[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5546-5548]
[FR Doc No: 2019-02955]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0027]

Hours of Service of Drivers: WestRock, Application for Renewal of
Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for renewal of exemption; request for
comments.

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SUMMARY: WestRock, formerly known as RockTenn has requested a renewal
of its exemption from certain provisions of the hours-of-service (HOS)
requirements for drivers of property-carrying vehicles. WestRock
currently holds an exemption for the period April 17, 2014, through
April 16, 2019 for 11 shipping department employees and occasional
substitute commercial driver's license (CDL) holders who transport
paper mill products over a 275-foot stretch of public road between its
shipping and receiving locations. WestRock requested an exemption from
the 14-hour rule and the requirement for 10 consecutive hours off duty
before the start of the workday. The renewal of the exemption would
allow these individuals occasionally to drive after the 14th hour after
coming on duty and allow them to return to work following eight
consecutive hours off-duty. FMCSA requests public comment on WestRock's
application for exemption.

DATES: If granted, this exemption would be effective during the period
of April 17, 2019 through April 16, 2024. Comments must be received on
or before March 25, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2010-0027 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to www.regulations.gov, including any personal
information provided. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments received, go to www.regulations.gov, and follow the online
instructions for accessing the dockets, or go to the street address
listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Public participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal website. If you want us to notify you
that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2010-0027), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2010-0027'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may grant or not grant this application
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, ``FMCSA-2010-0027'' in the ``Keyword'' box and click
``Search.'' Next, click ``Open Docket Folder'' button and choose the
document listed to review. If you do not have access to the internet,
you may view the docket online by visiting the Docket Management
Facility in Room W12-140 on the ground floor of the DOT West Building,
1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5
p.m., e.t., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations. FMCSA must publish a notice of each exemption request in
the Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also

provide an opportunity for public comment on the request.
    The Agency reviews the safety analyses and the public comments, and
determines whether granting the exemption would likely achieve a level
of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reason for the grant or denial, and, if granted,
the specific person or class of persons receiving the exemption, and
the regulatory provision or provisions from which exemption is granted.
The notice must also specify the effective period of the exemption (up
to 5 years), and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

III. WestRock Application for Exemption

    WestRock (USDOT 153734) operates a paper mill located in
Chattanooga, Tennessee, its principal place of business. Its shipping
and receiving departments are on opposite sides of the paper mill,
requiring driver/employees to travel on a public road to shuttle
trailers as needed. These drivers utilize this public road--Compress
Street--an average of forty times per day to go from their shipping to
receiving department and to load their trailers in the shipping
department. These drivers do not transport any material farther than
the paper mill lots and/or Compress Street. The distance traveled on
Compress Street is approximately 275 feet in one direction, and one
tractor is used to perform this work. Because the material being
transported is received from or destined for other States, the local
travel is interstate in nature.
    The initial WestRock exemption application for relief from the HOS
rule was submitted in 2009; a copy of the application is in the docket.
That application fully described the nature of shipping operations
encountered by CMV drivers employed by WestRock. On May 29, 2012, FMCSA
granted WestRock the proposed exemption (77 FR 31684). FMCSA has since
renewed this limited exemption [April 22, 2014 (77 FR 22571; and July
25, 2016 (81 FR 48496)]. The current exemption expires on April 16,
2019.
    WestRock's shipping department currently works 12-hour shifts for 4
days, and then allows employees 4 days off duty. The schedule is
subject to change. Usually there are two shipping department employees
on each shift. One employee drives a fork-lift truck loading trailers
with finished goods, and the other operates the tractor shuttling
trailers. These employees do not drive a CMV continuously during their
shift(s).
    At times, WestRock may operate on three 8-hour shifts with
employees working a double (16-hour) shift when ``rotating back.''
According to WestRock, the problem arises because of the double-shift,
and also on occasion when a shipping department driver does not report
for work as scheduled. On a Monday, for example, if an individual
worked the weekend, his or her shift would normally have to ``hurry
back'' within 8 hours. As a result of the mandatory 10 hours off-duty
requirement for drivers, without the exemption WestRock would be
required to schedule these drivers' shifts to start later than other
employees. This would create at least 2 hours when the company cannot
load or transport trailers with finished goods due to the absence of
the drivers. Furthermore, as a result of the 14-hour driving windows,
they would ``work short'' without the exemption, creating on-time
delivery issues for other employees, who are allowed to work an entire
``double shift'' (16 hours) when necessary.
    WestRock requested renewal of its exemption from 49 CFR part 395
for its shipping department CMV drivers, as well as others with a valid
CDL who on occasion must substitute, allowing all such drivers to drive
as late as the 16th hour since coming on duty and return to work with a
minimum of at least 8 hours off duty. If exempt from the normal HOS
requirements, these employees could follow the same work schedule as
other WestRock employees on their shift, and would be able to work for
the full 16 hours of a ``double shift.'' WestRock could therefore
minimize the chances of delayed shipments that might occur if their
drivers were not allowed to work the same schedule as other employees.
    WestRock acknowledged in its application that these drivers would
still be subject to all of the other FMCSRs, including possessing a
CDL, random drug testing, medical certification, and other driver-
qualification requirements.
    A copy of WestRock's application for exemption renewal is available
for review in the docket for this notice.

