[Federal Register: July 10, 2009 (Volume 74, Number 131)]
[Notices]
[Page 33260-33264]
[DOCID:fr10jy09-55]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0291]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Infectious Disease Issues in Xenotransplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to
this notice. This notice solicits comments on the collection of
information contained in the Public Health Service (PHS) guideline
entitled ``PHS Guideline on Infectious Disease Issues in
Xenotransplantation'' dated January 19, 2001.

DATES: Submit written or electronic comments on the collection of
information by September 8, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Infectious Disease Issues in Xenotransplantation (OMB Control Number
0910-0456)--Extension

    The statutory authority to collect this information is provided
under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and
the provisions of the Federal Food, Drug, and Cosmetic Act that apply
to drugs (21 U.S.C. 301 et seq.). The PHS guideline recommends
procedures to diminish the risk of transmission of infectious agents to
the xenotransplantation product recipient and to the general public.
The PHS guideline is intended to address public health issues raised by
xenotransplantation, through identification of general principles of
prevention and control of infectious diseases associated with
xenotransplantation that may pose a hazard to the public health. The
collection of information described in this guideline is intended to
provide to sponsors general guidance on the following topics: (1) The
development of xenotransplantation clinical protocols; (2) the
preparation of submissions to FDA; and (3) the conduct of
xenotransplantation clinical trials. Also, the collection of
information will help ensure that the sponsor maintains important
information in a cross-referenced system that links the relevant
records of the xenotransplantation product recipient,
xenotransplantation product, source animal(s), animal procurement
center, and significant nosocomial exposures. The PHS guideline
describes an occupational health service program for the protection of
health care workers involved in xenotransplantation procedures, caring
for xenotransplantation product recipients, and performing associated
laboratory testing. The guideline also describes a public health need
for a national xenotransplantation database, which is currently under
development by the PHS. The PHS guideline is intended to protect the
public health and to help ensure the safety of using
xenotransplantation products in humans by preventing the introduction,
transmission, and spread of infectious diseases associated with
xenotransplantation.
    The PHS guideline also recommends that certain specimens and
records be maintained for 50 years beyond the date of the
xenotransplantation. These include: (1) Records linking each
xenotransplantation product recipient with relevant health records of
the source animal, herd or colony, and the specific organ, tissue, or
cell type included in or used in the manufacture of the product
(<IP_ADDRESS>); (2) aliquots of serum samples from randomly selected animal
and specific disease investigations (<IP_ADDRESS>); (3) source animal
biological specimens designated for PHS use (3.7.1); animal health
records (3.7.2), including necropsy results (3.6.4); and (4)
recipients' biological specimens (4.1.2). The retention period is
intended to assist health care practitioners and officials in
surveillance and in tracking the source of an infection, disease, or
illness that might emerge in the recipient, the source animal, or the
animal herd or colony after a xenotransplantation.
    The recommendation for maintaining records for 50 years is based on
clinical experience with several human viruses that have presented
problems in human to human transplantation and are therefore thought to
share certain characteristics with viruses that may pose potential
risks in xenotransplantation. These characteristics include long
latency periods and the ability to establish persistent infections.
Several also share the possibility of transmission among individuals
through intimate contact with human body fluids. Human immunodeficiency
virus (HIV) and Human T-lymphotropic virus are human retroviruses.
Retroviruses contain ribonucleic acid that is reverse-transcribed into
deoxyribonucleic acid (DNA) using an enzyme provided by the virus and
the human cell machinery.

