[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57898-57899]
[FR Doc No: 2022-20473]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2022-0755; FRL-10216-01-OAR]

Phasedown of Hydrofluorocarbons: Notice of Grant of Request To
Extend Compliance Date for Requirements To Control Emissions of
Hydrofluorocarbon-23

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces that the U.S. Environmental Protection
Agency (EPA) granted a request for a six-month extension of the October
1, 2022, compliance date for a facility to control emissions of
hydrofluorocarbon-23. The requestor submitted a timely and complete
request with a credible rationale for an extension and a reasonable
plan to meet compliance requirements and reduce emissions of this
potent greenhouse gas. The Agency granted the request in a letter dated
September 13, 2022.

FOR FURTHER INFORMATION CONTACT: John Feather, U.S. Environmental
Protection Agency, Stratospheric Protection Division; telephone number
202-564-1230; or email address: [email protected]. You may also
visit our website at https://www.epa.gov/climate-hfcs-reduction/control-HFC-23-emissions for further information.

SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' ``the Agency,'' or ``our'' is used, we mean EPA. Acronyms that
are used in this rulemaking that may be helpful include:

AIM Act--American Innovation and Manufacturing Act
CFR--Code of Federal Regulations
EPA--Environmental Protection Agency
FR--Federal Register
GWP--Global Warming Potential
HCFC--hydrochlorofluorocarbon
HFC--hydrofluorocarbon
HFO--hydrofluoroolefin

Table of Contents

I. General Information
    A. Why is EPA issuing this notice?
    B. Background
II. What action was taken?

I. General Information

A. Why is EPA issuing this notice?

    This notice is directed to the public to announce an action that
EPA has taken. On September 13, 2022, EPA issued a letter granting a
request for a six-month extension of the October 1, 2022, compliance
date for a facility to control emissions of hydrofluorocarbon (HFC)-23,
which has been posted to EPA's website (https://www.epa.gov/climate-hfcs-reduction/control-HFC-23-emissions) and can be found in the docket
for this notice (Docket ID No. EPA-HQ-OAR-2022-0755).

B. Background

    HFC-23 is a very potent greenhouse gas with a 100-year global
warming potential (GWP) of 14,800.\1\ While EPA is also aware of
limited instances where HFC-23 is captured, purified, and used for
commercial purposes such as fire suppression, very low temperature
refrigeration, and semiconductor manufacturing, the majority of HFC-23
is unintentionally created as a byproduct during the production of

certain fluorinated compounds, including hydrochlorofluorocarbon
(HCFC)-22.\2\ Unless sold for a consumptive use, controlled, or
captured and destroyed, such creation of HFC-23 is ultimately vented to
the atmosphere where it contributes to climate change. HFC-23 is not an
air toxic and does not pose a direct risk to local communities, but, as
described in sections III and IV of a rulemaking published last year,
climate change threatens the public health of the U.S. population and
especially those that may be vulnerable based on their characteristics
or circumstances (86 FR 55116, October 5, 2021).
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    \1\ Exchange values of regulated substances, including for HFC-
23, are listed in 40 CFR part 84, appendix A. These exchange values
are identical to the 100-year GWPs included in IPCC (2007). In this
notice, EPA uses the terms ``global warming potential'' and
``exchange value'' interchangeably.
    \2\ HCFC-22 is an ozone-depleting substance that has been phased
out domestically under the Clean Air Act in line with the
international phase out occurring under the Montreal Protocol on
Substances that Deplete the Ozone Layer. While HCFC-22 has been
phased out of production and consumption, the chemical can still be
produced for use as a feedstock to make other chemicals, such as
low-GWP hydrofluoroolefins (HFOs). HFOs can be used in many of the
same applications as high-GWP HFCs, so transitioning to them from
HFCs can reduce emissions of greenhouse gases.
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    HFC-23 is a regulated substance under the American Innovation and
Manufacturing Act of 2020 (AIM Act) enacted December 27, 2020, as
section 103 in Division S, Innovation for the Environment, of the
Consolidated Appropriations Act, 2021 (42 U.S.C. 7675). Under the
implementing regulations at 40 CFR part 84, subpart A, EPA established,
among other things, HFC-23 emission control requirements and a process
for chemical producers to request limited extensions of the compliance
date. These provisions were intended to ensure that high-GWP emissions
of HFC-23 are promptly controlled, while allowing limited discretion to
account for individual circumstances where that timeline may not be
practicable. EPA estimates that from 2022 through 2050 these HFC-23
emission control requirements will have abated cumulative emissions
from the Chemours Louisville Works facility of more than 7,000 metric
tons of HFC-23, or more than 3.7 million metric tons of carbon dioxide
equivalent annually, and result in net present cumulative benefits of
$6.4 billion in 2020 dollars at a three percent discount rate (see
Regulatory Impact Analysis for Phasing Down Production and Consumption
of Hydrofluorocarbons (HFCs) available at https://www.epa.gov/climate-hfcs-reduction/final-rule-phasedown-hydrofluorocarbons-establishing-allowance-allocation).
    To reduce emissions of this potent greenhouse gas, the Agency
requires in 40 CFR 84.27(a) that ``[n]o later than October 1, 2022, as
compared to the amount of chemical intentionally produced on a facility
line, no more than 0.1 percent of HFC-23 created on the line may be
emitted.'' After such point, emissions of HFC-23 byproduct that exceed
the 0.1 percent will be treated as violations of an applicable
emissions limitation in violation of federal law and subject to any
appropriate enforcement action. In 40 CFR 84.27(b), EPA further
specifies that if captured HFC-23 is destroyed at a different facility
than where it was produced, then HFC-23 emissions during the
transportation to and destruction at the different facility are
calculated into whether the producer meets the 0.1 percent HFC-23
limit.
    EPA recognized that individual circumstances could arise that may
warrant a six-month deferral of the compliance date, subject to a one-
time additional six-month extension. Requests for an extension of the
HFC-23 emission control requirements were due to EPA by August 1, 2022,
and requests had to contain information including a description of the
specific actions the facility has taken to improve their HFC-23
control, capture, and destruction and the facility's plans to meet the
0.1 percent HFC-23 limit.

