AIPORT DEICING CBI REPLACEMENT PAGE

OW-2004-0038

DCN __AD00734____________

THE FOLLOWING HAS BEEN REMOVED BECAUSE IT CONTAINS CONFIDENTIAL BUSINESS INFORMATION (CBI) PER

40 CFR PART 2, SUBPART B.


[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Notices]
[Pages 38454-38455]
[FR Doc No: 2011-16414]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0171]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 of the Code of Federal
Regulations (CFR), this document provides the public notice that by a
document dated March 31, 2011, the California State Railroad Museum
(CSRM) has petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR parts 215, 223 and 224. FRA
assigned the petition Docket Number FRA-2010-0171.
    Specifically, CSRM seeks a waiver of compliance from the Railroad
Freight Car Safety Standards, 49 CFR 215.303, which requires stenciling
on restricted freight cars for caboose (UP 25256) and box car (PFE
300001); Safety Glazing Standards, 49 CFR 223.13, which requires safety
glazing for caboose (UP 25256); and Reflectorization of Rail Freight
Rolling Stock, 49 CFR 224.3, which requires application of reflective
materials for freight cars and locomotives for caboose (UP 25256), box
car (PFE 300001) and two locomotives (Sacramento Northern No. 402 and
Klamath Northern No. 206).
    As information, CSRM also requests continued in service of the
freight car caboose (UP 25256), box car (PFE 300001) and gondola car
(SSRR 6102 and SSRR 6108). The ages of these cars are more than 50
years from their original construction date.
    CSRM states that the caboose (UP 25256) was a gift to CSRM. CSRM
desires to retain and restore the original paint job, lettering and
markings. The caboose is an historical artifact. This car is used for
primarily for static display and is seldom moved or switched over
highway grade crossings. Likewise, it is seldom, if ever, used for
revenue passenger service or night time operations. The required
stenciling and application of reflective material would detract from
its overall historical appearance. Concerning the glazing requirement,
CSRM obtained a recent estimate for twenty-one compliant windows at
$4,861.79. CSRM stated that it will incur additional costs associated
with the purchase and installation of new window frames. Considering
the caboose's use mentioned above, CSRM believes it would not be cost
effective or necessary to upgrade the glazing fully to part 223
standards.
    CSRM cited the same reason for seeking waivers under 49 CFR 215.303
and 49 CFR 224.1 for box car PFE 30001.
    In support of its petition for waiver of 49 CFR 224.1073 and
224.107(b) for locomotives SN 402 and KN 206, CSRM states that it
operates weekend passenger excursion and occasional freight and work
train service on 3 miles of privately owned track with a 20 miles per
hour (mph) speed restriction. Included in this operation are five
public grade crossings (25 mph vehicle speed limit) through
commercially developed areas. All grade crossings are protected with
automatic warning devices with gates and flashing red lights.
Operational hours are generally 11 a.m. to 5 p.m. during the months of
April to September. There are some night time train operations during
the months of October, November and December. These two locomotives are
used primarily for yard switching, freight service, and rarely in
passenger

(excursion) train service, but only in cases of steam locomotive
failure.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at http://www.regulations.gov and in person at the Department of Transportation's
Docket Operations Facility, 1200 New Jersey Ave., SE., W12-140,
Washington, DC 20590. The Docket Operations Facility is open from 9
a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by August 15, 2011 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and 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 DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78) or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC on June 23, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory & Legislative Operations.
[FR Doc. 2011-16414 Filed 6-29-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25018-25020]
[FR Doc No: 2018-11641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1609]

Q12 Technical and Regulatory Considerations for Pharmaceutical
Product Lifecycle Management; International Council for Harmonisation;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance entitled ``Q12 Technical and Regulatory
Considerations for Pharmaceutical Product Lifecycle Management;
International Council for Harmonisation.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance, which consists of a Core Guideline
and an Annex, provides a framework to facilitate the management of
post-approval chemistry, manufacturing, and controls changes for new
and marketed pharmaceutical drug substances and drug products,
including marketed chemical and biotechnological/biological products.