Terms of the Exemption

Period of the Exemption

    The requested exemption is proposed to be effective April 17, 2019,
through 11:59 p.m. on April 16, 2024, for drivers employed by WestRock
operating CMVs on Compress Street in Chattanooga, Tennessee, between
the company's shipping and receiving departments.

Extent of the Exemption

    The exemption would be restricted to drivers employed by WestRock
operating CMVs on the route specified above. This exemption would be
strictly limited to the provisions of 49 CFR 395.3(a)(1), referring to
a required minimum of 10 hours off duty before the start of a duty
period, and 395.3(a)(2), commonly referred to as the ``14-hour rule.''
When operationally necessary, drivers would be allowed up to a 16-hour
duty period and no fewer than 8 hours off duty prior to the duty
period.

Preemption

    During the period this exemption would be in effect, no State would
be allowed to enforce any law or regulation that conflicted with or was
inconsistent with this exemption with respect to a firm or person
operating under the exemption (49 U.S.C. 31315(d)).

Notification to FMCSA

    WestRock would be required to notify FMCSA within 5 business days
of any accident (as defined in 49 CFR 390.5), involving any of the
motor carrier's CMVs operating under the terms of this exemption. The
notification would be required to include the following information:
    a. Name of the Exemption: ``WestRock''
    b. Date of the accident,
    c. City or town, and State, in which the accident occurred, or
which is closest to the scene of the accident,
    d. Driver's name and driver's license State, number, and class,
    e. Co-Driver's name and driver's license State, number, and class,
    f. Vehicle company number and power unit license plate State and
number,
    g. Number of individuals suffering physical injury,
    h. Number of fatalities,
    i. The police-reported cause of the accident,
    j. Whether the driver was cited for violation of any traffic laws,
or motor carrier safety regulations, and
    k. The total driving time and the total on-duty time of the CMV
driver at the time of the accident.
    Reports filed under this provision would be emailed to
<EMAIL_ADDRESS>
Termination

    The FMCSA does not believe the drivers covered by this exemption,
if granted, would experience any

deterioration of their safety record. However, should this occur, FMCSA
would take all steps necessary to protect the public interest,
including revocation of the exemption. The FMCSA would immediately
revoke the exemption for failure to comply with its terms and
conditions.

    Issued on: February 13, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-02955 Filed 2-20-19; 8:45 am]
BILLING CODE 4910-EX-P


Aaron Levy/DC/USEPA/US
12/01/2007 06:20 PM	To
<EMAIL_ADDRESS>	cc
	"Lee, Amanda I."<EMAIL_ADDRESS>Ross Brennan/DC/USEPA/US@EPA
	bcc

	Subject
	Re: 2008 CUE Methyl Bromide FRM:  CEQ comments

Mary,

Thanks for your comments.  I don't think any major changes will have to be
made in response, but you definitely make some good suggestions about how
to clarify the text.  For example, we will consider sub-sections in the
carry over section (V.D.4.).  Attached, I have tried to respond to your
comments (see blue colored comments on right side of document).

Feel free to call if you want to discuss anything further.

