[Federal Register: August 20, 2009 (Volume 74, Number 160)]
[Notices]
[Page 42068]
[DOCID:fr20au09-28]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF09-2011-000]

Bonneville Power Administration; Notice of Filing

August 13, 2009.
    Take notice that on July 31, 2009, Bonneville Power Administration
filed an application for confirmation and approval of its proposed 2010
wholesale power and transmission rates, to become effective October 1,
2009 through September 30, 2011, pursuant to sections 7(a)(2), 7(i)(6)
and 7(k) of the Pacific Northwest Electric Power Planning and
Conservation Act, 16 U.S.C. 839e(a)(2), 839e(1)(6), and 839e(k);
Subpart B of Part 300 of the Commission's regulations, 18 CFR Part 300;
and the Federal Columbia River Transmission System Act of 1974.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 31, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-19927 Filed 8-19-09; 8:45 am]

BILLING CODE 6717-01-P


Docket No. OW 2003 0075 Centralized Waste Treatment Industry Regulatory Record Record September 5, 2003 Section DCN Type Date Author/ Affiliation Receiver Subject CBI Pages 45 45.1 letter 10/ 8/ 2002 Jack E. Waggener Jan Matuszko, US EPA RE: Draft of the Molybdenum and Antimony Issue 26 45 45.2 email 2/ 26/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Molybdenum at a CWT Facility 5 45 45.3 email 3/ 5/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp CWT Mo & Sb Issues and the CIFS Facility 1 45 45.4 email 3/ 6/ 2003 Jack E. Waggener, URS Corp Elwood Forsht, US EPA RE: CWT Mo & Sb Issues and the CIFS Facility 1 45 45.5 email 3/ 6/ 2003 Jack E. Waggener, URS Corp Elwood Forsht, US EPA RE: CWT Mo & Sb Issues and the CIFS Facility 1 45 45.6 email 3/ 6/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Data on Barium at CWT Facilities 8 45 45.7 email 3/ 6/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp RE: CWT Mo & Sb Issues and the CIFS Facility 1 45 45.8 email 3/ 6/ 2003 Elwood Forsht, US EPA Lee Bagby, URS Corp RE: Data on Barium at CWT Facilities 6 45 45.9 email 3/ 10/ 2003 Jan Matuszko, US EPA Jack Waggener, URS Corp RE: CWT Mo & Sb Issues and the CIFS Facility 1 45 45.10. email 3/ 10/ 2003 Jack E. Waggener, URS Corp Jan Matuszko, US EPA RE: CWT Mo & Sb Issues and the CIFS Facility 1 45 45.11 email 3/ 14/ 2003 Jack E. Waggener, URS Corp Jan Matuszko, US EPA Request for Meeting on CWT Changes 1 45 45.12 email; 3/ 25/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Revised Comments on CWT Limits 1 45 45.12.1 attachment 3/ 25/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Moly & Antimony comments 25 45 45.12.2 attachment 3/ 25/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Industrial Water Services Comments Revised 5 45 45.12.3 attachment 3/ 25/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Clean Harbors Comments Revised 19 45 45.12.4 attachment 3/ 25/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA CIPF Comments Revised 25 45 45.13 email 3/ 27/ 2003 Jack Waggener, URS Corp Elwood Forsht, US EPA home address 1 45 45.14 email 3/ 27/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp Re: home address 1 45 45.15 email 3/ 27/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Re: home address ( response to questions) 1 45 45.16 email 3/ 27/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp Re: home address 1 45 45.17 email 3/ 29/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp Questions/ Comments on the March 25, 2003 Mo, SB,&

BA limits for IWS 1 45 45.18 email 3/ 30/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp A few more questions on Clean Harbors 1 45 45.19 email 3/ 31/ 2003 Elwood Forsht, US EPA Jack Waggener, URS Corp A few more questions on your Oct. 8/ March 21, 2003 Mo & Sb Comments 1 45 45.20. email 4/ 1/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA A few more questions on Clean Harbors 2 45 45.21 email 4/ 3/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Re: Questions/ Comments on the March 25, 2003 Mo,

Sb, & Ba limits for IWS 8 45 45.22 email 4/ 3/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Re: A few more questions on your Oct. 8/ March 21,

2003 Mo & Sb Comments 3 45.23 email 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Reading Material on molybdenum treatment 45 45.23.1 attachment 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Metal removal by physical and chemical treatment processes 14 45 45.23.2 attachment 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Meeting stringent metals removal requirements with iron adsorption/ coprecipitation 8 45 45.23.3 attachment 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Removal of uncommon trace metals by physical and chemical processes 13 45 45.23.4 attachment 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA removal of dissolved molybdenum from wastewater by precipitates of ferric iron 6 45.24 email 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Two papers on Sb 45 45.24.1 attachment 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Distribution and mobilization of arsenic and antimony species in the Coeur d'Alene river, Idaho 8 45 45.24.2 attachment 4/ 4/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Treatment of an Anionic Metal by Adsorption on Iron Oxides 5 45 45.25 email 4/ 7/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Draft Revisions of NORA Comments on Sb and Mo 1 45 45.25.1 attachment 4/ 7/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Moly& Antimony Comments April 7, 2003 redline/ strikeout 21 45 45.26 email 4/ 9/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA IndWater Services Comments Revision2 5 45 45.27 email 4/ 10/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Table 2 in the Sb and Mo comments 1 45 45.28 email 4/ 18/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA CWT Limits 1 45 45.29 email 5/ 9/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Some Additional Comments on Barium ( May 8, 2003 report) 35 45 45.30. email 6/ 4/ 2003 Elwood Forsht, US EPA Lee Bagby, URS Corp Re: Some Additional Comments on Barium 1 45 45.31 email 6/ 5/ 2003 Lee Bagby, URS Corp. Elwood Forsht, US EPA Re: Some Additional Comments on Barium 1 45 45.32 email 06/ 24/ 03 Jack Waggener, URS Corp Elwood Forsht, US EPA Molybdenum Revisions to CWT ( Deer Park) 5 45 45.33 email 07/ 03/ 03 Lee Bagby, URS Corp. Elwood Forsht, US EPA Molybdenum in CWT Organic and Combined Subcategory Wastewater 43 45 45.34 email 07/ 18/ 03 Jack Waggener, URS Corp Elwood Forsht, US EPA Re: CWT Molybdenum Limits for Organic and Oily Waste Subcategories 1 45 45.35 note 07/ 25/ 03 Elwood Forsht, US EPA CWT record April 11, 2003 Telecon Between Lee Bagby, URS ( NORA) and Forsht, EPA 1