DATES: Submit either electronic or written comments on the draft
guidance by December 15, 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-1609 for ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management; Draft Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mahesh
Ramanadham, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3272; or Ingrid Markovic, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
Agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the FDA; the Japanese
Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
    In November 2017, the ICH Assembly endorsed the draft guidance
entitled ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management'' and agreed that the
guidance should be made available for public comment. The draft
guidance is the product of the Q12 Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q12 Expert
Working Group.
    The guidance provides guidance on post-approval chemistry,
manufacturing, and controls changes for new and marketed pharmaceutical
drug substances and drug products. The guidance describes regulatory
tools and enablers, along with associated guiding principles, that are
intended to enhance the management of post-approval changes and
transparency between industry and regulatory authorities, encouraging
innovation and continual improvement. The guidance is intended to
demonstrate how increased product and process knowledge can contribute
to a reduction in the number of regulatory submissions needed for such
post-approval changes. Specifically, effective implementation of the
tools and enablers described in the guideline should enhance industry's
ability to manage many postapproval changes effectively under the
firm's Pharmaceutical Quality System with less need for extensive
regulatory oversight prior to implementation. The extent of operational
and regulatory flexibility is subject to product and process
understanding (ICH Q8 and Q11), application of risk management
principles (ICH Q9), and an effective pharmaceutical quality system
(ICH Q10).

    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 ``Q12
Technical and Regulatory Considerations for Pharmaceutical Product
Lifecycle Management.'' 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. Electronic Access

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

    Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11641 Filed 5-30-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Page 72681]
[FR Doc No: 2020-25081]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4559-DR; Docket ID FEMA-2020-0001]

Louisiana; Amendment No. 12 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4559-DR), dated August 28, 2020, and
related determinations.

DATES: This amendment was issued October 15, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Louisiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 28, 2020.

    St. Mary Parish for debris removal [Category A] (already
designated for emergency protective measures [Category B], including
direct federal assistance, under the Public Assistance program).
    Acadia, La Salle, Natchitoches, Sabine, and Vermilion Parishes
for permanent work [Categories C-G] (already designated for
Individual Assistance and debris removal and emergency protective
measures [Categories A and B], including direct federal assistance,
under the Public Assistance program).
    Bienville, Claiborne, Evangeline, and Webster Parishes for
permanent work [Categories C-G] (already designated for debris
removal and emergency protective measures [Categories A and B],
including direct federal assistance, under the Public Assistance
program).
    Lafayette, Pointe Coupee, St. Martin, and West Feliciana
Parishes for debris removal [Category A] and permanent work
[Categories C-G] (already designated for emergency protective
measures [Category B], including direct federal assistance, under
the Public Assistance program).
    Morehouse, St. Landry, and Union Parishes for debris removal
[Category A] and permanent work [Categories C-G] (already designated
for Individual Assistance and emergency protective measures
[Category B], including direct federal assistance, under the Public
Assistance program).

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-25081 Filed 11-12-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: October 20, 2009 (Volume 74, Number 201)]
[Notices]
[Page 53792-53793]
[DOCID:fr20oc09-106]

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

Federal Railroad Administration

[Docket No. FRA-2009-0001-N-25]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Requirement (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collection and its expected
burden. The Federal Register notice with a 60-day comment period
soliciting comments on the following collection of information was
published on August 10, 2009 (74 FR 39993).

DATES: Comments must be submitted on or before November 19, 2009.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590 (telephone:
(202) 493-6292), or Ms. Nakia Jackson, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6470). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, section 2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to issue two notices seeking public
comment on information collection activities before OMB may approve
paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1),
1320.12. On August 10, 2009, FRA published a 60-day notice in the
Federal Register soliciting comment on the ICR that the agency was
seeking OMB approval. 74 FR 39993. FRA received no comments in response
to this notice.
    Before OMB decides whether to re-approve this proposed collection
of information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5 CFR 1320.12(c); see also 60
FR 44983, Aug. 29, 1995.
    The summary below describes the nature of the information
collection requirement (ICR) and the expected burden. The ICR is being
submitted for clearance by OMB as required by the PRA.
    Title: Use of Locomotive Horns at Highway-Rail Grade Crossings.
    OMB Control Number: 2130-0560.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Public authorities/railroads.
    Form(s): N/A.
    Abstract: The collection of information is used by FRA to increase
safety at highway-rail grade crossings nationwide by requiring that
locomotive horns be sounded when trains approach and pass through these
crossings, or by ensuring that a safety level at least equivalent to
that provided by blowing horns exists for rail corridors in which horns
are silenced. Communities that qualify for this exception may create
``quiet zones'' within which locomotive horns would not be routinely
sounded. FRA reviews applications by public authorities intending to
establish new or, in some cases, continue pre-rule quiet zones to
ensure that the necessary level of safety is achieved.
    Annual Estimated Burden Hours: 5,575.

