1 Allowance Allocation: many allocation options and combinations ° Auction or free ° Permanent or updated ° Coal or Fossil units only, or all electricity generators including renewables, nuclear ° Input, output, or emission reduction based ° Hybrids Allocation Mechanism 1. Free vs. Auction Free Auction 2. Updated vs. Permanent Updated Permanent 3. Recipients Fossil All Fossil All ( Hybrid)

4. Basis Input Output Output Input Emission Reduction Output Output 1/ 2 Perm/ All/ Out 5. Options Analyzed Up/ Fos/ In Up/ Fos/ Out Up/ All/ Out Perm/ Fos/ In Perm/ Fos/ ER Perm/ Fos/ Out Perm/ All/ Out 1/ 2 Auction Auction   New units can be treated differently in permanent allocations   Non emitters can receive allocations 2 Allowance Allocations

Example Approach " Modified Output" allocation method :

  Input based allocations for existing fossil units with updating to take into account new generation on a " modified output" basis.

  Demonstrates one possible approach that incorporates new generation and is administratively straightforward. 3 Modified Output Approach ( overview)

° New unit " modified output" added to the original existing unit heat input. Allocations made to units in proportion to their share of updated and initial heat input.

  Alternately, existing unit heat input may be adjusted with a ratio to account for different fuel type use.

° Initial allocation made for first five years of program. Afterwards,

annual updating determines allocations for the year six years in advance.

° Heat input calculations for ALL new generating units: output multiplied by 8000 btu/ kWh ( cogen units also take into account steam output)

  Creates level output based benefits for new units and provides incentives for efficiency.

  This approach would require new sources to report output data.

  Alternately, can only include new fossil units. 4 Modified Output Approach ( overview)

° New units pick up allowances relative to their generation, and existing plants' allocations slowly decline with their share of total heat input.

° To avoid a generation subsidy, existing units would not update their heat input numbers and new units would update only once,

when they begin generating.

  Alternately, can have new units regularly update their output.

° A new source set aside would be established for units that have entered service but have not yet been allocated allowances through the updating mechanism.

° New fossil units could be allocated allowances relative to their NSPS rates until they have established a baseline of output data and have been included in the updating mechanism.

  In the interim, new non emitting units could be allocated allowances at the lowest fossil fuel NSPS rate.


[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21847-21848]
[FR Doc No: 2020-08253]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR20-50-000.
    Applicants: Enterprise Texas Pipeline LLC.
    Description: Tariff filing per 284.123(b)(2)+(g): ETP 311 Rate
Filing and Amended SOC to be effective 4/1/2020.
    Filed Date: 4/13/2020.
    Accession Number:<PHONE_NUMBER>69.
    Comments Due: 5 p.m. ET 5/4/2020.

    284.123(g) Protests Due: 5 p.m. ET 6/12/2020.

    Docket Numbers: RP20-779-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: GT&C Section 49 Tariff Change
to be effective 5/11/2020.
    Filed Date: 4/10/20.
    Accession Number: 20200410-5078.
    Comments Due: 5 p.m. ET 4/22/20.

    Docket Numbers: RP20-780-000.
    Applicants: Pine Needle LNG Company, LLC.
    Description: Compliance filing Petition for Approval of a
Negotiated Stipulation and Agreement.
    Filed Date: 4/10/20.
    Accession Number: 20200410-5150.
    Comments Due: 5 p.m. ET 4/22/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests

may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 14, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-08253 Filed 4-17-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 88 (Tuesday, May 9, 2017)]
[Notices]
[Pages 21535-21536]
[FR Doc No: 2017-09343]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6902-084]

American Municipal Power, Inc.; Notice of Application Accepted
for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Federal Energy Regulatory Commission and is available
for public inspection:

    a. Type of Application: Amendment of Project License.
    b. Project No: 6902-084.
    c. Date Filed: January 18, 2017.
    d. Applicant: American Municipal Power, Inc. (licensee).
    e. Name of Project: Willow Island Lock and Dam Hydroelectric
Project.
    f. Location: Ohio River in Pleasants County, West Virginia and
Washington County, Ohio.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Phillip E. Meier, American Municipal Power,
Inc., 1111 Schrock Road, Suite 100, Columbus, OH 43229; phone (614)
540-0913.
    i. FERC Contact: Michael Calloway at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file motions
to intervene, protests, and comments using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-6902-084.
    k. Description of Request: The licensee requests that the
Commission delete Article 404 from the project license. Article 404
requires the licensee to monitor fish mortality and develop a plan to
reduce mortality and compensate West Virginia and Ohio Departments of
Natural Resources for the remaining fish mortality. The licensee cited
the Court of Appeals in City of New Martinsville v. FERC, 103 F. 3d 567
(D.C. Cir. 1996), and stated that since the court case the Commission
policy regarding such compensation has changed. The licensee also cited
several Commission decisions that have occurred since the court case as
support for their request.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call<PHONE_NUMBER> or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title COMMENTS; PROTEST, or MOTION TO
INTERVENE as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to the amendment
application. Agencies may obtain copies of the application directly
from the applicant. A copy of any protest or motion to intervene must
be served upon each representative of the applicant specified in the
particular application. If an intervener files comments or documents
with the

Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: May 3, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-09343 Filed 5-8-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 42009-42014]
[FR Doc No: 2021-16540]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-4334; FMCSA-1999-5578; FMCSA-2000-7363; FMCSA-
2001-9258; FMCSA-2001-9561; FMCSA-2002-11714; FMCSA-2002-13411; FMCSA-
2003-14223; FMCSA-2003-14504; FMCSA-2003-15268; FMCSA-2005-20560;
FMCSA-2005-21254; FMCSA-2006-25246; FMCSA-2006-26066; FMCSA-2006-26653;
FMCSA-2007-2663; FMCSA-2007-27333; FMCSA-2007-27515; FMCSA-2007-27897;
FMCSA-2008-0021; FMCSA-2008-0106; FMCSA-2008-0340; FMCSA-2008-0398;
FMCSA-2009-0054; FMCSA-2009-0086; FMCSA-2009-0121; FMCSA-2009-0154;
FMCSA-2009-0291; FMCSA-2010-0082; FMCSA-2010-0187; FMCSA-2010-0354;
FMCSA-2010-0385; FMCSA-2010-0413; FMCSA-2011-0010; FMCSA-2011-0024;
FMCSA-2011-0092; FMCSA-2011-0102; FMCSA-2011-0140; FMCSA-2012-0040;
FMCSA-2012-0215; FMCSA-2012-0279; FMCSA-2012-0337; FMCSA-2013-0022;
FMCSA-2013-0024; FMCSA-2013-0025; FMCSA-2013-0027; FMCSA-2013-0028;
FMCSA-2013-0029; FMCSA-2013-0030; FMCSA-2014-0007; FMCSA-2014-0011;
FMCSA-2014-0296; FMCSA-2014-0298; FMCSA-2014-0302; FMCSA-2014-0304;
FMCSA-2014-0305; FMCSA-2015-0048; FMCSA-2015-0049; FMCSA-2015-0052;
FMCSA-2015-0053; FMCSA-2015-0055; FMCSA-2015-0072; FMCSA-2016-0030;
FMCSA-2016-0033; FMCSA-2016-0206; FMCSA-2016-0208; FMCSA-2016-0212;
FMCSA-2016-0213; FMCSA-2016-0214; FMCSA-2017-0014; FMCSA-2017-0017;
FMCSA-2017-0019; FMCSA-2017-0020; FMCSA-2018-0017; FMCSA-2019-0005;
FMCSA-2019-0009; FMCSA-2019-0011]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 123
individuals from the vision requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these individuals to continue to
operate CMVs in interstate commerce without meeting the vision
requirements in one eye.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before September
3, 2021.