[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Proposed Rules]
[Pages 22927-22930]
[FR Doc No: 2014-09380]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0232]
RIN 1625-AA00

Safety Zone: Smith Point Triathlon, Narrow Bay; Mastic Beach, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a temporary safety zone
on the navigable waters of Narrow Bay near Smith Point Park in Mastic
Beach, NY for the swim event associated with the Smith Point Triathlon.
The safety zone will provide protective measures for the event
participants and the maritime public from the hazards associated with
vessels operating in close proximity to the swim event. Entering into,
transiting through, remaining, anchoring or mooring within this
regulated area would be prohibited unless authorized by the Captain of
the Port (COTP) Sector Long Island Sound.

DATES: Comments and related material must be received by the Coast
Guard on or before May 27, 2014.
    Requests for public meetings must be received by the Coast Guard on
or before May 2, 2014.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Scott Baumgartner, Prevention Department,
Coast Guard Sector Long Island Sound,<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2014-0178] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2014-0178) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES on
or before May 2, 2014. Please explain why you believe a public meeting
would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

B. Regulatory History and Information

    The event sponsor, Event Power, has held the Smith Point Triathlon
in the same location for the past seven years. Last year, the event was
held on August 4, 2014 and a safety zone was established for the swim
portion of the triathlon in a temporary final rule entitled ``Special
Local Regulations and Safety Zones; Marine Events in Captain of the
Port Long Island Sound Zone''. This rulemaking was published on July
10, 2013 in the Federal Register (78 FR 41300).

C. Basis and Purpose

    The legal basis for this temporary rule is 33 U.S.C. 1231; 46
U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1,
6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1 which
collectively authorize the Coast Guard to define regulatory safety
zones.
    This temporary rule is necessary to promote the safety of life on
navigable waterways during the swim portion of the Smith Point
Triathlon in Narrow Bay near Mastic Beach, NY.

D. Discussion of Proposed Rule

    This temporary rule proposes to establish a safety zone for the
swim event associated with the Smith Point Triathlon. This proposed
regulated area includes all waters of Narrow Bay near Smith Point Park
in Mastic Beach, NY that are near or within the three swim legs for
this event and is specifically described as follows; the waters of
Narrow Bay within the area bounded by land along its southern edge and
points in position 40[deg]44'14.28'' N 072[deg]51'40.68'' W northerly
through position 40[deg]44'20.83'' N 072[deg]51'40.68'' W, then
easterly through position 40[deg]44'20.83'' N 072[deg]51'19.73'' W,
then southerly through position 40[deg]44'14.85'' N 072[deg]51'19.73''
W (NAD 83). All positions are approximate.
    This rule will be effective and enforced on June 1, 2014 from 6:00
a.m. through 9:30 a.m.
    The Smith Point Triathlon incorporates swim legs that will place
many swimmers in the navigable waters of Narrow Bay. A regulated area
is required to minimize the hazards posed by spectators and other
waterway users operating their vessels in close proximity to the event
participants. The safety zone established for the swim event will
minimize the risks to the event participants from this type of boat
traffic and improve visibility and maneuverability for the safety
vessels supporting the swim event.
    Public notifications will be made to the local maritime community
prior to the event through the Local Notice to Mariners and Broadcast
Notice to Mariners.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The Coast Guard determined that this rulemaking would not be a
significant regulatory action for the following reasons: The regulated
area will be of limited duration, the area covers only a small portion
of the navigable waterways and waterway users may transit around the
area. Also, mariners may request permission from the COTP Sector Long
Island Sound or the

designated representative to transit the zone.
    Advanced public notifications will also be made to the local
maritime community through the Local Notice to Mariners as well as
Broadcast Notice to Mariners.

2. 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. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to enter,
transit, anchor or moor within the regulated area during the effective
period. The temporary safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons: The regulated area will be of limited size and of short
duration and mariners may request permission from the COTP Sector Long
Island Sound or the designated representative to transit the zone.
Notifications will be made to the maritime community through the Local
Notice to Mariners and Broadcast Notice to Mariners well in advance of
the event.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    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 proposed 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. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    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 proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. 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.

7. 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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary 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 proposed rule
involves establishing a safety zone. This rule may be categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. A preliminary environmental analysis checklist
supporting this determination is available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREA AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T01-0232 to read as follows:

Sec.  165.T01-0232  Safety Zone; Smith Point Triathlon; Narrow Bay,
Mastic Beach, NY.

    (a) Location. The following area is a safety zone: Waters of Narrow
Bay near Smith Point Park in Mastic Beach, NY within the area bounded
by land along its southern edge and points in position
40[deg]44'14.28'' N 072[deg]51'40.68'' W northerly through position
40[deg]44'20.83'' N 072[deg]51'40.68'' W, then easterly through
position 40[deg]44'20.83'' N 072[deg]51'19.73'' W, then southerly
through position 40[deg]44'14.85'' N 072[deg]51'19.73'' W (NAD 83). All
positions are approximate.
    (b) Enforcement Period. This rule will be enforced on June 1, 2014
from 6:00 a.m. until 9:30 a.m.
    (c) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the COTP, Sector Long Island
Sound, to act on his or her behalf. The designated representative may
be on an official patrol vessel or may be on shore and will communicate
with vessels via VHF-FM radio or loudhailer. In addition, members of
the Coast Guard Auxiliary may be present to inform vessel operators of
this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP Sector Long Island Sound.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (d) Regulations. The general regulations contained in 33 CFR 165.23
apply. During the enforcement period, entering into, transiting
through, remaining, mooring or anchoring within this safety zone is
prohibited unless authorized by the Captain of the Port (COTP) or the
designated representatives.
    (1) Spectators desiring to enter or operate within the regulated
area should contact the COTP Sector Long Island Sound at<PHONE_NUMBER>
(Sector Long Island Sound Command Center) or the designated
representative via VHF channel 16 to obtain permission to do so.
Spectators given permission to enter or operate in the regulated area
must comply with all directions given to them by the COTP Sector Long
Island Sound or the designated on-scene representative.
    (2) Upon being hailed by an official patrol vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (3) Vessels not associated with the event shall maintain a
separation of at least 100 yards from the participants.

