[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Proposed Rules]
[Page 6708]
[FR Doc No: 2019-03397]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9139; Directorate Identifier 2016-CE-023-AD]
RIN 2120-AA64

Airworthiness Directives; Mitsubishi Heavy Industries, Ltd.
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The FAA is withdrawing a notice of proposed rulemaking (NPRM)
that proposed to adopt a new airworthiness directive (AD) that would
have applied to certain Mitsubishi Heavy Industries, Ltd. Models MU-2B-
10, MU-2B-15, MU-2B-20, MU-2B-25, MU-2B-26, MU-2B-26A, MU-2B-30, MU-2B-
35, MU-2B-36, MU-2B-36A, MU-2B-40, and MU-2B-60 airplanes. The NPRM
resulted from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product and would have
required repetitively inspecting the wing spacer plates for cracks
until they were replaced with an improved design wing spacer plates.
Since issuance of the NPRM, we determined that damage is contained to
the wing spacer plate with no evidence that primary structure is
affected. Accordingly, the NPRM is withdrawn.

DATES: As of February 28, 2019, the proposed rule, which published in
the Federal Register on September 16, 2016 (81 FR 63725), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Bang Nguyen, Aerospace Engineer, FAA,
Fort Worth ACO Branch, 10101 Hillwood Pkwy., Fort Worth, Texas 76177;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued an NPRM that proposed to amend 14 CFR part 39 to add an
AD that would apply to the specified products. The NPRM was published
in the Federal Register on September 16, 2016 (81 FR 63725). The NPRM
was prompted by the Japan Civil Aviation Bureau (JCAB), which is the
aviation authority for Japan, AD No. TCD-8783-2016, dated June 28, 2016
(referred to after this as ``the MCAI''), to correct an unsafe
condition for certain Mitsubishi Heavy Industries (MHI) Models MU-2B-
20, MU-2B-25, MU-2B-26, MU-2B-30, MU-2B-35, and MU-2B-36 airplanes.
    As part of the MHI MU-2B aging aircraft program, one-piece and
three-piece main wings were subjected to detailed teardown inspections,
and cracks were found in the wing spacer plates attached to the forward
lower spar area at wing station 580. It was determined that the cracks
resulted from fatigue caused by flight loads.
    Japan is the State of Design for the MHI airplane models that the
MCAI AD applies to: Models MU-2B-20, MU-2B-25, and MU-2B-26 with serial
numbers (S/Ns) 102 and 121 through 347, except 313 and 321; and Models
MU-2B-30, MU-2B-35, and MU-2B-36 with S/Ns 502 through 696, except 652
and 661. The United States is the State of Design for MHI Models MU-2B-
10, MU-2B-15, MU-2B-25, MU-2B-26, MU-2B-26A, and MU-2B-40 with S/Ns
313SA, 321SA, and 348SA through 459SA; and Models MU-2B-36A and MU-2B-
60 with S/Ns 661SA and 697SA through 1569SA airplanes. Japan is the
State of Design for Models MU-2B-10 and MU-2B-15 airplanes, but has
recently removed these models from the MHI Japanese type certificate.
These models remain on the FAA type certificate; however, none of these
airplanes are currently on the U.S. registry.
    The NPRM proposed to require repetitively inspecting the wing
spacer plates for cracks until they were replaced with an improved
design wing spacer plates. The proposed actions were intended to detect
and correct cracks in the wing spacer plates, which could result in
reduced structural integrity of the wings and loss of control.

Actions Since the NPRM Was Issued

    Since issuance of the NPRM, we have received data from operators
who completed the inspections specified in MHI MU-2 Service Bulletin
No. 245, dated April 21, 2016, and MU-2 Service Bulletin No. 107/57-
005, dated May 3, 2016. During the inspections, no cracking in a
primary wing structure has been detected. We have determined that
damage is contained to the wing spacer plates without affecting the
primary structure. Our analysis of fleet data also demonstrates that
the wing spar and the wing spar cap maintains conformity with the
structural requirements of the type certificate after complete fracture
of the wing spacer plate. Neither the JCAB nor the manufacturer has
provided the FAA with sufficient data that an unsafe condition exists.
Therefore, we have determined that AD action is not appropriate, and
the NPRM should be withdrawn.
    After we received numerous comments on the NPRM stating there is no
unsafe condition, we requested additional information from JCAB to
demonstrate that the cracks found in the spacers reduce the structural
integrity of primary structure. JCAB replied that it took AD action
because it is uncertain how the fatigue strength will be affected over
the life of the airplane. In addition to the lack of conclusive data
that there is an unsafe condition, we considered that removing the wing
in order to perform the proposed corrective action may be more
detrimental to the aircraft than the cracks themselves.
    Withdrawal of this NPRM constitutes only such action and does not
preclude the agency from issuing future rulemaking on this issue, nor
does it commit the agency to any course of action in the future.