II. What action was taken?

    By August 1, 2022, one company, Chemours Company FC, LLC, submitted
a request for a six-month extension of the HFC-23 control requirements
for its Chemours Louisville Works facility in Louisville, Kentucky. It
is EPA's understanding that the delays in installing new emission
control technology were due in part to supply chain issues which
prevented Chemours Louisville Works from physically taking possession
of all necessary parts until July 2022. However, Chemours reported that
the facility intends to have the new control technology operational and
effective by October 1, 2022, such that the facility should be able to
meet the emissions limit on the required timeline. The primary purpose
of Chemours requesting the extension is to allow time to measure,
validate, and optimize the effectiveness of the process change at the
facility. Chemours expects to complete this validation by the end of
the year, three months in advance of the extended compliance deadline.
    EPA determined that the requestor submitted a timely and complete
request with a credible rationale for an extension and a reasonable
plan to meet compliance requirements. The Agency granted this extension
with the understanding that Chemours will have all necessary equipment
onsite, operational, and effective by October 1, 2022, and will be
running that equipment from that date onwards. With this understanding
and EPA's review of the submitted information, the Agency granted the
request in a letter dated September 13, 2022.
    EPA will monitor the facility's progress on meeting the emission
control requirements and intends to post status updates to its website
at https://www.epa.gov/climate-hfcs-reduction/control-HFC-23-emissions
as information becomes available for public release. This will help
ensure interested stakeholders are aware of the facility's current
status and progress toward meeting the HFC-23 emission limit.

Cynthia A. Newberg,
Director, Stratospheric Protection Division.
[FR Doc. 2022-20473 Filed 9-21-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 9, 2009 (Volume 74, Number 109)]
[Notices]
[Page 27360-27361]
[DOCID:fr09jn09-147]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60035; File No. SR-FINRA-2009-034]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Extend FINRA's Authority Under the Cease and
Desist Pilot Program

June 3, 2009.
    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 May 18, 2009, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to extend FINRA's authority under its cease and
desist pilot program, as further detailed herein, and to make certain
technical amendments. The proposed rule change does not propose any
substantive changes to the existing cease and desist authority pilot
program.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    In May 2003, the Commission approved, on a two-year pilot basis, a
rule change that gave FINRA authority to issue temporary cease and
desist orders (``TCDOs'') \4\ and made explicit FINRA's ability to
impose permanent cease and desist orders as a remedy in disciplinary
cases.\5\ The pilot program also gave FINRA authority to enforce cease
and desist orders. In June 2005 and June 2007, the SEC approved [sic]
two-year extensions of the pilot program.\6\ The current two-year pilot
expires on June 23, 2009.\7\
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    \4\ A TCDO is a preliminary order issued in connection with an
underlying disciplinary proceeding that has been initiated or will
be initiated immediately.
    \5\ See Securities Exchange Act Release No. 47925 (May 23,
2003), 68 FR 33548 (June 4, 2003) (Order Approving File No. SR-NASD-
98-80).
    \6\ See Securities Exchange Act Release No. 51860 (June 16,
2005), 70 FR 36427 (June 23, 2005) (Notice of Filing and Immediate
Effectiveness of File No. SR-NASD-2005-061); Securities Exchange Act
Release No. 55819 (May 25, 2007), 72 FR 30895 (June 4, 2007) (Notice
of Filing and Immediate Effectiveness of File No. SR-NASD-2007-033).
    \7\ See Securities Exchange Act Release No. 55819 (May 25,
2007), 72 FR 30895 (June 4, 2007) (Notice of Filing and Immediate
Effectiveness of File No. SR-NASD-2007-033).
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    In a companion rule filing filed with the SEC on May 18, 2009,\8\
FINRA is proposing to make the pilot program permanent without any
substantive changes to the terms of the existing program. In the
current rule filing, FINRA seeks to extend the pilot until the SEC
approves or disapproves the proposal to make the pilot permanent so
that the cease and desist authority does not lapse while the proposal
is pending at the SEC. The proposed action would enable FINRA to
continue to issue TCDOs and impose permanent cease and desist orders as
a remedy in disciplinary cases. The proposed action also would give
FINRA authority to continue to initiate expedited proceedings when
respondents violate temporary or permanent cease and desist orders.
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    \8\ See Securities Exchange Act Release No. 60028 (June 2, 2009)
(SR-FINRA-2009-035).
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    When it first sought cease and desist authority, FINRA stated that
it would use the authority sparingly. That has been the case. Since the
pilot program was first approved in 2003, FINRA has issued only one
TCDO and one permanent cease and desist order (both in the same case,
which is described below). If the pilot is extended, the cease and
desist rules would continue to be used judiciously. There are times,
however, when their use is crucial.
    In the one case initiated under the pilot program, FINRA's
Department of Enforcement (``Enforcement'') alleged that the member in
question was engaged in widespread fraud that included, among other
things, making material misrepresentations and omissions in connection
with the private offering of its own stock, effecting unauthorized
transactions and using customer funds improperly.\9\ Enforcement showed
that not only was the member attempting to continue the fraudulent
offering, it also was funneling money and assets to a non-member
affiliate. Enforcement alleged, and a hearing panel found, that a TCDO
was necessary because the member's continuation of the misconduct was
likely to result in further dissipation or conversion of assets and
other significant harm to investors before the completion of the
underlying disciplinary proceeding. After the hearing panel issued a
permanent cease and desist order following a full disciplinary hearing,
the parties settled the case, resulting in the expulsion of the member,
the bar of its owner and the imposition of almost $12 million in fines
and restitution.
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    \9\ See L.H. Ross & Company, Securities Exchange Act Release No.
51270, 2005 SEC LEXIS 452 (February 28, 2005).
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    The proposed temporary extension of the pilot program will provide
FINRA with a mechanism to continue to take appropriate remedial action
against a member or an associated person that has engaged (or is
engaging) in violative conduct that could cause continuing harm to the
investing public if not addressed expeditiously while the SEC is
considering FINRA's proposal to permanently adopt the pilot program. It
must be emphasized, however, that the cease and desist provisions
contain numerous procedural protections for respondents to ensure that
the proceedings are fair.