ADDRESSES: You may submit comments identified by the Federal Docket

Management System (FDMS) Docket No. FMCSA-1998-4334, Docket No. FMCSA-
1999-5578, Docket No. FMCSA-2000-7363, Docket No. FMCSA-2001-9258,
Docket No. FMCSA-2001-9561, Docket No. FMCSA-2002-11714, Docket No.
FMCSA-2002-13411, Docket No. FMCSA-2003-14223, Docket No. FMCSA-2003-
14504, Docket No. FMCSA-2003-15268, Docket No. FMCSA-2005-20560, Docket
No. FMCSA-2005-21254, Docket No. FMCSA-2006-25246, Docket No. FMCSA-
2006-26066, Docket No. FMCSA-2006-26653, Docket No. FMCSA-2007-2663,
Docket No. FMCSA-2007-27333, Docket No. FMCSA-2007-27515, Docket No.
FMCSA-2007-27897, Docket No. FMCSA-2008-0021, Docket No. FMCSA-2008-
0106, Docket No. FMCSA-2008-0340, Docket No. FMCSA-2008-0398, Docket
No. FMCSA-2009-0054, Docket No. FMCSA-2009-0086, Docket No. FMCSA-2009-
0121, Docket No. FMCSA-2009-0154, Docket No. FMCSA-2009-0291, Docket
No. FMCSA-2010-0082, Docket No. FMCSA-2010-0187, Docket No. FMCSA-2010-
0354, Docket No. FMCSA-2010-0385, Docket No. FMCSA-2010-0413, Docket
No. FMCSA-2011-0010, Docket No. FMCSA-2011-0024, Docket No. FMCSA-2011-
0092, Docket No. FMCSA-2011-0102, Docket No. FMCSA-2011-0140, Docket
No. FMCSA-2012-0040, Docket No. FMCSA-2012-0215, Docket No. FMCSA-2012-
0279, Docket No. FMCSA-2012-0337, Docket No. FMCSA-2013-0022, Docket
No. FMCSA-2013-0024, Docket No. FMCSA-2013-0025, Docket No. FMCSA-2013-
0027, Docket No. FMCSA-2013-0028, Docket No. FMCSA-2013-0029, Docket
No. FMCSA-2013-0030, Docket No. FMCSA-2014-0007, Docket No. FMCSA-2014-
0011, Docket No. FMCSA-2014-0296, Docket No. FMCSA-2014-0298, Docket
No. FMCSA-2014-0302, Docket No. FMCSA-2014-0304, Docket No. FMCSA-2014-
0305, Docket No. FMCSA-2015-0048, Docket No. FMCSA-2015-0049, Docket
No. FMCSA-2015-0052, Docket No. FMCSA-2015-0053, Docket No. FMCSA-2015-
0055, Docket No. FMCSA-2015-0072, Docket No. FMCSA-2016-0030, Docket
No. FMCSA-2016-0033, Docket No. FMCSA-2016-0206, Docket No. FMCSA-2016-
0208, Docket No. FMCSA-2016-0212, Docket No. FMCSA-2016-0213, Docket
No. FMCSA-2016-0214, Docket No. FMCSA-2017-0014, Docket No. FMCSA-2017-
0017, Docket No. FMCSA-2017-0019, Docket No. FMCSA-2017-0020, Docket
No. FMCSA-2018-0017, Docket No. FMCSA-2019-0005, Docket No. FMCSA-2019-
0009, or Docket No. FMCSA-2019-0011 using any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number, FMCSA-1998-4334, FMCSA-1999-5578, FMCSA-2000-
7363, FMCSA-2001-9258, FMCSA-2001-9561, FMCSA-2002-11714, FMCSA-2002-
13411, FMCSA-2003-14223, FMCSA-2003-14504, FMCSA-2003-15268, FMCSA-
2005-20560, FMCSA-2005-21254, FMCSA-2006-25246, FMCSA-2006-26066,
FMCSA-2006-26653, FMCSA-2007-2663, FMCSA-2007-27333, FMCSA-2007-27515,
FMCSA-2007-27897, FMCSA-2008-0021, FMCSA-2008-0106, FMCSA-2008-0340,
FMCSA-2008-0398, FMCSA-2009-0054, FMCSA-2009-0086, FMCSA-2009-0121,
FMCSA-2009-0154, FMCSA-2009-0291, FMCSA-2010-0082, FMCSA-2010-0187,
FMCSA-2010-0354, FMCSA-2010-0385, FMCSA-2010-0413, FMCSA-2011-0010,
FMCSA-2011-0024, FMCSA-2011-0092, FMCSA-2011-0102, FMCSA-2011-0140,
FMCSA-2012-0040, FMCSA-2012-0215, FMCSA-2012-0279, FMCSA-2012-0337,
FMCSA-2013-0022, FMCSA-2013-0024, FMCSA-2013-0025, FMCSA-2013-0027,
FMCSA-2013-0028, FMCSA-2013-0029, FMCSA-2013-0030, FMCSA-2014-0007,
FMCSA-2014-0011, FMCSA-2014-0296, FMCSA-2014-0298, FMCSA-2014-0302,
FMCSA-2014-0304, FMCSA-2014-0305, FMCSA-2015-0048, FMCSA-2015-0049,
FMCSA-2015-0052, FMCSA-2015-0053, FMCSA-2015-0055, FMCSA-2015-0072,
FMCSA-2016-0030, FMCSA-2016-0033, FMCSA-2016-0206, FMCSA-2016-0208,
FMCSA-2016-0212, FMCSA-2016-0213, FMCSA-2016-0214, FMCSA-2017-0014,
FMCSA-2017-0017, FMCSA-2017-0019, FMCSA-2017-0020, FMCSA-2018-0017,
FMCSA-2019-0005, FMCSA-2019-0009, or FMCSA-2019-0011 in the keyword
box, and click ``Search.'' Next, sort the results by ``Posted (Newer-
Older),'' choose the first notice listed, and click on the ``Comment''
button. Follow the online instructions for submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-1998-4334; FMCSA-1999-5578; FMCSA-2000-7363;
FMCSA-2001-9258; FMCSA-2001-9561; FMCSA-2002-11714; FMCSA-2002-13411;
FMCSA-2003-14223; FMCSA-2003-14504; FMCSA-2003-15268; FMCSA-2005-20560;
FMCSA-2005-21254; FMCSA-2006-25246; FMCSA-2006-26066; FMCSA-2006-26653;
FMCSA-2007-2663; FMCSA-2007-27333; FMCSA-2007-27515; FMCSA-2007-27897;
FMCSA-2008-0021; FMCSA-2008-0106; FMCSA-2008-0340; FMCSA-2008-0398;
FMCSA-2009-0054; FMCSA-2009-0086; FMCSA-2009-0121; FMCSA-2009-0154;
FMCSA-2009-0291; FMCSA-2010-0082; FMCSA-2010-0187; FMCSA-2010-0354;
FMCSA-2010-0385; FMCSA-2010-0413; FMCSA-2011-0010; FMCSA-2011-0024;
FMCSA-2011-0092; FMCSA-2011-0102; FMCSA-2011-0140; FMCSA-2012-0040;
FMCSA-2012-0215; FMCSA-2012-0279; FMCSA-2012-0337; FMCSA-2013-0022;
FMCSA-2013-0024; FMCSA-2013-0025; FMCSA-2013-0027; FMCSA-2013-0028;
FMCSA-2013-0029; FMCSA-2013-0030; FMCSA-2014-0007; FMCSA-2014-0011;
FMCSA-2014-0296; FMCSA-2014-0298; FMCSA-2014-0302; FMCSA-2014-0304;
FMCSA-2014-0305; FMCSA-2015-0048; FMCSA-2015-