    Dated: April 8, 2014.
E. J. Cubanski, III,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2014-09380 Filed 4-24-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 6, 2006 (Volume 71, Number 66)]
[Notices]
[Page 17529-17532]
[DOCID:fr06ap06-110]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53580; File No. SR-NASD-2006-040]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Order Granting Accelerated Approval
of Proposed Rule Change To Expand NASD's Order Audit Trail System
Exemptive Authority To Include Recording Requirements

March 30, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on March 28, 2006, the National Association of Securities Dealers,
Inc. (``NASD'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by NASD. The
Commission is publishing this notice and order to solicit comments on
the proposed rule change from interested persons and to approve the
proposal on an accelerated basis.
---------------------------------------------------------------------------

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

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

    NASD is proposing to expand NASD's current Order Audit Trail System
(OATS) exemptive authority to include recording requirements. Below is
the text of the proposed rule change. Proposed new language is in
italics; proposed deletions are in [brackets].\3\
---------------------------------------------------------------------------

    \3\ The proposed changes indicated herein are based on rule text
approved by the SEC on September 28, 2005, which become effective on
May 8, 2006. See Securities Exchange Act Release No. 52521
(September 28, 2005), 70 FR 57909 (October 4, 2005) (File No. SR-
NASD-00-23).
---------------------------------------------------------------------------

* * * * *

6950. Order Audit Trail System

* * * * *

6955. Order Data Transmission Requirements

    (a) through (c) No Change.
    [(d) Exemptions]
    [(1) Pursuant to the Rule 9600 Series, the staff, for good cause
shown after taking into consideration all relevant factors, may exempt,
subject to specified terms and conditions, a member from the order data
transmission requirements of this Rule for manual orders, if such
exemption is consistent with the protection of investors and the public
interest, and the member meets the following criteria:]
    [(A) the member and current control affiliates and associated
persons of the member have not been subject within the last five years
to any final disciplinary action, and within the last ten years to any
disciplinary action involving fraud;]
    [(B) The member has annual revenues of less than $2 million;]
    [(C) The member does not conduct any market making activities in
Nasdaq Stock Market equity securities;]
    [(D) The member does not execute principal transactions with its
customers (with limited exception for principal transactions executed
pursuant to error corrections); and]
    [(E) The member does not conduct clearing or carrying activities
for other firms.]
    [(2) An exemption provided pursuant to this paragraph (d) shall not
exceed a period of two years. At or prior to the expiration of a grant
of exemptive relief under this paragraph (d), a member meeting the
criteria set forth in paragraph (d)(1) may request, pursuant to the
Rule 9600 Series, a subsequent exemption, which will be considered at
the time of the request, consistent with the protection of investors
and the public interest.]
    [(3) This paragraph shall be in effect until May 8, 2011.]
* * * * *

6958. Exemption to the Order Recording and Data Transmission
Requirements

    (a) Pursuant to the Rule 9600 Series, the staff, for good cause
shown after

taking into consideration all relevant factors, may exempt, subject to
specified terms and conditions, a member from the recording and order
data transmission requirements of Rules 6954 and 6955, respectively,
for manual orders, if such exemption is consistent with the protection
of investors and the public interest, and the member meets the
following criteria:
    (1) The member and current control affiliates and associated
persons of the member have not been subject within the last five years
to any final disciplinary action, and within the last ten years to any
disciplinary action involving fraud;
    (2) The member has annual revenues of less than $2 million;
    (3) The member does not conduct any market making activities in
Nasdaq Stock Market equity securities;
    (4) The member does not execute principal transactions with its
customers (with limited exception for principal transactions executed
pursuant to error corrections); and
    (5) The member does not conduct clearing or carrying activities for
other firms.
    (b) An exemption provided pursuant to this Rule shall not exceed a
period of two years. At or prior to the expiration of a grant of
exemptive relief under this Rule, a member meeting the criteria set
forth in paragraph (a) above may request, pursuant to the Rule 9600
Series, a subsequent exemption, which will be considered at the time of
the request, consistent with the protection of investors and the public
interest.
    (c) This Rule shall be in effect until May 8, 2011.
* * * * *

9600. Procedures for Exemptions

9610. Application

(a) Where to File
    A member seeking exemptive relief as permitted under Rules 1021,
1050, 1070, 2210, 2315, 2320, 2340, 2520, 2710, 2720, 2790, 2810, 2850,
2851, 2860, Interpretive Material 2860-1, 3010(b)(2), 3020, 3150, 3210,
3230, 3350, 695[5]8, 8211, 8212, 8213, 11870, or 11900, or Municipal
Securities Rulemaking Board Rule G-37 shall file a written application
with the appropriate department or staff of NASD and provide a copy of
the application to the Office of General Counsel of NASD.
    (b) and (c) No Change.
* * * * *

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

    In its filing with the Commission, NASD 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 III below. NASD 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
    On September 28, 2005, the SEC approved amendments to the OATS
Rules (NASD Rules 6950 through 6957) which, among other things,
implement the final phase of OATS (OATS Phase III) relating to manual
orders and permit NASD to grant exemptive relief from the OATS
reporting requirements for manual orders.\4\ The amendments become
effective on May 8, 2006. The new exemptive authority permits NASD to
grant exemptive relief only to those members that meet specified
criteria.\5\ The narrow scope is generally intended to permit NASD to
grant relief only to smaller member firms where the reporting of such
information would be unduly burdensome or where temporary relief from
the rules (in the form of additional time to achieve compliance) would
permit the member to avoid unnecessary expense or hardship.
---------------------------------------------------------------------------