    The proposed rule change also would make certain technical
amendments to the rule text, namely to correct punctuation in FINRA
Rule 9556 and update FINRA Rule 9810 to reflect a change in FINRA style
convention when referencing the federal securities laws.
    FINRA has filed the proposed rule change to extend FINRA's
authority under its cease and desist pilot program for immediate
effectiveness. The implementation date will be June 23, 2009. The pilot
program will remain in effect until the SEC approves FINRA's proposed
rule change to make the pilot permanent \10\ and such rule change
becomes effective or the SEC disapproves such proposed rule change.
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    \10\ See supra, note 8.
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2. Statutory Basis
    The proposed rule change is consistent with the provisions of
Section 15A(b)(6) of the Act,\11\ which requires, among other things,
that FINRA's rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. The proposed rule change also is consistent with the
provisions of Section 15A(b)(7) of the Act,\12\ which provides that
FINRA members, or persons associated with its members, must be
appropriately disciplined for violations of any provisions of the Act
or FINRA's rules. Extending the pilot program is consistent with
FINRA's obligations under the Act because cease and desist orders are
designed to stop violative conduct that is likely to cause dissipation
or conversion of assets or other significant harm to investors.
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    \11\ 15 U.S.C. 78o-3(b)(6).
    \12\ 15 U.S.C. 78o-3(b)(7).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    Written comments were neither solicited nor received.

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

    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) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2009-034 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-FINRA-2009-034. 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, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2009-034 and should be
submitted on or before June 30, 2009.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-13503 Filed 6-8-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Notices]
[Pages 22563-22564]
[FR Doc No: 2017-09868]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0010]

Fire Protection in Shipyard Employment Standard; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Fire Protection in
Shipyard Employment Standard.

DATES: Comments must be submitted (postmarked, sent or received) by
July 17, 2017.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2010-0010,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 10:00 a.m. to 3:00 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2010-0010) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other materials in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not
publically available to read or download from the Web site. All
submissions, including copyrighted material, are available for
inspection and copying at the OSHA Docket Office. You may contact Theda
Kenney at the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Todd Owen or Theda Kenney, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program

ensures that information is in the desired format, reporting burden
(time and costs) is minimal, collection instruments are clearly
understood, and OSHA's estimate of the information collection burden is
accurate. The Occupational Safety and Health Act of 1970 (the OSH Act)
(29 U.S.C. 651 et seq.) authorizes information collection by employers
as necessary or appropriate for enforcement of the OSH Act or for
developing information regarding the causes and prevention of
occupational injuries, illnesses, and accidents (29 U.S.C. 657). The
OSH Act also requires that OSHA obtain such information with minimum
burden upon employers, especially those operating small businesses, and
to reduce to the maximum extent feasible unnecessary duplication of
efforts in obtaining information (29 U.S.C. 657).
    The Fire Protection in Shipyard Employment Standard (29 CFR part
1915, subpart P) specifies a number of collection of information
(paperwork) requirements. In general, the Standard requires employers
to develop a written fire safety plan and written statements or
policies that contain information about fire watches and fire response
duties and responsibilities. The Standard also requires the employer to
obtain medical exams for certain workers and to develop training
programs and to train employees exposed to fire hazards. Additionally,
the Standard requires employers to create and maintain records to
certify that employees have been made aware of the details of the fire
safety plan and that employees have been trained as required by the
Standard.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements specified in the Fire Protection in Shipyard
Employment Standard (29 CFR part 1915, subpart P). The Agency is
requesting an increase in burden hours from 6,051 to 6,603 burden hours
(a total increase of 552 burden hours). The Agency will summarize the
comments submitted in response to this notice and will include this
summary in the request to OMB to extend the approval of the information
collection requirements.
    Type of Review: Extension of a currently approved collection.
    Title: Fire Protection in Shipyard Employment Standard (29 CFR part
1915, subpart P).
    OMB Control Number: 1218-0248.
    Affected Public: Business or other for-profits.
    Number of Respondents: 678.
    Number of Responses: 55,572.
    Frequency of Responses: Quarterly; Annually.
    Average Time per Response: Various.
    Estimated Total Burden Hours: 6,603.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other materials must identify the Agency
name and the OSHA docket number for the ICR (Docket No. OSHA-2010-
0010). You may supplement electronic submissions by uploading document
files electronically. If you wish to mail additional materials in
reference to an electronic or facsimile submission, you must submit
them to the OSHA Docket Office (see the section of this notice titled
ADDRESSES). The additional materials must clearly identify your
electronic comments by your name, date, and the docket number so the
Agency can attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publically available to read or download from this Web
site. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office.
    Information on using the http://www.regulations.gov Web site to
submit comments and access the docket is available at the Web site's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available from the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    Dorothy Dougherty, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Dated: May 10, 2017.
Dorothy Dougherty,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-09868 Filed 5-15-17; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11807-11808]
[FR Doc No: 2016-04947]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0539]

Clinical Considerations for Investigational Device Exemptions for
Neurological Devices Targeting Disease Progression and Clinical
Outcomes; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Clinical
Considerations for Investigational Device Exemptions (IDEs) for
Neurological Devices Targeting Disease Progression and Clinical
Outcomes.'' The Center for Devices and Radiological Health (CDRH)
developed this draft guidance to assist sponsors who intend to submit
an IDE to the FDA to conduct clinical trials on medical devices
targeting neurological disease progression and clinically meaningful
patient centered outcomes. This draft guidance is not final nor is it
in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 6, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-0539 for ``Clinical Considerations for Investigational
Device Exemptions (IDEs) for Neurological Devices Targeting Disease
Progression and Clinical Outcomes.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Clinical Considerations for Investigational Device Exemptions (IDEs)
for Neurological Devices Targeting Disease Progression and Clinical
Outcomes'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Carlos Pe[ntilde]a, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 301-
796-6610.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA believes that neurological devices intended to slow disease
progression and improve clinical outcomes that are meaningful may
represent a revolutionary option for patients. FDA developed this draft
guidance to assist sponsors who intend to submit an IDE to the FDA to
conduct clinical trials on medical devices targeting neurological
disease progression and clinically meaningful patient centered
outcomes. The draft guidance is intended to aid industry and FDA staff
in considering the benefits and risks of medical devices that target
either the cause or progression of the neurological disorder or
condition such as Alzheimer's disease, Parkinson's