0049; FMCSA-2015-0052; FMCSA-2015-0053; FMCSA-2015-0055; FMCSA-2015-
0072; FMCSA-2016-0030; FMCSA-2016-0033; FMCSA-2016-0206; FMCSA-2016-
0208; FMCSA-2016-0212; FMCSA-2016-0213; FMCSA-2016-0214; FMCSA-2017-
0014; FMCSA-2017-0017; FMCSA-2017-0019; FMCSA-2017-0020; FMCSA-2018-
0017; FMCSA-2019-0005; FMCSA-2019-0009; FMCSA-2019-0011), 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 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 that FMCSA can contact you if
there are questions regarding your submission.
    To submit your comment online, go to www.regulations.gov/, insert
the docket number, FMCSA-1998-4334, FMCSA-1999-5578, FMCSA-2000-7363,
FMCSA-2001-9258, FMCSA-2001-9561, FMCSA-2002-11714, FMCSA-2002-13411,
FMCSA-2003-14223, FMCSA-2003-14504, FMCSA-2003-15268, FMCSA-2005-20560,
FMCSA-2005-21254, FMCSA-2006-25246, FMCSA-2006-26066, FMCSA-2006-26653,
FMCSA-2007-2663, FMCSA-2007-27333, FMCSA-2007-27515, FMCSA-2007-27897,
FMCSA-2008-0021, FMCSA-2008-0106, FMCSA-2008-0340, FMCSA-2008-0398,
FMCSA-2009-0054, FMCSA-2009-0086, FMCSA-2009-0121, FMCSA-2009-0154,
FMCSA-2009-0291, FMCSA-2010-0082, FMCSA-2010-0187, FMCSA-2010-0354,
FMCSA-2010-0385, FMCSA-2010-0413, FMCSA-2011-0010, FMCSA-2011-0024,
FMCSA-2011-0092, FMCSA-2011-0102, FMCSA-2011-0140, FMCSA-2012-0040,
FMCSA-2012-0215, FMCSA-2012-0279, FMCSA-2012-0337, FMCSA-2013-0022,
FMCSA-2013-0024, FMCSA-2013-0025, FMCSA-2013-0027, FMCSA-2013-0028,
FMCSA-2013-0029, FMCSA-2013-0030, FMCSA-2014-0007, FMCSA-2014-0011,
FMCSA-2014-0296, FMCSA-2014-0298, FMCSA-2014-0302, FMCSA-2014-0304,
FMCSA-2014-0305, FMCSA-2015-0048, FMCSA-2015-0049, FMCSA-2015-0052,
FMCSA-2015-0053, FMCSA-2015-0055, FMCSA-2015-0072, FMCSA-2016-0030,
FMCSA-2016-0033, FMCSA-2016-0206, FMCSA-2016-0208, FMCSA-2016-0212,
FMCSA-2016-0213, FMCSA-2016-0214, FMCSA-2017-0014, FMCSA-2017-0017,
FMCSA-2017-0019, FMCSA-2017-0020, FMCSA-2018-0017, FMCSA-2019-0005,
FMCSA-2019-0009, or FMCSA-2019-0011 in the keyword box, and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, click the ``Comment'' button, and type your
comment into the text box on 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.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-1998-4334, FMCSA-1999-5578, FMCSA-2000-7363, FMCSA-2001-
9258, FMCSA-2001-9561, FMCSA-2002-11714, FMCSA-2002-13411, FMCSA-2003-
14223, FMCSA-2003-14504, FMCSA-2003-15268, FMCSA-2005-20560, FMCSA-
2005-21254, FMCSA-2006-25246, FMCSA-2006-26066, FMCSA-2006-26653,
FMCSA-2007-2663, FMCSA-2007-27333, FMCSA-2007-27515, FMCSA-2007-27897,
FMCSA-2008-0021, FMCSA-2008-0106, FMCSA-2008-0340, FMCSA-2008-0398,
FMCSA-2009-0054, FMCSA-2009-0086, FMCSA-2009-0121, FMCSA-2009-0154,
FMCSA-2009-0291, FMCSA-2010-0082, FMCSA-2010-0187, FMCSA-2010-0354,
FMCSA-2010-0385, FMCSA-2010-0413, FMCSA-2011-0010, FMCSA-2011-0024,
FMCSA-2011-0092, FMCSA-2011-0102, FMCSA-2011-0140, FMCSA-2012-0040,
FMCSA-2012-0215, FMCSA-2012-0279, FMCSA-2012-0337, FMCSA-2013-0022,
FMCSA-2013-0024, FMCSA-2013-0025, FMCSA-2013-0027, FMCSA-2013-0028,
FMCSA-2013-0029, FMCSA-2013-0030, FMCSA-2014-0007, FMCSA-2014-0011,
FMCSA-2014-0296, FMCSA-2014-0298, FMCSA-2014-0302, FMCSA-2014-0304,
FMCSA-2014-0305, FMCSA-2015-0048, FMCSA-2015-0049, FMCSA-2015-0052,
FMCSA-2015-0053, FMCSA-2015-0055, FMCSA-2015-0072, FMCSA-2016-0030,
FMCSA-2016-0033, FMCSA-2016-0206, FMCSA-2016-0208, FMCSA-2016-0212,
FMCSA-2016-0213, FMCSA-2016-0214, FMCSA-2017-0014, FMCSA-2017-0017,
FMCSA-2017-0019, FMCSA-2017-0020, FMCSA-2018-0017, FMCSA-2019-0005,
FMCSA-2019-0009, or FMCSA-2019-0011 in the keyword box, and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click ``Browse Comments.'' If you do not
have access to the internet, you may view the docket online by visiting
Dockets Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