Regards,

Aaron Levy
U.S. Environmental Protection Agency
Stratospheric Protection Division
1200 Pennsylvania Ave. NW (6205J)
Washington, DC 20460
Tel:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>

"Lee, Amanda I."<EMAIL_ADDRESS>11/29/2007 09:48 AM
	To
	Aaron Levy/DC/USEPA/US@EPA, Ross Brennan/DC/USEPA/US@EPA, Richard
Keigwin/DC/USEPA/US@EPA, Diane McConkey/DC/USEPA/US@EPA
	cc

	Subject
	2008 CUE Methyl Bromide FRM:  CEQ comments

-----Original Message-----
From: Belefski, Mary L.
Sent: Thursday, November 29, 2007 9:17 AM
To: Lee, Amanda I.
Cc: Farrell, Amy L.
Subject: RE: CUE Methyl Bromide Final Rulemaking: Informal Draft

Amanda-

Thanks for the opportunity to review.  Sorry for the lateness on getting
these to you.  As mentioned during yesterday's call, here are my
suggested edits and comments (nothing major, just clarifications).  Can
you please forward to the appropriate EPA people?

One overall comment is one you highlighted on the use of commenter
names-- I couldn't see the rationale for mentioning some and not others.
I hope the next version addresses as you suggested.  I wonder if all
commenters are named in the comment response document so that the two
documents are consistent.

Mary

Mary Belefski, DPA
ComSci Fellow
Council on Environmental Quality
202-456-5124
<EMAIL_ADDRESS>
-----Original Message-----
From: Lee, Amanda I.
Sent: Friday, November 16, 2007 4:22 PM
To: 'Thompson, John E (OES)'; 'Finman, Hodayah H (OES)'; Klein, Jeffrey
M<EMAIL_ADDRESS>Belefski, Mary L.; 'Vetter, Darci'; Smith,
Russell; MacNeil, John S.
Cc<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Subject: CUE Methyl Bromide Final Rulemaking: Informal Draft
Importance: High

Hi all,

Please find attached EPA's informal draft of the CUE methyl bromide
final rulemaking.  Once again, this package is on a fast track.  I would
appreciate your comments by COB Monday, November 26.  I also propose a
conference call on November 28th, 10 am-noon.  If you have concerns
about the timeline, please let me know as soon as possible.

Once again, thank you all for your continued work and cooperation!

Best,

Amanda


[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48870-48873]
[FR Doc No: 2017-22755]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81880; File No. SR-NYSE-2017-51]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rules 80C, 104, 107B, and 128