Regulatory Findings

    Since this action only withdraws an NPRM, it is neither a proposed
nor a final rule and therefore, not covered under Executive Order
12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979).

List of Subjects in 14 CFR Part 39

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

The Withdrawal

0
Accordingly, the notice of proposed rulemaking, Docket No. FAA-2016-
9139, which published in the Federal Register on September 16, 2016 (81
FR 63725), is withdrawn.

    Issued in Kansas City, Missouri, on February 19, 2019.
Melvin J. Johnson,
Aircraft Certification Service, Deputy Director, Policy and Innovation
Division, AIR-601.
[FR Doc. 2019-03397 Filed 2-27-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 250 (Thursday, December 30, 2010)]
[Notices]
[Pages 82416-82417]
[FR Doc No: 2010-32941]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 206(3)-3T, SEC File No. 270-571, OMB Control No. 3235-0630.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 350l et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Temporary rule 206(3)-3T (17 CFR 275.206(3)-3T) under the
Investment Advisers Act of 1940 (15 U.S.C. 80b-1 et seq.) is entitled:
``Temporary rule for principal trades with certain advisory clients.''
The temporary rule provides investment advisers who are registered with
the Commission as broker-dealers an alternative means to meet the
requirements of section 206(3) of the Advisers Act (15 U.S.C. 80b-6(3))
when they act in a principal capacity in transactions with certain of
their advisory clients.
    Temporary rule 206(3)-3T permits investment advisers also
registered as broker-dealers to satisfy the Advisers Act's principal
trading restrictions by: (i) Providing written, prospective disclosure
regarding the conflicts arising from principal trades; (ii) obtaining
written, revocable consent from the client prospectively authorizing
the adviser to enter into principal transactions; (iii) making oral or
written disclosure and obtaining the client's consent before each
principal transaction; (iv) sending to the client confirmation
statements disclosing the capacity in which the adviser has acted; and
(v) delivering to the client an annual report itemizing the principal
transactions.
    Providing the information required by rule 206(3)-3T is necessary
for investment advisers also registered as broker-dealers to obtain the
benefit of the alternative means of complying with section 206(3) of
the Advisers Act. Disclosures under the rule provide important investor
protections when advisers engage in principal trades. Clients of
advisers will primarily use

the information to monitor principal trades in their accounts.
    The Commission staff estimates that approximately 380 investment
advisers make use of rule 206(3)-3T, including an estimated 24 advisers
(on an annual basis) also registered as broker-dealers who do not offer
non-discretionary services, but whom the Commission staff estimates
will choose to do so and rely on rule 206(3)-3T. The Commission staff
estimates that these advisers spend, in the aggregate, approximately
378,992 hours annually in complying with the requirements of the rule,
including both initial and annual burdens. The aggregate hour burden,
expressed on a per-eligible-adviser basis, is therefore approximately
997 hours per eligible adviser (378,992 hours divided by the estimated
380 advisers that will rely on rule 206(3)-3T).
    Written comments are invited on: (a) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burdens
of the collections of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collections of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Thomas Bayer, Director/CIO,
Securities and Exchange Commission, C/O Remi Pavlik-Simon, 6432 General
Green Way, Alexandria, VA 22312; or send an e-mail to<EMAIL_ADDRESS>
    Dated: December 27, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-32941 Filed 12-29-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 229 (Wednesday, November 27, 2019)]
[Rules and Regulations]
[Pages 65298-65300]
[FR Doc No: 2019-25616]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2019-0823]
RIN 1625-AA09

Drawbridge Operation Regulation; Wolf River, Winneconne, WI

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is removing the existing drawbridge operation
regulation for the Winneconne Highway Bridge, mile 2.4, at Winneconne,
WI. The drawbridge was replaced with a fixed bridge through the Coast
Guard Bridge Permitting and Public Notice Process in 2018 and the
operating regulation is no longer applicable or necessary.

DATES: This rule is effective November 27, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov. Type USCG-
2019-0823 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Lee Soule, Bridge Management Specialist, Ninth Coast
Guard District; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations [Delete/add any Abbreviations not Used/Used
in This Document]

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because because on December 13, 2016, we
published PUBLIC NOTICE 09-04-16 and mailed out an availability of
public notice addressed to all adjacent ZIP codes and

interested parties as part of the bridge permit public notice and
comment process. The comment process was open for 30-days. We did not
receive any negative comments on this rule.
    We are issuing this rule under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective in less
than 30 days after publication in the Federal Register. The fixed
bridge is inplace and the drawbridge has been removed to the
satisfaction of the District Commander. This is an administrative
action to update the CFR.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
    Winneconne Highway Bridge, mile 2.4, at Winneconne, WI was a
vertical lift drawbridge that provided 23 feet vertical clearance in
the open position. The new Fixed Bridge provides the same 23 feet
vertical clearance the drawbridge provided.