C. 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.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

    The 123 individuals listed in this notice have requested renewal of
their exemptions from the vision standard in Sec.  391.41(b)(10), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 123
applicants has satisfied the renewal conditions for obtaining an
exemption from the vision standard (see 63 FR 66226, 64 FR 16517, 64 FR
27027, 64 FR 51568, 65 FR 45817, 65 FR 77066, 66 FR 17743, 66 FR 30502,
66 FR 33990, 66 FR 41654, 66 FR 41656, 66 FR 48504, 67 FR 15662, 67 FR
37907, 67 FR 76439, 68 FR 10298, 68 FR 10301, 68 FR 19596, 68 FR 19598,
68 FR 33570, 68 FR 35772, 68 FR 37197, 68 FR 44837, 68 FR 48989, 68 FR
54775, 69 FR 26206, 70 FR 7545, 70 FR 16886, 70 FR 17504, 70 FR 25878,
70 FR 30997, 70 FR 30999, 70 FR 33937, 70 FR 41811, 70 FR 42615, 70 FR
46567, 70 FR 53412, 71 FR 26602, 71 FR 63379, 72 FR 180, 72 FR 1051, 72
FR 7812, 72 FR 8417, 72 FR 9397, 72 FR 12666, 72 FR 18726, 72 FR 21313,
72 FR 25831, 72 FR 27624, 72 FR 28093, 72 FR 32703, 72 FR 32705, 72 FR
36099, 72 FR 39879, 72 FR 40359, 72 FR 40360, 72 FR 52419, 72 FR 62896,
73 FR 15568, 73 FR 27017, 73 FR 35198, 73 FR 48275, 73 FR 75803, 73 FR
78423, 74 FR 6209, 74 FR 6211, 74 FR 7097, 74 FR 11988, 74 FR 11991, 74
FR 15584, 74 FR 15586, 74 FR 19267, 74 FR 19270, 74 FR 20253, 74 FR
21427, 74 FR 23472, 74 FR 26461, 74 FR 26464, 74 FR 26466, 74 FR 28094,
74 FR 34074, 74 FR 34395, 74 FR 34630, 74 FR 34632, 74 FR 37295, 74 FR
41971, 74 FR 43221, 74 FR 48343, 74 FR 65842, 75 FR 9482, 75 FR 25918,
75 FR 27621, 75 FR 38602, 75 FR 39729, 75 FR 44051, 75 FR 47883, 75 FR
63257, 75 FR 72863, 75 FR 77492, 75 FR 77942, 75 FR 79083, 76 FR 1493,
76 FR 2190, 76 FR 4413, 76 FR 5425, 76 FR 9856, 76 FR 9865, 76 FR
12408, 76 FR 15361, 76 FR 17481, 76 FR 20076, 76 FR 21796, 76 FR 25762,
76 FR 25766, 76 FR 28125, 76 FR 29022, 76 FR 29026, 76 FR 32016, 76 FR
32017, 76 FR 34135, 76 FR 37168, 76 FR 37169, 76 FR 37173, 76 FR 37885,
76 FR 44082, 76 FR 44652, 76 FR 44653, 76 FR 49531, 76 FR 50318, 76 FR
53708, 76 FR 54530, 77 FR 10606, 77 FR 23799, 77 FR 27849, 77 FR 33558,
77 FR 36338, 77 FR 40945, 77 FR 46153, 77 FR 52381, 77 FR 60008, 77 FR
60010, 77 FR 64841, 77 FR 70534, 77 FR 71671, 77 FR 74273, 77 FR 74734,
78 FR 797, 78 FR 800, 78 FR 9772, 78 FR 11731, 78 FR 12813, 78 FR
12815, 78 FR 12822, 78 FR 16761, 78 FR 16762, 78 FR 16912, 78 FR 20376,
78 FR 22596, 78 FR 22602, 78 FR 24300, 78 FR 24798, 78 FR 26106, 78 FR
27281, 78 FR 29431, 78 FR 30954, 78 FR 32703, 78 FR 32708, 78 FR 34140,
78 FR 34141, 78 FR 34143, 78 FR 37270, 78 FR 41188, 78 FR 41975, 78 FR
46407, 78 FR 51268, 78 FR 51269, 78 FR 52602, 78 FR 56986, 78 FR 56993,
78 FR 57679, 78 FR 76705, 78 FR 78477, 79 FR 4531, 79 FR 14328, 79 FR
35220, 79 FR 38659, 79 FR 45868, 79 FR 46153, 79 FR 53514, 79 FR 56099,
79 FR 58856, 79 FR 59357, 79 FR 69985, 79 FR 70928, 79 FR 72754, 79 FR
73686, 79 FR 73687, 79 FR 73689, 80 FR 603, 80 FR 3305, 80 FR 3308, 80
FR 3723, 80 FR 8751, 80 FR 8927, 80 FR 12248, 80 FR 12254, 80 FR 14220,
80 FR 14223, 80 FR 15863, 80 FR 16500, 80 FR 16502, 80 FR 18696, 80 FR
20559, 80 FR 22773, 80 FR 25766, 80 FR 25768, 80 FR 26139, 80 FR 26320,
80 FR 29149, 80 FR 29152, 80 FR 29154, 80 FR 31636, 80 FR 31640, 80 FR
31957, 80 FR 33007, 80 FR 33009, 80 FR 33011, 80 FR 35699, 80 FR 36398,
80 FR 37718, 80 FR 40122, 80 FR 41547, 80 FR 41548, 80 FR 44185, 80 FR
44188, 80 FR 45573, 80 FR 48402, 80 FR 48404, 80 FR 48409, 80 FR 48411,
80 FR 48413, 80 FR 49302, 80 FR 50915, 80 FR 50917, 80 FR 53383, 80 FR
62161, 80 FR 62163, 80 FR 70060, 81 FR 15401, 81 FR 16265, 81 FR 45214,
81 FR 59266, 81 FR 60115, 81 FR 66726, 81 FR 70253, 81 FR 71173, 81 FR
72642, 81 FR 74494, 81 FR 81230, 81 FR 86063, 81 FR 90050, 81 FR 91239,
81 FR 96165, 81 FR 96180, 81 FR 96191, 81 FR 96196, 82 FR 12678, 82 FR
12683, 82 FR 13043, 82 FR 13048, 82 FR 13187, 82 FR 15277, 82 FR 17736,
82 FR 18818, 82 FR 18949, 82 FR 20962, 82 FR 22379, 82 FR 23712, 82 FR
26224, 82 FR 32919, 82 FR 33542, 82 FR 34564, 82 FR 35043, 82 FR 37499,
82 FR 47295, 82 FR 47296, 83 FR 4537, 83 FR 6919, 83 FR 28325, 83 FR
34661, 83 FR 40638, 83 FR 45750, 83 FR 53724, 83 FR 56137, 83 FR 56902,
84 FR 2311, 84 FR 2314, 84 FR 2326, 84 FR 10389, 84 FR 12665, 84 FR
16320, 84 FR 21393, 84 FR 21397, 84 FR 21401, 84 FR 23629, 84 FR 33801,
84 FR 47038, 84 FR 47045, 84 FR 47047, 84 FR 47057, 84 FR 52166). They
have submitted evidence showing that the vision in the better eye
continues to meet the requirement specified at Sec.  391.41(b)(10) and
that the vision impairment is stable. In addition, a review of each
record of safety while driving with the respective vision deficiencies
over the past 2 years indicates each applicant continues to meet the
vision exemption requirements. These factors provide an adequate basis
for predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of September
and are discussed below.
    As of September 6, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following 115 individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (63 FR 66226, 64 FR 16517, 65 FR
45817, 65 FR 77066, 66 FR 17743, 66 FR 30502, 66 FR 33990, 66 FR 41654,
66 FR 41656, 67 FR 15662, 67 FR 37907, 67 FR 76439, 68 FR 10298, 68 FR
10301, 68 FR 19596, 68 FR 19598, 68 FR 33570, 68 FR 35772, 68 FR 37197,
68 FR 44837, 68 FR 48989, 69 FR 26206, 70 FR 7545, 70 FR 16886, 70 FR
17504, 70 FR 25878, 70 FR 30997, 70 FR 30999, 70 FR 33937, 70 FR 41811,
70 FR 42615, 70 FR 46567, 71 FR 26602, 71 FR 63379, 72 FR 180, 72 FR
1051, 72 FR 7812, 72 FR 8417, 72 FR 9397, 72 FR 12666, 72 FR 18726, 72
FR 21313, 72 FR 25831, 72 FR 27624, 72 FR 28093, 72 FR 32703, 72 FR
32705, 72 FR 36099, 72 FR 40359, 72 FR 40360, 72 FR 62896, 73 FR 15568,
73 FR 27017, 73 FR 35198, 73 FR 48275, 73 FR 75803, 73 FR 78423, 74 FR
6209, 74 FR 6211, 74 FR 7097, 74 FR 11988, 74 FR 11991, 74 FR 15584, 74
FR 15586, 74 FR 19267, 74 FR 19270, 74 FR 20253, 74 FR 21427, 74 FR
23472, 74 FR 26461, 74 FR 26464, 74 FR 26466, 74 FR 28094, 74 FR 34074,
74 FR 34395, 74 FR 34630, 74 FR 34632, 74 FR 43221, 74 FR 65842, 75 FR
9482, 75 FR 25918, 75 FR 27621, 75 FR 38602, 75 FR 39729, 75 FR 44051,
75 FR 47883, 75 FR 63257, 75 FR 72863, 75 FR 77492, 75 FR 77942, 75 FR
79083, 76 FR 1493, 76 FR 2190, 76 FR 4413, 76 FR 5425, 76 FR 9856, 76
FR 9865, 76 FR 12408, 76 FR 15361, 76 FR 17481, 76 FR 20076, 76 FR
21796, 76 FR 25762, 76 FR 25766, 76 FR 28125, 76 FR 29022, 76 FR 29026,
76 FR 32016, 76 FR 32017, 76 FR 34135, 76 FR 37168, 76 FR 37169, 76 FR
37173, 76 FR 37885, 76 FR 44082, 76 FR 44652, 76 FR 44653, 76 FR 49531,
76 FR