That viral DNA can then be integrated into the human cellular DNA. Both
viruses establish persistent infections and have long latency periods
before the onset of disease, 10 years and 40 to 60 years, respectively.
The human hepatitis viruses are not retroviruses, but several share
with HIV the characteristic that they can be transmitted through body
fluids, can establish persistent infections, and have long latency
periods, e.g., approximately 30 years for Hepatitis C.
    In addition, the PHS guideline recommends that a record system be
developed that allows easy, accurate, and rapid linkage of information
among the specimen archive, the recipient's medical records, and the
records of the source animal for 50 years. The development of such a
record system is a one-time burden. Such a system is intended to cross-
reference and locate relevant records of recipients, products, source
animals, animal procurement centers, and nosocomial exposures.
    Respondents to this collection of information are the sponsors of
clinical studies of investigational xenotransplantation products under
investigational new drug applications (INDs) and xenotransplantation
product procurement centers, referred to as source animal facilities.
There are an estimated 12 respondents who are sponsors of INDs that
include protocols for xenotransplantation in humans. Other respondents
for this collection of information are an estimated 18 source animal
facilities which provide source xenotransplantation product material to
sponsors for use in human xenotransplantation procedures. These 18
source animal facilities keep medical records of the herds/colonies as
well as the medical records of the individual source animal(s). The
total annual reporting and recordkeeping burden is estimated to be
approximately 156 hours. The burden estimates are based on FDA's
records of xenotransplantation-related INDs and estimates of time
required to complete the various reporting and recordkeeping tasks
described in the guideline. FDA does not expect the level of clinical
studies using xenotransplantation to increase significantly in the next
few years.
    FDA is requesting an extension of OMB approval for the following
reporting and recordkeeping recommendations in the PHS guideline:

                   Table 1.--Reporting Recommendations
------------------------------------------------------------------------
 PHS Guideline
    Section                            Description
------------------------------------------------------------------------
<IP_ADDRESS>          Notify sponsor or FDA of new archive site when the
                  source animal facility or sponsor ceases operations.
------------------------------------------------------------------------
3.4              Standard operating procedures (SOPs) of source animal
                  facility should be available to review bodies.
------------------------------------------------------------------------
3.5.1            Include increased infectious risk in informed consent
                  if source animal quarantine period of 3 weeks is
                  shortened.
------------------------------------------------------------------------
3.5.4            Sponsor to make linked records described in section
                  3.2.7 available for review.
------------------------------------------------------------------------
3.5.5            Source animal facility to notify clinical center when
                  infectious agent is identified in source animal or
                  herd after xenotransplantation product procurement.
------------------------------------------------------------------------

                 Table 2.--Recordkeeping Recommendations
------------------------------------------------------------------------
 PHS Guideline
    Section                            Description
------------------------------------------------------------------------
3.2.7            Establish records linking each xenotransplantation
                  product recipient with relevant records.
------------------------------------------------------------------------
4.3              Sponsor to maintain cross-referenced system that links
                  all relevant records (recipient, product, source
                  animal, animal procurement center, and nosocomial
                  exposures).
------------------------------------------------------------------------
3.4.2            Document results of monitoring program used to detect
                  introduction of infectious agents which may not be
                  apparent clinically.
------------------------------------------------------------------------
<IP_ADDRESS>          Document full necropsy investigations including
                  evaluation for infectious etiologies.
------------------------------------------------------------------------
3.5.1            Justify shortening a source animal's quarantine period
                  of 3 weeks prior to xenotransplantation product
                  procurement.
------------------------------------------------------------------------
3.5.2            Document absence of infectious agent in
                  xenotransplantation product if its presence elsewhere
                  in source animal does not preclude using it.
------------------------------------------------------------------------
3.5.4            Add summary of individual source animal record to
                  permanent medical record of the xenotransplantation
                  product recipient.
------------------------------------------------------------------------
3.6.4            Document complete necropsy results on source animals
                  (50-year record retention).
------------------------------------------------------------------------
3.7              Link xenotransplantation product recipients to
                  individual source animal records and archived biologic
                  specimens.
------------------------------------------------------------------------
<IP_ADDRESS>          Record base-line sera of xenotransplantation health
                  care workers and specific nosocomial exposure.
------------------------------------------------------------------------
<IP_ADDRESS> and      Keep a log of health care workers' significant
 4.3.2            nosocomial exposure(s).
------------------------------------------------------------------------
4.3.1            Document each xenotransplant procedure.
------------------------------------------------------------------------
5.2              Document location and nature of archived PHS specimens
                  in health care records of xenotransplantation product
                  recipient and source animal.
------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                 Table 3.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
 PHS Guideline        No. of         Annual Frequency       Total Annual        Hours per
    Section        Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>\2\                      1                  1                     1               0.5                0.5
----------------------------------------------------------------------------------------------------------------
3.4\3\                         12                  0.17                  2               0.08               0.16
----------------------------------------------------------------------------------------------------------------
3.5.1\4\                       12                  0.08            (0-1) 1               0.25               0.25
----------------------------------------------------------------------------------------------------------------
3.5.4\5\                       12                  1                    12               0.5                6.0
----------------------------------------------------------------------------------------------------------------
3.5.5\4\                       18                  0.06            (0-1) 1               0.2                0.2
----------------------------------------------------------------------------------------------------------------
Total                                                                                7.11
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ No animal facility or sponsor has ceased operations in the last 3 years, however, we are using 1 for
  estimation purposes.
\3\ FDA's records indicate that an average of two INDs are expected to be submitted per year.
\4\ To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
\5\ Based on an estimate of 36 patients treated over a 3-year period, the average number of xenotransplantation
  product recipients per year is estimated to be 12.