IV. Discussion of Final Rule

    The Coast Guard is removing the operational schedule of the former
drawbridge because it has been replaced by a new fixed bridge that
allow vessels to pass under the bridge without the need to wait for an
opening.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive Orders, and we
discuss First Amendment rights of protesters.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, it has not been reviewed by the Office of
Management and Budget (OMB) and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action was supported by a public notice process and
the public was given the opportunity to participate in the planning of
the bridge replacement. We are now updating the CFR to reflect the
current condition of the waterway.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. This regulatory action determination is based on the ability
that vessels can still transit the bridge and that the public was
engaged in this decision through the Coast Guard Bridge Permit process
and public notice procedures. The Coast Guard received no comments from
the Small Business Administration durring the bridge permitting
process. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section IV.A
above this final rule would not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
    The public was engaged in this decision through the Coast Guard
Bridge Permit process and public notice procedures.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, U.S. Coast Guard Environmental Planning
Policy COMDTINST 5090.1 (series) and U.S. Coast Guard Environmental
Planning Implementation Procedures (series) which guide the Coast Guard
in complying with the National Environmental Policy Act of 1969 (NEPA)
(42 U.S.C. 4321-4370f). We have made a determination that this action
is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is removing the operating regulations or procedures for
drawbridges. This action is categorically excluded from further review,
under paragraph L49, of Chapter 3, Table3-1 of the U.S. Coast Guard
Environmental Planning Implementation Procedures.

    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

Sec.  117.1107  [Amended]

0
2. In Sec.  117.1107, remove paragraph (a), and remove the paragraph
(b) designation.

    Dated: November 19, 2019.
D.L. Cottrell,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2019-25616 Filed 11-26-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31974-31977]
[FR Doc No: 2016-11884]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77838; File No. SR-NYSE-2016-33]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Adopting New NYSE Rules 2090 (Know Your Customer) and 2111
(Suitability) That Are Substantially Similar to FINRA Rules 2090 and
2111 and Deleting Current Rule 405 and the Related NYSE Rule
Interpretation To Harmonize Its Rules With Certain Financial Industry
Regulatory Authority, Inc. Rules

May 16, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'' or ``Exchange Act'') \2\ and Rule 19b-4
thereunder,\3\ notice is hereby given that on May 3, 2016, New York
Stock Exchange LLC (``NYSE'' or the ``Exchange'') filed with the
Securities and Exchange Commission (the ``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been substantially prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes: (1) Adopting new NYSE Rules 2090 (Know Your
Customer) and 2111 (Suitability) that are substantially similar to
FINRA Rules 2090 (Know Your Customer) and 2111 (Suitability); (2)
deleting current Rule 405 (Diligence as to Accounts) and the related
NYSE Rule Interpretation in order to harmonize its rules with certain
Financial Industry Regulatory Authority, Inc. (``FINRA'') rules; and
(3) making other conforming changes. The proposed rule change is
available on the Exchange's Web site at www.nyse.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its rules to harmonize with certain
FINRA rules. Specifically, the Exchange proposes: (1) Adopting new NYSE
Rules 2090 and 2111 that are substantially similar to FINRA Rules 2090
and 2111; (2) deleting Rule 405 \4\ and the related NYSE Rule
Interpretation; and (3) making other conforming changes.
---------------------------------------------------------------------------

    \4\ References to ``Rules'' are to NYSE Rules unless otherwise
indicated.
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Background
    In 2007, the Exchange and FINRA \5\ entered into an agreement (the
``Agreement'') pursuant to Rule 17d-2 under the Act to reduce
regulatory duplication by allocating to FINRA certain regulatory
responsibilities for NYSE rules and rule interpretations (``FINRA
Incorporated NYSE Rules'').\6\ In order to reduce regulatory
duplication and relieve firms that are both members of the Exchange and
FINRA of conflicting or unnecessary regulatory burdens, FINRA has been
reviewing and amending the NASD and FINRA Incorporated NYSE Rules in
order to create a consolidated FINRA rulebook.\7\ NYSE MKT LLC (``NYSE

