[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65395-65396]
[FR Doc No: 2023-20592]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6530]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Prescription Drug User Fee Act Products;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products.'' This draft guidance outlines the recommendations to
industry on formal meetings between the FDA and sponsors or applicants
relating to the development and review of new drug or biological drug
products. This draft guidance replaces the guidance ``Formal Meetings
Between the FDA and Sponsors or Applicants of PDUFA Products'' issued
on December 29, 2017.

DATES: Submit either electronic or written comments on the draft
guidance by December 21, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6530 for ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Mercier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993-0002, 301-
796-0957; or Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products.'' This draft guidance outlines the recommendations
to industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of drug or biological drug
products as agreed upon during the Prescription Drug User Fee Act
(PDUFA) VII negotiations. The draft guidance describes the different
meeting types, formats, and timelines associated with those requests.
It also provides industry with the information necessary to have a
complete meeting request and background package to help facilitate the
meeting to gain useful feedback for product development. The draft

guidance provides examples to help guide stakeholders on selecting and
requesting the proper meeting type for a given scenario.
    This draft guidance replaces the draft guidance entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of PDUFA Products''
issued on December 29, 2017 (82 FR 61763). FDA considered comments
received on the draft guidance as the guidance was revised. Changes
made include the addition of Type D and Initial Targeted Engagement for
Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings,
request for clarification/followup opportunity correspondence, and
virtual meetings as a face-to-face meeting.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Formal
Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in
21 CFR part 312 pertaining to meetings, including ``End-of-phase 2''
and ``pre-NDA'', have been approved under OMB control number 0910-0014.
The collections of information in 21 CFR part 314 pertaining to formal
meetings between sponsors or applicants and FDA have been approved
under OMB control number 0910-0001. The collections of information
pertaining to formal meetings between the FDA and sponsors or
applicants for biological products have been approved under OMB control
number 0910-0718.

III. Electronic Access

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

    Dated: September 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20592 Filed 9-21-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Rules and Regulations]
[Pages 70114-70116]
[FR Doc No: 2012-26500]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0846; Directorate Identifier 2012-CE-021-AD;
Amendment 39-17237; AD 2012-22-01]
RIN 2120-AA64

Airworthiness Directives; Cessna Aircraft Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Cessna Aircraft Company Models 172R and 172S airplanes. This AD was
prompted by reports of chafed fuel return line assemblies, which were
caused by the fuel return line assembly rubbing against the right
steering tube assembly during full rudder pedal actuation. This AD
requires you to inspect the fuel return line assembly for chafing;
replace the fuel return line assembly if chafing is found; inspect the
clearance between the fuel return line assembly and both the right
steering tube assembly and the airplane structure; and adjust as
necessary. We are issuing this AD to correct the unsafe condition on
these products.

DATES: This AD is effective December 28, 2012.
    Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of March
13, 2012 (77 FR 6003, February 7, 2012).

ADDRESSES: For service information identified in this AD, contact
Cessna Aircraft Company, Customer service, P.O. Box 7706, Wichita, KS
67277; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet: http://www.cessnasupport.com. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jeff Janusz, Aerospace Engineer,
Wichita Aircraft Certification Office, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on August 20, 2012 (77 FR
50054). That NPRM proposed to require you to inspect the fuel return
line assembly for chafing; replace the fuel return line assembly if
chafing is found; inspect the clearance between the fuel return line
assembly and both the right steering tube assembly and the airplane
structure; and adjust as necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 50054, August 20,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 50054, August 20, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 50054, August 20, 2012).

Costs of Compliance

    We estimate that this AD affects 55 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                     Labor cost            Parts cost           product         operators
----------------------------------------------------------------------------------------------------------------
Inspection of the fuel return line  1 work-hour x $85     Not applicable......             $85           $4,675
 assembly for chafing and            per hour = $85.
 clearance.
----------------------------------------------------------------------------------------------------------------

     We estimate the following costs to do any necessary replacements
and adjustments that would be required based on the results of the
inspection. We have no way of determining the number of aircraft that
might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of the fuel return line assembly   1 work-hour x $85 per hour =               $123             $208
 and adjustment of the clearance between the    $85.
 fuel return line assembly and both the
 steering tube assembly and the airplane
 structure.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2012-22-01 Cessna Aircraft Company: Amendment 39-17237; Docket No.
FAA-2012-0846; Directorate Identifier 2012-CE-021-AD.

(a) Effective Date

    This AD is effective December 28, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Cessna Aircraft Company
(Cessna) airplanes, certificated in any category:
    (1) Model 172R, serial numbers (S/N) 17280001 through 17281187,
that have

incorporated Cessna Aircraft Company Service Bulletin SB04-28-03,
dated August 30, 2004, and Engine Fuel Return System, Modification
Kit MK172-28-01, dated August 30, 2004; and
    (2) Model 172S, S/N l72S8001 through 172S9490, that have
incorporated Cessna Aircraft Company Service Bulletin SB04-28-03,
dated August 30, 2004, and Engine Fuel Return System, Modification
Kit MK172-28-01; dated August 30, 2004.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 2820, Aircraft Fuel Distribution System.

(e) Unsafe Condition

    This AD was prompted by reports of chafed fuel return line
assemblies caused by the fuel return line assembly rubbing against
the right steering tube assembly during full rudder pedal actuation.
We are issuing this AD to correct the unsafe condition on these
products.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspect the Fuel Return Line Assembly

    At whichever of the following that occurs later, inspect the
fuel return line assembly (Cessna part number (P/N) 0500118-49) for
chafing following Cessna Service Bulletin SB07-28-01, Revision 1,
dated September 22, 2011.
    (1) At the next annual inspection after December 28, 2012 (the
effective date of this AD); or
    (2) Within the next 100 hours time-in-service (TIS) after
December 28, 2012 (the effective date of this AD); or
    (3) Within the next 12 calendar months after December 28, 2012
(the effective date of this AD).