                               Table 4.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
 PHS Guideline        No. of         Annual Frequency       Total Annual
    Section       Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
3.2.7\2\                        1                  1                     1              16                 16.0
----------------------------------------------------------------------------------------------------------------
4.3\3\                         12                  1                    12               0.83               9.96
----------------------------------------------------------------------------------------------------------------
3.4.2\4\                       12                 11                   132               0.25              33.0
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>\5\                     18                  4                    72               0.3               21.6
----------------------------------------------------------------------------------------------------------------
3.5.1\6\                       12                  0.08            (0-1) 1               0.5                0.5
----------------------------------------------------------------------------------------------------------------
3.5.2\6\                       12                  0.08            (0-1) 1               0.25               0.25
----------------------------------------------------------------------------------------------------------------
3.5.4                          12                  1                    12               0.17               2.04
----------------------------------------------------------------------------------------------------------------
3.6.4\7\                       12                  2                    24               0.25               6.0
----------------------------------------------------------------------------------------------------------------
3.7\7\                         18                  1.33                 24               0.08               1.92
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>\8\                     12                 25                   300               0.17              51.0
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>\6\                     12                  0.08            (0-1) 1               0.17               0.17
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS> and                    12                  0.08            (0-1) 1               0.17               0.17
 4.3.2\6\
----------------------------------------------------------------------------------------------------------------
4.3.1                          12                  1                    12               0.25               3.0
----------------------------------------------------------------------------------------------------------------
5.2\9\                         12                  3                    36               0.08               2.88
----------------------------------------------------------------------------------------------------------------
Total                                                                                148.49
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA
  estimates one new sponsor annually.
\3\ FDA estimates there is minimal recordkeeping burden associated with maintaining the record system.
\4\ Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are
  approximately 6 sentinel animals per herd x 1 herd per facility x 18 facilities = 108 sentinel animals. There
  are approximately 24 source animals per year (see footnote 7 of this table); 108 + 24 = 132 monitoring records
  to document.
\5\ Necropsy for animal deaths of unknown cause estimated to be approximately 4 per herd per year x 1 herd per
  facility x 18 facilities = 72.
\6\ Has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
\7\ On average two source animals are used for preparing xenotransplantation product material for one recipient.
  The average number of source animals is 2 source animals per recipient x 12 recipients annually = 24 source
  animals per year. (See footnote 5 of table 3 of this document.)
\8\ FDA estimates there are approximately 12 clinical centers doing xenotransplantation procedures x
  approximately 25 health care workers involved per center = 300 health care workers.
\9\ Twenty-four source animal records + 12 recipient records = 36 total records.