    \4\ Id.
    \5\ At a minimum, members must meet the following criteria to be
eligible to request an exemption to the OATS reporting requirements
for manual orders: (1) The member and current control affiliates and
associated persons of the member have not been subject within the
last five years to any final disciplinary action, and within the
last ten years to any disciplinary action involving fraud; (2) the
member has annual revenues of less than $2 million; (3) the member
does not conduct any market making activities in Nasdaq Stock Market
equity securities; (4) the member does not execute principal
transactions with its customers (with limited exceptions for error
corrections); and (5) the member does not conduct clearing or
carrying activities for other firms.
---------------------------------------------------------------------------

    NASD's exemptive authority is further limited in that it only
permits NASD to relieve members of their obligations to report OATS
information to NASD on a daily basis. Thus, while members that are
granted an exemption are exempt from reporting or submitting
information required under the OATS Rules to NASD, such members must
still record and electronically maintain all information required under
the OATS Rules. Certain smaller member firms that meet the criteria to
request an exemption from the reporting requirements have raised
concerns about having to comply with the OATS recording requirements.
Specifically, such firms have indicated that even if they ultimately
are granted an exemption from the reporting requirements, complying
with the OATS recording requirements will impose significant burdens
and costs on their firms.
    NASD understands the concerns raised by these firms and believes
that expanding its current exemptive authority to include recording
requirements will greatly assist these smaller member firms by
providing such firms more time to determine the best mechanism for
complying with the OATS requirements. At the same time, NASD does not
believe that such an exemption will have a material impact on NASD's
regulatory program because members currently are required to capture
and maintain much of the data via other NASD and SEC rules (e.g., NASD
Rule 3110 and Rule 17a-3 under the Act \6\), and any exemption granted
will be for a limited time period.
---------------------------------------------------------------------------

    \6\ 17 CFR 240.17a-3.
---------------------------------------------------------------------------

    NASD intends to grant exemptions from the OATS recording and
reporting requirements for manual orders for a period of six months to
those members that meet the minimum required criteria. This exemptive
relief is intended to provide such members additional time to determine
and implement an effective mechanism for recording and reporting OATS
information to NASD.
    In this regard, NASD has developed several new enhancements to
NASD's OATS Web interface, which are designed to significantly reduce
the OATS recording and reporting burdens for manual firms with limited
order volume.\7\ Specifically, the upgrades to the OATS Web interface,
which is available at no cost to members, will greatly improve
usability and reduce the number of fields users are required to enter
when recording an OATS event. The enhanced Web interface will enable a
user to submit the data to OATS, as well as download the data to its
own system prior to submission, to allow the

user to maintain on its own system a record of events submitted to
OATS.\8\
---------------------------------------------------------------------------

    \7\ While the enhanced OATS Web interface is designed to reduce
significantly the OATS recording and reporting burdens for manual
firms with limited order volume, the enhanced Web interface is
available as a mechanism for recording and reporting OATS
information to all eligible member firms, including member firms
already required to report to NASD during OATS Phase I and Phase II.
    \8\ The testing environment for the Web interface enhancements
will be available on April 24, 2006, and the production environment
will be available on May 8, 2006.
---------------------------------------------------------------------------

    During the six-month exemption period, NASD will be evaluating the
enhanced Web interface functionality to determine whether it reduces
significantly the reporting burdens for smaller member firms. The
availability of an effective OATS Web interface will be a major factor
in NASD's decision to grant further exemptions after the initial six-
month exemptive period expires. For this reason, NASD strongly
recommends that members granted an exemption contact NASD immediately
to begin testing usage of the Web interface enhancements. As NASD and
member firms gain experience with the Web interface, NASD will be in a
better position to evaluate and consider the effectiveness of Web
interface for OATS requirements and whether any future exemptive relief
beyond the initial six-month time frame is appropriate. Notwithstanding
the effectiveness of Web interface, NASD may decide to grant further
exemptions to certain smaller member firms where complying with the
OATS recording and reporting requirements for manual orders would
impose significant burdens and costs on their firms.
    The effective date of the proposed rule change would be May 8,
2006, if approved prior to that date; otherwise, the effective date
would be the date of SEC approval.
2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\9\ which requires, among
other things, that NASD 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. NASD believes expanding NASD's OATS exemptive
authority would provide smaller member firms additional time to
determine an appropriate mechanism for complying with the OATS
requirements, while not materially impacting NASD's regulatory
oversight.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    NASD 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 amended.

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

    While NASD did not specifically solicit comment on the proposed
rule change, NASD received one written comment letter regarding the
scope of the exemptive authority set forth in Rule 6955(d).\10\ The
commenter requests that NASD broaden its current exemptive authority to
include recording requirements. Specifically, the commenter argues that
NASD's exemptive authority was intended to include the requirement to
record information required under the OATS Rules and maintain such
information in an electronic format. The commenter contends that its
firm, as well as other firms, were confused that the current exemption
from the OATS reporting requirements included only the narrow exemption
from the requirement to transmit OATS data to NASD. The commenter
further contends that the distinction between the transmission
requirement and the electronic retention and collection of information
was not highlighted nor discussed. As noted above, NASD proposes to
expand its OATS exemptive authority to include recording requirements.
---------------------------------------------------------------------------

    \10\ See Letter to Paul J. McKenney, Assistant Director--OATS,
NASD, from Bonnie K. Wachtel, CEO, and Wendie L. Wachtel, COO,
Wachtel & Co., Inc. dated February 1, 2006.
---------------------------------------------------------------------------

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-040 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NASD-2006-040. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of the
filing also will be available for inspection and copying at the
principal office of NASD. 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-NASD-2006-040 and should be submitted on or before April 27, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a self-regulatory organization.\11\ In
particular, the Commission believes that the proposal is consistent
with Section 15A(b)(6) of the Act,\12\ which requires that the rules of
an association 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.
---------------------------------------------------------------------------