50318, 76 FR 53708, 77 FR 10606, 77 FR 23799, 77 FR 27849, 77 FR 33558,
77 FR 36338, 77 FR 40945, 77 FR 46153, 77 FR 52381, 77 FR 60008, 77 FR
60010, 77 FR 64841, 77 FR 70534, 77 FR 71671, 77 FR 74273, 77 FR 74734,
78 FR 797, 78 FR 800, 78 FR 9772, 78 FR 11731, 78 FR 12813, 78 FR
12815, 78 FR 12822, 78 FR 16761, 78 FR 16762, 78 FR 16912, 78 FR 20376,
78 FR 22596, 78 FR 22602, 78 FR 24300, 78 FR 24798, 78 FR 26106, 78 FR
27281, 78 FR 29431, 78 FR 30954, 78 FR 32703, 78 FR 32708, 78 FR 34140,
78 FR 34141, 78 FR 34143, 78 FR 37270, 78 FR 41188, 78 FR 46407, 78 FR
51268, 78 FR 51269, 78 FR 52602, 78 FR 56993, 78 FR 57679, 78 FR 76705,
78 FR 78477, 79 FR 4531, 79 FR 14328, 79 FR 35220, 79 FR 38659, 79 FR
45868, 79 FR 46153, 79 FR 53514, 79 FR 56099, 79 FR 58856, 79 FR 59357,
79 FR 69985, 79 FR 70928, 79 FR 72754, 79 FR 73686, 79 FR 73687, 79 FR
73689, 80 FR 603, 80 FR 3305, 80 FR 3308, 80 FR 3723, 80 FR 8751, 80 FR
8927, 80 FR 12248, 80 FR 12254, 80 FR 14220, 80 FR 14223, 80 FR 15863,
80 FR 16500, 80 FR 16502, 80 FR 18696, 80 FR 20559, 80 FR 22773, 80 FR
25766, 80 FR 25768, 80 FR 26139, 80 FR 26320, 80 FR 29149, 80 FR 29152,
80 FR 29154, 80 FR 31636, 80 FR 31640, 80 FR 31957, 80 FR 33007, 80 FR
33009, 80 FR 33011, 80 FR 35699, 80 FR 36398, 80 FR 37718, 80 FR 40122,
80 FR 41547, 80 FR 41548, 80 FR 44185, 80 FR 44188, 80 FR 45573, 80 FR
48404, 80 FR 48409, 80 FR 48413, 80 FR 50917, 80 FR 62161, 80 FR 62163,
80 FR 70060, 81 FR 15401, 81 FR 16265, 81 FR 45214, 81 FR 59266, 81 FR
60115, 81 FR 66726, 81 FR 70253, 81 FR 71173, 81 FR 72642, 81 FR 74494,
81 FR 81230, 81 FR 86063, 81 FR 90050, 81 FR 91239, 81 FR 96165, 81 FR
96180, 81 FR 96191, 81 FR 96196, 82 FR 12678, 82 FR 12683, 82 FR 13043,
82 FR 13048, 82 FR 13187, 82 FR 15277, 82 FR 17736, 82 FR 18818, 82 FR
18949, 82 FR 20962, 82 FR 22379, 82 FR 23712, 82 FR 26224, 82 FR 32919,
82 FR 33542, 82 FR 34564, 82 FR 35043, 82 FR 37499, 82 FR 47295, 82 FR
47296, 83 FR 4537, 83 FR 6919, 83 FR 28325, 83 FR 34661, 83 FR 40638,
83 FR 45750, 83 FR 53724, 83 FR 56137, 83 FR 56902, 84 FR 2311, 84 FR
2314, 84 FR 2326, 84 FR 10389, 84 FR 12665, 84 FR 16320, 84 FR 21393,
84 FR 21397, 84 FR 21401, 84 FR 23629, 84 FR 33801, 84 FR 47038, 84 FR
47045, 84 FR 47047, 84 FR 47057, 84 FR 52166):

Stanley C. Anders (SD)
Joseph W. Bahr (NJ)
Kreis C. Baldridge (TN)
Timothy D. Beaulier (MI)
Roosevelt Bell, Jr. (NC)
Rex A. Botsford (MI)
William L. Brady (KS)
Ryan L. Brown (IL)
Dale E. Bunke (ID)
Danny F. Burnley (KY)
Joseph L. Butler (IN)
Shawn M. Carroll (OK)
Bernabe V. Cerda (TX)
Paul M. Christina (PA)
Randy A. Cimei (IL)
Daniel G. Cohen (VT)
Gary G. Colby (UT)
Joseph W. Colecchi (PA)
Sean R. Conorman (MI)
William T. Costie (NY)
Jeffrey W. Cotner (OR)
Kenneth D. Craig (VA)
Edwin P. Davis (OR)
Edwin T. Donaldson (PA)
Everett A. Doty (AZ)
Rex A. Dyer (VT)
John A. Edison (GA)
Paul E. Emmons (RI)
James G. Etheridge (TX)
Randy L. Fales (MN)
Ray A. Fields (KS)
Dennis E. Fisher (NY)
Paul T. Fisher (MA)
Steven C. Fox (NC)
Steve L. Frisby (CA)
Patrick J. Goebel (IA)
Wladyslaw Gogola (IL)
Antonio Gomez (PA)
Timothy M. Good (MI)
Sanford L. Goodwin (TX)
Johnny J. Gowdy (MS)
Randy N. Grandfield (VT)
Edward J. Grant (IL)
Robert E. Graves (NE)
Samuel R. Graziano (PA)
Rocky D. Gysberg (MN)
Gary D. Hallman (AL)
Kenneth L. Handy (IA)
Paul R. Harpin (AZ)
Britt D. Hazelwood (IL)
George F. Hernandez, Jr. (AZ)
Andrew F. Hill (TX)
Wade M. Hillmer (MN)
Charlie E. Hoggard (TX)
David A. Inman (IN)
Donald M. Jenson (SD)
Daryl A. Jester (DE)
John T. Johnson (NM)
William D. Johnson (OK)
Christopher J. Kane (VT)
Christopher M. Keen (KS)
James J. Keranen (MI)
Lester H. Killingsworth (TX)
Laine Lewin (MN)
Craig M. Mahaffey (OH)
Michael G. Martin (CT)
Joe A. McIlroy (NY)
Luther A. McKinney (VA)
Gary G. McKown (WV)
Raymond W. Meier (WA)
Carlos A. Mendez-Castellon (VA)
Brian P. Millard (SC)
Jeffrey T. Molosz (IL)
Daniel R. Murphy (WI)
Warren J. Nyland (MI)
Jeffrey L. Olson (MN)
Mark A. Omps (WV)
Jerry D. Paul (OK)
Johnny A. Peery (MD)
David Perkins (NY)
Juan C. Puente (TX)
Donie L. Rhoads (MT)
Robert E. Richards (ME)
James R. Robinette (VA)
Steven D. Scharber (MN)
Mark A. Schlesselman (OH)
Raymond Sherrill (PA)
James Smentkowski (NJ)
Dennis J. Smith (CO)
Myron A. Smith (MN)
Harry Smith, Jr. (NC)
Francis A. St. Pierre (NH)
Jerry M. Stearns (AR)
Donald E. Stone (VA)
Thomas E. Summers, Sr. (OH)
Warren Supulski (NC)
Paul C. Swanson (IL)
Grover C. Taylor (VA)
Jon C. Thompson (TX)
Anthony J. Thornburg (MI)
Donald R. Torbett (IA)
Wesley E. Turner (TX)
Eric M. Turton (NY)
Donald A. Uplinger II (OH)
Mona J. Van Krieken (OR)
Lynn D. Veach (IA)
Scott Wallbank (MA)
Roy J. Ware (GA)
Donald L. Weston (PA)
Jeff L. Wheeler (IA)
Theodore A. White (PA)
Wayne A. Whitehead (NY)
Cameron R. Whitford (NY)
David Wiebe (TX)
Paul A. Wolfe (OH)

    The drivers were included in docket numbers FMCSA-1998-4334, FMCSA-
2000-7363, FMCSA-2001-9258, FMCSA-2001-9561, FMCSA-2002-11714, FMCSA-
2002-13411, FMCSA-2003-14223, FMCSA-2003-14504, FMCSA-2003-15268,
FMCSA-2005-20560, FMCSA-2005-21254, FMCSA-2006-25246, FMCSA-2006-26066,
FMCSA-2006-26653, FMCSA-2007-2663, FMCSA-2007-27333, FMCSA-2007-27515,
FMCSA-2008-0021, FMCSA-2008-0106, FMCSA-2008-0340, FMCSA-2008-0398,
FMCSA-2009-0054, FMCSA-2009-0086, FMCSA-2009-0121, FMCSA-2009-0291,
FMCSA-2010-0082, FMCSA-2010-0187, FMCSA-2010-0354, FMCSA-2010-0385,
FMCSA-2010-0413, FMCSA-2011-0010, FMCSA-2011-0024, FMCSA-2011-0092,
FMCSA-2011-0102, FMCSA-2011-0140, FMCSA-2012-0040, FMCSA-2012-0215,
FMCSA-2012-0279, FMCSA-2012-0337, FMCSA-2013-0022, FMCSA-2013-0024,
FMCSA-2013-0025, FMCSA-2013-0027, FMCSA-2013-0028, FMCSA-2013-0029,
FMCSA-2014-0007, FMCSA-2014-0011, FMCSA-2014-0296, FMCSA-2014-0298,
FMCSA-2014-

0302, FMCSA-2014-0304, FMCSA-2014-0305, FMCSA-2015-0048, FMCSA-2015-
0049, FMCSA-2015-0052, FMCSA-2015-0053, FMCSA-2015-0055, FMCSA-2015-
0072, FMCSA-2016-0030, FMCSA-2016-0033, FMCSA-2016-0206, FMCSA-2016-
0208, FMCSA-2016-0212, FMCSA-2016-0213, FMCSA-2016-0214, FMCSA-2017-
0014, FMCSA-2017-0017, FMCSA-2017-0019, FMCSA-2017-0020, FMCSA-2018-
0017, FMCSA-2019-0005, FMCSA-2019-0009, and FMCSA-2019-0011. Their
exemptions are applicable as of September 6, 2021 and will expire on
September 6, 2023.
    As of September 7, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following individual has satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (76 FR 37169, 76 FR 50318, 78 FR
78477, 80 FR 50915, 83 FR 4537, 84 FR 47038):