    Because of the potential risk for cross-species transmission of
pathogenic persistent virus, the guideline recommends that health
records be retained for 50 years. Because these records are medical
records, the retention of such records for up to 50 years is not
information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of
the limited number of clinical studies with small patient populations,
the number of records is expected to be insignificant at this time.
    Information collections in this guideline not included in tables 1
through 4 of this document can be found under existing regulations and
approved under the OMB control numbers as follows: (1) ``Current Good
Manufacturing Practice for Finished Pharmaceuticals,'' 21 CFR 211.1
through 211.208, approved under OMB control number 0910-0139; (2)
``Investigational New Drug Application,'' 21 CFR 312.1 through 312.160,
approved under OMB control number 0910-0014; and (3) information
included in a license application, 21 CFR 601.2, approved under OMB
control number 0910-0338. (Although it is possible that a
xenotransplantation product may not be regulated as a biological
product (e.g., it may be regulated as a medical device), FDA believes,
based on its knowledge and experience with xenotransplantation, that
any xenotransplantation product subject to FDA regulation within the
next 3 years will most likely be regulated as a biological product.)
However, FDA recognized that some of the information collections go
beyond approved collections; assessments for these burdens are included
in tables 1 through 4.
    In table 5 of this document, FDA identifies those collection of
information activities that are already encompassed by existing
regulations or are consistent with voluntary standards which reflect
industry's usual and customary business practice.

                Table 5.--Collection of Information Required by Current Regulations and Standards
----------------------------------------------------------------------------------------------------------------
                                                                                21 CFR Section (unless
   PHS Guideline Section       Description of Collection of Information Activity          otherwise stated)
----------------------------------------------------------------------------------------------------------------
2.2.1                       Document off-site collaborations                        312.52
----------------------------------------------------------------------------------------------------------------
2.5                         Sponsor ensures counseling patient + family + contacts  312.62(c)
----------------------------------------------------------------------------------------------------------------
3.1.1 and 3.1.6             Document well-characterized health history and lineage  312.23(a)(7)(a) and 211.84
                             of source animals
----------------------------------------------------------------------------------------------------------------
3.1.8                       Registration with and import permit from the Centers    42 CFR 71.53
                             for Disease Control and Prevention
----------------------------------------------------------------------------------------------------------------
3.2.2                       Document collaboration with accredited microbiology     312.52
                             labs
----------------------------------------------------------------------------------------------------------------
3.2.3                       Procedures to ensure the humane care of animals         9 CFR parts 1, 2, and 3 and
                                                                                PHS Policy\1\
----------------------------------------------------------------------------------------------------------------
3.2.4                       Procedures consistent for accreditation by the          AAALAC International Rules
                             Association for Assessment and Accreditation of         of Accreditation\2\ and NRC
                             Laboratory Animal Care International (AAALAC            Guide\3\
                             International) and consistent with the National
                             Research Council's (NRC) Guide
----------------------------------------------------------------------------------------------------------------
3.2.5, 3.4, and 3.4.1       Herd health maintenance and surveillance to be          211.100 and 211.122
                             documented, available, and in accordance with
                             documented procedures; record standard veterinary
                             care
----------------------------------------------------------------------------------------------------------------
3.2.6                       Animal facility SOPs                                    PHS Policy\1\
----------------------------------------------------------------------------------------------------------------
3.3.3                       Validate assay methods                                  211.160(a)
----------------------------------------------------------------------------------------------------------------
3.6.1                       Procurement and processing of xenografts using          211.100 and 211.122
                             documented aseptic conditions
----------------------------------------------------------------------------------------------------------------
3.6.2                       Develop, implement, and enforce SOP's for procurement   211.84(d) and 211.122(c)
                             and screening processes
----------------------------------------------------------------------------------------------------------------
3.6.4                       Communicate to FDA animal necropsy findings pertinent   312.32(c)
                             to health of recipient
----------------------------------------------------------------------------------------------------------------
3.7.1                       PHS specimens to be linked to health records; provide   312.23(a)(6)
                             to FDA justification for types of tissues, cells, and
                             plasma, and quantities of plasma and leukocytes
                             collected
----------------------------------------------------------------------------------------------------------------
4.1.1                       Surveillance of xenotransplant recipient; sponsor       312.23(a)(6)(iii)(f) and
                             ensures documentation of surveillance program life-     (a)(6)(iii)(g), and
                             long (justify >2 yrs.); investigator case histories     312.62(b) and (c)
                             (2 yrs. After investigation is discontinued)
----------------------------------------------------------------------------------------------------------------
4.1.2                       Sponsor to justify amount and type of reserve samples   211.122
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>                     System for prompt retrieval of PHS specimens and        312.57(a)
                             linkage to medical records (recipient and source
                             animal)
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>                     Notify FDA of a clinical episode potentially            312.32
                             representing a xenogeneic infection
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>                     Document collaborations (transfer of obligation)        312.52
----------------------------------------------------------------------------------------------------------------

