennsylvania Avenue NW., Washington, DC 20460; by
telephone:<PHONE_NUMBER>; or by email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Why is EPA issuing this Proposed Rule?

    On November 18, 2016, EPA published a rule finalizing a restriction
that non-exempt substitute refrigerants may only be sold to technicians
certified under sections 608 or 609 of the CAA (81 FR 82280). In the
case of refrigerant for use in motor vehicle air conditioning (MVAC),
EPA finalized the exemption for the sale of certain small cans of non-
ozone-depleting substitutes with a self-sealing valve to allow the do-
it-yourself community to continue servicing their personal vehicles.
However, the Agency did not finalize a sell-through provision as
proposed. Instead, EPA intended to allow the continued sale of small
cans without self-sealing valves that were manufactured or imported
before January 1, 2018, and described that intent in the preamble to
the final rule. See 81 FR 82280, 82342.
    These intentions were also expressed in the regulatory text at 40
CFR 82.154(c)(2), which was revised in the November 2016 rule to state:
``Self-sealing valve specifications. This provision applies starting
January 1, 2018, for all containers holding two pounds or less of non-
exempt substitute refrigerant for use in an MVAC that are manufactured
or imported on or after that date. (i) Each container holding two
pounds or less of non-exempt substitute refrigerant for use in an MVAC
must be equipped with a single self-sealing valve that automatically
closes and seals when not dispensing refrigerant . . . .'' However,
because of an editing error, another provision, 40 CFR
82.154(c)(1)(ix), contains text that could be construed as
contradicting the Agency's clearly expressed intent to allow non-
technicians to purchase, and retailers to sell, small cans of
refrigerant for use in MVAC that were manufactured or imported before
the January 1, 2018, compliance date irrespective of whether they have
a self-sealing valve.
    The Automotive Refrigeration Products Institute and the Auto Care
Association inquired about whether the language in 40 CFR
82.154(c)(1)(ix) effectively negates the provision in 40 CFR
82.154(c)(2) and the preamble discussion showing EPA's intention to
allow small cans of refrigerant for use in MVAC manufactured or
imported before January 1, 2018, to continue to be sold without self-
sealing valves. EPA is proposing this rule to revise the regulatory
text so that persons in possession of small cans of refrigerant for use
in MVAC without self-sealing valves that were manufactured or imported
before January 1, 2018, can be assured that they will be able to sell
off their existing inventories without disruption.
    EPA has published a direct final rule making identical edits to the
regulatory text as those proposed here in the ``Rules and Regulations''
section of this Federal Register because we view this as a
noncontroversial action and anticipate no adverse comment. We have
further explained our reasons for this action in the preamble to the
direct final rule. For additional information on the action being
taken, see the direct final rule published in the Rules and Regulations
section of this Federal Register.
    If we receive no adverse comment, we will not take further action
on this proposed rule. If we receive adverse comment, we will withdraw
the direct final rule and it will not take effect. In that case, we
would address all public comments in any subsequent final rule based on
this proposed rule.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
EPA is not proposing, and is not seeking comment on, any changes to the
regulations at 40 CFR part 82, subpart F other than the proposed
revisions discussed in this notice. For further information on how to
submit comments, please see the information provided in the ADDRESSES
section of this document.

II. Does this action apply to me?

    Categories and entities potentially affected by this action include
entities that distribute or sell small cans refrigerant for use in
MVAC. Regulated entities include, but are not limited to, manufacturers
and distributors of small cans of refrigerant (NAICS codes 325120,
441310, 447110) such as automotive parts and accessories stores and
industrial gas manufacturers.
    This list is not intended to be exhaustive, but rather to provide a
guide for readers regarding entities likely to be regulated by this
action. To determine whether your facility, company, business, or
organization could be regulated by this action, you should carefully
examine the regulations at 40 CFR part 82, subpart F. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the FOR FURTHER INFORMATION
CONTACT section.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities

contained in the existing regulations and has assigned OMB control
number 2060-0256. These changes do not add information collection
requirements beyond those currently required under the applicable
regulations.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. This action clarifies that small cans of
refrigerant for use in MVAC may be sold to persons who are not
certified technicians even if they are not equipped with a self-sealing
valve, so long as those small cans are manufactured or imported prior
to January 1, 2018. We have therefore concluded that this action will
have no net regulatory burden for all directly regulated small
entities.

D. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action corrects a potential conflict in the
refrigerant management regulations as to whether or not small cans of
refrigerant for use in MVAC could be sold to non-technicians if they
were manufactured or imported prior to January 1, 2018, and do not have
a self-sealing valve. This action clarifies that those small cans of
refrigerant for use in MVAC may be sold to persons who are not
certified technicians.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This action corrects a potential conflict in the
refrigerant management regulations as to whether or not small cans of
refrigerant for use in MVAC could be sold to non-technicians if they
were manufactured or imported prior to January 1, 2018, and do not have
a self-sealing valve. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
    This action does not affect the level of protection provided to
human health or the environment. This action corrects a potential
conflict in the refrigerant management regulations as to whether or not
small cans of refrigerant for use in MVAC could be sold to non-
technicians if they were manufactured or imported prior to January 1,
2018, and do not have a self-sealing valve. This action clarifies that
those small cans of refrigerant for use in MVAC may be sold to persons
who are not certified technicians. The documentation for this decision
is contained in Docket No. EPA-HQ-OAR-2017-0213, where EPA's assessment
of the underlying regulatory changes that necessitated this correction
found no disproportionately high and adverse human health or
environmental effects on minority populations, low-income populations
and/or indigenous peoples.

List of Subjects in 40 CFR Part 82

    Environmental protection, Air pollution control, Chemicals,
Reporting and recordkeeping requirements.

    Dated: September 21, 2017.
E. Scott Pruitt,
Administrator.

    For the reasons set forth in the preamble, the Environmental
Protection Agency proposes to amend 40 CFR part 82 as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority:  42 U.S.C. 7414, 7601, 7671-7671q.

0
2. In Sec.  82.154, revise paragraph (c)(1)(ix) to read as follows:

Sec.  82.154  Prohibitions.

* * * * *
    (c) * * *
    (1) * * *
    (ix) The non-exempt substitute refrigerant is intended for use in
an MVAC and is sold in a container designed to hold two pounds or less
of refrigerant, has a unique fitting, and, if manufactured or imported
on or after January 1, 2018, has a self-sealing valve that complies
with the requirements of paragraph (c)(2) of this section.
* * * * *
[FR Doc. 2017-20838 Filed 9-27-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Rules and Regulations]
[Page 52429]
[FR Doc No: 2013-20702]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

Indirect Food Additives: Adhesives and Components of Coatings

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 170 to 199,
revised as of April 1, 2013, on page 196, in Sec.  175.320, in
paragraph (c), in the first sentence, revise ``tables 1 and 2 of Sec.
176.17(c)'' to read ``tables 1 and 2 of Sec.  176.170(c)''.

[FR Doc. 2013-20702 Filed 8-22-13; 8:45 am]
BILLING CODE 1505-01-D