Disease, or Primary Dystonia, rather than their symptoms. This draft
guidance is intended to apply to neurological medical devices that are
designed to slow, stop, or reverse the progression of disease and
result in clinically meaningful patient outcomes. This draft guidance
provides general study design considerations for clinical trials that
investigate neurological devices using biological markers and clinical
outcome assessments.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Clinical
Considerations for Investigational Device Exemptions (IDEs) for
Neurological Devices Targeting Disease Progression and Clinical
Outcomes.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/ MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Clinical Considerations for
Investigational Device Exemptions (IDEs) for Neurological Devices
Targeting Disease Progression and Clinical Outcomes'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1500021 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
parts 801 and 809 have been approved under OMB control number 0910-
0485; the collections of information in 21 CFR part 50 have been
approved under OMB control number 0910-0755; and the collections of
information in the guidance document entitled ``Request for Feedback on
Medical Device Submissions: The Pre-submission Program and Meetings
With Food and Drug Administration Staff'' have been approved under OMB
control number 0910-0756.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04947 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P


Summary of Potential SER Written and Oral Comments

 Received in Response to SBREFA Panel Outreach Meetings

Worker Protection Standard

	Issue/Potential proposal	Comments	Time or Cost  ($) Related Comment
Alternate proposals	Response/Recommendations

A	REI /Field Posting

REI /Field Posting, continued	Time consuming, difficult , Too expensive
to orally notify and post all applications (Farm)

Supports mandatory posting only for RUP products.  Posting should be at
single, usual point of entry to field (Farm)

Only for double notification – workers read labels so know REIs can
refer to WPS, Retain central posting (AFBF)

Many fields are irregular in shape, no corners, posting is burdensome
(Aerial)

Numerous small fields of different crops also makes posting difficult
(Farm)	Up to 1 hour per application to orally notify and post(Farm)

Costly, time consuming and difficult to enforce.  Should only require
points of entry, not four corners (Ag custom applicator)

Posting all fields could increase cost to about one hour per day effort
and a $25 per day cost.  Small would have higher costs than large
because field size is smaller (thus more fields to post).  More signs
per acre on small than on large farms (Farm)

Impractical to post corners of field, Leads to loss of productivity,
Time consuming to post – hammering stake in ground, attaching sign to
stake. Aerial: would take an employee out of other productive work
(AFBF)

estimate 30 minutes to post a single reusable sign at point of entry.
Take at least one hour to post four corners.  Some growers have  many
fields resulting in heavy posting burden (Crop advisor)

15 minutes to post a field is too low (Aerial)	Central map with field
marked by flags and requirement for daily worker check in.  Or exempt
small farms, if all workers are certified and notified at time of
application (Farm)

 Posting should be for RUPs only, and at each possible entry point and
each corner. (Farm)

 Farms with less than 10 non-family employees should not be required to
post, just verbal notifications (Farm)

Fewer employees could be orally notified, not posting.  Perhaps
institute worker sign off for oral notification (Farm)

Consider an exception to field posting for farms with a few employees.
Oral notification with central posting is sufficient. (AFB)

	A	WPS Training/ Retraining Interval	Everyone retrains every year.
Can’t verify/turnover (Farm)

Retain 5-year interval(Farm)

Retain 5-year interval(Aerial)

Retraining interval should be same as recertification for applicators,
keep at 5 years (Farm)

Most workers trained annually, Retain 5 years – effective and not
unusual burden, Growers do not check for training history (AFBF)

Train annually even if previously trained although some may not (Crop
advisor)	PS Training burden:

30 mins worker

45 mins handler (AFBF)

worker training 30-60 minutes, handler training 45- 60 minutes.
Material cost is minimal. (Crop advisor)	5 yrs (as is) or when newly
hired Rather than reduce interval, require documentation of training
(Farm)

	A	WPS Training/ Grace period

WPS Training/ Grace period, continued

	Do not eliminate, bad idea.  Too much in first few days(Farm)

Need grace period for flexibility (Farm)

Retain 5-day grace period (Aerial)

Supports retention of grace periods (Ag custom applicator)

Need to retain a grace period for flexibility around busy schedules
(Farm)

Loss of GP would lead to earlier hiring and more cost to grower (AFBF)
Earlier hiring leads to increased input cost by $100 -200 per hire.
(AFBF)

A	Decontamination/ Handler showers	Major burden and employees would not
use(Farm)

Shower is unreasonably expensive(Farm)

Shower not justified (Farm)

Unnecessary(AFBF)

Crop advisor handlers are mobile and shower facilities would be
difficult and costly to provide (Crop advisor)

Ag custom applicators in the Midwest have showers, but are seldom used
(Ag custom applicator)	Shower facility would cost tens of thousands of
dollars (Farm)

Portable showers cost $5000 - $6000.  add cost of water. (AFBF)	Train
handlers on minimizing take-home exposure (Farm)

 Additional PPE for handlers /mixer/loaders (Farm)

Protect better by requiring workers to remove early entry clothing and
footwear – do not allow it to be taken home(AFBF)

	A	PPE /Enclosed cabs and respirators	Cabs should meet standards or
should use respirator. No manufacturers certify cabs for use without
respirator. (Farm)

Wants to use enclosed cab as substitute for respirator (Farm)

Label should specify what is allowed (Farm)

 well maintained cabs with charcoal filters are effective against
exposure (Ag custom applicator)

Questions the need for respirators instead of enclosed cabs (Aerial)

Roadside applicators should not have respirator requirements (Landscape
maintenance)

Encourage improvement of enclosed cab filtration (Farm)

	B	General	Flexibility is key, Define small by # employees, Oppose
curtailment of use of ag chemicals w/o research/scientific data showing
injury(AFBF)

Small farms could be defined by having 75% of labor and management by
family.  Short term workers (e.g., harvest) should not have to be
trained, unless an RUP has been used recently. (Farm)

	B	Crop Advisor Employees	Opposes any change to the current exemption
for protections during the REI.  Do not believe will reduce risk and
will be extra burden. (Crop advisor)	Estimate that a consultant would
have additional cost of  $2000 to $6000 per year. (Crop advisor)	If
employee exemption is revised, allow for incidental entry, such as time
limited entry without PPE (Crop advisor)

	B	 REI/ Notifications for early entry	Does not use exceptions to REI
(Farm)

Rarely needs to use early entry, but no need for written notification
(Farm)

	B	REI/ Records	Careful records of worker entry should be kept by grower
 (Farm)

