[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Proposed Rules]
[Pages 72906-72908]
[FR Doc No: 2021-27797]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2021-0799; FRL-9246-01-R9]

Air Plan Approval; California; San Joaquin Valley Unified Air
Pollution Control District; Open Burning

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the San Joaquin Valley Unified Air Pollution
Control District (SJVUAPCD or the ``District'') portion of the
California State Implementation Plan (SIP). This revision concerns
emissions of oxides of nitrogen (NOX) and particulate matter
(PM) from agricultural open burning. We are proposing to approve
additional local restrictions on such burning under the Clean Air Act
(CAA or the Act). We are taking comments on this proposal and plan to
follow with a final action.

DATES: Comments must be received on or before January 24, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2021-0799 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Kevin Gong, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

I. The State's Submittal
    A. Background
    B. What did the State submit?
    C. Completeness Review of the 2021 Technical Submittal
    D. What is the purpose of the submitted SIP revision?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the SIP revision?
    B. Does the SIP revision meet the evaluation criteria?
    C. The EPA's Recommendations To Further Improve the Control
Measure
    D. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. Background

    Most open burning activities in the San Joaquin Valley Air Basin
(``San Joaquin Valley'') are regulated by District Rule 4103 ``Open
Burning'' (``Rule 4103'' or ``the Rule''), which was most recently
revised by the District on April 15, 2010. Rule 4103's provisions on
open burning of agricultural waste, which constitutes the bulk of
activity regulated under this local measure, are implemented as a part
of a broader state-wide strategy on agricultural open burning, codified
in California Health and Safety Code sections 41855.5 and 41855.6.
Under Rule 4103's provisions implementing those State law requirements,
the SJVUAPCD may grant a temporary postponement of the prohibition of
open burning for specific agricultural material categories, if the
following four criteria are all met: (1) The SJVUAPCD Governing Board
(``District Board'') determines that there is no economically feasible
alternative of eliminating the waste; (2) the District Board determines
that there is no long-term Federal or State funding commitment for the
continued operation of biomass combustion facilities in the San Joaquin
Valley or development of alternatives to burning; (3) the District
Board determines that the continued issuance of permits for that
specific category or crop will not cause, or substantially contribute
to, a violation of an applicable Federal ambient air quality standard;
and (4) the California Air Resources Board (CARB or the ``State
Board'') concurs with the District Board's determinations.\1\ The
District's staff reports and the associated District Board and CARB
resolutions approving the postponements must be submitted to the EPA as
SIP revisions.\2\
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    \1\ Rule 4103, section 5.5.2.
    \2\ Id. section 6.3.
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    The EPA approved Rule 4103 and an initial prohibition schedule
(``2010 Schedule'') (entitled ``Table 9-1, Final Staff Report and
Recommendations on Agricultural Burning'') into the SIP on January 4,
2012.\3\
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    \3\ 77 FR 214.
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B. What did the State submit?

    On November 29, 2021, CARB submitted a document entitled ``Proposed
District Rule 4103 (Open Burning) Technical Submittal for Receiving SIP
Credit for Reductions in Agricultural Burning,'' dated November 18,
2021 (the ``2021 Technical Submittal''), to the EPA for inclusion in
the California SIP.\4\ The 2021 Technical Submittal includes a document
called the ``Supplemental Report and Recommendations on Agricultural
Burning'' (``2021 Supplemental Report''). Table 2-1 of the 2021
Supplemental Report, ``Accelerated Reductions by Crop Category''
includes an updated schedule of prohibitions (``2021 Schedule''), which
is the focus of our rulemaking. Further discussion and explanation of
this material is detailed in section I.D of this proposed rule.
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    \4\ CARB had previously submitted a proposed version of this
document with a request for parallel processing pursuant to 40 CFR
part 51, appendix V, section 2.3.1. The only substantive revision in
the final document was the addition of a response to public comments
submitted during the public comment period and hearing.
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C. Completeness Review of the 2021 Technical Submittal

    Section 110(k)(1)(B) of the CAA requires the EPA to determine
whether a SIP submission is complete within 60 days of receipt. The
EPA's SIP completeness criteria are found in 40 CFR part 51, appendix
V. The EPA has reviewed the 2021 Technical Submittal and finds that it
fulfills the completeness criteria of appendix V.

D. What is the purpose of the submitted SIP revision?

    The open burning of various materials regulated under the
District's authority, including agricultural waste, generates emissions
of NOX and PM. Emissions of NOX contribute to the
production of ground-level ozone, smog, and PM, which harm human health
and the environment. Direct emissions of PM, including PM equal to or
less than 2.5 microns in diameter (PM2.5) and PM