October 16, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on October 3, 2017, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rules 80C, 104, 107B, and 128. The
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 80C(b) (Limit Up-Limit Down
Plan and Trading Pauses in Individual Securities Due to Extraordinary
Market Volatility) to conform its rule governing trading pauses to
forthcoming changes to be implemented to the Regulation NMS Plan to
Address Extraordinary Market Volatility (``Plan''); \4\ Rule
104(a)(1)(B) (Dealings and Responsibilities of DMMs) and Rule 107B
(Supplemental Liquidity Providers) to delete obsolete rule cross
references; and Rule 128(a) (Clearly Erroneous Executions For NYSE
Equities) to exclude executions as a result of a reopening transaction
from review as clearly erroneous transactions.
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    \4\ See Securities Exchange Act Release No. 79845 (January 19,
2017), 82 FR 8551 (January 26, 2017) (File No. 4-631) (Order
Approving the twelfth amendment to the Plan) (``LULD Amendment
12''). See also Securities Exchange Act Release Nos. 80455 (April
13, 2017), 82 FR 18519 (April 19, 2017) (File No. 4-631) (Order
approving the thirteenth amendment to the Plan) and 81720 (September
26, 2017), 82 FR 45922 (October 2, 2017) (File No. 4-631) (Notice of
immediate effectiveness of fifteenth amendment to the Plan, which
extended the implementation date of LULD Amendment 12).
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Discussion
    Among other things, LULD Amendment 12 would require that trading
centers may not resume trading in an NMS Stock following a Trading
Pause without Price Bands in such NMS Stock.\5\ Such Price Bands would
be based on the Reopening Price reported by a Primary Listing Exchange,
unless a Primary Listing Exchange notifies the Processor that it is
unable to reopen trading in an NMS Stock due to a systems or technology
issue. In such case, the Price Band would be the last effective Price
Band that was in a Limit State before the Trading Pause. Accordingly,
once LULD Amendment 12 is implemented, trading centers may not resume
trading if a Primary Listing Exchange does not report a Reopening Price
within ten minutes after the declaration of a Trading Pause. In
addition, under LULD Amendment 12, if an NMS Stock is in a Trading
Pause during the last ten minutes of trading before the end of Regular
Trading Hours, the Primary Listing Exchange shall not reopen trading
and shall attempt to execute a closing transaction using its
established closing procedures.
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    \5\ Unless otherwise specified, capitalized terms used herein
have the same meaning as set forth in the Plan or in Exchange rules.
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    In anticipation of the implementation of LULD Amendment 12, the
Exchange proposes to amend Rule 80C(b) to delete obsolete text and
conform the remaining text to LULD Amendment 12.\6\ First, the Exchange
proposes to amend Rule 80C(b) to delete the text following the heading
of Rule 80C(b) and delete Rules 80C(b)(1), (b)(1)(A)-(C), and (b)(3).
This rule text governed how trading pauses were triggered before the
Plan was implemented and is now obsolete. Second, the Exchange proposes
that the text currently set forth in Rule 80C(b)(2), (b)(2)(B), and
(b)(2)(E) would be moved to be the rule text for Rule 80C(b). In moving
this rule text, the Exchange proposes to delete the rule text currently
set forth in Rules 80C(b)(2)(C) and (D) as inconsistent with LULD
Amendment 12, described above.\7\ Third, the Exchange proposes to re-
number current Rule 80C(b)(4) as proposed Rule 80C(b)(1) and amend this
paragraph to add that the Exchange would notify the Processor if the
Exchange is unable to reopen trading at the end of a Trading pause due
to a systems or technology issue, which is consistent with LULD
Amendment 12. Fourth, the Exchange proposes to delete Rule 80C(b)(5) as
inapplicable to the Exchange application of Rule 80C, which governs
trading only in NYSE-listed securities.
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    \6\ The proposed amendments to Rule 80C are based on amendments
to NYSE Arca, Inc. (``NYSE Arca'') Rule 7.11-E that similarly relate
to the implementation of LULD Amendment 12. See Securities Exchange
Act Release Nos. 79846 (January 19, 2017), 82 FR 8548 (January 26,
2017) (SR-NYSEArca-2016-130) (Approval Order) (the ``NYSE Arca
Reopening Filing'').
    \7\ The text that the Exchange would delete provides that ``[i]n
the event of a significant imbalance at the end of a Trading Pause,
the Exchange may delay the re-opening of a security'' and ``[t]he
Exchange will issue a notification if it cannot resume trading for a
reason other than a significant imbalance.''
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    Finally, the Exchange proposes to add proposed Rule 80C(b)(2),
which would specify how the Exchange would process orders if there is a
Trading Pause during the last ten minutes of trading before the end of
Regular Trading Hours. As proposed, if the reopening following a
Trading Pause would be in the last ten minutes of trading before the
end of regular trading hours, the Exchange would not reopen trading in
that security and would not transition to continuous trading. As
further proposed and consistent with LULD Amendment 12, the Exchange
would remain paused and would conduct a closing transaction in such
security as provided for in Rule 123C. The proposed rule would further
provide that in such circumstances, MOO and LOO Orders entered during
the Trading Pause would not participate in the closing auction and
would be cancelled.\8\ The Exchange proposes to add this rule text to
provide transparency to member organizations of how orders that are
designated to participate in a reopening transaction would be handled
if the Exchange transitions to a closing auction without first
reopening trading.\9\
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    \8\ This proposed rule text is based on NYSE Arca Rule 7.35-
E(e)(10). See Securities Exchange Act Release No. 81603 (September
13, 2017), 82 FR 43609 (September 18, 2017) (SR-NYSEArca-2017-102)
(``Arca Filing'').
    \9\ The Exchange also proposes non-substantive amendments to
changes references from the term ``shall'' to the term ``will.''
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    In addition, the Exchange proposes to amend Rule 104(a)(1)(B)(iii)
and (iv) and Rule 107B(d)(1)(B)(iii) and (iv) to remove obsolete cross
references and to reflect that the applicable percentages are based on
how a security is designated under the Plan.\10\ Rules 104(a)(1)(B) and
107B(d)(1)(B) set forth, among other things, the obligation of DMMs and
SLMMs to maintain a bid (offer) not more than the ``Designated
Percentage'' away from the then current National Best Bid (Offer)
(``NBBO'') and if the NBBO changes such that the DMM's or SLMM's bid/
offer is more than the ``Defined Limit'' away from the NBBO, the DMM or
SLMM must enter an updated bid (offer). The Exchange proposes to amend
Rule 104(a)(1)(B)(iii) and (iv) and Rule 107B(d)(1)(B)(iii) and (iv) to
remove cross-references to Rule 80C and instead use Plan definitions
for specifying which securities are subject to which ``Designated
Percentages'' and ``Defined Limits.'' Accordingly, as proposed, these
rules would be amended as follows:
---------------------------------------------------------------------------