	B	Posting content	Signs do not need to have specifics. Specifics may be
misinterpreted by workers. Skull and crossbones would be less effective
than current symbol (Farm).	Signs become consumable rather than reusable
(Farm)

Posting pesticide name and REI expiration would add 30 minutes per field
(Crop advisor)

B	Application entry restricted area	This restriction would not work, due
to conflicts with neighboring producers on different schedules (Farm)

No impact to aerial applicator (Aerial)

Not possible because of nearby residences (Farm)

Opposed – arbitrary and not based on science, Loss of productivity in
adjacent fields. (AFBF)	Result in significant economic loss(AFBF)

B	Hazard Comm /MSDS	This is a burden and no one ever asks for MSDS(Farm)

MSDS’s are not always available, so not a good idea(Farm)

PPE is on label.  No other document needed. (AFBF)

Filing and making available MSDS is burdensome (Crop advisor)

Posting MSDS would be possible, but would never be used by workers
(Aerial)	Will add hours of time for finding and printing, as well as
additional file space(Farm)

No burden to maintain MSDS file, since already required (Aerial)	Allow
some time period for supplying MSDS Database online for retrieval (Farm)

	B	WPS Training/ Trainers	Owner or employee does training (Aerial)

	B	WPS Training /Records	Do not supply training verification cards to
employees. Not aware of federally funded training resources (Crop
advisor)	Estimate that records would take 30 minutes per training
session (Crop advisor)

B	Safety Poster /Content and location

Poster at decon site should not cost much (Crop advisor)

B	Decontamination/ Eyeflush water	Excessive amounts of water not
justified (Farm)

	B	Decontamination/ Mix/load site water	Excessive amounts of water not
justified (Farm)

	B	Application Restrictions/ Application entry restricted area	Little
impact as long as reasonable distance (Farm).

	B	Application Restrictions/ Cholinesterase monitoring	Unnecessary,
label PPE should be sufficient (Farm)

Use of cholinesterase inhibiting chemicals has declined to less than 2%
of treatments in corn and soybeans, so testing is not useful (Ag custom
applicator)	Time consuming and expensive (Ag custom applicator)	Require
baseline for those who apply on regular basis for more than 30 days (Ag
custom applicator)

	B	PPE /Cab maintenance and records	Supports requirement for keeping
maintenance records (Farm)

	B	PPE /Respirators/ Medical monitoring	Medical monitoring and fit
testing are a major burden (Farm).	My applicators complete questionnaire
that is reviewed, some have follow-up medical visit, with little cost
difference (Structural pest control)

C	Hazard Comm/ Records

C	WPS Training/ Contents

C	Emergency Info

C	PPE /Closed Sys.

Certification Rule

	Issue/Potential proposal	Comments	Time or Cost ($) Related Comment
Alternate proposals	Response/ Recommendations

A	Commercial applicator competency /Minimum Age	Not over 14 for
commercial applicators, if can pass test (Landscape maintenance)

Commercial applicator 18, children of farmers age 16(Farm)

Supports 16 – 18 (Farm)

Minimum age for pilot’s license is 18, so no impact of 18 for aerial
applicator (Aerial)

Supports 18 as minimum age (Structural pest control)

One cannot understand the concept of safe and accurate application until
age 18 (Ag custom applicator).

No minimum, just written test (Farm)

Supports 18 as minimum age (Structural pest control)

Commercial – 16 or 18 OK(AFBF)

minimum for pilots makes this moot for aerial applicators (Aerial)

	A	Private applicator competency /Minimum Age

Private applicator competency /Minimum Age continued	Law sets minimum at
age 18 for non farm.  Farm children should be certified when pass test
(Farm).

Supports 16 (Farm)

One cannot understand the concept of safe and accurate application until
age 18 (Ag custom applicator).

No minimum, need to use family (Landscape maintenance)

Privates should be 15 or 16, not 12

Private – 16 OK(AFBF)

	Would be forced to hire certified applicators or older workers. Could
delay applications, affecting yield (Farm)

Cost to replace lost family worker: salary, unemployment and workman’s
comp taxes, loss of reliability (AFBF)

A	Application of RUP’s under the supervision of a certified applicator
/Minimum Age	Support for training or requirement for presence of
certified applicator (Landscape maintenance)

Minimum age of 16 for an apprentice program, but not working alone
(Structural pest control)

One cannot understand the concept of safe and accurate application until
age 18 (Ag custom applicator).

No minimum, need to use family (Farm)	Would be forced to hire certified
applicators or older workers. Could delay applications, affecting yield
(Farm).

A	Application of RUP’s under the supervision of a certified applicator
/Communication method	Radios and cell phones are problem in some remote
areas.  Generally supports good communication.  Insurance companies also
support (Farm)

Supports communication method rather than on-site presence(Farm)

Supports requirement for instant communication (Ag custom applicator)

While desirable, not always possible (Structural pest control)	Most, if
not all, have two-way radios or cell phones, so no additional cost, For
full coverage, could add several hundred if not thousands of dollars in
equipment and future subscriptions. (Farm)	Issues that may come up and
need communication should be covered in training.(Farm)

Should consider distance rather than communication requirement (Farm)

	B	General	Commercial applicators are extensively trained and face
tougher enforcement than private applicators, though may apply to
comparable acreage.  Since both commercial and private applicators are
applying the same products, training should be similar.  Ability to read
and understand label in English should be required. (Ag custom
applicator)	Do not see any additional burden, as requirements already
exist in state (Structural pest control)

B	Commercial Categories	Supports sub categories (Farm)

Supports categories except 1080 & M-44, as these do not pose human risk
(Farm)

WA does not have aerial applicator category and they should add it.
There should also be reciprocity between states (Aerial)

Already have similar state requirements, supports national
standardization (Farm)

Do not require states to adopt categories if they have no use(AFBF)

Applicators in new categories should be tested (Aerial)

	B	Commercial applicator competency /Exam Administration	Support
proposal for improved exams, and in English.  Supports testing as way to
facilitate movement of applicators between states (Landscape
maintenance)

Need provisions for continued review of tests (Structural pest control)

More difficult tests lead to more cost for grower and state, States
should retain flexibility for exam type(AFBF)	No cost for exam in IL and
tests are closed book and proctored (Aerial)

B	Commercial applicator competency /Recertification Req’s	Already have
3 yr. interval in effect (Landscape maintenance)

  Requirements for recertification should be tailored to categories
(Wood treatment)

	B	Private applicator competency /Exam requirements (if state chooses)
Tests should have open and closed book parts (Farm)	In MN, 3 hours to
travel and take test (Farm)

B	Application of RUP’s under the supervision of a certified applicator
/General 	All aerial applicators are certified, so no under-the
supervision applicators (Aerial)

In Iowa, commercial applicators do not have employees under the
supervision (Ag custom applicator)

	B	Application of RUP’s under the supervision of a certified
applicator /Training content	Supports training requirement, if certified
applicator can do training (Farm).	Off- farm trainers would add
unnecessary expense (Farm).	Certified applicator should determine if
individual is competent.  Would rather just have individual certified
(Farm).