ADDRESSES: Send comments regarding these information collections to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 Seventeenth Street, NW., Washington, DC 20503; Attention:
FRA Desk Officer. Comments may also be sent via e-mail to OMB at the
following address<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collections of information are necessary for the proper performance of
the functions of FRA, including whether the information will have
practical utility; the accuracy of FRA's estimates of the burden of the
proposed information

collections; ways to enhance the quality, utility, and clarity of the
information to be collected; and ways to minimize the burden of the
collections of information on respondents, including the use of
automated collection techniques or other forms of information
technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority:  44 U.S.C. 3501-3520.

    Issued in Washington, DC, on October 14, 2009.
Donna Alwine,
Acting Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E9-25078 Filed 10-19-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Page 47484]
[FR Doc No: 2021-18296]

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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:

Filings Instituting Proceedings

    Docket Numbers: RP21-1037-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Fuel Retention Rates--Winter
2021 to be effective 10/1/2021.
    Filed Date: 8/18/21.
    Accession Number: 20210818-5021.
    Comment Date: 5 p.m. ET 8/30/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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 comment date. 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: August 19, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-18296 Filed 8-24-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1474-1478]
[FR Doc No: 2016-00472]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0347]

Qualification of Drivers; Exemption Applications; Vision

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

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

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

SUMMARY: FMCSA announces receipt of applications from 28 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. They are unable to meet the vision requirement in
one eye for various reasons. The exemptions will enable these
individuals to operate commercial motor vehicles (CMVs) in interstate
commerce without meeting the prescribed vision requirement in one eye.
If granted, the exemptions would enable these individuals to qualify as
drivers of commercial motor vehicles (CMVs) in interstate commerce.

DATES: Comments must be received on or before [Insert date 30 days
after date of publication in the Federal Register]. All comments will
be investigated by FMCSA. The exemptions will be issued the day after
the comment period closes.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2015-0347 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line 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: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be

posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    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.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-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.'' FMCSA can renew exemptions at the end of each
2-year period. The 28 individuals listed in this notice have each
requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

II. Qualifications of Applicants

David W. Anderson

    Mr. Anderson, 47, has had amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/50. Following an examination in 2015, his optometrist stated,
``It is my opinion that David's vision is more than sufficient to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Anderson reported that he has driven straight trucks for 19 years,
accumulating 190,000 miles and tractor-trailer combinations for 19
years, accumulating 190,000 miles. He holds a Class A CDL from Oregon.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Charles H. Baim

    Mr. Baim, 57, has had a retinal detachment in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/150. Following an examination in 2015, his optometrist stated,
``In my medical opinion, Mr. Bain has sufficient vision to p0erform
[sic] the driving tasks required to operate a commercial vehicle.'' Mr.
Baim reported that he has driven tractor-trailer combinations for 35
years, accumulating 2.1 million miles. He holds a Class AM CDL from
Pennsylvania. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Troy C. Blackburn

    Mr. Blackburn, 40, has had an embryonic cataract in his right eye
since childhood. The visual acuity in his right eye is no light
perception, and in his left eye, 20/20. Following an examination in
2015, his optometrist stated, ``Based on Mr. Blackburn's exemplary
driving records, and the excellent vision he possesses in his left eye,
I strongly feel that he has the necessary vision to be a safe and
effective truck driver/operator.'' Mr. Blackburn reported that he has
driven straight trucks for 11 years, accumulating 385,000 miles and
tractor-trailer combinations for 11 years, accumulating 363,000 miles.
He holds a Class A CDL from Ohio. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Johnnie E. Byler

    Mr. Byler, 38, has had refractive amblyopia in his right eye since
birth. The visual acuity in his right eye is 20/400, and in his left
eye, 20/20. Following an examination in 2015, his optometrist stated,
``In my opinion, Johnnie's corrected vision and ocular health status
are adequate for him operate [sic] the driving tasks required to
operate a commercial vehicle.'' Mr. Byler reported that he has driven
straight trucks for 6 years, accumulating 498,000 miles. He holds an
operator's license from Pennsylvania. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Raymond E. Catanio

    Mr. Catanio, 75, has had amblyopia in his right eye since
childhood. The visual acuity in his right eye is 20/200, and in his
left eye, 20/20. Following an examination in 2015, his ophthalmologist
stated, ``In my medical opinion, he has sufficient vision to perform
tasks required to operate a commercial vehicle.'' Mr. Catanio reported
that he has driven straight trucks for 55 years, accumulating 2.2
million miles and tractor-trailer combinations for 55 years,
accumulating 165,000 miles. He holds a Class A CDL from New Jersey. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Dana L. Colberg