MKT'') became a party to the Agreement effective December 15, 2008.\8\
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    \5\ NYSE Regulation, Inc., a former not-for-profit subsidiary of
the Exchange, was also a party to the Agreement by virtue of the
fact that it performed regulatory functions for the Exchange
pursuant to a delegation agreement. See Exchange Act Release No.
53382 (Feb. 27, 2006), 71 FR 11251, 11264-65 (Mar. 6, 2006) (SR-
NYSE-2005-77) (approving delegation agreement). The delegation
agreement terminated on February 16, 2016, and NYSE Regulation has
ceased providing regulatory services to the Exchange, which has re-
integrated its regulatory functions.
    \6\ See Exchange Act Release Nos. 56148 (July 26, 2007), 72 FR
42146 (Aug. 1, 2007) (order approving the Agreement); 56147 (Jul.
26, 2007), 72 FR 42166 (Aug. 1, 2007) (SR-NASD-2007-054) (order
approving the incorporation of certain NYSE Rules as ``Common
Rules''). Paragraph 2(b) of the Agreement sets forth procedures
regarding proposed changes by FINRA or the Exchange to the substance
of any of the Common Rules.
    \7\ FINRA's rulebook currently has three sets of rules: (1) NASD
Rules; (2) FINRA Incorporated NYSE Rules; and (3) consolidated FINRA
Rules. The FINRA Incorporated NYSE Rules apply only to those members
of FINRA that are also members of the NYSE (``Dual Members''), while
the consolidated FINRA Rules apply to all FINRA members. For more
information about the FINRA rulebook consolidation process, see
FINRA Information Notice, March 12, 2008.
    \8\ See Exchange Act Release No. 60409 (Jul. 30, 2009), 74 FR
39353 (Aug. 6, 2009) (order approving the amended and restated
Agreement, adding NYSE MKT as a party). Paragraph 2(b) of the
Agreement sets forth procedures regarding proposed changes by FINRA,
NYSE or NYSE MKT to the substance of any of the Common Rules.
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    As part of the rule consolidation process, in 2010, FINRA
harmonized NASD and FINRA Incorporated NYSE Rules and interpretations
concerning know your customer and suitability.\9\ In its filing, FINRA:
(1) Adopted FINRA Rules 2090 (Know Your Customer) and 2090
(Suitability); and (2) deleted NASD Rule 2310 (Recommendations to
Customers (Suitability)), NYSE Rule 405 (Diligence as to Accounts), and
NYSE Rule Interpretations 405/01 through /04. The rule change was
effective July 9, 2012.\10\
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    \9\ See Exchange Act Release No. 63325 (Nov. 17, 2010), 75 FR
71479 (Nov. 23, 2010) (SR-FINRA-2010-039) (``FINRA Know Your
Customer and Suitability Approval'').
    \10\ See FINRA Regulatory Notice 11-25 (May 2011). The original
effective date was October 7, 2011.
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    Currently, the Exchange does not have separate rules for know your
customer and suitability. Rather, Rule 405 (Diligence as to Accounts)
requires every member organization, through a principal executive or a
person or persons designated under the provisions of Rule 3110(a), to
take certain actions relative to customers and customer accounts.
First, Rule 405(1) requires member organizations to use ``due
diligence'' to learn the ``essential facts relative to every customer,
every order, every cash or margin account accepted or carried by such
organization and every person holding power of attorney over any
account accepted or carried by such organization.'' Second, Rule 405(2)
requires member organizations to supervise diligently all accounts
handled by registered representatives. Finally, Rule 405(3) requires
persons designated by the member to be informed of the essential facts
relative to the customer and to the nature of the proposed account
prior to approving the opening of the account.
    Supplementary Material .10 of Rule 405 discusses the requirement
that firms know their customers and imposes specific knowledge and due
diligence requirements in connection with the authority of third
parties to act on behalf of customers that are legal entities,
including margin accounts carried by a member organization for a non-
member corporation, cash accounts carried for a non-member corporation,
and agency accounts carried by a member organization.\11\ Supplementary
Material .20 of Rule 405 refers to the requirements of Rule 4311
concerning the permitted allocation of responsibilities between
introducing and carrying organizations. Supplementary Material .30
cross references to Rule 414 (Index and Currency Warrants).\12\
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    \11\ As discussed below, the Exchange believes that
Supplementary Material .10 of Rule 405 is redundant of Proposed Rule
2090 and Proposed Supplementary Material .01 thereof that would
require firms to know the essential facts concerning every customer.
    \12\ Rule 414 provides that Rule 723 (Suitability) applies to
recommendations in currency warrants, currency index warrants and
stock index warrants. The Exchange proposes to replace the outdated
references to Rule 723 with a reference to Proposed Rule 2111. The
Exchange believes that the remaining cross references in Rule 405
are either no longer necessary or moot.
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Proposed Rule Change
    The Exchange proposes to delete current Rule 405 and the related
NYSE Rule Interpretation, which are, in main part, either duplicative
of, or do not align with, the proposed know your customer and
suitability requirements discussed below, and adopt the text of FINRA
Rules 2090 and 2111.\13\
---------------------------------------------------------------------------

    \13\ The Exchange would also make the following technical and
conforming changes: (1) Substitute the term ``member organization''
for the term ``member,'' which appears in FINRA's rules (see note
17, infra); (2) substitute the term ``person associated with a
member organization'' for the term ``associated person,'' which
appears in FINRA's rules (see note 17, infra); (3) substitute the
term ``Exchange'' for ``FINRA''; (4) change certain cross-references
to FINRA rules to cross-references to Exchange rules; and (5) add
references to Proposed Rules 2090 and 2111 in Rule 3170 (Tape
Recording of Registered Persons by Certain Firms).
---------------------------------------------------------------------------