    \11\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
    \12\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    The NASD's view that the benefits afforded to smaller member firms
by the proposed rule change seem to be significant, without materially
impacting the regulatory oversight, seems reasonable. Importantly, the
Commission notes that smaller firms may be exempt under NASD's current
exemptive authority from daily reporting requirements with respect to
OATS information under current rules, so the proposed change would not
affect the information received by the NASD on a daily basis.
Additionally, the NASD notes that member firms that may be eligible for
the proposed expanded

exemption are required to capture and maintain certain information
required by the OATS Rules pursuant to other NASD and Commission
rules.\13\
---------------------------------------------------------------------------

    \13\ See e.g., NASD Rule 3110 and 17 CFR 240.17a-3 and page 6,
supra.
---------------------------------------------------------------------------

    The Commission also notes that the NASD initially plans to limit an
exemption available under this proposal to six months and re-evaluate
whether to grant further exemptions after the expiration of the six-
month period. The Commission believes that by initially limiting the
exemption to qualifying member firms to six months, firms may have
sufficient time to become familiar with NASD's enhanced Web interface
and to discuss with NASD any problems encountered.
    Finally, the Commission believes that the NASD's proposed
requirement that a firm receiving an exemption under the proposed rule
change re-apply after six months and at least every two years should
help to ensure that firms applying for the exemption are continuing to
meet the exemption requirements.
    The Commission understands that the NASD wants to provide members
eligible for an exemption adequate notice as to whether they will be
required to comply with the OATS recording requirement on May 8, 2006.
The Commission believes that allowing accelerated approval of this
proposed rule change would give members eligible for the exemption more
time to evaluate their options with respect to the OATS Rules and
hopefully prevent unnecessary hardships or expense that may otherwise
occur without accelerated approval. The Commission, therefore, finds
good cause for approving this proposal before the thirtieth day after
the publication of notice thereof in the Federal Register.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\14\ that the proposed rule change, as amended (SR-NASD-2006-040),
is hereby approved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-4986 Filed 4-5-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27602-27605]
[FR Doc No: 2018-12631]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2285]

Medical Product Communications That Are Consistent With the Food
and Drug Administration-Required Labeling--Questions and Answers;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Medical Product
Communications That Are Consistent With the FDA-Required Labeling--
Questions and Answers.'' This guidance provides information for
manufacturers, packers, and distributors and their representatives
(collectively ``firms'') of drugs and medical devices for humans,
including those that are licensed as biological products, and animal
drugs (collectively ``medical products''), about how FDA evaluates
their medical product communications that present information that is
not contained in the FDA-required labeling for the product but that may
be

consistent with the FDA-required labeling for the product. The Agency
is issuing this guidance to explain FDA's current thinking on commonly
asked questions regarding such communications to provide clarity for
firms. FDA is also announcing that a proposed collection of information
has been submitted to the Office of Management and Budget (OMB) for
review and clearance under the Paperwork Reduction Act of 1995.

DATES: The announcement of the guidance is published in the Federal
Register on June 13, 2018. Submit written comments on the collection of
information by July 13, 2018.

ADDRESSES: To ensure comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--NEW and
title ``Recommended Content of Medical Product Communications That Are
Consistent With the FDA-Required Labeling--Questions and Answers;
Guidance for Industry.'' Also include the FDA docket number found in
brackets in the heading of this document.
    You may submit either electronic or written comments on Agency
guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2285 for ``Medical Product Communications That Are
Consistent With the FDA-Required Labeling--Questions and Answers;
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this 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; Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002;
Division of Small Manufacturers, International and Consumer Assistance,
Office of Communication, Education and Radiation Programs, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002;
or to Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Kristin Davis, Office of Policy, Office of
the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Elizabeth Pepinsky, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3248, Silver Spring, MD 20993-0002, 301-
796-1200; or Stephen Ripley, 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>; or Ana Loloei
Marsal, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Thomas Moskal, Center for
Veterinary Medicine, Food and Drug Administration, 7519

Standish Pl. (HFV-216), Rockville, MD 20855,<PHONE_NUMBER>.
    Regarding the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North,
11601 Landsdown St., 10A-12M, North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Medical Product Communications That Are Consistent With the
FDA-Required Labeling--Questions and Answers.'' This guidance provides
information for firms about how FDA evaluates their medical product
communications (that fall within the scope of FDA's regulatory
authority) that present information that is not contained in the FDA-
required labeling \1\ for the product but that may be consistent with
the FDA-required labeling for the product.
---------------------------------------------------------------------------

    \1\ As used in the guidance, the term FDA-required labeling
includes the labeling reviewed and approved by FDA as part of the
medical product marketing application review process. For products
not subject to premarket approval, but instead subject to premarket
notification (510(k)) requirements or exempt from premarket review,
the term FDA-required labeling includes the labeling that provides
adequate directions for use and other information required to appear
on the label or in labeling.
---------------------------------------------------------------------------