    Mr. Colberg, 63, has optic atrophy in his left eye due to a
traumatic incident in 1971. The visual acuity in his right eye is 20/
20, and in his left eye, hand motion. Following an examination in 2015,
his optometrist stated, ``In my opinion, Dana's right eye provides
vision sufficient to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Colberg reported that he has driven straight
trucks for 5 years, accumulating 225,000 miles and tractor-trailer
combinations for 32 years, accumulating 2.72 million miles. He holds a
Class A CDL from Oregon. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Peter D. Costas

    Mr. Costas, 56, has had a retinal detachment in his right eye since
2009. The visual acuity in his right eye is 20/400, and in his left
eye, 20/30. Following an examination in 2015, his ophthalmologist
stated, ``It is my clinical opinion that he is able to drive and has
sufficient visualization to meet the criteria for commercial vehicle
operation and that his visual acuity has been stable since his last
operation, which was in 2010.'' Mr. Costas reported that he has driven
straight trucks for 28 years, accumulating 420,000 miles. He holds a
operator's

license from New York. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Darrin G. Davis

    Mr. Davis, 49, has had strabismic amblyopia in his right eye since
birth. The visual acuity in his right eye is 20/80, and in his left
eye, 20/20. Following an examination in 2015, his optometrist stated,
``In my medical opinion, Mr [sic] Davis has sufficient vision to
perform the driving tasks required to operate a commercial motor
vehicle.'' Mr. Davis reported that he has driven tractor-trailer
combinations for 25 years, accumulating 3 million miles. He holds a
Class ABCD CDL from Wisconsin. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Rene Hernandez Gonzalez

    Mr. Hernandez Gonzalez, 44, has had strabismus amblyopia in his
left eye since birth. The visual acuity in his right eye is 20/20, and
in his left eye, 20/500. Following an examination in 2015, his
optometrist stated, ``Patient does have sufficient vision OU to operate
a commercial vehicle, but the field of vision has not been examined at
our office today.'' Mr. Hernandez Gonzalez reported that he has driven
straight trucks for 3 years, accumulating 48,000 miles. He holds an
operator's license from Florida. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Johnnie W. Hines, Jr.

    Mr. Hines, 49, has complete loss of vision in his right eye due to
a traumatic incident in childhood. The visual acuity in his right eye
is no light perception, and in his left eye, 20/20. Following an
examination in 2015, his optometrist stated, ``He has sufficient vision
on [sic] OS to perform commercial vehicle driving tasks with the
assistance of passenger and drivers side mirrors.'' Mr. Hines reported
that he has driven straight trucks for 15 years, accumulating 750,000
miles. He holds an operator's license from Florida. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Dean L. Knutson

    Mr. Knutson, 61, has had amblyopia in his right eye since birth.
The visual acuity in his right eye is 20/100, and in his left eye, 20/
20. Following an examination in 2015, his optometrist stated, ``I also
certify, that in my medical opinion, the patient has sufficient vision
to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Knutson reported that he has driven straight trucks for
5 years, accumulating 180,000 miles. He holds a Class A3 CDL from South
Dakota. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Melvin L. Lester

    Mr. Lester, 52, has complete loss of vision in his left eye due to
a traumatic incident in childhood. The visual acuity in his right eye
is 20/20, and in his left eye, no light perception. Following an
examination in 2015, his optometrist stated, ``It is my opinion that
Mr. Lester is capable of perform [sic] the driving tasks required to
operate a commercial vehicle.'' Mr. Lester reported that he has driven
straight trucks for 8 years, accumulating 576,000 miles, and tractor-
trailer combinations for 16 years, accumulating 1.84 million miles. He
holds a Class A CDL from Mississippi. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Gerald R. Metzler

    Mr. Metzler, 60, has a prosthetic right eye due to a traumatic
incident in 1962. The visual acuity in his right eye is no light
perception, and in his left eye, 20/20. Following an examination in
2015, his optometrist stated, ``In my medical opinion Gerald Metzler
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Metzler reported that he has driven
straight trucks for 31 years, accumulating 542,500 miles and tractor-
trailer combinations for 3 years, accumulating 24,000 miles. He holds a
Class AM CDL from Pennsylvania. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Kory M. Nelson

    Mr. Nelson, 32, has a prosthetic left eye due to a traumatic
incident in 2001. The visual acuity in his right eye is 20/15, and in
his left eye, no light perception. Following an examination in 2015,
his ophthalmologist stated, ``The examination of the right eye is
entirely normal with the exception of mild refractive error which has
not changed significantly when compared to his current glasses. I
believe that he is able to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Nelson reported that he has driven
straight trucks for 3 years, accumulating 262,500. He holds an
operator's license from Maryland. His driving record for the last 3
years shows no crashes and 2 convictions for moving violations in a
CMV; in one he exceeded the speed limit by 15 mph and in the other he
was impeding traffic with a commercial motor vehicle.