    \10\ The Exchange's affiliated equities exchanges have made
similar change to their rules. See Arca Reopen [sic] Filing, supra
note 8 (amending NYSE Arca Rule 7.23-E(a)(1)(B)(iii) and (iv)) and
Securities Exchange Act Release No. 80577 (May 2, 2017), 82 FR 21446
(May 8, 2017) (SR-NYSEMKT-2017-04) (Order approving NYSE American
LLC (``NYSE American'') Rule 7.23E(a)(1)(B)(iii) and (iv)). The
proposed rule changes are also based on Bats BZX, Inc. (``BZX'')
Rule 11.8(d)(2)(D) and (E).
---------------------------------------------------------------------------

     The phrase ``securities subject to Rule 80C(a)(i)'' would
be replaced with the phrases ``Tier 1 NMS Stocks under the Limit Up-
Limit Down Plan'' or ``Tier 1 NMS Stocks;''
     the phrase ``securities subject to Rule 80C(a)(ii)'' would
be replaced with the phrases ``Tier 2 NMS Stocks under the Limit Up-
Limit Down Plan with a price equal to or greater than $1.00'' or

``Tier 2 NMS Stocks with a price equal to or greater than $1.00;''
     the phrase ``securities subject to Rule 80C(a)(iii)''
would be replaced with the phrase ``Tier 2 NMS Stocks with a price
lower than $1.00;'' and
     The phrase ``when Rule 80C is not in effect'' would be
deleted.
    Because rights and warrants are not subject to the Plan, but are
subject to market maker quoting requirements, the Exchange proposes to
provide that for purposes of Rule 104(a)(1)(B)(iii) and (iv) and Rule
107B(d)(1)(B)(iii) and (iv), rights and warrants would be considered
Tier 2 NMS Stocks. This proposed rule text is consistent with current
practice and the now-obsolete cross references to Rule 80C.\11\
---------------------------------------------------------------------------

    \11\ Securities previously subject to Rule 80C(a)(ii) were all
NMS Stocks, other than securities included in the S&P 500[supreg]
Index, Russell 1000[supreg] Index, and a pilot list of Exchange
Traded Products, with a price equal to or greater than $1 and
securities previously subject to Rule 80C(a)(iii) were all NMS
Stocks, other than securities included in the S&P 500[supreg] Index,
Russell 1000[supreg] Index, and a pilot list of Exchange Traded
Products, with a price less than $1.00. See Securities Exchange Act
Release No. 64420 (May 6, 2011), 76 FR 27675 (May 12, 2011) (SR-
NYSE-2011-21) (Notice of filing).
---------------------------------------------------------------------------

    Finally, the Exchange proposes to amend Rule 128(a) to provide that
executions as a result of reopening transaction would not be eligible
for a request to review as clearly erroneous under paragraph (b) of
Rule 128. This proposed rule changes is based on changes approved in
the NYSE Arca Reopening Filing for NYSE Arca Rule 7.10-E.\12\ The
Exchange believes that the proposed rule text would implement the
standardized trading practice that reopening auctions would not be
eligible for review as a clearly erroneous execution.
---------------------------------------------------------------------------

    \12\ See NYSE Arca Reopening Filing, supra note 6.
---------------------------------------------------------------------------

    Because of the technology changes associated with the proposed
amendments to Rule 80C and 128, the Exchange will announce the
implementation date of those proposed rule changes by Trader Update,
which will be no later than the scheduled implementation date of LULD
Amendment 12. The Exchange proposes that the amendments to Rule 104 and
107B would be operative upon the operative date of this proposed rule
change.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\13\ in general, and
furthers the objectives of Section 6(b)(5),\14\ 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed changes would 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, because they are designed to conform the Exchange's rules
with LULD Amendment 12.
    The Exchange believes that the proposed amendments to Rule 80C
would remove impediments to and perfect the mechanism of a free and
open market and a national market system because they would remove
obsolete rule text and amend the remaining rule text to conform to the
requirements of LULD Amendment 12, described above. The Exchange
further believes that the proposed amendments to Rule 104(a)(1)(B) and
Rule 107B(d)(1)(B) would remove impediments to and perfect the
mechanism of a free and open market and a national market system
because they would remove obsolete rule references and conform the
Exchange's rules with those of NYSE American and BZX. Finally, the
Exchange believes that the proposed amendments to Rule 128(a) would
provide for uniform clearly erroneous rules across all Primary Listing
Exchanges, thus providing certainty to member organizations of when a
trade would be eligible for review as a clearly erroneous execution.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rule change is not designed to address any competitive
issues, but rather, to eliminate obsolete rule text and conform
Exchange rules with changes that will be implemented with LULD
Amendment 12.