equal to or less than 10 microns in diameter (PM10),
contribute to effects that are harmful to human health and the
environment, including premature mortality, aggravation of respiratory
and cardiovascular disease, decreased lung function, visibility
impairment, and damage to vegetation and ecosystems. Section 110(a) and
title I, part D of the CAA require states to submit regulations that
control NOX and PM emissions.
    Under the provisions of California Health and Safety Code sections
41855.5 and 41855.6 and SIP-approved District Rule 4103, the District
must review at least once every five years the feasibility for
prohibition from open burning the remaining categories of agricultural
waste that were previously found to be infeasible under the four
criteria described above in section I.A. That review results in a
``District Staff Report and Recommendations on Agricultural Burning,''
which must be approved by the District Board and receive concurrence
from the State Board in order to become effective. The District reports
have in the past contained a schedule for prohibiting additional
categories of agricultural waste from open burning, additional
limitations on open burning for that category, or a determination that
open burning should be allowed. This schedule implements sections 5.5.2
and 6.3 of the Rule and supports the enforceability of the control
requirements in Rule 4103. Therefore, it must be approved into the SIP
to ensure the integrity of the control strategy. As noted above, the
EPA approved the 2010 Schedule into the SIP in 2012.
    Pursuant to Rule 4103 section 5.5.2, the District adopted the 2021
Supplemental Report, including the 2021 Schedule, on June 17, 2021. The
CARB Executive Officer concurred on the 2021 Schedule in a letter dated
June 18, 2021, effective through December 31, 2024.\5\ The 2021
Schedule thus constitutes the enforceable measure needed to update the
SIP-approved open burning control measure.
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    \5\ The State Board had delegated the authority for this
concurrence on February 25, 2021.
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    The 2021 Schedule prohibits open burning for several previously
postponed categories of agricultural waste effective January 1, 2021,
and establishes a schedule for phase-out of open burning for other
categories including vineyard removals, orchard removals, and surface
harvested prunings by January 1, 2025. The EPA's technical support
document (TSD) has more information about the specific requirements in
the 2021 Schedule.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the SIP revision?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    The San Joaquin Valley is designated and classified as an Extreme
nonattainment area for the 1979 1-hour and 1997, 2008, and 2015 8-hour
ozone national ambient air quality standards (NAAQS).\6\ CAA section
172(c)(1) requires ozone nonattainment areas to implement all
reasonably available control measures (RACM), including such reductions
in emissions from existing sources in the area as may be obtained
through the adoption, at a minimum, of reasonably available control
technology (RACT), as expeditiously as practicable. While our
stringency discussion below focuses on PM emissions, we are not aware
of reasonably available control measures for ozone precursors that are
not also best available control measures for PM for this source
category.
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    \6\ 40 CFR 81.305.
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    San Joaquin Valley is designated and classified as a Serious
nonattainment area for the 1997, 2006, and 2012 PM2.5
NAAQS.\7\ CAA section 189(b)(1)(B) requires Serious PM2.5
nonattainment areas to implement best available control measures
(BACM), including best available control technology (BACT), within four
years after reclassification of the area to Serious. Therefore,
SJVUAPCD must implement BACM, including BACT, for PM2.5 and
PM2.5 precursors. Guidance and policy documents that we used
to evaluate enforceability, revision/relaxation and rule stringency
requirements for the applicable criteria pollutants include the
following:
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    \7\ Id. For the 2012 PM2.5 NAAQS, the EPA
reclassified the San Joaquin Valley as Serious nonattainment in a
final rule published November 26, 2021. 86 FR 67343. The effective
date of this reclassification is December 27, 2021.
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    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,'' 57
FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January 11,
1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. Preamble, Fine Particulate Matter National Ambient Air Quality
Standards: State Implementation Plan Requirements, 81 FR 58010 (August
24, 2016).

B. Does the SIP revision meet the evaluation criteria?

    The 2021 Schedule significantly enhances the overall stringency of
the District's open burning requirements by prohibiting open burning
for most remaining waste types by 2025. Furthermore, the District and
State have justified the remaining postponements on the basis of
technical and/or economic feasibility. Although the 2021 Schedule is
less stringent than the 2010 Schedule for the rice stubble category,
the potential emissions increase from this relaxation is more than
offset by the emissions reductions from additional prohibitions on
other categories of agricultural waste. Therefore, the EPA's initial
evaluation indicates that this SIP revision meets CAA requirements and
is consistent with relevant guidance regarding enforceability,
stringency, and SIP revisions. The EPA's TSD has more information on
our evaluation.

C. The EPA's Recommendations To Further Improve the Control Measure

    The EPA's TSD includes recommendations for the next time the
SJVUAPCD modifies the control measure.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted SIP revision because it fulfills all
relevant requirements. We will accept comments from the public on this
proposal until January 24, 2022. If we take final action to approve
Table 2-1 and the associated materials, our final action will
incorporate this revision into the federally enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the following materials: Table 2-1 ``Accelerated Reductions
by Crop Category'' of the ``Supplemental Report and Recommendations on
Agricultural

Burning'' and Resolution 21-06-12 that were adopted by the SJVUAPCD
Board on June 17, 2021; Resolution 21-4 ``San Joaquin Agricultural
Burning Assessment'' adopted by CARB on February 25, 2021; and the
letter dated June 18, 2021 from Richard W. Corey, Executive Officer,
CARB, to Samir Sheikh, Executive Director, SJVUAPCD, concurring on the
2021 Supplemental Report. The EPA has made, and will continue to make,
these materials available through https://www.regulations.gov and at
the EPA Region IX Office (please contact the person identified in the
FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the Act. Accordingly, this
proposed action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: December 16, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2021-27797 Filed 12-22-21; 8:45 am]
BILLING CODE 6560-50-P


 4/ 7/ 04 1 A Discussion with the FIFRA SAP Regarding the Terrestrial and Aquatic Level II Refined Risk Assessment Models ( Version 2.0)

March 30   April 2, 2004 Office of Pesticide Programs,

Environmental Fate and Effects Division 4/ 7/ 04 2 Introduction, Goals, and Objectives Ingrid M. Sunzenauer,

Office of Pesticide Programs,

Environmental Fate and Effects Division 4/ 7/ 04 3 Overview of Presentation ° Background on the Initiative to Revise the Ecological Assessment Process ° Conceptual Risk Assessment Process ° Level II Models, Version 1.0 ° Level II Models, Version 2.0 ° Steps to Finalize the Models ° Purpose of this Consultation 4/ 7/ 04 4 Background 1996 SAP Meeting ° Reaffirmed the value of the current assessment process as a deterministic screening method ° Provided comments for further improvement, including the recommendation for developing probabilistic tools and methods 4/ 7/ 04 5 Initiative to Revise the Ecological Assessment Process Following the SAP recommendations and in response to risk management questions,

an initiative began in 1997 to develop ° A conceptual approach for refining the risk assessment process ° Probabilistic tools and methods under the FIFRA regulatory framework 4/ 7/ 04 6 Goals of Initiative Implement a refined assessment process that ° Addresses a broad spectrum of effects ° Reflects more realistic use scenarios and field conditions ° Incorporates probabilistic tools and methods ° Designed to rely on existing data requirements for registration at lower tiers ° Focuses additional data requirements in upper tiers for reducing uncertainty 4/ 7/ 04 7 Initiative: Phase I ° Formed stakeholder workgroup ( ECOFRAM) in 1997 ° Make recommendations regarding the development of probabilistic tools and methods ° Issued draft reports in May 1999 ° Peer reviewed in June 1999 4/ 7/ 04 8 Initiative: Phase II ° Formed Implementation Team ° Began with technical evaluation of ECOFRAM reports and peer review comments ° Proposed conceptual process ° Reviewed by the SAP in 2000 ° Developed Level II models ( Version 1.0)