Proposed Rule 2090 (Know Your Customer)
    Like FINRA Rule 2090, Proposed NYSE Rule 2090 would encompass the
``main ethical standard'' of Rule 405(1).\14\ The proposed rule would
require every ``member organization through a principal executive or a
person or persons designated under the provisions of Rule 3110(a)''
\15\ to use ``reasonable diligence,'' with regard to the opening and
maintenance of every account, in order to know and retain the essential
facts concerning every customer. The proposed supplementary material
would define ``essential facts'' as those ``required to (a) effectively
service the customer's account, (b) act in accordance with any special
handling instructions for the account, (c) understand the authority of
each person acting on behalf of the customer, and (d) comply with
applicable laws, regulations, and rules.'' \16\ The proposed rule would
be identical to FINRA Rule 2090 except that the proposed rule would use
the term ``member organization'' rather than the term ``member,'' as
the terms have different meanings under the FINRA rules and the
Exchange rules.\17\
---------------------------------------------------------------------------

    \14\ See FINRA Know Your Customer and Suitability Approval, 75
FR at 71480.
    \15\ This is the current formulation in Rule 405, which the
Exchange proposes to retain. This formulation differs from that of
FINRA Rule 2090, which does not require a member to fulfill its
obligations under the rule ``through a principal executive or a
person or persons designated under the provisions of Rule 3110(a).''
    \16\ See Proposed Rule 2090.01. Like FINRA, the Exchange does
not propose to incorporate the requirement in NYSE Rule 405(1) to
learn the essential facts relative to ``every order.'' The Exchange
agrees with FINRA that the application of existing order-handling
rules renders this formulation unnecessary. See FINRA Know Your
Customer and Suitability Approval, 75 FR at 71480. Further, the
Exchange's proposed suitability rule would also require members and
member organizations and their associated persons to use reasonable
diligence to understand the securities and strategies they
recommend, further obviating the need for this language. See id.
    \17\ Under FINRA Rule 0160(b)(9), ``member'' means an
organization that is a member of FINRA. NYSE's equivalent term is
``member organization.'' See Rule 2(b)(i). Under NYSE Rule 2(a), the
term ``member'' means a natural person associated with a member
organization that has been approved by the Exchange and designated
by such member organization to effect transactions on the floor of
the Exchange or any facility thereof. A ``member'' is not a
registered broker-dealer and does not have employees; only member
organizations have employees. As noted below, for purposes of the
proposed change, the Exchange proposes to continue using the phrase
``person associated with a member organization'' to indicate
employees of a member organization for purposes of Proposed Rule
2111.
---------------------------------------------------------------------------

Proposed Rule 2111 (Suitability)
    Proposed Rule 2111, like its FINRA counterpart, would require a
member organization or person associated with a member organization
\18\ to have a ``reasonable basis'' to believe that a recommended
transaction or investment strategy involving a security or securities
is suitable for the customer. This assessment would be based on the
information obtained through the reasonable diligence of the member
organization or person associated with a member organization to
ascertain the customer's investment profile, which includes, but is not
limited to, the customer's age, other investments,

financial situation and needs, tax status, investment objectives,
investment experience, investment time horizon, liquidity needs, risk
tolerance, and any other information the customer may disclose to the
member organization or person associated with a member organization in
connection with such recommendation.\19\ Like the FINRA rule, the
proposed rule would explicitly cover a recommended investment
strategy.\20\ The proposed rule would exclude the following
communications from the coverage of Proposed Rule 2111 as long as they
do not include (standing alone or in combination with other
communications) a recommendation of a particular security or
securities:
---------------------------------------------------------------------------

    \18\ As proposed, Rule 2111 is identical to FINRA Rule 2111
except that the Exchange proposes to use the phrase ``member
organization or person associated with a member organization''
rather than ``member or an associated person'' to indicate the
coverage of the rule. As discussed above, ``member'' and ``member
organization'' have different meanings under the NYSE and FINRA
rules, and under the NYSE's rules only member organizations can have
employees. See note 17, supra. The Exchange thus proposes to use the
phrase ``person associated with a member organization'' to indicate
employees of a member organization for purposes of Proposed Rule
2111.
    \19\ See Proposed Rule 2111(a). For institutional customers, the
proposed rule would, like the FINRA rule, require that a member
organization or person associated with a member organization have a
reasonable basis to believe that the institutional customer is
capable of evaluating investment risks independently, both in
general and with regard to particular transactions and investment
strategies, and is exercising independent judgment in evaluating
recommendations. See Proposed Rule 2111(b). Institutional customers
would also be required to affirmatively indicate that they are
exercising independent judgment. See id.
    \20\ See FINRA Know Your Customer and Suitability Approval, 75
FR at 71481.
---------------------------------------------------------------------------