<IP_ADDRESS>                     Develop educational materials (sponsor provides         312.50
                             investigators with information needed to conduct
                             investigation properly)
----------------------------------------------------------------------------------------------------------------
4.3                         Sponsor to keep records of receipt, shipment, and       312.57 and 312.62(b)
                             disposition of investigative drug; investigator to
                             keep records of case histories
----------------------------------------------------------------------------------------------------------------
\1\ The ``Public Health Service Policy on Humane Care and Use of Laboratory Animals'' (http://www.grants.nih.gov/
  grants/olaw/references/phspol.htm). (FDA has verified the Web site address, but is not responsible for
  subsequent changes to the Web site address after this document publishes in the Federal Register.)
\2\ AAALAC International Rules of Accreditation (http://www.aaalac.org/accreditation/rules.cfm). (FDA has
  verified the Web site address, but is not responsible for subsequent changes to the Web site address after
  this document publishes in the Federal Register.)
\3\ The NRC's ``Guide for the Care and Use of Laboratory Animals'' (1996).

    Dated: July 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16334 Filed 7-9-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Page 48684]
[FR Doc No: 2020-17617]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF20-3-000]

Western Area Power Administration; Notice of Filing

    Take notice that on July 14, 2020, Western Area Power
Administration submitted tariff filing per: UGP_PSMBP-ED_WAPA188-
20200710 to be effective 8/2/2019.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 13, 2020.

    Dated: August 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-17617 Filed 8-11-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 53 (Tuesday, March 21, 2017)]
[Rules and Regulations]
[Page 14477]
[FR Doc No: 2017-05543]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Parts 571 and 585

[Docket No. NHTSA-2016-0125]
RIN 2126-AK93

Federal Motor Vehicle Safety Standards; Minimum Sound
Requirements for Hybrid and Electric Vehicles

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Final rule; delay of effective date.

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SUMMARY: In accordance with the Presidential directive as expressed in
the memorandum of January 20, 2017, from the Assistant to the President
and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this
action temporarily delays until May 22, 2017, the effective date of the
final rule titled ``Federal Motor Vehicle Safety Standards; Minimum
Sound Requirements for Hybrid and Electric Vehicles,'' initially
scheduled to become effective on February 13, 2017.

DATES: As of March 21, 2017, the effective date of the final rule
published on December 14, 2016 (81 FR 90416), delayed on February 6,
2017 (82 FR 9368), is further delayed until May 22, 2017. The
compliance date is September 1, 2018, with full phase in by September
1, 2019.

FOR FURTHER INFORMATION CONTACT: For legal issues, contact Tom Healy,
Office of Chief Counsel, at<PHONE_NUMBER>. For non-legal issues,
contact Mike Pyne, Office of Rulemaking, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NHTSA bases this action on the Presidential
directive expressed in the memorandum of January 20, 2017, from the
Assistant to the President and Chief of Staff, entitled ``Regulatory
Freeze Pending Review'' (the January 20, 2107 memorandum). That
memorandum directed the heads of Executive Departments and Agencies to
temporarily postpone for 60 days from the date of the memorandum the
effective dates of certain regulations that had been published in the
Federal Register, but had not yet taken effect. Because the original
effective date of the final rule published on December 14, 2016, fell
within that 60-day window, the effective date of the rule was extended
to March 21, 2017, in a final rule published on February 6, 2017 (82 FR
9368). Consistent with the memorandum of the Assistant to the President
and Chief of Staff, and as stated in the February 6, 2017, final rule
delaying the effective date, the Agency further delays the effective
date of this regulation until May 22, 2017.
    The Agency's implementation of this action without opportunity for
public comment is based on the good cause exceptions in 5 U.S.C.
553(b)(B) and 553(d)(3), in that seeking public comment is
impracticable, unnecessary and contrary to the public interest. The
delay in the effective date until May 22, 2017, is necessary to provide
the opportunity for further review and consideration of this new
regulation, consistent with the January 20, 2017 memorandum. Given the
imminence of the effective date of the ``Federal Motor Vehicle Safety
Standards; Minimum Sound Requirements for Hybrid and Electric
Vehicles'' final rule, seeking prior public comment on this temporary
delay would be impractical, as well as contrary to the public interest
in the orderly promulgation and implementation of regulations.