° Reviewed by the SAP in 2001 ° Refined models ( Version 2.0) 4/ 7/ 04 9 Initiative: Phase II cont'd ° Participated in scientific exchange   National and international professional meetings   Briefings with other Divisions and other Offices ° Collaborating with EPA's Office of Research and Development and the Office of Economy and Environment 4/ 7/ 04 10 Initiative: Phase II cont'd ° Involved risk managers through workshops and briefings ° Maintained web site ° Participated in meetings with stakeholders and the States 4/ 7/ 04 11 Conceptual Process Level I ° Current screening level Level II ° Initial estimate of probability and magnitude of effects ° Designed to rely on existing data sets ° Plan to include simplistic estimates of population impacts in the future 4/ 7/ 04 12 Conceptual Process cont'd Levels III and IV ° More refined predictions of probability and magnitude of impacts ° More refined use scenarios ° Will address population impacts ° May potentially require new information or data, especially at Level IV 4/ 7/ 04 13 Level II Models, Version 1.0 ° Developed Version 1.0 of the models ° Used to conduct a probabilistic risk assessment for a specific pesticide ° Reviewed by the SAP using a generic chemical, ChemX ° Aquatic risk assessment Level II ° Terrestrial risk assessment Level II+ 4/ 7/ 04 14 Terrestrial Level II Model,

Version 2.0 ° Evaluates avian acute mortality levels from oral,

dermal, and inhalation exposure ° Uses generic species from feeding and nesting guilds or specific species ° Includes a new model for estimating residues in puddles ° Spatial scale   pesticide treated field and surrounding area ° Temporal scale   exposure at and following a single application 4/ 7/ 04 15 Aquatic Level II Model,

Version 2.0 ° Evaluates impacts to freshwater and saltwater fish and aquatic invertebrates   Acute mortality   Chronic survival, growth and/ or reproduction ° Spatial scale is a   Single treated field   Scenario specific water body 4/ 7/ 04 16 Aquatic Level II Model,

Version 2.0 ° Temporal scale is multiple applications over multiple years ° Incorporates new surface water fate model   Allows volume to vary according to weather conditions   Provides daily variations in parameter values,

such as wind speed, temperature, flows, etc. 4/ 7/ 04 17 Finalizing the Level II Models,

Version 2.0 ° Conduct sensitivity analyses ° Complete documentation of models according to QA/ QC procedures ° Complete alpha testing of the model ° Develop user manual ° Conduct beta testing, focusing on rigorous case studies which will test model features and components ° Develop procedures and mechanisms for model maintenance 4/ 7/ 04 18 Moving Toward Implementation:

Training ° Risk assessors   Technical training: Use of the models and the development of a robust risk characterization ° Risk managers   Briefings: Provide model overview and sample case studies 4/ 7/ 04 19 Moving Toward Implementation:

Outreach ° Updating web site ° Participating in meetings with stakeholders ° Conducting briefings for other Federal agencies ° Participating in EPA Probabilistic Risk Assessment Colloquium and national and international professional meetings 4/ 7/ 04 20 Why Are We Here?

Purpose of Consultation Focusing on model modifications from Version 1.0 ° Seek general comments and recommendations on these modifications ° Maintain an open and transparent process to keep the public informed ° Provide an opportunity for public comment 4/ 7/ 04 21 Agenda Day 1:

° Introduction ° Overview of Terrestrial Level II Model ( Version 2.0)

° Public Comment ° Panel Discussion Day 2:

° Panel Discussion cont'd ° Adjournment 4/ 7/ 04 22 Agenda cont'd Day 3:

° Introduction ° Overview of Aquatic Level II Model ( Version 2.0)

° Public Comment ° Panel Discussion Day 4:

° Panel Discussion cont'd ° Adjournment 4/ 7/ 04 23 Implementation Team Chair: Ingrid Sunzenauer Terrestrial Team ° Edward Fite, Chair ° Tim Barry, OEE ° Edward Odenkirchen ° Dirk Young Aquatic Team ° Donna Randall, Chair ° Tim Barry, OEE ° Marietta Echeverria ° Dirk Young Supporting Members ° Stephanie Irene ° Doug Urban ( Deceased)

Additional Contributors ° James Carleton ° Christine Hartless ° Henry Nelson 4/ 7/ 04 24 For More Information http:// www. epa. gov/ oppefed1/ ecorisk/ index.

htm


[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4923-4926]
[FR Doc No: 2016-01685]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0297]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs
During Production; Recordkeeping and Registration Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's recordkeeping and registration requirements for
shell egg producers.

DATES: Submit either electronic or written comments on the collection
of information by March 28, 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-2013-N-0297 for Agency Information Collection Activities; Proposed
Collection; Comment Request; Prevention of Salmonella Enteritidis in
Shell Eggs During Production--Recordkeeping and Registration
Provisions. 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined

in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests
or requirements that members of the public submit reports, keep
records, or provide information to a third party. Section 3506(c)(2)(A)
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to
provide a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, before submitting the
collection to OMB for approval. To comply with this requirement, we are
publishing notice of the proposed collection of information set forth
in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Prevention of Salmonella Enteritidis in Shell Eggs During Production--
Recordkeeping and Registration Provisions--21 CFR 118.10 and 118.11
(OMB Control Number 0910-0660)--Extension