Charles E. Carter (MI)

    The driver was included in docket number FMCSA-2011-0140. The
exemption is applicable as of September 7, 2021 and will expire on
September 7, 2023.
    As of September 13, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (72 FR 39879, 72 FR 52419, 74 FR
41971, 76 FR 54530, 78 FR 78477, 80 FR 48402, 83 FR 4537, 84 FR 47038):

Ray C. Johnson (AR); and Joshua R. Perkins (ID)

    The drivers were included in docket number FMCSA-2007-27897. Their
exemptions are applicable as of September 13, 2021 and will expire on
September 13, 2023.
    As of September 16, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (78 FR 41975, 78 FR 56986, 80 FR
48411, 83 FR 4537, 84 FR 47038):

Carl H. Block (NY); and Vincent E. Marsee, Sr. (NC)

    The drivers were included in docket number FMCSA-2013-0030. Their
exemptions are applicable as of September 16, 2021 and will expire on
September 16, 2023.
    As of September 22, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following individual has satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (74 FR 37295, 74 FR 48343, 76 FR
53708, 78 FR 78477, 80 FR 49302, 83 FR 4537, 84 FR 47038):

Samuel A. Miller (IN)

    The driver was included in docket number FMCSA-2009-0154. The
exemption is applicable as of September 22, 2021 and will expire on
September 22, 2023.
    As of September 23, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (64 FR 27027, 64 FR 51568, 66 FR
48504, 68 FR 19598, 68 FR 33570, 68 FR 54775, 70 FR 53412, 72 FR 62896,
74 FR 43221, 76 FR 53708, 78 FR 78477, 80 FR 53383, 83 FR 4537, 84 FR
47038):

Weldon R. Evans (OH); and Orasio Garcia (TX)

    The drivers were included in docket numbers FMCSA-1999-5578 and
FMCSA-2003-14504. Their exemptions are applicable as of September 23,
2021 and will expire on September 23, 2023.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must undergo an annual physical examination (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a certified medical examiner (ME), as defined by Sec.
390.5, who attests that the driver is otherwise physically qualified
under Sec.  391.41; (2) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the ME at the time of the
annual medical examination; and (3) each driver must provide a copy of
the annual medical certification to the employer for retention in the
driver's qualification file or keep a copy of his/her driver's
qualification if he/her is self-employed. The driver must also have a
copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official. The exemption
will be rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 123 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the vision
requirement in Sec.  391.41(b)(10), subject to the requirements cited
above. In accordance with 49 U.S.C. 31136(e) and 31315(b), each
exemption will be valid for 2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-16540 Filed 8-3-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: April 27, 2010 (Volume 75, Number 80)]
[Notices]
[Page 22169-22170]
[DOCID:fr27ap10-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61947; File No. SR-NYSE-2010-18]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving Proposed Rule Change To Amend the Bylaws of NYSE Euronext To
Adopt a Majority Voting Standard in Uncontested Elections of Directors

April 20, 2010.
    On March 5, 2010, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend the By-Laws of its parent corporation,
NYSE Euronext (``Corporation''). The proposed rule change was published
for comment in the Federal Register on March 18, 2010.\3\ The
Commission received no comment letters on the proposed rule change.
This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61694 (March 11,
2010), 75 FR 13170.
---------------------------------------------------------------------------

    On behalf of the Corporation, NYSE proposed to make certain
amendments to the Corporation's By-Laws to modify its direct election
procedures. Under the existing By-Laws, directors are elected by a
plurality of the votes of the shares present in person or represented
by proxy at the meeting and entitled to vote on the election of
directors. Under the Corporation's corporate governance guidelines
previously adopted by the Board, however, any director nominee in an
uncontested election (being an election in which the number of nominees
equals the number of directors to be elected) who receives a greater
number of ``withheld'' votes than ``for'' votes (including any
``against'' votes if that option were to be made available on the proxy
card) must immediately tender his or her resignation from the Board.
    NYSE proposed to amend the Corporation's By-Laws to add an explicit
majority voting provision for uncontested director elections that would
replace the plurality vote standard for such elections that is
currently in the By-Laws. Contested elections would remain subject to
the plurality standard.
    Under the proposed amendment to the Bylaws, the proxy card would
change for an uncontested election, and the stockholders would be given
the choice to vote ``for,'' ``against'' or ``abstain'' with respect to
each director nominee individually. In such an election, each director
would be elected by the vote of the majority of the votes cast with
respect to such director's election, meaning that the number of votes
cast ``for'' such director's election exceeded the number of votes cast
``against'' that director's election (with ``abstentions'' not counted
as a vote either ``for'' or ``against'' such director's election). If
any incumbent director fails to receive a majority of the votes cast,
such director would be required to tender his or her resignation to the
Nominating and Governance Committee of the Board (or another committee
designated by the Board), and such committee would recommend to the
Board whether to accept or reject such resignation or whether other
action should be taken. The Board would then act on the recommendation
of such committee and publicly disclose its decision regarding the
tendered resignation and the rationale behind the decision.\4\
---------------------------------------------------------------------------

    \4\ The proposed amendment to the Bylaws also provides that a
director who tenders his or her resignation would not participate in
the recommendation by the Nominating and Governance Committee or the
Board of Directors action regarding whether to accept the tendered
resignation. If each member of the Nominating and Governance
Committee fails to receive a majority of the votes cast in the same
uncontested election, then the independent directors who received a
majority of the votes cast in such election must appoint a committee
among themselves to consider the tendered resignation and recommend
to the Board whether to accept it. However, if the only directors
who received a majority of the votes cast in such election
constitute three or fewer directors, all directors may participate
in the action regarding whether to accept the tendered resignation.
---------------------------------------------------------------------------

    Pursuant to the proposed amendment to the By-Laws, if the Board
accepts a director's resignation as part of the process described above
for uncontested elections, or if a nominee for director is not elected
and the nominee is not an incumbent director, the Board may (i) fill
the remaining vacancy as provided in Section 3.6 of the By-Laws and
Article VI, Section 6 of the Certificate of Incorporation (involving a
majority vote of the remaining directors then in office, though less
than a quorum, or by the sole remaining director) or (ii) decrease the
size of the Board as provided in Section 3.1 of the Bylaws and Article
VI, Section 3 of the Certificate of Incorporation (involving adoption
of a resolution by two-thirds of the directors then in office).
    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\5\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(1) of the Act,\6\ which requires an
exchange to be so organized and have the capacity to carry out the
purposes of the Act and to comply and to enforce compliance by its
members and persons associated with its members with the Act. The
Commission also finds that the

proposed rule change is consistent with Section 6(b)(5) of the Act,\7\
which requires that the rules of the exchange be designed, among other
things, to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \5\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78(b)(1).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule change to amend the
Corporation's By-Laws to adopt a majority vote standard for uncontested
elections is consistent with the Act. The Commission believes that the
proposed rule change is designed to allow the members of the
Corporation's Board of Directors to be elected in a manner that closely
reflects the desires of its shareholders, while also providing a
process for addressing the circumstance when a director fails to
receive a majority of votes in an uncontested election.\8\
---------------------------------------------------------------------------

    \8\ The Commission notes that NYSE represented that the proposed
change would not affect the voting limitations contained in the
Corporation's certificate of incorporation.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-NYSE-2010-18) be, and it hereby is,
approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-9679 Filed 4-26-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49400-49403]
[FR Doc No: 2018-21314]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3124]

Adaptive Designs for Clinical Trials of Drugs and Biologics;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Adaptive
Designs for Clinical Trials of Drugs and Biologics.'' This document
provides guidance to sponsors and applicants submitting investigational
new drug applications (INDs), new drug applications (NDAs), biologics
license applications (BLAs), or supplemental applications on the
appropriate use of adaptive designs for clinical trials to provide
evidence of the effectiveness and safety of a drug or biologic. The
guidance describes the basic principles for designing, conducting, and
reporting the results from an adaptive clinical trial. The draft
guidance will replace the 2010 draft guidance for industry entitled
``Adaptive Design Clinical Trials for Drugs and Biologics.''