    FDA determines whether a medical product is safe and effective for
use under the conditions prescribed, recommended, or suggested in the
proposed labeling submitted with the product's marketing application or
submission (and for devices, also during the classification process).
In making this determination, FDA evaluates whether the conditions of
use in the proposed labeling are supported by the required levels and
types of evidence of safety and effectiveness and whether the benefits
of using the product under those specific conditions of use outweigh
the risks of the product. After FDA approves, clears, or licenses a
medical product, the FDA-required labeling sets forth the conditions of
use under which the product has been shown to meet the relevant
standard for marketing, and it provides directions and information on
how to use the product safely and effectively under those conditions.
    Medical product firms have told FDA that they are interested in
communicating, including in their promotional materials, data and
information about the approved/cleared/licensed uses of their products
that are not contained in their products' FDA-required labeling. We are
aware that firms have questions about how FDA determines whether such
communications are consistent with the FDA-required labeling.
    The guidance describes FDA's thinking when examining the
consistency of a firm's product communications with that product's own
FDA-required labeling. As explained in the guidance, if a firm
communicates information that is not contained in its product's FDA-
required labeling but that is determined to be consistent with the FDA-
required labeling, FDA does not intend to rely on that communication to
establish a new intended use, different from the use(s) for which the
product is legally marketed. Establishing a product's intended uses is
an element in establishing certain violations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act.
However, firms' communications about their products that are consistent
with the products' FDA-required labeling but that are false or
misleading may subject a firm to enforcement action under the FD&C Act.
Thus, the guidance not only describes FDA's thinking on communications
that are consistent with the FDA-required labeling, but also provides
general recommendations intended to aid firms in complying with
requirements in the FD&C Act and FDA's implementing regulations for
conveying information that is consistent with the FDA-required labeling
in a truthful and non-misleading way. The general recommendations
provided in the guidance for conveying information in a truthful and
non-misleading way are applicable only to drug and device labeling and
prescription drug and restricted device advertising that are consistent
with the FDA-required labeling. Communication of information that is
not consistent with the FDA-required labeling is outside the scope of
these recommendations.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on firms' communications for their medical
products that may be consistent with the FDA-required labeling. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection for OMB review and clearance.
    Title: Recommended Content of Medical Product Communications That
Are Consistent With the FDA-Required Labeling; OMB Control No. 0910--
NEW.
    The guidance includes third-party disclosure recommendations
regarding information that firms should include in communications that
contain information not found in the FDA-required labeling for their
medical products but that are consistent with the FDA-required labeling
(as explained in the guidance) if they choose to publicly disseminate
such materials. The guidance recommends that various aspects of study
design and methodology for studies relied on in such communications be
disclosed to provide material contextual information (e.g., type of
study, study objectives, product dosage/use regimens, control(s) used,
patient population studied), and that material limitations related to
the study design, methodology, and results also be disclosed in a clear
and prominent manner to help ensure that the communications are not
false or misleading. Additionally, the guidance recommends that firms
accurately characterize and contextualize the relevant information
about the product, including by disclosing unfavorable or inconsistent
findings. Finally, the guidance recommends that firms disclose material
contextual information from the FDA-required labeling in these
communications, such as data and information from studies in the FDA-
required labeling that are relevant to the data or information
presented in the communication (e.g., if a communication provides post-
market information about the types and rates of occurrence of adverse
events that have been observed in practice, the communication should
also include information from the FDA-required labeling about the types
and rates of occurrence of adverse reactions observed in clinical
trials to provide context).
    In the Federal Register of January 19, 2017 (82 FR 6575), we
published a notice announcing the availability of the draft guidance
document and included an analysis under the PRA of the information
collection burden associated with our recommendations. No comments were
received in response to the four information collection topics
solicited in the notice.
    According to FDA data, approximately 162,000 FDA-regulated

promotional materials are prepared by approximately 500 firms annually.
Of these materials, we estimate approximately 5 percent contain unique
presentations of information consistent with FDA-required labeling, as
described in the guidance, submitted by approximately 64 percent (or
324) of the firms. Anticipating that the number of these FDA-regulated
promotional materials will soon increase to 6 percent, we estimate the
324 firms will prepare and disseminate annually 9,720 FDA-regulated
promotional materials that contain unique presentations of information
that is consistent with the FDA-required labeling, as described in the
guidance, and that therefore are recommended to include the proposed
third party disclosures. Based on our experience reviewing FDA-
regulated promotional materials for medical products, we estimate it
will take respondents approximately 4 hours per unique presentation to
prepare and incorporate the disclosures recommended in the guidance, if
they choose to disseminate this information.
    We therefore estimate the burden of the information collection as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Type of information                             Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to                     324               30            9,720                4           38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA is issuing this final guidance subject to OMB approval of the
collection of information. Before implementing the information
collection provisions of the guidance, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the collection of information, including OMB control
number(s) for newly approved collections.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://www.regulations.gov.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12631 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Notices]
[Pages 12037-12040]
[FR Doc No: 2020-04074]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88273; File No. SR-GEMX-2020-06]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 9,
Section 21 (Anti-Money Laundering Compliance Program)

February 24, 2020.
    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 February 18, 2020, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') 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 the Exchange. The Exchange files the
proposed rule change as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) \3\ of the Act and Rule 19b-
4(f)(6) \4\ thereunder. 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. The Exchange provided the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing the proposed
rule change as required by Rule 19b-4(f)(6)(iii). 17 CFR 240.19b-
4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Options 9, Section 21, ``Anti-Money
Laundering Compliance Program.'' This rule change is intended to
reflect the Financial Crimes Enforcement Network's (``FinCEN'')
adoption of a final rule on Customer Due Diligence Requirements for
Financial Institutions (``CDD Rule''). Specifically, the proposed
amendments would conform Options 9, Section 21 to the CDD Rule's
amendments to the minimum regulatory requirements for Members' anti-
money laundering (``AML'') compliance programs by requiring such
programs to include risk-based procedures for conducting ongoing
customer due diligence. This ongoing customer due diligence element for
AML programs includes: (1) Understanding the nature and purpose of
customer relationships for the purpose of developing a customer risk
profile; and (2) conducting ongoing monitoring to identify and report
suspicious transactions and, on a risk basis, to maintain and update
customer information.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqgemx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose

I. Background

    The Bank Secrecy Act \5\ (``BSA''), among other things, requires
financial institutions,\6\ including broker-dealers, to develop and
implement AML programs that, at a minimum, meet the statutorily
enumerated ``four pillars.'' \7\ These four pillars currently require
broker-dealers to have written AML programs that include, at a minimum:
---------------------------------------------------------------------------

    \5\ 31 U.S.C. 5311, et seq.
    \6\ See U.S.C. 5312(a)(2) (defining ``financial institution'').
    \7\ 31 U.S.C. 5318(h)(1).
---------------------------------------------------------------------------

     The establishment and implementation of policies,
procedures and internal controls reasonably designed to achieve
compliance with the applicable provisions of the BSA and implementing
regulations;
     independent testing for compliance by broker-dealer
personnel or a qualified outside party;
     designation of an individual or individuals responsible
for implementing and monitoring the operations and internal controls of
the AML program; and
     ongoing training for appropriate persons.\8\
---------------------------------------------------------------------------