    Shell eggs contaminated with Salmonella Enteritidis (SE) are
responsible for more than 140,000 illnesses per year. The Public Health
Service Act (PHS Act) authorizes the Secretary to make and enforce such
regulations as ``are necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the States * * * or from one State * * * into any other State''
(section 361(a) of the PHS Act). This authority has been delegated to
the Commissioner of Food and Drugs. Under section 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(4)), a food is adulterated if it is prepared, packed, or held
under insanitary conditions whereby it may have been contaminated with
filth or rendered injurious to health. Under section 701(a) of the FD&C
Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the
efficient enforcement of the FD&C Act.
    Under part 118 (21 CFR part 118), shell egg producers are required
to implement measures to prevent SE from contaminating eggs on the farm
and from further growth during storage and transportation. Shell egg
producers also are required to maintain records concerning their
compliance with part 118 and to register with FDA. As described in more
detail with regard to each information collection provision of part
118, each farm site with 3,000 or more egg laying hens that sells raw
shell eggs to the table egg market, other than directly to the
consumer, must refrigerate, register, and keep certain records. Farms
that do not send all of their eggs to treatment are also required to
have an SE prevention plan and to test for SE.
    Section 118.10 of FDA's regulations requires recordkeeping for all
measures the farm takes to prevent SE in its flocks. Since many
existing farms participate in voluntary egg quality assurance programs,
those respondents may not have to collect any additional information.
Records are maintained on file at each farm site and examined there
periodically by FDA inspectors.
    Section 118.10 also requires each farm site with 3,000 or more egg
laying hens that sells raw shell eggs to the table egg market, other
than directly to the consumer, and does not have all of the shell eggs
treated, to design and implement an SE prevention plan. Section 118.10
requires recordkeeping for each of the provisions included in the plan
and for plan review and modifications if corrective actions are taken.
    Finally, Sec.  118.11 of FDA's regulations requires that each farm
covered by Sec.  118.1(a) register with FDA using Form FDA 3733. The
term ``Form FDA 3733'' refers to both the paper version of the form and
the electronic system known as the Shell Egg Producer Registration
Module, which is available at http://www.access.fda.gov. We strongly
encourage electronic registration because it is faster and more
convenient. The system can accept electronic registrations 24 hours a
day, 7 days a week. A registering shell egg producer receives
confirmation of electronic registration instantaneously once all the
required fields on the registration screen are completed. However,
paper registrations will also be accepted. Form FDA 3733 is available
for download for registration by mail or CD-ROM.
    Recordkeeping and registration are necessary for the success of the
SE prevention measures. Written SE prevention plans and records of
actions taken due to each provision are essential for farms to
implement SE prevention plans effectively. Further, they are essential
for us to be able to determine compliance. Information provided under
these regulations helps us to notify quickly the facilities that might
be affected by a deliberate or accidental contamination of the food
supply. In addition, data collected through registration is used to
support our enforcement activities.
    Description of Respondents: Respondents to this information
collection include farm sites with 3,000 or more egg laying hens that
sell raw eggs to the table egg market, other than directly to the
consumer.
    We estimate the burden of this collection of information as
follows:

Recordkeeping Burden

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                        Number of        Number of                    Average  burden
  Description and 21 CFR section      recordkeepers     records per    Total annual         per          Total
                                           \2\         recordkeeper       records      recordkeeping     hours
----------------------------------------------------------------------------------------------------------------
Refrigeration Records, Sec.                    2,600              52         135,200              0.5     67,600
 118.10(a)(3)(iv).................
Testing, Diversion, and Treatment                343              52          17,836              0.5      8,918
 Records, Sec.   118.10(a)(3)(v)
 through (viii) (positive) \3\....
Egg Testing, Sec.                                331               7           2,317              8.3     19,231
 118.10(a)(3)(vii)................
Environmental Testing, Sec.                    6,308              23         145,084             0.25     36,271
 118.10(a)(3)(v) \3\..............
Testing, Diversion, and Treatment              5,965               1           5,965              0.5      2,983
 Records, Sec.   118.10(a)(3)(v)
 through (viii) (negative) \3\....
Prevention Plan Review and                       331               1             331               10      3,310
 Modifications, Sec.
 118.10(a)(4).....................
Chick and Pullet Procurement                   4,731               1           4,731              0.5      2,366
 Records, Sec.   118.10(a)(2).....

Rodent and Other Pest Control,                 9,462              52         492,024              0.5    246,012
 Sec.   118.10(a)(3)(ii), and
 Biosecurity Records, Sec.
 118.10(a)(3)(i)..................
Prevention Plan Design, Sec.                     300               1             300               20      6,000
 118.10(a)(1).....................
Cleaning and Disinfection Records,               331               1             331              0.5        166
 Sec.   118.10(a)(3)(iii).........
                                   -----------------------------------------------------------------------------
    Total hours...................  ................  ..............  ..............  ...............    392,857
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Some records are kept on a by-farm basis and others are kept on a by-house basis.
\3\ Calculations include requirements for pullet and layer houses.