DATES: Submit either electronic or written comments on the draft
guidance by November 30, 2018 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-2018-D-3124 for ``Adaptive Designs for Clinical Trials of Drugs and
Biologics; Draft Guidance for Industry.'' 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 office between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Scott Goldie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301-
794-2055; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Adaptive Designs for Clinical Trials of Drugs and
Biologics.'' This document provides guidance to sponsors and applicants
submitting INDs, NDAs, BLAs, or supplemental applications on the
appropriate use of adaptive designs

for clinical trials to provide evidence of the effectiveness and safety
of a drug or biologic. The guidance describes the basic principles for
designing, conducting, and reporting the results from an adaptive
clinical trial. The guidance also advises sponsors on the types of
information FDA needs to evaluate the results from clinical trials with
adaptive designs, including Bayesian adaptive designs and complex
designs that rely on computer simulations for their design. This
guidance meets FDA's performance commitment under PDUFA (Prescription
Drug User Fee Act) VI to publish draft guidance on complex adaptive
(including Bayesian adaptive) trial designs by the end of fiscal year
2018.
    The primary focus of this guidance is on adaptive designs for
clinical trials intended to support the effectiveness and safety of
drugs or biologics. The concepts discussed are also useful for early
phase or exploratory clinical trials as well as trials conducted to
satisfy postmarketing commitments or requirements. The draft guidance
will replace the 2010 draft guidance for industry entitled ``Adaptive
Design Clinical Trials for Drugs and Biologics.''
    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 ``Adaptive
Designs for Clinical Trials of Drugs and Biologics.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    The draft guidance discusses several collections of information
that have been approved by OMB. For example, the draft guidance
explains that sponsors who have questions about adaptive design
elements in an early-phase exploratory trial should seek FDA feedback
by either identifying specific questions in a submission containing the
protocol or by requesting a meeting to discuss those questions.
Discussion of the plans for an adaptive trial can be the basis for
requesting a Type C meeting. Regulatory mechanisms for obtaining
formal, substantive feedback from FDA on clinical trials may also
include end-of-phase 2 meetings. The draft guidance also recommends
that special protocol assessments (given the 45-day response timeline)
are submitted for trials with complex adaptive designs only if there
has been extensive previous discussion between FDA and the sponsor
regarding the proposed trial and design. The draft guidance explains
that in their submissions, the sponsors should pre-specify the details
of the adaptive design and provide justification that the chances of
erroneous conclusions will be adequately controlled, estimation of
treatment effects will be sufficiently reliable, and trial integrity
will be appropriately maintained. The draft guidance notes that the
sponsor should advise FDA during the course of a trial of any proposed
changes to the trial design (usually through protocol amendments), and
that FDA may request that the sponsor submit minutes from open sessions
of a monitoring committee during an ongoing trial.
    FDA has OMB approval under the PRA for the submission of INDs,
including protocol amendments and information amendments, in 21 CFR
part 312, subpart B, and sponsors may request comment and advice on an
IND as well as request meetings with FDA under subpart C (OMB control
number 0910-0014). In addition, the following collections of
information that have been approved by OMB would cover other
submissions discussed in the draft guidance:
     Guidance for industry on formal meetings with sponsors and
applicants for PDUFA products (OMB control number 0910-0429);
     Guidance for Industry on special protocol assessment (OMB
control number 0910-0470);
     Guidance for industry on clinical trial data monitoring
committees (OMB control number 0910-0581);
     Guidance for industry on oversight of clinical
investigations (OMB control number 0910-0733);
     International Council for Harmonization guidance for
industry ``E6(R2) Good Clinical Practice'' (OMB control number 0910-
0843);
     Protection of Human Subjects: Informed Consent;
Institutional Review Boards (21 CFR parts 50 and 56) (OMB control
number 0910-0755);
     Institutional Review Boards (21 CFR 56.115) (OMB control
number 0910-0130); and
     Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products (OMB control number 0910-
0572).
    In addition, the submission of NDAs, including 21 CFR 314.50(d)(5)
(clinical data section) and (d)(6) (statistical section), has been
approved under OMB control number 0910-0001. The submission of BLAs and
their supplements has been approved under OMB control number 0910-0338.
    The draft guidance also requests the submission of information that
has not been approved by OMB under the PRA.
    In section VIII.B, the draft guidance states that the documented
plan for a clinical trial with a proposed adaptive design should
include the information described below. The information could be
included in the clinical trial protocol and/or in separate documents,
such as a statistical analysis plan, a data monitoring committee (DMC)
charter, or an adaptation committee charter. Although different types
of information might be included in different documents, all important
information described below should be submitted to FDA during the
design stage so that FDA has sufficient time to provide feedback prior
to initiation of the clinical trial:
     A rationale for the selected design;
     A detailed description of the monitoring and adaptation
plan, including the anticipated number and

timing of interim analyses, the specific aspects of the design that may
be modified, and the specific rule that will be used to make adaptation
decisions;
     Information on the roles of the bodies responsible for
implementing the adaptive design, such as the DMC and/or the dedicated
adaptation committee;
     Pre-specification of the statistical methods that will be
used to produce interim results and guide adaptation decisions, and to
carry out hypothesis tests, estimate treatment effects, and estimate
uncertainty in treatment effect estimates at the end of the trial;
     Evaluation and discussion of the design operating
characteristics;
     When simulations are the primary or sole technique for
evaluating trial operating characteristics, a detailed simulation
report should be submitted, including:
    [cir] An overall description of the trial design;
    [cir] Example trials, in which a small number of hypothetical
trials are described with different conclusions, such as a positive
trial with the original sample size, a trial stopped for futility after
the first interim look, a positive trial after increasing the sample
size;
    [cir] A description of the set of parameter configurations used for
the simulation scenarios, including a justification of the adequacy of
the choices;
    [cir] Simulation results detailing the estimated Type I error
probability and power under the various scenarios;
    [cir] Simulation code that is readable and adequately commented and
should include the random seeds used to generate the simulation
results;
    [cir] A summary providing overall conclusions.
     A comprehensive written data access plan defining how
trial integrity will be maintained in the presence of the planned
adaptations. This documentation should include the following
information: (1) The personnel who will perform the interim analyses;
(2) the personnel who will have access to interim results; (3) how that
access will be controlled; (4) how adaptive decisions will be made; and
(5) what type of information will be disseminated following adaptive
decisions, and to whom it will be disseminated. The data access plan
should describe what information, under what circumstances, is
permitted to be passed to the sponsor or investigators. In addition, it
is recommended that sponsors establish procedures to evaluate
compliance with the data access plan and to document all interim
meetings of the committee tasked with making adaptation decisions,
i.e., the DMC or other adaptation committee (e.g., with written minutes
describing what was reviewed, discussed, and decided).
    In section VIII.C, the draft guidance states that a marketing
application to FDA that relies on a trial with an adaptive design
should include, in addition to the typical content of that marketing
application, sufficient information and documentation to allow FDA to
thoroughly review the results, including:
     All prospective plans, any relevant committee charters
(e.g., the DMC or adaptation committee charter), and any supporting
documentation (e.g., literature references, programming code,
simulation report);
     Information on compliance with the planned adaptation rule
and with the procedures outlined in the data access plan to maintain
trial integrity;
     Records of deliberations and participants for any interim
discussions by any committees involved in the adaptive process;
     Results of the interim analyses used for the adaptation
decisions;
     Appropriate reporting of the adaptive design and trial
results in the proposed package insert. For example, the trial summary
should describe the adaptive design utilized. In addition, treatment
effect estimates should appropriately take the design into account, or
if na[iuml]ve estimates such as unadjusted sample means are used, the
extent of bias should be evaluated and estimates should be presented
with appropriate cautions regarding their interpretation.
    Based on our review of INDs, NDAs, BLAs, and supplemental
applications for the use of adaptive designs for clinical trials to
provide evidence of effectiveness and safety, we estimate that
approximately 40 sponsors or applicants (``number of respondents'' in
table 1, row 1) will prepare approximately 240 documented plans for
clinical trials containing a proposed adaptive design and analysis plan
and will submit this information to FDA in a clinical trial protocol
and/or in separate documents such as a statistical analysis plan, a DMC
charter, or an adaptation committee charter (``total annual responses''
in table 1, row 1), and that preparing and submitting this information
will take approximately 50 hours per sponsor or applicant (``average
burden per response'' in table 1, row 1).
    In addition, we estimate that approximately 15 sponsors or
applicants (``number of respondents'' in table 1, row 2) will prepare
and submit to FDA approximately 20 marketing applications that rely on
a trial with an adaptive design (``total annual responses'' in table 1,
row 2), and that preparing and submitting this information will take
approximately 50 hours per sponsor or applicant (``average burden per
response'' in table 1, row 2).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Guidance on adaptive designs for                     Number of                        Average
  clinical trials of drugs and       Number of     responses per   Total  annual    burden per      Total hours
            biologics               respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Clinical trial protocols and                  40               6             240              50          12,000
 related submissions to FDA with
 an adaptive design and analysis
 plan should contain the
 information in section VIII.B..
Marketing applications that rely              15            1.33              20              50           1,000
 on studies with an adaptive
 design should contain the
 information in section VIII.C..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          13,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21314 Filed 9-28-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Rules and Regulations]
[Pages 52392-52393]
[FR Doc No: 2015-21414]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-1623; Airspace Docket No. 15-AWP-10]