	B	Application of RUP’s under the supervision of a certified
applicator /Label with applicator	Should not have to carry labels, too
many labels (Landscape maintenance)

Label should not have to be carried by applicator, but available at the
site (Farm)

C

Application of RUP’s under the supervision of a certified applicator
/Training Records

C	Recertification

Page   PAGE  1  of   NUMPAGES  11

Summary of SER comments

October 16, 2008


[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67047-67049]
[FR Doc No: 2022-24212]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2671]

Drug Supply Chain Security Act Implementation and Readiness
Efforts for 2023; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual public meeting entitled ``Drug Supply
Chain Security Act Implementation and Readiness Efforts for 2023'' to
allow supply chain stakeholders an opportunity to share their
perspectives. The topics to be discussed are stakeholder experiences
with implementation and overall readiness regarding implementation of
enhanced drug distribution security requirements that will go into
effect on November 27, 2023, standards for the interoperable data
exchange of product tracing information, requests for product tracing
information or verification from FDA for the purpose of investigating
suspect or illegitimate products or for recalls, steps taken to build
capacity for package-level tracing, pharmaceutical distribution supply
chain best practices, and, in general, the impact that the Drug Supply
Chain Security Act (DSCSA) requirements would have on public health,
including patient safety and access to prescription drugs, and on

stakeholders, in terms of costs, benefits, and regulatory burden.

DATES: The public meeting will be held on December 7 and 8, 2022, from
10 a.m. to 3 p.m. eastern time and will take place virtually. Either
electronic or written comments on this public meeting must be submitted
by February 6, 2023. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public meeting will be held virtually and hosted by FDA.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. eastern
time at the end of February 6, 2023. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.

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-2022-N-2671 for ``Drug Supply Chain Security Act Implementation and
Readiness Efforts for 2023; Public Meeting; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kristle Green, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave. Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (title II, Pub. L. 113-54) was
signed into law. The DSCSA outlines critical steps to achieve
electronic, interoperable tracing at the package level by 2023 to
identify and trace certain prescription drugs as they are distributed
within the United States. DSCSA requirements enhance FDA's ability to
protect U.S. consumers from exposure to drugs that may be counterfeit,
diverted, stolen, intentionally adulterated, or otherwise harmful by
improving the detection and removal of potentially dangerous drugs from
the drug supply chain.
    Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360eee-1(g)(1)) imposed requirements for enhanced drug
distribution security that go into effect on November 27, 2023. Section
582(i) of the FD&C Act directs FDA to hold public meetings to enhance
the safety and security of the pharmaceutical distribution supply chain
and provide opportunities for comment from members of the
pharmaceutical distribution supply chain and other interested
stakeholders. Since enactment of the law, FDA has held multiple public
meetings that address specific topics as they relate to implementation
of DSCSA requirements. As the capabilities of the pharmaceutical
distribution supply chain have progressed and matured, this public
meeting will be used to gather stakeholder perspectives on DSCSA
implementation.

II. Topics for Discussion at the Public Meeting

     Stakeholder experiences with implementation and overall
readiness regarding implementation of enhanced drug distribution
security requirements that will go into effect on November 27, 2023.
     DSCSA standards for the interoperable data exchange of
product tracing information for enhanced product tracing and
verification.
     FDA requests to trading partners for product tracing
information, verification for the purpose of investigations of suspect
or illegitimate products, or recalls to support enhanced drug

distribution requirements under section 582(g) of the FD&C Act.
     Steps taken by the pharmaceutical distribution supply
chain to build capacity for package-level tracing, including the
ability of the healthcare system to maintain patient access to
medicines, scalability of DSCSA requirements, and best practices.
     Technical capabilities and legal authorities, if any,
needed to establish interoperable, electronic product tracing at the
package level.
     General impact that the DSCSA requirements would have on
public health, including patient safety and access to prescription
drugs, and on stakeholders, in terms of costs, benefits, and regulatory
burden.
    If other topics are identified as appropriate, FDA will post these
on the designated public meeting web page prior to the meeting.

III. Participating in the Public Meeting

    Registration: This will be a virtual public meeting and there are
no fees for this meeting. FDA may limit registration once the meeting
capacity is reached. Individuals who wish to attend the general session
of the public meeting must register by December 2, 2022, and provide
the following information on the public meeting registration page: Your
name, organization name, stakeholder type, email address, and telephone
number to FDA at https://dscsapublicmeeting2022.eventbrite.com. Meeting
information for virtual participation will be emailed by December 5,
2022, to those that registered.
    If you need special accommodations due to a disability, please
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) no later
than 7 days before the public meeting.
    Breakout Sessions: Any person interested in participating in small
group discussions must register by November 28, 2022, following the
instructions above, and indicate your request for breakout session
participation. There will be no same-day registration for breakout
sessions. FDA will organize breakout sessions based on registration and
interest to help ensure varied stakeholder representation, including
across the pharmaceutical distribution supply chain. FDA may limit the
number of participants from each organization if interest exceeds
breakout session capacity.
    Request for Oral Presentations: Any person interested in presenting
during the public meeting must register by November 28, 2022, following
the instructions above, and indicate your request to present. There
will be no same-day registration for oral presentations. FDA will do
its best to accommodate requests for oral presentations. Individuals
and organizations with common interests are encouraged to consolidate
or coordinate their presentations and can submit a single request to
present. Time allotted for each presentation will depend on the number
of requests received and may be limited.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Other Issues for Consideration: FDA will provide a recording of the
public meeting and materials from the meeting at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022 after the public meeting.

    Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24212 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64375-64377]
[FR Doc No: 2019-25208]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87547; File No. SR-CboeBZX-2019-095]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the Definition of the Final Last Sale Eligible Trade

November 15, 2019.
    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 November 12, 2019, Cboe BZX Exchange, Inc. (``BZX'' or ``Exchange'')
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 the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (``BZX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend the definition of the Final Last Sale
Eligible Trade (``FLSET'') such that odd lot trades executed on BZX
would not be eligible to establish the FLSET for a security. The text
of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of 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
    The purpose of the proposed rule change is to amend the definition
of the Final Last Sale Eligible Trade (``FLSET'') such that odd lot
trades executed on BZX would not be eligible to establish the FLSET for
a security. The FLSET is used by the Exchange for a number of important
purposes related to auctions in BZX-listed securities. For example, the
FLSET sets the Halt Auction Reference Price for Halt Auctions following
Non-LULD Regulatory Halts,\3\ and, in some cases, becomes the BZX
Official Closing Price for a security where there is no Closing
Auction, or where there is a Closing Auction but only an odd lot
quantity is executed.\4\ Today, pursuant to BZX Rule 11.23(a)(9), the
last trade occurring during Regular Trading Hours on the Exchange sets
the FLSET if the trade was executed within the last one second prior to
either the Closing Auction or, for Halt Auctions, trading in the
security being halted. The last trade executed on BZX during Regular
Trading Hours could be for a round lot or odd lot quantity. The
Exchange believes, however, that it is undesirable for an odd lot
execution that may be for an economically insignificant notional value
to set the FLSET. The Exchange therefore proposes to amend BZX Rule
11.23(a)(9) such that the FLSET would be set by the last round lot
trade occurring during Regular Trading Hours on the Exchange if the
trade was executed within the last one second prior to either the
Closing Auction or, for Halt Auctions, trading in the security being
halted.
---------------------------------------------------------------------------

    \3\ See BZX Rule 11.23(d)(2)(C)(i)(B).
    \4\ See BZX Rule 11.23(c)(2)(B), (B)(ii)(a). For BZX-listed
corporate securities, the FLSET would be the BZX Official Closing
price if there is no Closing Auction. If there is no round lot
Closing Auction in a BZX-listed ETP, the FLSET would be the BZX
Official Closing Price if a trade that would qualify as the FLSET
occurred within the last five minutes before the end of Regular
Trading Hours, or if there is no such qualifying trade but a time-
weighted average price of the NBBO midpoint cannot be determined
pursuant to BZX Rule 11.23(c)(2)(B)(ii)(b).
---------------------------------------------------------------------------

    In addition, BZX Rule 11.23(a)(9) further provides that where the
trade was not executed within the last one second, the last trade
reported to the consolidated tape received by BZX Exchange during
Regular Trading Hours and, where applicable, prior to trading in the
security being halted will be used. The Exchange proposes two changes
to this language. First, the Exchange proposes to replace language that
references ``BZX Exchange'' with simply ``the Exchange'' consistent
with the defined term codified in BZX Rule 1.5(k) and used throughout
the rulebook. Second, the Exchange proposes to amend the rule such that
the last round lot trade reported to the consolidated tape received by
the Exchange during Regular Trading Hours and, where applicable, prior
to trading in the security being halted will be used. Although the
Exchange has generally interpreted this requirement to convey that the
last round lot trade reported to the consolidated tape, i.e.,
consolidated last sale eligible trade, would set the FLSET, it is
currently possible for an odd lot trade that was executed in the
Exchange's Opening Auction to set the FLSET in limited circumstances
where the opening print was the last reported trade. Thus, adding this
language to the rule would both increase clarity now that odd lot
trades are reported to the consolidated tape,\5\ and ensure that odd
lot Opening Auctions would no longer be used to set the FLSET. Further,
the proposed change would assist in conforming the descriptions in the
rule given the changes previously discussed to the FLSET definition to
explicitly reference round lot trades in the first part of the rule. As
is the case today, if there is no qualifying trade for the current day,
the BZX Official Closing Price from the previous trading day would
continue to be used.
---------------------------------------------------------------------------

    \5\ Historically, odd lot trades were not reported to the
consolidated tape. In 2013, the CTA and UTP Plans were amended such
that odd lot trades would be reported but would continue to be
ineligible to set the consolidated last sale. See Securities
Exchange Act Release Nos. 70794 (October 31, 2013), 78 FR 66789
(November 6, 2013) (SR-CTA-2013-05), 70793 (October 31, 2013), 78 FR
66788 (November 6, 2013) (S7-24-89).

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

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\6\ in general, and Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, to promote just and equitable principles of
trade, and, in general, to protect investors and the public interest
and not to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The FLSET is the last sale formulation designed for use in BZX
auctions pursuant to BZX Rule 11.23, and is used for a number of
purposes including to set various reference prices, and in some cases
to set the BZX Official Closing Price in the absence of a Closing
Auction where sufficient size is executed to set the closing price.
Given the importance of the FLSET to the Exchange's auction processes,
the Exchange believes that it is consistent with the public interest
and the protection of investors to eliminate odd lot executions from
the FLSET determination. Today, as discussed in the purpose section of
this proposed rule change, only round lot executions from other
exchanges are eligible to establish the FLSET used by BZX but an odd
lot trade on BZX would nevertheless be FLSET eligible if executed in
the last one second, or in limited circumstances where an odd lot
Opening Auction sets the last reported trade. Further, this may be true
whether or not there is a round lot execution on the Exchange or
another exchange that would otherwise have set the FLSET, and that
would have been for a more economically significant notional value. The
consolidated last sale price disseminated pursuant to the CTA and UTP
Plans similarly disregard odd lot executions in an effort to ensure
that such last sale prices remain economically significant, even though
the CTA and UTP Plans otherwise provide transparency into odd lot
executions. The Exchange believes that it is similarly appropriate to
limit the Exchange's last sale calculation, i.e., the FLSET, to round
lot executions to ensure that this value represents an economically
significant last sale price to be utilized for the Exchange's auction
processes. With this change, the Exchange's FLSET calculation will also
be more aligned with other equities exchanges, such as NYSE Arca, Inc.
(``Arca'') that also disregard odd lot executions in similar
situations. \8\ Arca's auction processes are not identical to those of
the Exchange--e.g., Arca uses a weighting of the consolidated last sale
eligible trade and the time weighted average price of the NBBO midpoint
to set the official closing price in certain circumstances.\9\
Nevertheless, Arca similarly excludes odd lot executions from its last
sale formulation where relevant to its auction process. The Exchange
believes that a similar restriction would be appropriate for its FLSET
formulation, notwithstanding any differences in the auction processes
employed by each exchange.
---------------------------------------------------------------------------