    We are basing our estimates for the recordkeeping burden and the
reporting burden on our experience with similar recordkeeping
activities and the number of registrations and cancellations received
in the past 3 years.
    The number of recordkeepers estimated in column 2 of table 1 is
drawn from estimates of the total number of layer and pullet houses
affected by part 118. We assume that those farms that are operating
according to recognized industry or State quality assurance plans are
already largely in compliance with the plan design and recordkeeping
provisions discussed in this section, and therefore are not
experiencing additional costs to comply with recordkeeping provisions.
We found that 59 percent of farms with more than 50,000 layers are
members of State or industry quality assurance plans. Fewer than 8
percent of farms with fewer than 50,000 layers are members of quality
assurance plans. Thus, we estimate the number of layer farms incurring
a new recordkeeping burden because of part 118 to be 2,600, and the
number of houses affected to be 4,731.
    Prevention plan design (Sec.  118.10(a)(1)) records are kept on a
per farm basis, so we assume that new prevention plan design is only
undertaken by new entrants to the industry. Refrigeration records
(Sec.  118.10(a)(3)(iv)) are also kept on a per farm basis so the
estimated number of recordkeepers for this provision is 2,600.
    Records of chick and pullet procurement (Sec.  118.10(a)(2)),
rodent and other pest control (Sec.  118.10(a)(3)(ii)), and biosecurity
(Sec.  118.10(a)(3)(i)) are kept on a per house basis, so the estimated
number of recordkeepers for these provisions is 4,731.
    Records of cleaning and disinfection (Sec.  118.10(a)(3)(iii)) are
also kept on a per house basis, but only need to be kept in the event
that a layer house tests environmentally positive for SE. Prevention
plan review and modifications (Sec.  118.10(a)(4)) also need to be
performed every time a house tests positive, which we estimate that 7.0
percent tests positive. Therefore, the number of recordkeepers for
these provisions is calculated to be 331 (4,731 houses x 0.070)
annually.
    Records of testing, diversion, and treatment (Sec.  118.10(a)(3)(v)
through (viii)) are kept on a per house basis and include records on
flocks from pullet houses. We estimate that there are one-third as many
pullet houses as there are layer houses. Therefore the total number of
recordkeepers for these provisions is 6,308 (4,731 + (4,731/3)). The
number of annual records kept depends on whether or not houses test
positive for SE. Annually, 343 layer and pullet houses ((4,731 layer
houses x 0.070) + (4731/3 pullet houses) x 0.0075)) are expected to
test positive and 5,965 are expected to test negative ((4,731 layer
houses x 0.930) + (4731/3 pullet houses) x 0.9925)).
    We assume that refrigeration records are kept on a weekly basis on
a per farm basis under Sec.  118.10(a)(3)(iv)). We estimate that 2,600
recordkeepers maintain 52 records each for a total of 135,200 records
and that it takes approximately 0.5 hour per recordkeeping. Thus, the
total annual burden for refrigeration records is calculated to be
67,600 hours (135,200 x 0.5 hour).
    We assume that records of testing, diversion, and treatment under
Sec.  118.10(a)(3)(v) through (viii) are kept weekly in the event a
layer house tests environmentally positive for SE. We estimate that 343
layer and pullet houses test positive and thus 343 recordkeepers
maintain 52 records each for a total of 17,836 records and that it
takes approximately 0.5 hour per recordkeeping. Thus, the total annual
burden for testing, diversion, and treatment records in the event of a
positive test result is calculated to be 8,918 hours (17,836 x 0.5
hour).
    Given a positive environmental test for SE, we estimate the
weighted average number of egg tests per house under Sec.
118.10(a)(3)(vii)) to be 7. We estimate that 331 recordkeepers maintain
7 records each for a total of 2,317 records and that it takes
approximately 8.3 hours per recordkeeping. Thus, the total annual
burden for egg testing is calculated to be 19,231 hours (2,317 x 8.3
hours).
    We estimate that all 1,577 pullet and 4,731 layer houses not
currently testing (6,308 recordkeepers) incur the burden of a single
environmental test annually under Sec.  118.10(a)(3)(v)). The number of
samples taken during the test depends on whether a farm employs the row
based method (an average of 12 samples per house) or the random
sampling method (32 samples per house). We estimate that roughly 50
percent of the houses affected employs a row based method and 50
percent employs a random sampling method, implying an average of 23
samples per house. Thus, we estimate that 6,308 recordkeepers take 23
samples each for a total of 145,084 samples. The time burden of
sampling is estimated on a per swab sample basis. We estimate that it
takes approximately 15 minutes to collect and pack each sample. Thus,
the total annual burden for environmental testing is calculated to be
36,271 hours (145,084 x 0.25 hour).
    We estimate that records of testing, diversion, and treatment under
Sec.  118.10(a)(3)(v) through (viii) are kept annually in the event a
layer house tests environmentally negative for SE. We estimate that
5,965 layer and pullet houses test negative and thus 5,965
recordkeepers maintain one record of that testing that takes
approximately 0.5 hour per record. Thus, the total annual burden for
testing, diversion, and treatment records in the event of a negative
test result is calculated to be 2,983 hours (5,965 x 0.5 hour).
    Prevention plan review and modifications under Sec.  118.10(a)(4))
need to be performed every time a house tests positive. We estimate
that 331 layer houses test positive requiring plan

review and modifications and that it takes 10 hours to complete this
work. Thus, the total annual burden for prevention plan review and
modifications in the event of a positive test result is calculated to
be 3,310 hours (331 x 10 hours).
    We estimate that chick and pullet procurement records under Sec.
118.10(a)(2) is kept roughly once annually per layer house basis. We
estimate that 4,731 layer houses maintain 1 record each and that it
takes approximately 0.5 hour per recordkeeping. Thus, the total annual
burden for chick and pullet procurement recordkeeping is calculated to
be 2,366 hours (4,731 x 0.5 hour).
    We estimate that rodent and other pest control records under Sec.
118.10(a)(3)(ii)) and biosecurity records under Sec.  118.10(a)(3)(i)
are kept weekly on a per layer house basis. We assume that 4,731 layer
houses maintain a weekly record under each provision. Thus, we estimate
9,462 recordkeepers maintain 52 records each for a total of 492,024
records. We estimate a recordkeeping burden of 0.5 hours per record for
a total of 246,012 burden hours (492,024 x 0.5 hour).
    New prevention plan design required by Sec.  118.10(a)(1) is only
undertaken by new farms and records are kept on a per farm basis. We
estimate that there are 300 new farm registrations annually and we
assume that this reflects 300 new farms requiring prevention plan
design. This is an increase from our previous estimate based on new
registrations received. We estimate that it takes 20 hours to complete
this work. Thus, the total annual burden for prevention plan design is
calculated to be 6,000 hours (300 x 20 hours).
    Cleaning and disinfection recordkeeping under Sec.
118.10(a)(3)(iii) needs to be performed every time a house tests
positive. We estimate that 331 layer houses test positive requiring 1
record each and that it takes approximately 0.5 hour per recordkeeping.
Thus, the total annual burden for cleaning and disinfection
recordkeeping in the event of a positive test result is calculated to
be 166 hours (331 x 0.5 hour).

Reporting Burden

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
      Description and 21 CFR section               FDA Form number           Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates, Sec.   118.11...  Form FDA 3733 \2\...........             300               1             300             2.3             690
Cancellations, Sec.   118.11..............  Form FDA 3733...............              30               1              30               1              30
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............             720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration
  Module, which is available at http://www.access.fda.gov per Sec.   118.11(b)(1).

    This estimate is based on the average number of new shell egg
producer registrations and cancellations received in the past 3 years
under Sec.  118.11. We estimate that we will receive an average of 300
registrations or updates per year over the next 3 years. Based on the
number of cancellations previously received, we estimate that we will
receive approximately 30 cancellations per year over the next 3 years.
    We estimate that it takes the average farm 2.3 hours to register
taking into account that some respondents completing the registration
may not have readily available Internet access. Thus, the total annual
burden for new shell egg producer registrations or updates is
calculated to be 690 hours (300 x 2.3 hours).
    We estimate cancelling a registration, on average, requires a
burden of approximately 1 hour, taking into account that some
respondents may not have readily available Internet access. Thus, the
total annual burden for cancelling shell egg producer registrations is
calculated to be 30 hours (30 cancellations x 1 hour).