     General financial and investment information, including
(i) basic investment concepts, such as risk and return,
diversification, dollar cost averaging, compounded return, and tax
deferred investment, (ii) historic differences in the return of asset
classes (e.g., equities, bonds, or cash) based on standard market
indices, (iii) effects of inflation, (iv) estimates of future
retirement income needs, and (v) assessment of a customer's investment
profile;
     Descriptive information about an employer-sponsored
retirement or benefit plan, participation in the plan, the benefits of
plan participation, and the investment options available under the
plan;
     Asset allocation models that are (i) based on generally
accepted investment theory, (ii) accompanied by disclosures of all
material facts and assumptions that may affect a reasonable investor's
assessment of the asset allocation model or any report generated by
such model, and (iii) in compliance with FINRA Rule 2214 (Requirements
for the Use of Investment Analysis Tools) if the asset allocation model
is an ``investment analysis tool'' covered by FINRA Rule 2214; and
     Interactive investment materials that incorporate the
above.\21\
---------------------------------------------------------------------------

    \21\ See Proposed Rule 2111.03.
---------------------------------------------------------------------------

    Again, like its FINRA counterpart, the proposed rule would be
composed of three main suitability obligations, as follows:
     The reasonable-basis suitability obligation, which
requires a member organization or person associated with a member
organization to have a reasonable basis to believe, based on reasonable
diligence, that the recommendation is suitable for at least some
investors; \22\
---------------------------------------------------------------------------

    \22\ See Proposed Rule 2111.05(a). The proposed rule would
clarify that, in general, what constitutes reasonable diligence will
vary depending on, among other things, the complexity of and risks
associated with the security or investment strategy and the member
organization's or person associated with a member organization's
familiarity with the security or investment strategy. Further, a
member organization's or person associated with a member
organization's reasonable diligence must provide the member
organization or person associated with a member organization with an
understanding of the potential risks and rewards associated with the
recommended security or strategy. Finally, the proposed rule would
specify that the lack of such an understanding when recommending a
security or strategy violates the suitability rule. See generally
id.
---------------------------------------------------------------------------

     The customer-specific suitability obligation, which
requires that a member organization or person associated with a member
organization have a reasonable basis to believe that the recommendation
is suitable for a particular customer based on that customer's
investment profile, as delineated in Proposed Rule 2111(a); \23\ and
---------------------------------------------------------------------------

    \23\ See Proposed Rule 2111.05(b).
---------------------------------------------------------------------------

     The quantitative suitability obligation, which requires a
member organization or person associated with a member organization who
has actual or de facto control over a customer account to have a
reasonable basis for believing that a series of recommended
transactions, even if suitable when viewed in isolation, are not
excessive and unsuitable for the customer when taken together in light
of the customer's investment profile, as delineated in Proposed Rule
2111(a).\24\
---------------------------------------------------------------------------

    \24\ See Proposed Rule 2111.05(c). The proposed rule would
provide that no single test defines excessive activity but that
factors such as the turnover rate, the cost-equity ratio, and the
use of in-and-out trading in a customer's account may provide a
basis for a finding that a member organization or person associated
with a member organization has violated the quantitative suitability
obligation. See id.
---------------------------------------------------------------------------

    Proposed Rule 2111 would also prohibit a member organization or
person associated with a member organization from recommending a
transaction or investment strategy involving a security or securities
or the continuing purchase of a security or securities or use of an
investment strategy involving a security or securities unless the
member organization or person associated with a member organization has
a reasonable basis to believe that the customer has the financial
ability to meet such a commitment.\25\
---------------------------------------------------------------------------

    \25\ See Proposed Rule 2111.06.
---------------------------------------------------------------------------

    Finally, like the FINRA rule, Proposed Rule 2111 would provide an
exemption to customer-specific suitability for institutional investors,
who would be required to affirmatively indicate that they are
exercising independent judgment in evaluating the recommendations of
the member organization or person associated with a member organization
on a trade-by-trade basis, on an asset-class-by-asset-class basis, or
in terms of all potential transactions for its account.\26\
---------------------------------------------------------------------------

    \26\ See Proposed Rule 2111.07. Like the FINRA rule, the
institutional-customer exemption would apply only if both parts of
the two-part test are met: (1) There is a reasonable basis to
believe that the institutional customer is capable of evaluating
investment risks independently, in general and with regard to
particular transactions and investment strategies, and (2) the
institutional customer affirmatively indicates that it is exercising
independent judgment in evaluating recommendations. See Proposed
Rule 2111(b); FINRA Know Your Customer and Suitability Approval, 75
FR at 71481, n. 25.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\27\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\28\ in particular, because
the proposed rule change would be consistent with and facilitate a
governance and regulatory structure that is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest. The Exchange believes the
proposed rule change is consistent with the Exchange's obligations
under the Exchange Act to prevent fraudulent or manipulative acts and
practices, and to promote just and equitable principles of trade,
because the proposed rule would incorporate the FINRA ``know your
customer'' rule and related suitability standards into the Exchange's
rules. The ``know your customer'' and suitability obligations are
critical to ensuring investor protection and fair dealing with
customers.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f(b).
    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Further, the Exchange believes that the proposed rule change
supports the objectives of Section 6(b)(5) of the Act