    \8\ For example, the last consolidated round lot price is
ordinarily used to set the reference price for trading halt auctions
on Arca. See Arca Rule 7.35-E(a)(8)(A). Similarly, the consolidated
last sale eligible trade, which as previously explained must be for
a round lot, may be used in determining the official closing price
on Arca. See Arca Rule 1.1(ll)(1).
    \9\ See Arca Rule 1.1(ll)(1).
---------------------------------------------------------------------------

    The Exchange also notes that clarifying change to replace the term
``BZX Exchange'' with ``the Exchange'' as defined pursuant to the
Exchange's rules is non-substantive and is being made to enhance the
readability of the Exchange's rules. The Exchange therefore believes
that this change is consistent with the protection of investors and the
public interest.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
designed to ensure that the FLSET continues to be a meaningful value to
be used for auctions in BZX-listed securities. The Exchange believes
the proposed changes would improve the experience of members and
investors trading on the Exchange without imposing any significant
burden on competition. In today's highly competitive market, the
Exchange must continually refine its offerings to ensure the best
trading experience for members and investors. Rather than burden
competition, the Exchange believes that the proposed rule change is
evidence of robust competition between equities markets that benefits
the industry.

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

    No comments were solicited or received on the proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative for 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay so that
the proposed rule change may become operative immediately. In its
request, the Exchange states that it currently uses a combination of
both round lot and odd lot trades in calculating the FLSET while other
exchanges disregard odd lot executions in similar situations, and
expresses its belief that it is desirable to limit the FLSET to round
lot executions as it would help to ensure that the FLSET represents an
economically significant last sale price to be utilized for its auction
processes. The Exchange states that waiver of the operative delay would
allow it to promptly amend its rules to ensure that only round lot
trades are eligible to set the FLSET, to the benefit of members and
investors, and is therefore consistent with the protection of investors
and the public interest. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the

public interest, and therefore hereby waives the 30-day operative delay
and designates the proposal operative upon filing.\16\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of 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 change 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-CboeBZX-2019-095 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 No. SR-CboeBZX-2019-095. 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 No. SR-CboeBZX-2019-095, and should be submitted
on or before December 12, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12), (59).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-25208 Filed 11-20-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 23, 2009 (Volume 74, Number 224)]
[Notices]
[Page 61162-61163]
[DOCID:fr23no09-73]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2009-0846]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Number: 1625-0100

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
request for comments announces that the U.S. Coast Guard is forwarding
an Information Collection Request (ICR), abstracted below, to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB) requesting an extension of its approval for
the following collection of information: 1625-0100, Advance Notice of
Vessel Arrival. Our ICR describes the information we seek to collect
from the public. Review and comments by OIRA ensure we only impose
paperwork burdens commensurate with our performance of duties.

DATES: Please submit comments on or before December 23, 2009.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2009-0846] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) or to OIRA. To avoid
duplication, please submit your comments by only one of the following
means:
    (1) Electronic submission. (a) To Coast Guard docket at http://
www.regulation.gov. (b) To OIRA by e-mail via: oira_
<EMAIL_ADDRESS>    (2) Mail or Hand delivery. (a) DMF (M-30), DOT, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590-0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. The telephone number is 202-
366-9329. (b) To OIRA, 725 17th Street, NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax. (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http: //www.regulations.gov.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), ATTN Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd St., SW., Stop 7101, Washington, DC 20593-7101.

FOR FURTHER INFORMATION: Contact Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER>

or fax<PHONE_NUMBER>, for questions on these documents. Contact Ms.
Renee V. Wright, Program Manager, Docket Operations,<PHONE_NUMBER>, for
questions on the docket.

SUPPLEMENTARY INFORMATION:
    The Coast Guard invites comments on whether this ICR should be
granted based on it being necessary for the proper performance of
Departmental functions. In particular, the Coast Guard would appreciate
comments addressing: (1) The practical utility of the collections; (2)
the accuracy of the estimated burden of the collections; (3) ways to
enhance the quality, utility, and clarity of information subject to the
collections; and (4) ways to minimize the burden of collections on
respondents, including the use of automated collection techniques or
other forms of information technology.
    Comments to Coast Guard or OIRA must contain the OMB Control Number
of the ICR. They must also contain the docket number of this request,
[USCG 2009-0846]. For your comments to OIRA to be considered, it is
best if they are received on or before the December 23, 2009.
    Public participation and request for comments: We encourage you to
respond to this request by submitting comments and related materials.
We will post all comments received, without change, to http://
www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2009-0846], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit comments and material by electronic means, mail, fax, or
delivery to the DMF at the address under ADDRESSES; but please submit
them by only one means. If you submit them by mail or 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 them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. In response to your comments, we
may revise the ICR or decide not to seek an extension of approval for
this collection. The Coast Guard and OIRA will consider all comments
and material received during the comment period.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Click on the ``read comments'' box, which will then become
highlighted in blue. In the ``Keyword'' box insert ``USCG-2009-0846''
and click ``Search.'' Click the ``Open Docket Folder'' in the
``Actions'' column. You may also visit the DMF in room W12-140 on the
West Building Ground Floor, 1200 New Jersey Avenue, SE., Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in 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 the Privacy
Act statement regarding our public dockets in the January 17, 2008
issue of the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (74 FR 47949, September 18,
2009) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments.

Information Collection Request

    Title: Advance Notice of Vessel Arrival.
    OMB Control Number: 1625-0100.
    Type of Request: Revision of a currently approved collection.
    Respondents: Vessel owners and operators.
    Abstract: This information is required to control vessel traffic,
develop contingency plans and enforce regulations.
    Forms: None.
    Burden Estimate: The estimated burden remains 200,039 hours a year.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended.

    Dated: November 18, 2009.
M.B. Lytle,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. E9-28082 Filed 11-20-09; 8:45 am]

BILLING CODE 9110-04-P