    Dated: January 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01685 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19059-19060]
[FR Doc No: 2017-08314]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1572]

Cybersecurity of Medical Devices: A Regulatory Science Gap
Analysis; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), in
association with National Science Foundation (NSF) and Department of
Homeland Security, Science and Technology (DHS S&T) is announcing the
following public workshop entitled ``Cybersecurity of Medical Devices:
A Regulatory Science Gap Analysis.'' The objective of the workshop is
to facilitate a discussion on the current state of regulatory science
in the field of cybersecurity of medical devices, with a focus on
patient safety. The purpose of this public workshop is to catalyze
collaboration among Health Care and Public Health (HPH) stakeholders to
identify regulatory science challenges, discuss innovative strategies
to address those challenges, and encourage proactive development of
analytical tools, processes, and best practices by the stakeholder
community to strengthen medical device cybersecurity.

DATES: The public workshop will be held on May 18 and 19, 2017, from 8
a.m. to 6 p.m. Submit either electronic or written comments on the
public workshop by June 23, 2017. Late untimely filed comments will not
be considered. Electronic comments must be submitted on or before June
23, 2017. The https://www.regulations.gov/ electronic filing system
will accept comments until midnight Eastern Time at the end of June 23,
2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date. See
the SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the public workshop participants (non-
FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov/.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov/
will be posted to the docket unchanged. Because your comments will be
made public, you are solely responsible for ensuring that your comments
do not include any confidential information that you or a third party
may not wish to be public, 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): 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-2017-N-1572 for ``Cybersecurity of Medical Devices: A Regulatory
Science Gap Analysis.'' Received comments, those filed in a timely
manner (see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the

electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Dinesh Patwardhan, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 64, Rm. 4076, Silver Spring, MD 20993, 301-796-
2622, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Regulatory Science is defined as the science of developing new
tools, standards, and approaches to assess the safety, efficacy,
quality, and performance of all FDA-regulated medical products. At the
Center for Devices and Radiological Health (CDRH), regulatory science
serves to accelerate improving the safety, effectiveness, performance,
and quality of medical devices and radiation-emitting products, and to
facilitate entry of innovative medical devices into the marketplace.
The Regulatory Science Subcommittee of the CDRH Center Science Council
assessed and prioritized the regulatory science gaps for medical
devices based on input from CDRH Offices (https://www.fda.gov/downloads/MedicalDevices/ScienceandResearch/UCM467552.pdf). These new
regulatory science scientific tools, technologies, and approaches form
the bridge to critical 21st century advances in public health.
Cybersecurity of medical devices was identified as one of the top 10
regulatory science gaps. FDA, NSF, and DHS S&T are therefore seeking
input to create a framework to address the cybersecurity regulatory
science gaps. The scope and nature of this cybersecurity regulatory
science research framework is designed to be broad to foster
collaboration across all interested stakeholders. The framework may
include collaborative research conducted between federal agencies such
as NSF, DHS S&T, academia, medical device industry, and third party
experts and other organizations with input from FDA. The collaborative
research may include one or more of the following settings:
    1. Intramural cybersecurity research conducted within FDA;
    2. Extramural cybersecurity research in collaboration with other
federal agencies (e.g. DHS S&T); and
    3. Collaborative long term cybersecurity research conducted among
federal agencies, NSF, academia, medical device industry, and third
party experts and organizations.
    This public workshop is not designed to discuss FDA policy
regarding cybersecurity of medical devices.

II. Topics for Discussion at the Public Workshop

    The public workshop sessions are planned to include a number of
short opening plenary talks, followed by multiple simultaneous working
sessions organized by broad themes. Attendees are encouraged to
participate in at least one working session of their choice providing
unique views, insights, and challenges.
    Following are a list of general topics that are planned to be
included for discussion during the public workshop.
     Relationship between medical device cybersecurity and
patient safety;
     Unique cybersecurity and regulatory challenges for medical
devices;
     Differences in cybersecurity between home care, large
health care providers, and acute care settings (e.g., ambulance,
emergency room);
     The roles and intersection of information technology
professionals and biomedical engineering staff;
     Potential metrics, evaluation tools to test and quantify
the cybersecurity of medical devices and systems;
     Automated and manual tools for communicating cybersecurity
information about medical device design and function;
     Best practices for cybersecurity of medical devices at
deployment and how to apply updates throughout the medical device
lifecycle;
     Human factor issues in cybersecurity of medical device
development, deployment, and use of devices; and
     Best practices in cybersecurity design, deployment, and
post-deployment activities and procedures.
    Additional suggested topics may be submitted at the time of
registration.
    Each break out session discussion may include following discussion
elements: (1) Immediate cybersecurity challenges and potential
solutions to facilitate entry of innovative medical devices into the
marketplace; (2) Cybersecurity regulatory science gaps to which
solutions can be developed through additional scientific research; and
(3) Long-term cybersecurity research challenges which may need
significant additional basic research.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by May 4, 2017, by 4 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted. If
time and space permit, onsite registration on the day of the public
meeting/public workshop will be provided beginning at 8 a.m. We will
let registrants know if registration closes before the day of the
public meeting/public workshop.
    If you need special accommodations due to a disability, please
contact Susan Monahan,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
no later than May 4, 2017.
    Transcripts: Please be advised that as soon as a transcript of the
plenary session portion of the public workshop is available, it will be
accessible at https://www.regulations.gov/. It may be viewed at the
Division of Dockets Management (see ADDRESSES). A link to the
transcript will also be available on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list).

    Dated: April 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-08314 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 82024-82026]
[FR Doc No: 2011-33445]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66031; File No. SR-NYSE-2011-62]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Supplementary Material .26 (Pegging for d-Quotes and e-Quotes)
to NYSE Rule 70

December 22, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on December 14, 2011, New York Stock Exchange LLC (the
``Exchange'' or ``NYSE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Exchange filed the proposal as a ``non-controversial'' proposed
rule change pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and
Rule 19b-4(f)(6) thereunder.\4\ The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).

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

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

    The Exchange proposes to amend Supplementary Material .26 (Pegging
for d-Quotes and e-Quotes) to NYSE Rule 70. The text of the proposed
rule change is available at the Exchange, at www.nyse.com, the
Commission's Public Reference Room, and at www.sec.gov.