(h) Replace the Fuel Line Assembly

    If you find evidence of chafing of the fuel return line assembly
(Cessna P/N 0500118-49) as a result of the inspection required by
paragraph (g) of this AD, then before further flight, replace the
fuel return line assembly (Cessna P/N 0500118-49) following Cessna
Service Bulletin SB07-28-01, Revision 1, dated September 22, 2011.

(i) Inspect for a Minimum Clearance Between Certain Parts

    After any inspection required by paragraph (g) of this AD and no
chafing of the fuel return line assembly (Cessna P/N 0500118-49) is
found or after replacement of the fuel return line assembly (Cessna
P/N 0500118-49) required by paragraph (h) of this AD, before further
flight, inspect for a minimum clearance between the following parts
throughout the range of copilot pedal travel:
    (1) A minimum clearance of 0.5 inch between the fuel return line
assembly (Cessna P/N 0500118-49) and the right steering tube
assembly (Cessna P/N MC0543022-2C); and
    (2) Visible positive clearance between the fuel return line
assembly (Cessna P/N 0500118-49) and the airplane structure.

(j) Adjust Clearance for Fuel Return Line Assembly

    If the clearance between the fuel return line assembly and the
right steering tube assembly and the clearance between the fuel
return line assembly and the aircraft structure do not meet the
minimums as specified in paragraphs (i)(l) and (i)(2) of this AD,
before further flight, adjust the clearances to meet the required
minimums following the Instructions paragraph of Cessna Service
Bulletin SB07-28-01, Revision 1, dated September 22, 2011.

(k) Engine Fuel Return System Modification

    Do not incorporate Cessna Aircraft Company Engine Fuel Return
System Modification Kit MK 172-28-01 as referenced in Service
Bulletin SB 04-28-03, both dated August 30, 2004, without performing
the actions in this AD before further flight after installation.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    For more information about this AD, contact Jeff Janusz,
Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax: (316) 946-
4107; email<EMAIL_ADDRESS>
(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
March 13, 2012 (77 FR 6003, February 7, 2012).
    (i) Cessna Aircraft Company Cessna Service Bulletin SB07-28-01,
Revision 1, dated September 22, 2011.
    (ii) Reserved.
    (4) For Cessna Aircraft Company service information identified
in this AD, contact Cessna Aircraft Company, Customer service, P.O.
Box 7706, Wichita, KS 67277; telephone:<PHONE_NUMBER>; fax: (316)
517-7271; Internet: http://www.cessnasupport.com.
    (5) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on October 22, 2012.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-26500 Filed 11-21-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76129-76131]
[FR Doc No: 2012-31015]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68475; File No. SR-FINRA-2012-054]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Add the Term Chief Legal Officer to the
Definition of General Counsel

December 19, 2012.
    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 11, 2012, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as concerned solely with the
administration of the self-regulatory organization under Section
19(b)(3)(A)(iii) of the Act\3\ and Rule 19b-4(f)(3) thereunder,\4\
which renders the proposal effective upon receipt of this filing by 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)(iii).
    \4\ 17 CFR 240.19b-4(f)(3).

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

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

    FINRA is proposing to amend to amend [sic] FINRA Rule 9120
(Definitions) to add the term ``Chief Legal Officer'' to the definition
of ``General Counsel.''
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    FINRA is proposing to expand the definition of General Counsel to
acknowledge changes in FINRA's executive management. When FINRA adopted
the Code of Procedure in 1997, it defined ``General Counsel'' as
meaning ``the General Counsel of [FINRA], or his or her delegatee, who
shall be a person who reports to the General Counsel of [FINRA] * *
*.''\5\ Recently FINRA has appointed a Chief Legal Officer, an action
that is similar to appointments made in the legal departments of other
self-regulatory organizations. The proposed rule change adds the term
``Chief Legal Officer'' to the definition of ``General Counsel.'' This
addition will confirm that when the Code of Procedure refers to the
General Counsel, the reference includes FINRA's Chief Legal Officer and
his or her delegatees.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 38908 (August 7,
1997), 62 FR 43385 (August 13, 1997) (Order Approving File No. SR-
NASD-97-28).
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness. The effective date and the implementation date will be
the date of filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(8) of the Act,\6\ which requires, among
other things, that FINRA rules provide a fair procedure for the
disciplining of members and persons associated with members, and
Section 15A(b)(6) of the Act,\7\ 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. The proposed rule change will confirm that the Chief
Legal Officer may take certain actions that the Code of Procedure also
authorizes the General Counsel to take. In making this clarification,
FINRA believes that the proposed rule change will assist in the
efficient administration of actions governed by the Code of Procedure.
Adding the term ``Chief Legal Officer'' will allow the Code of
Procedure to match its terms with the titles currently used by FINRA's
executives. FINRA believes that the proposed rule change will,
accordingly, make the Code of Procedure easier to understand and apply.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o-3(b)(8).
    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act as the proposed rule change is
concerned solely with the administration of the FINRA.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act\8\ and paragraph (f)(3) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:
Electronic Comments
     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2012-054 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 Number SR-FINRA-2012-054. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the FINRA's principal office.
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-FINRA-2012-
054, and should be submitted on or before January 16, 2013

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-31015 Filed 12-21-12; 4:15 pm]
BILLING CODE 8011-01-P