Douglas L. Peterson

    Mr. Peterson, 76, has had age-related macular degeneration in his
left eye since 2010. The visual acuity in his right eye is 20/20, and
in his left eye, 20/400. Following an examination in 2015, his
ophthalmologist stated, ``In my medical opinion, Douglas Peterson has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Peterson reported that he has driven straight
trucks for 35 years, accumulating 700,000 miles, and tractor-trailer
combinations for 10 years, accumulating 750,000 miles. He holds a Class
ABCD CDL from Wisconsin. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Ramon S. Puente

    Mr. Puente, 34, has a macular scar in his right eye due to a
traumatic incident in 2003. The visual acuity in his right eye is 20/
300, and in his left eye, 20/20. Following an examination in 2015, his
optometrist stated, ``I certify that his medical/visual condition does
NOT preclude him from operating a commercial vehicle.'' Mr. Puente
reported that he has driven straight trucks for 10 years, accumulating
3,500 miles and tractor-trailer combinations for 10 years, accumulating
3,500 miles. He holds a Class A CDL from Iowa. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Dennis W. Rhoades

    Mr. Rhoades, 59, has had refractive amblyopia in his right eye
since childhood. The visual acuity in his right eye is 20/60, and in
his left eye, 20/20. Following an examination in 2015, his optometrist
stated, ``It remains my opinion that Mr. Dennis Rhoades has more that
[sic] sufficient vision to safely operate a commercial vehicle.'' Mr.
Rhoades reported that he has driven straight trucks for 39 years,
accumulating 1.17 million miles and tractor-trailer combinations for 39
years, accumulating 585,000 miles. He holds a Class A CDL from Vermont.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Jose H. Rivas

    Mr. Rivas, 56, has optic nerve damage in his left eye due to a
traumatic

incident in 1987. The visual acuity in his right eye is 20/20, and in
his left eye, no light perception. Following an examination in 2015,
his ophthalmologist stated, ``I certify in my medical opinion Mr. Rivas
is able to perform the task required to operate a commercial vehicle.''
Mr. Rivas reported that he has driven tractor-trailer combinations for
32 years, accumulating 576,000 miles. He holds a Class A CDL from New
Mexico. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Joseph T. Saba

    Mr. Saba, 36, has had amblyopia in his right eye since childhood.
The visual acuity in his right eye is 20/160, and in his left eye, 20/
20. Following an examination in 2015, his optometrist stated, ``The
amblyopia in his right eye has not changed since I first examined him
on 7/28/1998 . . . In my opinion has condition has not changed and
therefore should not restrict ability to operate a commercial motor
vehicle.'' Mr. Saba reported that he has driven straight trucks for 15
years, accumulating 375,000 miles. He holds a Class B CDL from
Minnesota. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

LeRoy W. Scharkey

    Mr. Scharkey, 74, has had a corneal scar in his left since 2005.
The visual acuity in his right eye is 20/25, and in his left eye, 20/
100. Following an examination in 2015, his optometrist stated, ``In my
opinion, Mr. Scharkey has sufficient vision to perform vision tasks
required to operate a commercial vehicle.'' Mr. Scharkey reported that
he has driven straight trucks for 5 years, accumulating 50,000 miles,
tractor-trailer combinations for 5 years, accumulating 12,500 miles. He
holds a Class A CDL from Minnesota. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Roger H. Schwisow

    Mr. Schwisow, 72, has had amblyopia in his left eye since birth.
The visual acuity in his right eye is 20/20, and in his left eye, 20/
400. Following an examination in 2014, his optometrist stated, ``Based
on this testing I would say that in my opinion he has sufficient vision
to perform driving tasks required to operate a commercial vehicle.''
Mr. Schwisow reported that he has driven straight trucks for 59 years,
accumulating 1.18 million miles, tractor-trailer combinations for 44
years, accumulating 220,000 miles. He holds a Class B CDL from
Nebraska. His driving record for the last 3 years shows no crashes and
1 conviction for a moving violation in a CMV; he exceeded the speed
limit by 6-10 MPH.