by providing greater harmonization between Exchange rules and FINRA
rules of similar purpose, resulting in less burdensome and more
efficient regulatory compliance. In particular, Exchange member
organizations that are also FINRA members are subject to NYSE Rule 405
and FINRA Rules 2090 and 2111, and harmonizing these rules by adopting
proposed rules identical to FINRA Rules 2090 and 2111would promote just
and equitable principles of trade by providing greater harmonization
between NYSE rules and FINRA rules of similar purpose by requiring the
same standards for ``know your customer'' and suitability, resulting in
less burdensome and more efficient regulatory compliance for Dual
Members. As previously noted, the proposed rule text is substantially
the same as FINRA's rule text. To the extent the Exchange has proposed
changes that differ from the FINRA version of the Exchange rules, such
changes are technical in nature and do not change the substance of the
proposed rules. The Exchange also believes that the proposed rule
change will update and add specificity to the requirements governing
``know your customer'' and suitability requirements, which will promote
just and equitable principles of trade and help to protect investors.

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

    In accordance with Section 6(b)(8) of the Act,\29\ the Exchange
does not believe that the proposed rule change will impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. The proposed rule change is not intended to
address competitive issues but rather to achieve greater consistency
between the Exchange's rules and FINRA's rules concerning ``know your
customer'' and suitability.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \30\ and Rule 19b-4(f)(6) thereunder.\31\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \31\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\32\
However, pursuant to Rule 19b-4(f)(6)(iii), the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.\33\
---------------------------------------------------------------------------

    \32\ 17 CFR 240.19b-4(f)(6)(iii).
    \33\ Id.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \34\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSE-2016-33 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2016-33. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2016-33 and should be
submitted on or before June 10, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\35\
---------------------------------------------------------------------------

    \35\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-11884 Filed 5-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56636-56637]
[FR Doc No: 2023-17784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2558]

David Winne; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by David Roy Winne (Winne) and is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Winne from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Winne was convicted
of multiple felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Winne was given notice
of the proposed debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Winne submitted a
request for hearing but failed to file with the Agency information and
analysis sufficient to create a basis for a hearing.

DATES: The order is applicable August 18, 2023.

ADDRESSES: Any application for termination of debarment by Winne under
section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application) may be
submitted as follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application,
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application 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 a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All applications must include the Docket No. FDA-
2022-N-2558. An application will be placed in the docket and, unless
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application 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 your application. 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 application 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, 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 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993,
[email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act mandates permanent debarment
if FDA finds that the individual has been convicted of a felony under
Federal law for conduct relating to the regulation of any drug product
under the FD&C Act. On September 29, 2022, the U.S. District Court for
the Southern District of New York entered a judgment against Winne,
after a guilty plea, for one count of conspiracy to commit wire fraud
in violation of 18 U.S.C. 1349 and one count of wire fraud in violation
of 18 U.S.C. 1343. The court sentenced Winne to 6 months in prison on
each count, to run concurrently; $1,431,524.00 in restitution; and upon
his release from prison, a 2-year supervised release for each count, to
run concurrently. The bases for his convictions stem from his
employment as a technical director with AMA Laboratories (AMA) a
consumer product testing company.
    According to FDA's Office of Regulatory Affairs' (ORA's) proposal
to debar, AMA, for a fee paid by consumer product companies, purported
to test the safety and effectiveness of cosmetics, sunscreens, and
other products on a specified number of volunteer panelists. ORA found
that, from 1987 to April 2017, Winne and other AMA personnel defrauded
AMA customers by testing products on fewer panelists than were agreed
to and paid for by AMA's customers. Specifically, Winne and other AMA
personnel falsely represented to AMA's customers that AMA had tested
products on the number of pre-specified panelists and then sent those
customers fraudulent test results, which included false data.
    By letter dated January 24, 2023, ORA notified Winne of a proposal
to permanently debar him from providing services in any capacity to a
person having an approved or pending drug product application, based on
the felony convictions and underlying conduct outlined above. In
addition to outlining

the above information, ORA found that the felony convictions were for
conduct relating to the regulation of drug products. The product
testing at issue included drug products, specifically sunscreens.\1\
---------------------------------------------------------------------------

    \1\ See section 201(g) of the FD&C Act (21 U.S.C. 321(g))
(defining drugs, inter alia, to include products for use in
preventing disease in man or intended to affect the structure or
function of the body); ``Sunscreen Drug Products for Over-the-
Counter Human Use,'' 43 FR 38206 at 38209 (August 25, 1978) (stating
an FDA-convened panel's conclusion that ``products intended to be
used for prevention of sunburn or any other such similar condition
should be regarded as drugs''); see also 21 CFR 201.327 (2011)
(outlining certain testing requirements for certain over-the-counter
sunscreen drug products and declaring such products to be misbranded
if SPF labeling claims not supported by adequate testing).
---------------------------------------------------------------------------