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30116;
delegation of authority at 49 CFR 1.95.

    Issued on: March 16, 2017.
Jack Danielson,
Acting Deputy Administrator.
[FR Doc. 2017-05543 Filed 3-20-17; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63285-63290]
[FR Doc No: 2013-24753]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA- 2013-0185]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemptions request for comments.

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SUMMARY: FMCSA announces receipt of applications from 37 individuals
for exemptions from the prohibition against persons with insulin-
treated diabetes mellitus (ITDM) operating commercial motor vehicles
(CMVs) in interstate commerce. If granted, the exemptions would enable
these individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before November 22, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0185 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 Federal Docket Management System (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: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

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.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 37 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.

Qualifications of Applicants

Charles A. Adams, Jr.

    Mr. Adams, 44, has had ITDM since 1995. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Adams understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Adams meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Connecticut.

Thomas W. Allee

    Mr. Allee, 60, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Allee understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Allee meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

J.D. Ashcraft, Jr.

    Mr. Ashcraft, 40, has had ITDM since 1978. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ashcraft understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ashcraft meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class D operator's
license from Alabama.

Robert J. Berger III

    Mr. Berger, 53, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Berger understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Berger meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Pennsylvania.

Michael E. Bingham

    Mr. Bingham, 56, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bingham understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bingham meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Danny W. Bradley

    Mr. Bradley, 47, has had ITDM since 1968. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bradley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bradley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
non-proliferative diabetic retinopathy. He holds a Class D operator's
license from Delaware.

Richard A. Clark

    Mr. Clark, 63, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Clark understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Clark meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he has stable non-proliferative diabetic
retinopathy. He holds a Class A CDL from Georgia.

Winfred G. Clemenson

    Mr. Clemenson, 58, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Clemenson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Clemenson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Washington.

Romero Coleman

    Mr. Coleman, 46, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist

certifies that Mr. Coleman understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Coleman meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Wisconsin.

Thomas J. Crawford

    Mr. Crawford, 46, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Crawford understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Crawford meets the
vision requirements of 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2013 and certified that he does not have diabetic
retinopathy. He holds a Class A CDL from NY.

William N. Drake

    Mr. Drake, 40, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Drake understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Drake meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2013 and certified that he does not have diabetic retinopathy. He holds
a Class D operator's license from New York.

John S. Duvall

    Mr. Duvall, 50, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Duvall understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Duvall meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Robert B. Engel

    Mr. Engel, 48, has had ITDM since 2006. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Engel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Engel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Indiana.

Carolyn C. Gardner

    Ms. Gardner, 34, has had ITDM since 2012. Her endocrinologist
examined her in 2013 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Gardner understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Gardner meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2013 and certified that she does not have
diabetic retinopathy. She holds a Class D operator's license from
Connecticut.

Brian L. Gregory

    Mr. Gregory, 48, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gregory understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gregory meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Illinois.

Alfonso Grijalva

    Mr. Grijalva, 29, has had ITDM since 1991. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Grijalva understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Grijalva meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
non-proliferative diabetic retinopathy. He holds a Class C operator's
license from California.

Jason E. Jacobus

    Mr. Jacobus, 43, has had ITDM since approximately 2005. His
endocrinologist examined him in 2013 and certified that he has had no
severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function that occurred without warning in the past 12 months
and no recurrent (2 or more) severe hypoglycemic episodes in the last 5
years. His endocrinologist certifies that Mr. Jacobus understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Jacobus meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Kentucky.

Ervin A. Klocko, Jr.