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \15\ and Rule 19b-4(f)(6) thereunder.\16\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \16\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \17\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\18\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \19\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2017-51 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2017-51. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2017-51 and should be
submitted on or before November 13, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-22755 Filed 10-19-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[CORRECTIONS]
[Page 22017]
[DOCID:fr23ap08-169]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Parts 240 and 249

[Release 34-57526A; File No. S7-06-07]
RIN 3235-AJ80

Proposed Rule Changes of Self[dash]Regulatory Organizations

Correction

    In rule document E8-8267 appearing on page 20782 in the issue of
Thursday, April 17, 2008, make the following correction:
    In the third column, under the SUPPLEMENTARY INFORMATION heading,
in the 14th line, ``May 8, 2008.'' should read ``[insert date 21 days
from publication in the Federal Register].''''.

[FR Doc. Z8-8267 Filed 4-22-08; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Proposed Rules]
[Pages 28386-28388]
[FR Doc No: 2011-12005]

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

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-1016]
RIN 1625-AA00

Safety Zone: Ohio River Mile 355.5 to 356.5 Portsmouth, OH

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a safety zone in the
Ohio Valley Captain of the Port Zone on the Ohio River in Portsmouth,
OH. This safety zone is proposed to begin at mile 355.5 and end at mile
356.5, extending the entire width of the river. This Safety Zone is
intended to protect persons and vessels from the potential safety
hazards associated with the Civic Forum Fireworks Display, which occurs
annually. This safety zone is proposed to become a permanent final
rule.

DATES: Comments and related material must be received by the Coast
Guard on or before June 16, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-1016 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail Petty Officer Marceli Rogoza, Marine Safety Unit
Huntington Coast Guard; telephone<PHONE_NUMBER> extension 2137, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

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

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2010-1016), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2010-1016'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2010-1016'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

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

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before March 27, 2011 using one of the four
methods specified under ADDRESSES. Please explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact Petty Officer Marceli Rogoza at the telephone number or e-mail
address indicated under the FOR FURTHER INFORMATION CONTACT section of
this notice.

Basis and Purpose

    The Civic Forum is sponsoring a fireworks display on the 4th of
July. Fireworks will be launched from the left descending bank on the
Ohio River at mile 356. A hazardous situation could exist for vessels,
mariners and spectators in the vicinity of the fireworks display. A
safety zone is needed to protect those vessels, mariners and spectators
from the hazards associated with this fireworks display.

Discussion of Proposed Rule

    The Captain of the Port Ohio Valley proposes to establish a safety
zone for the waters of the Ohio River beginning at mile 355.5 and
ending at mile 356.5. The term ``participating vessel'' includes all
vessels registered with the fireworks event officials to work in the
event. With the exception of participating vessels and those mariners
operating participating vessels, all vessels and persons are prohibited
from transiting within this safety zone unless authorized by the
Captain of the Port Ohio Valley or a designated representative. The
Captain of the Port Ohio Valley may be contacted on VHF-FM Channels 13
or 16, or by telephone at<PHONE_NUMBER>. The proposed safety zone will
be enforced on the 4th of July each year beginning in 2011. The Captain
of the Port Ohio Valley will inform the public through broadcast notice
to mariners of the enforcement period for the safety zone.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. We expect the economic
impact of this rule to be so minimal, rendering a full regulatory
evaluation unnecessary. The basis of this finding is that the safety
zone will only be in effect for a limited time period on one day each
year and notifications to the marine community will be made through
broadcast notice to mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This rule will affect the following entities,
some of which may be small entities: The owners or operators of vessels
intending to transit the Ohio River beginning at mile 355.5 and ending
at mile 356.5 on the 4th of July each year. This safety zone will not
have a significant economic impact on a substantial number of small
entities because this rule will only be in effect for limited time
period on one day each year during Civic Forum Fireworks Display.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Petty Officer Marceli Rogoza.
The Coast Guard will not retaliate against small entities that question
or complain about this proposed rule or any policy or action of the
Coast Guard.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That