    \8\ 31 CFR 1023.210(b).
---------------------------------------------------------------------------

    In addition to meeting the BSA's requirement with respect to AML
programs, Exchange Members must also comply with Options 9, Section 21,
which incorporates the BSA's four pillars, as well as requires Members'
AML programs to establish and implement policies and procedures that
can be reasonably expected to detect and cause the reporting of
suspicious transactions.
    On May 11, 2016, FinCEN, the bureau of the Department of the
Treasury responsible for administering the BSA and its implementing
regulations, issued the CDD Rule \9\ to clarify and strengthen customer
due diligence for covered financial institutions,\10\ including broker-
dealers. In its CDD Rule, FinCEN identifies four components of customer
due diligence: (1) Customer identification and verification; (2)
beneficial ownership identification and verification; (3) understanding
the nature and purpose of customer relationships; and (4) ongoing
monitoring for reporting suspicious transactions and, on a risk basis,
maintaining and updating customer information.\11\ As the first
component is already required to be part of a broker-dealers AML
program under the BSA, the CDD Rule focuses on the other three
components.
---------------------------------------------------------------------------

    \9\ FinCEN Customer Due Diligence Requirements for Financial
Institutions; CDD Rule, 81 FR 29397 (May 11, 2016) (CDD Rule
Release); 82 FR 45182 (September 28, 2017) (making technical
correcting amendments to the final CDD Rule published on May 11,
2016). FinCEN is authorized to impose AML program requirements on
financial institutions and to require financial institutions to
maintain procedures to ensure compliance with the BSA and associated
regulations. 31 U.S.C. 5318(h)(2) and (a)(2). The CDD Rule is the
result of the rulemaking process FinCEN initiated in March 2012. See
77 FR 13046 (March 5, 2012) (Advance Notice of Proposed Rulemaking)
and 79 FR 45151 (Aug. 4, 2014) (Notice of Proposed Rulemaking).
    \10\ See 31 CFR 1010.230(f) (defining ``covered financial
institution'').
    \11\ See CDD Rule Release at 29398.
---------------------------------------------------------------------------

    Specifically, the CDD Rule focuses particularly on the second
component by adding a new requirement that covered financial
institutions identify and verify the identity of the beneficial owners
of all legal entity customers at the time a new account is opened,
subject to certain exclusions and exemptions.\12\ The CDD Rule also
addresses the third and fourth components, which FinCEN states ``are
already implicitly required for covered financial institutions to
comply with their suspicious activity reporting requirements,'' by
amending the existing AML program rules for covered financial
institutions to explicitly require these components to be included in
AML programs as a new ``fifth pillar.''
---------------------------------------------------------------------------

    \12\ See 31 CFR 1010.230(d) (defining ``beneficial owner'') and
31 CFR 1010.230(e) (defining ``legal entity customer'').
---------------------------------------------------------------------------

    On November 21, 2017, FINRA published Regulatory Notice 17-40 to
provide guidance to member firms regarding their obligations under
FINRA Rule 3310 in light of the adoption of FinCEN's CDD Rule. In
addition, the Notice summarized the CDD Rule's impact on member firms,
including the addition of the new fifth pillar required for member
firms' AML programs. FINRA also amended FINRA Rule 3310 to explicitly
incorporate the fifth pillar.\13\ This proposed rule change amends
Options 9, Section 21 to harmonize it with the FINRA rule and
incorporate the fifth pillar.
---------------------------------------------------------------------------

    \13\ See Securities Exchange Act Release No. 83154 (May 2,
2018), 83 FR 20906 (May 8, 2018) (File No. SR-FINRA-2018-016).
---------------------------------------------------------------------------

II. Options 9, Section 21 and Amendment to Minimum Requirements for
Members' AML Programs

    Section 352 of the USA PATRIOT Act of 2001 \14\ amended the BSA to
require broker-dealers to develop and implement AML programs that
include the four pillars mentioned above. Consistent with Section 352
of the PATRIOT Act, and incorporating the four pillars, Options 9,
Section 21 requires each Member to develop and implement a written AML
program reasonably designed to achieve and monitor the Member's
compliance with

the BSA and implementing regulations. Among other requirements, Options
9, Section 21 requires that each Member firm, at a minimum: (1)
Establish and implement policies and procedures that can be reasonably
expected to detect and cause the reporting of suspicious transactions;
(2) establish and implement policies, procedures, and internal controls
reasonably designed to achieve compliance with the BSA and implementing
regulations; (3) provide independent testing for compliance to be
conducted by Member personnel or a qualified outside party; (4)
designate and identify to the Exchange an individual or individuals
(i.e., AML compliance person(s)) who will be responsible for
implementing and monitoring the day-to-day operations and internal
controls of the AML program and provide prompt notification to the
Exchange of any changes to the designation; and (5) provide ongoing
training for appropriate persons.
---------------------------------------------------------------------------

    \14\ Uniting and Strengthening America by Providing Appropriate
Tools Required to Intercept and Obstruct Terrorism Act of 2001,
Public Law 107-56, 115 Stat. 272 (2001) (``PATRIOT Act'').
---------------------------------------------------------------------------

    FinCEN's CDD Rule does not change the requirements of Options 9,
Section 21, and Members must continue to comply with its
requirements.\15\ However, FinCEN's CDD Rule amends the minimum
regulatory requirements for broker-dealers' AML programs by explicitly
requiring such programs to include risk-based procedures for conducting
ongoing customer due diligence.\16\ Accordingly, the Exchange is
proposing to amend Options 9, Section 21 to incorporate this ongoing
customer due diligence element, or ``fifth pillar'' required for AML
programs. Thus, proposed Options 9, Section 21(f) would provide that
the AML programs required by this Rule shall, at a minimum include
appropriate risk-based procedures for conducting ongoing customer due
diligence, to include, but not be limited to: (1) Understanding the
nature and purpose of customer relationships for the purpose of
developing a customer risk profile; and (2) conducting ongoing
monitoring to identify and report suspicious transactions and, on a
risk basis, to maintain and update customer information.
---------------------------------------------------------------------------