Walton W. Smith, Jr.

    Mr. Smith, Jr., 62, has a prosthetic right eye due to a traumatic
incident in 1971. The visual acuity in his right eye is no light
perception, and in his left eye, 20/20. Following an examination in
2015, his optometrist stated, ``In my opinion Mr. Smith has sufficient
vision to continue safely operating a commercial vehicle.'' Mr. Smith
reported that he has driven straight trucks for 40 years, accumulating
120,000 miles, tractor-trailer combinations for 30 years, accumulating
450,000 miles. He holds a Class A CDL from Virginia. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Dustin W. Tharp

    Mr. Tharp, 34, has had a prosthetic right eye due to a persistent
primary hyperplastio vitreous since childhood. The visual acuity in his
right eye has no light perception, and in his left eye, 20/20.
Following an examination in 2015, his optometrist stated, ``It is my
medical opinion that Mr. Tharp has sufficient vision to perform the
driving task required to operate a commercial vehicle.'' Mr. Tharp
reported that he has driven straight trucks for 8 months, accumulating
15,000 miles and tractor-trailer combinations for 15 years,
accumulating 187,500 miles. He holds a Class A CDL from Iowa. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Aaron D. Tillman

    Mr. Tillman, 48, has had refractive amblyopia in his right eye
since childhood. The visual acuity in his right eye is 20/70, and in
his left eye, 20/20. Following an examination in 2015, his optometrist
stated, ``It is my opinion that his vision is sufficient to drive and
operate a commercial vehicle.'' Mr. Tillman reported that he has driven
straight trucks for 5 years, accumulating 340,000 miles, tractor-
trailer combinations for 8 years, accumulating 680,000 miles, and buses
for 2 years, accumulating 38,000 miles. He holds a Class CA CDL from
Delaware. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Larry J. Weber

    Mr. Weber, 73, has had refractive amblyopia in his left eye since
birth. The visual acuity in his right eye is 20/25, and in his left
eye, 20/200. Following an examination in 2015, his optometrist stated,
``In my medical opinion, Larry Weber has sufficient vision to perform
the driving tasks required to operate a commercial vehicle.'' Mr. Weber
reported that he has driven straight trucks for 2 years, accumulating
24,000 miles, tractor-trailer combinations for 40 years, accumulating
2.6 million miles, and buses for 3 years, accumulating 240,000 miles.
He holds a Class ABCDM CDL from Wisconsin. His driving record for the
last 3 years shows no crashes and one conviction for a moving violation
in a CMV; the driver was cited for improper/erratic lane change.

Richard N. Wescott

    Mr. Wescott, 50, has had refractive amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/80. Following an examination in 2015, his optometrist stated,
``Mr. Wescott has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Wescott reported that
he has driven tractor-trailer combinations for 13 years, accumulating
1.43 million miles. He holds a Class A CDL from Maine. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Oscar M. Wilkins

    Mr. Wilkins, 65, has had reduced vision due to retinal membrane in
his left eye since 2010. The visual acuity in his right eye is 20/25,
and in his left eye, 20/50. Following an examination in 2015, his
optometrist stated, ``It is my professional opinion that Mr. Wilkins
has adequate visual skills to operate commercial vehicles without
restrictions.'' Mr. Wilkins reported that he has driven straight trucks
for 35 years, accumulating 700,000 miles, and tractor-trailer
combinations for 35 years, accumulating 700,000 miles. He holds a Class
A CDL from Maine. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Rodney W. Wright

    Mr. Wright, 51, has had amblyopia in his left eye since childhood.
The visual acuity in his right eye is 20/15, and in his left eye, 20/
60. Following an examination in 2015, his optometrist stated, ``As a
result, without question, it is my professional medical opinion that

Rodney has more than sufficient vision to perform all the tasks
necessary for operating a commercial vehicle.'' Mr. Wright reported
that he has driven straight trucks for 20 years, accumulating 520,000
miles. He holds a Class B CDL from Pennsylvania. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

III. 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, 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 the
Agency can contact you if it has questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
put the docket number FMCSA-2015-0347 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 change this notice 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 and
insert the docket number FMCSA-2015-0347 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.

    Dated: December 31, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-00472 Filed 1-11-16; 8:45 am]
BILLING CODE 4910-EX-P