Significantly Affect Energy Supply, Distribution, or Use. We have
determined that it is not a ``significant energy action'' under that
order because it is not a ``significant regulatory action'' under
Executive Order 12866 and is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. The Administrator
of the Office of Information and Regulatory Affairs has not designated
it as a significant energy action. Therefore, it does not require a
Statement of Energy Effects under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
made a preliminary determination that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. A preliminary environmental analysis
checklist supporting this determination is available in the docket
where indicated under ADDRESSES. This proposed rule is categorically
excluded, under figure 2-1, paragraph (34)(g.), of the Instruction.
This rule involves regulations establishing, disestablishing, or
changing Regulated navigation areas and security or safety zones. The
rule fits this category because the Coast Guard proposes to establish a
safety zone from mile 355.5 to mile 356.5 on the Ohio River. We seek
any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. A new temporary Sec.  165.T08-1016 is added to read as follows:

Sec.  165.T018-1016  Safety Zone; Ohio River Mile 355.5 to Mile 356.5
Portsmouth, OH.

    (a) Location. The waters of the Ohio River beginning at mile 355.5
and ending at mile 356.5, extending the entire width of the river.
    (b) Effective date. This section of this rule is effective on the
4th of July each year beginning in 2011.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Ohio Valley.
    (2) Persons or vessels requiring entry into or passage through this
zone must request permission from the Captain of the Port Ohio Valley,
or a designated representative. They may be contacted on VHF-FM
Channels 13 or 16, or by telephone at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port Ohio Valley and designated on-scene U.S. Coast
Guard patrol personnel.
    (4) On-scene U.S. Coast Guard patrol personnel include
commissioned, warrant, and petty officers of the U.S. Coast Guard.

    Dated: March 15, 2011.
L.W. Hewett,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2011-12005 Filed 5-16-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72969-72971]
[FR Doc No: 2021-27812]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0980]

Assessing the Credibility of Computational Modeling and
Simulation in Medical Device Submissions; Draft Guidance for Industry
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Assessing the
Credibility of Computational Modeling and Simulation in Medical Device
Submissions.'' Computational modeling and simulation (CM&S) can be used
in a variety of ways in medical device applications, including to
perform ``in silico'' device testing or as part of software embedded in
a device. This guidance provides a risk-based framework that can be
used in the credibility assessment of computational modeling and
simulation (CM&S) used in medical device regulatory submissions. The
draft guidance is intended to improve the consistency and transparency
of the review of computational modeling evidence. This draft guidance
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance

by February 22, 2022 to ensure that the Agency considers your comment
on this draft guidance before it begins work on the final version of
the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0980 for ``Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Assessing the Credibility of Computational Modeling and Simulation in
Medical Device Submissions'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Pras Pathmanathan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1133, Silver Spring, MD 20993-0002, 301-
796-3490.

SUPPLEMENTARY INFORMATION:

I. Background

    CM&S can be used in a variety of ways in medical device
applications, including to perform in silico (virtual) device testing
or as part of algorithms within software embedded in a device. However,
regulatory submissions involving CM&S often lack clear information for
why model predictions can be considered credible. This draft guidance
provides a risk-based framework that can be used in the credibility
assessment of CM&S used in medical device regulatory submissions. This
draft guidance builds upon the FDA-recognized consensus standard
American Society of Mechanical Engineers V&V 40, ``Assessing
Credibility of Computational Modeling Through Verification and
Validation: Application to Medical Devices,'' by providing a general
framework for demonstrating CM&S credibility that incorporates the
different types of evidence typically generated for regulatory
submissions. The framework is intended to be applicable to any use of
CM&S in a medical device submission. It is not specific to any device
type, modeling discipline or clinical specialty.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Assessing
the Credibility of Computational Modeling and Simulation in Medical
Device Submissions.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document
is also available at https://www.regulations.gov and at https://
www.fda.gov/regulatory-information/search-fda-guidance-documents.
Persons unable to download

an electronic copy of ``Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1500056 and
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidances have been
approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB Control
     21 CFR part; or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback and         Q-submissions; pre-        0910-0756
 Meetings for Medical Device         submissions.
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------

    Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27812 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P