Amendment of Class E Airspace; Tracy, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace extending upward from
700 feet above the surface at Tracy Municipal Airport, Tracy, CA. After
a review, and the decommissioning of the Manteca VHF omnidirectional
radio range and distance measuring equipment (VOR/DME), the FAA found
it necessary to amend the airspace area for the safety and management
of Standard Instrument Approach Procedures for Instrument Flight Rules
(IFR) operations at the airport.

DATES: Effective 0901 UTC, October 15, 2015. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. For further information, you can
contact the Airspace Policy and ATC Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 29591;
Telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call (202)
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Rob Riedl, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106,
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Tracy, CA.

History

    On June 23, 2015, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to modify Class E airspace at
Tracy Municipal Airport, Tracy, CA (80 FR 35890) . Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, Airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class E airspace areas extending upward from 700 feet
or more above the surface of the earth at Tracy Municipal Airport,
Tracy, CA. Decommissioning of the Manteca VOR/DME and further review of
the airspace has made this action necessary for the safety and
management of standard instrument approach procedures for IFR
operations at the airport. Class E airspace extending upward from 700
feet above the surface is modified to

within a 3.9-mile radius of Tracy Municipal Airport with segments
extending from the 3.9-mile radius to 11 miles northwest, 6.4 miles
east, and 9 miles southeast, of the airport.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(f), 106(g): 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth

* * * * *

AWP CA E5 Tracy, CA (Modified)

Tracy Municipal Airport, CA
    (lat. 37[deg]41'21'' N., long. 121[deg]26'31'' W.)

    That airspace extending upward from 700 feet above the surface
within a 3.9-mile radius of Tracy Municipal Airport, and within 2
miles each side of the 326[deg] bearing from the airport extending
from the 3.9-mile radius to 11 miles northwest of the airport, and
that airspace 1.8 miles either side of the airport 132[deg] bearing
from the 3.9-mile radius to 9 miles southeast of the airport, and
that airspace 2.2 miles either side of the airport 097[deg] bearing
from the 3.9-mile radius to 6 miles east of the airport.

    Issued in Seattle, Washington, on August 17, 2015.
Christopher Ramirez,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-21414 Filed 8-28-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 238 (Thursday, December 10, 2020)]
[Notices]
[Page 79489]
[FR Doc No: 2020-27121]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2020-0673; FRL-10018-43-OW]

Applying the Supreme Court's County of Maui v. Hawaii Wildlife
Fund Decision in the Clean Water Act Section 402 National Pollutant
Discharge Elimination System Permit Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of draft guidance and request for
comment.

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

SUMMARY: The Environmental Protection Agency (EPA) is issuing a draft
memorandum to provide guidance to the regulated community and
permitting authorities on applying the recent decision of the United
States Supreme Court in County of Maui v. Hawaii Wildlife Fund, 140 S.
Ct. 1462 (2020), in the Clean Water Act Section 402 National Pollutant
Discharge Elimination System (NPDES) permit program for point source
discharges that travel through groundwater before reaching waters of
the United States. Consistent with EPA Guidance; Administrative
Procedures for Issuance and Public Petitions, published in the Federal
Register on October 19, 2020, EPA is soliciting public comments on the
draft memorandum for thirty days. The Agency may pursue a future
rulemaking action to provide greater regulatory certainty concerning
discharges subject to the NPDES permit program. This draft guidance
document does not have the force and effect of law and it does not bind
the public in any way. By issuing this draft guidance memorandum, the
Agency intends only to provide clarity to the public regarding existing
requirements under the law or Agency policies.

DATES: Comments must be received on or before January 11, 2021.

ADDRESSES: You may submit comments, identified by Docket ID No. EPA-HQ-
OW-2020-0673, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from regulations.gov. 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. 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, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epadockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email and telephone. For the latest status information on
EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Scott Wilson, Office of Wastewater
Management, Water Permits Division (MC4203M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
A. How can I get copies of this document and other related information?

    You may access this document electronically at https://www.epa.gov/npdes/releases-point-source-groundwater or at https://www.federalregister.gov. EPA has established an official public docket
for receiving comments under Docket ID No. EPA-HQ-OW-2020-0673 which is
accessible electronically at http://www.regulations.gov that will also
contain copies of this Federal Register notice. The public docket does
not include CBI or other information whose disclosure is restricted by
statute. The telephone number for the Water Docket is<PHONE_NUMBER>.

    Dated: December 4, 2020.
David P. Ross,
Assistant Administrator, Office of Water.
[FR Doc. 2020-27121 Filed 12-9-20; 8:45 am]
BILLING CODE 6560-50-P


October 31, 2006

Ms. Kelly Sherman

U.S. EPA

Office of Pesticide Programs

Document Processing Desk

Room S-4900

One Potomac Yard

2777 S. Crystal Drive

Arlington, VA  22202

Dear Kelly,

There has been considerable activity these past couple of days among the
rodenticide stakeholders in an effort to propose a unified position on
mitigation.  This position has already been communicated to the EPA via
the Rodenticide Registrants Task Force. The National Pest Management
Association will do likewise. Bell Laboratories, Inc. supports the
position of these groups. Because I feel that it has not been fully
addressed or considered, I would like to reinforce the importance of
those engaged in farming operations.

Farmers are businessmen and wear many hats due to the nature of their
business. They are usually engaged in a wide array of activities in
running their operation.  They are usually do-it-yourself minded and
don’t enlist in professional for hire services unless it is absolutely
essential.  This is no different when it comes to rodent control.
Rodents are an ongoing problem on nearly all farms, including poultry,
dairy, grain, vegetable, fruit, cotton and seed operations, just to name
a few. Some farm operations include on-site food processing and
packaging which are required to be rodent free for obvious contamination
concerns. Rodents infringe on all of these types of operations in a very
significant way.

Farmers don’t purchase their rodenticides from Wal-Mart, Home Depot
and many other chains of this type like urbanites and suburbanites are
accustomed to doing. Their purchases are at farm stores where they buy
in larger volumes because they have so much to tend to.  They also do it
for cost-savings, convenience and one-stop shopping for other items that
may be needed for their farm operation. My opinion is that farmers have
done a remarkable job in their rodent control efforts.  While many
farmers have some type of pesticide applicators license, there are many
more that do not have such a license. They are accustomed to buying
their product at the farm store and then simply placing the product
where necessary according to the label directions given.  I see them as
being very experienced and responsible and place them in a category of
someone who is required to use rodenticides as part of their job and
running their business.  They are in a unique class, different from
professional pest control operators and different from the urban
consumer.

In the mitigation measures offered up by industry, the farmer is listed
alongside the certified applicator so that he/she will have access to
those products that have professional labels and can use these products
outdoors as well as indoors. Bell Laboratories, Inc. and the rest of the
industry supports this as illustrated in their mitigation proposal.  I
felt it important elaborate on the importance of the farming operation
segment and ask that you support their efforts by allowing continued
access to professional products for rodent control.

Sincerely,

John Lublinkhof, Ph.D.

Director of Regulatory Affairs

Cc:  Dr. Debra Edwards

        Ms. Susan Lewis