    On March 14, 2023, Winne submitted a request for a hearing. Winne's
request for a hearing does not provide any information or factual
analysis rebutting the findings in ORA's proposal to debar him.
Instead, Winne's request for a hearing raises three policy
considerations. First, Winne admits his wrongdoing and confirms the
appropriateness of debarment but asks FDA to consider a ``reduced
decision'' due to his ability to ``make a significant difference in the
industry by offering my unique perspective on clinical studies and
clinical data.'' Second, Winne mentions the debarment of another
individual linked to the same investigation and states that his actions
stemmed from that individual's direction. Third, Winne asserts that he
cooperated with Federal investigators throughout the investigation
process.
    Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Winne's request for a
hearing. Hearings are granted only if there is a genuine and
substantial issue of fact. Hearings will not be granted on issues of
policy or law, on mere allegations, denials or general descriptions of
positions and contentions, or on data and information insufficient to
justify the factual determination urged (see 21 CFR 12.24(b)). Winne
has not raised a genuine and substantial issue of fact regarding
whether he was convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
Rather, Winne affirms that he engaged in fraudulent conduct regarding
the product testing that this conduct formed the factual basis of the
felony convictions. Insofar as Winne intends to argue that he provided
``substantial assistance'' in the investigation or prosecution of
qualifying offenses under section 306(d)(4)(C) of the FD&C Act, he may
apply for special termination of his debarment. While the statute does
not define substantial assistance, FDA ``considers a determination by
the Department of Justice concerning the substantial assistance of a
debarred individual conclusive in most cases.'' \2\
---------------------------------------------------------------------------

    \2\ ``Baldev Raj Bhutani; Denial of Hearing on Application for
Special Termination of Debarment,'' 77 FR 75636 at 75638 (December
12, 2012) (citing ``Amirul Islam; Grant of Special Termination;
Final Order Terminating Debarment,'' 68 FR 58352 (October 9, 2003)).
---------------------------------------------------------------------------

II. Findings and Order

    The Chief Scientist, under section 306(a)(2) of the FD&C Act and
under the authority delegated to her, finds that David Roy Winne has
been convicted of felonies under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act. As a result of the
foregoing findings, Winne is permanently debarred from providing
services in any capacity to a person with an approved or pending drug
product application under section 505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective (see DATES) (21 U.S.C.
335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with
an approved or pending drug product application who knowingly uses the
services of Winne, in any capacity during his period of debarment, will
be subject to civil money penalties (section 307(a)(6) of the FD&C Act
(21 U.S.C. 335b(a)(6))). If Winne, during his period of debarment,
provides services in any capacity to a person with an approved or
pending drug product application, he will be subject to civil money
penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will
not accept or review any abbreviated new drug applications submitted by
or with the assistance of Winne during his period of debarment.

    Dated: August 14, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-17784 Filed 8-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Page 10171]
[FR Doc No: 2015-03947]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
February 26, 2015 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: February 20, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-03947 Filed 2-23-15; 11:15 am]
BILLING CODE 8011-01-P


                          Pebble Limited Partnership
               HDR "MesoHabitat" Database - Data Dictionary

Table of Contents
	Database Description
	Data Table Descriptions
	Figure 1  Field Descriptions

Database Description
Meso habitat survey locations, habitat types, bed width measurements, and habitat features from meso habitat surveys in the NFK, SFK, and UTC in 2007.

Location data from these tables are not found in the GLR, just in the data tables.  R2 did QC3 GIS analysis on the latitude / longitude coordinates, so they are labeled as QC3.  Future QC3 revisions to location data can be made to this database.

The database consists of the following data tables (listed in alphabetical order):
   MesoHabitat
   OffChannelMesoFeatures

Data Table Descriptions (listed as ordered above)

Note on data names:  Data attribute names are listed as TableName.AttributeName.  Sometimes a database name is also needed, and will be listed first.  Example:  GLR.tblGeoLoc_Fish_HDR.GeoLocName.

MesoHabitat
   PK = LocID
   MesoHabitat observations and measurements.  Location data are not in the GLR, so are provided within this data table.
   FK to GLR:  none

OffChannelMesoFeatures
   PK = Lat_WGS84 + Long_WGS84
   Observations recorded during the 2007 MesoHabitat study, only for the NFK and SFK.  These are stream features that are not located on the mainstem channel.  Location data are included within this data table.
   FK to GLR:  none

Figure 1.  Field Descriptions
Fields are listed for each table separately, and in the order as within the table.

 (see "EIS HDRMesoHabitat Dict Fields v20180227.xls")