    Mr. Klocko, 42, has had ITDM since 2005. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting

in loss of consciousness, requiring the assistance of another person,
or resulting in impaired cognitive function that occurred without
warning in the past 12 months and no recurrent (2 or more) severe
hypoglycemic episodes in the last 5 years. His endocrinologist
certifies that Mr. Klocko understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Klocko meets the vision requirements of
49 CFR 391.41(b)(10). His optometrist examined him in 2013 and
certified that he does not have diabetic retinopathy. He holds a Class
D operator's license from Ohio.

Stephen C. Koktavy

    Mr. Koktavy, 21, has had ITDM since 2008. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Koktavy understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Koktavy meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class D operator's license from Arizona.

Richard J. Long

    Mr. Long, 42, has had ITDM since 1992. His endocrinologist examined
him in 2013 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Long understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Long meets the vision requirements
of 49 CFR 391.41(b)(10). His optometrist examined him in 2013 and
certified that he does not have diabetic retinopathy. He holds a Class
D operator's license from Minnesota.

Margaret Lopez

    Ms. Lopez, 53, has had ITDM since 2009. Her endocrinologist
examined her in 2013 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Lopez understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Lopez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2013 and certified that she does not have
diabetic retinopathy. She holds a Class A CDL from New York.

John D. May

    Mr. May, 54, has had ITDM since 1998. His endocrinologist examined
him in 2013 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. May understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. May meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2013 and certified that he does not have diabetic retinopathy. He
holds a Class C operator's license from Kansas.

Michael C. McDowell

    Mr. McDowell, 62, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. McDowell understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McDowell meets the
vision requirements of 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2013 and certified that he does not have diabetic
retinopathy. He holds a Class A CDL from Texas.

Charles B. McKay

    Mr. McKay, 21, has had ITDM since 2005. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. McKay understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McKay meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Florida.

Norman C. Mertz

    Mr. Mertz, 55, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Mertz understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mertz meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he has stable non-proliferative diabetic
retinopathy. He holds a Class A CDL from Pennsylvania.

Gary D. Peters

    Mr. Peters, 66, has had ITDM since 1998. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Peters understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Peters meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class O operator's license from
Nebraska.

Mark R. Phillips

    Mr. Phillips, 51, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Phillips understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Phillips meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Francis J. Shultz

    Mr. Shultz, 46, has had ITDM since 1977. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Shultz understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Shultz meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2012 and certified that he does not have diabetic retinopathy. He holds
a Class C operator's license from Pennsylvania.

Gary L. Snelling

    Mr. Snelling, 38, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Snelling understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Snelling meets the
vision requirements of 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2013 and certified that he has stable non-proliferative
diabetic retinopathy. He holds a Class A CDL from Alabama.

Joseph L. Stevenson

    Mr. Stevenson, 57, has had ITDM since 1983. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stevenson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Stevenson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Illinois.

Matthew S. Thompson

    Mr. Thompson, 31, has had ITDM since 2002. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Thompson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Thompson meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class C operator's license from Pennsylvania.

Robin S. Travis

    Mr. Travis, 28, has had ITDM since 2008. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Travis understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Travis meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he does not have diabetic retinopathy. He
holds a Class R operator's license from Colorado.

William R. Van Gog

    Mr. Van Gog, 60, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Van Gog understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Van Gog meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Washington.

Charles S. Watson

    Mr. Watson, 33, has had ITDM since 2000. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Watson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Watson meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2013 and certified that he does not have diabetic retinopathy. He holds
a Class D operator's license from Illinois.

David H. Wilkins

    Mr. Wilkins, 59, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wilkins understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wilkins meets the
vision

requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he has stable non-proliferative diabetic
retinopathy. He holds a Class A CDL from Pennsylvania.

Mark A. Yurian

    Mr. Yurian, 48, has had ITDM since 2004. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Yurian understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Yurian meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Montana.

David M. Zanicky

    Mr. Zanicky, 40, has had ITDM since 1995. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Zanicky understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Zanicky meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class B CDL from Pennsylvania.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441).\1\. The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136 (e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

Submitting Comments

    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 http://www.regulations.gov and
in the search box insert the docket number FMCSA-2013-0185 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8 1/2
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2013-0185 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Issued on: October 8, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-24753 Filed 10-22-13; 8:45 am]
BILLING CODE 4910-EX-P