    \15\ FinCEN notes that broker-dealers must continue to comply
with FINRA Rules, notwithstanding differences between the CDD Rule
and FINRA Rule 3310, which is substantially identical to Options 9,
Section 21. See CDD Rule Release 29421, n. 85.
    \16\ See CDD Rule Release at 29420; 31 CFR 1023.210.
---------------------------------------------------------------------------

    As stated in the CDD Rule, these provisions are not new and merely
codify existing expectations for Members to adequately identify and
report suspicious transactions as required under the BSA and
encapsulate practices generally already undertaken by securities firms
to know and understand their customers.\17\ The proposed rule change
simply incorporates into Options 9, Section 21 the ongoing customer due
diligence element, or ``fifth pillar,'' required for AML programs by
the CDD Rule to aid Members in complying with the CDD Rule's
requirements. However, to the extent that these elements, which are
briefly summarized below, are not already included in Members' AML
programs, the CDD Rule requires Members to update their AML programs to
explicitly incorporate them.
---------------------------------------------------------------------------

    \17\ Id. at 29419.
---------------------------------------------------------------------------

III. Summary of Fifth Pillar's Requirements

Understanding the Nature and Purpose of Customer Relationships
    FinCEN states in the CDD Rule that firms must necessarily have an
understanding of the nature and purpose of the customer relationship in
order to determine whether a transaction is potentially suspicious and,
in turn, to fulfill their SAR obligations.\18\ To that end, the CDD
Rule requires that firms understand the nature and purpose of the
customer relationship in order to develop a customer risk profile. The
customer risk profile refers to information gathered about a customer
to form the baseline against which customer activity is assessed for
suspicious transaction reporting.\19\ Information relevant to
understanding the nature and purpose of the customer relationship may
be self-evident and, depending on the facts and circumstances, may
include such information as the type of customer, account or service
offered, and the customer's income, net worth, domicile, or principal
occupation or business, as well as, in the case of existing customers,
the customer's history of activity.\20\ The CDD Rule also does not
prescribe a particular form of the customer risk profile.\21\ Instead,
the CDD Rule states that depending on the firm and the nature of its
business, a customer risk profile may consist of individualized risk
scoring, placement of customers into risk categories or another means
of assessing customer risk that allows firms to understand the risk
posed by the customer and to demonstrate that understanding.\22\
---------------------------------------------------------------------------

    \18\ Id. at 29421.
    \19\ Id. at 29422.
    \20\ Id.
    \21\ Id.
    \22\ Id.
---------------------------------------------------------------------------

    The CDD Rule also addresses the interplay of understanding the
nature and purpose of customer relationships with the ongoing
monitoring obligation discussed below. The CDD Rule explains that firms
are not necessarily required or expected to integrate customer
information or the customer risk profile into existing transaction
monitoring systems (for example, to serve as the baseline for
identifying and assessing suspicious transactions on a contemporaneous
basis).\23\ Rather, FinCEN expects firms to use the customer
information and customer risk profile as appropriate during the course
of complying with their obligations under the BSA in order to determine
whether a particular flagged transaction is suspicious.\24\
---------------------------------------------------------------------------

    \23\ Id.
    \24\ Id.
---------------------------------------------------------------------------

Conduct Ongoing Monitoring
    As with the requirement to understand the nature and purpose of the
customer relationship, the requirement to conduct ongoing monitoring to
identify and report suspicious transactions and, on a risk basis, to
maintain and update customer information, merely adopts existing
supervisory and regulatory expectations as explicit minimum standards
of customer due diligence required for firms' AML programs.\25\ If, in
the course of its normal monitoring for suspicious activity, the Member
detects information that is relevant to assessing the customer's risk
profile, the Member must update the customer information, including the
information regarding the beneficial owners of legal entity
customers.\26\ However, there is no expectation that the Member update
customer information, including beneficial ownership information, on an
ongoing or continuous basis.\27\
---------------------------------------------------------------------------

    \25\ Id. at 29402.
    \26\ Id. at 29420-21. See also FINRA Regulatory Notice 17-40
(discussing identifying and verifying the identity of beneficial
owners of legal entity customers).
    \27\ Id.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\28\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\29\ in particular, in that it
is designed to promote just and equitable principles of trade, 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. Specifically, the Exchange believes the proposed rule
change will protect investors, because it will aid Members in complying
with the CDD Rule's requirement that Members' AML programs include
risk-based procedures for conducting ongoing customer due diligence by
also incorporating the requirement into Options 9, Section 21.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78f(b).
    \29\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
simply incorporates into Options 9, Section 21 the ongoing customer due
diligence element, or ``fifth pillar,'' required for AML programs by
the CDD Rule. Regardless of the proposed rule change, to the extent
that the elements of the fifth pillar are not already included in
Members' AML programs, the CDD Rule requires Members to update their
AML programs to explicitly incorporate them. In addition, as stated in
the CDD Rule, these elements are already implicitly required for
covered financial institutions to comply with their suspicious activity
reporting requirements. Further, all Exchange Members that have
customers are required to be members of FINRA pursuant to Rule 15b9-1
under the Exchange Act,\30\ and are therefore already subject to the
requirements of FINRA Rule 3310. Additionally, the proposed rule change
is virtually identical \31\ to FINRA Rule 3310. The Exchange is not
imposing any additional direct or indirect burdens on member firms or
their customers through this proposal, and as such, the proposal
imposes no new burdens on competition.
---------------------------------------------------------------------------

    \30\ 17 CFR 240.15b9-1.
    \31\ The Exchange notes that changes between the proposed Rule
and FINRA Rule 3310 are non-substantive and relate to cross
references.
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \32\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\33\
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \33\ 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.
---------------------------------------------------------------------------

    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.

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-GEMX-2020-06 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-GEMX-2020-06. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-GEMX-2020-06 and should be submitted on
or before March 20, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-04074 Filed 2-27-20; 8:45 am]
BILLING CODE 8011-01-P