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

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

1. Purpose
    The Exchange proposes to amend Supplementary Material .26 (Pegging
for d-Quotes and e-Quotes) to NYSE Rule 70.
    Paragraph (i) of Supplementary Material .26 states that an e-Quote
may be set to provide that it will be available for execution at the
national best bid (``NBB'') (for an e-Quote that represents a buy
order) or at the national best offer (``NBO'') (for an e-Quote that
represents a sell order) as the national best bid or offer (``NBBO'')
changes, so long as the NBBO is at or within the e-Quote's limit price.
Paragraph (x) of Supplementary Material .26 further provides that, as
long as the NBB or NBO is within the pegging price range selected by
the Floor broker, the pegging e-Quote or d-Quote will join the NBB or
NBO as it is autoquoted. As such, pegging interest may peg to a price
that may not be displayed at the Exchange. For example, if the NBB is
$10.05 and the Exchange best bid is $10.04, a pegging e-Quote to buy
will display at the Exchange at $10.05, thus creating a new Exchange
best bid.
    Because pegging interest automatically pegs to the NBBO, under
current rules and functionality, a pegging e-Quote could peg to an NBB
or NBO that is locking or crossing an existing Exchange best bid or
offer. For example, if the Exchange best bid is $10.04 and the NBO
locks it at $10.04, a pegging e-Quote to sell would peg to the $10.04
NBO price and then immediately execute against the Exchange's best bid
of $10.04. In such scenario, a pegging e-Quote, which is intended to be
reactive, becomes taker interest. Similarly, if automatic executions on
the buy (sell) side are suspended at the Exchange, for example, if a
liquidity replenishment point is reached pursuant to NYSE Rule 1000,
the NYSE would not be displaying a protected bid (offer) and therefore
other markets could display a protected offer (bid) that crosses the
Exchange best bid (offer). In such scenario, if the NBO moved to below
the Exchange best bid of $10.04, a pegging e-Quote to sell would peg to
that NBO, which would cross the Exchange best bid.
    The Exchange proposes to add new paragraph (x)(A) to Supplementary
Material .26 to provide that a pegging e-Quote or d-Quote to buy (sell)
would not peg to an NBB (NBO) that is locking or crossing the Exchange
best offer (bid), but would instead join the next available best-priced
non-pegging interest that does not lock or cross the Exchange best
offer (bid).\5\ Customers have requested this change because in the
infrequent circumstances when the NBBO is locking or crossing the
Exchange best bid or offer,\6\ customers do not want their pegging
interest, for which the ultimate goal is to be passive liquidity for
purposes of execution, to become taker interest. Because the next
available best-priced non-pegging interest may be on an away market,
the Exchange further proposes to amend paragraph (vii) to Supplementary
.26 to specify that the non-pegging interest against which pegging
interest pegs may either be available on the Exchange or may be a
protected bid or offer on an away market. The Exchange believes that
this is already implied in Supplementary .26, particularly because
pegging interest can peg to the NBB or NBO, which may or may not be a
displayed price at the Exchange,\7\ and is proposing this change only
to add greater specificity to Supplementary Material .26.
---------------------------------------------------------------------------

    \5\ When an exception to the prohibition against trade-throughs
is in effect, pursuant to Rule 611(b)(4) of Regulation NMS,
technically, there are no available protected bids or offers against
which an e-Quote or d-Quote can peg. In such situations, the pegging
interest would peg to the next available best-priced non-pegging
interest on the Exchange that is within the price range selected by
the Floor broker.
    \6\ The Exchange would re-price pegging interest only if the
NBBO is locking or crossing the Exchange best bid or offer and not
if the NBBO is ``locking'' or ``crossing'' undisplayed liquidity at
the Exchange. For example, where the Exchange best bid and offer is
$10.02 and $10.04 and there is ``dark'' reserve buy interest at
$10.03, if the NBO becomes $10.03, pegging sell interest will peg to
the $10.03 NBO and will execute against the Exchange ``dark''
reserve interest priced at $10.03.
    \7\ See Securities Exchange Act Release No. 61072 (November 30,
2009), 74 FR 64103 (December 7, 2009) (SR-NYSE-2009-106).
---------------------------------------------------------------------------

    The Exchange also proposes to add new paragraph (x)(B) to
Supplementary Material .26 to provide that the converse of paragraph
(x) is also true. Specifically, if the NBB (NBO) is not within the
pegging price range selected by the Floor broker, then a pegging e-
Quote or d-Quote to buy (sell) will join the next available best-priced
non-pegging interest that is within the price range selected by the
Floor broker.
    Finally, the Exchange proposes to amend paragraph (xiii) to
Supplementary Material .26 to delete the text that permits Floor
brokers to specify a maximum size validation for e-Quotes and d-Quotes.
Floor brokers have not availed themselves of this functionality and the
Exchange has therefore decided to eliminate it from Supplementary
Material .26. In addition, because pegging interest is considered when
assessing the minimum volume size of same-side interest against which
to peg, the Exchange proposes to delete the last sentence of paragraph
(xiii) to Supplementary Material .26.
    Because of the related technology changes that this proposed rule
change would require, the Exchange proposes to announce the initial
implementation date and related roll-out schedule, if applicable, via
Trader Update.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\8\ in general, and
furthers the objectives of Section 6(b)(5),\9\ in particular, because
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to, and perfect the
mechanism of, a free and open market and a national market system and,
in general, to protect investors and the public interest. Specifically,
the Exchange believes that the proposed changes to Supplementary
Material .26 to NYSE Rule 70 would promote just and equitable
principles of trade and remove impediments to, and perfect the

mechanism of, a free and open market because they would reduce the
potential for the Exchange best bid or offer to be locked or crossed.
The proposed changes would also promote transparency by adding greater
specificity with respect to the interest to which pegging e-Quotes and
d-Quotes may peg and would remove text corresponding to a functionality
that Floor brokers have not availed themselves of and therefore is no
longer necessary to promote just and equitable principles of trade.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not 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 \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 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.
---------------------------------------------------------------------------

    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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2011-62 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-NYSE-2011-62. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2011-62 and should be
submitted on or before January 19, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-33445 Filed 12-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19963-19965]
[FR Doc No: 2018-09662]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0077]
RIN 1625-AA00

Safety Zone; Ohio River, Metropolis, IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing an emergency temporary safety
zone for all navigable waters of the Ohio River extending from mile
marker (MM) 939.8 to MM 943.0 near Metropolis, IL. This emergency
safety zone is needed to protect life, vessels, and the marine
environment due to the sinking of one barge in the navigable channel of
the Ohio River near MM 940.8 and one barge near the left descending
bank at MM 942.5. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Sector Ohio Valley (COTP) or a designated representative.

DATES: This rule is effective without actual notice from 12:01 a.m.
until 11:59 p.m. on May 7, 2018. For the purposes of enforcement,
actual notice will be used from May 1, 2018 until May 7, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0077 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Joshua Herriott, Sector Ohio Valley, U.S.
Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because publishing an NPRM would be
impracticable and contrary to the public interest. On May 1, 2018, a
towing vessel struck the I-24 Bridge near mile marker (MM) 940.8,
causing 12 barges to break away. One barge sank near MM 940.8, and
another sank near MM 942.5 on the left-descending bank. This safety
zone must be established immediately to protect people and vessels
associated with and resulting from the hazard to navigation created by
the sunken barges and we lack sufficient time to provide a reasonable
comment period and then consider those comments before issuing this
rule. This safety zone includes closures and navigation restrictions
and requirements that are vital to maintaining safe navigation on the
Ohio River during the recovery of the sunken barges. Therefore,
delaying the effective date for this emergency safety zone to complete
the NPRM process would also be contrary to the public interest as it
would delay the safety measures vital to safe navigation.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is needed to protect personnel, vessels, and the marine environment
from potential hazards created by the sunken barges.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Sector Ohio Valley (COTP) has determined
that potential hazards associated with the sunken barges will be a
safety concern for anyone within MM 939.8 to MM 943.0 of the Ohio
River, starting on May 1, 2018, and continuing 24 hours daily through
11:59 p.m. on May 7, 2018. This rule is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
safety zone while the sunken barges are being recovered.

IV. Discussion of the Rule

    The Coast Guard is establishing a temporary emergency safety zone
for all navigable waters of the Ohio River from MM 939.8 and MM 943.0,
extending the entire width of the river. Entry is prohibited for all
traffic beginning on May 1, 2018 and will continue to be prohibited
through midnight on May 7, 2018 or until the hazard has been mitigated.
The COTP will terminate the enforcement of this safety zone before May
7, 2018, if the sunken barges have been recovered. Entry into this
safety zone is prohibited unless authorized by the COTP or his
designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Ohio
Valley.
    Requests for entry will be considered and reviewed on a case-by-
case basis. The COTP may be contacted by telephone at<PHONE_NUMBER> or
can be reached by VHF-FM channel 16. Persons and vessels permitted to
enter this safety zone must transit at their slowest safe speed and
comply with all lawful directions issued by the COTP or the designated
representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.

    This determination is based on the limited size, location, and
duration the safety zone, and the time of year. This safety zone will
restrict vessel traffic from entering or transiting within a 3.2 mile
area of navigable waterways on the Ohio River between MM 939.8 and MM
943.0. Moreover, the Coast Guard will issue Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the zone, and the rule
allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.1D, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves an emergency safety zone lasting less than one week that
will prohibit entry on a 3.2 mile stretch of the Ohio River during
recovery of sunken barges. It is categorically excluded from further
review under paragraph L60(c) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 01. Because this safety zone is established
in response to an emergency situation and is less than one week in
duration, a Record of Environmental Consideration (REC) is not
required. Should this emergency situation require a safety zone lasting
longer than one week, a REC will be made available as indicated under
ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0077 to read as follows:

Sec.  165.T08-0077  Safety Zone; Ohio River, Metropolis, IL.

    (a) Location. The following area is a safety zone: All navigable
waters of the Ohio River from mile marker (MM) 939.8 to MM 943.0,
extending the entire width of the river.
    (b) Enforcement period. This section will be enforced from May 1,
2018, through May 7, 2018, or until the sunken barges are recovered,
whichever occurs first.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of vessels or persons into this zone is prohibited
unless authorized by the Captain of the Port Sector Ohio Valley (COTP)
or designated representative. A ``designated representative'' is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to

units under the operational control of USCG Sector Ohio Valley.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at<PHONE_NUMBER> or on VHF-FM channel 16.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and dates for this
safety zone through Broadcast Notices to Mariners (BNMs), Local Notices
to Mariners (LNMs), and/or Marine Safety Information Broadcasts
(MSIBs), as appropriate.

    Dated: May 2, 2018.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2018-09662 Filed 5-4-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55259]
[DOCID:fr28se07-133]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56508]

Securities Exchange Act Of 1934; Order Granting Registration Of
DBRS Limited As A Nationally Recognized Statistical Rating Organization

September 24, 2007.
    DBRS Limited, a credit rating agency, furnished to the Securities
and Exchange Commission (``Commission'') an application for
registration as a nationally recognized statistical rating organization
(``NRSRO'') under Section 15E of the Securities Exchange Act of 1934
(``Exchange Act'') for the classes of credit ratings described in
clauses (i) through (v) of Section 3(a)(62)(B) of the Exchange Act. The
Commission finds that the application furnished by DBRS Limited is in
the form required by Exchange Act Section 15E, Exchange Act Rule 17g-1
(17 CFR 240.17g-1), and Form NRSRO (17 CFR 249b.300) and contains the
information described in subparagraph (B) of Section 15E(a)(1) of the
Exchange Act.
    Based on the application, the Commission finds that the
requirements of Section 15E of the Exchange Act are satisfied.
    Accordingly, It is ordered, under paragraph (a)(2)(A) of Section
15E of the Exchange Act, that the registration of DBRS Limited with the
Commission as an NRSRO under Section 15E of the Exchange Act for the
classes of credit ratings described in clauses (i) through (v) of
Section 3(a)(62)(B) of the Exchange Act is granted.

    By the Commission.
Nancy M. Morris,
Secretary.
 [FR Doc. E7-19170 Filed 9-27-07; 8:45 am]

BILLING CODE 8010-01-P